PCSA 10-K & 10-Q changes, risk factors and insider trading
Processa Pharmaceuticals, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1533743 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Risks Related to our Digital Asset Treasury Strategy”
New heading “Risks Related to our Digital Asset Treasury Strategy”
New heading “Investments in Digital Assets are substantially speculative and have a significant risk of resulting in a loss compared to other forms of investment.”
New heading “Digital Assets have historically experienced, and are expected to continue to experience, high price volatility which may influence our financial results and the market price of our common stock.”
New heading “We may be unable to successfully implement our Digital Asset Strategy.”
New heading “Our Digital Asset holdings will be less liquid than existing cash and cash equivalents and may not be able to serve as a source of liquidity to the same extent as cash and cash equivalents.”
New heading “If we or our third-party service providers experience a security breach or cyberattack and unauthorized parties obtain access to our Digital Assets, we may lose some or all of our Digital Assets and our financial condition and results of operations could be materially adversely affected.”
New heading “We face risks relating to the custody of our Digital Assets, including the loss or destruction of private keys required to access our Digital Assets, and cyberattacks or other data loss relating to our Digital Assets.”
New heading “Our custodially-held Digital Assets may become part of the custodian’s insolvency estate if one or more of our custodians enters bankruptcy, receivership or similar insolvency proceedings.”
New heading “Digital Assets held by us are not subject to FDIC or SIPC protections.”
New heading “Digital Assets are novel assets, and are subject to significant legal, commercial, regulatory, and technical uncertainty.”
New heading “We could be subject to legal or regulatory action, including fines, in the event the SEC, a foreign regulatory authority, or a court were to determine that a digital asset held by us is a “security” under applicable laws.”
Removed heading “If securities or industry analysts do not publish research or reports about our business, or if they publish negative evaluations of our stock or negative reports about our business, our stock price and trading volume could decline.”
Largest changes
“If we or our third-party service providers experience a security breach or cyberattack and unauthorized parties obtain access to our Digital Assets, we may lose some or all of our Digital Assets and our financial condition and results of operations could be materially adversely affected.”see in full comparison
“Our custodially-held Digital Assets may become part of the custodian’s insolvency estate if one or more of our custodians enters bankruptcy, receivership or similar insolvency proceedings.”see in full comparison
“If our Digital Assets held by a custodian are considered to be the property of our custodians’ estates in the event that any such custodians were to enter bankruptcy, receivership or similar insolvency proceedings, we could be treated as a general unsecured creditor of such custodians, inhibiting our ability to exercise ownership rights with respect to such Digital Asset and this may ultimately result in the loss of the value related to some or all of such Digital Assets. …”see in full comparison
“While all investments entail a risk of loss of capital, investments in digital assets such as CHZ and other cryptocurrencies, tokens, and rights of a similar nature (collectively referred to as, “Digital Assets”) should be considered substantially more speculative and significantly more likely to result in a loss, including a total loss of capital, than many other forms of investment. The investment characteristics of Digital Assets differ from those of many traditional currencies, commodities, and securities. …”see in full comparison
“While all investments entail a risk of loss of capital, investments in Digital Assets should be considered substantially more speculative and significantly more likely to result in a loss, including a total loss of capital, than many other forms of investment. The investment characteristics of Digital Assets differ from those of many traditional currencies, commodities, and securities. …”see in full comparison
“Digital Assets are relatively novel and are subject to rapidly evolving legal, commercial, regulatory, and technical landscapes. Because the application of federal and state securities and other applicable laws, regulations, and rules (“Applicable Law”) remain unsettled in several material respects, there is substantial risk that a governmental or regulatory authority could adopt or interpret Applicable Law in a manner that adversely affects the price of Digital Assets. …”see in full comparison
Full comparison: every changed paragraph (53)
Risks Related to our Digital Asset Treasury Strategy
We
have incurred recurring losses since inception and had an accumulated deficit of approximately $87.2$100.8 million at December 31, 2024.2025.
At At
December 31, 2024,2025, we had cash and cash equivalents totaling $1.2$5.5 million and prepaid expenses with the clinical research
organizations organizations
of our Phase 1B and Phase 2 trials of $1.7$1.0 million. FollowingWe our January public offering,believe we believe that our cash on hand will allow
usneed to continueraise our Phase 2 trial of NGC-Cap and satisfy ouradditional capital needsin intothe mid-2025second quarter of
2026 under our
current business plan. In 2025, weWe will need to raise additional capital to fund our operations and continue our planned
development development
of our NGC drugs.drugs in the first half of 2026.
We
will need to raise additional capital to complete the development efforts for NGC-Cap, NGC-GemNGC-Cap and/or NGC-Iri. If we are unable to raise capital
capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations.
During
the year ended December 31, 2025, we received $20,000 for the binding term sheet with Intact, net of amounts paid to Yuhan in accordance
with our licensing agreement. We
had no other revenue during the year ended December 31, 20242025 or in prior years, and do not have any
revenue under contract or any immediate
sales prospects. Our primary uses of cash are to fund our planned clinical trials, research and
development expenditures and for operating
expenses. Cash used to fund operating expenses is impacted by the timing of when we incur
and pay these expenses. Our consolidated financial
statements have been prepared using U.S. GAAP, and are based on the assumption that
we will continue as a going concern, which contemplates
the realization of assets and liquidation of liabilities in the normal course
of business. We face certain risks and uncertainties that
are present in many emerging pharmaceutical companies regarding product development,
limited working capital, recurring losses and negative
cash flow from operations, future profitability, ability to obtain future capital,
protection of patents, technologies and property rights,
competition, rapid technological change, navigating the domestic and major foreign
markets’ regulatory and clinical environment,
recruiting and retaining key personnel, dependence on third party manufacturing organizations,
third party collaboration and licensing
agreements, lack of sales and marketing activities. We currently have no customers or pharmaceutical
products to sell or distribute.
These risks and other factors raise substantial doubt about our ability to continue as a going concern.
As
previously disclosed, on May 7, 2024, the Company received notification from Elion purporting to terminate the license agreement by and
and between us and Elion as a result of the Company’s alleged breach thereof. The Company believes that Elion’s claims
are without
merit and disputes that the license agreement has been validly terminated. We are now in litigation regarding our
license agreement. The Company intends to enforce its rights under the license agreement and will pursue such other remedies as it
determines are appropriate. Any termination of the Elion license would have a material adverse impact on our business and
prospects.
Additionally,
we have not met certain specific diligence milestones under our license agreements with Ocuphire and Yuhan. Although we are working to extend the
deadlines, there can be no assurance
that we will be successful and that such agreements will not be terminated, resulting in a loss
of important rights.
Disruptions
at the FDA and other government agencies could hinder their ability to hire, retain or deploy key leadership and other personnel, or
otherwise prevent new or modified products from being developed, approved, or commercialized in a
timely manner or at all, which could
negatively impact our business.
The
ability of the FDA and other government agencies to review and approve new products can be affected by a variety of factors, including
government budget and funding levels, statutory, regulatory and policy changes, staffing cuts, the FDA’s ability to hire and retain
key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine
functions. Average review times at the FDA have fluctuated in recent years as a result. In addition, government funding of other government
government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.
unpredictable. The ability of the FDA and other government agencies to properly administer their functions is highly dependent on the
levels of government
funding and the ability to fill key leadership appointments, among various factors. Delays in filling or replacing
key positions could significantly impact the ability of the FDA and other agencies to fulfill their functions and could greatly impact
healthcare and the drug industry. Disruptions at the FDA and other agencies may also slow the time necessary for new drugs and biologics
or modifications to approved drugs and biologics to be reviewed and/or approved by necessary government agencies, which would adversely
affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory
agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. If disruptions at the FDA or other
agencies occurs, such as those resulting from a restructuring of these agencies, a prolonged government shutdown, or uncertainty regarding
U.S. federal government funding, could significantly affect the ability of the FDA to review and process our regulatory submissions in
a timely manner, or other factors prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews
or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review
and process our regulatory submissions, which could have a material adverse effect on our business.
Recent actions by the United States federal government have caused concern in the industry that the FDA will experience staffing reductions and budget cuts. In addition, some senior FDA employees with responsibility for regulation of drugs and biologics have already resigned from the FDA. There are also reports that the United States federal government intends to request Congress reduce FDA funding in upcoming budgets. Such funding cuts may also delay the development and approval of our products.
In
addition, a reduction or delay in government funding of research and development may adversely affect our business. Government funding
of research and development is subject to the political process, which is inherently fluid and unpredictable. For example, the NIH announced
on February 7, 2025, a policy significantly reducing research grants by limiting payments for indirect overhead. While, as of the date
of this filing, the order has been temporarily stayed, there can be no assurance that it will not take effect or that other adverse actions
will not be taken. Government proposals to reduce or eliminate budgetary deficits have sometimes included reduced allocations to the
NIH and other government agencies that fund research and development activities, or NIH funding may not be directed towards our products
and studies, both of which could adversely affect our business and our financial results.
Further,
in June 2024, the U.S. Supreme Court reversed its longstanding approach under the Chevron doctrine, which provided for judicial deference
to regulatory agencies, including the FDA. As a result of this decision, we cannot be sure whether there will be increased challenges
to existing agency regulations or how lower courts will apply the decision in the context of other regulatory schemes without more specific
guidance from the U.S. Supreme Court. For example, this decision may result in more companies bringing lawsuits against the FDA to challenge
longstanding decisions and policies of the FDA, which could undermine the FDA’s authority, lead to uncertainties in the industry,
and disrupt the FDA’s normal operations, which could impact the timely review of any regulatory filings or applications we submit
to the FDA.
The
Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010 or,
collectively, the ACA,ACA is a sweeping law intended 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
healthcare and health insurance industries,
impose new taxes and fees on the health industry and impose additional health policy reforms.
The ACA revised the definition of “average
manufacturer price” for reporting purposes, which could increase the amount of
Medicaid drug rebates to states. The law also imposed
a significant annual fee on companies that manufacture or import branded prescription
drug products. Further, on August 16, 2022, President
Biden signed the Inflation Reduction Act of 2022 (IRA), into law which, among other
things, extendsextended enhanced subsidies for individuals
purchasing health insurance coverage in ACA marketplaces through plan year 2025. These
enhanced subsidies expired on December 31, 2025. The Trump administration has taken steps to undo certain Biden-era executive orders,
including those intended to lower drug costs for beneficiaries, and to freeze funding for federal programs. While the administration’s
initial freeze has since been rescinded, the administration is likely to make other attempts to reduce federal program expenditures and
can generally be expected to oppose increases in ACA and Medicaid enrollment. The IRA also eliminateseliminated the “donut hole” under
under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating
a new
manufacturer discount program. It is unclear how such challenges, and the healthcare reform measures of the Biden administration and the potential
rollback of such reform measures by the Trump administration will impact the ACA and our business.
If
a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such
designation, the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other applications to market
the same drug for the same indication for seven years, except in limited circumstances, such as (i) the drug’s orphan designation
is revoked; (ii) its marketing approval is withdrawn; (iii) the orphan exclusivity holder consents to the approval of another applicant’s
product; (iv) the orphan exclusivity holder is unable to assure the availability of a sufficient quantity of drug; or (v) a showing of
clinical superiority to the product with orphan exclusivity by a competitor product. If a drug designated as an orphan product receives
marketing approval for an indication broader than what is designated, it may not be entitled to orphan drug exclusivity. While the FDA
granted orphan-drug designation to PCS499 for the treatment of NL and to NGC-Gem for the treatment of pancreatic cancer,NL, there can be
no assurance that we will receive orphan drug designation
for any additional product candidates in the indications for which we think
they might qualify, if we elect to seek such applications.
The
U.S. government has recently made statements and taken certain actions
that may lead to potential changes to U.S. and international trade
policies, including imposing several rounds of tariffs and export control
restrictions affecting certain products manufactured in China.
Both China and the United States have each imposed tariffs indicating the potential
for further trade barriers, including the U.S. Commerce
Department adding numerous Chinese entities to its “unverified list,”
which requires U.S. exporters to go through more procedures
before exporting goods to such entities.entities, and China imposing aggressive retaliatory
measures. Further, the current administration has imposed tariffs on foreign imports into the United States
from China, signaled intent to negotiatenegotiated and enter
entered into a new trade agreement with IndiaIndia, and has imposed a new 10% global tariff to replace certain previous tariffs struck down
by the endU.S. ofSupreme calendarCourt 2025,in andFebruary is expected
to issue a plan for reciprocal tariffs broadly.2026. It is unknown whether and to what extent new tariffs, export controls, or other new laws or
or regulations will be adopted, or the effect that any such actions would have on us or our industry. Any unfavorable government policies
on international trade, such as export controls, capital controls or tariffs, may increase the cost of manufacturing our product candidates
and platform materials, affect our ability to commercialize our product candidates if approved, the competitive position of our product
candidates, and import or export of raw materials and finished product candidate used in our preclinical studies and clinical trials,
particularly with respect to any product candidates and materials that we import from China. If any new tariffs, export controls, legislation
and/or regulations are implemented, or if existing trade agreements are renegotiated or, in particular, if either the U.S. or Chinese
government takes retaliatory trade actions due to the recent trade tension, such changes could have an adverse effect on our business,
financial condition and results of operations.
Risks Related to our Digital Asset Treasury Strategy
Investments in Digital Assets are substantially speculative and have a significant risk of resulting in a loss compared to other forms of investment.
While all investments entail a risk of loss of capital, investments in digital assets such as CHZ and other cryptocurrencies, tokens, and rights of a similar nature (collectively referred to as, “Digital Assets”) should be considered substantially more speculative and significantly more likely to result in a loss, including a total loss of capital, than many other forms of investment. The investment characteristics of Digital Assets differ from those of many traditional currencies, commodities, and securities. A particular Digital Asset’s status as a “security” in any relevant jurisdiction is subject to a high degree of uncertainty, and if we are unable to properly characterize a Digital Asset, we may be subject to regulatory scrutiny, investigations, fines, and other penalties, which may adversely affect our business, results of operations and/or financial condition.
The legal test for determining whether any given Digital Asset is a security is a highly complex, fact-driven analysis and the outcome is difficult to predict. The SEC generally does not provide advance guidance or confirmation on the status of any particular asset as a security. The classification of a Digital Asset as a security under applicable law has wide-ranging implications for the regulatory obligations that flow from the offer, sale and trading of such assets. For example, a Digital Asset that is a security in the United States may generally only be offered or sold in the United States pursuant to a registration statement filed with the SEC or in an offering that qualifies for an exemption from registration. Persons that effect transactions in assets that are securities in the United States may be subject to registration with the SEC as a “broker” or “dealer.” Platforms that bring together purchasers and sellers to trade Digital Assets that are securities in the United States are generally subject to registration as national securities exchanges, or must qualify for an exemption, such as by being operated by a registered broker-dealer as an alternative trading system (“ATS”), in compliance with rules for ATSs. Persons facilitating clearing and settlement of securities may be subject to registration with the SEC as a clearing agency. Foreign jurisdictions may have similar licensing, registration, and qualification requirements. As a result, certain Digital Assets may be deemed to be a “security” under the laws of some jurisdictions but not others. Further, various foreign jurisdictions may, in the future, adopt additional laws, regulations, or directives that affect the characterization of Digital Assets as “securities.”
We could be subject to legal or regulatory action in the event the SEC, a foreign regulatory authority, or a court were to determine that a digital asset held by us is a “security” under applicable laws.
Digital Assets have historically experienced, and are expected to continue to experience, high price volatility which may influence our financial results and the market price of our common stock.
Digital Assets have historically experienced, and are expected to continue to experience, high price volatility. Such price fluctuations are likely to influence our financial results and the market price of our common stock. Our financial results and the market price of our common stock would be adversely affected, and our business and financial condition would be negatively impacted, if the price of Digital Assets we hold decrease substantially, including as a result of:
We may be unable to successfully implement our Digital Asset Strategy.
Our Digital Asset treasury reserve strategy has only been recently approved by our Board. There is no assurance that we will be able to successfully implement this new strategy or operate Digital Asset-related activities at the scale or profitability currently anticipated. Successfully implementing this strategy may present organizational and infrastructure challenges, and we may not be able to fully implement or realize the intended benefits of our strategy. There can be no assurance that we will be successful in implementing its new business strategy. In addition, moving to a new business strategy may result in a loss of established efficiency, which may have a negative impact on our business. We may also face an increased amount of competition as we attempt to expand and grow its business, which may negatively impact our results of operations, cash flows and financial condition.
Our Digital Asset holdings will be less liquid than existing cash and cash equivalents and may not be able to serve as a source of liquidity to the same extent as cash and cash equivalents.
Historically, the Digital Assets markets have been characterized by significant volatility in price, limited liquidity and trading volumes compared to sovereign currencies markets, relative anonymity, a developing regulatory landscape, potential susceptibility to market abuse and manipulation, compliance and internal control failures at exchanges, and various other risks inherent in its entirely electronic, virtual form and decentralized network. During times of market instability, we may not be able to sell our Digital Assets at favorable prices or at all. As a result, our Digital Asset holdings may not be able to serve as a source of liquidity for us to the same extent as cash and cash equivalents. Further, the Digital Assets we intend to hold with our custodians and transact with our trade execution partners does not enjoy the same protections as are available to cash or securities deposited with or transacted by institutions subject to regulation by the Federal Deposit Insurance Corporation or the Securities Investor Protection Corporation. Additionally, we may be unable to enter into term loans or other capital raising transactions collateralized by our unencumbered Digital Assets, or otherwise generate funds using our Digital Asset holdings, including in particular during times of market instability or when the price of a Digital Asset has declined significantly. If we are unable to sell any of our Digital Assets, enter into additional capital raising transactions using any of our Digital Assets as collateral, or otherwise generate funds using our Digital Assets holdings, or if we are forced to sell our Digital Assets at a significant loss, in order to meet our working capital requirements, our business and financial condition could be negatively impacted.
If we or our third-party service providers experience a security breach or cyberattack and unauthorized parties obtain access to our Digital Assets, we may lose some or all of our Digital Assets and our financial condition and results of operations could be materially adversely affected.
Our Digital Assets are or will be held in custody accounts. We could have a high concentration of Digital Assets in one location or with one custodian, which may be prone to losses arising out of hacking, loss of passwords, comprised access credentials, malware, or cyberattacks. Security breaches and cyberattacks are of particular concern with respect to our Digital Asset holdings. Digital Assets and the entities that provide services to participants in the Digital Asset ecosystem have been, and may in the future be, subject to security breaches, cyberattacks, or other malicious activities. A successful security breach or cyberattack could result in:
Further, any actual or perceived data security breach or cybersecurity attack directed at other companies with Digital Assets or companies that operate blockchain networks, regardless of whether we are directly impacted, could lead to a general loss of confidence in the broader blockchain ecosystem or in the use of the digital asset network to conduct financial transactions, which could negatively impact us.
Attacks upon systems across a variety of industries, including industries related to Digital Assets, are increasing in frequency, persistence, and sophistication, and, in many cases, are being conducted by sophisticated, well-funded and organized groups and individuals, including state actors. Any future breach of our operations or those of others in the digital asset industry, including third-party services on which we rely, could materially and adversely affect our financial condition and results of operations.
We face risks relating to the custody of our Digital Assets, including the loss or destruction of private keys required to access our Digital Assets, and cyberattacks or other data loss relating to our Digital Assets.
We hold our Digital Assets with regulated custodians that have duties to safeguard our private keys. Our custodial services contracts do not restrict our ability to reallocate our Digital Assets among our custodians, and our Digital Assets holdings may be concentrated with a single custodian from time to time. In light of the significant amount of Digital Assets we anticipate that we may hold, we continually seek to engage additional custodians to achieve a greater degree of diversification in the custody of our Digital Assets as the extent of potential risk of loss is dependent, in part, on the degree of diversification. If there is a decrease in the availability of Digital Asset custodians that we believe can safely custody our Digital Assets, for example, due to regulatory developments or enforcement actions that cause custodians to discontinue or limit their services in the United States, we may need to enter into agreements that are less favorable than our current agreements or take other measures to custody our Digital Assets, and our ability to seek a greater degree of diversification in the use of custodial services would be materially adversely affected. In addition, holding our Digital Assets with regulated custodians could affect the availability of receiving Digital Assets that may result from “forks” of the blockchain networks if our custodians are unable to support or otherwise provide us with such Digital Assets, thereby reducing the amount of Digital Assets we may hold as a result. While our custodians carry insurance policies to cover losses for commercial crimes, cyber and cold storage, the policy limits vary per provider and would be shared among all of their customers, and subject to various limitations and exclusions (such as if a loss arises due to our failure to protect our login credentials and devices). The insurance that covers losses of our Digital Asset holdings may cover only a small fraction of the value of the entirety of our Digital Asset holdings, and there can be no guarantee that such insurance will be maintained as part of the custodial services we have or that such coverage will cover losses with respect to our Digital Assets. Moreover, our use of custodians exposes us to the risk that the Digital Assets our custodians hold on our behalf could be subject to insolvency proceedings and we could be treated as a general unsecured creditor of the custodian, inhibiting our ability to exercise ownership rights with respect to such Digital Assets. Any loss associated with such insolvency proceedings is unlikely to be covered by any insurance coverage we maintain related to our Digital Assets.
Digital Assets are controllable only by the possessor of both the unique public key and private key(s) relating to the local or online digital wallet in which the assets are held. While the digital asset blockchain ledger requires a public key relating to a digital wallet to be published when used in a transaction, private keys must be safeguarded and kept private in order to prevent a third party from accessing the digital asset held in such wallet. To the extent the private key(s) for a digital wallet are lost, destroyed, or otherwise compromised and no backup of the private key(s) is accessible, neither we nor our custodians will be able to access the digital asset held in the related digital wallet. Furthermore, we cannot provide assurance that our digital wallets, nor the digital wallets of our custodians held on our behalf, will not be compromised as a result of a cyberattack. The digital asset and blockchain ledger, as well as other Digital Assets and blockchain technologies, have been, and may in the future be, subject to security breaches, cyberattacks, or other malicious activities.
Our custodially-held Digital Assets may become part of the custodian’s insolvency estate if one or more of our custodians enters bankruptcy, receivership or similar insolvency proceedings.
If our Digital Assets held by a custodian are considered to be the property of our custodians’ estates in the event that any such custodians were to enter bankruptcy, receivership or similar insolvency proceedings, we could be treated as a general unsecured creditor of such custodians, inhibiting our ability to exercise ownership rights with respect to such Digital Asset and this may ultimately result in the loss of the value related to some or all of such Digital Assets. A series of recent high-profile bankruptcies, closures, liquidations, regulatory enforcement actions and other events relating to companies operating in the Digital Asset industry, including the filings for bankruptcy protection by Three Arrows Capital, Celsius Network, Voyager Digital, FTX Trading and Genesis Global Capital, the closure or liquidation of certain financial institutions that provided lending and other services to the Digital Assets industry, including Signature Bank and Silvergate Bank, SEC enforcement actions against Coinbase, Inc. and Binance Holdings Ltd., the placement of Prime Trust, LLC into receivership following a cease-and-desist order issued by Nevada’s Department of Business and Industry, and the filing and subsequent settlement of a civil fraud lawsuit by the New York Attorney General against Genesis Global Capital, its parent company Digital Currency Group, Inc., and former partner Gemini Trust Company, have highlighted the counterparty risks applicable to owning and transacting in Digital Assets. Additional bankruptcies, closures, liquidations, regulatory enforcement actions or other events involving participants in the Digital Asset industry in the future may further negatively impact the adoption rate, price, and use of Digital Assets, limit the availability to us of financing collateralized by Digital Assets that we hold, or create or expose additional counterparty risks. Any loss associated with such insolvency proceedings is unlikely to be covered by any insurance coverage we maintain related to our Digital Assets. Even if we are able to prevent our Digital Assets from being considered the property of a custodian’s bankruptcy estate as part of an insolvency proceeding, it is possible that we would still be delayed or may otherwise experience difficulty in accessing our Digital Assets held by the affected custodian during the pendency of the insolvency proceedings. Any such outcome could have a material adverse effect on our financial condition and the market price of our common stock.
Digital Assets held by us are not subject to FDIC or SIPC protections.
We will not hold our Digital Assets with a banking institution or a member of the Federal Deposit Insurance Corporation (“FDIC”) or the Securities Investor Protection Corporation (“SIPC”), and, therefore, our Digital Assets are not subject to the protections enjoyed by depositors with FDIC or SIPC member institutions. As a result, we may suffer a loss with respect to our Digital Assets that is not covered by insurance, and we may not be able to recover any of our carried value in these Digital Assets if they are lost or stolen or suffer significant and sustained reduction in conversion spot price. If we are not otherwise able to recover damages from a malicious actor in connection with these losses, our business and results of operations may suffer, which may have a material negative impact on our stock price.
Digital Assets are novel assets, and are subject to significant legal, commercial, regulatory, and technical uncertainty.
Digital Assets are relatively novel and are subject to rapidly evolving legal, commercial, regulatory, and technical landscapes. Because the application of federal and state securities and other applicable laws, regulations, and rules (“Applicable Law”) remain unsettled in several material respects, there is substantial risk that a governmental or regulatory authority could adopt or interpret Applicable Law in a manner that adversely affects the price of Digital Assets. Increased regulatory scrutiny may result in additional costs for us and may require our management team to devote increased time and attention to regulatory matters, change aspects of our business, or result in limits on the utility of Digital Assets. Moreover, the regulatory landscape with respect to Digital Assets is rapidly changing and we may be required to comply with any new laws, regulations, or interpretations, which may result in heightened regulatory and compliance related costs, litigation, regulatory investigations, and enforcement or other actions. Adverse changes to, or our failure to comply with Applicable Law may have an adverse effect on our reputation, brand, our business, operating results, and financial condition. Further, if any of our Digital Assets are determined to constitute a security for purposes of U.S. federal securities laws, the additional regulatory restrictions imposed by such a determination could adversely affect the market price of the Digital Assets we hold.
The U.S. federal government, states, regulatory agencies, and foreign countries may also enact new laws and regulations, or pursue regulatory, legislative, enforcement or judicial actions, that could materially impact the price of Digital Assets or the ability of individuals or institutions such as us to own or transfer Digital Assets. Regulatory authorities have been evolving in their approach to Digital Assets. It is not possible to predict whether, or when, any of these developments will lead to U.S. Congress granting additional authorities to the SEC or other regulators, or whether any other federal, state, or foreign legislative bodies will take any similar actions. It is also not possible to predict the nature of any such additional authorities, how additional legislation or regulatory oversight might impact the ability of Digital Asset markets to function or the willingness of financial and other institutions to continue to provide services to the Digital Assets industry, nor how any new regulations or changes to existing regulations might impact the value of Digital Assets generally and any Digital Assets we hold specifically. The consequences of increased regulation of Digital Assets and Digital Asset-related activities could adversely affect the market price of any Digital Assets we hold and in turn adversely affect the market price of our common stock.
Moreover, the risks of engaging in a Digital Asset treasury strategy are relatively novel and have created, and could continue to create, complications due to the lack of experience that third parties have with companies engaging in such a strategy, such as increased costs of director and officer liability insurance or the potential inability to obtain such coverage on acceptable terms in the future.
The liquidity of Digital Assets may also be impacted to the extent that changes in Applicable Laws and regulatory requirements negatively impact the ability of exchanges and trading venues to provide services for Digital Assets. The evolving regulatory landscape creates uncertainty for the Company, as new regulations or changes to existing regulations could materially and adversely affect our business operations, financial condition, and results of operations. The effect of any future regulatory change on the Company is impossible to predict, but such change could be substantial and adverse.
We could be subject to legal or regulatory action, including fines, in the event the SEC, a foreign regulatory authority, or a court were to determine that a digital asset held by us is a “security” under applicable laws.
While all investments entail a risk of loss of capital, investments in Digital Assets should be considered substantially more speculative and significantly more likely to result in a loss, including a total loss of capital, than many other forms of investment. The investment characteristics of Digital Assets differ from those of many traditional currencies, commodities, and securities. A particular Digital Asset’s status as a “security” in any relevant jurisdiction is subject to a high degree of uncertainty, and if we are unable to properly characterize a Digital Asset, we may be subject to regulatory scrutiny, investigations, fines, and other penalties, which may adversely affect our business, results of operations and/or financial condition.
On May 10, 2024, we filed a lawsuit against Elion Oncology, Inc. disputing the purported termination of a license agreement, which lawsuit is subject to counterclaims by Elion. On December 3, 2024, two of the investors in our February 2021 private offering filed a lawsuit alleging fraud and negligent misrepresentation in connection therewith and seeking monetary damages.
On December 3, 2024, two of theWe
investors in our February 2021 private offering filed a lawsuit alleging fraud and negligent misrepresentation in connection therewith
and seeking monetary damages. In addition, on May 10, 2024, we filed a lawsuit against Elion Oncology, Inc. disputing the purported
termination of a license agreement, which lawsuit is subject to counterclaims by Elion. We intend to vigorously defend ourselves
in these lawsuits and cannot at this time predict the likely outcome of any litigation, reasonably
determine either the probability of
a material adverse result or any estimated range of potential exposure, or reasonably determine how
these matters or any future matters
might impact our business, our financial condition, or our results of operations, although such impact,
including the costs of defense,
as well as any judgments or indemnification obligations, among other things, could be materially adverse
to us.
We
arehave been and may in the future be subject to cyber-attacks. These cyber-attacks can vary in scope and intent from attacks with the objective of compromising our systems,
networks and communications for economic gain to attacks with the objective of disrupting, disabling or otherwise compromising our operations.
The attacks can encompass a wide range of methods and intent, including phishing attacks, illegitimate requests for payment, theft of
intellectual property, theft of confidential or non-public information, installation of malware, installation of ransomware and theft
of personal or business information. The breadth and scope of these attacks, as well as the techniques and sophistication used to conduct
these attacks, have grown over time.
In addition, we currently use some artificial intelligence (AI) solutions for certain administrative and other functions. The use of AI by us and/or our business partners creates the additional risk for the potential loss or misuse of personal data or the dissemination of confidential information, either of which may result in significantly increased business and security costs, a damaged reputation, administrative penalties, or costs related to defending legal claims.
Our common stock is currently listed for trading on The Nasdaq Capital Market. We must satisfy The Nasdaq Capital Market’s continued listing requirements, including, among other things, a minimum bid price requirement of $1.00 per share or risk delisting, which would have a material adverse effect on our business. A delisting of our common stock from The Nasdaq Capital Market could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities.
Our common stock is currently listed for trading on The Nasdaq Capital
Market. We must satisfy The Nasdaq Capital Market’s continued listing requirements risk delisting, which would have a material adverse
effect on our business.
On
FebruaryWe 4,have 2025,in wethe past received notice from
the Listing Qualifications Staff of Nasdaq indicating that, based upon the closing bid price
of our common stock for the prior 30 consecutive
business days, we were not in compliance with the requirement to maintain a minimum
bid price of $1.00 per share for continued listing
on Nasdaq as set forth in Nasdaq Listing Rule 5550(a)(2). WeAlthough we regained compliance with such requirement as of January 6, 2026, there is no assurance that we will havebe 180 days from
February 4, 2025, or through August 4, 2025, to regain compliance. If we do not regainin compliance duringin the compliance period ending
August 4, 2025, then Nasdaq may grant us a second 180 calendar day period to regain compliance, provided we meet the continued listing
requirement for market value of publicly-held shares and all other initial listing standards for The Nasdaq Capital Market, other than
the minimum closing bid price requirement, and notify Nasdaq of our intent to cure the deficiency. If we do not regain compliance within
the allotted compliance periods, including any extensions that may be granted by Nasdaq, we may be subject to delisting. In order to satisfy the bid price requirement, we may be required to complete
a reverse stock split.future.
Our
common stock price is expected to be volatile.
If
securities or industry analysts do not publish research or reports about our business, or if they publish negative evaluations of our
stock or negative reports about our business, our stock price and trading volume could decline.
The
trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about
us or our business. We do not have any control over these analysts. We may never obtain research coverage by industry or financial analysts.
If no or few analysts commence coverage of us, the trading price of our stock would likely decrease. Even if we do obtain analyst coverage,
there can be no assurance that analysts will cover us or provide favorable coverage. If one or more of the analysts who cover us downgrades
our stock or changes his or her opinion of our stock, our stock price would likely decline. If one or more of these analysts cease coverage
of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which could cause our stock
price or trading volume to decline.
Management's Discussion & Analysis (MD&A)
New heading “Private Placement”
New heading “Liquidity and Capital Resources”
New heading “Valuation and Classification of Digital Assets”
Removed heading “Public Offering”
Largest changes
“We measure our Digital Assets at fair value, with changes in fair value recognized in net income in the period of change. The most critical estimate inherent in the valuation of our Digital Assets is the determination of the principal market under ASC 820, Fair Value Measurement. We evaluate the liquidity, trading volume, and regulatory viability of various exchanges to identify the principal market – the market with the greatest volume and level of activity for the asset that we can access. We have determined that the Coinbase exchange represents the principal market for CHZ. …”see in full comparison
“At December 31, 2024, we had $1.2 million in cash and cash equivalents. On January 27, 2025, we closed a public offering where we sold 1,030,972 shares of our common stock, and/or pre-funded warrants to purchase up to 7,019,700 shares of our common stock, accompanying Series A warrants to purchase up to 8,050,672 shares of our common stock (the “Series A Warrants”) and Series B warrants to purchase up to 4,025,336 shares of our common stock (the “Series B Warrants” and collectively with the Series A Warrants, the “Common Warrants”) for net proceeds of $4.5 million, after deducting placement …”see in full comparison
Full comparison: every changed paragraph (26)
PCS499
is a drug that can be used to treat unmet medical need conditions caused by multiple pathophysiological changes.
We are presently
defining the development plan for the use of PCS499 in a primary glomerular disease. We believe that PCS499 could be successfully
successfully developed in a primary glomerular disease such as focal segmental glomerulosclerosis, or FSGS, and IgA. The use of proteinuria for
the primary endpoint in FSGS has been accepted by FDA in our protocol discussions. We intendare todesigning design
athe FSGS development program
with a Phase 2 and Phase 3 trial per our discussions with the nextFDA. studyWe being an adaptive designed Phase 3 trial, meet with the FDA, and then find a partnercontinue to explore potential partnership opportunities to
take
the drug to approval.
Private Placement
[OPEN]
Public
Offering
On
January 27, 2025, we raised gross proceeds in a public offering of $5.0 million (net proceeds of $4.5 million) from the sale of
1,030,972 shares of our common stock, pre-funded warrants to purchase up to 7,019,700 shares of our common stock, accompanying
Series A warrants to purchase up to 8,050,672 shares of our common stock and Series B warrants to purchase up
to 4,025,336 shares of common stock, as described in Note 14. Since the offering closed, pre-funded warrants were exercised in
exchange for 525,700 shares of our common stock and, as of March 12, 2025, pre-funded warrants to purchase up to 6,494,000
shares of our common stock remain available to be exercised. We plan to use the net proceeds from this financing for continued
research and development for NCG-Cap, and for working capital and general corporate purposes.
In
May 2024, we filed with the SEC a registration statement on Form S-3
(Registration No. 333-279588) (as amended and supplemented, the “Registration Statement”),
including a base prospectus relating
to the offering of up to $50,000,000 in the aggregate of the securities identified in the base prospectus
from time to time in one or
more offerings; and a prospectus supplement relating to the shares of our common stock that may be issued
and sold under a sales agreement
dated May 21, 2024 (the “Sales Agreement”) between us and A.G.P./Alliance Global Partners
(the “Sales Agent”),
through which we may issue and sell in a registered “at the market offering” shares of our
common stock having an aggregate
offering price of up to $2.4$5.2 million (subject to adjustment) from time to time through or to our Sales
Agent (the “ATM Offering”).
We expect to use net proceeds, if any, from the ATM Offering over time for continued research
and development for our portfolio of drug
candidates, especially our oncology products, and working capital and general corporate purposes.
The shares under the ATM Offering will
be sold and issued pursuant to the Registration Statement. During the year ended December 31,
2024, 2025, we received $1.5$3.0 million in net proceeds
from the sale of 800,994475,905 shares of common stock under the ATM Offering, of which 426,804 shares of common stock were sold during the quarter
ended December 31, 2024 for net proceeds of approximately $575,000.Offering.
During
the year ended December 31, 2024,2025, our research and development expenses increased by $1.5 million$541,000 to $7.3$7.8 million when compared to $5.8$7.3
million million
for the year ended December 31, 2023.2024. This was primarily attributable to an increase of approximately $2.0 million$790,000 for ongoing
testing testing
and related expenses related to our Phase 1B trial for NGC-Cap and the IND/initiation of our Phase 2 trial for NGC-Cap.
Expenses include
costs related to contract research organizations, regulatory filing and maintenance fees, drug product testing and
stability, consulting,
and other clinical fees. The increase was offset by a $352,000decrease decreaseof $248,000 for salaries and other
payroll-related expenses due to a reduction in professionalstaff feesduring andthe inyear employeeended stock-basedDecember compensation
of31, $195,000. While we have increased salary rates for some personnel, we had fewer full-time R&D employees in 2024 than 2023.2025.
Our
general and administrative expenses for the year ended December 31, 20242025 decreasedincreased by approximately $875,000$1.4 million to $6.2 million
when compared to $4.8 million when compared
to $5.7 million for the same period in 2023.2024. This was mostly due to a $1.2$474,000 million decrease in professional fees and approximately $201,000
decrease in employee stock-based compensation. The decreases were primarily offset by increasesincrease in salaries and other
payroll-related payroll-relatedexpenses, a $322,000 increase in employee stock-based compensation, a $313,000 increase in professional fees, a
costs$164,000 ofincrease approximatelyin $443,000franchise taxes, and neta increases$174,000 increase in taxes,investment travel,fees, insurance, and other miscellaneous costs. The
increases were offset by decreases of $38,000 in office and other miscellaneous expenses ofand approximately$22,000 $50,000.in rent expense. We sharehave officeshared
spaceexpenses with CorLyst, a related party, and during the years ended December 31, 20242025 and 2023,2024, they reimbursed us approximately$100,000 $110,000and
and $112,000,$110,000, respectively, for rent and other costs we incurred on their behalf.
Net other income for the year ended December 31, 2025 consisted of $295,180 in unrealized gains on our digital asset, $109,491 in interest income, and $20,000 other income from our Term Sheet with Intact. Net other income during the year ended December 31, 2024 solely consisted of interest income.
Net
other income consisting primarily of interest income was $207,567 and $335,541 for the years ended December 31, 2024 and 2023, respectively.
Liquidity and Capital Resources
Liquidity
At December 31, 2025, we had $5.5 million in cash and cash equivalents. On February 17, 2026, we sold 86,956 shares of our common stock to an accredited investor in a private placement transaction for $200,000.
At
December 31, 2024, we had $1.2 million in cash and cash equivalents. On January 27, 2025, we closed a public offering where we sold
1,030,972 shares of our common stock, and/or pre-funded warrants to purchase up to 7,019,700 shares of our common stock,
accompanying Series A warrants to purchase up to 8,050,672 shares of our common stock (the “Series A Warrants”) and
Series B warrants to purchase up to 4,025,336 shares of our common stock (the “Series B Warrants” and collectively with
the Series A Warrants, the “Common Warrants”) for net proceeds of $4.5 million, after deducting placement agent fees and
offering-related expenses (see Note 14 to the Consolidated Financial Statements for additional details). On January 30, 2025,
pre-funded warrants to purchase 525,700 shares of our common stock were exercised. As of March 12, 2025, pre-funded warrants for the
purchase of 6,494,000 remain outstanding.
We
have incurred losses and net cash used in our operating activities during
the year ended December 31, 2024,2025, which we expect to continue
for the foreseeable future. We have incurred losses since our inception,
devoting substantially all of our efforts toward research and
development, and have an accumulated deficit of approximately $87.2$100.8 million at
December 31, 2024.2025. During the year ended December 31,
2024, 2025, we generated a net loss of approximately $11.9$13.6 million. Based on our current
business plans, we believe these fundswe will satisfy
ourneed to raise additional capital needsin intothe mid-2025.second quarter of 2026. Our ability to execute our
longer-term operating plans, including unplanned future clinical trials for
our portfolio of drugs depend on our ability to obtain additional
funding from the sale of equity and/or debt securities, a strategic
transaction or other funding transactions. We plan to continue to
actively pursue financing alternatives, but there can be no assurance
that we will obtain the necessary funding in the future when needed.
We
used net cash in our operating activities of $11,245,042$11,385,195 and $8,063,346$11,245,042 during the years ended December 31, 20242025 and 2023,2024, respectively.
The increase in cash used in operating activities was primarily attributable to increased costs related to closing our Phase 1B and commencing
our Phase 2 trial for NGC-Cap, including the prepayment of expenses to our CRO for the Phase 2 trialNGC-Cap;
increased salaries and other payroll-related
expenses; and professional fees during the year ended December 31, 2024.2025. As we continue
our Phase 2 trial for NGC-Cap and evaluate the
other NGC drugs in our portfolio,NGC-Iri, we anticipate our research and development efforts and ongoing general and administrative
costs will
continue to generate negative cash flows from operating activities for the foreseeable future.
At
December 31, 2024,2025, our prepaid expense and other consisted primarily of $1.8$1.0 million for advanced payments we made to the CRO and other
vendors related to our Phase 1B and Phase 2 trials of NGC-Cap that have not yet been applied; and$42,000 approximatelyfor $85,000upcoming patent annuities;
$32,000 in various insurance
policies, such as directors’ and officers’ insurance and product liability insurance for conducting
our clinical trials.trials; and $16,000 in other miscellaneous general and administrative expenses.
We
used net cash$850,000 in our investing activities ofto $3,244purchase our digital assets during the year ended December 31, 2025 and $2,776used $3,244
during year ended December 31, 2024 and 2023 to purchase property and
equipment.
Net
cash provided by (used in) financing activities
During
the year ended December 31, 2024,2025, we sold 476,000613,639 shares of common stock, pre-funded warrants to purchase up to 1,079,555828,388 shares of
common common
stock in lieu of shares of common stock, all of which were exercised into shares of our common stock, and warrants to
purchase up to
1,555,555 1,603,041 shares of our common stock pursuant to aour publicJanuary offering2025 and June 2025 Offerings for net proceeds of $6.3 $10.6
million. We also sold 800,994476,028 shares of common
stock under our ATM Offering for net proceeds of approximately $1.5$3.0 million and
218,688 shares of common stock under a Securities Purchase Agreement for net proceeds of $1.2 million. Warrants to purchase 281,749
shares of common stock were also exercised for $1.8 million. We used cash, classified as financing activities, of approximately
$16,000$10,000 to pay income taxes owed on stock-based compensation, approximately $9,000 for the settlement of a stock award,compensation and approximately
$5,000 $7,000 for payments owed under a financing lease
obligation. During the year ended December 31, 2023, we raised net proceeds of $6.4
million from the sale of 421,611 shares of our common stock and used $31,000 in legal expenses related to our January 2024 raise and
$53,000 for the settlement of a stock award.
During the year ended December 31, 2024, we sold 19,040 shares of common stock, pre-funded warrants to purchase up to 43,183 shares of common stock in lieu of shares of common stock, all of which were exercised into shares of our common stock, and warrants to purchase up to 62,223 shares of our common stock pursuant to a public offering for net proceeds of $6.3 million. We also sold 32,030 shares of common stock under our ATM Offering for net proceeds of approximately $1.5 million. We used cash, classified as financing activities, of approximately $16,000 to pay income taxes owed on stock-based compensation, approximately $9,000 for the settlement of a stock award, and approximately $5,000 for payments owed under a financing lease obligation.
The
following table summarizes our contractual obligations at December 31, 2024:
We
account for income taxes in accordance with ASC Topic 740, Income Taxes. Deferred income taxes are recorded for the expected tax
consequences of temporary differences between the basis of assets and liabilities for financial reporting purposes and amounts recognized
for income tax purposes. We have recorded a valuation allowance equal to the full recorded amount of our net deferred tax assets since
it was more-likely-than-not that benefits from our deferred tax assets would not be realized. The valuation allowance is reviewed quarterlyannually
and is maintained until sufficient positive evidence exists to support its reversal. As part of an evaluation of our tax attributes in
2022, we recharacterized approximately $7.4 million of startup costs previously capitalized as an IRC Section 195 asset as net operating
losses. The recharacterization has no impact on total deferred tax assets since we had previously and will continue to provide a full
valuation allowance on our unutilized net deferred tax assets. Deferred tax assets and liabilities are measured using enacted tax rates
expected to apply to taxable income in the year in which those temporary differences are expected to be recovered or settled. The effect
of changes in tax rates on deferred tax assets and liabilities is recognized in income in the period such changes are enacted. No income
tax benefit or expense was recorded for any periods presented nor is expected in the foreseeable future since we expect to generate future
taxable net operating losses.
Valuation and Classification of Digital Assets
We measure our Digital Assets at fair value, with changes in fair value recognized in net income in the period of change. The most critical estimate inherent in the valuation of our Digital Assets is the determination of the principal market under ASC 820, Fair Value Measurement. We evaluate the liquidity, trading volume, and regulatory viability of various exchanges to identify the principal market – the market with the greatest volume and level of activity for the asset that we can access. We have determined that the Coinbase exchange represents the principal market for CHZ. We calculate the fair value of our holdings using the quoted price on the Coinbase exchange as of midnight UTC on the measurement date. The digital asset market is characterized by significant volatility and fragmented liquidity. A change in our determination of the principal market, or the use of a different data source (such as a composite index versus a specific exchange), could result in materially different fair value measurements.
RecentlyRecent
Issued Accounting Pronouncements
What changed in the latest 10-Q
Risk Factors
New heading “Risks Related to the Vidya Acquisition”
New heading “Our business is highly dependent on the success of VT-7208. VT-7208 will require additional clinical and manufacturing development before we may be able to seek regulatory approval for and launch a product commercially and we may not be successful in our efforts.”
New heading “Pursuant to the terms of the Vidya Acquisition, we are required to recommend that our stockholders approve the conversion of all outstanding shares of our Series A Preferred Stock into shares of our common stock. We cannot guarantee that our stockholders will approve this matter, and if they fail to do so we may be required to settle such shares in cash and our operations may be materially harmed.”
New heading “There is no guarantee that the Vidya Acquisition will increase stockholder value.”
New heading “The failure to successfully integrate the businesses of our company and Vidya in the expected timeframe could adversely affect our results of operations, financial condition, and future results.”
New heading “We expect to incur substantial expenses related to the integration of Vidya.”
New heading “A substantial number of shares of our common stock will become available for sale and may be sold upon conversion of our Series A Preferred Stock, and additional shares may be sold by existing common stockholders, which could cause the price of our common stock to decline.”
New heading “We may become involved in litigation, including securities class action litigation, that could divert management’s attention and harm our business, and insurance coverage may not be sufficient to cover all costs and damages.”
Largest changes
“We may become involved in litigation, including securities class action litigation, that could divert management’s attention and harm our business, and insurance coverage may not be sufficient to cover all costs and damages.”see in full comparison
“In the past, litigation, including securities class action litigation, has often followed certain significant business transactions, such as the Vidya Acquisition. These events may also result in investigations by the SEC or other government agencies. We may be exposed to such litigation and resulting costs in connection with the Vidya Acquisition even if no wrongdoing occurred.”see in full comparison
“Furthermore, the stock market in general, and Nasdaq and biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. In the past, companies that have experienced volatility in the market price of their stock have been subject to securities class action litigation. The market price of our common stock may be volatile, and we may be the target of this type of litigation in the future.”see in full comparison
“Pursuant to the terms of the Vidya Acquisition, we are required to recommend that our stockholders approve the conversion of all outstanding shares of our Series A Preferred Stock into shares of our common stock. We cannot guarantee that our stockholders will approve this matter, and if they fail to do so we may be required to settle such shares in cash and our operations may be materially harmed.”see in full comparison
“A substantial number of shares of our common stock will become available for sale and may be sold upon conversion of our Series A Preferred Stock, and additional shares may be sold by existing common stockholders, which could cause the price of our common stock to decline.”see in full comparison
“Our business is highly dependent on the success of VT-7208. VT-7208 will require additional clinical and manufacturing development before we may be able to seek regulatory approval for and launch a product commercially and we may not be successful in our efforts.”see in full comparison
Full comparison: every changed paragraph (25)
Risks Related to the Vidya Acquisition
Our business is highly dependent on the success of VT-7208. VT-7208 will require additional clinical and manufacturing development before we may be able to seek regulatory approval for and launch a product commercially and we may not be successful in our efforts.
We currently have no products that are approved for commercial sale and may never be able to develop marketable products. Following the Vidya Acquisition, we are focusing the majority of our resources on the development of VT-7208 in food allergy, CSU and RMS and continuing the development of our legacy pharmaceutical assets, including PCS499, PCS12852 and PCS11T, while evaluating strategic opportunities designed to maximize their clinical and long-term value. If VT-7208, across the various target indications, encounters safety or efficacy problems, development delays, regulatory issues or other problems, our development plans and forecasted timelines and business could be significantly harmed. Because we are focusing the vast majority of our resources on a single product candidate, any failure or significant delay in VT-7208’s development would have a disproportionate impact on our business, financial condition and prospects, and our other clinical-stage programs would not be able to offset such a setback.
We cannot provide you with any assurance that we will be able to successfully advance VT-7208 or any additional product candidates through the development process in any particular target indication. Our research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development or commercialization for many reasons, including the following:
If any of these events occur, we may be forced to abandon our development efforts for a program or programs, or we may not be able to identify, discover, develop, or commercialize additional product candidates, which could have a material adverse effect on our business and could potentially cause us to cease operations.
If we do not successfully develop, secure regulatory approval for, and commercialize product candidates or collaborate with others to do so, we will not be able to obtain product revenue in future periods, which would significantly harm our financial position and adversely affect the trading price of our common stock.
Pursuant to the terms of the Vidya Acquisition, we are required to recommend that our stockholders approve the conversion of all outstanding shares of our Series A Preferred Stock into shares of our common stock. We cannot guarantee that our stockholders will approve this matter, and if they fail to do so we may be required to settle such shares in cash and our operations may be materially harmed.
Under the terms of the Merger Agreement and the Purchase Agreement, as promptly as practicable following the date of the Merger Agreement and pursuant to the Nasdaq Stock Market Rules, we will call and hold a meeting of our stockholders to obtain the requisite approval from our legacy stockholders for, among other things, (i) the approval, in accordance with the applicable rules of Nasdaq, of the conversion of the Series A Preferred Stock into shares of our common stock, or the Preferred Stock Conversion Proposal, (ii) the approval of a 2026 Equity Incentive Plan, subject to approval by the Board, (iii) the approval of a 2026 Employee Stock Purchase Plan, and (iv) to the extent deemed necessary or advisable by us and/or Vidya, approval of an amendment to our certificate of incorporation to effect a reverse stock split (the matters contemplated in items (i) through (iv) collectively, the “Stockholder Matters”). If we fail to receive sufficient proxies to constitute a quorum or to obtain the required vote on the Stockholder Matters, we would be required to adjourn the meeting one or more times for up to 30 days per adjournment. If stockholder approval of the Stockholder Matters is still not obtained following such adjournment(s), we will be obligated to continue soliciting stockholder approval at subsequent annual or special meetings of our stockholders, held at intervals of no more than six months, until such approvals are obtained, which would be time consuming and costly.
There can be no assurance that our legacy stockholders will approve the Stockholder Matters. Additionally, if at any time following the date that is six months following the initial issuance date of the Series A Preferred Stock, we fail to deliver to the holders of the Series A Preferred Stock shares of common stock underlying such shares of Series A Preferred Stock, (other than in certain circumstances set forth in the Certificate of Designation, as defined below) the holders of the Series A Preferred Stock would be entitled to require us to settle such undelivered shares for cash in an amount equal to the fair value of such undelivered shares of common stock at such time, as described in the Certificate of Designation of Preferences, Rights and Limitations of the Series A Preferred Stock, or the Certificate of Designation. If we are forced to cash settle a significant amount of the shares of our common stock underlying the Series A Preferred Stock, it could materially affect our results of operations, business and financial condition.
There is no guarantee that the Vidya Acquisition will increase stockholder value.
In July 2026, we consummated the Vidya Acquisition, pursuant to which we acquired Vidya, and we closed the 2026 Private Placement. We cannot guarantee that implementing the Vidya Acquisition and related transactions will not impair stockholder value or otherwise adversely affect our business. The Vidya Acquisition poses significant integration challenges between our businesses and employees which could result in management and business disruptions, any of which could harm our results of operation, business prospects, and impair the value of the Vidya Acquisition to our stockholders.
The failure to successfully integrate the businesses of our company and Vidya in the expected timeframe could adversely affect our results of operations, financial condition, and future results.
Our ability to successfully integrate the operations of our company and Vidya will depend, in part, on our ability to realize the anticipated benefits from the Vidya Acquisition. If we are not able to achieve these objectives within the anticipated time frame, or at all, the anticipated benefits of the Vidya Acquisition may not be realized fully, or at all, or may take longer to realize than expected, and the value of our common stock may be adversely affected. In addition, the integration of our company’s and Vidya’s respective businesses will be a time-consuming and expensive process. Proper planning and effective and timely implementation will be critical to avoid any significant disruption to our operations. There can be no assurance that we will effectively manage the increased complexity of our business without experiencing operating inefficiencies or control deficiencies. Delays encountered in the integration process could have a material adverse effect on our expenses, operating results and financial condition, including the value of shares of our common stock.
We expect to incur substantial expenses related to the integration of Vidya.
We have incurred, and expect to continue to incur, substantial expenses in connection with the Vidya Acquisition and the integration of Vidya. There are a large number of processes, policies, procedures, operations, technologies and systems that must be integrated, including accounting and finance, billing, payroll, and benefits. Both our company and Vidya have incurred significant transaction expenses in connection with the drafting and negotiation of the Merger Agreement, and the related ancillary agreements. While we have assumed that a certain level of expenses will be incurred, there are many factors beyond our control that could affect the total amount or the timing of the integration expenses. Moreover, many of the expenses that will be incurred are, by their nature, difficult to estimate accurately. These integration expenses likely will result in our taking significant charges against earnings following the completion of the Vidya Acquisition, and the amount and timing of such charges are uncertain at present.
A substantial number of shares of our common stock will become available for sale and may be sold upon conversion of our Series A Preferred Stock, and additional shares may be sold by existing common stockholders, which could cause the price of our common stock to decline.
If stockholders approve the Preferred Stock Conversion Proposal, the up to 307,063,330 shares of our common stock issuable upon conversion of the Series A Preferred Stock issued in connection with the Vidya Acquisition and the 2026 Private Placement, subject to beneficial ownership limitations, will represent approximately 99.0% of the issued and outstanding shares of our common stock as of August 7, 2026, on an as-converted basis. The sale of a substantial number of shares of our securities in the public market, or the perception that such sales may occur, could adversely affect the price of our common stock on Nasdaq. We cannot predict the effect, if any, that market sales of those shares of common stock or the availability of those shares of common stock for sale will have on the market price of our common stock.
In addition, in the future, we may also issue shares of our common stock in connection with investments or acquisitions. The amount of shares of our common stock issued in connection with an investment or acquisition could substantially increase our shares of common stock outstanding, which could adversely affect the price of our common stock on Nasdaq.
Concurrently and in connection with the execution of the Merger Agreement, certain officers, directors and stockholders of Vidya, and the directors and officers of the Company as of immediately following the Vidya Acquisition entered into lock-up agreements with the Company, pursuant to which each such stockholder will be subject to a 180-day lock-up on the sale or transfer of shares of our common stock and Series A Preferred Stock held by each such stockholder at the closing of the Vidya Acquisition, including those shares received by former Vidya securityholders in the Vidya Acquisition. Upon expiration of this 180-day lock-up period, these shares will become eligible for sale in the public market.
In connection with the closing of the 2026 Private Placement, we entered into a Registration Rights Agreement with the investors, and pursuant to the Merger Agreement, we are required to register the resale of all shares of common stock underlying the Series A Preferred Stock issued in connection with the Vidya Acquisition and the 2026 Private Placement. Under the Registration Rights Agreement, we are required to prepare and file a resale registration statement with the SEC within 75 calendar days following the closing of the 2026 Private Placement. We are obligated to use our reasonable best efforts to cause this registration statement to be declared effective by the SEC within five business days of the date we are notified by the SEC that the registration statement will not be reviewed or will not be subject to further review (or within 60 calendar days following the filing deadline if the SEC reviews the registration statement). Once this registration statement is declared effective and the restricted securities legends on the shares issued in connection with the Vidya Acquisition and the 2026 Private Placement are removed, the shares subject to such registration statement will no longer constitute restricted securities and may be sold freely in the public markets, subject to any beneficial ownership limitations set by the holder of Series A Preferred Stock or lapse on any related contractual restrictions of any Investor. If our stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after legal restrictions on resale lapse, the trading price of our common stock could decline. In addition, shares of our common stock that are subject to outstanding options will become eligible for sale in the public market to the extent permitted by the provisions of various vesting agreements and Rules 144 and 701 under the Securities Act of 1933, as amended.
We may become involved in litigation, including securities class action litigation, that could divert management’s attention and harm our business, and insurance coverage may not be sufficient to cover all costs and damages.
In the past, litigation, including securities class action litigation, has often followed certain significant business transactions, such as the Vidya Acquisition. These events may also result in investigations by the SEC or other government agencies. We may be exposed to such litigation and resulting costs in connection with the Vidya Acquisition even if no wrongdoing occurred.
Furthermore, the stock market in general, and Nasdaq and biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. In the past, companies that have experienced volatility in the market price of their stock have been subject to securities class action litigation. The market price of our common stock may be volatile, and we may be the target of this type of litigation in the future.
Litigation is usually expensive and diverts management’s attention and resources from other business concerns, which could adversely affect our business and cash resources.
There
have been no material changes to our risk factors as described in Item 1A of our Annual Report on Form 10-K for the year ended December
31, 2025.
Management's Discussion & Analysis (MD&A)
New heading “Vidya Acquisition”
New heading “Elion Settlement Agreement”
New heading “Other 2026 Fundraising”
Largest changes
“Following our acquisition of Vidya and closing of the related $200 million gross private placement (from which we received net proceeds of $183.3 million) on July 30, 2026, we believe our cash and cash equivalents will be sufficient to satisfy our cash requirements over the next 12 months and beyond. This represents a material change from what we reported in our 2025 Form 10-K that disclosed substantial doubt of our ability to continue as a going concern.”see in full comparison
“On July 23, 2026, we entered into a settlement agreement with Elion Oncology, Inc. (“Elion”) to resolve all claims arising from the parties’ litigation concerning the license agreement dated August 23, 2020, relating to the commercialization of PCS6422 (the “Elion License Agreement”). Under the settlement agreement, the Elion License Agreement was terminated, the PCS6422 program was returned to Elion, and the parties exchanged mutual releases of all claims relating to the Elion License Agreement, the PCS6422 program, and the related litigation.”see in full comparison
“As a result of the settlement and the return of the PCS6422 program to Elion, we are closing our ongoing Phase 2 clinical trial of PCS6422 in advanced or metastatic breast cancer. On August 7, 2026, the stipulation of dismissal became effective, resulting in the dismissal of the litigation with prejudice.”see in full comparison
Full comparison: every changed paragraph (38)
We are a clinical-stage biotechnology company. In July 2026, we acquired Vidya Therapeutics, Inc. (“Vidya”), a clinical-stage biotechnology company developing VT-7208, a Bruton’s tyrosine kinase (“BTK”) inhibitor therapy for immune-mediated diseases with an initial focus on food allergy, chronic spontaneous urticaria (“CSU”) and relapsing multiple sclerosis (“RMS”). We are also continuing the development of our legacy pharmaceutical assets, including PCS499, PCS12852 and PCS11T, while evaluating strategic opportunities designed to maximize their clinical and long-term value.
Vidya Acquisition
On July 28, 2026, we acquired Vidya, which brought Vidya’s lead asset VT-7208 into our pipeline. In connection with our acquisition of Vidya, we received $200 million in gross proceeds from a private placement financing of shares of our non-voting convertible preferred stock. We intend to use the net proceeds of $183.3 million from the private placement to fund operations into the second half of 2029 and through key clinical milestones, including top-line data from Phase 2 proof-of-concept studies for food allergy, CSU and RMS.
Elion Settlement Agreement
On July 23, 2026, we entered into a settlement agreement with Elion Oncology, Inc. (“Elion”) to resolve all claims arising from the parties’ litigation concerning the license agreement dated August 23, 2020, relating to the commercialization of PCS6422 (the “Elion License Agreement”). Under the settlement agreement, the Elion License Agreement was terminated, the PCS6422 program was returned to Elion, and the parties exchanged mutual releases of all claims relating to the Elion License Agreement, the PCS6422 program, and the related litigation.
In connection with the settlement, we paid Elion $650,000 toward its attorneys’ fees and other out-of-pocket costs. We also agreed to grant Elion a non-voting equity interest equal to 7.5% of the fully diluted pre-money equity capitalization of any newly formed entity whose assets include one or more of PCS499, PCS12852, or PCS11T, provided that the formation or spin-out of such entity is completed within 365 days after the effective date of the settlement agreement.
As a result of the settlement and the return of the PCS6422 program to Elion, we are closing our ongoing Phase 2 clinical trial of PCS6422 in advanced or metastatic breast cancer. On August 7, 2026, the stipulation of dismissal became effective, resulting in the dismissal of the litigation with prejudice.
Other 2026 Fundraising
On February 17, 2026 where we sold 86,956 shares of our common stock to an accredited investor in a private placement transaction for $200,000. During the six months ended June 30, 2026, certain directors, officers, and employees purchased 82,205 shares of common stock for approximately $207,000. In April 2026, we also sold 50,330 shares of common stock under our ATM Offering for approximately $153,000 in net proceeds. Concurrent with the acquisition of Vidya, we entered into a definitive agreement for a private placement financing to raise approximately $200 million in gross proceeds, which we expect to use to support the advancement of VT-7208 through multiple clinical milestones, including data from a Phase 2 proof-of-concept study in food allergy anticipated in the second half of 2027, data from a Phase 2 proof-of-concept study in CSU anticipated in the first half of 2028, and data from a Phase 2 proof-of-concept study in RMS anticipated in the second half of 2028.
We
are a publicly listed clinical-stage biopharmaceutical company. We are developing a pipeline of Next Generation Cancer therapy (“NGC”)
small molecules, one of which is currently in a Phase 2 trial, while the other is in pre-clinical development. Our risk-mitigated strategy
is to identify existing cancer therapies where the mechanism of action is well understood and that are cornerstones of current treatment
regimens, but are highly toxic, with side effects that are often treatment limiting. We devise technologies to change the way the body
metabolizes them, or the way they are distributed within the body, to improve the therapeutic effect and reduce toxicity. We then efficiently
develop our pipeline of Next Generation Cancer therapies utilizing our proprietary Regulatory Science Approach, which we believe will
further increase the likelihood of regulatory approval. Since the underlying active metabolites of these drugs are already commonly used
in cancer therapy, we believe that if our clinical trials are successful and are showing a better safety-efficacy profile than the currently
used drugs, the commercial adoption for our NGC therapies will be rapid and broad.
Our
oncology pipeline currently consists of NGC-Cap and NGC-Iri (also identified as PCS6422 and PCS11T, respectively) and two non-oncology
drugs (PCS12852 and PCS499). We are exploring options for our non-oncology drugs, which may include out-licensing or partnership opportunities.
The current status of our drug pipeline is set forth below:
In addition to advancing the clinical-stage BTK inhibitor program in multiple indications, we continue to evaluate the development of our other legacy pharmaceutical assets PCS499, PCS12852, and PCS11T, including strategic opportunities designed to maximize the clinical and long-term value of all assets.
In
2025, we continued our Phase 2 trial of NGC-Cap in advanced or metastatic breast cancer patients. We have enrolled and dosed the 20 patients
required for the planned first interim analysis, which is expected to be completed in the first half of 2026.
Fundraising
On February 17, 2026 where we
sold 86,956 shares of our common stock to an accredited investor in a private placement transaction for $200,000. On March 31, 2026, certain
directors, officers, and employees purchased 17,796 shares of common stock for approximately $45,000. They also purchased 22,008 shares
of common stock for approximately $62,000 during the month ended April 30, 2026. In April 2026, we also sold 50,330 shares of common
stock under our ATM Offering for approximately $157,000 in net proceeds. We plan to use the net proceeds from these raises for continued
research and development for NGC-Cap, and for working capital and general corporate purposes.
Comparison
of the three and six months ended MarchJune 31,30, 2026 and 2025
Costs for the three and six months ended June 30, 2026 and 2025 were as follows:
During
the three months ended March 31, 2026, our research and development expenses increased by approximately $221,000 to $1.8 million from
$1.6 million for the three months ended March 31, 2025. Costs for the three months ended March 31, 2026 and 2025 were as follows:
The
increasedecrease in research and development expenses was primarily due to ana increasedecrease in professionalpreclinical, feesclinical astrial, weand utilizedother morecosts consultantsrelated
to for
our NGC-Cap Phase 2 clinical trial for NGC-Cap during the three and six months ended MarchJune 31,30, 2026 when compared to the same period in 2025. The increase
was offset by decreases in employee stock-based compensation because of fewer outstanding equity grants, and in testing and related expenses
asDuring the R&Dsix teammonths areended June 30, 2026, we placed the study on hold while performing theirour interim analysis for the NGC-Cap Phase 2 trial.analysis.
Our
general and administrative expenses for the three months ended MarchJune 31,30, 2026 increased by approximately $264,000$183,000 to $1.5$1.7 million
from $1.3$1.5 million for the three months ended MarchJune 31,30, 2025. This increase was due primarily to increases in professional fees of
approximately $226,000$179,000; insurance expense of approximately $85,000$58,000; franchise tax expense of approximately $50,000; salaries and
payroll-related expenses of $60,000$34,000; and travel-relatedother miscellaneous office expenses of approximately $33,000.$4,000. The increases were offset by decreases in
employee franchise tax expense of $35,000; office and
other miscellaneousstock-based expenses of $26,000$74,000; rent expense of $22,000; office and employeeother stock-basedmiscellaneous expenses of $70,000.$20,000; repairs and
maintenance expense of $12,000; and travel expenses of $11,000. We
received approximately $13,000$3,000 lessmore in reimbursements from CorLyst
during the three months ended MarchJune 31,30, 2026 when compared to the
same period in 2025.
Our general and administrative expenses for the six months ended June 30, 2026 increased by approximately $446,000 to $3.2 million from $2.8 million for the six months ended June 30, 2025. This increase was due primarily to increases in professional fees of approximately $405,000; insurance expense of approximately $144,000; salaries and payroll-related expenses of $94,000; travel expenses of $22,000; and franchise tax expense of approximately $15,000. The increases were offset by decreases in employee stock-based expenses of $144,000; rent expense of $46,000; office and other miscellaneous expenses of $42,000; and repairs and maintenance expense of $12,000. We received approximately $10,000 less in reimbursements from CorLyst during the six months ended June 30, 2026 when compared to the same period in 2025.
Other Income/Expense
Other income/expense for the three and six months ended June 30, 2026 and 2025 were as follows:
Other
income represents interest income of approximately $14,000 and an unrealized loss on our digital assets of $60,000 for the three months
ended March 31, 2026; and interest income of approximately $13,000 for the three months ended March 31, 2025.
We
did not recognize any income tax benefit for the three and six months ended MarchJune 31,30, 2026 or 2025.
The
following table sets forth our sources and uses of cash and cash equivalents for the threesix months ended MarchJune 31,30, 2026 and 2025:
We
used net cash in our operating activities of $3.6$5.6 million and $2.7$5.0 million during the threesix months ended MarchJune 31,30, 2026 and 2025, respectively.
respectively. The increase in cash used in operating activities during the first quarterhalf of 2026 compared to the same period in 2025
of approximately $861,000 was primarily related to the increased professional/consulting fees, insurance, payroll, and travel related expenses
incurred, as well as a paydown in our accounts payable.incurred.
As
we continueadvance ourVT-7208 developmentthrough ofthree NGC-CapPhase 2 proof-of-concept studies, and evaluate the otherlegacy NGCproduct drugscandidates in our portfolio, we
anticipate our research and development
efforts and ongoing general and administrative costs will continue to generate negative cash
flows from operating activities for the
foreseeable future. As we continue our Phase 2 clinical trial for NGC-Cap in 2026, weWe anticipate our clinical trial costs will increase in the second half
of 2026 when compared to prior periods as we initiate Phase 2 studies of VT-7208 in food allergy and chronic spontaneous urticaria,
since activities in 2025 were primarily related to the completion of our Phase 1B trial and setup of our
NGC-Cap Phase 2 trial for NGC-Cap.
trial.
We
used $500,000 in investing activities to purchase additionaldigital assets and received $186,000 for the sale of digital assets during the three six
months ended MarchJune 31,30, 2026. We did not
use any cash in investing activities during the same period in 2025.
During
the threesix months ended MarchJune 31,30, 2026, we sold 104,752219,491 shares of our common stock to an accredited investor, and certain directors, officers,
and employees for cumulative net proceeds of $245,000.$560,270. We also used cash classified as financing activities of $320 to pay income taxes owed
owed on stock-based compensation.
During
the threesix months ended MarchJune 31,30, 2025, we sold 41,239613,639 shares of our common stock, pre-funded warrants to purchase up to 280,788828,388 shares
of our common stock, and accompanying Series A Warrants to purchase up to 322,027 shares of our common stock and Series B Warrants to purchase
purchase up to 161,014 shares of our common stock, and common accompanying warrants to purchase up to 1,120,000 shares of common stock for net
proceeds of $4.4$10.7 million. We also received $100,000 from the exercise of warrants to purchase 16,000 shares of common stock. We also
used cash classified as financing activities
of $1,439$10,000 to pay income taxes owed on stock-based compensation, and $1,536$3,000 for payments
owed under a financing lease obligation.
Following our acquisition of Vidya and closing of the related $200 million gross private placement (from which we received net proceeds of $183.3 million) on July 30, 2026, we believe our cash and cash equivalents will be sufficient to satisfy our cash requirements over the next 12 months and beyond. This represents a material change from what we reported in our 2025 Form 10-K that disclosed substantial doubt of our ability to continue as a going concern.
At
March 31, 2026, we had cash and cash equivalents totaling $1.7 million. Together with the $219,000 we raised in April 2026, we believe
we will need to raise additional capital in the second quarter of 2026 based on our current business plans. However, absent additional
funding, our current cash and cash equivalents will not be sufficient to fund our planned operations for a period of one year or more
after the date that these condensed consolidated financial statements were available to be issued based on the timing and amount of our
projected net loss from continuing operations and the related amount of cash to be used in operating activities during that period of
time. Our ability to execute our longer-term operating plans, including future preclinical studies and clinical trials for our portfolio
of drugs depend on our ability to obtain additional funding from the sale of equity and/or debt securities, a strategic transaction or
other funding transactions.
We
have incurred losses since inception, currently devoting substantially all our efforts toward research and development of our next generationproduct
chemotherapy drug product candidates, including conducting clinical trials and providing general and administrative support for these
operations, and have an accumulated
deficit of $104.2$107.4 million at MarchJune 31,30, 2026. During the threesix months ended MarchJune 31,30, 2026, we generated
a net loss of $3.4$6.6 million and used $3.6 million in net cash for operating activities from continuing operations.million. To date,
none of our
drug candidates have been approved for sale, and therefore we have not generated any product revenue and do not expect positive
cash cash
flow from operations in the foreseeable future. We will continue to be dependent upon equity and/or debt financing until we are
able able
to generate positive cash flows from its operations.
On February
17, 2026 where we sold 86,956 shares of our common stock to an accredited investor in a private placement transaction for $200,000.
On March 31, 2026, certain directors, officers, and employees purchased 17,796 shares of common stock for approximately $45,000. They
also purchased 22,008 shares of common stock for approximately $62,000 during the month ended April 30, 2026. In April 2026, we
also sold 50,330 shares of common stock under our ATM Offering for approximately $157,000 in net proceeds. We will continue to be dependent
upon equity and/or debt financing until we are able to generate positive cash flows from its operations.
ThereDuring the six months ended June 30, 2026, there
have been no significant changes to the contractual obligations reported in our Annual Report on Form 10-K for the fiscal year ended
December 31, 2025.
At
MarchJune 31,30, 2026, we did not have any off-balance sheet arrangements.
ThereDuring the six months ended June 30, 2026, there
have been no changes in our critical accounting policies from those included in our most recent Annual Report on Form 10-K.
PCSA insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 36 Form 4 filings (6 insiders, 8 trade dates, 71,575 shares, about $181.9K) and open-market sales in 0 filings. Net open-market shares: 71,575 (purchases minus sales); net value about $181.9K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-08-08 | Ng George K |
Option exercise | 1,600 | — | — |
| 2026-07-01 | Ng George K |
Open-market purchase | 3,057 | $1.93 | $5.9K |
| 2026-06-30 | Guy Wendy |
Open-market purchase | 2,436 | $1.93 | $4.7K |
| 2026-06-30 | Lin Patrick |
Open-market purchase | 2,106 | $1.93 | $4.1K |
| 2026-06-30 | Skibsted Russell |
Open-market purchase | 3,277 | $1.93 | $6.3K |
| 2026-06-30 | Young David |
Open-market purchase | 2,531 | $1.93 | $4.9K |
| 2026-06-26 | Yorke Justin W |
Option exercise | 203 | — | — |
| 2026-06-26 | Pannu Geraldine |
Option exercise | 203 | — | — |
| 2026-06-26 | Neal James R |
Option exercise | 203 | — | — |
| 2026-06-26 | Baluch Khoso |
Option exercise | 203 | — | — |
| 2026-06-15 | Young David |
Open-market purchase | 2,067 | $2.22 | $4.6K |
| 2026-06-15 | Skibsted Russell |
Open-market purchase | 2,654 | $2.22 | $5.9K |
| 2026-06-15 | Ng George K |
Open-market purchase | 2,465 | $2.22 | $5.5K |
| 2026-06-15 | Lin Patrick |
Open-market purchase | 1,831 | $2.22 | $4.1K |
| 2026-06-15 | Guy Wendy |
Open-market purchase | 2,118 | $2.22 | $4.7K |
| 2026-05-29 | Young David |
Open-market purchase | 1,786 | $2.57 | $4.6K |
| 2026-05-29 | Skibsted Russell |
Open-market purchase | 2,292 | $2.57 | $5.9K |
| 2026-05-29 | Ng George K |
Open-market purchase | 2,129 | $2.57 | $5.5K |
| 2026-05-29 | Lin Patrick |
Open-market purchase | 1,582 | $2.57 | $4.1K |
| 2026-05-29 | Guy Wendy |
Open-market purchase | 1,829 | $2.57 | $4.7K |
| 2026-05-15 | Ng George K |
Open-market purchase | 1,843 | $2.97 | $5.5K |
| 2026-05-15 | Young David |
Open-market purchase | 1,545 | $2.97 | $4.6K |
| 2026-05-15 | Lin Patrick |
Open-market purchase | 1,369 | $2.97 | $4.1K |
| 2026-05-15 | Guy Wendy |
Open-market purchase | 1,583 | $2.97 | $4.7K |
| 2026-05-15 | Skibsted Russell |
Open-market purchase | 1,984 | $2.97 | $5.9K |
| 2026-04-30 | Bigora Sian |
Open-market purchase | 1,971 | $2.71 | $5.3K |
| 2026-04-30 | Young David |
Open-market purchase | 1,706 | $2.69 | $4.6K |
| 2026-04-30 | Skibsted Russell |
Open-market purchase | 2,190 | $2.69 | $5.9K |
| 2026-04-30 | Ng George K |
Open-market purchase | 2,034 | $2.69 | $5.5K |
| 2026-04-30 | Lin Patrick |
Open-market purchase | 1,511 | $2.69 | $4.1K |
| 2026-04-30 | Guy Wendy |
Open-market purchase | 1,748 | $2.69 | $4.7K |
| 2026-04-30 | Bigora Sian |
Open-market purchase | 1,986 | $2.69 | $5.3K |
| 2026-04-15 | Ng George K |
Open-market purchase | 1,843 | $2.97 | $5.5K |
| 2026-04-15 | Ng George K |
Open-market purchase | 1,843 | $2.97 | $5.5K |
| 2026-04-15 | Young David |
Open-market purchase | 1,545 | $2.97 | $4.6K |
| 2026-04-15 | Ng George K |
Open-market purchase | 1,843 | $2.97 | $5.5K |
| 2026-04-15 | Lin Patrick |
Open-market purchase | 1,369 | $2.97 | $4.1K |
| 2026-04-15 | Guy Wendy |
Open-market purchase | 1,583 | $2.97 | $4.7K |
| 2026-04-15 | Bigora Sian |
Open-market purchase | 1,799 | $2.97 | $5.3K |
| 2026-04-15 | Skibsted Russell |
Open-market purchase | 1,984 | $2.97 | $5.9K |
| 2026-03-31 | Ng George K |
Open-market purchase | 2,136 | $2.54 | $5.4K |
Well-known investors holding PCSA (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 21,306 | $40.9K | 0.0% | New position |