OTLC 10-K & 10-Q changes, risk factors and insider trading
Oncotelic Therapeutics, Inc. · OTC · Pharmaceutical Preparations · CIK 908259 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Our principal asset is our minority investment in a JV, which makes an evaluation of our financial condition more difficult for investors.”
New heading “The JV is a pre-revenue life sciences venture that is difficult to value, and changes in development results, market conditions, valuation methodology or assumptions could result in material impairment charges, significant volatility in our financial results and/or a material reduction in our reported asset values.”
New heading “RISKS RELATED TO OUR FINANCIAL CONDITION”
New heading “The JV may not be able to successfully complete its planned IPO which could reduce its access to capital and may impair the value of our investment in the JV.”
New heading “RISKS RELATED TO OUR BUSINESS AND INDUSTRY”
New heading “We rely on a limited number of employees at the JV to manage and operate our business.”
New heading “We and the JV intend to take advantage of regulatory pathways to accelerate product candidate development, and failure to secure such pathways would result in increased product development costs and longer regulatory approval as we seek to commercialize our product candidates.”
New heading “A limited trading market may increase the volatility of trading in our stock.”
New heading “We may not be able to uplist our stock to a national stock exchange which could subject our stockholders to significant restrictions and costs.”
New heading “RISKS RELATED TO MAST HILL EQUITY LINE”
New heading “Mast Hill’s sales of our Shares into the open market may cause material decreases in our stock price.”
New heading “Funding from our Equity Purchase Agreement with Mast Hill will be limited by our current shares outstanding and may be insufficient to fund our operations or to implement our strategy.”
New heading “The sale or issuance of our common stock to Mast Hill at a discount may cause substantial dilution and the resale of the shares of common stock by Mast Hill into the public market, or the perception that such sales may occur, could cause the price of our common stock to fall.”
New heading “We may use the net proceeds from sales of our common stock to Mast Hill pursuant to the Equity Purchase Agreement in ways with which you may disagree.”
New heading “Cautionary Note”
Removed heading “We may not be able to partner with other pharmaceutical companies or even form any types of alliances with third parties.”
Removed heading “We may not be able to successfully set up an IPO with third parties.”
Removed heading “We may not be able to successfully develop the product portfolio through our JV.”
Removed heading “We only have a limited number of employees to manage and operate our business.”
Removed heading “If we or our JV follows certain regulatory pathways, we may not be successful in our plans and, as such, we may not be able to obtain regulatory approval for or commercialize our product candidates.”
Removed heading “The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.”
Removed heading “We will require additional capital funding, the receipt of which may impair the value of our common stock.”
Removed heading “The Company will require additional capital funding, the receipt of which may impair the value of our Common Stock and EdgePoint’s Common Stock.”
Removed heading “GENERAL RISK FACTORS”
Removed heading “Unfavorable global epidemic or pandemic conditions could adversely affect our business, financial condition or results of operations.”
Removed heading “Our business may suffer from the severity or longevity of the COVID-19 Global Outbreak.”
Removed heading “We, or the third parties upon whom we depend, may be adversely affected by earthquakes or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.”
Removed heading “We have formed a DAO company to operate with a DAO infrastructure within the rigor of a corporation.”
Largest changes
see in full comparisonTheWeCompany,haveasexperiencedofnet losses every year since inception, except for the year ending December 31, 2025. Since inception and as of December 31, 2024, the Company had an accumulated deficit of approximately$38.038.0million,million.includingDuringathe year ended December 31, 2025, the Company earned netlossincome of approximately$4.8 million$250.3inmillion,2024,primarilywhichonincludedaccount of recording a non-cashgoodwillchangeimpairmentinlossfair value of our investment in the JV of$3.2approximately $365.4 million and correspondingly recording a deferred tax liability of approximately $111.6 million. We have no source of product revenue and do not expect to receive any product revenue in the nearfuture, except if we generate product revenues from Artemisinin in countries around the globe other than India and which at the current time is not anticipated.future. We may generate revenues from services rendered in the future, but wecannotdo not expect that to be of a regular and of a recurring nature. If we remain in business, we expect to incur additional operating losses over the next several years, principally as a result of our plans to continue clinical trials for our investigational drugs. As of December 31,2024,2025, we had approximately $0.1 million incashcash, otherand current liabilitiesassets of approximately$16.9$1.1million,million and $17.9 million in current liabilities, of which $1.3 million pertains to Mateon’s liabilities prior to the Merger and $2.6 million of contingent liabilities, incurred upon our merger with PointR Data, Inc. in November 2019, that would be issuable in shares of common stock of the Company to the PointR shareholders upon satisfaction of certain conditions. Based on our planned operations, we expect our cash to only support our operations for a short periodperiodof time.Therefore, we will need to secure near-term funding, or we will be forced to curtail or terminate operations. Because we do not currently have a guaranteed source of capital that will sustain operations for at least the next twelve months, Management has determined that there is substantial doubt about our ability to continue as a going concern.
“The JV is a pre-revenue life sciences venture that is difficult to value, and changes in development results, market conditions, valuation methodology or assumptions could result in material impairment charges, significant volatility in our financial results and/or a material reduction in our reported asset values.”see in full comparison
“If the carrying value of our investment is not recoverable or is otherwise required to be adjusted under applicable accounting standards, we could be required to recognize material non-cash impairment charges, mark-to-market adjustments, or other valuation-related losses in future periods. Any such charges could adversely affect our results of operations, financial condition, stockholders’ equity and key financial metrics, and could increase volatility in our reported earnings. …”see in full comparison
“As of December 31, 2024, our gross intangible assets and goodwill from our 2019 PointR acquisition represented approximately $1.1 million and approximately $2.8 million, respectively and after recording an impairment loss of $3.2 million; and the fair value of our investment in our JV was approximately $22.7 million, representing approximately 99% of our total assets. Goodwill is generated in our acquisitions when the cost of an acquisition exceeds the fair value of the net tangible and identifiable intangible assets we acquire. …”see in full comparison
“As of December 31, 2025, our gross intangible assets and goodwill, from our 2019 PointR acquisition, represented approximately $1.1 million and approximately $2.8 million, respectively and the fair value of our investment in our JV was approximately $388 million, combined representing approximately 99% of our total assets. Goodwill is generated in our acquisitions when the cost of an acquisition exceeds the fair value of the net tangible and identifiable intangible assets we acquire. …”see in full comparison
“Unfavorable global epidemic or pandemic conditions could adversely affect our business, financial condition or results of operations.”see in full comparison
Full comparison: every changed paragraph (82)
Investing in our common stock involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this Annual Report, including our financial statements and the related notes thereto and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding whether to invest in our common stock. The occurrence of any of the events or developments described below could harm our business, financial condition, operating results, and growth prospects. In such an event, the market price of our common stock could decline, and you may lose part or all of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations. The risk factors also include, by reference, to any risk factors previously stated in our other regulatory filings, especially if not specified in the risks enumerated below.
RISKS
RELATED TO OUR BUSINESS AND INDUSTRYINVESTMENTS
Our principal asset is our minority investment in a JV, which makes an evaluation of our financial condition more difficult for investors.
Our principal asset is our minority interest in GMP Bio in connection with the JV. We account for our interest on the fair value method and our financial statements reflect only the fair value of that investment. Our financial statements do not include a balance sheet or statement of operations for the JV. We will adjust the value of our holdings in the JV from time to time when sufficient indications of a change in value exist, but the timing of those changes may depend on circumstances that are outside of our control. Accordingly, investors may find it more difficult to assess the underlying value of our company.
The JV is a pre-revenue life sciences venture that is difficult to value, and changes in development results, market conditions, valuation methodology or assumptions could result in material impairment charges, significant volatility in our financial results and/or a material reduction in our reported asset values.
Our principal asset is our investment in the JV. The JV is in the development stage, has not generated any revenue and has no approved or commercially marketed products. There is currently no established public trading market for interests in the JV, and the fair value of our investment is inherently difficult to determine. A recent third party ASC-compliant valuation substantially increased the estimated value of the JV and, as a result, increased the carrying value of our investment on our balance sheet. There can be no assurance that this increased valuation accurately reflects the realizable value of our investment or that such valuation will be sustained in future periods.
The valuation is based in part on management estimates and assumptions, including projections regarding development milestones, the probability of technical and regulatory success, market opportunity, timing of commercialization, comparable company or transaction metrics, discount rates and other inputs. There can be no assurance that this increased valuation is, or will remain, realizable. Future events—such as delays or failures in development, adverse clinical or regulatory outcomes, changes in the competitive landscape, deterioration in capital market conditions, higher discount rates, changes in comparable company valuations, or the JV’s inability to obtain additional financing, could cause the JV’s estimated value to decline, potentially materially.
If the carrying value of our investment is not recoverable or is otherwise required to be adjusted under applicable accounting standards, we could be required to recognize material non-cash impairment charges, mark-to-market adjustments, or other valuation-related losses in future periods. Any such charges could adversely affect our results of operations, financial condition, stockholders’ equity and key financial metrics, and could increase volatility in our reported earnings. In addition, because our ability to monetize our investment may depend on a future financing, sale, collaboration, licensing arrangement or other liquidity event at the JV level, we may not be able to realize value on a timeline or at a valuation that supports the current carrying value of our investment, or at all.
As of December 31, 2025, our gross intangible assets and goodwill, from our 2019 PointR acquisition, represented approximately $1.1 million and approximately $2.8 million, respectively and the fair value of our investment in our JV was approximately $388 million, combined representing approximately 99% of our total assets. Goodwill is generated in our acquisitions when the cost of an acquisition exceeds the fair value of the net tangible and identifiable intangible assets we acquire. Goodwill and indefinite-lived intangible assets are subject to an impairment analysis at least annually based on fair value. Intangible assets relate primarily to in-process research and development (“IPR&D”) and patents acquired by us as part of our acquisitions of other companies and are subject to an impairment analysis whenever events or changes in circumstances exist that indicate that the carrying value of the intangible asset might not be recoverable. If market and economic conditions or business performance deteriorates, the likelihood that we would record an impairment charge would increase, which impairment charge could materially and adversely affect our financial condition and operating results.
RISKS RELATED TO OUR FINANCIAL CONDITION
We
have experienced net losses every year since inception. In April 2019, the Company entered into an Agreement and Plan of Merger with
Oncotelic Inc. for developing investigational drugs for the treatment of orphan oncology indications. The Company completed the Merger
and Oncotelic Inc. became a wholly-owned subsidiary of the Company. The Merger was treated as a recapitalization and reverse acquisition
for financial accounting purposes. Oncotelic was considered the acquirer for accounting purposes, and the Company’s historical
financial statements before the Merger have been replaced with the historical financial statements of Oncotelic Inc. prior to the Merger
in the financial statements and filings with the Securities and Exchange Commission.
TheWe
Company,have asexperienced ofnet losses every year since inception, except for the year ending December 31, 2025. Since inception and as of
December 31, 2024, the Company had an accumulated deficit of approximately $38.038.0 million,million. includingDuring athe year ended December 31, 2025,
the Company earned net lossincome of approximately $4.8
million$250.3 inmillion, 2024,primarily whichon includedaccount of recording a non-cash goodwillchange impairmentin lossfair value of
our investment in the JV of $3.2approximately $365.4 million and correspondingly recording a deferred tax liability of approximately
$111.6 million. We have no source of product revenue and do not
expect to receive any product revenue in the near future, except if we generate product revenues from Artemisinin in countries around
the globe other than India and which at the current time is not anticipated.future. We may
generate revenues from services rendered in the future,
but we cannotdo not expect that to be of a regular and of a recurring nature. If
we remain in business, we expect to incur additional operating
losses over the next several years, principally as a result of our
plans to continue clinical trials for our investigational drugs. As
of December 31, 2024,2025, we had approximately $0.1 million in cashcash,
other and current liabilitiesassets of approximately $16.9$1.1 million,million and $17.9 million in current liabilities, of which $1.3
million pertains to
Mateon’s liabilities prior to the Merger and $2.6 million of contingent liabilities, incurred upon our merger
with PointR
Data, Inc. in November 2019, that would be issuable in shares of common stock of the Company to the PointR shareholders upon
satisfaction of certain conditions. Based on our planned operations, we expect our cash to only support our operations for a short
period period
of time. Therefore, we will need to secure near-term funding, or we will be forced to curtail or terminate operations. Because we do
not currently have a guaranteed source of capital that will sustain operations for at least the next twelve months, Management has determined
that there is substantial doubt about our ability to continue as a going concern.
In
the Notes to the Consolidated Financial Statements, and in their audit report with regard to our Financial Statements as of and
for the years ended December 31, 2024,2025, and 2023, we, as well as
our independent registered public accountants, have expressed an
opinion that substantial doubt exists as to whether we can continue
as a going concern. Because we have limited cash resources, we
believe that it will be necessary for us to either raise additional capital
in the near term or to enter into a license or other
agreement with a larger pharmaceutical company. If we do not succeed in doing so,
we may be required to suspend or cease our
business, which would likely materially harm the value of our common stock.
The JV may not be able to successfully complete its planned IPO which could reduce its access to capital and may impair the value of our investment in the JV.
The JV is planning to secure additional financing for its operations through an initial public offering in Hong Kong. While the JV has engaged an investment banker and is taking active steps to progress to an initial public offering, there are no firm commitments to underwrite any public offering at this time. We cannot assure you that any public offering will occur at all, will occur within a specific timeframe, will raise sufficient funds to meet the JV’s needs, or will be on terms that will be beneficial to the Company. If the JV is unsuccessful in its efforts to complete the IPO it will have to find alternative financing to support its operations. There are no arrangement for any such financing at this time, and a lack of capital could cause the JV to have to reduce or suspend its operations. Any adverse financing impact on the JV could decrease its value, the value of our investment and the price of our common stock.
RISKS RELATED TO OUR BUSINESS AND INDUSTRY
We
may not be able to partner with other pharmaceutical companies or even form any types of alliances with third parties.
As
we plan to advance our product candidates through later stages of clinical trials but with lack of adequate capital resources, we will
need to form alliances or enter into partnerships with other pharmaceutical companies or even other third parties. We cannot assure you
that we would be able to do so at terms beneficial to the Company or at all.
We
may not be able to successfully set up an IPO with third parties.
As
we plan to advance our product candidates through later stages of clinical trials but with lack of adequate capital resources, we will
need to form alliances or enter into partnerships with other pharmaceutical companies or even other third parties and create shareholder
value, including through IPOs. We cannot assure you that we would be able to do so at terms beneficial to the Company or at all. While
the Company has formed a joint venture with Dragon Overseas and GMP Bio, and plans on taking that through an IPO, there can be no assurances
that such IPO will be made or will be successful.
We
may not be able to successfully develop the product portfolio through our JV.
As
we plan to advance the product candidates being established through our JV, through later stages of development, manufacturing of the
products for clinical trials and ultimately commercial manufacturing, we may need to form alliances or enter into partnerships with other
pharmaceutical companies or even other third parties to work with us in the JVs endeavors to achieve success for the Product. That would
ensure success for the JV and create shareholder value for our Company. We cannot assure you that the JV would be able to do so and the
Company get’s the benefits of that at all.
We
only have a limited number of employees to manage and operate our business.
We
had a combined total of 40 full-time, part-time employees and consultants as of December 31, 2024; however, all the employees have
been compensated through the JV since March 2022. We rely on external consultants or outsource nearly all our research, development,
preclinical testing, and clinical trial activity, although we maintain managerial and quality control over our clinical trials. We
expect to continue to rely on external service providers and to maintain a small number of executives and other employees. Our
limited financial resources require us to manage and operate our business in a highly efficient manner. We cannot assure you that we
will be able to retain adequate staffing levels to run our operations and/or to accomplish all the objectives that we otherwise
would seek to accomplish.
We
believe that our success depends, and will likely continue to depend, upon our ability to retain the services of our current executive
officers, particularly our Chief Executive Officer, Chief Business Officer, Chief Medical Officer, Chief Regulatory Officer and Chief
Financial Officer, our principal consultants, and others. This increases the risk that we may not be able to retain their services. The
loss of the services of any of these individuals could have a material adverse effect on our business. In addition to these key service
providers, we have established relationships with universities, hospitals and research institutions, which have historically provided,
and continue to provide, us with access to research laboratories, clinical trials, facilities and patients. Additionally, we believe
that we may, at any time and from time to time, materially depend on the services of consultants and other unaffiliated third parties.
We cannot assure you that consultants and other unaffiliated third parties will provide the level of service to us that we require in
order to achieve our business objectives.
Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products.
We rely on a limited number of employees at the JV to manage and operate our business.
We had thirty eight full-time employees, five part-time employees and thirteen consultants as of December 31, 2025, however, all employees and consultants were compensated by the JV during the years ended December 31, 2025 and 2024, respectively. We rely on external consultants or outsource nearly all our research, development, preclinical testing, and clinical trial activity, although we maintain managerial and quality control over our clinical trials. We expect to continue to rely on external service providers and to maintain a small number of executives and other employees. Our limited financial resources require us to manage and operate our business in a highly efficient manner. We cannot assure you that we will be able to retain adequate staffing levels to run our operations and/or to accomplish all the objectives that we otherwise would seek to accomplish.
We believe that our success depends, and will likely continue to depend, upon our ability to retain the services of our current executive officers, particularly our Chief Executive Officer, Chief Business Officer, Chief Medical Officer, Chief Regulatory Officer and Chief Financial Officer, our principal consultants, and others. The loss of the services of any of these individuals could have a material adverse effect on our business. In addition to these key service providers, we have established relationships with universities, hospitals and research institutions, which have historically provided, and continue to provide, us with access to research laboratories, clinical trials, facilities and patients. Additionally, we believe that we may, at any time and from time to time, materially depend on the services of consultants and other unaffiliated third parties. We cannot assure you that consultants and other unaffiliated third parties will provide the level of service to us that we require in order to achieve our business objectives.
In
March 2010, the Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or collectively, ACA,
became law in the U.S. The goal of ACA is to reduce the cost of health care and substantially change the way health care is financed
by both government and private insurers. While we cannot predict what impact on federal reimbursement policies this legislation will
have in general or on our business specifically, the ACA may result in downward pressure on pharmaceutical reimbursement, which could
negatively affect market acceptance of, and the price we may charge for, any products we develop that receive regulatory approval.
More
recently, a past U.S. presidential administration had made statements suggesting plans to seek repeal of all or portions of the ACA.
There could be uncertainty regarding the impact that a future Presidential administration may have on matters governed by the ACA, if
any, and any regulatory or legislative changes will likely take time to unfold. These changes could have an impact on coverage and reimbursement
for healthcare items and services covered by plans that were authorized by the ACA. However, we cannot predict the ultimate content,
timing or effect of any healthcare reform legislation or the impact of potential legislation on us. Any reduction in reimbursement from
Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment
measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products.
REGULATORY
AND LEGAL RISK FACTORSRISKS
If
we or our JV follows certain regulatory pathways, we may not be successful in our plans and, as such, we may not be able to obtain regulatory
approval for or commercialize our product candidates.
In
addition to regular pathways of filing INDs and NDAs, we, or our partners, including the JV, may also plan to follow expedited pathways such as 505(b)(2) pathway of expedited
approvals so as to get our products to market and patients for unmet medical needs on an expedited basis. However, we cannot guarantee
that the regulatory bodies would approve our approach or approve our products as planned.
If
we or the third parties on which we rely for the conduct of our clinical trials and results do not perform our clinical trial activities
in accordance
with good clinical practices and related regulatory requirements, we may not be able to obtain regulatory approval for
or commercialize
our product candidates.
We and the JV intend to take advantage of regulatory pathways to accelerate product candidate development, and failure to secure such pathways would result in increased product development costs and longer regulatory approval as we seek to commercialize our product candidates.
In addition to regular pathways of filing INDs and NDAs, we, or our partners, including the JV, also plan to follow expedited pathways such as 505(b)(2) pathway of expedited approvals so as to get our products to market and patients for unmet medical needs on an expedited basis. However, we cannot guarantee that the regulatory bodies would approve our approach or approve our products as planned. If we are unable to secure approval for such expedited pathways, we will incur increased research and development costs and longer regulatory approval times as we seek to commercialize our products.
Although
we expect to seek patent protection for any compounds we discover and/or for any specific use we discover for new or previously known
compounds, any or all of them may not be subject to effective patent protection. Further, the development of regimens for the administration
of pharmaceuticals, which generally involve specifications for the frequency, timing and amountamounts of dosages, has been, and we believe,
may continue to be, important to our effort, although those processes, as such, may not be patentable. In addition, the issued patents
may be declared invalid, or our competitors may find ways to avoid the claims in the patents. Further, our lack of access to adequate
capital may cause us to curtail payment of fees necessary to maintain patents that we otherwise would seek to maintain, and we may make
incorrect decisions regarding which patents to keep and which to abandon.
RISKS
RELATED TO OUR COMMON STOCK AND FINANCING ACTIVITIES
The
price of our common stock is volatile and is likely to continue to fluctuate due to reasons beyond our control; a limited public trading
market may cause volatility in the price of our common stock.control.
The
market price of our common stock has been, and likely will continue to be, highly volatile. Factors, including our financial results
or our competitors’ financial results, clinical trial and research development announcements and government regulatory action affecting
our potential products in both the United States and foreign countries, have had, and may continue to have, a significant effect on our
results of operations and on the market price of our common stock. We cannot assure you that an investment in our common stock will not
fluctuate significantly. One or more of these factors could significantly harm our business and cause a decline in the price of our common
stock in the public market. Substantially all of the shares of our common stock issuable upon exercise of outstanding options and warrants
have been registered or are likely to be registered for resale or are available for sale pursuant to Rule 144 under the Securities Act
and may be sold from time to time. As of December 31, 2024, we had approximately 289.5 million shares of common stock underlying currently
outstanding convertible debt, warrants and options. Sales of any of these shares on the market, as well as future sales of our common
stock by existing stockholders, or the perception that sales may occur at any time, could adversely affect the market price of our common
stock.
Our
common stock is currently quoted on the OTCQB Market. The quotation of our common stock on the OTCQB Market does not assure that a meaningful,
consistent, and liquid trading market currently exists, and in recent years such market has experienced extreme price and volume fluctuations
that have particularly affected the market prices of many smaller companies like us. Our common stock is subject to this volatility.
Sales of substantial amounts of common stock, or the perception that such sales might occur, could adversely affect prevailing market
prices of our common stock and our stock price may decline substantially in a short time and our stockholders could suffer losses or
be unable to liquidate their holdings.
The
price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our
common stock.
We cannot assure you that an investment in our common stock will not fluctuate significantly. One or more of these factors could significantly harm our business and cause a decline in the price of our common stock in the public market.
A limited trading market may increase the volatility of trading in our stock.
Our common stock is currently quoted on the OTCQB Market. The quotation of our common stock on the OTCQB Market does not assure that a meaningful, consistent, and liquid trading market currently exists, and in recent years such market has experienced extreme price and volume fluctuations that have particularly affected the market prices of many smaller companies like us. Our common stock is subject to this volatility.
Substantially all of the shares of our common stock issuable upon exercise of outstanding options and warrants have been registered or are likely to be registered for resale or are available for sale pursuant to Rule 144 under the Securities Act and may be sold from time to time. As of December 31, 2025, we had approximately 205.6 million shares of common stock underlying currently outstanding convertible debt, warrants and options. Sales of any of these shares on the market, as well as future sales of our common stock by existing stockholders, or the perception that sales may occur at any time, could adversely affect the market price of our common stock.
Sales of substantial amounts of common stock, or the perception that such sales might occur, could adversely affect prevailing market prices of our common stock and our stock price may decline substantially in a short time and our stockholders could suffer losses or be unable to liquidate their holdings.
We
will require additional capital funding, the receipt of which may impair the value of our common stock.
Our
future capital requirements depend on many factors, including our research, development, sales, and marketing activities. We will need
to raise additional capital through public or private equity or debt offerings or through arrangements with strategic partners or other
sources in order to continue to develop our product candidates. There can be no assurance that additional capital will be available when
needed or on terms satisfactory to us, if at all. To the extent we raise additional capital by issuing equity securities, our shareholders
may experience substantial dilution and the new equity securities may have greater rights, preferences, or privileges than our existing
common stock.
As
of December 31, 2024,2025, while we had net assets of approximately $7.5$262.8 million andmillion, our common stock had a market price per share of
less less
than $5.00. As a result, transactions in our common stock are subject to the SEC’s “penny stock” rules. The
designation of our common stock as a “penny stock” likely limits the liquidity of our common stock. Prices for penny
stocks are often not available to buyers and sellers and the market may be very limited. Penny stocks are among the riskiest equity
investments. Broker-dealers who sell penny stocks must provide purchasers of these stocks with a standardized risk-disclosure
document prepared by the SEC. The document provides information about penny stocks and the nature and level of risks involved in
investing in the penny stock market. A broker must also provide purchasers with bid and offer quotations and information regarding
broker and salesperson compensation and make a written determination that the penny stock is a suitable investment for the purchaser
and obtain the purchaser’s written agreement to the purchase. Many brokers choose not to participate in penny stock
transactions. Because of the penny stock rules, there may be less trading activity in penny stocks. Because shares of our common
stock are currently subject to these penny stock rules, your ability to trade or dispose of shares of our common stock may be
adversely affected.
We may not be able to uplist our stock to a national stock exchange which could subject our stockholders to significant restrictions and costs.
Our common stock is not currently eligible for trading on the Nasdaq Capital Market or on a national securities exchange. While we are working to get our stock to trade on a nationally recognized stock exchange, we may not be able to do so.
We
were are authorized to issue
up to 750,000,000 shares of our common stock. As of December 31, 2024,2025, we had approximately 407.3444.2 million shares
of common stock issued
and outstanding, including approximately 1 million shares of common stock to be issued. As of December 31, 2024,
2025, we also had approximately 31.9
59.4 million warrants outstanding, approximately 24 million options and approximately 233.4122.4 million shares
of common stock issuable upon
conversion of convertible notes.
Additionally, the Company has authorized 15,000,000 shares of Convertible Preferred Stock. As of December 31, 2025, 24,388 shares of the Company’s Preferred Stock were issued to our CEO, of which 4,065 were earned and vested and an additional 8,131 shares have been earned but not yet issued. Each share of Preferred Stock is convertible into 1,000 shares of the Company’s Common Stock, and votes with the Common Stock on an as converted basis.
RISKS RELATED TO MAST HILL EQUITY LINE
Mast Hill’s sales of our Shares into the open market may cause material decreases in our stock price.
On August 1, 2025 we entered into an Equity Purchase Agreement with Mast Hill Fund L.P. (“Mast Hill”). In connection with that agreement we filed a Registration Statement covering the re-sale of up to 115.6 million shares of our common stock may be sold into the market by Mast Hill under the terms of the Equity Purchase Agreement and related agreements. Under the terms of the Equity Purchase Agreement, we can issue Put Notices to sell shares of common stock to Mast Hill, at prices based on recent trading prices. The sale of shares common stock by Mast Hill under the Registration Statement could cause our stock price to decline. In turn, if our stock price declines and we issue more Put Notices, this could cause more shares to come into the market, which could cause a further drop in our stock price.
Funding from our Equity Purchase Agreement with Mast Hill will be limited by our current shares outstanding and may be insufficient to fund our operations or to implement our strategy.
Under the Equity Purchase Agreement, and subject to other conditions, we may direct Mast Hill to purchase up to $25,000,000 worth of shares of our common stock over a 24-month period. However, we have limited shares of our common stock that have not already been reserved for outstanding derivative securities. Accordingly, we have registered 100,000,000 shares for issuance under the Equity Purchase Agreement. At an assumed hypothetical purchase price of $0.0912 equal to 97% of the closing price of our common stock of $0.0940 on December 17, 2025, as defined in the section entitled “Equity Purchase Agreement with Mast Hill Fund” in this prospectus) and assuming the sale by us to Mast Hill of all 100,000,000 Shares we would receive gross proceeds of approximately $9.1 million. We would need to eliminate outstanding derivative securities, authorize additional capital stock or effect another capital reorganization in order to sell more shares to Mast Hill and secure access to the full $25,000,000 in proceeds.
Management's Discussion & Analysis (MD&A)
New heading “Recent Financing Transactions”
New heading “Jefferson Capital Ventures, LLC and Valor Nation, Inc Independent Contractor Agreements”
Removed heading “August 2021 Notes”
Removed heading “November / December 2021 and March 2022 Financing”
Removed heading “Equity Purchase Agreement”
Removed heading “Mosaic ImmunoEngineering, Inc. Term Sheet”
Largest changes
“Further in January 2026, the Company entered into a Securities Purchase Agreement (the “2026 Mast Hill Purchase Agreement”), with Mast Hill Fund, LP (“Mast Hill”), and the Company issued a convertible promissory note in the aggregate gross principal amount of approximately $398,333 (the “2026 Mast Hill Note”). …”see in full comparison
“In June 2022, the Company entered into a securities purchase agreement with one institutional investor, whereby the Company issued one convertible note in the aggregate principal amount of $335,000 convertible into shares of common stock of the Company (“June 2022 Blue Lake Note”). The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one year from issuance or upon event of default. …”see in full comparison
“In May 2022, the Company entered into a securities purchase agreement with one institutional investor, whereby the Company issued one convertible note in the aggregate principal amount of $0.6 million, convertible into shares of common stock of the Company (“May 2022 Mast Note”). The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one year from issuance or upon event of default. …”see in full comparison
“In July 2025, the Company entered into a securities purchase agreement with Mast Hill Fund LP (“Mast Hill”), under which the Company issued one convertible note in the aggregate principal amount of $560,000 to Mast Hill (“2025 Mast Note”). The 2025 Mast Hill Note has an original issue discount of 10%, carries an interest rate of 10% per annum and matures on the earlier of July 31, 2026, subject to acceleration in an event of default. …”see in full comparison
“During 2024, our stock price, solely based on the market capitalization of our Company, and the general economic conditions, which adversely impacted the majority of the pharmaceutical and biotechnology industry, were indicative of a potential impairment of our goodwill. …”see in full comparison
“During the year ended December 31, 2023, the Company converted the balance of approximately $243,000 of Blue Lake November / December 2021 convertible notes, inclusive of accrued interest, into 3,466,583 shares of the Company’s Common Stock, which fully retired the convertible notes as of December 31, 2023. …”see in full comparison
Full comparison: every changed paragraph (89)
Although
we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels
of activity, or performance. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors.
Some of these risks are included in the section entitled “Risk Factors” set forth in this Annual Report and in other reports
that we file with the SEC. The occurrence of any of these risks, or others of which we are currently unaware, may cause our company’s
actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity,
performance or achievements expressed or implied by these forward-looking statements. These risks include, by way of example and without
limitation:
Readers
are urged to carefully review and consider the various disclosures made by us in this Annual Report and in our other reports filed with
the SEC. We undertake no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of
unanticipated events or changes in the future operating results over time except as required by law. We believe that our assumptions
are based upon reasonable data derived from and known about our business and operations. No assurances are made that the actual results
of operations or the results of our future activities will not differ materially from our assumptions.
The Company is a clinical stage biopharmaceutical company developing drugs for the treatment of cancer. The Company’s proprietary product candidates have shown promising clinical activity in phase 2 trials for the treatment of gliomas and pancreatic cancers. The Company aims to translate its unique insights, which span more than three decades of original work using RNA therapeutics, into the deployment of antisense as a RNA therapeutic for diseases which are caused by TGF-β overexpression, starting with cancer and expanding to Duchenne Muscular Dystrophy and others. OT-101, the Company’s lead product candidate, is being developed as a broad-spectrum anti-cancer drug that can also be used in combination with other standard cancer therapies to establish an effective multi-modality treatment strategy for difficult-to-treat cancers.
Since April 2022, the Company has conducted the vast majority of its development efforts for OT-101 through a joint venture (the “JV”), with Dragon Overseas Capital (“Dragon”). In connection with the formation of the JV, the Company contributed license rights OT-101 for both U.S. and the rest of the world, in exchange for a 45% equity interest in GMP Biotechnology Limited (“GMP Bio”), the JV, and Dragon agreed to provide approximately $27.6 million of research and development funding in exchange for a 55% ownership stake in GMP Bio. The Company accounts for its holdings in GMP Bio as an equity investment under the fair value option. Accordingly, the Company accounts for only its change in fair value in the Company’s investment in GMP Bio, and the income and expenses of the JV are not consolidated in the Company’s financial statements.
The Company announced in November 2025 that the JV obtained a preliminary independent third-party valuation of approximately $2.3 billion for its therapeutic pipeline, assuming and implying an illustrative value of approximately $1 billion based on the Company’s 45% ownership interest in the JV. The Company had previously stated that this valuation was non-binding, forward-looking, and not determinative of fair value under U.S. GAAP, and that a separate ASC-compliant valuation process would be done. Under the fair value option, the Company periodically conducts a fair value assessment and records a change in the value when circumstances warrant reassessing the value of investment in GMP Bio. The Company conducted an ASC-compliant valuation, including through an independent valuation expert based on the same parameters and conditions envisioned in the valuation conducted by the JV. Based on the Company’s evaluation, the Company proceeded to record a change in the value of the Company’s interest in the JV of approximately $365.4 million. The Company relied on the inputs by the JV valuation, however, certain parameters like lack of marketability and lack of control discounts and other standard discounts, specific to the Company, have been applied to the independent valuation done by the Company to derive the ASC-compliant valuation. The Company will also appropriately adjust the fair value of the interest of the Company’s interest in the JV at the end of reporting periods and when key value inflection points are met. As previously announced, GMP Bio is progressing with its strategic and operational plans, which include efforts to secure third-party financing and a possible initial public offering in Hong Kong during 2026. For more information on, refer to Recent Joint Venture Developments below.
We
are a clinical stage biopharmaceutical company developing drugs for the treatment of cancer. Our goal is to advance our drug candidates
into late-stage pivotal clinical trials and either sell marketing rights to a larger pharmaceutical company or seek FDA approval ourselves.
The
Company is currently developing OT-101, through its JV with Dragon, and GMP Bio and its wholly owned subsidiaries, both affiliates
of Golden Mountain Partners (“GMP”), for various cancers and COVID-19, Artemisinin for COVID-19 and 5 additional nanoparticle
products for treatments of various cancers; our portfolio products Apomorphine for various indications; OXi4503, as a treatment for acute
myeloid leukemia and myelodysplastic syndromes; CA4P, in combination with a checkpoint inhibitor for the treatment of advanced metastatic
melanoma; and AI technologies for clinical development and manufacturing. The Company is also planning to develop OT-101 for certain
animal health indications and contemplating using crypto currencies for that platform. The Company has acquired apomorphine for Parkinson’s
Disease, erectile dysfunction and female sexual dysfunction. In addition, the Company is evaluating the further development of its product
candidates OXi4503 as a treatment for acute myeloid leukemia and myelodysplastic syndromes and CA4P in combination with a checkpoint
inhibitor for the treatment of advanced metastatic melanoma.
In
2020, the Company had entered into an agreement and supplemental agreement with GMP for a total of $1.2 million to render services for
the development of OT-101 for COVID-19. The Company had also secured various financings from GMP between 2020 and early 2022, primarily
in this connection. For more information on the GMP debt financing and the JV, refer to Notes 5 and 6 of the Notes to the Consolidated
Financial Statements.
In
November 2022, the Company formed a Decentralized autonomous organization (“DAO”) entity, Pet2DAO, Inc. (“Pet2DAO”),
as a wholly owned subsidiary. For more information on Pet2DAO, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April
12, 2024.
Since
April 2019, we have been operating under significant capital constraints, which has curtailed our ability to achieve meaningful progress
in either of the Company’s two clinical programs – one of which is developing OXi4503 as a treatment for acute myeloid leukemia
and myelodysplastic syndromes and the other of which is developing CA4P in combination with a checkpoint inhibitor for the treatment
of advanced metastatic melanoma. We believe that the merger of Oncotelic and Oncotelic Inc. creates a combined company that has potential
to generate shareholder value through a promising pipeline of next generation immunotherapies targeting several significant cancer markets
where there is a lack of therapeutic options and lack of an effective immunotherapy protocol.
Forever
Prosperity, LLC (previously GMP) Note purchase agreements and unsecured notes Between
June 2020 and January 2022, the Company entered into various purchase agreements and promissory notes with GMP, cumulatively totaling
$4.5 million. Such notes were assigned to Forever Prosperity, LLC, an affiliated entity of GMP.
For
more information on the Forever Prosperity, LLC debt financing, refer to Note 5 of the Notes to the Consolidated Financial Statements.
Recent Joint Venture Developments
In
March 2022, the Company entered into (i) a joint venture (the “JV”) agreement with Dragon and GMP Bio, both affiliates
of GMP, (and the Company, Dragon and GMP Bio are collectively called the “Parties”) (the “JVA”),
(ii) a license agreement for rights to OT-101 (the “US License Agreement”) for the territory within the United States
of America (the “US”) with Sapu Holdings, LLC, a subsidiary of GMP Bio and (iii) a license agreement for rights to
OT-101 for the rest of the world with GMP Bio (the “Ex-US Rights Agreement”, and the US License Agreement and the
Ex-US License Agreement are collectively called the “Agreements”). For more information on the JV, JVA, and Agreements,
refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.
The
JV is conducting a clinical trial for OT-101 for pancreatic cancer in the US and which the JV is planning to expand to other countries
in eastern Europe. In addition, OT-101 is also being evaluated for treatments of gliomas and pediatric DIPG. In late 2023, the JV initiated
a plan to start evaluating various nanoparticles that could treat various cancers. In this regard, the JV identified a total of 4 compounds,
in addition to OT-101, which had the potential of significant revenue generation for the JV. In the same year, the JV signed a lease
agreement to set up a GMP manufacturing facility in San Diego (“SD”), California. The main purpose of this facility
was to initially commence an aggressive formulation development of newly planned nanoparticle platform (“Nano Platform”).
The GMP manufacturing facility was initiated in January 2024. Upon the initiation of this facility by the JV, the JV commenced the development
work on two of the four identified compounds, as well as other activities, in tandem with the development of OT-101. The JV has since
completed the formulation development of one of the products and is moving to complete the formulation development for the three additional
products. The JV is also working on improved formulations for OT-101 with new nanoparticle sizes. The JV also has started clinical development
for OT-101 for pancreatic cancer. Significant progress has been made in the development of the products and the JV anticipates to complete
the formulation development work in 2025 and pushing to initiate clinical trials for the various compounds. In late 2024, the GMP facility
in SD was issued a Drug Manufacturing License by the State of California Department of Public Health and Food and Drug Branch. Further,
in late 2024, the JV identified a sixth candidate as a compound for development for the JV and has already started to work on the formulation
development of that compound as well. A lot of the manufacturing, including Phase 1 clinical trial materials, will be performed at the
SD site.
Further,The
JV’s inprincipal lateactivities 2024, the JV identified a
sixth candidate as a compound for development for the JV and has already started to workcentered on the formulation developmentcommercialization of thatOT-101 for certain oncology indications in the US and looking at
compoundother territories as well. In early 2025, the Company announced that it had entered into a strategic partnership with Shanghai Medicilon, Inc.
(“Medicilon”) to access its industry-leading rapid investigational new drug (“IND”)
development platform to support up to 20 IND projects, the support of which can even be used by the JV. All six of our compounds the JV is developing are planned to be these INDs,
and are focused on next-generation anticancer agents. The JV anticipates that all these six anticancer agents have the potential to
become significant growth contributors to the JV, which in turn would add substantial value to the Company. In March 2025, the Company announcedJV successfully completingcompleted a Phase
1 clinical trial evaluating OT-101, in combination with
IL-2 for advanced or metastatic solid tumors, on behalf of the JV.tumors. These results
set the stage for new studies that combine OT-101, an antisense therapeutic
targeting Transforming Growth Factor Beta 2 (TGFβ2),
with checkpoint inhibitors (“CKIs”) and recombinant IL-2 (aldesleukin)
(“IL-2”). The Phase 1 trial (ClinicalTrials.gov
ID: NCT04862767) investigated the safety and tolerability of OT-101 in combination
with recombinant IL-2 in patients with advanced or
metastatic solid tumors. The combination showed a tolerable safety profile at the
planned dosing schedule, with no unexpected safety signals
identified. Based on the favorable safety data, the JV, through the Company,JV plans to advance OT-101
plus IL-2 into further clinical studies,
exploring synergies with CKIs such as PD-1 blockers. The JV is also sponsoring investigator-initiated
studies for OT-101 for other oncology indications including lung cancer (non small cell lung cancer(“NSCLC”)and Mesothelioma.(“MPM”)
and has started clinical development for OT-101 for pancreatic cancer. Over ten patent families have been filed exploiting the central role
of TGFB2 as prognostic indicator for cancer survival and one patent family for the intracranial delivery device of brain cancer with
issued patents in China and Germany.
In addition to OT-101, the JV has developed a nanoparticle platform (“Nano Platform”) that entails the formulation of products in new nanoparticle sizes. The JV anticipates that the Nano Platform may offer superior platform for the absorption of water insoluble drugs across a broad spectrum of cancers. The JV is working on improved formulations for OT-101 with new nanoparticle sizes. In addition, the JV has identified five additional compounds as product candidates on the Nano Platform, including the following:
The Nano or DeciparticleTM platform has proven robust and is being expand to other drug candidates through partnering. The platform is protected by more than 15 patent families covering chemical composition, manufacturing, and method of use.
The JV built a GMP manufacturing facility in San Diego, California (the “San Diego Facility”). In late 2024, the San Diego Facility was issued a Drug Manufacturing License by the State of California Department of Public Health and Food and Drug Branch. A significant portion of the manufacturing for the Nano Platform, including the development of Phase I clinical trial materials, is conducted at the San Diego Facility. Evaluation of larger commercial scale manufacturing is ongoing.
In early 2025, the Company entered into a strategic partnership with Shanghai Medicilon, Inc. (“Medicilon”) to access its industry-leading rapid IND development platform to support up to 20 IND projects, including INDs developed by the JV. All six of the compounds that the JV is developing are planned to be initiated under these INDs, and are focused on next-generation anticancer agents.
The JV was initially funded by equity contributions from Dragon under the terms of the joint venture agreement. That equity funding commitment has been fully paid as of June 30, 2025. In May 2025, GMP Bio and Golden Mountain Partners, an affiliate of Dragon, entered into a note purchase agreement and promissory note pursuant to which Golden Mountain Partners agreed to loan funds to the JV sufficient to meet its operating expenses for 2025 and beyond. The loans are made as monthly advances, bear interest at the Wall Street Journal “Prime” rate, and matures on December 31, 2026. Amounts due under the promissory note are convertible into equity of the JV at the election of Golden Mountain Partner at a price equal to 80% of the price for shares issued in connection with an equity financing of $20 million or more, or otherwise at a mutually agreed price.
The JV is planning to conduct an initial public offering on the Hong Kong Stock Exchange in approximately late 2026. In connection with the planned public offering, the JV venture has retained an investment banker and a big four accounting firm as its independent accounting firm to audit the financial statements that would be included in the public filings. The JV also hired a valuation consultant to provide guidance on the potential pricing for the planned IPO. GMP Bio completed an independent third-party valuation, which preliminarily estimated the potential value of the drug pipeline under development at approximately $2.3 billion. As of December 31, 2025, the Company owns 45% of GMP Bio.
The JV’s planned public offering is subject to a number of risks and uncertainties, some involving the JV’s ability to execute on its business plan, but others outside the JV’s control including market forces. Consequently, there is no assurance that the planned Hong Kong public offering will take place in late 2026, or at all, and there is no assurance as to what enterprise value would be ascribed to the JV at that time.
Based on the JV’s advances, including the development of the Nano Platform and pipeline and the planned Hong Kong public offering the Company believed that its ownership interest in the JV would be significantly higher than the reported value on its financial statements, which was based on the valuation at the time of its initial investment in the JV in 2022.
All these factors formed a basis for a triggering event of significant development for the JV and justified the JV, and consequently the Company, to reassess the fair value of the JV. After the business valuation exercise by GMP Bio, the Company proceeded to conduct its own independent assessment of the valuation of the JV. The basis for the valuation was utilizing the same conditions, financial projection, risks and parameters of assessment as done by the offshore independent valuation firm, and then applying additional independent parameters required to adhere to the strict ASC-compliant standards as generally used in the United States. The Company hired the services of an independent, ASC-compliant valuation firm to review, perform and validate the assumptions considered by the Company and provide an ASC-compliant valuation of the JV under U.S. GAAP standards. The valuation conducted by the independent ASC-compliant valuation firm of the JV was based on various methods compliant with ASC and US GAAP to derive the fair value. The Company then utilized the fair value of GMP Bio, as assessed by the ASC-compliant valuation firm, attributed the ownership percentage of the Company in GMP Bio, to ascertain the Company’s interest in GMP Bio and recorded the resulting gain to the investment in GMP Bio at fair value of approximately $365.4 million. The Company relied on the inputs by the JV valuation, however, certain parameters like lack of marketability and lack of control discounts and other standard discounts, specific to the Company, have been applied to the independent valuation done by the Company to derive the ASC-compliant valuation. The Company will also appropriately adjust the fair value of the interest of the Company’s interest in the JV at the end of reporting periods and when key value inflection points are met.
PDAOAI
PDAOAI is the Company’s proprietary artificial intelligence–enabled knowledge platform, developed to support scientific, translational, and regulatory activities across its oncology pipeline. The platform was initially implemented by Oncotelic Therapeutics to streamline document search, synthesis, and analysis in knowledge-intensive environments, particularly within pharmaceutical research and development. Since its initial deployment, the Company has progressively expanded PDAOAI into a core infrastructure layer supporting research generation, biomarker discovery, and regulatory documentation across multiple programs. Unlike general-purpose artificial intelligence tools, PDAOAI has been designed specifically for pharmaceutical and biotechnology applications, with an emphasis on regulatory-grade documentation, scientific traceability, and reproducibility. The platform is intended to operate as an “evidence-interrogation” system rather than a black-box predictive engine, enabling structured ingestion, semantic indexing, and clustering of large biomedical corpora. This design allows users to query, retrieve, and synthesize information in a manner that is auditable and aligned with regulatory expectations for data provenance and scientific justification. During 2025, the Company significantly expanded the functional scope of PDAOAI and integrated it into its translational research workflow. This included the use of PDAOAI to support the preparation of peer-reviewed manuscripts, development reports, and regulatory documentation, as well as to enable interactive interrogation of scientific literature. The Company introduced interfaces that allow users to query individual publications and their associated reference networks, thereby facilitating deeper exploration of mechanistic hypotheses and clinical correlations within defined therapeutic areas. PDAOAI has also been applied to the assembly and interrogation of multi-omic and clinical datasets, particularly in the context of biomarker-driven oncology research. The platform has been used to identify, prioritize, and validate biomarkers associated with treatment response, disease progression, and survival outcomes. This capability has been most prominently demonstrated in the Company’s work on TGFB2 signaling and tumor microenvironment biology, where PDAOAI has supported analyses across multiple tumor types, including ovarian cancer, breast cancer, pancreatic cancer, hepatocellular carcinoma, and glioblastoma.
As disclosed in Company press releases, PDAOAI contributed to the generation of at least seven peer-reviewed publications during 2025. These publications collectively span bioinformatic biomarker discovery, tumor microenvironment analysis, nanoparticle drug delivery, and clinical outcome correlations, and include studies demonstrating prognostic and predictive roles of TGFB2 methylation and expression across multiple cancers. The Company believes that this body of work provides validation of PDAOAI’s utility as a research acceleration platform and supports its role in generating clinically relevant insights.
By late 2025, the Company had further evolved PDAOAI into a large-scale knowledge platform built around a comprehensive TGF-β–centric biomedical corpus, comprising over one hundred thousand curated abstracts and associated datasets. Within this framework, PDAOAI enables semantic retrieval, clustering of related concepts, and cross-referencing of molecular, clinical, and literature-derived data. The platform is designed to generate hypotheses that are not only computationally derived but also traceable to underlying evidence, thereby facilitating scientific validation and regulatory acceptance. The Company has now positioned PDAOAI as a cross-program decision-support system integrating molecular biology, pharmacology, clinical outcomes, and regulatory-grade literature. The platform is used to inform multiple aspects of the Company’s operations, including target identification, biomarker strategy, clinical trial design, and regulatory positioning. In particular, PDAOAI is intended to complement the Company’s nanomedicine and biomarker platforms by identifying patient subpopulations most likely to benefit from specific therapeutic approaches and by supporting the development of precision oncology strategies.
The Company believes that PDAOAI represents a differentiating capability within its integrated platform, enabling the convergence of artificial intelligence, molecular biology, and clinical data into a unified framework. By embedding PDAOAI across its discovery and development processes, the Company aims to accelerate insight generation, improve decision-making, and enhance the probability of clinical and commercial success across its pipeline.
On April 2, 2026, the Company announced that it had entered into a strategic partnership with TechForce Robotics, Inc. (“TechForce”) to advance the commercialization of its PDAOAI-enabled, GMP-compliant robotics platform. This milestone reflects the culmination of several years of research and development efforts, resulting in an integrated platform designed to combine Oncotelic’s proprietary PDAOAI capabilities with TechForce’s robotics hardware and manufacturing expertise. The system under development is designed to operate within GMP-regulated environments and is intended to enable automated material handling, real-time monitoring, and PDAOAI-enhanced compliance workflows across pharmaceutical manufacturing and related applications. The key highlights of the commercialization include:
Recent Financing Transactions
In July 2025, the Company entered into a securities purchase agreement with Mast Hill Fund LP (“Mast Hill”), under which the Company issued one convertible note in the aggregate principal amount of $560,000 to Mast Hill (“2025 Mast Note”). The 2025 Mast Hill Note has an original issue discount of 10%, carries an interest rate of 10% per annum and matures on the earlier of July 31, 2026, subject to acceleration in an event of default. Mast Hill has the right, at any time, to convert all or any part of the outstanding and unpaid balance under of the 2025 Mast Hill Note into shares of Company’s Common Stock at a conversion price of $0.07 per share. In connection with the issuance of the 2025 Mast Note, the Company issued Mast Hill 2,000,000 warrants to purchase Common Stock at a strike price of $0.15 up to five years after issuance. The Company also issued to Mast Hill 2,250,000 shares of the Company’s Common Stock as a commitment fee. For more information on the 2025 Mast Note, refer to Note 5 of the Notes to the Consolidated Financial Statements included in this report.
In August 2025, the Company entered into an Equity Purchase Agreement (the “Mast EPA”) and Registration Rights Agreement with Mast Hill. Under the terms of the Mast EPA, Mast Hill agreed to purchase from the Company up to $25,000,000 of shares of the Company’s Common stock upon effectiveness of a registration statement on Form S-1 filed with the U.S. Securities and Exchange Commission and subject to certain limitations and conditions set forth in the Mast EPA. The Registration Rights Agreement provided that the Company would (i) file the Registration Statement with the SEC by October 1, 2025: and (ii) use its best efforts to have the Registration Statement declared effective by the Commission at the earliest possible date (in any event, within 90 after days after the execution date of the definitive agreements). The Company intends to file the Registration Statement on Form S-1 with the SEC as soon as possible. In connection with the EPA, the Company issued 3,350,000 warrants to Mast Hill and recorded a fair value deferred finance cost of approximately $122,000.
Following effectiveness of the Registration Statement, and subject to certain limitations and conditions set forth in the Mast EPA, the Company shall have the discretion to deliver put notices to the Investor and the Investor will be obligated to purchase shares of the Company’s Common Stock based on the investment amount specified in each put notice. The minimum amount that the Company shall be entitled to put to the Investor in each put notice is $5,000 and the maximum amount is up to the lesser of $0.5 million or twenty percent (20%) of the average daily trading value of the Company’s Common stock. Pursuant to the Equity Purchase Agreement, the Mast Hill will not be permitted to purchase, and the Company may not put shares of the Company’s Common Stock to the Investor that would result in the Investor’s beneficial ownership of the Company’s outstanding Common Stock exceeding 4.99%. The price of each put share shall be equal to ninety seven percent (97%) of the market price, which is defined as the lesser of (i) closing bid price of the Common stock on the trading date immediately preceding the respective put date, or (ii) the lowest closing bid price of the Common Stock during the seven (7) trading days immediately following the clearing date associated with the applicable put notice.
Further in January 2026, the Company entered into a Securities Purchase Agreement (the “2026 Mast Hill Purchase Agreement”), with Mast Hill Fund, LP (“Mast Hill”), and the Company issued a convertible promissory note in the aggregate gross principal amount of approximately $398,333 (the “2026 Mast Hill Note”). The 2026 Mast Hill Note is convertible into shares of the Company’s Common Stock The 2026 Mast Hill Note has an original issue discount of 10%, carries an interest rate of 10% per annum and matures on the earlier of (a) the one-year anniversary of the date of the 2026 Mast Hill Purchase Agreement, or (b) the acceleration of the maturity of the 2026 Mast Hill Note by Mast Hill upon occurrence of an Event of Default (as defined below) or (c) on prepayment in full. The 2026 Mast Hill Note contains a voluntary conversion mechanism whereby Mast Hill may convert the outstanding principal and accrued interest under the terms of the 2026 Mast Hill Note into shares of Common Stock (the “Conversion Shares”), at a fixed price of $0.07 per share (the “Conversion Price”), subject to adjustments upon the occurrence of certain corporate events. The 2026 Mast Hill Note is secured against the assets of the Company, including all the assets owned by the Company’s direct or indirect subsidiaries, but other than and excluding the equity interests and the assets of the Company licensed or assigned within our joint venture agreement with Dragon Overseas Capital Limited, namely GMP Biotechnology and its subsidiaries. These assets include OT-101, CA4P, Oxi4503, AI and AI CDMO technologies and the nanoparticle platform. The Company also issued 1,422,613 warrants to purchase shares (the “Note Warrants”) of Common Stock of the Company at an exercise price of $0.15. Prepayment of the 2026 Mast Hill Note may be made at any time upon three trading days’ prior written notice to the respective holder, by payment of the then outstanding principal amount plus accrued and unpaid interest and reimbursement of such holder’s administrative fees. The 2026 Mast Hill Note contains customary events of default (each an “Event of Default”). If an Event of Default occurs, at the respective holder’s election, the outstanding principal amount of the 2026 Mast Hill Note, plus accrued but unpaid interest, will become immediately due and payable in cash. The 2026 Mast Hill Purchase Agreement require the Company to use the proceeds for general working capital, and not for (i) the repayment of any indebtedness owed to officers, directors or employees of the Company or their affiliates, (iii) any loan to or investment in any other corporation, partnership, enterprise or other person (except in connection with the Company’s currently existing operations), (iv) any loan, credit, or advance to any officers, directors, employees, or affiliates of the Company, or (v) in violation or contravention of any applicable law, rule or regulation. Further, on January 23, 2026, the Company entered into a Registration Rights Agreement with Mast Hill (the “Mast Hills Registration Rights Agreement - Note”), to register the shares of Common Stock issuable under and related to the 2026 Mast Hill Notes and the attached Note Warrants to purchase shares of the Company’s Common Stock.
Jefferson Capital Ventures, LLC and Valor Nation, Inc Independent Contractor Agreements
In August, 2025, the Company entered into independent contractor agreements with each of Jefferson Capital Ventures, LLC (“Jefferson”) and Valor Nation, Inc. (“Valor”) to provide consulting and advisory services including strategic planning meetings, coordination non-legal support for SEC compliance, balance sheet and income statement optimization strategies, shareholder and investor communication planning, liaison with investment bankers, analysts, and institutional investors, operational efficiency and cost-saving recommendations and ancillary strategic services not requiring a license, corporate planning, operations and capital markets advisory services not requiring licenses. Such services shall be provided by Jefferson and Valor for a period of 18 months, unless terminated earlier by either party under certain predefined conditions. Jefferson has agreed to be compensated $20,000 per month in cash and to be issued 20,322,930 restricted shares of the Company’s Common Stock and Valor has agreed to be compensated with 4,064,586 shares of Common Stock. While the shares of Common Stock will be issued to Jefferson, they are subject to forfeiture, and Jefferson will earn the Common Stock only upon the achievement of milestones, which were a) the Company’s market capitalization exceeding $45 million on any single trading day’s close, (b) the cumulative increase of at least $10 million in shareholder equity from the start of engagement, and (c) the successful uplisting to a U.S. national exchange (e.g., Nasdaq or NYSE American) with at least one full day of trading. Subsequently, on January 6, 2026, there was an amendment to the agreement with Jefferson. The amendment amended one clause within the original agreement for Jefferson to earn the first milestone shares upon the Company reaching $45 million of market capitalization on any single trading day and which was achieved by the Company in November 2025. On the accomplishment of each milestone an amount equal to the greater of 6,774,300 or 1.663% of the Company’s fully diluted outstanding shares shall vest. For more information on the Jefferson and Valor ICAs, refer to our Current Report on Form 8-K filed with the SEC on August 12, 2025 and on January 7, 2026.
In
July 2023,December 2025, the Company entered into a series of subscription agreements
with 1544 accredited investors which resulted in a conversion of
a gross87 convertible promissory notes with an aggregate principal amount of $1.0approximately
$2.2 million, consisting of 40 notes, under the prior JH Darbie Financing into new debt to the Company. JH Darbie and
the Company are parties to a MarchMay 20232024 placement
agent agreement (“Agreement”) pursuant to which JH Darbie has the right
to sell/convert a minimum of 10 Units and a maximum
of 200 Units on a best-efforts basis. Further, in October 2023, the Company entered
into a series of subscription agreements with 27 accredited investors which resulted in a conversion of a gross amount of $1.05 million,
consisting of 42 notes, under the prior JH Darbie Financing into new debt to the Company. Additionally, in January 2024, Company entered
into a series of subscription agreements with 4 accredited investors which resulted in a conversion of a gross amount of $0.3 million,
consisting of 12 notes. The JulyDecember 2023, October 2023 and January 20242025 conversions fully converted JH Darbie PPM-1PPM-2 notes into PPM-2PPM-3 notes.
For more information
on the new JH Darbie Financing, refer to Note 8 of these Notes to the Consolidated Financial Statements.
August
2021 Notes
In
August 2021, the Company entered into Note Purchase Agreements with Autotelic, the Company’s CFO, and certain other accredited
investors. Under the terms of the Note Purchase Agreements, the Company issued an aggregate of $698,500 (the “Principal Amount”)
in debt in the form of unsecured convertible promissory notes (collectively, the “August 2021 Notes”). For more information
on the August 2021 Notes, refer to Note 5 of the current Notes to the Consolidated Financial Statements.
November
/ December 2021 and March 2022 Financing
In
November / December 2021, the Company entered into securities purchase agreement with five institutional investors, whereby the Company
issued five convertible notes in the aggregate principal amount of $1,250,000 convertible into shares of common stock of the Company.
The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one year from issuance
or upon event of default. Investors has the right at any time following issuance date to convert all or any part of the outstanding and
unpaid amount of the note into the Company’s common stock at a conversion price established at a fixed rate of $0.07. The Company
granted a total number of 9,615,385 warrants convertible into an equivalent number of the Company Common Stock at a strike price of $0.13
up to five years after issuance. The Placement agent was also granted a total of 961,540 warrants convertible into an equivalent number
of the Company Common Stock at a strike price of $0.13 up to five years after issuance, as part of a finder’s fee agreement.
During
the year ended December 31, 2023, the Company converted the balance of approximately $243,000 of Blue Lake November / December 2021 convertible
notes, inclusive of accrued interest, into 3,466,583 shares of the Company’s Common Stock, which fully retired the convertible
notes as of December 31, 2023. Further, during the year ended December 31, 2023, the Company fully converted the balance of Fourth Man
convertible note of approximately $127,000 into 1,820,395 shares of the Company’s common stock, which fully retired the convertible
note as of December 31, 2023 In
March 2022, the Company entered into a Securities Purchase Agreement with Fourth Man, pursuant to which the Company issued convertible
promissory note in the aggregate principal amount of $0.25 million, convertible into shares of common stock of the Company. The convertible
notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one year from issuance or upon event
of default. As of December 31, 2023, this note was in default. The investors have the right at any time following issuance date to convert
all or any part of the outstanding and unpaid amount of the note into the Company’s Common Stock at a conversion price established
at a fixed rate of $0.10. The Company granted a total number of 1,250,000 warrants convertible into an equivalent number of the Company
common shares at a strike price of $0.20 up to five years after issuance. The Placement agent was also granted a total of 125,000 warrants
convertible into an equivalent number of the Company Common Stock at a strike price of $0.20 up to five years after issuance, as part
of a finder’s fee agreement. In February 2024, the Company converted $35,000 in principal, legal fees and accrued interest of the
Fourth Man March 2022 note, into 500,000 shares of common stock.
For
more information on the November-December 2021 and March 2022 Financing, refer to Note 5 of current Notes to the Consolidated Financial
Statements.
May
2022 Note
In
May 2022, the Company entered into a securities purchase agreement with one institutional investor, whereby the Company issued one convertible
note in the aggregate principal amount of $0.6 million, convertible into shares of common stock of the Company (“May 2022 Mast
Note”). The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one
year from issuance or upon event of default. Investor has the right at any time following issuance date to convert all or any part of
the outstanding and unpaid amount of the note into the Company’s common stock at a conversion price established at a fixed rate
of $0.10. The Company granted a total number of 3,025,000 warrants convertible into an equivalent number of Company common shares at
a strike price of $0.20 up to five years after issuance. The Placement agent was also granted a total of 302,500 warrants convertible
into an equivalent number of the Company Common Stock at a strike price of $0.20 up to five years after issuance, as part of a finder’s
fee agreement. A portion of the proceeds were used to retire some of the November/December 2021 notes. In May 2024, the May 2022 Note
was extended till May 2025, at a cost of 10% of the outstanding Note amount, including interest and penalty.
For
more information on the May 2022 Financing, refer to Note 5 of current Notes to the Consolidated Financial Statements.
June
2022 Note
In
June 2022, the Company entered into a securities purchase agreement with one institutional investor, whereby the Company issued one convertible
note in the aggregate principal amount of $335,000 convertible into shares of common stock of the Company (“June 2022 Blue Lake
Note”). The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one
year from issuance or upon event of default. The investor has the right at any time following issuance date to convert all or any part
of the outstanding and unpaid amount of the note into the Company’s common stock at a conversion price established at a fixed rate
of $0.10. The Company granted a total number of 837,500 warrants convertible into an equivalent number of the Company common shares at
a strike price of $0.20 up to five years after issuance. The Placement agent was also granted a total of 83,750 warrants convertible
into an equivalent number of the Company Common Stock at a strike price of $0.20 up to five years after issuance, as part of a finder’s
fee agreement. A portion of the proceeds were used to retire some of the November/December 2021 notes. In May 2024, Blue Lake converted
remainder of their debt balance, including accrued interest and penalty, of approximately $531,000 into 7,605,760 shares of the Company’s
Common Stock.
For
more information on the June 2022 Financing, refer to Note 5 of current Notes to the Consolidated Financial Statements.
In
May 2021, Autotelic provided an additional short-term funding of approximately $0.3 million to the Company, which was converted into
the August 2021 Notes. Autotelic provided an additional $0.1 million short term loan to the Company during the year ended December 31,
2022. During the year ended December 31, 2023, Autotelic provided $1.4 million in various short-term loans to the Company. During the
year ended December 31, 2024 Autotelic Inc. provided additional short-term funding of $656,000 to the Company. As such, approximately
$2.1 million was outstanding and payable to Autotelic at December 31, 2024.
TheAs
Company’sof CFOJanuary 1, 2025, approximately $2.1 million was owedoutstanding approximatelyand $25payable thousandto at December 31, 2022.Autotelic. During the year ended December 31, 2023,2025, the company’sAutotelic
CFOInc. provided additional short-term advance of $10 thousand. During the year ended December 31, 2024, the CFO provided additional short-term
funding of $41approximately thousand.$0.9 million to the Company. As such, approximately $76$3 thousandmillion was outstanding
and frompayable theto Company’s CFOAutotelic at December 31, 2024.2025.
As of January 1, 2025, approximately $76,000 was outstanding and payable to the Company’s CFO. During the year ended December 31, 2025, the CFO further provided additional short-term funding of $10,000 to the Company. As such, approximately $86,000 was outstanding and payable to the Company’s CFO at December 31, 2025.
InAt December
2023,January 1, 2025, $50,000 was outstanding and payable to the CompanyCompany’s
CEO. received $50 thousand fromDuring the company’syear CEO.ended December 31, 2025, the PPM-2 note of $125,000 with the CEO was converted into a short term loan. As such, $50 thousand
$175,000 was outstanding to the Company’s CEO
at December 31, 2024.2025. As of December 31, 2024 and December 31, 2023, respectively,2025, approximately $210,000 was outstanding
as short-term
advances from certain bridge investors.
During the year ended December 31, 2025, one accredited investor from PPM-2 did not participate in PPM-3 and his balance of $50,000 was converted into short-term loan to the Company Such short term loan, including accrued interest thereon, was repaid to the investor during the first quarter of 2026, after the period covered by the financial statements included in this Annual Report.
Equity
Purchase Agreement
In
May 2021, the Company entered into an Equity Purchase Agreement (the “EPL”) and Registration Rights Agreement (the
“Registration Rights Agreement”) with Peak One Opportunity Fund, L.P. (“Peak One”), pursuant to
which the Company shall have the right, but not the obligation, to direct Peak One to purchase up to $10.0 million (the “Maximum
Commitment Amount”) in shares of the common stock, par value $0.01 per share (“Common Stock”) in multiple
tranches. The Company filed a post-effective amendment for the EPL on April 12, 2024 with the SEC and the SEC has made the post-effective
amendment effective on April 22, 2024. The Company filed a prospectus under rule 424b3 with the SEC on April 26, 2024. For more information
on the EPL, refer to Note 10 of the Notes to the Unaudited Consolidated Financial Statements.
Mosaic
ImmunoEngineering, Inc. Term Sheet
In
April 2024, the Company entered into a binding term sheet (the “Term Sheet”) with Mosaic ImmunoEngineering, Inc. (“Mosaic”).
For more information on the Term Sheet, refer to the Current Report on Form 8-K filed with the SEC on April 29, 2024. In August 2024,
Mosaic and the Company mutually agreed to extend the date of the Term Sheet to expire at the earlier of (1) the signing of definitive
agreements or (2) December 31, 2024. Mosaic and the Company further agreed to extend the Term Sheet to expire at the earlier of (1) the
signing of definitive agreements or (2) June 30, 2025. This was to allow for both Companies to complete due diligence as well as agree
and finalize the definitive agreements.
What changed in the latest 10-Q
Risk Factors
For information about the risks and uncertainties related to our business, please see the risk factors described in our 2025 Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on April 15, 2026, and other SEC filings. The risks described below and in our 2025 Annual Report on Form 10-K are not the only risks facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.
No wording changes found in this section (only numbers or dates changed in 1 paragraph).
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “Transactions with Lunai Bioworks”
New heading “2026 Pacific Pier Note”
New heading “Fair Value of the Company’s equity investment”
New heading “Comparison of the Results of Operations for the Six Months Ended June 30, 2026, to the Six Months Ended June 30, 2025”
Removed heading “Impairment of Long-Lived Assets”
Removed heading “Variable Interest Entity (VIE) Accounting”
Removed heading “Joint Venture agreement”
Removed heading “Research and Development Expense”
Largest changes
“The 2026 Mast Hill Note has an original issue discount of 10%, carries an interest rate of 10% per annum and matures on the earlier of (a) the one-year anniversary of the date of the 2026 Mast Hill Purchase Agreement, or (b) the acceleration of the maturity of the 2026 Mast Hill Note by Mast Hill upon occurrence of an Event of Default (as defined below) or (c) on prepayment in full. …”see in full comparison
“The 2026 Pacific Pier Note has an original issue discount of 12%, carries an interest rate of 12% per annum and matures on the earlier of (a) the one-year anniversary of the date of the 2026 Pacific Pier Purchase Agreement, or (b) the acceleration of the maturity of the 2026 Pacific Pier Note by Pacific Pier upon occurrence of an event of default or (c) on prepayment in full. …”see in full comparison
“We have the option to first perform a qualitative assessment (commonly referred to as “Step 0”) to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If we determine that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, no further quantitative testing is required. …”see in full comparison
“The first step involves comparing the fair value of the reporting unit to its carrying amount. If the fair value of the reporting unit is determined to be greater than its carrying amount, there is no impairment. If the reporting unit’s carrying amount is determined to be greater than the fair value, the second step must be completed to measure the amount of impairment, if any. …”see in full comparison
“Research and development expense consists of costs we incur for the development of our investigational drugs and, to a lesser extent, for preclinical research activities. Research and development costs are expensed as incurred. Research and development expense include clinical trial costs, salaries, and benefits of employees, including associated stock-based compensation, payments to clinical investigators, drug manufacturing costs, laboratory supplies and facility costs. …”see in full comparison
Full comparison: every changed paragraph (87)
This
Quarterly Report on Form 10-Q for the period ended MarchJune 31,30, 2026
(this “Quarterly Report” or “Report”)
contains statements that are, or may be deemed to be, “forward-looking
statements” within the meaning of Section 27A of the
Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”).
Oncotelic
Therapeutics, Inc. (“Oncotelic”), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated
in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November
2020. Oncotelic conducts business activities through Oncotelic and its wholly-ownedwholly owned subsidiaries, Oncotelic, Inc., a Delaware corporation,
PointR Data, Inc. (“PointR”), a Delaware corporation, Pet2DAO Inc., a Delaware corporation and EdgePoint AI, Inc.
(“EdgePoint”), a Delaware Corporation for which there are non-controlling interests, (Oncotelic, Oncotelic Inc., PointR,
Pet2DAO and EdgePoint are collectively called the “Company” or “We”). The Company completed a reverse
merger with Oncotelic Inc in April 2019, a merger with PointR in November 2019 and formed a subsidiary EdgePoint in February 2020. For
more information on these mergers, 2025 Annual Report on Form 10-K filed with the SEC on April 15, 2026.
For more information on, refer to Recent Joint Venture Developments below.
The Company announced in November
2025 that the JV obtained a preliminary independent third-party valuation of approximately $2.3 billion for its therapeutic pipeline,
assuming and implying an illustrative value of approximately $1 billion based on the Company’s 45% ownership interest in the JV.
The Company had previously stated that this valuation was non-binding, forward-looking, and not determinative of fair value under U.S.
GAAP, and that a separate ASC-compliant valuation process would be done. Under the fair value option, the Company periodically conducts
a fair value assessment and records a change in the value when circumstances warrant reassessing the value of investment in GMP Bio. The
Company conducted an ASC-compliant valuation, including through an independent valuation expert based on the same parameters and
conditions envisioned in the valuation conducted by the JV. Based on the Company’s evaluation, the Company proceeded to record a
change in the value of the Company’s interest in the JV of approximately $365.4 million. The Company relied on the inputs by the
JV valuation, however, certain parameters like lack of marketability and lack of control discounts and other standard discounts, specific
to the Company, have been applied to the independent valuation done by the Company to derive the ASC-compliant valuation. As the circumstances
related to the JV have not materially changed since December 31, 2025, the Company assessed and determined that no additional fair value
adjustment was required during the three months ended March 31, 2026, and hence, the Company has not recorded a change in value of the
Company’s interest in the JV. The Company will also appropriately adjust the fair value of the interest of the Company’s interest
in the JV at the end of reporting periods and when key value inflection points are met. As previously announced, GMP Bio is progressing
with its strategic and operational plans, which include efforts to secure third-party financing and a possible initial public offering
in Hong Kong during 2026. For more information on, refer to Recent Joint Venture Developments below.
The
JV’s principal activities centered on the commercialization of OT-101 for certain oncology indications in the US and looking
at at
other territories as well. In March 2025, the JV successfully completed a Phase 1 clinical trial evaluating OT-101, in
combination with
IL-2 for advanced or metastatic solid tumors. These results set the stage for new studies that combine OT-101, an
antisense therapeutic
targeting Transforming Growth Factor Beta 2 (TGFβ2), with checkpoint inhibitors (“CKIs”) and
recombinant IL-2 (aldesleukin)
(“IL-2”). The Phase 1 trial (ClinicalTrials.gov ID: NCT04862767) investigated the safety
and tolerability of OT-101 in combination
with recombinant IL-2 in patients with advanced or metastatic solid tumors. The
combination showed a tolerable safety profile at the
planned dosing schedule, with no unexpected safety signals identified. Based on
the favorable safety data, the JV plans to advance OT-101
plus IL-2 into further clinical studies, exploring synergies with CKIs
such as PD-1 blockers. The JV is also sponsoring investigator-initiated
studies for OT-101 for other oncology indications including
lung cancer (non smallnon-small cell lung cancer(“NSCLC”) and Mesothelioma.Mesothelioma (“MPM”)
and has started clinical
development for OT-101 for pancreatic cancer. Over ten patent families have been filed exploiting the central
role of TGFB2 as
prognostic indicator for cancer survival and one patent family for the intracranial delivery device of brain cancer
with issued
patents in China and Germany.
The
JV is planning to conduct an initial public offering on the Hong Kong Stock Exchange in approximately late 2026. In connection with the
planned public offering, the JV venture has retained an investment banker and a big four accounting firm as its independent accounting
firm to audit the financial statements that would be included in the public filings. The JV also hired a valuation consultant to provide
guidance on the potential pricing for the planned IPO. GMP Bio completed an independent third-party valuation, which preliminarily estimated
the potential value of the drug pipeline under development at approximately $2.3 billion. As of DecemberJune 31,30, 2025,2026, the Company owns 45% of
of GMP Bio.
AllThe theseCompany factorsannounced formedin aNovember basis2025 for a triggering event of significant
development forthat the JV obtained a preliminary independent third-party valuation of approximately $2.3
billion for its therapeutic pipeline, assuming and justifiedimplying an illustrative value of approximately $1 billion based on the
Company’s 45% ownership interest in the JV,JV. The Company had previously stated that this valuation was non-binding,
forward-looking, and consequentlynot thedeterminative Company,of tofair reassessvalue under U.S. GAAP, and that a separate ASC-compliant valuation process would be
done. Under the fair value of the JV. After the business valuation
exercise by GMP Bio,option, the Company proceededperiodically toconducts conducta itsfair own independentvalue assessment ofand records a change in the valuationvalue when
circumstances warrant reassessing the value of the JV. The basis for the valuation
was utilizing the same conditions, financial projection, risks and parameters of assessment as done by the offshore independent valuation
firm, and then applying additional independent parameters required to adhere to the strict ASC-compliant standards as generally usedinvestment in
the UnitedGMP States.Bio. The Company hired the services of an independent,
ASC-compliant valuation firm to review, perform and validate the
assumptions considered by the Company and provide an ASC-compliant
valuation of the JV under U.S. GAAP standards. The valuation conducted
by the independent ASC-compliant valuation firm of the JV was
based on various methods compliant with ASC and USU. S. GAAP to derive the fair
value. The Company then utilized the fair value of GMP
Bio, as assessed by the ASC-compliant valuation firm, attributed the ownership
percentage of the Company in GMP Bio, to ascertain
the Company’s interest in GMP Bio and recorded the resulting gain to the investment
in GMP Bio at fair value of approximately
$365.4 million. The Company relied on the inputs by the JV valuation, however, certain parameters
like lack of marketability and
lack of control discounts and other standard discounts, specific to the Company, have been applied to the
independent valuation done
by the Company to derive the ASC-compliant valuation. The Company will also appropriately adjust the fair value
of the interest of
the Company’s interest in the JV at the end of reporting periods and when key value inflection points are met.
As the
circumstances related to the JV have not materially changed since December 31, 2025, the Company assessed and determined that no
additional fair value adjustment was required during the three and six months ended MarchJune 31,30, 2026, and hence, the Company has not
recorded a
change in value of the Company’s interest in the JV.
On March 31,In
March, 2026, the
Company entered into a Joint Development, Manufacturing, and Licensing Agreement (the “Joint Development
Agreement”)
with TechForce Robotics, Inc. (“TechForce”), a Nevada corporation. The Joint Development Agreement
establishes a framework
for the joint development, and manufacturing of AI-enabled, GMP-compliant robotic systems for use in
pharmaceutical and related manufacturing
environments. The integrated product to be developed combines
TechForce’s robotic hardware with the Company’s proprietary
PDAOAI Platform.
Transactions with Lunai Bioworks
On
April 17, 2026, the Company
and Lunai Bioworks, Inc., a Delaware corporation (“Lunai”) entered into an
intellectual property development and services
agreement (“IP Services Agreement”), whereby the Company was to
perform intellectual property development and business
development services relating to a Nose-to-Brain (“N2B”)
delivery platform. This includes applications in biodefense,
Alzheimer’s disease (“AD”), and broader
central nervous system (“CNS”) indications and excludes
Parkinson’s disease and sexual dysfunction. The
work shall focus on direct-to-CNS delivery to bypass the blood-brain barrier.
The scope of services included scientific development,
IP execution, technical data delivery, business development support and broadened
biodefense focus. In connection with these
services, Lunai agreed to compensate the Company a total compensation of $250,000, of which
$62,500 was payable upon signing of the
IP Services Agreement, $62,500 upon filing of provisional patents and $125,000 payable upon the
execution of a biodefense and
neurodegenerative platform IP acquisition agreement by Lunai, which was the agreement and plan for merger
with Lunai, described
below. The Company has completed all it’sits obligations under the IP Services Agreement, has invoiced Lunai
for the services and will recognizehas
recognized the revenue under the IP Services Agreement during the three and six months ended June 30, 2026.
During the three and six months ended June 30, 2026, the Company recorded services revenue of approximately $0.3 million in connection with the IP Services Agreement described above. No similar services revenue was recorded in the three and six months ended June 30, 2025.
The Company received Series B Preferred Stock from Lunai with a stated Value of $12.5 million in exchange for the Company’s 62.5% equity interest in Neurobridge IP Holdings Incorporated. The transaction was accounted for as a sale of nonfinancial asset under FASB ASC 610-20 since the Company transferred control of the nonfinancial asset. The Series B Preferred Stock received was recorded at its initial fair value of $1.1 million. Because the net book value of the contributed asset was $0, the Company recognized a pre-tax gain on derecognition of non-financial assets of $1.1 million, which is included within “Other Income” in the unaudited Condensed Consolidated Statement of Operations.
The subsequent remeasurement of the Series B Preferred Stock at fair value is governed by FASB ASC 321, Investments – Equity Securities. The Company holds its investment in publicly traded companies that have readily determinable fair value based on quoted market prices. Its investment is carried at fair value on the unaudited Condensed Consolidated balance sheets. Realized and unrealized gains and losses resulting from changes in the fair value are recognized each period in earnings within other income on the unaudited Condensed Consolidated Statements of Operations. The Company recognized $0.3 million changes in fair value of its equity investment during the three and six months ended June 30, 2026.
Further,
on April 30, 2026, Oncotelic Inc. on behalf of the Company, and Autotelic Inc. (“Autotelic”) entered into an asset
transfer transfer
agreement (the “Asset Transfer Agreement”) pursuant to which Autotelic agreed to transfer all the rights,
title and
interest to certain assets (“Assets”), described below and owned by Autotelic to Oncotelic Inc. This Asset
Transfer Transfer
Agreement was entered into by both parties to effectuate the Merger Agreement. Dr. Trieu, Chairman and CEO of Oncotelic Therapeutics,
Inc., is a partial owner and control person in Autotelic Inc. Autotelic Inc. currently owns less than 10% of the Company. The Assets
transferred transferred
pursuant to the Asset Transfer Agreement include Peptide Y (including all variants, analogs, derivatives); Parathyroid Hormone
(“PTH”),
including PTH 1-34, PTH 1-84, and derivatives; Insulin (including intranasal and other formulations); Apomorphine
(including intranasal
and other formulations); Carbetocin (including intranasal and other formulations); any associated combination therapies,
including multi-agent
CNS, AD, metabolic, endocrine, or biodefense applications; and all delivery platforms, including nasal, injectable,
and device-based systems
and includes all patents, patent applications, know-how, trade secrets, data, formulations, manufacturing processes,
regulatory filings,
and all related rights associated with the Assets. In consideration for the transfer of the Assets, the Company shall
issue equity of
ten percent (10%) of the fully diluted outstanding shares of the Company, issuable on an uplisting of its capital stock
to NYSE/NASDAQ.
No cash was paid for the Asset Transfer Agreement. For more information on the Merger Agreement, refer to our Current Report on Form 8-K
filed with the SEC on May 5, 2026.
The consideration payable to Autotelic is contingent on the Company uplisting its Common Stock to a nationally recognized stock exchange. Such shares of the Company have not been issued to Autotelic as of the date of this filing and are not due to be issued till the uplisting of the Company’s stock onto a nationally recognized stock exchange. If the uplisting does not occur, then the shares would not be issuable and neither would the transaction with Lunai be invalidated.
2026 Pacific Pier Note
In June 2026, the Company entered into a Securities Purchase Agreement (the “2026 Pacific Pier SPA”), with Pacific Pier Capital II, LP (“Pacific Pier”), pursuant to which Company issued a convertible promissory note in the aggregate gross principal amount of $178,410 (the “2026 Pacific Pier Note”). The 2026 Pacific Pier Note is convertible into shares of the Company’s common stock, par value $0.01 per share. For more information on the 2026 Pacific Pier Note, refer to Note 5 of the Notes to the unaudited Condensed Consolidated Financial Statements.
The 2026 Pacific Pier Note has an original issue discount of 12%, carries an interest rate of 12% per annum and matures on the earlier of (a) the one-year anniversary of the date of the 2026 Pacific Pier Purchase Agreement, or (b) the acceleration of the maturity of the 2026 Pacific Pier Note by Pacific Pier upon occurrence of an event of default or (c) on prepayment in full. The 2026 Pacific Pier Note contains a voluntary conversion mechanism whereby Pacific Pier may convert the outstanding principal and accrued interest under the terms of the 2026 Pacific Pier Note into shares of Common Stock (the “Conversion Shares”), following six (6) calendar months after the Issue Date, at a price that is lesser of (i) $0.06 (as adjusted for any stock dividend, stock split, stock combination, rights offerings, reclassification or similar transaction that proportionately decreases or increases the Common Stock) or (ii) 85% of the lowest traded price of the Common Stock on the Principal Market on any Trading Day during the ten (10) Trading Days prior to the respective conversion date, subject to adjustments upon the occurrence of certain corporate events. The Company also issued 500,000 shares of Common Stock as commitment shares. For more information on the 2026 Pacific Pier Note, refer to Note 5 of the Notes to the unaudited Condensed Consolidated Financial Statements included in this report.
In addition, on August 3, 2026, the Company entered into a new SPA and note with Pacific Pier, with the exact same terms and conditions, for an additional approximately $0.2 million. For more information on the new SPA and note, refer to Note 16 of the Notes to the unaudited Condensed Consolidated Financial Statements included in this report.
In
January 2026, the Company entered into a Securities Purchase Agreement (the “2026 Mast Hill Purchase Agreement”),
with Mast Hill Fund, LP (“Mast Hill”), and the Company issued a convertible promissory note in the aggregate
gross gross
principal amount of approximately $398,333 (the “2026 Mast Hill Note”). The 2026 Mast Hill Note is
convertible into
shares of the Company’s Common Stock. For more information on the 2026 Mast Hill Note, refer to Note 5 of the
Notes to
the unaudited Condensed Consolidated Financial Statements included in this report.
The
2026 Mast Hill Note has an original issue discount of 10%, carries an interest rate of 10% per annum and matures on the earlier of (a)
the one-year anniversary of the date of the 2026 Mast Hill Purchase Agreement, or (b) the acceleration of the maturity of the 2026 Mast
Hill Note by Mast Hill upon occurrence of an Event of Default (as defined below) or (c) on prepayment in full. The 2026 Mast Hill Note
contains a voluntary conversion mechanism whereby Mast Hill may convert the outstanding principal and accrued interest under the terms
of the 2026 Mast Hill Note into shares of Common Stock (the “Conversion Shares”), at a fixed price of $0.07 per share
(the “Conversion Price”), subject to adjustments upon the occurrence of certain corporate events. The 2026 Mast Hill
Note is secured against the assets of the Company, including all the assets owned by the Company’s direct or indirect subsidiaries,
but other than and excluding the equity interests and the assets of the Company licensed or assigned within our joint venture agreement
with Dragon Overseas Capital Limited, namely GMP Biotechnology and its subsidiaries. These assets include OT-101, CA4P, Oxi4503, AI and
AI CDMO technologies and the nanoparticle platform. The Company also issued 1,422,613 warrants to purchase shares (the “Note
Warrants”) of Common Stock of the Company at an exercise price of $0.15. Prepayment of the 2026 Mast Hill Note may be made
at any time upon three trading days’ prior written notice to the respective holder, by payment of the then outstanding principal
amount plus accrued and unpaid interest and reimbursement of such holder’s administrative fees. The 2026 Mast Hill Note contains
customary events of default (each an “Event of Default”). If an Event of Default occurs, at the respective holder’s
election, the outstanding principal amount of the 2026 Mast Hill Note, plus accrued but unpaid interest, will become immediately due
and payable in cash. The 2026 Mast Hill Purchase Agreement require the Company to use the proceeds for general working capital, and not
for (i) the repayment of any indebtedness owed to officers, directors or employees of the Company or their affiliates, (iii) any loan
to or investment in any other corporation, partnership, enterprise or other person (except in connection with the Company’s currently
existing operations), (iv) any loan, credit, or advance to any officers, directors, employees, or affiliates of the Company, or (v) in
violation or contravention of any applicable law, rule or regulation. Further, on January 23, 2026, the Company entered into a Registration
Rights Agreement with Mast Hill (the “Mast Hills Registration Rights Agreement - Note”), to register the shares of
Common Stock issuable under and related to the 2026 Mast Hill Notes and the attached Note Warrants to purchase shares of the Company’s
Common Stock.
As
of January 1, 2025, approximately $2 million was outstanding and payable to Autotelic. During the year ended December 31, 20252025, Autotelic
Inc. provided additional short-term funding of approximately $0.9 million to the Company. In the three and six months ended MarchJune 31, 202630,
2026, Autotelic
Inc. provided additional short-term funding of $17,000 and approximately $58,000 to the Company. As such, approximately $3
$3.1 million was outstanding and payable
to Autotelic at MarchJune 31,30, 2026.
As
of January 1, 2025, approximately $76,000 was outstanding and payable to the Company’s CFO. During the year ended December 31,
2025, the CFO provided additional short-term funding of $10,000. As such, approximately $86,000 was outstanding and payable to the Company’s
CFO at MarchJune 31,30, 2026.
In
December 2023, the Company received $50,000 from the Company’s CEO. In December 2025, the amount due from PPM-2 payable to the
CEO of $125,000 was converted into a short-term loan. As such, $175,000 was outstanding to the Company’s CEO at MarchJune 31,30, 2026.
As of MarchJune 31,30, 2026, approximately $210,000 was outstanding as short-term advances from certain bridge investors.
The
preparation of financial statements in accordance with U.S. generally accepted accounting principles (“US GAAP”) requires
us to make estimates and assumptions that affect the
reported amounts of assets and liabilities and the disclosure of contingent assets
and liabilities at the date of the financial
statements, as well as the reported revenues and expense during the reporting periods. We
base our estimates on historical
experience and on various other assumptions that we believe to be reasonable under the circumstances
at the time we make such
estimates. Actual results and outcomes may differ materially from our estimates, judgments, and assumptions.
We periodically review
our estimates considering changes in circumstances, facts, and experience. The effects of material revisions in
estimates are
reflected in the financial statements prospectively from the date of the change in estimate. Our significant accounting
policies are
more fully described in Note 2 to our condensed financial statements included elsewhere in this AnnualQuarterly Report.
Impairment
of Long-Lived Assets
The
Company reviews long-lived assets, including definite-lived intangible assets, for impairment whenever events or changes in circumstances
indicate that the carrying amount of such assets may not be recoverable. The recoverability of these assets is determined by comparing
the forecasted undiscounted net cash flows of the operation to which the assets relate to the carrying amount. If the operation is determined
to be unable to recover the carrying amount of its assets, then these assets are written down first, followed by other long-lived assets
of the operation to fair value. Fair value is determined based on discounted cash flows or appraised values, depending on the nature
of the assets.
Goodwill
represents the excess of the purchase price of acquired business over the estimated fair value of the identifiable net assets acquired.acquired in a business combination.
Goodwill is not amortized but is tested for impairment at least once annually, at the reporting unit levellevel, or more frequently if events or
or changes in circumstances indicate that the asset might be impaired. The goodwill impairment test is applied by performing a qualitative
assessment before calculating the fair value of the reporting unit. If, on the basis of qualitative factors, it is considered not more
likely than not that the fair value of the reporting unit is less than the carrying amount, further testing of goodwill for impairment
would not be required. Otherwise, goodwill impairment is tested using a two-step approach.
We have the option to first perform a qualitative assessment (commonly referred to as “Step 0”) to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If we determine that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, no further quantitative testing is required. If we choose to bypass the qualitative assessment, or if the qualitative assessment indicates it is more likely than not that the fair value of a reporting unit is less than its carrying amount, we perform a quantitative impairment test. The quantitative test compares the fair value of the reporting unit with its carrying amount, including goodwill. If the carrying amount of the reporting unit exceeds its estimated fair value, an impairment charge is recognized in an amount equal to that excess, limited to the total amount of goodwill allocated to that reporting unit.
Fair Value of the Company’s equity investment
The Company accounts for its investment in the Series Preferred stock of Lunai Bioworks in accordance with ASC 321. Because the asset’s underlying common stock has a readily determinable fair value via an active public exchange, the investment is measured at fair value at each reporting date. The investment is measured using an as-converted basis, anchoring to the observable, quoted market price of Lunai’s underlying common stock on the Nasdaq. Because the preferred shares cannot be immediately liquidated on the open market, management applies a Discount for lack of marketability and other valuation discounts to reflect contractual and regulatory holding restrictions.
The
first step involves comparing the fair value of the reporting unit to its carrying amount. If the fair value of the reporting unit is
determined to be greater than its carrying amount, there is no impairment. If the reporting unit’s carrying amount is determined
to be greater than the fair value, the second step must be completed to measure the amount of impairment, if any. The second step involves
calculating the implied fair value of goodwill by deducting the fair value of all tangible and intangible assets, excluding goodwill,
of the reporting unit from the fair value of the reporting unit as determined in step one. The implied fair value of the goodwill in
this step is compared to the carrying value of goodwill. If the implied fair value of the goodwill is less than the carrying value of
the goodwill, an impairment loss equivalent to the difference is recorded.
We
have generally issued derivative financial instruments, such as warrants, in connection with our equity offerings. We evaluate the
terms terms
of these derivative financial instruments in order to determine their accounting treatment in our financial statements. Key
considerations considerations
include whether the financial instruments are freestanding and whether they contain conditional obligations. If the
warrants are freestanding,
do not contain conditional obligations and meet other classification criteria, we account for the
warrants as an equity instrument. However,
if the warrants contain conditional obligations, then we account for the warrants as a
liability until the conditional obligations are
met or are no longer relevant. Because no established market prices exist for the
warrants that we issue in connection with our equity
offerings, we must estimate the fair value of the warrants, which is as
inherently subjective as itthey isare for stock options, and for similar
reasons as noted in the stock-based compensation section above.
For financial instruments which are accounted for as a liability, we
report any changes in their estimated fair values as gains or
losses in our Condensed Consolidated Statement of Income.
Variable
Interest Entity (VIE) Accounting
We
evaluate our ownership, contractual relationships and other interests in entities to determine the nature and extent of the interests,
whether such interests are variable interests and whether the entities are VIEs in accordance with ASC 810, Consolidations. These evaluations
can be complex and involve Management judgment as well as the use of estimates and assumptions based on available historical information,
among other factors. Based on these evaluations, if the Company determines that it is the primary beneficiary of a VIE, the entity is
consolidated into the financial statements.
InvestmentsInvestment
- Equity Method (Fair Value Election)
The
Company accounts for equity method investments at cost, adjusted for the Company’s share of the investee’s earnings or losses,
which are reflected in the consolidated statements of operations. The Company periodically reviews the investments for other than temporary
declines in fair value below cost and more frequently when events or changes in circumstances indicate that the carrying value of an
asset may not be recoverable.
The Investment in GMP Bio represents the investment into equity securities for which the Company elected the fair value option pursuant to ASC 825-10-15 and subsequent fair value changes in the GMP Bio shares are included in the result from continuing operations. Refer to Note 6 of these Notes to the unaudited Condensed Consolidated Financial Statements.
Joint
Venture agreement
We
have equity interest in unconsolidated arrangement that is primarily engaged in the business of drug discovery, development, and commercialization,
including but not limited to development and commercialization of TGF-beta therapeutics as well as establishing and operating contract
development and manufacturing organization (CDMO) facilities and capabilities. The Company first reviewed the arrangement to determine
if it meets the definition of an accounting joint venture pursuant to ASC 323-10-20. In order to meet the definition of a joint venture,
the arrangement must have all of the following characteristics, (i) the arrangement is organized within a separate legal entity, (ii)
the entity is under the joint control of the venturers, (iii) the venturers must be able to exercise joint control through their equity
investments, (iv) the qualitative characteristics of the entity, including its purpose and design must be consistent with the definition
of a joint venture.
We
consolidate arrangements that are considered to be VIEs where we are the primary beneficiary. We analyze our investments in joint ventures
to determine if the joint venture is considered a VIE and would require consolidation. We (i) evaluate the sufficiency of the total equity
investment at risk, (ii) review the voting rights and decision-making authority of the equity investment holders as a group and whether
there are limited partners (or similar owning entities) that lack substantive participating or kick out rights, guaranteed returns, protection
against losses, or capping of residual returns within the group and (iii) establish whether activities within the venture are on behalf
of an investor with disproportionately few voting rights in making this VIE determination. To the extent that we own interests in a VIE
and we (i) have the power to direct the activities that most significantly impact the economic performance of the VIE and (ii) have the
obligation or rights to absorb losses or receive benefits that could potentially be significant to the VIE, then we would be determined
to be the primary beneficiary and would consolidate the VIE. To the extent that we own interests in a VIE, then at each reporting period,
we re-assess our conclusions as to which, if any, party within the VIE is considered the primary beneficiary. To the extent that our
arrangements do not qualify as VIEs, they are consolidated if we control them through majority ownership interests or if we are the managing
entity (general partner or managing member) and our partner does not have substantive participating rights. Control is further demonstrated
by our ability to unilaterally make significant operating decisions, refinance debt, and sell the assets of the joint venture without
the consent of the non-managing entity and the inability of the non-managing entity to remove us from our role as the managing entity.
We use the equity method of accounting for those arrangements where we exercise significant influence but do not have control. Under
the equity method of accounting, our investment in each arrangement is included on our consolidated balance sheet; however, the assets
and liabilities of the joint ventures for which we use the equity method are not included on our consolidated balance sheet.
When
we sell or contribute properties to unconsolidated arrangements and retain a non-controlling ownership interest in such assets, we recognize
the difference between the consideration received and the carrying amount of the asset sold or contributed when its derecognition criteria
are met. The equity method investment we retain in such partial sale transactions is noncash consideration and is measured at fair value.
As a result, the accounting for a partial sale will result in the recognition of a full gain or loss. When circumstances indicate there
may have been a reduction in the value of an equity investment, we evaluate whether the loss in value is other than temporary. If we
conclude it is other than temporary, we recognize an impairment charge to reflect the equity investment at fair value. The Company elected
the fair value option under the fair value option Subsection of Section 825-10-15 to account for its equity-method investment.
Research
and Development Expense
Research
and development expense consists of costs we incur for the development of our investigational drugs and, to a lesser extent, for preclinical
research activities. Research and development costs are expensed as incurred. Research and development expense include clinical trial
costs, salaries, and benefits of employees, including associated stock-based compensation, payments to clinical investigators, drug manufacturing
costs, laboratory supplies and facility costs. Clinical trial costs are a significant component of our research and development expenses,
and these can be difficult to accurately estimate. Included in clinical trial costs are fees paid to other entities that conduct certain
research and development activities on our behalf, such as clinical research organizations, or CROs. We estimate clinical trial expense
based on the services performed pursuant to contracts with research institutions such as CROs and the actual clinical investigators.
These estimates are based on actual time and expenses incurred by the CRO and the clinical investigators. Also included in clinical trial
expense are costs based on the level of patient enrollment into the clinical trial and the actual services performed under the related
clinical trial agreement. Changes in clinical trial assumptions, such as the length of time estimated to enroll all patients, rate of
screening failures, patient drop-out rates, number and nature of adverse event reports and the total number of patients enrolled can
impact the average and expected cost per patient and the overall cost of the clinical trial. Based on patient enrollment reports and
services provided, we may periodically adjust estimates for the clinical trial costs. If we do not identify costs that we have begun
to incur or if we underestimate or overestimate the level of services performed, the length of time for these services or the costs of
these services, our actual expenses could differ from our estimates.
We
record the estimated fair value of all share-based payments issued to employees and other service providers. Our share-based payments
consist primarily of stock options. The valuation of stock options is an inherently subjective process,process since market values are not available
for any stock options in our equity securities. Market values are also not available on long-term, non-transferable stock options in
other equity securities. With no market values on options to trade in our common stock and no comparable market values on any long-term
non-transferable stock options, the process of valuing our stock options is even more uncertain and subjective. Accordingly, we use a
Black-Scholes option pricing model to derive an estimated fair value of the stock options which we issue. The Black-Scholes option pricing
model requires certain input assumptions, including the expected term of the options and the expected volatility of our common stock.
Changes in these assumptions could have a material impact on the estimated fair value that we record for share-based payments that we
issue. We determine the term of the options based on the simplified method, which averages the vesting period and the contractual life
of the stock option. We determine the expected volatility based on the historical volatility of our common stock over a period commensurate
with the option’s expected term. The Black-Scholes option pricing model also requires assumptions for risk-free interest rates
and the expected dividend yield of our common stock, but we feel that these values are more objective and note that changes in these
values do not have a significant impact on the estimated value of the options when compared to the volatility and term assumptions.
The impacts of any of the critical accounting policies and significant judgments and estimates, if applicable, have been reflected in the Notes to the unaudited Condensed Consolidated Financial Statements in this Report.
AComparison
comparison of the Company’sResults operatingof resultsOperations for the threeThree monthsMonths endedEnded MarchJune 31,30, 20262026, andto 2025,the respectively,Three isMonths asEnded follows.June 30, 2025
The following table sets forth key components of our results of operations for the periods indicated:
Net Income before controlling interests
Net income for the three months ended June 30, 2026, was approximately $0.3 million, a $0.1 million increase from the $0.2 million recorded in the same period of 2025.. The increase was primarily driven by a $1.1 million non-cash gain on derecognition of non-financial asset attributable to the Lunai Series preferred received in exchange for the Company’s equity interest in Neurobridge IP Holdings Incorporated, a gain of $0.3 million from the mark to market of such investment at period end in accordance with ASC 321, and approximately $0.3 million recorded due to services provided to Lunai under the IP Services Agreement (See Transactions with Lunai Bioworks described above). No similar income was recorded during the three months ended June 30, 2025.
The Company recorded higher operating expenses of approximately $1 million, of which approximately $0.7 million related to higher stock-based compensation, approximately $0.4 million of higher legal and professional expenses and approximately $0.1 million of higher other operational expenses during the three months ended June 30, 2026, as compared to the same period of 2025. In addition, the Company recorded higher interest expense of approximately $0.1 million following the additional convertible debts incurred in the period and a lower gain from change in fair value of derivatives by approximately $0.4 million, incurred during the three months ended June 30, 2026, as compared to the same period of 2025.
Service revenue
During the three months ended June 30, 2026, we recorded service revenue of $250,000 as received from Lunai for certain services in connection with the IP Services Agreement. No similar revenues were recorded during the same period in 2025.
Net
Loss
We
recorded a net loss of approximately $2.2 million for the three months ended March 31, 2026 as compared to approximately $0.4 million
for the three months ended March 31, 2025. The higher loss of approximately $1.9 million for the three months ended March 31, 2026 as
compared to the same period of 2025 was primarily due to higher operating expenses of approximately $1.8 million, of which approximately $1.6 million relates to higher stock-based compensation, and higher interest
expense of approximately $0.1 million incurred during the three months ended March 31, 2026 as compared to the same period of 2025.
Research
and development (“R&D”) expenses increasedremained marginally by approximately $500similar for the three months ended MarchJune 31,
30, 2026 compared to the same
period in 2025. The lower R&D cost was primarily related to lower operational costs, as these costs are
now being borne by our JV since April 2022.costs.
Now that we have formed a joint venture with GMP Bio, whereby we are able to transfer the responsibility of our drug development program related to OT-101 to the JV, we plan to increase research and development activities related to apomorphine, the initiation of new clinical trials for our other oncology indications as well continuing or expanding on the trials and development of AI based tools and applications for OT-101; and Artemisinin for COVID-19 and other epidemics, and therefore believe that research and development expense may increase in the future, subject to our continuing ability to secure sufficient funding to continue planned operations.
General and Administrative Expenses
General and administrative (“G&A”) expenses increased by approximately $1.0 million for the three months ended June 30, 2026, compared to the same period in 2025, primarily due to an increase in stock-based compensation of approximately $0.7 million, and approximately $0.4 million in legal and professional fee. The higher legal and professional costs are primarily attributed to the Company’s efforts to uplist the Company’s Common Stock to a nationally recognized stock exchange. The higher operating expenses were partially offset by lower operating expenses of approximately $0.1 million incurred during the three months ended June 30, 2026 as compared to the same period of 2025.
Gain on derecognition of non-financial asset and change in value of equity securities of Lunai During the three months ended June 30, 2026, the Company recorded total non-cash income of $1.4 million related to transactions with Lunai. This income consists of a $1.1 million gain on the derecognition of a non-financial asset, alongside a subsequent $0.3 million upward fair value adjustment on the underlying equity securities received in exchange for the Company’s interest in Neurobridge IP Holdings Incorporated. While the Series B Preferred Stock received from Lunai carries a stated value of $12.5 million, the Company recorded such consideration based on the fair value of these equity securities. No similar income was recorded during the three months ended June 30, 2025. For more information on the fair value of the equity securities in Lunai, refer to Note 2 of the unaudited Condensed Consolidated Financial Statement under “Fair Value Hierarchy – Lunai”.
OTLC insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 4 Form 4 filings (2 insiders, 6 trade dates, 850,759 shares, about $37.7K) and open-market sales in 0 filings. Net open-market shares: 850,759 (purchases minus sales); net value about $37.7K.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 |
|---|---|---|---|---|---|
| 2026-07-01 | Trieu Vuong |
Open-market purchase | 240,000 | $0.04 | $9.6K |
| 2026-06-24 | Trieu Vuong |
Open-market purchase | 115,000 | $0.05 | $5.8K |
| 2026-06-23 | Trieu Vuong |
Open-market purchase | 75,000 | $0.05 | $3.8K |
| 2026-06-22 | Trieu Vuong |
Open-market purchase | 65,000 | $0.05 | $3.2K |
| 2026-06-22 | Shah Amit B. |
Open-market purchase | 20,000 | $0.05 | $1.0K |
| 2026-06-17 | Trieu Vuong |
Open-market purchase | 239,759 | $0.04 | $9.6K |
| 2026-06-15 | Trieu Vuong |
Open-market purchase | 96,000 | $0.05 | $4.8K |
Well-known investors holding OTLC (13F)
None of the 59 investors we track reported a position in their latest 13F.