What changed in this filing

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Item 1A. Risk Factors

2025-03-27 compared with 2024-03-28 · 822 added, 797 removed, 948 unchanged (63% of the section changed)

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profitability.

We are dependent on the success of our Versamune® and Infectimune® products, which are still in early-stage clinical development, and if our Versamune® and

Infectimune® products do not receive regulatory approval or are not successfully commercialized, our business may be harmed.

We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and

commercialization of our Versamune® and Infectimune® based products.

Raising additional funds by issuing securities may cause dilution to existing stockholders and raising funds through lending and licensing arrangements may restrict

our operations or require us to relinquish proprietary rights.

We are dependent on the success of our Versamune® and Infectimune® products, which are still in early-stage clinical development, and if our

Versamune® and Infectimune® products do not receive regulatory approval or are not successfully commercialized, our business may be harmed.

We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the

development and commercialization of our Versamune® and Infectimune® based products.

Raising additional funds by issuing securities may cause dilution to existing stockholders and raising funds through lending and licensing

arrangements may restrict our operations or require us to relinquish proprietary rights.

We will need to expand our organization, and may experience difficulties in managing this growth, which could disrupt operations.

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We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern.

Clinical trials are very expensive, time-consuming, difficult to design and implement and involve an uncertain outcome, and if they fail to demonstrate safety and

efficacy to the satisfaction of the FDA, or similar regulatory authorities, we will be unable to commercialize Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products.

Enrollment and retention of subjects in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple

factors outside our control.

We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.

Clinical trials are very expensive, time-consuming, difficult to design and implement and involve an uncertain outcome, and if they fail to

demonstrate safety and efficacy to the satisfaction of the FDA, or similar regulatory authorities, we will be unable to commercialize Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products.

Enrollment and retention of subjects in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered

impossible by multiple factors outside our control.

We face significant competition from other biotechnology and biopharmaceutical companies, and our operating results will suffer if we fail to

compete effectively.

We rely, and intend to continue to rely, on third parties to conduct our clinical trials and perform some of our research and preclinical studies.

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be unable to obtain regulatory approval, each of which may have an adverse effect on our business, financial condition, results of operations and prospects.

Our product candidates are in various stages of development and we will not be able to commercialize our product candidates if our preclinical studies do not produce

successful results and/or our clinical trials do not demonstrate the safety and efficacy of our product candidates;

early results and early understanding of product candidate potential may not be predictive of later success.

Our clinical and product candidates are in various stages of development, and we will not be able to commercialize our product candidates if our

preclinical studies do not produce successful results and/or our clinical trials do not demonstrate the safety and efficacy of our product candidates;

early results and early understanding of product candidate potential may not be

predictive of later success.

We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be

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our operations, any of which could harm our business.

If we are unable to establish sales, marketing and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in

commercializing PDS0101, PDS01ADC and other product candidates, if approved.

If we obtain approval to commercialize PDS0101, PDS01ADC or other product candidates outside of the United States, a variety of risks associated with international

operations could harm our business.

If we are unable to establish sales, marketing and distribution capabilities either on our own or in collaboration with third parties, we may not

be successful in commercializing Versamune® HPV, PDS01ADC and other product candidates, if approved.

If we obtain approval to commercialize Versamune® HPV, PDS01ADC or other product candidates outside of the United States, a variety of risks associated with

international operations could harm our business.

Recently enacted and future healthcare legislation, regulations, and policy initiatives may increase the difficulty and cost for us to obtain marketing approval of

and commercialize PDS0101, PDS01ADC or other product candidates and affect the prices we may obtain and our profitability.

and commercialize Versamune® HPV, PDS01ADC or other product candidates and affect the prices we may obtain and our profitability.

We have no manufacturing, sales, marketing or distribution capability and we must rely upon third parties for such.

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which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations.

If we are unable to obtain and/or maintain patent protection for our Versamune®, Versamune® in combination with PDS01ADC platforms, PDS0101, or other

If we are unable to obtain and/or maintain patent protection for our Versamune®, Versamune® in combination with PDS01ADC, Versamune® HPV, or other

Versamune® or Infectimune® based Products or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.

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We are a clinical-stage biopharmaceutical company with a limited operating history.

Our operations to date have been limited to

organizing our company and developing the Versamune® platform and related immunotherapy product candidates that incorporate the technology of our Versamune® platform.

We have not yet successfully completed a large-scale, pivotal clinical trial,

obtained marketing approval, manufactured Versamune® at commercial scale, or conducted sales and marketing activities that will be necessary to successfully commercialize our Versamune® products.

Consequently, predictions about our future

success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing immunotherapies.

Our operations to date have been limited to organizing

our company and developing the Versamune® platform and related immunotherapy product candidates that incorporate the technology of our Versamune® platform.

We have not yet successfully completed a large-scale, pivotal clinical trial, obtained

marketing approval, manufactured Versamune® at commercial scale, or conducted sales and marketing activities that will be necessary to successfully commercialize our Versamune® products.

Consequently, predictions about our future success or

viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing immunotherapies.

Our product candidates will require additional clinical development, evaluation of clinical, preclinical and manufacturing activities, marketing approval in multiple

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Our ability to generate revenue and achieve and maintain profitability will depend upon our ability to successfully complete the development of our Versamune® based oncology

products PDS0101, PDS0102, PDS0103, PDS0104 alone or in combination with PDS01ADC and Infectimune® to treat infectious diseases and to obtain the necessary regulatory approvals.

products Versamune® HPV, PDS0102, PDS0103, alone or in combination with PDS01ADC and Infectimune® to treat infectious diseases and to obtain the necessary regulatory approvals.

We have never generated any product revenue and have no

immunotherapy candidate in late-stage clinical development or approved for commercial sale.

Even if we receive regulatory approval for the sale of the Versamune®, Versamune® in combination with PDS01ADC and Infectimune® Products, we do not know when we will begin

to generate revenue from PDS0101 or other products, if at all.

Even if we receive regulatory approval for the sale of the Versamune®, Versamune® in combination with PDS01ADC and Infectimune® Products, we do not know when we will begin to

generate revenue from Versamune® HPV or other products, if at all.

Our ability to generate revenue depends on a number of factors, including our ability to:

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add operational, financial and management information systems and personnel, including personnel to support our clinical, manufacturing and planned future clinical development and commercialization efforts and operations as a public company;

develop manufacturing capabilities for bulk materials and manufacture commercial quantities of Versamune® PDS0101, PDS01ADC and other Versamune® products at acceptab le cost levels;

achieve broad market acceptance of PDS0101 and other Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based-products in the medical community and with third-party payors and

develop manufacturing capabilities for bulk materials and manufacture commercial quantities of Versamune® HPV, PDS01ADC and other Versamune® products at acceptab le cost levels;

achieve broad market acceptance of Versamune® HPV and other Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based-products in the medical community and with third-party payors and

attract and retain an experienced management and advisory team;

launch commercial sales of Versamune® PDS0101 in combination with PDS01ADC and other oncology products, and Infectimune® based-products, whether alone or in collaboration w ith others;

launch commercial sales of Versamune® HPV, Versamune® in combination with PDS01ADC and other oncology products, and Infectimune® based-products, whether alone or in collaboration w ith others;

maintain, expand and protect our intellectual prop erty portfolio.

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regulatory authorities, to perform studies or clinical trials in addition to those we currently anticipate.

Even if PDS0101 alone or in combination with PDS01ADC is approved for commercial sale, we anticipate incurring significant costs

associated with the commercial launch of and the related commercial-scale manufacturing requirements for PDS0101, PDS01ADC, other Versamune® and Infectimune® products.

If we cannot successfully execute on any of the factors listed above, our

business may not succeed, and your investment will be adversely affected.

We have incurred significant losses since our inception and expect to continue to incur significant losses for the foreseeable future and may never

achieve or maintain profitability.

We have never generated any product revenues and expect to continue to incur substantial and increasing losses as we continue to develop Versamune®, Versamune® in combination

with PDS01ADC and Infectimune® based products.

Even if Versamune® HPV alone or in combination with PDS01ADC is approved for commercial sale, we anticipate incurring significant costs

associated with the commercial launch of and the related commercial-scale manufacturing requirements for Versamune® HPV, PDS01ADC, other Versamune® and Infectimune® products.

If we cannot successfully execute on any of the factors listed above,

our business may not succeed, and your investment will be adversely affected.

We have incurred significant losses since our inception and expect to continue to incur significant losses for the foreseeable future and may never achieve or

maintain profitability.

We have never generated any product revenues and expect to continue to incur substantial and increasing losses as we continue to develop Versamune®, Versamune® in combination with

PDS01ADC and Infectimune® based products.

None of our products have been approved for marketing in the United States and may never receive such approval.

As a result, we are uncertain when or if we will achieve profitability and, if so,

whether we will be able to sustain it.

Our ability to generate revenue and achieve profitability is dependent on our ability to complete development, obtain necessary regulatory approvals, and have our products manufactured and successfully

We cannot assure you that we will be profitable even if we successfully commercialize PDS0101, PDS01ADC or other Versamune® and Infectimune® based products.

If we successfully obtain regulatory approval to market PDS0101 alone or in

As a result, we are uncertain when or if we will achieve profitability and, if so, whether

we will be able to sustain it.

cannot assure you that we will be profitable even if we successfully commercialize Versamune® HPV, PDS01ADC or other Versamune® and Infectimune® based products.

If we successfully obtain regulatory approval to market Versamune® HPV alone or in

combination with PDS01ADC, our revenues will be dependent, in part, upon, the size of the markets in the territories for which regulatory approval is received, the number of competitors in such markets for the approved indication, and the price

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We expect research and development expenses to increase significantly for Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products.

even if we obtain regulatory approval, significant sales and marketing expenses will be required to commercialize our products.

As a result, we expect to continue to incur significant and increasing operating losses and negative cash flows for

the foreseeable future.

In addition, even if

we obtain regulatory approval, significant sales and marketing expenses will be required to commercialize our products.

As a result, we expect to continue to incur significant and increasing operating losses and negative cash flows for the

foreseeable future.

These losses have had and will continue to have an adverse effect on our financial position and working capital.

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PDS01ADC and Infectimune® products do not receive regulatory approval or are not successfully commercialized, our business may be harmed.

PDS0101 and PDS01ADC are in mid clinical development, and as a consequence, it is too early to determine whether our products will ever be approved for commercial sale or

Versamune® HPV and PDS01ADC are in mid clinical development, and as a consequence, it is too early to determine whether our products will ever be approved for commercial sale or

be marketable.

We expect that a substantial portion of our efforts and expenditures over the next few years will be devoted to Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products.

Accordingly, our business

currently depends heavily on the successful development, regulatory approval and commercialization of PDS0101 alone or in combination with PDS01ADC.

PDS0101 and PDS01ADC may not receive regulatory approval or be successfully commercialized even

if regulatory approval is received.

The research, testing, manufacturing, labeling, approval, sale, marketing and distribution of PDS0101 and PDS01ADC is and will remain subject to extensive regulation by the FDA and other regulatory

We expect that a substantial portion of our efforts and expenditures over the next few years will be devoted to Versamune® and Versamune® in combination with PDS01ADC products.

Accordingly, our business currently depends heavily

on the successful development, regulatory approval and commercialization of Versamune® HPV alone or in combination with PDS01ADC.

Versamune® HPV and PDS01ADC may not receive regulatory approval or be successfully commercialized even if

regulatory approval is received.

The research, testing, manufacturing, labeling, approval, sale, marketing and distribution of Versamune® HPV and PDS01ADC is and will remain subject to extensive regulation by the FDA and other regulatory

authorities in the United States and other countries that each have differing regulations.

We are not permitted to market PDS0101 or PDS01ADC in the United States until it receives approval of a biologics license application, or BLA, from the

FDA, or in any foreign countries until it receives the requisite approval from such countries.

To date, we have only completed Phase 2 clinical trials for certain applications of PDS0101.

As a result, we have not submitted a BLA to the FDA or

comparable applications to other regulatory authorities and do not expect to be in a position to do so for the foreseeable future.

Obtaining approval of a BLA is an extensive, lengthy, expensive and inherently uncertain process, and the FDA may

delay, limit or deny approval of PDS0101 or PDS01ADC for many reasons, including:

we may not be able to demonstrate that PDS0101 alone or in combination with PDS01ADC is safe and effective to the satisfaction of the FDA;

the FDA may not agree that the completed Phase 2 clinical trials of PDS0101 and PDS01ADC satisfy the FDA’s requirements and may require us to conduct addi tional testing;

We are not permitted to market Versamune® HPV or PDS01ADC in the United States until it receives approval of a biologics license application, or BLA,

from the FDA, or in any foreign countries until it receives the requisite approval from such countries.

To date, we have only completed Phase 2 clinical trials for certain applications of Versamune® HPV.

As a result, we have not submitted a BLA

to the FDA or comparable applications to other regulatory authorities and do not expect to be in a position to do so for the foreseeable future.

Obtaining approval of a BLA is an extensive, lengthy, expensive and inherently uncertain process,

and the FDA may delay, limit or deny approval of Versamune® HPV or PDS01ADC for many reasons, including:

we may not be able to demonstrate that Versamune® HPV alone or in combination with PDS01ADC is safe and effective to the satisfaction of the FDA;

the FDA may not agree that the completed Phase 2 clinical trials of Versamune® HPV and PDS01ADC satisfy the FDA’s requirements and may require us to conduct addi tional testing;

the results of our future clinical trials may not meet the level of statistical or clinical significance required by the FDA for mark eting approval;

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the contract research organizations, or CROs, that we retain to conduct clinical trials may take actions outside of our control that materially and adversely impact our c linical trials;

the FDA may not find the data from our preclinical studies and clinical trials sufficient to demonstrate that the clinical and other benefits of PDS0101 and PDS01ADC outweigh th e safety risks;

the FDA may not find the data from our preclinical studies and clinical trials sufficient to demonstrate that the clinical and other benefits of Versamune® HPV and PDS01ADC outweigh th e safety risks;

the FDA may disagree with our interpretation of data from our preclinical studies and c linical trials;

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the FDA may change its approval policies or adopt n ew regulations.

We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development

and commercialization of our Versamune®, PDSO1ADC and Infectimune® based products.

We expect to spend substantial amounts to complete the development of, seek regulatory approvals for and commercialize PDS0101 alone or in combination with PDS01ADC.

with our current cash reserves, we will require substantial additional capital to complete the development and potential commercialization of PDS0101 and PDS01ADC and the development of other Versamune® and Infectimune® based products.

are unable to raise capital or find appropriate partnering or licensing collaborations or other nondilutive financing, when needed or on acceptable terms, if at all, we could be forced to delay, reduce or eliminate one or more of our

We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and

commercialization of our Versamune®, PDS01ADC and Infectimune® based products.

We expect to spend substantial amounts to complete the development of, seek regulatory approvals for and commercialize Versamune® HPV alone or in combination with PDS01ADC.

with our current cash reserves, we will require substantial additional capital to complete the development and potential commercialization of Versamune® HPV and PDS01ADC and the development of other Versamune® and Infectimune® based products.

If we are unable to raise capital or find appropriate partnering or licensing collaborations or other nondilutive financing, when needed or on acceptable terms, if at all, we could be forced to delay, reduce or eliminate one or more of our

development programs or any future commercialization efforts.

In addition, attempting to secure additional financing may divert the time and attention of our management from day-to-day activities and harm our development efforts.

Our estimate as to what we will be able to accomplish is based on assumptions that may prove to be inaccurate, and we could exhaust our available capital resources sooner

than is currently expected.

Because the length of time and activities associated with successful development of PDS0101 and PDS01ADC is highly uncertain, we are unable to estimate the actual funds we will require for development and any

Our estimate as to what we will be able to accomplish is based on assumptions that may prove to be inaccurate, and we could exhaust our available capital resources sooner than

is currently expected.

Because the length of time and activities associated with successful development of Versamune® HPV and PDS01ADC is highly uncertain, we are unable to estimate the actual funds we will require for development and any

approved marketing and commercialization activities.

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the effect of competing technological and marke t developments;

the cost of establishing sales, marketing and distribution capabilities in regions where we choose to commercialize PDS0101 and PDS01ADC on our own;

the initiation, progress, timing and results of the commercialization of PDS0101, if approved, for c ommercial sale.

the cost of establishing sales, marketing and distribution capabilities in regions where we choose to commercialize Versamune® HPV and PDS01ADC on our own;

the initiation, progress, timing and results of the commercialization of Versamune® HPV, if approved, for c ommercial sale.

Additional funding may not be available on acceptable terms, or at all.

If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we

may have to significantly delay, scale back or discontinue the development or commercialization of PDS0101 or potentially discontinue operations.

Raising additional funds by issuing securities may cause dilution to existing stockholders and raising funds through lending and licensing arrangements

may restrict our operations or require us to relinquish proprietary rights.

If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may

have to significantly delay, scale back or discontinue the development or commercialization of Versamune® HPV or potentially discontinue operations.

Raising additional funds by issuing securities may cause dilution to existing stockholders and raising funds through lending and licensing arrangements may

restrict our operations or require us to relinquish proprietary rights.

We expect that significant additional capital will be needed in the future to continue our planned operations.

Until such time, if ever, as we can generate substantial

product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, strategic alliances and license and development agreements in connection with any collaborations.

In February 2020, we completed

an underwritten public offering, in which we sold 10,000,000 shares of common stock at a public offering price of $1.30 per share.

Until such time, if ever, as we can generate substantial product

revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, strategic alliances and license and development agreements in connection with any collaborations.

In February 2020, we completed an

underwritten public offering, in which we sold 10,000,000 shares of common stock at a public offering price of $1.30 per share.

The shares sold included 769,230 shares issued upon the exercise by the underwriter of its option to purchase

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Riley Securities, Inc.

and BTIG, LLC, each an Agent and collectively

the Agents, with respect to an at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of our common stock, having an aggregate offering price of up to $50.0 million, or the Placement

and BTIG, LLC, each an Agent and collectively the

Agents, with respect to an at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of our common stock, having an aggregate offering price of up to $50.0 million, or the Placement

Shares, through or to the Agents, as sales agents or principals.

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We will pay the

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

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

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.

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

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

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

During the year ended December 31, 2023, we sold 2,642,269 shares of our common stock for a net value of $16.1 million pursuant to the Sales Agreement.

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

As of the date of this Annual Report, in the first quarter of 2024 we sold 3,428,681 shares of our

common stock for a net value of $ 19.5 million pursuant to the Sales Agreement.

To the extent that we raise additional capital by issuing equity securities, our existing stockholders’ ownership may experience substantial dilution, and the terms of

these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder.

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

Riley Securities, Inc.

Wainwright & Co., LLC, with terms that are substantially consistent with those included in the original Sales Agreement.

The New Sales Agreement superseded and replaced the Sales Agreement.

During 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.

As of the date of this Annual

Report, in the first quarter of 2025 we sold 205,350 shares of our common stock for a net value of $0.30 million pursuant to the New Sales Agreement.

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, 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.

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 placement agent fees and offering expenses were accounted for as a reduction of additional paid in capital.

The February 2025 Offering closed on February 28, 2025.

To the extent that we raise additional capital by issuing equity securities, our existing stockholders’ ownership may experience substantial dilution, and the terms of these

securities may include liquidation or other preferences that adversely affect your rights as a common stockholder.

Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or

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If we are unable to raise additional funds through equity or debt financings when

needed, or through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties on acceptable terms, we may be required to delay, limit, reduce or terminate our PDS0101 and PDS01ADC development or

future commercialization efforts or grant rights to develop and market other Versamune® and Infectimune® products that we would otherwise develop and market.

Our operating activities may be restricted as a result of covenants related to the outstanding indebtedness under our venture loan and security

agreement with Horizon and we may be required to repay the outstanding indebtedness in an event of default, which could have a materially adverse effect on our business.

In August 2022, we entered into a Venture loan and security agreement, or the Loan and Security Agreement, for separate term

loans of up to an aggregate amount of $35.0 million, with Horizon Technology Finance Corporation, or Horizon, in its capacity as a lender and collateral agent for itself and the other financial institutions that from time to time become

parties to the Loan and Security Agreement, collectively referred to as the Lenders, secured by a security interest in all of our respective rights, title, interests, claims and demands in, to and under all of our respective properties and

other assets, subject to limited exceptions and excluding our intellectual property.

development or future commercialization efforts or grant rights to develop and market other Versamune® and Infectimune® products that we would otherwise develop and market.

Our operating activities may be restricted as a result of covenants related to the outstanding indebtedness under our venture loan and security agreement

with Horizon and we may be required to repay the outstanding indebtedness in an event of default, which could have a materially adverse effect on our business.

In August 2022, we entered into a Venture loan and security agreement, or the Loan and Security Agreement, for separate term loans of up to an aggregate amount of $35.0 million,

with Horizon Technology Finance Corporation, or Horizon, in its capacity as a lender and collateral agent for itself and the other financial institutions that from time to time become parties to the Loan and Security Agreement, collectively

referred to as the Lenders, secured by a security interest in all of our respective rights, title, interests, claims and demands in, to and under all of our respective properties and other assets, subject to limited exceptions and excluding our

intellectual property.

The Loan and Security Agreement contains various covenants that limit our ability to engage in specified types of transactions.

These covenants include

requirements to maintain minimum cash balances as well as covenants limiting our ability to, among other things, sell, transfer, lease or dispose of certain assets;

These covenants include requirements to maintain minimum cash balances as well as covenants

limiting our ability to, among other things, sell, transfer, lease or dispose of certain assets;

incur indebtedness;

encumber or permit liens on certain assets;

make certain restricted payments, including paying dividends on, or repurchasing or making distributions with respect to, our common stock;

make certain investments;

make certain restricted payments, including paying

dividends on, or repurchasing or making distributions with respect to, our common stock;

and enter into certain transactions with affiliates.

Our business may be adversely

affected by these restrictions on our ability to operate our business.

Our business may be adversely affected by these restrictions on our ability to operate our business.

A breach of any of the covenants under the Loan and Security Agreement could result in a default.

Upon the occurrence of an event of default, the Lenders could elect to

declare all amounts outstanding, if any, to be immediately due and payable.

Upon the occurrence of an event of default, the Lenders could elect to declare all amounts outstanding, if any, to be immediately due and payable.

If there are any amounts outstanding that we are unable to repay, the Lenders could proceed against the collateral granted to them to secure such indebtedness.

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Kirk Shepard, our Chief Financial Officer, Mr.

Lars Boesgaard and our Chief Scientific Officer, Dr.

The loss of the services of any of our senior executive officers could

impede the achievement of our research, development and commercialization objectives.

Lars Boesgaard, our Chief Operating Officer, Mr.

Stephan Toutain and our Chief Scientific Officer, Dr.

The loss of the

services of any of our senior executive officers could impede the achievement of our research, development and commercialization objectives.

We do not maintain “key person” insurance for any executive officer or employee.

Recruiting and retaining qualified scientific, clinical, and operational personnel is also critical to our success.

We may not be able to attract and retain these personnel

on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel.

We may not be able to attract and retain these personnel on

acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel.

We also experience competition for the hiring of scientific and clinical personnel from universities and research

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If any of these advisors or consultants can no longer dedicate a sufficient amount of time to us, our business may be harmed.

If we fail to obtain or maintain adequate coverage and reimbursement for PDS0101 or PDS01ADC, our ability to generate revenue could be limited.

If we fail to obtain or maintain adequate coverage and reimbursement for Versamune® HPV or PDS01ADC, our ability to generate revenue could be limited.

The availability and extent of reimbursement by governmental and private payors is essential for most patients to be able to afford expensive treatments.

Sales of any of

PDS0101 or PDS01ADC that receive marketing approval will depend substantially, both in the United States and internationally, on the extent to which the costs of PDS0101 or PDS01ADC will be paid by health maintenance, managed care, pharmacy

benefit and similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers and other third-party payors.

If reimbursement is not available, or is available only on a

limited basis, we may not be able to successfully commercialize PDS0101 alone or in combination with PDS01ADC.

Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain adequate

pricing that will allow it to realize a sufficient return on our investment.

Outside the United States, international operations are generally subject to extensive governmental price controls and other market regulations, and we believe the

increasing emphasis on cost-containment initiatives in Europe, Canada and other countries may cause us to price PDS0101 alone or in combination with PDS01ADC on less favorable terms than we currently anticipate.

In many countries, particularly

the countries of the European Union, the prices of medical products are subject to varying price control mechanisms as part of national health systems.

Versamune® HPV or PDS01ADC that receive marketing approval will depend substantially, both in the United States and internationally, on the extent to which the costs of Versamune® HPV or PDS01ADC will be paid by health maintenance, managed

care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers and other third-party payors.

If reimbursement is not available, or is

available only on a limited basis, we may not be able to successfully commercialize Versamune® HPV alone or in combination with PDS01ADC.

Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to

establish or maintain adequate pricing that will allow it to realize a sufficient return on our investment.

Outside the United States, international operations are generally subject to extensive governmental price controls and other market regulations, and we believe the increasing

emphasis on cost-containment initiatives in Europe, Canada and other countries may cause us to price Versamune® HPV alone or in combination with PDS01ADC on less favorable terms than we currently anticipate.

In many countries, particularly the

countries of the European Union, the prices of medical products are subject to varying price control mechanisms as part of national health systems.

In these countries, pricing negotiations with governmental authorities can take considerable

time after the receipt of marketing approval for a product.

To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of PDS0101 or PDS01ADC to other

available therapies.

To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of Versamune® HPV or PDS01ADC to

other available therapies.

In general, the prices of products under such systems are substantially lower than in the United States.

Other countries allow companies to fix their own prices for products, but monitor and control company profits.

Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for PDS0101 alone or in combination with PDS01ADC.

Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for Versamune® HPV alone or in combination with PDS01ADC.

Accordingly, in markets outside the United States, the

reimbursement for our products may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenues and profits.

Moreover, increasing efforts by governmental and third-party payors, in the United States and internationally, to cap or reduce healthcare costs may cause such

organizations to limit both coverage and level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for PDS0101 or PDS01ADC.

We expect to experience pricing pressures in connection with

the sale of PDS0101 or PDS01ADC due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes.

Moreover, increasing efforts by governmental and third-party payors, in the United States and internationally, to cap or reduce healthcare costs may cause such organizations to

limit both coverage and level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for Versamune® HPV or PDS01ADC.

We expect to experience pricing pressures in connection with the sale of

Versamune® HPV or PDS01ADC due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes.

The downward pressure on healthcare costs in general, particularly

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As a result, increasingly high barriers are being erected to the entry of new products into the healthcare market.

The Inflation Reduction Act, referred to as the IRA, was recently signed into law by President Biden, which makes significant changes to how drugs are covered and paid for

under the Medicare program, including the creation of financial penalties for drugs whose prices rise faster than the rate of inflation, redesign of the Medicare Part D program to require manufacturers to bear more of the liability for certain

drug benefits, and government price-setting for certain Medicare Part D drugs, starting in 2026, and Medicare Part B drugs starting in 2028.

The Inflation Reduction Act, referred to as the IRA, was recently signed into law by President Biden, which makes significant changes to how drugs are covered and paid for under

the Medicare program, including the creation of financial penalties for drugs whose prices rise faster than the rate of inflation, redesign of the Medicare Part D program to require manufacturers to bear more of the liability for certain drug

benefits, and government price-setting for certain Medicare Part D drugs, starting in 2026, and Medicare Part B drugs starting in 2028.

We have evaluated, and will continue to evaluate, the effect of the IRA on our business.

At this time,

we do not expect the IRA to have a material effect on our financial position.

We are unable to predict the future course of federal or state healthcare legislation in the United States directed at broadening the availability of healthcare and

containing or lowering the cost of healthcare.

The ACA and any further changes in the law or regulatory framework that reduce our revenue or increase our costs could also have a material and adverse effect on our business, financial condition

and results of operations.

Even if any of our product candidates receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical

community necessary for commercial success.

If any of our product candidates receive marketing approval, they may nonetheless fail to gain sufficient market acceptance by physicians, patients, healthcare payors and others in the medical community.

current cancer treatments like chemotherapy and radiation therapy are well-established in the medical community, and doctors may continue to rely on these treatments.

If our product candidates do not achieve an adequate level of acceptance, we

may not generate significant revenues from sales of drugs and we may not become profitable.

The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:

At this time, we do

not expect the IRA to have a material effect on our financial position.

We are unable to predict the future course of federal or state healthcare legislation in the United States directed at broadening the availability of healthcare and containing

or lowering the cost of healthcare.

The ACA and any further changes in the law or regulatory framework that reduce our revenue or increase our costs could also have a material and adverse effect on our business, financial condition and results

of operations.

Even if any of our product candidates receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and

others in the medical community necessary for commercial success.

If any of our product candidates receive marketing approval, they may nonetheless fail to gain sufficient market acceptance by physicians, patients, healthcare payors and others in the medical

For example, current cancer treatments like chemotherapy and radiation therapy are well-established in the medical community, and doctors may continue to rely on these treatments.

If our product candidates do not achieve an adequate

level of acceptance, we may not generate significant revenues from sales of drugs and we may not become profitable.

The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors,

the efficacy and safety of the product;

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We will need to expand our organization, and may experience difficulties in managing this growth, which could disrupt operations.

Our future financial performance and our ability to commercialize PDS0101 alone or in combination with PDS01ADC and compete effectively will depend, in part, on our ability

to effectively manage any future growth.

Our future financial performance and our ability to commercialize Versamune® HPV alone or in combination with PDS01ADC and compete effectively will depend, in part, on our

ability to effectively manage any future growth.

As of December 31, 2024, we had 24 employees and 22 consultants.

We expect to hire additional employees for our managerial, clinical, scientific and engineering, operational, manufacturing, sales and

marketing teams.

We expect to hire additional employees for our managerial, clinical, scientific and engineering, operational, manufacturing,

sales and marketing teams.

We may have operational difficulties in connection with identifying, hiring and integrating new personnel.

Future growth would impose significant additional responsibilities on our management, including the need to identify,

recruit, maintain, motivate and integrate additional employees, consultants and contractors.

Also, our management may need to divert a disproportionate amount of our attention away from our day-to-day activities and devote a substantial amount

of time to managing these growth activities.

We may not be able to effectively manage the expansion of our operations, which may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss

of employees and reduced productivity among remaining employees.

Our expected growth could require significant capital expenditures and may divert financial resources from other projects, such as the development of PDS0101.

If we are unable to

effectively manage our growth, our expenses may increase more than expected, our ability to generate and/or grow revenues could be reduced, and we may not be able to implement our business strategy.

Many of the other pharmaceutical companies that we compete against for qualified personnel and consultants have greater financial and other resources, different risk profiles

and a longer history in the industry than us.

Future growth would impose significant additional responsibilities on our management, including the need to

identify, recruit, maintain, motivate and integrate additional employees, consultants and contractors.

Also, our management may need to divert a disproportionate amount of our attention away from our day-to-day activities and devote a

substantial amount of time to managing these growth activities.

We may not be able to effectively manage the expansion of our operations, which may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of business

opportunities, loss of employees and reduced productivity among remaining employees.

Our expected growth could require significant capital expenditures and may divert financial resources from other projects, such as the development of

Versamune® HPV.

If we are unable to effectively manage our growth, our expenses may increase more than expected, our ability to generate and/or grow revenues could be reduced, and we may not be able to implement our business strategy.

Many of the other pharmaceutical companies that we compete against for qualified personnel and consultants have greater financial and other resources, different risk profiles and

a longer history in the industry than us.

They also may provide more diverse opportunities and better chances for career advancement.

Some of these characteristics may be more appealing to high-quality candidates and consultants than what it

has to offer.

If we are unable to continue to attract and retain high-quality personnel and consultants, the rate and success at which we can select and develop PDS0101 or PDS01ADC and our business will be limited.

Our employees, independent contractors, principal investigators, consultants, commercial collaborators, service providers and other vendors may engage

in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.

We are exposed to the risk that our employees and contractors, including principal investigators, consultants, commercial collaborators, service providers and other vendors

may engage in fraudulent or other illegal activity.

Misconduct by these parties could include intentional, reckless and/or negligent conduct or other unauthorized activities that violate the laws and regulations of the FDA and other similar

regulatory bodies, including those laws that require the reporting of true, complete and accurate information to such regulatory bodies, manufacturing standards, federal and state healthcare fraud and abuse and health regulatory laws and other

similar foreign fraudulent misconduct laws, or laws that require the true, complete and accurate reporting of financial information or data.

Misconduct by these parties may also involve the improper use or misrepresentation of information

obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation.

It is not always possible to identify and deter third-party misconduct, and the precautions we take to detect and prevent

this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.

If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and financial results, including the imposition of

significant civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, reputational harm, diminished profits and future earnings, and

curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

Some of these characteristics may be more appealing to high-quality candidates and consultants than what it has

If we are unable to continue to attract and retain high-quality personnel and consultants, the rate and success at which we can select and develop Versamune® HPV or PDS01ADC and our business will be limited.

Our employees, independent contractors, principal investigators, consultants, commercial collaborators, service providers and other vendors may engage in

misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.

We are exposed to the risk that our employees and contractors, including principal investigators, consultants, commercial collaborators, service providers and other vendors may

engage in misconduct or fraudulent or other illegal activity.

Misconduct by these parties could include intentional, reckless and/or negligent conduct or other unauthorized activities that violate the laws and regulations of the FDA and other

similar regulatory bodies, including those laws that require the reporting of true, complete and accurate information to such regulatory bodies, manufacturing standards, federal and state healthcare fraud and abuse and health regulatory laws

and other similar foreign fraudulent misconduct laws, or laws that require the true, complete and accurate reporting of financial information or data.

Misconduct by these parties may also involve the improper use or misrepresentation of

information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation.

It is not always possible to identify and deter third-party misconduct, and the precautions we take to detect

and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or

of significant civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, reputational harm, diminished profits and future earnings,

and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

Our business and operations would suffer, and could be negatively affected, in the event of system failures or cyberattacks.

Our computer systems and those of our service providers, including our CROs, are vulnerable to damage from computer viruses, unauthorized access, natural disasters,

terrorism, war and telecommunication and electrical failures.

Our computer systems and those of our service providers, including our CROs, are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism,

war and telecommunication and electrical failures.

If such an event were to occur and cause interruptions in our or their operations, it could result in a material disruption of our development programs.

For example, the loss of

preclinical or clinical trial data from completed, ongoing or planned trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

To the extent that any disruption or

security breach were to result in a loss of or damage to data or applications, or inappropriate disclosure of personal, confidential or proprietary information, we could incur liability and the further development of PDS0101 and PDS01ADC could

For example, the loss of preclinical or

clinical trial data from completed, ongoing or planned trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

To the extent that any disruption or security breach

were to result in a loss of or damage to data or applications, or inappropriate disclosure of personal, confidential or proprietary information, we could incur liability and the further development of Versamune® HPV and PDS01ADC could be

A cyberattack or similar incident could occur and result in information theft, data corruption, operational disruption, damage to our reputation or financial loss.

industry has become increasingly dependent on digital technologies to conduct certain development and financial activities.

Our technologies, systems, networks, or other proprietary information, and those of our vendors, suppliers and other

business partners, may become the target of cyberattacks or information security breaches that could result in the unauthorized release, gathering, monitoring, misuse, loss or destruction of proprietary and other information, or could otherwise

lead to the disruption of our business operations.

Cyberattacks are becoming more sophisticated and certain cyber incidents, such as surveillance, may remain undetected for an extended period and could lead to disruptions in critical systems or

the unauthorized release of confidential or otherwise protected information.

has become increasingly dependent on digital technologies to conduct certain development and financial activities.

Our technologies, systems, networks, or other proprietary information, and those of our vendors, suppliers and other business

partners, may become the target of cyberattacks or information security breaches that could result in the unauthorized release, gathering, monitoring, misuse, loss or destruction of proprietary and other information, or could otherwise lead to

the disruption of our business operations.

Cyberattacks are becoming more sophisticated and certain cyber incidents, such as surveillance, may remain undetected for an extended period and could lead to disruptions in critical systems or the

unauthorized release of confidential or otherwise protected information.

These events could lead to financial loss from remedial actions, loss of business, disruption of operations, damage to our reputation or potential liability.

systems and insurance coverage for protecting against cybersecurity risks may not be sufficient.

Further, as cyberattacks continue to evolve, we may be required to expend significant additional resources to continue to modify or enhance our

protective measures or to investigate and remediate any vulnerability to cyberattacks.

Our failure to comply with international data protection laws and regulations could lead to government enforcement actions and significant penalties

against us, and adversely impact our operating results.

and insurance coverage for protecting against cybersecurity risks may not be sufficient.

Further, as cyberattacks continue to evolve, we may be required to expend significant additional resources to continue to modify or enhance our protective

measures or to investigate and remediate any vulnerability to cyberattacks.

Our failure to comply with international data protection laws and regulations could lead to government enforcement actions and significant penalties against

us, and adversely impact our operating results.

EU member states and other foreign jurisdictions, including Switzerland, have adopted data protection laws and regulations which impose significant compliance obligations.

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regulations and industry standards relating to privacy and data protection in the United States, the EU and other jurisdictions, and we cannot determine the impact such future laws, regulations and standards may have on our business.

Our failure to comply with state and/or national data protection laws and regulations could lead to government enforcement actions and significant

penalties against us, and adversely impact our operating results.

There are numerous other laws and legislative and regulatory initiatives at the federal and state levels addressing privacy and security concerns, and some state privacy

laws apply more broadly than the Health Insurance Portability and Accountability Act, or HIPAA, and associated regulations.

For example, California recently enacted legislation – the California Consumer Privacy Act, or CCPA – which went into

effect January 1, 2020.

The CCPA, among other things, creates new data privacy obligations for covered companies and provides new privacy rights to California residents, including the right to opt out of certain disclosures of their

The CCPA also creates a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach.

The CCPA was recently amended by the California Privacy Rights

Act, or CPRA, expanding certain consumer rights such as the right to know.

Our failure to comply with state and/or national data protection laws and regulations could lead to government enforcement actions and significant penalties

against us, and adversely impact our operating results.

There are numerous other laws and legislative and regulatory initiatives at the federal and state levels addressing privacy and security concerns, and some state privacy laws

apply more broadly than the Health Insurance Portability and Accountability Act, or HIPAA, and associated regulations.

For example, California recently enacted legislation – the California Consumer Privacy Act, or CCPA – which went into effect

January 1, 2020.

CCPA also creates a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach.

The CCPA was recently amended by the California Privacy Rights Act, or CPRA,

expanding certain consumer rights such as the right to know.

It remains unclear what, if any, additional modifications will be made to these laws by the California legislature or how these laws will be interpreted and enforced.

The potential effects of the CCPA and CPRA and implementing regulations are significant and may cause us to incur substantial costs and expenses to comply.

If we fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately report our

financial condition, results of operations or cash flows, which may adversely affect investor confidence in us and, as a result, the value of our common stock.

Further, we continue to incur significant increased costs as a result of operating

as a public company, and our management is required to devote substantial time to compliance initiatives.

The potential

effects of the CCPA and CPRA and implementing regulations are significant and may cause us to incur substantial costs and expenses to comply.

If we fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately report our financial

condition, results of operations or cash flows, which may adversely affect investor confidence in us and, as a result, the value of our common stock.

Further, we continue to incur significant increased costs as a result of operating as a public

company, and our management is required to devote substantial time to compliance initiatives.

As a public company, we continue to incur significant legal, accounting and other expenses that we did not incur as a private company.

In addition, the Sarbanes-Oxley Act,

as well as rules subsequently implemented by the SEC and Nasdaq, impose various requirements on public companies, including requiring establishment and maintenance of effective disclosure controls and internal control over financial reporting

and changes in corporate governance practices.

In addition, the Sarbanes-Oxley Act, as

well as rules subsequently implemented by the SEC and Nasdaq, impose various requirements on public companies, including requiring establishment and maintenance of effective disclosure controls and internal control over financial reporting and

changes in corporate governance practices.

Our management and other personnel devote a substantial amount of time to these compliance initiatives.

Moreover, these rules and regulations have increased our legal and financial compliance costs

and have made some activities more time-consuming and costly.

Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure controls and

procedures, are designed to prevent fraud.

Moreover, these rules and regulations have increased our legal and financial compliance costs and

have made some activities more time-consuming and costly.

Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures,

are designed to prevent fraud.

Any failure to implement required new or improved controls, or difficulties encountered in their implementation, could cause us to fail to meet our reporting obligations.

In addition, any testing by us

conducted in connection with Section 404 of the Sarbanes-Oxley Act, may reveal deficiencies in our internal control over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our

financial statements or identify other areas for further attention or improvement.

If we are unable to conclude that our internal control over financial reporting is effective, or if our independent registered public accounting firm determines

we have a material weakness or significant deficiency in our internal control over financial reporting once that firm begins its Section 404 reviews or becomes aware of either during the conduct of an audit, we could lose investor confidence in

the accuracy and completeness of our financial reports, the market price of our common stock could decline, and we could be subject to sanctions or investigations by the Nasdaq Capital Market, the SEC or other regulatory authorities.

In addition, any testing by us conducted

in connection with Section 404 of the Sarbanes-Oxley Act, may reveal deficiencies in our internal control over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial

statements or identify other areas for further attention or improvement.

If we are unable to conclude that our internal control over financial reporting is effective, or if our independent registered public accounting firm determines we have a

material weakness or significant deficiency in our internal control over financial reporting once that firm begins its Section 404 reviews or becomes aware of either during the conduct of an audit, we could lose investor confidence in the

accuracy and completeness of our financial reports, the market price of our common stock could decline, and we could be subject to sanctions or investigations by the Nasdaq Capital Market, the SEC or other regulatory authorities.

remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the capital markets.

Periodic reporting requirements under the Exchange Act and compliance with the Sarbanes-Oxley Act of 2002, including establishing and maintaining

acceptable internal control over financial reporting, are costly and may increase substantially and, as a smaller reporting company, we may take advantage of reduced reporting requirements which may make our common stock less attractive to

Periodic reporting requirements under the Exchange Act and compliance with the Sarbanes-Oxley Act of 2002, including establishing and maintaining acceptable

internal control over financial reporting, are costly and may increase substantially and, as a smaller reporting company, we may take advantage of reduced reporting requirements which may make our common stock less attractive to investors.

We are subject to the periodic reporting requirements of the Securities Exchange Act of 1934, as amended, or the Exchange Act.

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We have incurred net losses and utilized cash in operations since inception.

In addition, as of December 31, 2023, we had

approximately $56.6 million in cash and cash equivalents, and during the twelve months ended December 31, 2023, we used $33.6 million of cash in operations and expect to continue to incur significant cash outflows and incur future

additional losses to execute our operating plan.

While we intend to finance our cash needs principally through collaborations, strategic alliances, or license agreements with third parties and/or debt or equity financings, there is no

assurance that new financing will be available to us on commercially acceptable terms or in the amounts required, if at all.

In addition, the Loan and Security

Agreement allows for the lenders to call the outstanding balance of the term loans if the minimum cash balances outlined in the Loan and Security Agreement are not maintained.

Due to the uncertainty in securing additional funding,

and the insufficient amount of cash and cash equivalents as of December 31, 2023, we have concluded that substantial doubt exists about our ability to continue as a going concern within one year after the date of the filing of this Annual

If we are unsuccessful in securing sufficient financing, we may need to delay, reduce, or eliminate our research and development programs, which could adversely affect our business prospects, or cease operations.

Our consolidated financial statements included in this Annual Report have been prepared on a going concern basis under which an entity is able to realize its assets and

satisfy its liabilities in the ordinary course of business.

The consolidated financial statements do not give effect to any adjustments relating to the carrying values and classification of assets and liabilities that would be necessary should

we be unable to continue as a going concern within one year after the date that the financial statements are issued.

Our future operations are dependent upon the successful entry into collaborations, strategic alliances, or license agreements with third parties and/or on the

identification and successful completion of equity or debt financing and the achievement of profitable operations at an indeterminate time in the future.

There can be no assurances that we will be successful in completing these collaborations

or alliances, equity or debt financing or in achieving profitability.

In addition, as of December 31, 2024, we had approximately $41.7 million in cash and cash

equivalents, and during the twelve months ended December 31, 2024, we used $35.0 million of cash in operations and expect to continue to incur significant cash outflows and incur future additional losses to execute our operating plan.

intend to finance our cash needs principally through collaborations, strategic alliances, or license agreements with third parties and/or debt or equity financings, there is no assurance that new financing will be available to us on

commercially acceptable terms or in the amounts required, if at all.

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

Security Agreement are not maintained.

Due to the uncertainty in securing additional funding, and the insufficient amount of cash and cash equivalents as of December 31, 2024, we have concluded that substantial doubt exists about our ability to

continue as a going concern within one year after the date of the filing of this Annual Report.

If we are unsuccessful in securing sufficient financing, we may need to delay, reduce, or eliminate our research and development programs, which

could adversely affect our business prospects, or cease operations.

Our consolidated financial statements included in this Annual Report have been prepared on a going concern basis under which an entity is able to realize its assets and satisfy

its liabilities in the ordinary course of business.

The consolidated financial statements do not give effect to any adjustments relating to the carrying values and classification of assets and liabilities that would be necessary should we be

unable to continue as a going concern within one year after the date that the financial statements are issued.

Our future operations are dependent upon the successful entry into collaborations, strategic alliances, or license agreements with third parties and/or on the identification and

successful completion of equity or debt financing and the achievement of profitable operations at an indeterminate time in the future.

There can be no assurances that we will be successful in completing these collaborations or alliances, equity

or debt financing or in achieving profitability.

As such, there can be no assurance that we will be able to continue as a going concern.

Substantial doubt about our ability to continue as a going concern may materially and adversely affect the price per share of our common stock, and it may be more difficult

for us to obtain financing.

Substantial doubt about our ability to continue as a going concern may materially and adversely affect the price per share of our common stock, and it may be more difficult for

us to obtain financing.

If potential collaborators decline to do business with us or potential investors decline to participate in any future financings due to such concerns, our ability to increase our cash position may be limited.

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Risks Related to Clinical Development, Regulatory Approval and Commercialization

Clinical trials are very expensive, time-consuming, difficult to design and implement and involve an uncertain outcome, and if they

fail to demonstrate safety and efficacy to the satisfaction of the FDA, or similar regulatory authorities, we will be unable to commercialize Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products.

PDS0101 and PDS01ADC are still in clinical development and will require additional clinical testing before we are prepared to submit a BLA for regulatory approval for any

Clinical trials are very expensive, time-consuming, difficult to design and implement and involve an uncertain outcome, and if they fail to

Versamune® HPV and PDS01ADC are still in clinical development and will require additional clinical testing before we are prepared to submit a BLA for regulatory approval for any

indication or for any other treatment regime.

We cannot predict with any certainty if or when we might submit a BLA for regulatory approval for PDS0101, PDS01ADC and other Versamune® based products or whether any such BLAs will be approved by

We cannot predict with any certainty if or when we might submit a BLA for regulatory approval for Versamune® HPV, PDS01ADC and other Versamune® based products or whether any such BLAs will be

approved by the FDA.

Human clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.

For instance, the FDA may not agree with our proposed endpoints for any clinical

trial we propose, which may delay the commencement of our clinical trials.

For instance, the FDA may not agree with our proposed endpoints for any

clinical trial we propose, which may delay the commencement of our clinical trials.

The clinical trial process is also time-consuming.

We estimate that the clinical trials we need to conduct to be in a position to submit BLAs for PDS0101 alone or in

combination with PDS01ADC will take several years to complete.

We estimate that the clinical trials we need to conduct to be in a position to submit BLAs for Versamune® HPV

alone or in combination with PDS01ADC will take several years to complete.

We cannot predict the timeline for review of submissions to any regulatory authorities or when any of our product candidates will receive marketing approval, if at all.

for regulatory approval can be affected by a variety of factors, including, budget and funding levels, agency staffing, and statutory, regulatory and policy changes.

The timeline for regulatory approval can be affected by a variety of factors, including, budget and funding levels, agency staffing, and statutory, regulatory and policy changes.

Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials.

In later stages of clinical

trials, PDS0101 and PDS01ADC may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials, and the results of current clinical trials of PDS0101 therefore may not be

predictive of the results of our continued or planned Phase 2 and 3 trials.

A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety

profiles, notwithstanding promising results in earlier stages of clinical trials.

trials, Versamune® HPV and PDS01ADC may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials, and the results of current clinical trials of Versamune® HPV

therefore may not be predictive of the results of our continued or planned Phase 2 and 3 trials.

A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or

adverse safety profiles, notwithstanding promising results in earlier stages of clinical trials.

Moreover, preclinical and clinical data are often susceptible to multiple interpretations and analyses.

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Product development costs will also increase if we experience delays in testing or in receiving marketing approvals.

We do not know whether any clinical trials will begin

as planned, will need to be restructured or will be completed on schedule, or at all.

Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize PDS0101 alone or in combination

with PDS01ADC, could allow our competitors to bring products to market before we do, and could impair our ability to successfully commercialize PDS0101 or PDS01ADC, any of which may harm our business and results of operations.

We do not know whether any clinical trials will begin as

planned, will need to be restructured or will be completed on schedule, or at all.

Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize Versamune® HPV alone or in

combination with PDS01ADC, could allow our competitors to bring products to market before we do, and could impair our ability to successfully commercialize Versamune® HPV or PDS01ADC, any of which may harm our business and results of

Clinical drug development is a lengthy and expensive process, with an uncertain outcome.

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unable to obtain marketing approval.

Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must complete preclinical development and then conduct extensive clinical trials to

demonstrate the safety and efficacy of our product candidates.

Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must complete preclinical development and testing and then conduct extensive clinical

trials to demonstrate the safety and efficacy of our product candidates.

Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome.

A failure of one or more clinical trials can occur at

any stage of testing.

A failure of one or more clinical trials

can occur at any stage of testing.

The outcome of preclinical studies and early-stage clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results.

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obtaining institutional review board or ethics committee approval at each clinical trial site;

recruiting suitable patients to participate in a trial;

obtaining satisfactory review by Data Safety Monitoring Boards or DSMBs;

recruiting, enrolling, and retaining suitable patients to participate in a trial;

patients failing to comply with the clinical trial protocol or dropping out of a trial;

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our third-party contractors, including our CROs, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

we, our investigators, or any of the overseeing IRBs or ethics committees might decide to suspend or terminate clinical trials of our product candidates for various reasons, including non-compliance with regulatory requirements, a

finding that our product candidates have undesirable side effects or other unexpected characteristics, or a finding that the participants are being exposed to unacceptable health risks;

we, our investigators, or any of the overseeing IRBs, DSMBs or ethics committees might decide to suspend or terminate clinical trials of our product candidates for various reasons, including non-compliance with regulatory requirements,

a finding that our product candidates have undesirable side effects or other unexpected characteristics, or a finding that the participants are being exposed to unacceptable health risks;

the cost of clinical trials of our product candidates may be greater than we anticipate;

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retain a sufficient number of participants to complete any of our trials.

Late-stage clinical trials of PDS0101 alone or in combination with PDS01ADC or other agents may require the enrollment and retention of large numbers of subjects.

enrollment and retention in clinical trials depends on many factors, including the size of the subject population, the nature of the trial protocol, the existing body of safety and efficacy data with respect to the study drug, the number and

nature of competing treatments and ongoing clinical trials of competing drugs for the same indication, patients’ and clinicians’ perceived risks and benefits of the product candidate under study the proximity of subjects to clinical sites and

the eligibility criteria for the study.

Furthermore, any negative results we may report in clinical trials of PDS0101 and PDS01ADC may make it difficult or impossible to recruit and retain participants in other

clinical trials of PDS0101.

Delays or failures in planned subject enrollment or retention may result in increased costs, program delays or both, which could have a harmful effect on our ability to develop PDS0101 and PDS01ADC, or could render

further development impractical.

In addition, we expect to rely on CROs and clinical trial sites to ensure proper and timely conduct of our future clinical trials and, while we intend to enter into agreements governing their services, we will

be limited in our ability to compel their actual performance in compliance with applicable regulations.

Enforcement actions brought against these third parties may cause further delays and expenses related to our clinical development programs.

Our inability to enroll a sufficient number of patients for our clinical trials would result in significant delays or may require us to abandon one or more clinical trials

Late-stage clinical trials of Versamune® HPV alone or in combination with PDS01ADC or other agents may require the enrollment and retention of large numbers of subjects.

Subject enrollment and retention in clinical trials depends on many factors, including the size of the subject population, the nature of the trial protocol, the existing body of safety and efficacy data with respect to the study drug, the

number and nature of competing treatments and ongoing clinical trials of competing drugs for the same indication, patients’ and clinicians’ perceived risks and benefits of the product candidate under study the proximity of subjects to clinical

sites and the eligibility criteria for the study.

Furthermore, any negative results we may report in clinical trials of Versamune® HPV and PDS01ADC may make it difficult or impossible to recruit and retain participants in other

clinical trials of Versamune® HPV.

Delays or failures in planned subject enrollment or retention may result in increased costs, program delays or both, which could have a harmful effect on our ability to develop Versamune® HPV and PDS01ADC, or

could render further development impractical.

In addition, we expect to rely on CROs and clinical trial sites to ensure proper and timely conduct of our future clinical trials and, while we intend to enter into agreements governing their

services, we will be limited in our ability to compel their actual performance in compliance with applicable regulations.

Enforcement actions brought against these third parties may cause further delays and expenses related to our clinical

development programs.

Our inability to enroll and retain a sufficient number of patients for our clinical trials would result in significant delays or may require us to abandon one or more clinical

trials altogether.

Enrollment delays in our clinical trials may result in increased development costs for our product candidates, which would cause the value of our company to decline and limit our ability to obtain additional financing.

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Successful development of immunotherapies is highly uncertain and is dependent on numerous factors, many of which are beyond our control.

Immunotherapies that appear

promising in the early phases of development may fail to reach, or be delayed in reaching, the market for several reasons including:

preclinical study results that may show the immunotherapy to be less effective than desired (e.g., the study

failed to meet its primary objectives) or to have harmful or problematic side effects;

clinical study results that may show the immunotherapy to be less effective than expected (e.g., the study failed to meet its primary endpoint) or to have

unacceptable side effects;

failure to receive the necessary regulatory approvals or a delay in receiving such approvals.

Among other things, such delays may be caused by slow enrollment in clinical studies, length of time to achieve study

endpoints, delays in receiving the necessary products or supplies for the conduct of clinical or preclinical trials, additional time requirements for data analysis, or Biologics License Application preparation, discussions with the FDA, an FDA

request for additional preclinical or clinical data, FDA delays in inspecting manufacturing establishments, failure to receive FDA approval for manufacturing processes or facilities, or unexpected safety or manufacturing issues;

manufacturing

costs, formulation issues, pricing or reimbursement issues, or other factors that make the immunotherapy uneconomical;

and the proprietary rights of others and their competing products and technologies that may prevent the immunotherapy from

being commercialized.

Immunotherapies that appear promising

in the early phases of development may fail to reach, or be delayed in reaching, the market for several reasons including:

preclinical study results that may show the immunotherapy to be less effective than desired (e.g., the study failed to

meet its primary objectives) or to have harmful or problematic side effects;

clinical study results that may show the immunotherapy to be less effective than expected (e.g., the study failed to meet its primary endpoint) or to have unacceptable

side effects;

or failure to receive the necessary regulatory approvals or a delay in receiving such approvals.

Among other things, such delays may be caused by multiple factors including:

slow enrollment in clinical studies, inability to retain

study participants, length of time to achieve study endpoints, delays in receiving the necessary products or supplies for the conduct of clinical or preclinical trials, additional time requirements for data analysis, or Biologics License

Application preparation, discussions with the FDA, an FDA request for additional preclinical or clinical data, FDA delays in inspecting manufacturing establishments, failure to receive FDA approval for manufacturing processes or facilities, or

unexpected safety or manufacturing issues;

manufacturing costs, formulation issues, pricing or reimbursement issues, or other factors that make the immunotherapy uneconomical;

and the proprietary rights of others and their competing products

and technologies that may prevent the immunotherapy from being commercialized.

Success in preclinical and early and interim clinical studies does not ensure that large-scale clinical studies will be successful.

Clinical results are frequently susceptible to varying interpretations that may delay,

limit or prevent regulatory approvals.

The length of time necessary to complete clinical studies and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one immunotherapy to

the next and may be difficult to predict.

Even if our product candidates are approved, they may be subject to limitations on the indicated uses and populations for which they may be marketed.

They may also be subject to other conditions of

approval, may contain significant safety warnings, including boxed warnings, contraindications, and precautions, may not be approved with label statements necessary or desirable for successful commercialization, or may contain requirements for

costly post-market testing and surveillance, or other requirements, including the submission of a REMS, to monitor the safety or efficacy of the products.

If we do not receive FDA approval for, and successfully commercialize our product

candidates, we will not be able to generate revenue from these product candidates in the United States in the foreseeable future, or at all.

Any significant delays in obtaining approval for and commercializing our product candidates will have a

material adverse impact on our business and financial condition.

Clinical results are frequently

susceptible to varying interpretations that may delay, limit or prevent regulatory approvals.

The length of time necessary to complete clinical studies and to submit an application for marketing approval for a final decision by a regulatory

authority varies significantly from one immunotherapy to the next and may be difficult to predict.

Even if our product candidates are approved, they may be subject to limitations on the indicated uses and populations for which they may be

They may also be subject to other conditions of approval, may contain significant safety warnings, including boxed warnings, contraindications, and precautions, may not be approved with label statements necessary or desirable for

successful commercialization, or may contain requirements for costly post-market testing and surveillance, or other requirements, including the submission of a REMS, to monitor the safety or efficacy of the products.

If we do not receive FDA

approval for, and successfully commercialize our product candidates, we will not be able to generate revenue from these product candidates in the United States in the foreseeable future, or at all.

Any significant delays in obtaining approval

for and commercializing our product candidates will have a material adverse impact on our business and financial condition.

In addition, the success of our products will depend on several factors, including the following:

successful initiation, successful patient enrollment and timely completion of clinical trials of these products;

successful initiation and successful patient enrollment and completion of additional clinical trials, for our product candidates;

our ability to demonstrate our products’ safety, tolerability and efficacy to the FDA or any comparable foreign regulatory authority for marketing approval;

successful initiation, successful patient enrollment, successful study subject retention, and timely completion of clinical trials of these products;

successful initiation, successful patient enrollment, successful study subject retention, and timely completion of additional clinical trials, for our product candidates;

our ability to demonstrate our products’ safety, potency, purity, tolerability and efficacy to the FDA or any comparable foreign regulatory authority for marketing approval;

timely receipt of marketing approvals for our products;

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For example, we may experience manufacturing delays or other delays with IND-enabling studies.

Moreover, we cannot be sure that submission of an IND will result in the FDA allowing further clinical trials to begin, or that, once begun, issues will not arise that lead FDA, IRBs, or other authorities to suspend, terminate, or require changes

to our clinical trials.

Additionally, even if such regulatory and other authorities agree with the design and implementation of the clinical trials set forth in an IND, we cannot guarantee that such regulatory authorities will not change their

requirements in the future.

Moreover, we cannot be sure that submission of an IND will result in the FDA allowing further clinical trials to begin, or that, once begun, issues will not arise that lead FDA, IRBs, DSMBs or other authorities to suspend, terminate, or require

changes to our clinical trials.

their requirements in the future.

These considerations also apply to new clinical trials or changes to existing clinical trials we may submit as amendments to existing INDs or to a new IND.

Any failure to file INDs on the timelines we expect or to

obtain regulatory clearance or approvals for our trials may prevent us from completing our clinical trials or commercializing our products on a timely basis, if at all.

We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete

Any failure to file INDs on the timelines we expect or

to obtain regulatory clearance or approvals for our trials may prevent us from completing our clinical trials or commercializing our products on a timely basis, if at all.

We face significant competition from other biotechnology and biopharmaceutical companies, and our operating results will suffer if we fail to compete

The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition.

As a result, PDS0101, PDS01ADC or

other Versamune® and Infectimune® based products could become obsolete before we recoup any portion of our related research and development and commercialization expenses.

Competition in the biopharmaceutical industry is based significantly on

scientific and technological factors.

These factors include the availability of patent and other protection for technology and products, the ability to commercialize technological developments and the ability to obtain governmental approval for

testing, manufacturing and marketing.

As a result, Versamune® HPV, PDS01ADC

or other Versamune® and Infectimune® based products could become obsolete before we recoup any portion of our related research and development and commercialization expenses.

Competition in the biopharmaceutical industry is based significantly

on scientific and technological factors.

for testing, manufacturing and marketing.

We compete with specialized biopharmaceutical firms in the United States, Europe and elsewhere, as well as a growing number of large pharmaceutical companies that are applying biotechnology to their

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diseases we have targeted for drug development.

Various companies are developing biopharmaceutical products that have the potential to directly compete with PDS0101 and PDS01ADC even though their approach to may be different.

We believe our top

clinical-stage competitors pursuing cancer immunotherapies and/or vaccines for infectious diseases include, but not limited to Merus N.V., F-Star Therapeutics, Johnson & Johnson Innovative Medicine (part of Johnson & Johnson),

Sanofi-Aventis, GlaxoSmithKline plc, Merck and Pfizer, Inovio, Kite Pharma, Hookipa, Moderna, ZIOPHARM Oncology, Heat Biologics, Harpoon Therapeutics, BioNTech, Osivax, Medicago, Vaxart, and Flugen.

Many of these companies have substantially

greater financial, marketing, and human resources than we do (including, in some cases, substantially greater experience in clinical testing, manufacturing, and marketing of pharmaceutical products).

If one or more of these companies is

successful in developing their technologies, it could materially impact our business.

We also experience competition in the development of our immunotherapies from universities and other research institutions and compete with others in

acquiring technology from such universities and institutions.

Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these

Our competitors may succeed in developing, acquiring or licensing, on an exclusive basis, drugs that are more effective or less costly than PDS0101, PDS01ADC or our other Versamune® and Infectimune® based products.

Various companies are developing biopharmaceutical products that have the potential to directly compete with Versamune® HPV and PDS01ADC even though their approach to may be different.

our top clinical-stage competitors pursuing cancer immunotherapies and/or vaccines for infectious diseases include, but not limited to Merus, F-Star Therapeutics, Johnson & Johnson Innovative Medicine (part of Johnson & Johnson),

Sanofi-Aventis, GlaxoSmithKline plc, Merck and Pfizer, Inovio, Kite Pharma, Hookipa, Moderna, ZIOPHARM Oncology, Heat Biologics, Harpoon Therapeutics, BioNTech, Osivax, Medicago, Vaxart, IO Biotech, Exelixis and Flugen.

Many of these companies

have substantially greater financial, marketing, and human resources than we do (including, in some cases, substantially greater experience in clinical testing, manufacturing, and marketing of pharmaceutical products).

If one or more of these

companies is successful in developing their technologies, it could materially impact our business.

We also experience competition in the development of our immunotherapies from universities and other research institutions and compete with

others in acquiring technology from such universities and institutions.

Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries.

Our competitors may succeed in developing, acquiring or licensing, on an exclusive basis, drugs that are more effective or less costly than Versamune® HPV, PDS01ADC or our other Versamune® and Infectimune® based products.

We will face competition from other drugs currently approved or that will be approved in the future for the treatment of the other cancers and infectious diseases we are

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develop and commercialize immunotherapies that are superior to other alternatives in the market;

demonstrate through our clinical trials that PDS0101 alone or in combination with PDS01ADC is differentiated from existing and fu ture therapies;

demonstrate through our clinical trials that Versamune® HPV alone or in combination with PDS01ADC is differentiated from existing and fu ture therapies;

attract qualified scientific, immunotherapy development and commer cial personnel;

obtain additional patent or other proprietary protection for PDS0101, PDS01ADC and other Versamune® and Infectimune®- based products;

obtain additional patent or other proprietary protection for Versamune® HPV, PDS01ADC and other Versamune® and Infectimune®- based products;

obtain required regula tory approvals;

obtain coverage and adequate reimbursement from, and negotiate competitive pricing with, third-pa rty payors;

successfully develop and commercialize, independently or with collaborators, new applications for PDS0101, PDS01ADC or i mmunotherapies.

The availability of our competitors’ immunotherapies and other treatments could limit the demand, and the price we are able to charge, for PDS0101 alone or in combination

successfully develop and commercialize, independently or with collaborators, new applications for Versamune® HPV, PDS01ADC or i mmunotherapies.

The availability of our competitors’ immunotherapies and other treatments could limit the demand, and the price we are able to charge, for Versamune® HPV alone or in combination

with PDS01ADC.

The inability to compete with existing or subsequently introduced immunotherapies and other treatments would have an adverse impact on our business, financial condition and prospects.

Established pharmaceutical companies may invest heavily to accelerate discovery and development of novel compounds or to license novel compounds that could make PDS0101 and

PDS01ADC less competitive.

Established pharmaceutical companies may invest heavily to accelerate discovery and development of novel compounds or to license novel compounds that could make Versamune® HPV

and PDS01ADC less competitive.

In addition, any new immunotherapy that competes with an approved treatment must demonstrate compelling advantages in efficacy, convenience, tolerability and safety in order to overcome price competition and to be

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business and results of operations.

PDS0101 and PDS01ADC may cause adverse effects or have other properties that could delay or prevent its regulatory approval or limit the scope of any

approved label or market acceptance.

Adverse events caused by PDS0101 or PDS01ADC could cause reviewing entities, clinical trial sites or regulatory authorities to interrupt, delay or halt clinical trials and

could result in the denial of regulatory approval.

If clinical trials for PDS0101 and PDS01ADC report an unacceptable frequency or severity of adverse events, our ability to obtain regulatory approval for PDS0101 and PDS01ADC may be negatively

Furthermore, if PDS0101 alone or in combination with PDS01ADC is approved and then causes serious or unexpected side effects, a number of potentially significant negative

Versamune® HPV and PDS01ADC may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the scope of

any approved label or market acceptance.

Adverse events caused by Versamune® HPV or PDS01ADC could cause reviewing entities, clinical trial sites or regulatory authorities to interrupt, delay or halt clinical trials

and could result in the denial of regulatory approval.

If clinical trials for Versamune® HPV and PDS01ADC report an unacceptable frequency or severity of adverse events, our ability to obtain regulatory approval for Versamune® HPV and PDS01ADC

may be negatively impacted.

Furthermore, if Versamune® HPV alone or in combination with PDS01ADC is approved and then causes serious or unexpected side effects, a number of potentially significant negative

consequences could result, including:

regulatory authorities may withdraw their approval of PDS0101 or PDS01ADC or impose restrictions on its distribution or other risk management measures;

regulatory authorities may withdraw their approval of Versamune® HPV or PDS01ADC or impose restrictions on its distribution or other risk management measures;

regulatory authorities may require the addition of labeling statements, such as warnings or con traindications;

we may be required to change the way PDS0101 or PDS01ADC is administered or to conduct additional c linical trials;

we may be required to change the way Versamune® HPV or PDS01ADC is administered or to conduct additional c linical trials;

we could be sued and held liable for injuries sustain ed by patients;

we could elect to discontinue the s ale of PDS0101 or PDS01ADC;

we could elect to discontinue the s ale of Versamune® HPV or PDS01ADC;

our entire Versamune® and Infectimune®-based pipeline could be then p ut at risk;

our reputat ion may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of PDS0101 and PDS01ADC and could substantially increase the costs of

Any of these events could prevent us from achieving or maintaining market acceptance of Versamune® HPV and PDS01ADC and could substantially increase the costs of

commercialization.

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operations, financial condition and prospects significantly.

If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize, or will be

delayed in commercializing, PDS0101 and PDS01ADC, and our ability to generate revenue will be impaired.

PDS0101 and PDS01ADC and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy,

If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize, or will be delayed in

commercializing, Versamune® HPV and PDS01ADC, and our ability to generate revenue will be impaired.

Versamune® HPV and PDS01ADC and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy,

recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by comparable authorities in other countries.

Failure to obtain marketing approval for PDS0101 alone or in combination with PDS01ADC will prevent us from commercializing our products.

We have not received approval to market PDS0101 or PDS01ADC from regulatory authorities in any

jurisdiction.

Failure to obtain marketing approval for Versamune® HPV alone or in combination with PDS01ADC will prevent us from commercializing our products.

We have not received approval to market Versamune® HPV or PDS01ADC from regulatory authorities in

any jurisdiction.

We have only limited experience in filing and supporting the applications necessary to gain marketing approvals and expect to rely on contract research organizations to assist us in this process.

Securing regulatory approval

requires the submission of extensive preclinical and clinical data and supporting information to the various regulatory authorities for each therapeutic indication to establish the safety and efficacy of PDS0101 and PDS01ADC.

regulatory approval also requires the submission of information about the product manufacturing process, and inspection of manufacturing facilities by, the relevant regulatory authority.

PDS0101 and PDS01ADC may not be effective, may be only

moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude it from obtaining marketing approval or prevent or limit commercial use.

Versamune® HPV and PDS01ADC may not be effective, may be

only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude it from obtaining marketing approval or prevent or limit commercial use.

The process of obtaining marketing approvals, both in the United States and elsewhere, is expensive, may take many years and can vary substantially based upon a variety of

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In addition, varying interpretations of the data obtained from preclinical

testing and clinical trials could delay, limit or prevent marketing approval of PDS0101 and PDS01ADC.

Additionally, any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render

the approved product not commercially viable.

If any of our product candidates receives marketing approval and we, or others, later discover that the drug is less effective than

previously believed or causes undesirable side effects that were not previously identified, our ability, or that of any future collaborators, to market the drug could be compromised.

Clinical trials of our product candidates must be conducted in carefully defined subsets of patients who have agreed to enter into clinical trials.

Consequently, it is

possible that our clinical trials, or those of any future collaborator, may indicate an apparent positive effect of a product candidate that is greater than the actual positive effect, if any, or alternatively fail to identify undesirable side

If one or more of our product candidates receives marketing approval and we, or others, discover that the drug is less effective than previously believed or causes undesirable side effects that were not previously identified, a number

testing and clinical trials could delay, limit or prevent marketing approval of Versamune® HPV and PDS01ADC.

Additionally, any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that

render the approved product not commercially viable.

If any of our product candidates receives marketing approval and we, or others, later discover that the drug is less safe or effective than previously

believed or causes undesirable side effects that were not previously identified, our ability, or that of any future collaborators, to market the drug could be compromised.

Clinical trials of our product candidates must be conducted in carefully defined groups of patients who have agreed to enter into clinical trials.

Consequently, it is possible

that our clinical trials, or those of any future collaborator, may appear to indicate a positive effect of a product candidate that is greater than the actual positive effect, if any, or alternatively fail to identify undesirable side effects.

If one or more of our product candidates receives marketing approval and we, or others, discover that the drug is less safe or effective than previously believed or causes undesirable side effects that were not previously identified, a number

of potentially significant negative consequences could result, including:

regulatory authorities may withdraw their approval of the drug or seize the drug;

we, or any future collaborators, may be required to recall the drug, change the way the drug is administered or conduct additional clinical trials;

we, or any future collaborators, may determine it is necessary to or it may be required to recall the drug, change the way the drug is administered or conduct additional clinical trials;

additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the particular drug;

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We rely, and intend to continue to rely, on third parties to conduct our clinical trials and perform some of our research and preclinical studies.

these third parties do not satisfactorily carry out their contractual duties, fail to comply with applicable regulatory requirements or do not meet expected deadlines, our development programs may be delayed or subject to increased costs or we

may be unable to obtain regulatory approval, each of which may have an adverse effect on our business, financial condition, results of operations and prospects.

third parties do not satisfactorily carry out their contractual duties, fail to comply with applicable regulatory requirements or do not meet expected deadlines, our development programs may be delayed or subject to increased costs or we may be

unable to obtain regulatory approval, each of which may have an adverse effect on our business, financial condition, results of operations and prospects.

There is no guarantee that any such CROs, clinical trial investigators or other third parties on which we rely will devote adequate time and resources to our development

activities or perform as contractually required.

If any of these third parties fail to meet expected deadlines, adhere to our clinical protocols or meet regulatory requirements, otherwise perform in a substandard manner, or terminate their

engagements with us, the timelines for our development programs may be extended or delayed or our development activities may be suspended or terminated.

If our clinical trial site terminates for any reason, we may experience the loss of

follow-up information on subjects enrolled in such clinical trial unless we are able to transfer those subjects to another qualified clinical trial site, which may be difficult or impossible.

In addition, certain of our scientific advisors or

consultants who receive compensation from us are clinical trial investigators for our clinical trial.

Although we believe our existing relationships are within the FDA’s guidelines, if these relationships and any related compensation result in

perceived or actual conflicts of interest, or the FDA concludes that the financial relationship may have affected the interpretation of the trial, the integrity of the data generated at the applicable clinical trial site may be questioned and

the utility of the clinical trial itself may be jeopardized, which could result in the delay or rejection of any marketing application we submit by the FDA.

Any such delay or rejection could prevent us from commercializing PDS0101, PDS01ADC or

any other product candidates.

Even if we obtain FDA approval in the United States, we may never obtain approval for or commercialize PDS0101 or PDS01ADC in any other jurisdiction,

activities or perform as contractually required or in accordance with applicable laws and regulations.

If any of these third parties fail to meet expected deadlines, adhere to our clinical protocols or meet regulatory requirements, otherwise

perform in a substandard manner, or terminate their engagements with us, the timelines for our development programs may be extended or delayed or our development activities may be suspended or terminated.

If any of our clinical trial sites

terminate for any reason, we may experience the loss of follow-up information on subjects enrolled in such clinical trial unless we are able to transfer those subjects to another qualified clinical trial site, which may be difficult or

In addition, certain of our scientific advisors or consultants who receive compensation from us are clinical trial investigators for our clinical trial.

Although we believe our existing relationships are within the FDA’s guidelines,

if these relationships and any related compensation result in perceived or actual conflicts of interest, or the FDA concludes that the financial relationship may have affected the interpretation of the trial, the integrity of the data generated

at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized, which could result in the delay or rejection of any marketing application we submit by the FDA.

Any such delay or rejection

could prevent us from commercializing Versamune® HPV, PDS01ADC or any other product candidates.

Even if we obtain FDA approval in the United States, we may never obtain approval for or commercialize Versamune® HPV or PDS01ADC in any other jurisdiction,

which would limit our ability to realize each product’s full market potential.

In order to market PDS0101 or PDS01ADC in a particular jurisdiction, we must establish and comply with numerous and varying regulatory requirements on a country-by-country

basis regarding safety and efficacy.

In order to market Versamune® HPV or PDS01ADC in a particular jurisdiction, we must establish and comply with numerous and varying regulatory requirements on a

country-by-country basis regarding safety and efficacy.

Approval by the FDA in the United States does not ensure approval by regulatory authorities in other countries or jurisdictions.

In addition, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not

guarantee regulatory approval in any other country.

In addition, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not guarantee

regulatory approval in any other country.

Approval processes vary among countries and can involve additional testing and validation and additional administrative review periods.

Seeking foreign regulatory approval could result in

difficulties and costs for us and require additional preclinical studies or clinical trials that could be costly and time consuming.

Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of

PDS0101 or PDS01ADC in those countries.

PDS0101 or PDS01ADC is not approved for sale in any jurisdiction, including in international markets, and we do not have experience in obtaining regulatory approval in international markets.

If we fail to

comply with regulatory requirements in international markets or to obtain and maintain required approvals, or if regulatory approvals in international markets are delayed, our target market will be reduced.

Seeking foreign regulatory approval could result in difficulties

and costs for us and require additional preclinical studies or clinical trials that could be costly and time consuming.

Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of Versamune®

HPV or PDS01ADC in those countries.

Versamune® HPV or PDS01ADC is not approved for sale in any jurisdiction, including in international markets, and we do not have experience in obtaining regulatory approval in international markets.

to comply with regulatory requirements in international markets or to obtain and maintain required approvals, or if regulatory approvals in international markets are delayed, our target market will be reduced.

Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more subject data becomes

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results which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a full analysis of all data related to the particular trial.

assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data.

In addition, we may report preliminary analyses of only

certain endpoints rather than all endpoints.

As a result, the interim, topline or preliminary results that we report may differ from future results of the same trials, or different conclusions or considerations may qualify such results, once

additional data has been received and fully evaluated.

assumptions, estimations, calculations and conclusions as part of our analyses of data, and in doing so we may not have received or had the opportunity to fully and carefully evaluate all data.

In addition, we may report preliminary analyses of

only certain endpoints rather than all endpoints.

As a result, the interim, topline or preliminary results that we report may differ from future results of the same trials, or different conclusions or considerations may qualify such results,

once additional data has been received and fully evaluated.

Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published.

result, interim, topline and preliminary data should be viewed with caution until the final data is available.

a result, interim, topline and preliminary data should be viewed with caution until the final data are available.

We may also disclose interim data from our clinical trials.

Interim data from clinical trials that we may complete are subject to the

risk that one or more of the clinical outcomes may materially change as subject enrollment continues and more subject data becomes available.

Adverse differences between interim, topline or preliminary data and final data could significantly

harm our reputation and business prospects.

Interim data from clinical trials that we may complete are subject to

the risk that one or more of the clinical outcomes may materially change as subject enrollment continues and more subject data becomes available.

Adverse differences between interim, topline or preliminary data and final data could

significantly harm our reputation and business prospects.

Further, disclosure of interim, topline or preliminary data by us or by our competitors could result in volatility in the price of our common stock.

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program, drug candidate or our business.

If the interim, topline or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions

reached, our ability to pursue strategic alternatives, including identifying and consummating transactions with third-party partners, to further develop, obtain marketing approval for and/or commercialize our drug candidates may be harmed,

which could harm our business, operating results, prospects or financial condition.

The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, interim

results of a clinical trial do not necessarily predict final results, and the results of our clinical trials may not satisfy the requirements of the FDA or comparable foreign regulatory authorities.

If the interim, topline or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our

ability to pursue strategic alternatives, including identifying and consummating transactions with third-party partners, to further develop, obtain marketing approval for and/or commercialize our drug candidates may be harmed, which could harm

our business, operating results, prospects or financial condition.

The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, interim results of a clinical

trial do not necessarily predict final results, and the results of our clinical trials may not satisfy the requirements of the FDA or comparable foreign regulatory authorities.

We currently have no drugs approved for sale and we cannot guarantee that we will ever have marketable drugs.

Clinical failure can occur at any stage of clinical

Clinical failure can occur at any stage of clinical development.

Clinical trials may produce negative or inconclusive results, and we or any future collaborators may decide, or regulators may require us, to conduct additional clinical trials or preclinical studies.

We will be required to

demonstrate with substantial evidence through adequate and well-controlled clinical trials that our product candidates are safe and effective for use in treating specific conditions in order to obtain marketing approvals for their commercial

Success in preclinical studies and early-stage clinical trials does not mean that future larger registration clinical trials will be successful because product candidates in later-stage clinical trials may fail to demonstrate safety and

efficacy to the satisfaction of the FDA and non-U.S.

We will be required to demonstrate with

substantial evidence through adequate and well-controlled clinical trials that our product candidates are safe and effective for use in treating specific conditions in order to obtain marketing approvals for their commercial sale.

preclinical studies and early-stage clinical trials does not mean that future larger registration clinical trials will be successful because product candidates in later-stage clinical trials may fail to demonstrate safety and efficacy to the

satisfaction of the FDA and non-U.S.

regulatory authorities despite having progressed through preclinical studies and early-stage clinical trials.

Product candidates that have shown promising results in preclinical studies and

early-stage clinical trials may still suffer significant setbacks in subsequent registration clinical trials.

Additionally, the outcome of preclinical studies and early-stage clinical trials may not be predictive of the success of later-stage

clinical trials.

In addition, the design of a clinical trial can determine whether its results will support approval of a drug and flaws in the design of a clinical trial may not become

apparent until the clinical trial is well advanced.

Product candidates that have shown promising results in preclinical studies and early-stage

clinical trials may still suffer significant setbacks in subsequent registration clinical trials.

Additionally, the outcome of preclinical studies and early-stage clinical trials may not be predictive of the success of later-stage clinical

In addition, the design of a clinical trial can effect whether its results will support approval of a drug and flaws in the design of a clinical trial may not become apparent

until the clinical trial is well advanced.

We have limited experience in designing clinical trials and may be unable to design and conduct a clinical trial to support marketing approval.

Further, if our product candidates are found to

be unsafe or lack efficacy, we will not be able to obtain marketing approval for them and our business would be harmed.

A number of companies in the pharmaceutical industry, including those with greater resources and experience than us, have

suffered significant setbacks in advanced clinical trials, even after obtaining promising results in preclinical studies and earlier clinical trials.

In some instances, there can be significant variability in safety and efficacy results between different clinical trials of the same product candidate due to numerous

factors, including changes in trial protocols, differences in size and type of the patient populations, differences in and adherence to the dosing regimen and other trial protocols and the rate of dropout among clinical trial participants.

do not know whether any clinical trials we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain marketing approval to market our product candidates.

In addition, in the event that an adverse safety issue, clinical hold, or other adverse finding occurs in one of our clinical trials, that event could adversely affect any

other clinical trials for the same product candidate.

An adverse safety issue or other adverse finding in a clinical trial conducted by a third party with a similar mechanism of action could adversely affect clinical trials involving our

product candidates.

Further, if our product candidates are found to lack

safety or efficacy, we will not be able to obtain marketing approval for them and our business would be harmed.

A number of companies in the pharmaceutical industry, including those with greater resources and experience than us, have suffered

significant setbacks in advanced clinical trials, even after obtaining promising results in preclinical studies and earlier clinical trials.

In some instances, there can be significant variability in safety and efficacy results between different clinical trials of the same product candidate due to numerous factors,

including changes in trial protocols, differences in size and type of the patient populations, differences in and adherence to the dosing regimen and other trial protocols and the rate of dropout among clinical trial participants.

know whether any clinical trials we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain marketing approval to market our product candidates.

In addition, in the event that a safety issue, clinical hold, or other adverse finding occurs in one of our clinical trials, that event could adversely affect any other clinical

trials for the same product candidate.

A safety or efficacy issue or other adverse finding in a clinical trial conducted by a third party with a similar mechanism of action could adversely affect clinical trials involving our product

Further, our product candidates may not be approved even if they achieve their primary endpoints in clinical trials, including registration trials.

The FDA or comparable

foreign regulatory authorities may disagree with our trial design and our interpretation of data from preclinical studies and clinical trials.

In addition, any of these regulatory authorities may change requirements for the approval of a

product candidate even after reviewing and providing comments or advice on a protocol for a pivotal clinical trial that has the potential to result in approval by the FDA or comparable foreign regulatory authorities.

The FDA or comparable foreign

regulatory authorities may disagree with our trial design and our interpretation of data from preclinical studies and clinical trials.

In addition, any of these regulatory authorities may change requirements for the approval of a product

candidate even after reviewing and providing comments or advice on a protocol for a pivotal clinical trial that has the potential to result in approval by the FDA or comparable foreign regulatory authorities.

In addition, any of these

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efficacy traits even if they have progressed through preclinical studies or initial clinical trials.

Preclinical studies and clinical trials may also reveal unfavorable product candidate characteristics, including safety concerns.

companies in the biopharmaceutical industry have suffered significant setbacks in clinical trials, notwithstanding promising results in earlier preclinical studies or clinical trials or promising mechanisms of action.

In some instances, there

can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type

of the patient populations, changes in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants.

Moreover, should there be an issue with the design of a clinical trial, our results may be impacted.

Preclinical studies and clinical trials may also reveal unfavorable product candidate characteristics, including safety or efficacy concerns.

number of companies in the biopharmaceutical industry have suffered significant setbacks in clinical trials, notwithstanding promising results in earlier preclinical studies or clinical trials or promising mechanisms of action.

instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in

the size and type of the patient populations, changes in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants.

Moreover, should there be an issue with the design of a clinical trial, our

results may be impacted.

We may not discover such a flaw until the clinical trial is at an advanced stage.

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disagree with our study design, including endpoints, or our interpretation of data from preclinical studies and clinical trials or find that a product candidate’s benefits do not outweigh its safety risks.

Even if we obtain regulatory approval, we will still face extensive ongoing regulatory requirements, and PDS0101, PDS01ADC and other candidates may face

future development and regulatory difficulties.

Marketing of PDS0101 alone or in combination with PDS01ADC, if approved, along with the manufacturing processes, post- approval clinical data, labeling, packaging,

distribution, adverse event reporting, storage, recordkeeping, export, import, advertising and promotional activities for PDS0101, among other things, will be subject to extensive and ongoing requirements of and review by the FDA and other

regulatory authorities.

Even if we obtain regulatory approval, we will still face extensive ongoing regulatory requirements, and Versamune® HPV, PDS01ADC and other candidates may

face future development and regulatory difficulties.

Marketing of Versamune® HPV alone or in combination with PDS01ADC, if approved, along with the manufacturing processes, post- approval clinical data, labeling, packaging,

distribution, adverse event reporting, storage, recordkeeping, export, import, advertising and promotional activities for Versamune® HPV, among other things, will be subject to extensive and ongoing requirements of and review by the FDA and

other regulatory authorities.

These requirements include submissions of safety, efficacy and other post-marketing information and reports, establishment of registration and drug listing requirements, continued compliance with current Good

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recordkeeping and current Good Clinical Practice, or cGCP requirements for any clinical trials that we conduct post-approval.

Even if marketing approval of PDS0101 or PDS01ADC is granted, the approval may be subject to limitations on the

indicated uses for which PDS0101 may be marketed or to the conditions of approval.

If PDS0101 or PDS01ADC receives marketing approval, an accompanying label may limit the approved use of the product(s), which could limit sales.

The FDA may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety and/or efficacy of PDS0101 and PDS01ADC.

Even if marketing approval of Versamune® HPV or PDS01ADC is granted, the approval may be subject to limitations on the

indicated uses for which Versamune® HPV may be marketed or to the conditions of approval.

If Versamune® HPV or PDS01ADC receives marketing approval, an accompanying label may limit the approved use of the product(s), which could limit sales.

We may agree to or the FDA may impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety and/or efficacy of Versamune® HPV

and PDS01ADC.

The FDA closely regulates the post-approval marketing and promotion of drugs to ensure drugs are marketed only for the approved indications and in accordance with the provisions of the approved labeling.

The FDA imposes stringent restrictions

on manufacturers’ communications regarding off-label use and if we promote or otherwise market PDS0101 or PDS01ADC for indications other than those for which it is approved, we may be subject to certain enforcement actions.

Violations of the

Federal Food, Drug, and Cosmetic Act relating to the promotion of prescription biopharmaceutical products may lead to FDA enforcement actions and investigations alleging violations of federal and state health care fraud and abuse laws, as well

as state consumer protection laws.

In addition, later discovery of previously unknown adverse events or other problems with PDS0101, manufacturers or manufacturing processes, or failure to comply with

The FDA imposes stringent

restrictions on manufacturers’ communications regarding off-label use and if we promote or otherwise market Versamune® HPV or PDS01ADC for indications other than those for which it is approved, we may be subject to certain enforcement actions.

Violations of the Federal Food, Drug, and Cosmetic Act relating to the promotion of prescription biopharmaceutical products may lead to FDA enforcement actions and investigations alleging violations of federal and state health care fraud and

abuse laws, as well as state consumer protection laws.

In addition, later discovery of previously unknown adverse events or other problems with Versamune® HPV, manufacturers or manufacturing processes, or failure to comply with

regulatory requirements, may yield various results, including:

restrictions on manufacturing PDS0101 or PDS01ADC;

restrictions on the labeling or market ing of PDS0101 or PDS01ADC;

restrictions on distribution or use of PDS0101 or PDS01ADC ;

restrictions on manufacturing Versamune® HPV or PDS01ADC;

restrictions on the labeling or market ing of Versamune® HPV or PDS01ADC;

restrictions on distribution or use of Versamune® HPV or PDS01ADC ;

requirements to conduct post-marketing studies or c linical trials;

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w arning letters;

withdrawal of PDS0101 or PDS01ADC f rom the market;

withdrawal of Versamune® HPV or PDS01ADC f rom the market;

refusal to approve pending applications or supplements to approved applications that we submit;

reca lls of PDS0101 or PDS01ADC;

reca lls of Versamune® HPV or PDS01ADC;

fines, restitution or disgorgement of profi ts or revenues;

suspension or withdrawal of marke ting approvals;

refusal to permit the import or exp ort of PDS0101 or PDS01ADC;

seizures of PDS0101 or PDS01ADC;

refusal to permit the import or exp ort of Versamune® HPV or PDS01ADC;

seizures of Versamune® HPV or PDS01ADC;

injunctions or the imposition of civil or crim inal penalties.

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Further, the cost of compliance with post-approval regulations may have a negative effect on our operating results and financial condition.

Even if PDS0101 or PDS01ADC receives licensure, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the

Even if Versamune® HPV or PDS01ADC receives licensure, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the

medical community necessary for commercial success.

If PDS0101 alone or in combination with PDS01ADC receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients,

If Versamune® HPV alone or in combination with PDS01ADC receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients,

third-party payors and others in the medical community.

If PDS0101 or PDS01ADC does not achieve an adequate level of acceptance, we may not generate significant revenues and become profitable.

The degree of market acceptance, if approved for

commercial sale, will depend on a number of factors, including but not limited to:

If Versamune® HPV or PDS01ADC does not achieve an adequate level of acceptance, we may not generate significant revenues and become profitable.

The degree of market acceptance, if approved

for commercial sale, will depend on a number of factors, including but not limited to:

the efficacy and potential advantages compared to alternative treatments;

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the cost of treatment in relation to alternat ive treatments;

our ability to offer PDS0101 or PDS01ADC for sale at comp etitive prices;

our ability to offer Versamune® HPV or PDS01ADC for sale at comp etitive prices;

the convenience and ease of administration compared to alternat ive treatments;

the willingness of the target patient population to try new therapies and of physicians to prescribe t hese therapies;

the willingness of the medical community to offer customers PDS0101 or PDS01ADC in addition to or in the place of other i mmunotherapies;

the willingness of the medical community to offer customers Versamune® HPV or PDS01ADC in addition to or in the place of other i mmunotherapies;

the strength of marketing and distri bution support;

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the prevalence and severity of any si de effects;

any restrictions on the use of PDS0101 or PDS01ADC together with oth er medications.

Because we expect sales of PDS0101 alone or in combination with PDS01ADC, if approved, to generate substantially all of our revenues for the foreseeable future, the failure

of PDS0101 or PDS01ADC to achieve market acceptance would harm our business and could require us to seek additional financing sooner than we otherwise plan.

We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications

that may be more profitable or for which there is a greater likelihood of success.

Because we have limited financial and managerial resources, we are initially developing our product candidates PDS0101, PDS01ADC and the other Versamune and Infectimune based

As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential.

Our resource allocation decisions may cause us to fail to

timely capitalize on viable commercial products or profitable market opportunities.

Our spending on current and future research and development programs and product candidates for specific indications may not yield any commercially viable

If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements

in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.

If we fail to comply with federal and state healthcare regulatory laws, including in our relationships with healthcare providers and customers and

third-party payors, we could face criminal prosecution and sanctions, substantial civil penalties, damages, fines, disgorgement, exclusion from participation in governmental healthcare programs, contractual damages, reputational harm, and the

curtailment of our operations, any of which could harm our business.

Although we do not provide healthcare services or submit claims for third-party reimbursement, we are subject to healthcare fraud and abuse regulation and enforcement by

federal and state governments, which could significantly impact our business, particularly if and when we commercialize any product candidates and if and when payment becomes available from payors for our products.

Additionally, our future

arrangements with third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market,

sell and distribute our medicines for which we obtain marketing approval.

any restrictions on the use of Versamune® HPV or PDS01ADC together with oth er medications.

Because we expect sales of Versamune® HPV alone or in combination with PDS01ADC, if approved, to generate substantially all of our revenues for the foreseeable future, the

failure of Versamune® HPV or PDS01ADC to achieve market acceptance would harm our business and could require us to seek additional financing sooner than we otherwise plan.

We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that

may be more profitable or for which there is a greater likelihood of success.

Because we have limited financial and managerial resources, we are initially developing our product candidates Versamune® HPV, PDS01ADC and the other Versamune® and Infectimune® based products.

As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have

greater commercial potential.

Our resource allocation decisions may cause us to fail to timely capitalize on viable commercial products or profitable market opportunities.

Our spending on current and future research and development programs

and product candidates for specific indications may not yield any commercially viable products.

If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights

to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.

If we fail to comply with federal and state healthcare regulatory laws, including in our relationships with healthcare providers and customers and third-party

payors, we could face criminal prosecution and sanctions, substantial civil penalties, damages, fines, disgorgement, exclusion from participation in governmental healthcare programs, contractual damages, reputational harm, and the curtailment of

our operations, any of which could harm our business.

Although we do not provide healthcare services or submit claims for third-party reimbursement, we are subject to healthcare fraud and abuse regulation and enforcement by federal

and state governments, which could significantly impact our business, particularly if and when we commercialize any product candidates and if and when payment becomes available from payors for our products.

Additionally, our future arrangements

with third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and

distribute our medicines for which we obtain marketing approval.

The laws that may affect our ability to operate include, but are not limited to:

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using, or causing to be made or used, a false record or statement to avoid, decrease or conceal an obligation to pay money to the federal government.

Intent to deceive is not required to establish liability under the civil False Claims Act.

The intent to deceive is not required to establish liability under the civil False Claims Act.

The False Claims Act’s criminal provisions, which imposes criminal fines or imprisonment against individuals or entities who make or present a claim to the government knowing such claim to be

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business associates independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity.

Section 5(a) of the Federal Trade Commission Act, or the FTCA, 15 USC § 45(a), given that even for entities that are not deemed “ covered entities ” or “ business associates ” under HIPAA, according to the United States Federal

Trade Commission, or the FTC, failing to take appropriate steps to keep consumers ’ personal information secure constitutes unfair acts or practices in or affecting commerce in violation of its laws.

FTC expects a company ’ s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the

cost of available tools to improve security and reduce vulnerabilities.

or the FTC, failing to take appropriate steps to keep consumers ’ personal information secure constitutes unfair acts or practices in or affecting commerce in violation of its laws.

The FTC expects a company ’ s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to

improve security and reduce vulnerabilities.

Medical data is considered sensitive data that merits stronger safeguards.

The FTC ’ s guidance for appropriately securing consumers ’ personal information is similar to what is required by the HIPAA Security Rule.

The FTC ’ s guidance for appropriately securing consumers ’

personal information is similar to what is required by the HIPAA Security Rule.

The federal ”Sunshine” and “Open Payments” requirements under the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation Act, or collectively, the

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Failure to submit timely, accurately, and completely the

required information may result in civil monetary penalties of up to an aggregate of $150,000 per year and up to an aggregate of $1 million per year for “ knowing failures .” In 2022 the Sunshine Act was extended to payments and transfers of value to physician assistants, nurse practitioners, and other mid-level practitioners (with reporting requirements going into effect in 2022 for payments made in

In addition, Section 6004 of the ACA requires annual reporting of information about drug samples that manufacturers and authorized distributors provide to healthcare providers.

State law equivalents of each of the above federal laws and state laws otherwise addressing the pharmaceutical and healthcare industries, such as anti-kickback and false

claims laws that may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including commercial insurers, and in some cases that may apply regardless of payor, i.e., even

if reimbursement is not available;

state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines (the PhRMA Code) and the relevant compliance program guidance promulgated by the

federal government (HHS-OIG), or otherwise prohibit, restrict or impose tracking and disclosure requirements related to payments, gifts, or others remuneration that may be made to healthcare providers and other potential referral sources, or

marketing practices to such persons and entities or drug pricing information;

data privacy and security laws and regulations in foreign jurisdictions that may be more stringent than those in the United States (such as the European Union, which

adopted the General Data Protection Regulation, which became effective in May 2018) and state laws governing the privacy and security of information in certain circumstances, many of which differ from each other in significant ways and may not

have the same effect, and may apply more broadly than HIPAA, thus complicating compliance efforts.

In our business, healthcare providers, physicians and third-party payors will play a primary role in the recommendation and prescription of our product candidates, if

approved for marketing.

required information may result in civil monetary penalties of up to an aggregate of $150,000 per year and up to an aggregate of $1 million per year for “ knowing failures .”

In 2022 the Sunshine Act was extended to payments and transfers of value to physician assistants, nurse practitioners, and other mid-level practitioners (with reporting requirements going into effect in 2022 for payments made in 2021).

addition, Section 6004 of the ACA requires annual reporting of information about drug samples that manufacturers and authorized distributors provide to healthcare providers.

State law equivalents of each of the above federal laws and state laws otherwise addressing the pharmaceutical and healthcare industries, such as anti-kickback and false claims

laws that may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including commercial insurers, and in some cases that may apply regardless of payor, i.e., even if

reimbursement is not available;

government (HHS-OIG), or otherwise prohibit, restrict or impose tracking and disclosure requirements related to payments, gifts, or others remuneration that may be made to healthcare providers and other potential referral sources, or marketing

practices to such persons and entities or drug pricing information;

data privacy and security laws and regulations in foreign jurisdictions that may be more stringent than those in the United States (such as the European Union, which adopted the

General Data Protection Regulation, which became effective in May 2018) and state laws governing the privacy and security of information in certain circumstances, many of which differ from each other in significant ways and may not have the same

effect, and may apply more broadly than HIPAA, thus complicating compliance efforts.

In our business, healthcare providers, physicians and third-party payors will play a primary role in the recommendation and prescription of our product candidates, if approved for

Moreover, while we do not plan to submit claims and our customers will make the ultimate decision on how to submit claims, from time to time, we may provide reimbursement guidance to our customers.

Current or future

arrangements with physicians and other healthcare providers and customers, and third-party payors, may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial

arrangements and relationships through which we market, sell and distribute our medicines for which we obtain marketing approval.

If a government authority were to conclude that we provided improper advice to our customers or encouraged the

submission of false claims for reimbursement or failed to comply with government price reporting requirements, or engaged in off-label promotion of products, we could face action by government authorities.

Any violations of these laws, or any

action against us for violation of these laws, even if we successfully defend against it, could result in a material adverse effect on our reputation, business, results of operations and financial condition.

Current or future arrangements with

physicians and other healthcare providers and customers, and third-party payors, may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and

relationships through which we market, sell and distribute our medicines for which we obtain marketing approval.

If a government authority were to conclude that we provided improper advice to our customers or encouraged the submission of false

claims for reimbursement or failed to comply with government price reporting requirements, or engaged in off-label promotion of products, we could face action by government authorities.

Any violations of these laws, or any action against us for

violation of these laws, even if we successfully defend against it, could result in a material adverse effect on our reputation, business, results of operations and financial condition.

We have entered into consulting and employment arrangements with individuals, physicians and other healthcare providers.

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otherwise have an adverse effect on our business.

Even if we are able to commercialize any product candidate, such product candidate may become subject to unfavorable pricing regulations, third-party

coverage and reimbursement policies or healthcare reform initiatives, which could harm our business.

Even if we are able to commercialize any product candidate, such product candidate may become subject to unfavorable pricing regulations, third-party coverage

and reimbursement policies or healthcare reform initiatives, which could harm our business.

The regulations that govern marketing approval, pricing, coverage and reimbursement for new drugs vary widely from country to country.

Some countries require approval of the

sale price of a drug before it can be marketed.

Some countries require approval of the sale

price of a drug before it can be marketed.

In many countries, the pricing review period begins after marketing approval is granted.

In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental

control even after initial approval is granted.

As a result, we might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay our commercial launch of the product, possibly for lengthy

time periods, and negatively impact the revenues we are able to generate from the sale of the product in that country.

Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if our

product candidates obtain marketing approval.

Our ability to commercialize any products successfully also will depend in part on the extent to which reimbursement and coverage for these products and related treatments

will be available from government authorities, private health insurers and other organizations, and if reimbursement and coverage is available, the level of reimbursement and coverage.

Government authorities and third-party payors, such as

private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels.

In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control

even after initial approval is granted.

As a result, we might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay our commercial launch of the product, possibly for lengthy time

periods, and negatively impact the revenues we are able to generate from the sale of the product in that country.

Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if our product

candidates obtain marketing approval.

Our ability to commercialize any products successfully also will depend in part on the extent to which reimbursement and coverage for these products and related treatments will be

available from government authorities, private health insurers and other organizations, and if reimbursement and coverage is available, the level of reimbursement and coverage.

Government authorities and third-party payors, such as private health

insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels.

A primary trend in the healthcare industry in the United States and elsewhere is cost containment.

Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications.

Increasingly, the third-party payors who reimburse patients or healthcare providers,

such as government and private insurance plans, are requiring that drug companies provide them with predetermined discounts from list prices, and are seeking to reduce the prices charged or the amounts reimbursed for medical products.

be sure that coverage and reimbursement will be available for any drug that we commercialize and, if coverage and reimbursement are available, we cannot be sure as to the level of reimbursement.

Reimbursement may impact the demand for, or the

price of, any product candidate for which we obtain marketing approval.

If reimbursement is not available or is available only to limited levels, we may not be able to successfully commercialize any product candidate for which we obtain marketing

There may be significant delays in obtaining reimbursement for newly approved drugs, and coverage may be more limited than the purposes for which the drug is approved by the

FDA or comparable foreign regulatory authorities.

authorities and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications.

Increasingly, the third-party payors who reimburse patients or healthcare providers, such as

government and private insurance plans, are requiring that drug companies provide them with predetermined discounts from list prices, and are seeking to reduce the prices charged or the amounts reimbursed for medical products.

We cannot be sure

that coverage and reimbursement will be available for any drug that we commercialize and, if coverage and reimbursement are available, we cannot be sure as to the level of reimbursement.

Reimbursement may impact the demand for, or the price of,

any product candidate for which we obtain marketing approval.

If reimbursement is not available or is available only to limited levels, we may not be able to successfully commercialize any product candidate for which we obtain marketing approval.

There may be significant delays in obtaining reimbursement for newly approved drugs, and coverage may be more limited than the purposes for which the drug is approved by the FDA

or comparable foreign regulatory authorities.

Moreover, eligibility for reimbursement does not imply that any drug will be reimbursed in all cases or at a rate that covers our costs, including research, development, manufacture, sale and

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overall financial condition.

Product liability lawsuits against us could cause us to incur substantial liabilities and could limit the commercialization of PDS0101 and PDS01ADC.

We face an inherent risk of product liability exposure related to the testing of PDS0101 alone or in combination with PDS01ADC in human clinical trials and will face an

Product liability lawsuits against us could cause us to incur substantial liabilities and could limit the commercialization of Versamune® HPV and PDS01ADC.

We face an inherent risk of product liability exposure related to the testing of Versamune® HPV alone or in combination with PDS01ADC in human clinical trials and will face an

even greater risk if we commercially sell any products that we may develop after approval.

Regardless of merit or eventual outcome, liability claims may result in:

decreased demand for PDS0101, PDS01ADC or other immunotherapies that we may develop;

decreased demand for Versamune® HPV, PDS01ADC or other immunotherapies that we may develop;

injury to our reputation and significant negative m edia attention;

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If we are unable to establish sales, marketing and distribution capabilities either on our own or in collaboration with third parties, we may not be

successful in commercializing PDS0101, PDS01ADC and other product candidates, if approved.

We do not have any infrastructure for the sales, marketing or distribution of PDS0101, PDS01ADC or other product candidates, and the cost of establishing and maintaining

successful in commercializing Versamune® HPV, PDS01ADC and other product candidates, if approved.

We do not have any infrastructure for the sales, marketing or distribution of Versamune® HPV, PDS01ADC or other product candidates, and the cost of establishing and maintaining

such an organization may exceed the cost-effectiveness of doing so.

In order to market PDS0101, PDS01ADC or other product candidates, we must build our sales, distribution, marketing, managerial and other non-technical capabilities or make

arrangements with third parties to perform these services.

To achieve commercial success for PDS0101, PDS01ADC or other product candidates, we will need either our own, or a third party’s, sales and marketing organization.

There are significant

expenses and risks involved with creating teams for, or contracting for, sales, marketing and distribution capabilities.

Any failure or delay in the development of our sales, marketing and distribution capabilities, either internally or in

collaboration with third parties, could delay the launch of PDS0101, PDS01ADC or other product candidates, which would adversely affect commercialization.

In order to market Versamune® HPV, PDS01ADC or other product candidates, we must build our sales, distribution, marketing, managerial and other non-technical capabilities or

make arrangements with third parties to perform these services.

To achieve commercial success for Versamune® HPV, PDS01ADC or other product candidates, we will need either our own, or a third party’s, sales and marketing organization.

significant expenses and risks involved with creating teams for, or contracting for, sales, marketing and distribution capabilities.

Any failure or delay in the development of our sales, marketing and distribution capabilities, either

internally or in collaboration with third parties, could delay the launch of Versamune® HPV, PDS01ADC or other product candidates, which would adversely affect commercialization.

We may be competing with many companies that currently have extensive and well-funded marketing and sales operations.

Without an internal team or the support of a

third-party to perform marketing and sales functions, we may be unable to compete successfully against these more established companies.

If we obtain approval to commercialize PDS0101, PDS01ADC or other product candidates outside of the United States, a variety of risks associated with

Without an internal team or the support of a third-party to

perform marketing and sales functions, we may be unable to compete successfully against these more established companies.

If we obtain approval to commercialize Versamune® HPV, PDS01ADC or other product candidates outside of the United States, a variety of risks associated with

international operations could harm our business.

If PDS0101, PDS01ADC or other product candidates is approved for commercialization, we may enter into agreements with third parties to market them in certain jurisdictions

outside the United States.

If Versamune® HPV, PDS01ADC or other product candidates is approved for commercialization, we may enter into agreements with third parties to market them in certain

jurisdictions outside the United States.

We expect that we will be subject to additional risks related to international operations or entering into international business relationships, including:

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We have no prior experience in these areas.

In addition, there are complex regulatory, tax, labor and other legal requirements imposed by both the European Union and many

of the individual countries in Europe with which we will need to comply.

In addition, there are complex regulatory, tax, labor and other legal requirements imposed by both the European Union and many of the

individual countries in Europe with which we will need to comply.

Recently enacted and future healthcare legislation, regulations, and policy initiatives may increase the difficulty and cost for us to obtain marketing

approval of and commercialize PDS0101, PDS01ADC or other product candidates and affect the prices we may obtain and our profitability.

In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system

that could, among other things, prevent or delay marketing approval of PDS0101 alone or in combination with PDS01ADC and our other product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell

PDS0101, PDS01ADC and other product candidates.

approval of and commercialize Versamune® HPV, PDS01ADC or other product candidates and affect the prices we may obtain and our profitability.

In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that

could, among other things, prevent or delay marketing approval of Versamune® HPV alone or in combination with PDS01ADC and our other product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell

Versamune® HPV, PDS01ADC and other product candidates.

For example, in March 2010, the Affordable Care Act, or ACA, was enacted to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance

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interpretations will be changed, or what the impact of such changes on our business, if any, may be.

We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state

governments will pay for immunotherapies, which could result in reduced demand for PDS0101 and other product candidates or additional pricing pressures.

We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments

will pay for immunotherapies, which could result in reduced demand for Versamune® HPV and other product candidates or additional pricing pressures.

Risks Related to Our Dependence on Third Parties

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We currently have agreements with various third-party manufacturing facilities for production of our products for research and development and testing purposes.

on third-party manufacturers to supply our preclinical and clinical materials and will be reliant on a third-party manufacturer to produce PDS0101 or PDS01ADC on a commercial scale, should that product receive regulatory approval.

manufacturers must be able to meet our deadlines and adhere to quality standards and specifications.

Our predominant reliance on third parties for the manufacture of PDS0101, PDS01ADC and all of our Versamune® and Infectimune® based products

creates a dependency that could severely disrupt our research and development, clinical testing, and sales and marketing efforts if the source of such supply proves to be unreliable or unavailable.

There is no assurance that any third-party

manufacturers will be able to meet commercialized scale production requirements in a timely manner or in accordance with applicable standards or cGMP.

third-party manufacturers to supply our preclinical and clinical materials and will be reliant on a third-party manufacturer to produce Versamune® HPV or PDS01ADC on a commercial scale, should that product receive regulatory approval.

Third-party manufacturers must be able to meet our deadlines and adhere to quality standards and specifications.

Our predominant reliance on third parties for the manufacture of Versamune® HPV, PDS01ADC and all of our Versamune® and

Infectimune® based products creates a dependency that could severely disrupt our research and development, clinical testing, and sales and marketing efforts if the source of such supply proves to be unreliable or unavailable.

assurance that any third-party manufacturers will be able to meet commercialized scale production requirements in a timely manner or in accordance with applicable standards or cGMP.

We expect to rely on third-party manufacturers or third-party collaborators for the manufacture of our product candidates for commercial supply of any of our product candidates for which we or

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receive marketing approval on a timely and competitive basis.

We intend to rely on third parties to conduct, supervise and monitor our clinical trials, and if those third parties perform in an unsatisfactory

manner, it may harm our business.

We intend to rely on third parties to conduct, supervise and monitor our clinical trials, and if those third parties perform in an unsatisfactory manner, it

may harm our business.

We intend to rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials, and we expect to have limited influence over their actual

We intend to rely upon CROs to monitor and manage data for our clinical programs.

We expect to control only certain aspects of our CROs’ activities.

Nevertheless, we will

be responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards and our reliance on the CROs does not relieve us of our regulatory responsibilities.

We intend to rely upon CROs to monitor and manage data for our clinical programs and we do expect to be able to exert direct control over all aspects of our CROs’

Nevertheless, we will be responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards and our reliance on the CROs does not relieve us of our

regulatory responsibilities.

We and our CROs will be required to comply with the Good Laboratory Practices and GCPs, which are regulations and guidelines enforced by the FDA and are also required by the

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we may be required to repeat clinical trials, which would delay the regulatory approval process.

Our CROs will not be our employees, and we will not control whether or not they devote sufficient time and resources to our future clinical and nonclinical programs.

CROs may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials, or other drug development activities which could harm our competitive position.

We face the risk

of potential unauthorized disclosure or misappropriation of our intellectual property by CROs, which may reduce our trade secret protection and allow our potential competitors to access and exploit our proprietary technology.

If our CROs do not

successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory

requirements or for any other reasons, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize PDS0101 alone or in combination with PDS01ADC.

result, our financial results and the commercial prospects for PDS0101 and PDS01ADC would be harmed, our costs could increase, and our ability to generate revenues could be delayed.

Our CROs will not be our employees, and we will not be able to exert direct control over whether or not they devote sufficient time and resources to our future clinical and

nonclinical programs.

These CROs may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials, or other drug development activities which could harm our competitive

position, or as to which they could prioritize their activities to other products over activities related to our products.

We face the risk of potential unauthorized disclosure or misappropriation of our intellectual property by CROs, which may

reduce our trade secret protection and allow our potential competitors to access and exploit our proprietary technology.

If our CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if

the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for any other reasons, our clinical trials may be extended, delayed or terminated, and

we may not be able to obtain regulatory approval for, or successfully commercialize Versamune® HPV alone or in combination with PDS01ADC.

As a result, our financial results and the commercial prospects for Versamune® HPV and PDS01ADC would be

harmed, our costs could increase, and our ability to generate revenues could be delayed.

If our relationship with these CROs terminate, we may not be able to enter into arrangements with alternative CROs or do so on commercially reasonable terms.

adding additional CROs involves substantial cost and requires management time and focus.

Switching or adding

additional CROs involves substantial cost and requires management time and focus.

In addition, there is a natural transition period when a new CRO commences work.

As a result, delays occur, which can materially impact our ability to meet

our desired clinical development timelines.

Though we intend to carefully manage our relationships with our CROs, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will

not have an adverse impact on our business, financial condition and prospects.

As a result, delays occur, which can materially impact our ability to meet our

desired clinical development timelines.

Though we intend to carefully manage our relationships with our CROs, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not

have an adverse impact on our business, financial condition and prospects.

If we are unable to establish or manage strategic collaborations in the future, our revenue and drug development may be limited.

Our strategy may include potential reliance upon strategic collaborations for marketing and commercialization of PDS0101 and other Versamune®, Versamune® in combination

with PDS01ADC and Infectimune® Products.

We also rely on strategic collaborations for research, development, marketing and commercialization for PDS0101 and other Versamune® Products.

We have also been heavily reliant upon third-party

outsourcing for our clinical trials execution and production of drug supplies for use in clinical trials.

Our strategy may include potential reliance upon strategic collaborations for marketing and commercialization of Versamune® HPV and other Versamune®, Versamune® in combination

with PDS01ADC Products.

We also rely on strategic collaborations for research, development, marketing and commercialization for our Products.

We have also been heavily reliant upon third-party outsourcing for our clinical trials execution and

production of drug supplies for use in clinical trials.

Establishing strategic collaborations is difficult and time-consuming.

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Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA

or similar regulatory authorities outside the United States, the potential market for PDS0101 and other Versamune® and Versamune® in combination with PDS01ADC Products, the costs and complexities of manufacturing and delivering PDS0101 and

other Versamune® and Versamune® in combination with PDS01ADC Products to patients, the potential of competing products, the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such

ownership without regard to the merits of the challenge and industry and market conditions generally.

The collaborator may also consider alternative immunotherapies for similar indications that may be available to collaborate on and whether

such a collaboration could be more attractive than the one with us for PDS0101 and other Versamune® and Versamune® in combination with PDS01ADC Products.

Our current collaborations, as well as any future new collaborations, may never result in the successful development or commercialization of PDS0101 and other Versamune®,

or similar regulatory authorities outside the United States, the potential market for Versamune® HPV and other Versamune® and Versamune® in combination with PDS01ADC Products, the costs and complexities of manufacturing and delivering

Versamune® HPV and other Versamune® and Versamune® in combination with PDS01ADC Products to patients, the potential of competing products, the existence of uncertainty with respect to our ownership of technology, which can exist if there is a

challenge to such ownership without regard to the merits of the challenge and industry and market conditions generally.

The collaborator may also consider alternative immunotherapies for similar indications that may be available to collaborate

on and whether such a collaboration could be more attractive than the one with us for Versamune® HPV and other Versamune® and Versamune® in combination with PDS01ADC Products.

Our current collaborations, as well as any future new collaborations, may never result in the successful development or commercialization of Versamune® HPV and other Versamune®,

Versamune® in combination with PDS01ADC and Infectimune® Products or the generation of sales revenue.

To the extent that we have entered or will enter into co-promotion or other collaborative arrangements, PDS0101 and other Versamune® and

Versamune® in combination with PDS01ADC Products revenues are likely to be lower than if we directly marketed and sold any products that we develop.

To the extent that we have entered or will enter into co-promotion or other collaborative arrangements, Versamune® HPV and other Versamune®

and Versamune® in combination with PDS01ADC Products revenues are likely to be lower than if we directly marketed and sold any products that we develop.

Management of our relationships with our collaborators will require:

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If we continue to enter into research and development collaborations, our success will in part depend on the performance of our collaborators.

We will not directly control

the amount or timing of resources devoted by our collaborators to activities related to PDS0101 and other Versamune® and Versamune® in combination with PDS01ADC Products.

Our collaborators may not commit sufficient resources to our research and

development programs or the commercialization, marketing or distribution of PDS0101 and other Versamune® and Versamune® in combination with PDS01ADC Products.

If any collaborator fails to commit sufficient resources, our preclinical or clinical

development programs related to this collaboration could be delayed or terminated.

We will not directly control the

amount or timing of resources devoted by our collaborators to activities related to Versamune® HPV and other Versamune® and Versamune® in combination with PDS01ADC Products.

Our collaborators may not commit sufficient resources to our research

and development programs or the commercialization, marketing or distribution of Versamune® HPV and other Versamune® and Versamune® in combination with PDS01ADC Products.

If any collaborator fails to commit sufficient resources, our preclinical

or clinical development programs related to this collaboration could be delayed or terminated.

Also, our collaborators may pursue existing or other development-stage products or alternative technologies in preference to those being developed in

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may face legal claims that may involve considerable expense and could negatively affect our financial results.

We enter into various contracts in the normal course of our business in which we agree to indemnify the

other party to the contract.

We enter into various contracts in the normal course of our business in which we may be obligated to

indemnify the other party to the contract.

In the event we have to perform under these indemnification provisions, it could have a material adverse effect on our business, financial condition and results of operations.

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indemnification provisions.

With respect to our academic and other research agreements, we typically agree to indemnify the institution and related parties from losses arising from claims relating to the products, processes or services made,

With respect to our academic and other research agreements, we may be obligated to indemnify the institution and related parties from losses arising from claims relating to the products, processes or services made,

used, sold or performed pursuant to the agreements for which we have secured licenses, and from claims arising from our or our sub licensees’ exercise of rights under the agreement.

With respect to our commercial agreements, we have agreed to

indemnify our vendors from any third-party product liability claims that could result from the production, use or consumption of the product, as well as for alleged infringements of any patent or other intellectual property right by a third

With respect to consultants, we typically agree to indemnify them from claims arising from the good faith performance of their services.

With respect to our commercial agreements, we may be obligated

to indemnify our vendors from any third-party product liability claims that could result from the production, use or consumption of the product, as well as for alleged infringements of any patent or other intellectual property right by a third

With respect to consultants, we may be obligated to indemnify them from claims arising from the good faith performance of their services.

Should our obligation under an indemnification provision exceed applicable insurance coverage or if we were denied insurance coverage or not covered by insurance, our

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otherwise does not have assets available to indemnify us, our business, financial condition and results of operations could be adversely affected.

The failure of third parties to meet their contractual, regulatory, and other obligations could adversely affect our business.

We rely on suppliers, vendors, outsourcing partners, consultants, alliance partners and other third parties to research, develop, manufacture and commercialize our products

and manage certain parts of our business.

The failure of third parties to meet their contractual, legal, regulatory, and other obligations could adversely affect our business.

We rely on suppliers, vendors, outsourcing partners, consultants, alliance partners and other third parties to research, develop, manufacture and commercialize our products and

manage certain parts of our business.

Using these third parties poses a number of risks, such as:

they may not perform to our standards or legal requirements;

they may not perform to our standards or legal or regulatory requirements;

they may not produce re liable results;

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significant disruption in the operations of third-party manufacturers and CROs upon whom we rely.

As a result of pandemics, and related “shelter in place” orders and other public health guidance measures, we have and may in the future experience disruptions that

materially and adversely impact our clinical trials, business, financial condition and results of operations.

As a result of pandemics, and related “shelter in place” orders and other public health guidance measures, we have and may in the future experience disruptions that materially

and adversely impact our clinical trials, business, financial condition and results of operations.

Potential disruptions include but are not limited to:

delays or difficulties in enrolling patients in our clinical trials;

delays or difficulties in enrolling patients and retaining study subjects in our clinical trials;

delays or difficulties in initiating or expanding clinical trials, including delays or difficulties with clinical site initiation and recruiting clinical site investigators and clinical site staff;

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interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others or

interruption of clinical trial subject visits and study procedures, which may impact the integrity of subject data and clinical study endpoints;

interruption of clinical trial subject visits and study procedures, which may impact the integrity of subject data and clinical trial endpoints;

interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines;

delays or disruptions in preclinical experiments and investigational new drug application-enabling studies due to restrictions of on-site staff and unforeseen circumstances at contract research

organizations and vendors;

interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in

delivery systems;

delays or disruptions in preclinical experiments and investigational new drug application-enabling studies due to restrictions of on-site staff and unforeseen circumstances at contract research organizations and

limitations on our ability to recruit and hire key personnel due to our inability to meet with candidates because of travel restrictions and “shelter in place” orders;

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Risks Related to Our Intellectual Property

If we are unable to obtain and/or maintain patent protection for our Versamune®, Versamune® in combination with PDS01ADC platforms, PDS0101, other Versamune®

based Products or Infectimune®, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.

If we are unable to obtain and/or maintain patent protection for our Versamune®, Versamune® in combination with PDS01ADC platforms, Versamune® HPV, other

Versamune® based Products or Infectimune®, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.

We rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related to Versamune® and Infectimune®.

Our success depends in large part on our ability to obtain and maintain patent protection in the United States and other countries.

We seek to protect our proprietary position by filing patent applications in the United States and abroad

related to Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products.

The patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent

applications at a reasonable cost or in a timely manner.

success depends in large part on our ability to obtain and maintain patent protection in the United States and other countries.

We seek to protect our proprietary position by filing patent applications in the United States and abroad related to

Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products.

The patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at

a reasonable cost or in a timely manner.

It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection.

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Any successful challenge to these patents or any other patents owned by or licensed to us could

deprive us of rights necessary for the successful commercialization of PDS0101 and other Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products that we may develop.

Further, if we encounter delays in regulatory

approvals, the period of time during which we could exclusively market PDS0101 and other Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products under patent protection could be reduced.

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been

the subject of much litigation.

deprive us of rights necessary for the successful commercialization of Versamune® HPV and other Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products that we may develop.

Further, if we encounter delays in

regulatory approvals, the period of time during which we could exclusively market Versamune® HPV and other Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products under patent protection could be reduced.

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the

subject of much litigation.

In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States.

For example, European patent law restricts the patentability of methods of treatment of

the human body more than U.S.

Publications of discoveries in scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18

months after filing, or in some cases not at all.

Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we were the first to

file for patent protection of such inventions.

For example, European patent law restricts the patentability of methods of treatment of the

human body more than U.S.

Publications of discoveries in scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months

after filing, or in some cases not at all.

Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we were the first to file for

patent protection of such inventions.

As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain.

Our pending and future patent applications may not result in patents being

issued which protect PDS0101 or other Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and

Our pending and future patent applications may not result in patents being issued

which protect Versamune® HPV or other Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and

immunotherapies.

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An adverse determination in any such submission or proceeding could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or immunotherapies and compete directly with

us, without payment to us, or result in our inability to manufacture or commercialize PDS0101 without infringing third- party patent rights.

In addition, if the breadth or strength of protection provided by our patents and patent applications

is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize PDS0101 and other Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products.

us, without payment to us, or result in our inability to manufacture or commercialize Versamune® HPV without infringing third- party patent rights.

In addition, if the breadth or strength of protection provided by our patents and patent

applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize Versamune® HPV and other Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products.

The issuance of a patent is not conclusive as to our inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or

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however, the life of a patent, and the protection it affords, is limited.

Without patent protection for PDS0101 and other Versamune®,

Versamune® in combination with PDS01ADC and Infectimune® based products, we may be open to competition from generic versions of PDS0101 or other similar products using our technology.

Given the amount of time required for the development,

testing and regulatory review of new immunotherapy candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.

As a result, our owned and licensed patent portfolio may not provide us

with sufficient rights to exclude others from commercializing immunotherapies similar or identical to ours.

Without patent protection for Versamune® HPV and other Versamune®,

Versamune® in combination with PDS01ADC and Infectimune® based products, we may be open to competition from generic versions of Versamune® HPV or other similar products using our technology.

Given the amount of time required for the

development, testing and regulatory review of new immunotherapy candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.

As a result, our owned and licensed patent portfolio may not

provide us with sufficient rights to exclude others from commercializing immunotherapies similar or identical to ours.

We may have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.

We may have limited intellectual property rights outside the U.S.

Filing, prosecuting and defending patents on product candidates in all countries throughout the world

would be prohibitively expensive, and our intellectual property rights in some countries outside the U.S.

Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be

prohibitively expensive, and our intellectual property rights in some countries outside the U.S.

can be less extensive than those in the U.S.

In addition, the laws of some foreign countries do not protect intellectual property rights

to the same extent as federal and state laws in the U.S.

Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the U.S., or from selling or importing products made using our inventions

in and into the U.S.

In addition, the laws of some foreign countries do not protect intellectual property rights to the

same extent as federal and state laws in the U.S.

Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the U.S., or from selling or importing products made using our inventions in and

into the U.S.

or other jurisdictions.

Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories

where we have patent protection, but enforcement is not as strong as that in the U.S.

These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from

Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where we

have patent protection, but enforcement is not as strong as that in the U.S.

These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.

The legal systems of certain countries, particularly certain developing countries, do not favor

the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biopharmaceutical products, which could make it difficult for us to stop the infringement of our patents or marketing of

competing products in violation of our proprietary rights generally.

Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business,

could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate, and

the damages or other remedies awarded, if any, may not be commercially meaningful.

The legal systems of certain countries, particularly certain developing countries, do not favor the

enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biopharmaceutical products, which could make it difficult for us to stop the infringement of our patents or marketing of competing

products in violation of our proprietary rights generally.

Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put

our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate, and the

damages or other remedies awarded, if any, may not be commercially meaningful.

Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the

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Competitors may infringe or otherwise violate our patents, the patents of our licensors or our other intellectual property rights.

To counter infringement or unauthorized

use, we may be required to file legal claims, which can be expensive and time-consuming.

In addition, in an infringement proceeding, a court may decide that a patent of ours or our licensors is not valid or is unenforceable, or may refuse to

stop the other party from using the technology at issue on the grounds that such patents do not cover the technology in question.

To counter infringement or unauthorized use,

we may be required to file legal claims, which can be expensive and time-consuming.

In addition, in an infringement proceeding, a court may decide that a patent of ours or our licensors is not valid or is unenforceable, or may refuse to stop

the other party from using the technology at issue on the grounds that such patents do not cover the technology in question.

An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being

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If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of any future patent

protection on PDS0101 and other Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products.

protection on Versamune® HPV and other Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products.

Such a loss of patent protection could harm our business.

We may also face claims that our products infringe patents that our competitors hold.

Claims for alleged infringement and any resulting lawsuit, if successful, could

subject us to significant liability for damages and invalidations of our proprietary rights.

Claims for alleged infringement and any resulting lawsuit, if successful, could subject us

to significant liability for damages and invalidations of our proprietary rights.

Any such lawsuit, regardless of our success, would likely be time consuming and expensive to resolve and would divert management time and attention.

Any potential intellectual property litigation could also force us to do one or more of the following:

Any potential

intellectual property litigation could also force us to do one or more of the following:

(a) stop selling our products;

(b) obtain a license(s), from the owner of any asserted intellectual property, to sell or use the relevant

technology, which license may not be available on reasonable terms, or at all;

(b) obtain a license(s), from the owner of any asserted intellectual property, to sell or use the relevant technology, which

license may not be available on reasonable terms, or at all;

or (c) redesign our products to avoid using the relevant technology.

We may not be able to prevent, alone or with our licensors, misappropriation of our intellectual property rights, particularly in countries where the laws may not protect

those rights as fully as in the United States.

We may not be able to prevent, alone or with our licensors, misappropriation of our intellectual property rights, particularly in countries where the laws may not protect those

rights as fully as in the United States.

Our business could be harmed if in litigation the prevailing party does not offer us a license on commercially reasonable terms.

Any litigation or other proceedings to enforce our intellectual

property rights may fail, and even if successful, may result in substantial costs and distract our management and other employees.

Any litigation or other proceedings to enforce our intellectual property

rights may fail, and even if successful, may result in substantial costs and distract our management and other employees.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential

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perceive these results to be negative, it could have an adverse effect on the price of our common stock.

Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to

protect our products.

Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect

our products.

As is the case with other biotechnology companies, our success is heavily dependent on intellectual property, particularly patents.

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we may obtain patent protection, but where patent enforcement is not as strong as that in the United States.

These immunotherapies may compete with PDS0101 in jurisdictions where we do not have any issued or licensed patents and any future

patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing.

These immunotherapies may compete with Versamune® HPV in jurisdictions where we do not have any issued or licensed patents and any

future patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing.

Many countries, including European Union countries, India, Japan and China, have compulsory licensing laws under which a patent owner may be compelled under specified

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develop or license.

Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our

trade secrets will be misappropriated or disclosed.

We seek to protect our proprietary technology in part by entering into confidentiality agreements with third parties and, if applicable, material transfer agreements,

consulting agreements or other similar agreements with our advisors, employees, third-party contractors and consultants prior to beginning research or disclosing proprietary information.

These agreements typically limit the rights of the third

parties to use or disclose our confidential information, including our trade secrets.

Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the

risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements.

Given that our proprietary position is based, in part, on our

know-how and trade secrets, a competitor’s discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may have an adverse effect on our business and results of operations.

Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade

secrets will be misappropriated or disclosed.

We seek to protect our proprietary technology in part by entering into confidentiality agreements with third parties and, if applicable, material transfer agreements, consulting

agreements or other similar agreements with our advisors, employees, third-party contractors and consultants prior to beginning research or disclosing proprietary information.

These agreements typically limit the rights of the third parties to

use or disclose our confidential information, including our trade secrets.

Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that

such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements.

Given that our proprietary position is based, in part, on our know-how

and trade secrets, a competitor’s discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may have an adverse effect on our business and results of operations.

In addition, these agreements typically restrict the ability of our advisors, employees, third-party contractors and consultants to publish data potentially relating to our

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Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies.

broad market fluctuations may also adversely affect the trading price of our common stock.

In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against

those companies.

market fluctuations may also adversely affect the trading price of our common stock.

In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against those

Such litigation, if instituted, could result in substantial costs and diversion of management attention and resources, which could significantly harm our profitability and reputation.

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Delisting could negatively affect the price of our common stock, which could make it more difficult for us to sell securities in a future financing or for you to sell our common stock.

We are required to meet the continued listing requirements of the Nasdaq Capital Market and other Nasdaq rules, including those regarding director independence and

independent committee requirements, minimum stockholders’ equity, minimum share price and certain other corporate governance requirements.

In particular, we are required to maintain a minimum bid price for our listed common stock of $1.00 per

If we do not meet these continued listing requirements, our common stock could be delisted.

Delisting from the Nasdaq Capital Market would cause us to pursue eligibility for trading of these securities on other markets or exchanges,

including the over-the-counter (OTC) BB or QB markets, or on the OTC “pink sheets.” In such case, our stockholders’ ability to trade, or obtain quotations of the market value of our common stock would be severely limited because of lower

trading volumes and transaction delays.

We are required to meet the continued listing requirements of the Nasdaq Capital Market and other Nasdaq rules, including those regarding director independence and independent

committee requirements, minimum stockholders’ equity, minimum share price and certain other corporate governance requirements.

In particular, we are required to maintain a minimum bid price for our listed common stock of $1.00 per share.

do not meet these continued listing requirements, our common stock could be delisted.

Delisting from the Nasdaq Capital Market would cause us to pursue eligibility for trading of these securities on other markets or exchanges, including the

over-the-counter (OTC) BB or QB markets, or on the OTC “pink sheets.” In such case, our stockholders’ ability to trade, or obtain quotations of the market value of our common stock would be severely limited because of lower trading volumes and

transaction delays.

These factors could contribute to lower prices and larger spreads in the bid and ask prices of our securities.

There can be no assurance that our securities, if delisted from the Nasdaq Capital Market in

the future, would be listed on a national securities exchange, a national quotation service, the OTC markets or the pink sheets.

Delisting from the Nasdaq Capital Market, or even the issuance of a notice of potential delisting, would also

result in negative publicity, make it more difficult for us to raise additional capital, cause us to lose eligibility to register the sale or resale of our shares on Form S-3 and the automatic exemption from registration under state securities

laws for exchange-listed securities, adversely affect the market liquidity of our securities, decrease securities analysts’ coverage of us or diminish investor, supplier and employee confidence.

There can be no assurance that our securities, if delisted from the Nasdaq Capital Market in the future, would be

listed on a national securities exchange, a national quotation service, the OTC markets or the pink sheets.

Delisting from the Nasdaq Capital Market, or even the issuance of a notice of potential delisting, would also result in negative

publicity, make it more difficult for us to raise additional capital, cause us to lose eligibility to register the sale or resale of our shares on Form S-3 and the automatic exemption from registration under state securities laws for

exchange-listed securities, adversely affect the market liquidity of our securities, decrease securities analysts’ coverage of us or diminish investor, supplier and employee confidence.

We do not anticipate that we will pay any cash dividends in the foreseeable future.

We currently expect to retain our future earnings, if any, to fund the development and growth of our business.

As a result, capital appreciation, if any, of our company

will be the sole source of our stockholders’ gain, if any, for the foreseeable future.

As a result, capital appreciation, if any, of our company will be

the sole source of our stockholders’ gain, if any, for the foreseeable future.

Future sales of shares by existing stockholders could cause our stock price to decline.

If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after certain legal restrictions on resale

lapse, the trading price of our common stock could decline.

If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after certain legal restrictions on resale lapse,

the trading price of our common stock could decline.

As of December 31, 2024, we had 37,987,380 shares of common stock outstanding.

Approximately 36,606,110 of such shares are freely tradable, without restriction, in the public market.

Approximately 1,383,670 of such shares of common stock are held by directors, executive officers and other affiliates and will be subject to volume limitations under Rule 144 under the Securities Act and various vesting agreements.

Approximately 1,381,270 shares of common stock are held by directors, executive officers and other affiliates and will be subject to volume limitations under Rule 144 under the Securities Act and various vesting agreements.

Because the Merger resulted in an ownership change under Section 382 of the Code for Edge, pre-merger U.S.

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tax attributes will be subject to limitations.

On March 15, 2019, we, then operating as Edge Therapeutics, Inc., or Edge, completed a reverse merger with privately held PDS Biotechnology Corporation, or Private PDS,

pursuant to and in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of November 23, 2018, as amended on January 24, 2019, by and among us, Echos Merger Sub, a wholly-owned subsidiary of Edge, or Merger

Sub, and Private PDS, whereby Private PDS merged with and into Merger Sub, with Private PDS surviving as our wholly-owned subsidiary, which we refer to as the Merger.

In connection with and immediately following completion of the Merger, we

changed our corporate name from Edge Therapeutics, Inc.

On March 15, 2019, we, then operating as Edge Therapeutics, Inc., or Edge, completed a reverse merger with privately held PDS Biotechnology Corporation, or Private PDS, pursuant

to and in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of November 23, 2018, as amended on January 24, 2019, by and among us, Echos Merger Sub, a wholly-owned subsidiary of Edge, or Merger Sub, and

Private PDS, whereby Private PDS merged with and into Merger Sub, with Private PDS surviving as our wholly-owned subsidiary, which we refer to as the Merger.

In connection with and immediately following completion of the Merger, we changed our

corporate name from Edge Therapeutics, Inc.

to PDS Biotechnology Corporation, and Private PDS changed its name to PDS Operating Corporation.

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In particular, the U.S.

government may enact significant changes to the taxation of business entities including, among others, an increase in the corporate income tax rate,

the imposition of minimum taxes or surtaxes on certain types of income, significant changes to the taxation of income derived from international operations, and an addition of further limitations on the deductibility of business interest.

government may enact significant changes to the taxation of business entities including, among others, an increase in the corporate income tax rate, the

imposition of minimum taxes or surtaxes on certain types of income, significant changes to the taxation of income derived from international operations, and an addition of further limitations on the deductibility of business interest.

certain draft legislation has been publicly released and is under development in Congress at this time, the likelihood of these changes being enacted or implemented is unclear.

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There can be no assurance that our effective income tax rate will not change in future periods.

Accordingly, if our effective tax rate were to increase, it may have a

material adverse effect on our business, financial condition and results of operations.

Anti-takeover provisions under Delaware law could make an acquisition more difficult and may prevent attempts by our stockholders to replace or remove

our current or future management.

Because we are incorporated in Delaware, our company is governed by the provisions of Section 203 of the DGCL, which prohibits stockholders owning in excess of 15% of our

voting stock from merging or combining with us.

Although we believe these provisions collectively will provide for an opportunity to receive higher bids by requiring potential acquirors to negotiate with our board of directors, they would apply

even if the offer may be considered beneficial by some stockholders.

In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove then current management by making it more difficult for

stockholders to replace members of the board of directors, which is responsible for appointing the members of management.

Our eighth amended and restated certificate of incorporation, as amended, provides that, unless we consent to the selection of an alternative forum, the Court of Chancery

of the State of Delaware is the sole and exclusive forum, to the fullest extent permitted by law, for:

Accordingly, if our effective tax rate were to increase, it may have a material

adverse effect on our business, financial condition and results of operations.

Anti-takeover provisions under Delaware law could make an acquisition more difficult and may prevent attempts by our stockholders to replace or remove our

current or future management.

Because we are incorporated in Delaware, our company is governed by the provisions of Section 203 of the DGCL, which prohibits stockholders owning in excess of 15% of our voting

stock from merging or combining with us.

Although we believe these provisions collectively will provide for an opportunity to receive higher bids by requiring potential acquirors to negotiate with our board of directors, they would apply even

if the offer may be considered beneficial by some stockholders.

In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove then current management by making it more difficult for stockholders to

replace members of the board of directors, which is responsible for appointing the members of management.

Our eighth amended and restated certificate of incorporation, as amended, provides that, unless we consent to the selection of an alternative forum, the Court of Chancery of the

State of Delaware is the sole and exclusive forum, to the fullest extent permitted by law, for:

(a) any derivative action or proceeding brought on our behalf;

(b) any action asserting a claim of breach of a fiduciary duty owed by any of

our directors, officers or other employees to us or our stockholders;

(b) any action asserting a claim of breach of a fiduciary duty owed by any of our

directors, officers or other employees to us or our stockholders;

(c) any action asserting a claim arising pursuant to the DGCL, our eighth amended and restated certificate of incorporation, as amended, or our amended and restated bylaws;

or (d) any action asserting a claim against us governed by the internal affairs doctrine.

(d) any action asserting a claim against us governed by the internal affairs doctrine.

This choice of forum provision does not preclude or contract the scope of exclusive federal or concurrent jurisdiction for any actions brought under the

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officers and other employees.

If a court were to find the choice of forum provision contained in our eighth amended and restated certificate of incorporation, as amended, to be inapplicable or

unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, results of operations, and financial condition.

Even if we are successful in defending

against these claims, litigation could result in substantial costs and be a distraction to management and other employees.

If a court were to find the choice of forum provision contained in our eighth amended and restated certificate of incorporation, as amended, to be inapplicable or unenforceable

in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, results of operations, and financial condition.

Even if we are successful in defending against these

claims, litigation could result in substantial costs and be a distraction to management and other employees.

Provisions in our amended and restated bylaws could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our

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brought under the Securities Act and does not apply to actions arising under the Exchange Act, which is already subject to federal courts as the exclusive forum.

If a court were to find these provisions of our amended and restated bylaws inapplicable to, or unenforceable in respect of, one or more of the specified types of actions

or proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions, which could adversely affect our business, results of operations and financial condition.

Even if we are successful in defending

against these claims, litigation could result in substantial costs and be a distraction to management and other employees.

We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical

instability, an ongoing military conflict between Russia and Ukraine, Israel and Hamas and record inflation.

Our business, financial condition and results of operations could be materially adversely affected by any negative impact on the global

economy and capital markets resulting from the conflict in Ukraine, the Middle East, geopolitical tensions or record inflation.

and global markets are experiencing volatility and disruption following the escalation of geopolitical tensions and the start of the military conflict between Russia

On February 24, 2022, a full-scale military invasion of Ukraine by Russian troops was reported.

Although the length and impact of the ongoing military conflict is highly unpredictable, the conflict in Ukraine could lead to market

disruptions, including significant volatility in commodity prices, credit and capital markets, as well as supply chain interruptions, which has led to record inflation globally.

We are continuing to monitor inflation, the situation in Ukraine

and global capital markets and assessing the potential impacts on our business.

The global economy has been, and may continue to be, negatively impacted by Russia’s invasion of Ukraine.

As a result of Russia's invasion of Ukraine, the U.S., the

European Union, the United Kingdom, and other G7 countries, among other countries, have imposed substantial financial and economic sanctions on certain industry sectors and parties in Russia.

Broad restrictions on exports to Russia have also

been imposed.

These measures include:

(i) comprehensive financial sanctions against major Russian banks;

(ii) additional designations of Russian individuals with significant business interests and government connections;

(iii) designations of

individuals and entities involved in Russian military activities;

and (iv) enhanced export controls and trade sanctions limiting Russia's ability to import various goods.

Russian military actions and the resulting sanctions could continue to

adversely affect the global economy and financial markets and lead to instability and lack of liquidity in capital markets, potentially making it more difficult for us to obtain additional funds.

There are current geopolitical tensions with China.

Recently, the Biden administration has signed multiple executive orders regarding China.

One particular executive order

titled Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy signed on September 12, 2022 will likely impact the pharmaceutical industry to encourage U.S.

domestic manufacturing of

pharmaceutical products.

Any additional executive orders or potential sanctions with China could materially impact our current manufacturing partners.

In addition, on October 7, 2023, Hamas militants and members of other terrorist organizations infiltrated Israel’s southern border from the Gaza Strip and conducted a

series of terror attacks on civilian and military targets.

Thereafter, Hamas launched extensive rocket attacks on Israeli population and industrial centers located along the Israeli border within the Gaza Strip.

Shortly following the attack,

Israel’s security cabinet declared war against Hamas and launched an aerial bombardment of various targets within the Gaza Strip.

It is possible that other terrorist organizations will join the hostilities as well, including Hezbollah in

Lebanon, the Houthi in Yemen and Palestinian military organizations in the West Bank, resulting in a widening of the conflict.

The intensity and duration of Israel’s current war against Hamas is difficult to predict as are such war’s economic

implications on the global economy.

Although our business has not been materially impacted by the ongoing military conflict between Russian and Ukraine, Israel and Hamas, geopolitical tensions, or record inflation to date, it is

impossible to predict the extent to which our operations, or those of our suppliers and manufacturers, will be impacted in the short and long term, or the ways in which the conflict may impact our business.

The extent and duration of the

conflict in Ukraine, the Middle East, geopolitical tensions, record inflation, sanctions and resulting market disruptions are impossible to predict, but could be substantial.

Any such disruptions may also magnify the impact of other risks

described herein.

If a court were to find these provisions of our amended and restated bylaws inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or

proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions, which could adversely affect our business, results of operations and financial condition.

Even if we are successful in defending against

these claims, litigation could result in substantial costs and be a distraction to management and other employees.

We are currently operating in a period of global economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical

conflicts, natural and man-made disasters, global health emergencies and uncertainties in regulatory developments and legislative actions, which could adversely affect our business, financial condition and results of operations.

Our results of operations could be adversely affected by general conditions in the global economy, uncertainty from political conditions and changing regulations, and disruption

of global financial markets that may result in a recession or market correction.

The financial markets and the global economy may be adversely affected by the current or anticipated impact of war, terrorism and geopolitical conflicts, including

in Russia and Ukraine, the Middle East and other areas.

Sanctions and enhanced export controls imposed by the United States and other countries in response to such conflicts may also adversely impact the financial markets and the global

economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability.

Changes in regulations and policies by the new U.S.

administration and the resulting political and economic uncertainty in the United States may also impact us, the financial

markets and the global economy.

In particular, there is currently significant uncertainty about the future relationship between the United States and various other countries, most significantly China, with respect to trade policies, treaties,

tariffs, taxes and other limitations on cross-border operations that impact U.S.-China relations and escalate tensions between China and Taiwan.

For example, legislation such as the BIOSECURE Act, which was not enacted in 2024, has been

introduced in Congress to limit certain U.S.

biotechnology companies from using equipment or services produced or provided by selected Chinese biotechnology companies, and others in Congress have advocated for the use of existing executive

branch authorities to limit those Chinese service providers’ ability to engage in business in the U.S.

In addition, the current U.S.

administration has recently issued regulations to restrict direct and indirect investment by U.S.

companies with specified connections to China that use specific technologies of concern.

Such changes in the regulations and policies by the current U.S.

administration and the resulting political and economic uncertainty materially impact our

operations and those of our third-party service providers and reduce our ability to access capital, which could negatively affect our liquidity and adversely affect our business and the value of our common stock.

In addition, natural and man-made disasters and global health emergencies, including pandemics and epidemics, may adversely affect the financial markets and global economy,

increase inflation and result in significant business disruptions.

We and our third-party services providers could be subject to the impact of natural or man-made disasters and other business disruptions, which include, but are not limited to,

hurricanes, flooding, typhoons, tornados, wildfires and fires, drought, extreme heat, earthquakes, water shortages, blizzards and other extreme weather conditions, resulting in significant damage to our facilities, inventory or equipment, which

could disrupt, delay or curtail our operations.

Such business disruptions may also heighten the risk of power outages, telecommunications, transportation or other infrastructure failure, cybersecurity incidents or physical security breaches.

The cost of insurance has increase significantly, including as a result of the impact of climate change and inflation, and we may not be able to obtain sufficient coverage at a reasonable cost to protect us against losses from such disasters

and unforeseen events.

The volatile business environment or continued unpredictable and unstable market conditions may result in further deterioration of the equity and credit markets,

significant volatility in commodity prices, as well as supply chain interruptions and result in an economic downturn, which would make any equity or debt financing more difficult, costly and dilutive.

Failure to secure any necessary financing

in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance and stock price and could require us to delay, limit, reduce, or terminate our product development or future

commercialization efforts .

Disruptions at the FDA, the SEC and other government agencies caused by funding shortages, government shutdowns or global health emergencies or their

inability to hire, retain or deploy key leadership and other personnel, could prevent new or modified products from being developed, approved or commercialized in a timely manner or at all or otherwise prevent those agencies from performing

normal business functions on which the operation of our business may rely, which could negatively impact our operations.

The ability of the FDA and other government agencies to review and approve new or modified products can be affected by a variety of factors, including government budget and

funding levels, statutory, regulatory and policy changes, a government agency’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the government agency’s ability to perform

routine functions.

Average review times at the FDA and other government agencies have fluctuated in recent years as a result.

For example, over the last several years, the U.S.

government has shut down several times and certain regulatory

agencies, such as the FDA and SEC, have had to furlough critical employees and stop critical activities.

In addition, government funding of agencies on which our operations may rely, including those that fund research and development

activities, is subject to the political process, which is inherently fluid and unpredictable.

Such disruptions at the FDA and other agencies may also increase review and approval timelines, which would adversely affect our business.

Our results of operations and liquidity needs could be materially affected by market fluctuations and general economic conditions.

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

What changed 10-K

Item 1A. Risk Factors