What changed in this filing

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Item 1A. Risk Factors

2022-11-14 compared with 2022-08-08 · 130 added, 41 removed, 16 unchanged (91% of the section changed)

3 unchanged sentences

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, 2021 filed on March 31, 2022, including our financial statements and related notes contained therein,

and the additional information in the other reports we file with the Securities and Exchange Commission.

therein, and the additional information in the other reports we file with the Securities and Exchange Commission.

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.

We are currently operating in a period of economic uncertainty and capital markets disruption,

which has been significantly impacted by geopolitical instability, an ongoing military conflict between Russia and Ukraine, and record inflation.

Our business, financial condition and results of operations could be materially adversely affected by

any negative impact on the global economy and capital markets resulting from the conflict in Ukraine, geopolitical tensions, or record inflation.

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 currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability,

an ongoing military conflict between Russia and Ukraine, and record inflation.

Our business, financial condition and results of operations could be materially adversely affected by any negative impact on the global economy and capital markets

resulting from the conflict in Ukraine, geopolitical tensions, or record inflation.

We are exposed to the risk of changes in social, geopolitical, legal, and economic conditions.

The global economy has

been, and may continue to be, negatively impacted by Russia’s invasion of Ukraine.

As a result of Russia’s invasion of Ukraine, the United States, the European Union, the United Kingdom, and other G7 countries, among other countries, have imposed

substantial financial and economic sanctions on certain industry sectors and parties in Russia.

The global economy has been, and may continue to be, negatively impacted by Russia’s

invasion of Ukraine.

As a result of Russia’s invasion of Ukraine, the United States, the European Union, the United Kingdom, and other G7 countries, among other countries, have imposed substantial financial and economic sanctions on certain

industry sectors and parties in Russia.

Broad restrictions on exports to Russia have also been imposed.

These measures include:

(i) comprehensive financial sanctions against major Russian

(ii) additional designations of Russian individuals with significant business interests and government connections;

(i) comprehensive financial sanctions against major Russian banks;

(ii) additional designations of Russian individuals

with significant business interests and government connections;

(iii) designations of individuals and entities involved in Russian military activities;

and (iv) enhanced export controls and

trade sanctions limiting Russia’s ability to import various goods.

Although the length and impact of the ongoing military conflict is highly unpredictable, the conflict in Ukraine has

led to market disruptions, including significant volatility in commodity prices, credit markets, as well as supply chain interruptions, which has contributed to record inflation globally.

In addition, the ongoing Russian military actions and the

resulting sanctions could continue to adversely affect the global economy and financial markets and lead to instability and lack of liquidity in capital markets, potentially making it more difficult for us to obtain additional funds.

continuing to monitor inflation, the situation in Ukraine and global capital markets and assessing its potential impact on our business.

Although, to date, our business has not been materially impacted by the ongoing military conflict between Russian and

Ukraine, geopolitical tensions, or record inflation, it is impossible to predict the extent to which our operations will be impacted in the short and long term, or the ways in which such matters may impact our business.

The extent and duration of

the conflict in Ukraine, geopolitical tensions, record inflation and resulting market disruptions are impossible to predict but could be substantial.

Any such disruptions may also magnify the impact of other risks described in our Annual Report on

Form 10-K for the year ended December 31, 2021.

Our results of operations and

liquidity needs could be materially affected by market fluctuations and general economic conditions.

Our results of operations could be materially affected by economic

conditions generally, both in the United States and elsewhere around the world.

Concerns over inflation, energy costs, geopolitical issues, and the availability and cost of credit have in the past and may continue to contribute to increase

volatility and diminished expectations of the economy and markets going forward.

Market upheavals may have an adverse effect on us.

and (iv) enhanced export controls and trade sanctions limiting Russia’s ability to import

various goods.

Although the length and impact of the ongoing military conflict is highly unpredictable, the conflict in Ukraine has led to market disruptions, including significant volatility in

commodity prices, credit markets, as well as supply chain interruptions, which has contributed to record inflation globally.

In addition, the ongoing Russian military actions and the resulting sanctions could continue to adversely affect the global

economy and financial markets and lead to instability and lack of liquidity in capital markets, potentially making it more difficult for us to obtain additional funds.

We are continuing to monitor inflation, the situation in Ukraine and global

capital markets and assessing its potential impact on our business.

Although, to date, our business has not been materially impacted by the ongoing military conflict between Russian and Ukraine, geopolitical tensions, or record inflation, it is

impossible to predict the extent to which our operations will be impacted in the short and long term, or the ways in which such matters may impact our business.

The extent and duration of the conflict in Ukraine, geopolitical tensions, record

inflation and resulting market disruptions are impossible to predict but could be substantial.

Any such disruptions may also magnify the impact of other risks described in our Annual Report on Form 10-K for the year ended December 31, 2021.

Our results of operations and liquidity needs could be materially affected by market fluctuations and general economic conditions.

Our results of operations could be materially affected by economic conditions generally, both in the United States and elsewhere around the world.

Concerns over inflation, energy

costs, geopolitical issues, and the availability and cost of credit have in the past and may continue to contribute to increase volatility and diminished expectations of the economy and markets going forward.

Market upheavals may have an adverse

effect on us.

In the event of a market downturn, our results of operations could be adversely affected.

Our future cost of equity

or debt capital and access to the capital markets could be adversely affected, and our stock price could decline.

Our future cost of equity or debt capital and access to the capital markets could be adversely affected, and our stock price could decline.

There may be disruption or delay in the performance of our third-party contractors and suppliers.

If our contractors, suppliers and

partners are unable to satisfy their contractual obligations, our business could suffer.

If our contractors, suppliers and partners are unable to satisfy their contractual obligations, our business could suffer.

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

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

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

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

by a security interest in all of our respective rights, title, interests, claims and demands in, to and under all of our respective properties and other assets, subject to limited exceptions and excluding our intellectual property.

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

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

incur indebtedness;

or permit liens on certain assets;

make certain investments;

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

and enter into certain transactions with

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

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

Upon the occurrence of an event of default, the

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

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

indebtedness.

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

commercialization of our Versamune and Infectimune based products.

We expect to spend substantial amounts to complete the development of, seek regulatory approvals for and commercialize PDS0101.

Even with our current cash reserves, we will require substantial

additional capital to complete the development and potential commercialization of PDS0101 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.

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

Based upon our current operating plan, we believe that our cash reserves will be sufficient to fund our operating expenses and capital expenditure requirements for at least the next 12 months

from the date of this report.

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.

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

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

initiation the, 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 PDS0101 on our own;

the initiation, progress, timing and results of the commercialization of PDS0101, 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 PDS0101 or potentially discontinue operations.

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

restrict our operations or require us to relinquish proprietary rights.

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

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

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

In February 2020, we completed an underwritten public offering, in which we sold 10,000,000 shares of common stock at a public offering price of $1.30 per share.

The shares sold included 769,230

shares issued upon the exercise by the underwriter of its option to purchase additional shares at the public offering price.

We received gross proceeds of approximately $13 million and net proceeds of approximately $11.9 million after deducting

underwriting discounts and commissions.

In July 2020, we filed a shelf registration statement, or the 2020 Shelf Registration Statement, with the SEC, for the issuance of common stock, preferred stock, warrants, rights, debt securities and units,

which we refer to collectively as the Shelf Securities, up to an aggregate amount of $100 million.

The 2020 Shelf Registration Statement was declared effective on July 31, 2020.

The 2020 Registration Statement was terminated upon effectiveness of

the 2022 Registration Statement (as discussed below).

On August 13, 2020, we sold 6,900,000 shares of our common stock at a public offering price of $2.75 per share pursuant to the 2020 Shelf Registration Statement, which includes 900,000 shares

issued upon the exercise by the underwriter of its option to purchase additional shares at the public offering price, minus underwriting discounts and commissions.

We received gross proceeds of approximately $19.0 million and net proceeds of

approximately $17.1 million, after deducting underwriting discounts and offering expenses.

In June 2021, we completed an underwritten public offering in which we sold 6,088,235 shares of common stock at a public offering price of $8.50 per share

pursuant to the 2020 Shelf Registration Statement, which includes 794,117 shares issued upon the exercise by the underwriter of its option to purchase additional shares at the public offering price, minus underwriting discounts and commissions.

We received gross proceeds of approximately $51.7 million and net proceeds of approximately $48.5 million, after deducting underwriting discounts and offering expenses.

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

securities, and units up to an aggregate amount of $150 million, $50 million of which covers the offer, issuance and sale by the Company of its common stock under the Sales Agreement (as discussed below).

The 2022 Shelf Registration Statement

was declared effective on September 2, 2022.

In August 2022, we entered into an At Market Issuance Sales Agreement, or the Sales Agreement, with B.

Riley Securities, Inc.

and BTIG, LLC, each an Agent and collectively the Agents, with respect to

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

Agents, as sales agents or principals.

Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the Agents may sell the Placement Shares by any method permitted by law deemed to be an “at the market”

offering as defined in Rule 415 of the Securities Act of 1933, as amended, including, without limitation, sales made through The Nasdaq Capital Market or on any other existing trading market for our common stock.

The Agents will use commercially

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

We will pay the Agents a commission equal to

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

We are not obligated to make any

sales of our common stock under the Sales Agreement.

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

the Sales Agreement in accordance with its terms.

We have not sold any shares of our common stock pursuant to the Sales Agreement.

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

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

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

take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends, creating liens, redeeming our stock or making investments.

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 PDS0101 development or future commercialization efforts

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

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 June 30, 2022.

There were no unregistered sales of the Company’s equity securities during the three months ended September 30, 2022.

DEFAULTS UPON SENIOR SECURITIES

2 unchanged sentences

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

What changed 10-Q

Item 1A. Risk Factors