What changed in this filing

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Item 1A. Risk Factors

2026-08-13 compared with 2026-05-14 · 799 added, 13 removed, 2 unchanged (100% of the section changed)

There have been no material changes from our risk factors as previously reported in our Annual Report on Form 10-K for the year ended December 31, 2025.

investment in our business involves a high degree of risk.

Before making an investment decision, you should carefully consider the information we include in this Quarterly Report on Form 10-Q, including our unaudited interim Condensed

Consolidated Financial Statements and accompanying notes, our Annual Report on Form 10-K for the year ended December 31, 2025 filed on March 30, 2026, including the risk factors and our financial statements and related notes contained therein,

and the additional information in the other reports we file with the Securities and Exchange Commission, including, without limitation, the risk factors previously disclosed in our prior quarterly reports on Form 10-Q filed during this fiscal

With the exception of the risk factors noted below, there have been no material changes from our risk factors as previously reported in

our Annual Report on Form 10-K for the year ended December 31, 2025.

However, any investment in our business involves a high degree of risk.

Before making an investment decision, you should carefully consider the information we include in this

Quarterly Report on Form 10-Q, including our unaudited interim Condensed Consolidated Financial Statements and accompanying notes, our Annual Report on Form 10-K for the year ended December 31, 2025 filed on March 30, 2026, including the risk factors

and our financial statements and related notes contained therein, and the additional information in the other reports we file with the Securities and Exchange Commission, including, without limitation, the risk factors previously disclosed in our prior

quarterly reports on Form 10-Q filed during this fiscal year.

These risks may result in material harm to our business and our financial condition and results of operations.

In this event, the market price of our common stock may decline and you could lose part or all of your investment.

In this event, the market price of our common stock may decline and you could

lose part or all of your investment.

Additional risks that we currently believe are immaterial may also impair our business operations.

Our business, financial conditions and future prospects and the trading price of our common stock could be

harmed as a result of any of these risks.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

There were no unregistered sales of the Company’s equity securities during the three months ended March 31, 2026.

DEFAULTS UPON SENIOR SECURITIES

MINE SAFETY DISCLOSURES

Not applicable.

business, financial conditions and future prospects and the trading price of our common stock could be harmed as a result of any of these risks.

We are required to meet the Nasdaq Capital Market’s continued listing requirements and other Nasdaq rules, and if we

fail to meet such rules and requirements, we may be subject to delisting.

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

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.

continued listing standards of Nasdaq applicable to the Nasdaq Capital Market require, among other things, that the minimum price of a listed company’s stock be at or above $1.00.

If the minimum bid price is below $1.00 for a period of more than 30

consecutive trading days, the listed company will fail to be in compliance with Nasdaq’s listing rules and, if the listed company does not regain compliance within an 180-day grace period, it may be subject to delisting.

In order to regain

compliance, the bid price of the listed company’s common stock must close at a price of at least $1.00 per share for a minimum of 10 consecutive trading days within an 180-day grace period.

In addition, in July 2026 Nasdaq approved a new rule requiring listed companies to maintain a minimum market value of listed securities (MVLS) of $5 million.

If our MVLS falls below this threshold for 30 consecutive

business days, we may be subject to delisting proceedings.

On July 30, 2026, we received a deficiency letter from Nasdaq notifying us that, for the last 30 consecutive business days, the closing bid price for our common stock was below the minimum

$1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2).

The letter also indicated that, pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we would be afforded 180 calendar days to regain

compliance with the bid price requirement.

There can be no assurance that we will regain compliance with the minimum bid price requirement or, if we do so, that we will maintain compliance with the minimum bid price requirement or any other Nasdaq

listing standards.

Pursuant to the Promissory Note (as defined below), if we fail to cure the minimum bid price requirement within seventy-five (75) calendar days of receipt of the deficiency letter, or the Special Amortization Event, then commencing with the next installment date and each successive installment date

for so long as any Special Amortization Event is continuing, we will be required to pay to the Investor (as defined below) (i) the principal amount of $2,000,000 (or the outstanding principal if less than such amount), and such increased amount shall

be (x) payable in lieu of, and not in addition to, the installment principal amount that would otherwise be payable on such installment date and (y) applied against future installment principal amounts in reverse chronological order), (ii) the

payment premium in respect of such increased installment principal amount, and (iii) accrued and unpaid interest hereunder as of such installment date.

If we fail to regain compliance with the minimum bid price requirement or other Nasdaq listing standards, our common stock will be subject

to delisting.

Delisting from Nasdaq could adversely affect our ability to raise additional financing through the public or private sale of equity securities, would significantly affect the ability of investors to trade our securities and would

negatively affect the value and liquidity of our common stock.

Delisting could also have other negative results, including the potential loss of confidence by employees, the loss of institutional investor interest and fewer business development

opportunities.

Delisting from the Nasdaq Capital Market could also 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 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

Our recent strategic refocus to

prioritize the development of PDS0301, to cease further internal investments in PDS0101 and to discontinue the VERSATILE-003 Phase 3 clinical trial may not achieve the anticipated benefits and involves significant risks and uncertainties.

In August 2026, we announced a strategic refocus to prioritize PDS0301, our tumor-targeted IL-12 immunocytokine, as our lead development

As part of this refocus, we ceased further internal investments in PDS0101 and discontinued the VERSATILE-003 Phase 3 clinical trial evaluating PDS0101 in

combination with pembrolizumab in HPV16-positive first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma, and we announced our intention to pursue strategic partnerships or other externally funded opportunities for the continued development of PDS0101.

This strategic refocus involves significant risks, including but not limited to the following:

the clinical data supporting PDS0301 in metastatic colorectal cancer is based on Phase 2 results, and future clinical trials, including the planned randomized Phase 2b

trial, may not replicate or confirm these results;

we may not be successful in advancing PDS0301 through a randomized Phase 2b development program on the timeline or within the budget we anticipate;

the reallocation of resources away from PDS0101 may result in a loss of value for our PDS0101 program if we are unable to secure a strategic partnership on favorable terms, or at all;

we may have expended significant resources on the PDS0101 program, including the VERSATILE-003 trial, that will not result in any direct commercial benefit to us;

our strategic refocus narrows the breadth of our clinical pipeline, which increases our dependence on the success of PDS0301;

the discontinuation of the VERSATILE-003 trial may negatively affect our relationships with clinical trial investigators, trial participants, or collaborators;

our stockholders, potential investors, or potential partners may view the strategic refocus unfavorably, which could adversely affect the market price of our common stock

and our ability to raise capital.

We have become substantially more dependent on the success of PDS0301 and the

failure of PDS0301 could disproportionately impact the success of our business.

If the anticipated benefits of this strategic refocus are not realized, our business, financial condition, results of operations, and prospects could be

materially and adversely affected.

We may not be able to identify, negotiate, or consummate strategic partnerships or other externally funded

opportunities for the continued development of PDS0101, and any such partnerships may not be on favorable terms.

As part of our strategic refocus, we intend to pursue strategic partnership or other externally funded opportunities for PDS0101.

Establishing strategic partnerships is difficult and time-consuming.

Our discussions with potential partners may not lead to the establishment of partnerships on favorable terms, if at all.

We face significant competition in seeking appropriate

partners, and potential partners may evaluate alternative immunotherapies for similar indications that may be available or more attractive than PDS0101.

In addition, a potential partner’s evaluation of PDS0101 may be adversely affected by our decision

to discontinue the VERSATILE-003 trial.

Whether we reach a definitive agreement for a partnership will depend, among other things, upon the potential partner’s assessment of

the Versatile-002 Phase 2 clinical data generated to date, the design and results of any further clinical trials necessary for approval, the potential market for

PDS0101, the costs and complexities of completing development and commercialization, the competitive landscape, and the existence of alternative product candidates.

If we are unable to establish a strategic partnership for PDS0101 on acceptable

terms, or at all, the potential value of the PDS0101 program may diminish, and we may not recoup the significant investment we have made in the program.

To the extent that we enter into partnership, licensing, or other arrangements, we may have to

relinquish valuable rights to PDS0101, including future revenue streams, or grant licenses on terms that may not be favorable to us.

We may expend our limited resources to pursue PDS0301 and fail to capitalize on other product candidates or

indications that may be more profitable or for which there is a greater likelihood of success.

Because we have limited financial and managerial resources, our decision to prioritize PDS0301 as our lead development program means that

we will allocate substantially all of our development resources toward the advancement of PDS0301 in metastatic colorectal cancer and other solid tumors.

As a result, we may forego or delay pursuit of opportunities with PDS0101 or other product

candidates that later prove to have greater commercial potential or a greater likelihood of success.

Our resource allocation decisions may cause us to fail to timely capitalize on viable commercial products or profitable market opportunities.

not accurately evaluate the commercial potential or target market for PDS0301, or if PDS0301 does not demonstrate the safety and efficacy we expect in future clinical trials, we will have further narrowed our development pipeline without achieving

meaningful clinical or commercial progress.

Our spending on the PDS0301 development program may not yield any commercially viable products.

The discontinuation of the VERSATILE-003 Phase 3 trial and our limited cash resources may further impact our ability

to continue as a going concern.

As of June 30, 2026, we had $5.6 million in cash and cash equivalents, and we have concluded that substantial doubt exists about our

ability to continue as a going concern.

The discontinuation of the VERSATILE-003 trial, combined with our strategic refocus on PDS0301, may increase investor uncertainty regarding our prospects and make it more difficult to obtain financing on

acceptable terms, or at all.

Our ability to advance PDS0301 through its planned Phase 2b clinical trial and to maintain operations is dependent upon our ability to raise additional capital.

If we are unable to raise capital or secure a strategic

partnership for PDS0101 that provides non-dilutive funding, we may be required to delay, reduce, or terminate our PDS0301 development program or potentially cease operations.

Any inability to continue as a going concern would have a material adverse

effect on our stockholders, and you could lose all or part of your investment in the Company.

We have a limited operating history and have never generated any product revenue.

We have no products approved for sale.

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

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® product candidates.

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 jurisdictions, substantial investment and significant marketing efforts before we generate any revenues from product sales.

We are not permitted to market or promote any of our product candidates before we receive

marketing approval from the FDA and comparable foreign regulatory authorities, and we may never receive such marketing approvals.

Our ability to generate revenue and achieve and maintain profitability will depend upon our ability to successfully complete the

development of our oncology products 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 sale of PDS0301,

our Versamune ® products or Infectimune® products , we do not know when we

will begin to generate revenue from PDS0301 or other products, if at all.

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

set and obtain an acceptable price for PDS0301 or Versamune® products , and obtain coverage and adequate reimbursement from third-party payors;

establish sales, marketing, manufacturing and distribution systems;

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 PDS0301 or Versamune® products at acceptable cost levels;

achieve broad market acceptance of PDS0301 and other Versamune® products, Versamune® in combination with PDS0301 or Infectimune® based-products in the medical community and with third-party payors and consumers;

attract and retain an experienced management and advisory team;

launch commercial sales of PDS0301 , Versamune® products , Versamune®

in combination with PDS0301 and other oncology products, and Infectimune® based-products, whether alone or in collaboration with others;

maintain, expand and protect our intellectual property portfolio.

Because of the numerous risks and uncertainties associated with immunotherapy development and manufacturing, we are unable to predict

the timing or amount of increased development expenses, or when we will be able to achieve or maintain profitability, if at all.

Our expenses could increase beyond expectations if we are required by the U.S.

Food and Drug Administration, or FDA, or

comparable non-U.S.

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

Even if PDS0301 is approved for commercial sale, we anticipate incurring significant costs associated with the commercial

launch of and the related commercial-scale manufacturing requirements for PDS0301 , Versamune® or 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

PDS0301, Versamune ® products, Versamune® in combination with PDS0301 and

Infectimune® 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

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 marketed.

We cannot assure you that

we will be profitable even if we successfully commercialize PDS0301 , Versamune® or

Infectimune® based products.

If we successfully obtain regulatory approval to market any product , 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 at which we can offer our products.

If the indication approved by regulatory authorities is

narrower than we expect, or the treatment population is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of our products, even if approved.

Even if we do achieve profitability, we

may not be able to sustain or increase profitability on a quarterly or annual basis.

If we fail to become and remain profitable the market price of our common stock and our ability to raise capital and continue operations will be adversely affected.

We expect research and development expenses to increase significantly for PDS0301 if we initiate the planned Phase 2b trial.

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.

As of December 31, 2025 and 2024,

we had an accumulated deficit of $216.6 and $182.1 million, respectively.

We are dependent on the success of our

PDS0301, Versamune® and Infectimune® products, which are still in clinical development, and if our PDS0301, Versamune® and

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

PDS0301 is 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 PDS0301.

Accordingly, our business currently depends heavily on the successful development, regulatory

approval and commercialization of PDS0301.

PDS0301 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 PDS0301 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 PDS0301 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

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 PDS0301 for many reasons, including:

we may not be able to demonstrate that PDS0301 is safe and effective to the satisfaction of the FDA;

the FDA may not agree that the completed Phase 2 clinical trials of PDS0301 satisfy the FDA’s requirements and may require us to conduct additional testing;

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

the FDA may disagree with the number, design, size, conduct or implementation of one or more of our clinical trials;

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

clinical 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 PDS0301 outweigh the

safety risks;

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

the FDA may not accept data generated at our clinical trial sites;

if our BLA is reviewed by an advisory committee, the FDA may have difficulties scheduling an advisory committee meeting in a timely manner or the advisory committee may

recommend against approval of our application or may recommend that the FDA require, as a condition of approval, additional preclinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions;

the FDA may require development of a risk evaluation and mitigation strategy, or REMS, as a condition of approval;

the FDA may identify deficiencies in our manufacturing processes or facilities;

the FDA may change its approval policies or adopt new 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 PDS0301, Versamune ®

and Infectimune® based products.

We expect to spend substantial amounts to complete the development of, seek regulatory approvals for and commercialize PDS0301.

our current cash reserves, we will require substantial additional capital to complete the development and potential commercialization of PDS0301 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 PDS0301 is highly uncertain, we are unable to estimate the actual funds we will require for development

and any approved marketing and commercialization activities.

Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:

the initiation, progress, timing, costs and results of our planned clinical trials;

the outcome, timing and cost of meeting regulatory requirements established by the FDA and other comparable foreign regulatory authorities;

the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;

the cost of defending potential intellectual property disputes, including any patent infringement actions brought by third parties against us now or in the future;

the effect of competing technological and market developments;

the cost of establishing sales, marketing and distribution capabilities in regions where we choose to commercialize PDS0301 on our own;

the initiation, progress, timing and results of the commercialization of PDS0301, if approved, for commercial 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 PDS0301 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 our expenses to increase in connection with our planned operations.

Although we believe we will reduce expenses in the near term from historical levels, such expenses will begin to increase as the planned Phase 2 PDS0301 clinical trial is initiated.

Until such time, if ever, as we can

generate substantial revenues from the sale of drugs, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and/or licensing arrangements.

To the extent that we raise

additional capital through the sale of equity or convertible debt securities, ownership interests in our securities may be diluted, and the terms of these securities could include liquidation or other preferences and anti-dilution protections that

could adversely affect the rights of our common stockholders.

In addition, debt financing, if available, would result in fixed payment obligations and may involve agreements that include restrictive covenants that limit our ability to take specific

actions, such as incurring additional debt, making capital expenditures, creating liens, redeeming stock or declaring dividends, that could adversely impact our ability to conduct our business.

In addition, securing financing could require a

substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development of our product

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third

parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or Versamune® products or grant licenses on terms that may not be favorable to us.

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 PDS0301

development or future commercialization efforts or grant rights to develop and market 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 issued

pursuant to the transactions contemplated by that certain securities purchase agreement with YA II PN, LTD, and we may be required to repay the outstanding indebtedness in an event of default, which could have a materially adverse effect on our

On April 30, 2026, the Company entered into a securities purchase agreement, or the April 2026 Securities Purchase Agreement, with YA II

PN, LTD., a Cayman Islands exempt limited company, or the Investor.

Pursuant to the April 2026 Securities Purchase Agreement, the Company agreed to issue and sell to the Investor and the Investor agreed to purchase from the Company (i) a promissory

note, or the Promissory Note, in an aggregate principal amount of $6,000,000, and (ii) a warrant to purchase up to 2,158,274 shares of common stock of the Company, par value $0.00033 per share, at an exercise price of $1.1824 per share, subject to

Additionally, until the Promissory Note has been repaid in full, without the prior written consent of the Investor, we shall not, and

shall not permit any of our subsidiaries to, directly or indirectly (A) enter into, create, incur, assume, guarantee or suffer to exist any indebtedness with customary exceptions for Permitted Indebtedness (as defined in the April 2026 Purchase

Agreement), and (B) enter into, create, incur, assume or suffer to exist any lien on or with respect to any of its property or assets now owned or hereafter acquired or any interest therein or any income or profits therefrom with customary exceptions

for Permitted Liens (as defined in the April 2026 Purchase Agreement).

In addition, for as long as the Promissory Note remains outstanding, we are generally restricted from entering into any agreement,

arrangement or transaction in or of which the terms thereof would materially restrict, materially delay, conflict with or materially impair the ability of the Company to perform its obligations under the Promissory Note or amending any material term of

its organizational documents so as to adversely affect any rights of the Investor.

The Promissory Note also sets forth certain customary events of default after which the Promissory Note may be declared immediately due

and payable, including certain types of bankruptcy or insolvency events of default involving the Company and its significant subsidiaries.

A breach of any of the covenants under the Promissory Note could result in a default under the Promissory Note.

Upon the occurrence of an

event of default under the Promissory Note, the Investor could elect to declare all amounts outstanding, if any, to be immediately due and payable.

If we fail to obtain or maintain adequate

coverage and reimbursement for PDS0301, 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 PDS0301 that receive marketing approval will depend substantially, both in the United States and internationally, on the extent to which the costs of PDS0301 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 PDS0301.

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 PDS0301 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 PDS0301 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 PDS0301.

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 PDS0301.

We expect to experience pricing pressures in connection with

the sale of PDS0301 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 prescription drugs and

surgical procedures and other treatments, has become very intense.

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

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.

Throughout 2025, the U.S.

federal government pursued multiple initiatives aimed at tying U.S.

drug prices to those paid in certain other

developed countries through a “Most‑Favored‑Nation”, or MFN, pricing framework.

These actions included a 2025 Executive Order entitled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” in which CMS was instructed to create

plans to impose MFN pricing on drug manufacturers.

Following the Executive Order, CMS advanced three MFN-based payment models through the Center for Medicare and Medicaid Innovation :

the “Global Benchmark for Efficient Drug Pricing”, which would

implement a new, mandatory drug rebate program tied to MFN pricing for select drugs in Medicare Part B and is proposed to go into effect on October 1, 2026;

“Guarding U.S.

Medicare Against Rising Drug Costs”, which would implement a similar mandatory

drug rebate program for select drugs in Medicare Part D and is proposed to go into effect on January 1, 2027;

and “GENErating cost Reductions for U.S.

Medicaid”, launched in January 2026, under which manufacturers who choose to participate in the model

would pay MFN-based supplemental rebates under the Medicaid program in exchange for standardized coverage criteria in participating states.

These models are likely to face legal and operational challenges, and the implementation of these models remains

In parallel to these CMS initiatives, several major pharmaceutical manufacturers have entered into voluntary agreements with the U.S.

federal government to provide discounted prices aligned to MFN prices on certain of the manufacturers’

drugs to the Medicaid program and direct to patients.

We will need to expand our organization and may experience difficulties in doing so which could disrupt operations.

Our future financial performance and our ability to commercialize PDS0301 and compete effectively will depend, in part, on our ability

to effectively manage any future growth.

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

Expanding our

organization could require significant capital expenditures which we may not be able to sustain and may divert financial resources from other projects, such as the development of PDS0301.

If we are unable to effectively expand our organization, 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 PDS0301 and our business will be limited.

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.

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.

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 PDS0301 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.

Our 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.

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

potential liability.

Our 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.

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®, PDS0301 and Infectimune® based products.

PDS0301 is 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 PDS0301 or 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.

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 PDS0301 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.

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

In later stages of clinical trials, PDS0301 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 PDS0301

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.

Many companies that have believed

their immunotherapies performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their products.

Success in preclinical testing and early clinical trials does not ensure that later

clinical trials, which involve many more subjects and different indications than we have studied in Phase 2 clinical trials to date, and the results of later clinical trials may not replicate the results of prior clinical trials and preclinical

In particular, the small number of patients in our planned early clinical trials may make the results of these trials less predictive of the outcome of later clinical trials.

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

PDS0301, could allow our competitors to bring products to market before we do, and could impair our ability to successfully commercialize PDS0301, any of which may harm our business and results of operations.

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 may encounter delays in enrolling, or be unable to enroll, a sufficient number of participants to complete any of our clinical trials.

Once enrolled, we may be unable to retain a sufficient number of participants to complete any of our trials.

Late-stage clinical trials of PDS0301 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

Furthermore, any negative results we may report in clinical trials of PDS0301 may make it difficult or impossible to recruit and retain

participants in other clinical trials of PDS0301.

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 PDS0301, 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.

We face substa ntial competition in the development and commercialization of cancer therapies, including therapies that may compete directly with PDS0301 or reduce the

need for therapies designed to modify the tumor microenvironment.

The biotechnology and pharmaceutical industries are highly competitive and subject to rapid and significant technological change.

face competition from pharmaceutical and biotechnology companies, academic institutions, governmental agencies and other public and private research organizations, many of which have substantially greater financial, technical, manufacturing, clinical

development, regulatory and commercial resources than we do.

Our current development strategy prioritizes PDS0301, our investigational tumor-targeted interleukin-12 (IL-12) immunocytokine.

is designed to deliver IL-12 preferentially to the tumor microenvironment and thereby enhance anti-tumor immune activity while limiting systemic exposure.

We face, and expect to continue to face, competition from companies developing other approaches

intended to improve the therapeutic index of IL-12 and other potent cytokines, including tumor-targeted cytokines, conditionally activated cytokines, engineered cytokines, cytokine fusion proteins, intratumorally administered agents and other

approaches designed to localize or regulate cytokine activity.

PDS0301 may also compete with a substantially broader and rapidly evolving range of oncology therapies.

These include immune checkpoint

inhibitors, antibody-drug conjugates, bispecific and multispecific antibodies, RAS and KRAS pathway inhibitors, radiopharmaceuticals, cell therapies and other targeted and immune-based therapies.

Many of these therapeutic classes are advancing

rapidly, and new agents and combinations may become standards of care in indications in which we may seek to develop PDS0301.

Our strategy contemplates the potential development of PDS0301 in combination with other cancer therapies.

Accordingly, changes in

standards of care may both create potential development opportunities and present competitive risks.

New therapies or combinations may demonstrate greater efficacy, improved durability, greater convenience, lower toxicity or lower cost than treatment

approaches incorporating PDS0301.

In addition, improvements in existing or emerging therapies could reduce the clinical need for an additional agent intended to modify the tumor microenvironment or otherwise limit the patient populations for which

PDS0301 could ultimately be developed.

The competitive landscape for colorectal cancer, prostate cancer and other solid tumors in which we may evaluate PDS0301 is particularly

Numerous companies are developing new targeted agents, bispecific antibodies, antibody-drug conjugates and other treatment modalities, including therapies directed at molecularly defined patient populations.

Because the standards of care in

these indications may change substantially during the time required to complete clinical development of PDS0301, the clinical development strategy, potential combination partners, patient populations and regulatory pathways that appear attractive

today may become less attractive or commercially viable in the future.

Some of our competitors have greater experience conducting large and complex clinical trials, obtaining regulatory approvals,

manufacturing biologic products and commercializing oncology therapies.

Competitors may also obtain regulatory approval for their product candidates before we obtain approval for PDS0301, develop products that are more effective or better tolerated,

establish intellectual property positions that limit our ability to develop or commercialize our product candidates, or enter into strategic collaborations with third parties that could otherwise be potential development or commercialization partners

Our ability to compete successfully will depend on numerous factors, including the safety, efficacy and durability of PDS0301;

ability to demonstrate clinical benefit in appropriately designed trials;

our ability to identify appropriate indications and combination strategies;

the timing and scope of regulatory approvals, if any;

our ability to obtain and maintain

intellectual property protection;

our ability to secure sufficient capital and strategic partnerships;

and the commercial acceptance of PDS0301 if approved.

If competing therapies are approved more rapidly, demonstrate superior clinical outcomes or

safety, become more widely adopted, or otherwise alter the applicable standard of care, our ability to successfully develop, obtain regulatory approval for or commercialize PDS0301 could be materially and adversely affected.

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 PDS0301 or 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 currently targeting.

Therefore, our ability to compete successfully will depend largely on our ability to:

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

demonstrate through our clinical trials that PDS0301 is differentiated from existing and future therapies;

attract qualified scientific, immunotherapy development and commercial personnel;

obtain additional patent or other proprietary protection for PDS0301 or

Versamune® and Infectimune®-based products;

obtain required regulatory approvals;

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

successfully develop and commercialize, independently or with collaborators, new applications for PDS0301 or immunotherapies.

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

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 PDS0301 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 commercially successful.

Accordingly, our competitors may succeed in obtaining patent protection, discovering, developing, receiving the FDA’s approval for or commercializing medicines before we do, which would have an adverse

impact on our business and results of operations.

PDS0301 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 PDS0301 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 PDS0301 report an unacceptable frequency or severity of adverse events, our ability to obtain regulatory approval for PDS0301 may be negatively impacted.

Furthermore, if PDS0301 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 PDS0301 or impose restrictions on its distribution or other risk management measures;

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

we may be required to change the way PDS0301 is administered or to conduct additional clinical trials;

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

we could elect to discontinue the sale of PDS0301;

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

our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of PDS0301 and could substantially increase the costs

of commercialization.

In addition, if any of our product candidates are associated with adverse events or undesirable side effects or have properties that are

unexpected, our trials could be suspended or terminated and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of our product candidates for any or all targeted indications.

future collaborators, may abandon development or limit development of that product candidate to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a

risk-benefit perspective.

Drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims.

Any of these occurrences may harm our business, results of

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, PDS0301, and our ability to generate revenue will be impaired.

PDS0301 and the activities associated with its 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 PDS0301 will prevent us from commercializing our products.

We have not received approval to market PDS0301 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 PDS0301.

Securing regulatory approval also requires the submission of information about the product manufacturing

process, and inspection of manufacturing facilities by, the relevant regulatory authority.

PDS0301 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 factors.

We cannot assure you that we will ever obtain any marketing approvals in any jurisdiction.

Changes in marketing approval policies during the development period, changes in or the enactment of additional

statutes or regulations or changes in regulatory review for each submitted product application may cause delays in the approval or rejection of an application.

The FDA and comparable authorities in other countries have substantial discretion in the

approval process and may refuse to accept any application or may decide that our data is insufficient for approval and require additional preclinical or other studies, and clinical trials.

In addition, varying interpretations of the data obtained from

preclinical testing and clinical trials could delay, limit or prevent marketing approval of PDS0301.

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.

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.

If 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.

There is no guarantee that any 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 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 PDS0301 or any other product candidates.

Even if we obtain FDA approval in the United States, we may never obtain approval for or commercialize PDS0301 in any

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

In order to market PDS0301 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.

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 PDS0301 in those countries.

PDS0301 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.

Even if we obtain regulatory approval, we will still face extensive ongoing regulatory requirements, and PDS0301 and

other candidates may face future development and regulatory difficulties.

Marketing of PDS0301, 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 PDS0301, among other things, will be subject to extensive and ongoing requirements of and review by the FDA and other regulatory

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 Manufacturing Practice, or

cGMP, requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians and recordkeeping and current Good Clinical

Practice, or cGCP requirements for any clinical trials that we conduct post-approval.

Even if marketing approval of PDS0301 is granted, the approval may be subject to limitations on the indicated uses for which PDS0301 may be marketed or to the

conditions of approval.

If PDS0301 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 PDS0301.

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.

imposes stringent restrictions on manufacturers’ communications regarding off-label use and if we promote or otherwise market PDS0301 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 PDS0301, manufacturers or manufacturing

processes, or failure to comply with regulatory requirements, may yield various results, including:

restrictions on manufacturing PDS0301;

restrictions on the labeling or marketing of PDS0301;

restrictions on distribution or use of PDS0301;

requirements to conduct post-marketing studies or clinical trials;

suspension of any of our ongoing clinical trials;

warning letters;

withdrawal of PDS0301 from the market;

refusal to approve pending applications or supplements to approved applications that we submit;

recalls of PDS0301;

fines, restitution or disgorgement of profits or revenues;

suspension or withdrawal of marketing approvals;

refusal to permit the import or export of PDS0301;

seizures of PDS0301;

injunctions or the imposition of civil or criminal penalties.

Even if PDS0301 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 PDS0301 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 PDS0301 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;

effectiveness of sales and marketing efforts;

the cost of treatment in relation to alternative treatments;

our ability to offer PDS0301 for sale at competitive prices;

the convenience and ease of administration compared to alternative treatments;

the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

the willingness of the medical community to offer customers PDS0301 in addition to or in the place of other immunotherapies;

the strength of marketing and distribution support;

the availability of third-party coverage and adequate reimbursement;

whether the product is designated under physician and other provided treatment guidelines as a first, second, or third line therapy;

the prevalence and severity of any side effects;

any restrictions on the use of PDS0301 together with other medications.

Because we expect sales of PDS0301, if approved, to generate substantially all of our revenues for the foreseeable future, the failure of

PDS0301 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 PDS0301 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.

Product liability lawsuits against us could cause us to incur substantial liabilities and could limit the

commercialization of PDS0301.

We face an inherent risk of product liability exposure related to the testing of PDS0301 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 PDS0301 or other immunotherapies that we may develop;

injury to our reputation and significant negative media attention;

withdrawal of clinical trial participants;

significant costs to defend any related litigation;

substantial monetary awards to trial subjects or patients;

loss of revenue;

the inability to commercialize any products we may develop.

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 PDS0301 and other product candidates, if approved.

We do not have any infrastructure for the sales, marketing or distribution of PDS0301 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 PDS0301 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 PDS0301 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 PDS0301 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

PDS0301 or other product candidates outside

of the United States, a variety of risks associated with international operations could harm our business.

If PDS0301 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:

different regulatory requirements for drug approvals and rules governing drug commercialization in foreign countries;

reduced protection for intellectual property rights;

unexpected changes in tariffs, trade barriers and regulatory requirements;

economic weakness, including inflation, or political instability in particular foreign economies and markets;

compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

foreign reimbursement, pricing and insurance regimes;

foreign taxes;

foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another

workforce uncertainty in countries where labor unrest is more common than in the United States;

potential noncompliance with the U.S.

Foreign Corrupt Practices Act, the U.K.

Bribery Act 2010 and similar anti-bribery and anticorruption laws in other jurisdictions;

shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;

business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.

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.

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 PDS0301 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 PDS0301 and our other product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell PDS0301 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 remedies against fraud and abuse, add new transparency requirements for health care and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms.

Since its enactment, there have been judicial, executive and Congressional challenges to certain aspects of the ACA.

On June 17, 2021, the U.S.

Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without

specifically ruling on the constitutionality of the Act.

Prior to the Supreme Court’s decision, President Biden issued an executive order to initiate a special enrollment period from February 15, 2021 through August 15, 2021 for purposes of obtaining

health insurance coverage through the ACA marketplace.

The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining

Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA.

It is unclear how other healthcare reform

measures of the Biden administration or other efforts, if any, to challenge, repeal or replace the ACA will impact health care laws and regulations or our business.

As another example, the Drug Supply Chain Security Act imposes obligations on manufacturers of prescription biopharmaceuticals in finished

dosage forms for commercial distribution.

We have not yet adopted the significant measures that will be required to comply with this law.

We are not sure whether additional legislative changes will be enacted, or whether the current regulations,

guidance or 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 PDS0301 and other product candidates or additional pricing pressures.

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

We currently have agreements with various third-party manufacturing facilities for production of our products for research and

development and testing purposes.

We depend on third-party manufacturers to supply our preclinical and clinical materials and will be reliant on a third-party manufacturer to produce PDS0301 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 PDS0301 and 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.

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 any of our future collaborators obtain marketing approval.

We may be unable to establish any agreements with third-party manufacturers or to do so on acceptable terms.

Even if we are able to

establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

the possible failure of the third party to manufacture our product candidate according to our schedule, or at all, including if our third-party contractors give greater

priority to the supply of other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreements between us and them;

the possible termination or nonrenewal of agreements by our third-party contractors at a time that is costly or inconvenient for us;

the possible breach by the third-party contractors of our agreements with them;

the failure of third-party contractors to comply with applicable regulatory requirements;

the possible failure of the third party to manufacture our product candidates according to our specifications;

the possible mislabeling of clinical supplies, potentially resulting in issues including the wrong dose amounts being supplied or active drug or placebo not being

properly identified;

the possibility of clinical supplies not being delivered to clinical sites on time, leading to clinical trial interruptions, or of drug supplies not being distributed to

commercial vendors in a timely manner, resulting in lost sales;

the possible misappropriation of our proprietary information, including our trade secrets and know-how.

The facilities used by our contract manufacturers to manufacture our product candidates must be approved by the FDA or the EMA pursuant to

inspections that will be conducted after we submit our BLA to the FDA or our MAA to the EMA.

We do not have complete control over all aspects of the manufacturing process of, and are dependent on, our contract manufacturing partners for compliance with

cGMP regulations for manufacturing both active drug substances and finished drug products.

Third-party manufacturers may not be able to comply with cGMP regulations or similar regulatory requirements outside of the United States.

If our contract

manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or comparable foreign regulatory bodies, they will not be able to secure and/or maintain marketing approval for

their manufacturing facilities.

In addition, we do not have complete control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel.

If the FDA, the EMA or a comparable foreign

regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our

ability to develop, obtain marketing approval for or market our product candidates, if approved.

Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed

on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or drugs, operating restrictions and criminal prosecutions, any of which could

significantly and adversely affect supplies of our product candidates and harm our business and results of operations.

Any drugs that we may develop may compete with other product candidates and drugs for access to manufacturing facilities.

limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us.

Any performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval.

We do not currently have arrangements in place for redundant supply of the components of our product candidates.

If our current contract

manufacturer cannot perform as agreed, we may be required to replace that manufacturer.

Although we believe that there are several potential alternative manufacturers who could manufacture our product candidates, we may incur added costs and delays in

identifying and qualifying any such replacement.

Our current and anticipated future dependence upon others for the manufacture of our product candidates or drugs may adversely affect our

future profit margins and our ability to commercialize any drugs that 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 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 performance.

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’ 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 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 Competent Authorities of the Member States of the European Economic Area and comparable foreign regulatory authorities in the form of International Conference on Harmonization guidelines for our products.

Regulatory authorities enforce GCPs through periodic inspections of trial sponsors, principal investigators and clinical trial sites.

If we or our CROs fail to comply with GCPs, the clinical data generated in our clinical trials may be deemed

unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications.

Accordingly, if our CROs fail to comply with these regulations or fail to recruit a

sufficient number of subjects, 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 be able to exert direct control over whether or not they devote sufficient time and

resources to our future clinical and preclinical 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.

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 PDS0301.

As a result, our financial results and the commercial

prospects for PDS0301 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.

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.

If we are unable to establish or manage strategic collaborations in the future, our revenue and drug development may

Our strategy may include potential reliance upon strategic collaborations for marketing and commercialization of PDS0301 or Versamune® 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.

Our discussions with potential collaborators may not lead to the

establishment of collaborations on favorable terms, if at all.

We face significant competition in seeking appropriate collaborators.

Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the

collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors.

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 PDS0301 or Versamune® products, the costs and complexities of

manufacturing and delivering PDS0301 or Versamune® 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 PDS0301 or Versamune® products.

Our current collaborations, as well as any future new collaborations, may never result in the successful development or commercialization

of PDS0301 or Versamune® 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, PDS0301 or Versamune® 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:

significant time and effort from our management team;

financial funding to support said collaboration;

coordination of our research and development programs with the research and development priorities of our collaborators;

effective allocation of our resources to multiple projects.

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 PDS0301 or Versamune® products.

Our collaborators may not commit sufficient resources to our research and development programs or the commercialization, marketing or distribution of PDS0301 or

Versamune® 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 collaboration with us.

If we fail to make required milestone or royalty payments to our collaborators or to observe other obligations in our agreements

with them, our collaborators may have the right to terminate those agreements.

Additionally, our collaborators may seek to renegotiate agreements we have entered into, or may disagree with us about the terms and implementation of these agreements.

collaborators disagree with us about the terms or implementation of our agreements, we may face legal claims that may involve considerable expense and could negatively affect our financial results.

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What changed 10-Q

Item 1A. Risk Factors