ABPO 10-K & 10-Q changes, risk factors and insider trading
Abpro Holdings, Inc. (also ABPWW) · OTC · Biological Products, (No Diagnostic Substances) · CIK 1893219 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Holders of our warrants will have no rights as a common stockholder until they acquire our common stock.”
New heading “Our Reverse Stock Split may decrease the liquidity of the shares of our Common Stock.”
New heading “Following a reverse stock split, the resulting market price of our Common Stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our Common Stock may not improve.”
Removed heading “We reached a determination to restate certain of our previously issued consolidated financial statements as a result of the identification of errors in previously issued consolidated financial statements, which resulted in unanticipated costs and may affect investor confidence and raise reputational issues.”
Removed heading “Our management has limited experience in operating a U.S.-listed public company.”
Removed heading “An active market for our securities may not develop, which would adversely affect the liquidity and price of our securities.”
Removed heading “Concentration of ownership among existing executive officers, directors and their affiliates, including the investment funds they represent, may prevent new investors from influencing significant corporate decisions.”
Removed heading “If securities or industry analysts do not publish research or reports about our business, if they change their recommendations regarding our Common Stock or if our operating results do not meet their expectations, our Common Stock price and trading volume could decline.”
Removed heading “There is no guarantee that the warrants will ever be in the money; they may expire worthless or the terms of warrants may be amended.”
Removed heading “Our Warrant Agreement designates the courts of the State of New York or the United States District Court for the Southern District of New York as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by holders of our warrants, which could limit the ability of warrant holders to obtain a favorable judicial forum for disputes with us.”
Removed heading “We may redeem unexpired warrants prior to their exercise at a time that is disadvantageous to warrantholders, thereby making their warrants worthless.”
Removed heading “There may be sales of a substantial amount of our Common Stock by current stockholders, and these sales could cause the price of our Common Stock to fall.”
Removed heading “Future resales of our Common Stock may cause the market price of our securities to drop significantly, even if our business is doing well.”
Removed heading “Our Warrants may not be exercised at all or may be exercised on a cashless basis and we may not receive any cash proceeds from the exercise of the Warrants.”
Removed heading “It is not possible to predict the actual number of shares we will sell under the SEPA, or the actual gross proceeds resulting from those sales. Further, we may not have access to any or the full amount available under the SEPA.”
Largest changes
“Following a reverse stock split, the resulting market price of our Common Stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our Common Stock may not improve.”see in full comparison
“On February 18, 2026, the Company received written notification from the Nasdaq Listings Qualifications Panel that the Company’s securities were to be delisted from Nasdaq, effective February 23, 2026. Following the delisting, our securities are currently quoted on the OTC Markets Pink Limited tier (the “OTC Pink”) under the symbol “ABPO.” Trading on the OTC Pink may result in reduced liquidity, fewer market makers for our Common Stock, greater volatility in the market price of our Common Stock, and reduced ability for us to raise additional capital.”see in full comparison
“An active market for our securities may not develop, which would adversely affect the liquidity and price of our securities.”see in full comparison
“Our Reverse Stock Split may decrease the liquidity of the shares of our Common Stock.”see in full comparison
“The Trump administration is also pursuing a two-fold strategy to reduce drug costs in the U.S. While it is unclear whether and how the Trump proposals will be implemented, the Trump policies are likely to have a negative impact on the pharmaceutical industry and on our ability to receive adequate revenues for our product candidates, if approved. On the one hand, President Trump has threatened to impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing, which would tie the price for drugs in the U.S. …”see in full comparison
“Our Warrant Agreement designates the courts of the State of New York or the United States District Court for the Southern District of New York as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by holders of our warrants, which could limit the ability of warrant holders to obtain a favorable judicial forum for disputes with us.”see in full comparison
Full comparison: every changed paragraph (170)
You should carefully consider all the following risk factors, together with all of the other information included or incorporated by reference in this Annual Report, including the consolidated financial statements and the accompanying notes and matters addressed in the section titled “Cautionary Note Regarding Forward-Looking Statements,” in evaluating an investment in our Common Stock. The occurrence of one or more of the events or circumstances described in these risk factors, alone or in combination with other events or circumstances, may adversely affect our business, cash flows, financial condition and results of operations. We may face additional risks and uncertainties that are not presently known to us or that we currently deem immaterial, which may also impair our business, cash flows, financial condition and results of operations.
An
investment in our securities involves a high degree of risk. You should carefully consider the following risks and all of the other information
contained in this Annual Report before deciding whether to invest in our securities. If any of the following risks are realized, our
business, financial condition and results of operations could be materially and adversely affected. In that event, the trading price
of our securities could decline, and you could lose all or part of your investment in our securities. Additional risks of which we are
not presently aware or that we currently believe are immaterial may also harm our business and results of operations. Some statements
in this Annual Report, including such statements in the following risk factors, constitute forward-looking statements. See
the section entitled “Cautionary Note Regarding Forward-Looking Statements.”
Our
management has concluded that uncertainties around our ability to raise additional capitalcapital, raisecombined with our cash on hand, raises substantial
doubt about our ability
to continue as a going concern, including drug development.concern. We will require additional financing to fund our future operations. Any failure
to obtain additional capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our operations.
We
have concluded that we do not have sufficient cash to fund our operations and drug development and to meet our obligations as they become
due withinfor a period of one year from the date that our consolidated financial statements arewere issued and as a result, there is substantial
doubt about
our ability to continue as a going concern. Our ability to continue as a going concern is an issue raised as a result of our ongoing operating
losses and aour lack of financing commitments to meet cashboth requirements,current obligations and isfuture subjectoperating cash requirements. Our ability to
continue as a going concern depends upon our ability to generate a profit or obtain appropriate
financing from outside sources, including
obtaining additional funding from the sale of our securities or obtaining loans from third
parties whereon possible.commercially reasonable terms.
We will need to raise additional capital to fund our operations and drug development. We cannot assure you that
we will be able to raise
additional capital on commercially reasonable terms or at all. The perception that we may not be able to continue
as a going concern
may materially limit our ability to raise additional funds through the issuance of new debt or equity securities or
otherwise otherwise, and no
assurance can be given that sufficient funding will be available when needed to allow us to continue as a going concern.
This perception
may also make it more difficult to operate our business due to concerns about our ability to meet our contractual obligations.
If we
cannot continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are
are carried on our consolidated financial statements, and it is likely that our stockholders may lose some or all of their investment in
us. us.All of these factors could materially and adversely affect the market value of our Common Stock.
Drug
development is a highly uncertain undertaking and involves a substantial degree of risk. We are a preclinicalpre-clinical stage biopharmaceutical
company with a history of losses,losses. We expect to continue to incur significant losses for the foreseeable future and we may never achieve
or or
maintain profitability, which could result in a decline in the market value of our commonCommon stock.Stock.
Pharmaceutical
and biopharmaceutical product development
is a highly speculative undertaking and involves a substantial degree of risk. We are a preclinical stage pre-clinical-stage
biopharmaceutical company with
a history of losses. Since our inception, we have devoted our resources to the development of antibody
product candidates, our technologies
and our DiversImmune® and MultiMabTM platforms. We are not
profitable and
have had significant operating losses since our inception. As of December 31, 2024,2025, we had an accumulated deficit of $116.1 $119.0
million. For
the years ended December 31, 20242025 and 2023,December 31, 2024, our net loss was $7.2$2.9 million and $11.7$7.2 million, respectively. Substantially
all of our losses have resulted from expenses incurred in connection with our collaboration agreements, research and development programs
and from general and
administrative costs associated with our operations. We continue to incur significant research and development (“R&D”)
and other expenses related to ongoing operations and expect to incur losses for the foreseeable future.
PreclinicalPre-clinical
studies and clinical trials are long, expensive and unpredictable processes that can be subject to extensive delays. We cannot guarantee
that any clinical trials will be conducted as planned or completed on schedule, if at all. It may take several years and require significant
expenditures to complete the preclinicalpre-clinical studies and clinical trials necessary to commercialize a product candidate, and delays or failure
are inherently unpredictable and can occur at any stage. We may also be required to conduct additional clinical trials or other testing
of our product candidates beyond the trials and testing that we contemplate, which may lead to us incurring additional unplanned costs
or result in delays in clinical development. In addition, we may be required to redesign or otherwise modify our plans with respect to
an ongoing or planned clinical trial, and changing the design of a clinical trial can be expensive and time consuming. An unfavorable
outcome in one or more trials would be a major setback for our product candidates and for us. An unfavorable outcome in one or more trials
may require us to delay, reduce the scope of or eliminate one or more product development programs, which could have a material adverse
effect on our business, financial position, results of operations and future growth prospects.
Our
product candidates are in early stages of development, and we are subject to the risks of failure inherent in the development of product
candidates based on novel technologies. We believe that we are at a sufficiently mature development stage with both lead candidates that
given adequate funding and, in the case of ABP-102, continued successful collaboration with Celltrion, thesethe programsABP-102 program would be able
to to
enter clinical trials in 20262026. (ABP-102 is in the case of ABP-102 and ABP-201). However, there can be no guarantee that both or either will do so,
andpre-clinical to date,Phase we1 havetransition notstage, yethaving had any discussions with thereceived U.S. FoodFDA andInvestigational
New Drug Administration (the “FDA”IND) regardingclearance thein clinical
trialJanuary design for our lead product candidates.2026. We have never generated any revenue from product sales,sales and have not obtained regulatory approval
approval for any of our product candidates. Accordingly, you should consider our prospects in light of the costs, uncertainties, delays,
and difficulties
frequently encountered by preclinical stagepre-clinical-stage biopharmaceutical companies such as ours. We currently do not expect to
generate any near-term
revenue other than from certain milestone payments under the collaboration agreements relating to our two lead
antibodies. We do not
expect to generate any revenue from product sales for the foreseeable future, and we expect to continue to incur
significant operating
losses for the foreseeable future due to the costcosts of research and development,development preclinicaland pre-clinical studies and clinical
trials, and due
to the regulatory approval process for our product candidates. We expect our net losses to increase substantially as we enter
into clinical
development of our lead programs. However, the amount of our future losses is uncertain. Our ability to achieve profitability,
if ever,
will depend on, among other things, our, and our existing or future partners, successfully developing product candidates, obtaining regulatory
regulatory approvals to market and commercialize product candidates, achieving contractual milestones under our collaboration agreements, manufacturing
manufacturing any approved products on commercially reasonable terms, realizing royalties on any approved products under our collaboration agreements,
agreements, establishing a sales and marketing organization or suitable third-party alternatives for any approved product and raising sufficient
sufficient funds to finance business activities. If we, and our existing or future partners, are unable to develop our technologies and commercialize
commercialize one or more of our product candidates or if sales revenue from any product candidate that receives approval is insufficient,
we will
not achieve profitability, which will have a material and adverse effect on our business, financial condition, results of operations
and prospects. Any predictions you make about our future success or viability may not be as accurate as they could be if we had a history
of successfully
developing and commercializing pharmaceutical products.
We
have no products on the market and all of our product candidates, including ABP-102, for the potentialtreatment treatment
of breast and gastric cancers,
and ABP-201, for the potential treatment of wet age-related macular degeneration
(Wet AMD) and diabetic macular edema (DME), have not yet entered
clinical trials. In particular, none of our product candidates has ever
been tested in a human subject. Our ability to achieve and sustain
profitability depends on obtaining regulatory approvals for and successfully
commercializing our product candidates, either alone or
with third parties. Before obtaining regulatory approval for the commercial distribution
of our product candidates, we or an existing
or future partner must conduct extensive preclinicalpre-clinical studies and clinical trials to demonstrate
the safety and efficacy in humans of
our product candidates.
None
of our product candidates have been tested in humans. We may ultimately discover that our product candidates do not possess certain properties
that we believe are helpful for therapeutic effectiveness, including strong binding for increased efficacy and increased binding sites
for increased potency, and safety, including reduced immunogenicity and optimized binding domain position, or dosing, including a longer
circulating half-life resulting in reduced dosing required. For example, when administered in a human, we may find that our product candidates
perform differently than in preclinicalpre-clinical studies. We currently have only limited preclinicalpre-clinical data, and no conclusive evidence, to suggest
that we can introduce these favorable properties into any of our product candidates. We may spend substantial funds attempting to introduce
these properties and may never succeed in doing so. In addition, certain of our product candidates may demonstrate different chemical
and pharmacological properties in patients than they do in laboratory studies. Although certain of our product candidates have successful
results in animal studies, they may not demonstrate the same chemical and pharmacological properties in humans and may interact with
human biological systems in unforeseen, ineffective or harmful ways. As a result, we may never succeed in developing a marketable product,
we may not become profitableprofitable, and in that case the value of our commonCommon stockStock will decline.
Further,
we are aware of onlyup nineto fifteen bispecific antibodies that have been approved by the FDA.FDA, nine of which involve bispecific T cell engagers.
As such, we believe the FDA has limited early experience
with bispecific antibody-based therapeutics, which may increase the complexity,
uncertainty and length of the regulatory approval process
for our product candidates. For example, the FDA may require us to provide
additional data to support our regulatory applications. We
and our existing or future partners may never receive approval to market and
commercialize any product candidate. Even if we or an existing
or future partner obtains regulatory approval, the approval may be for
targets, disease indications or patient populations that are not
as broad as we intended or desired or may require labeling that includes
significant use or distribution restrictions or safety warnings.
We or an existing or future partner may be subject to post-marketing
testing requirements to maintain regulatory approval. If any of
our product candidates proveproves to be ineffective, unsafe or commercially
unviable, our entire pipeline could have little, if any, value,
which could require us to change our focus,focus and approach to antibody development
and reengineer the antibody. Any of these events could have
a material and adverse effect on our business, financial condition, results
of operations and prospects.
Even if regulatory approval is obtained for a product candidate, we may not generate or sustain revenue from sales of the product due to factors such as whether the product can be sold at a competitive cost and otherwise be accepted in the market. The antibodies we are developing use relatively new technologies. Market participants with significant influence over acceptance of new treatments, such as physicians and third-party payors, may not adopt a product or treatment based on our platforms and technologies, and we may not be able to convince the medical community and third-party payors to accept and use, or to provide favorable reimbursement for, any product candidates developed by us or our existing or future partners. Market acceptance of our product candidates will depend on, among other factors:
The
development of biopharmaceutical product candidates is capital-intensive. If our product candidates enter and advance through preclinicalpre-clinical
studies and clinical trials, we will need substantial additional funds to expand our development, regulatory, manufacturing, marketing
and sales capabilities. We have used substantial funds to develop our technology and product candidates and will require significant
additional funds to conduct further research and development and preclinicalpre-clinical testing and clinical trials of our product candidates,
to to
seek regulatory approvals for our product candidates and to manufacture and market products, if any, that are approved for commercial
sale. In addition, we expect to incur additional costs associated with operating as a public company.company, which will require additional funding
to operate in parallel with and in addition to our clinical and development costs of our assets.
If
we are unable to obtain funding on a timely basis or on acceptable terms, we may have to delay, reduce or terminate our research and
development programs and preclinicalpre-clinical studies or clinical trials, if any, limit strategic opportunities or undergo reductions in our
workforce workforce
or other corporate restructuring activities. We also could be required to seek funds through arrangements with partners or
others that
may require us to relinquish rights to some of our technologies or product candidates that we would otherwise pursue on our
own. We do
not expect to realize revenue from sales of products or royalties from licensed products in the foreseeable future, if at
all, and unless
and until our product candidates are clinically tested, approved for commercialization and successfully marketed. To
date, we have primarily
financed our operations through the sale of debt and equity securities and payments received under our collaboration
agreements. We will
be required to seek additional funding in the future and currently intend to do so through additional collaborations,
public or private
equity offerings or debt financings, credit or loan facilities or a combination of one or more of these funding sources.
Our ability
to raise additional funds will depend on financial, economic and other factors, many of which are beyond our control. Additional
funds funds
may not be available to us on acceptable terms or at all. If we raise additional funds by issuing equity securities, our stockholders
will suffer dilutiondilution, and the terms of any financing may adversely affect the rights of our stockholders. In addition, as a condition
to providing additional funds to us, future investors may demand, and may be granted, rights superior to those of existing stockholders.
Debt financing, if available, is likely to involve restrictive covenants limiting our flexibility in conducting future business activities,
and, in the event of insolvency, debt holders would be repaid before holders of our equity securities received any distribution of our
corporate assets.
Our
ability to generate revenues from our existing collaborations for licensing and co-development of our product candidates and
any future
similar arrangements,arrangements will depend on our ability to successfully develop the product candidates and receive necessary product approvals
approvals for commercialization in the agreed territories. We have limited ability to control the actions of our joint development and
any other
third-party partners, and successful product development will depend to some extent on such third parties to performperforming the functions assigned
assigned to them in our contracts.
Collaboration
agreements may not lead to development or commercialization of our product candidates in the most efficient mannermanner, or at all. If a partner
of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization
program could be delayed, diminished or terminated. Any failure of our existing and any future collaborations would negatively affect
our business plans and strategy for our product candidate pipeline, which could have a material and adverse effect on our business, financial
condition, results of operations and prospects.
In
addition, to the extent that any of our existing or future partners were to terminate a collaboration agreement, we may be forced to
independently develop these product candidates, including funding preclinicalpre-clinical studies or clinical trials, assuming marketing and distribution
costs and maintaining, enforcing and defending intellectual property rights, or, in certain instances, abandon product candidates altogether,
any of which could result in a change to our business plan and a material and adverse effect on our business, financial condition, results
of operations and prospects.
We
may not successfully engage in strategic transactions, including any additional collaborations we seek, which could adversely affect
our ability to develop and commercialize product candidates, impact our cash position, increase our expense,expenses, and present significant
distractions to our management.
From
time to time, we may consider strategic transactions, such as additional collaborations, acquisitions of companies, asset purchases,
joint ventures and out- or in-licensing of product candidates or technologies. In particular, we will evaluate and,
if strategically
attractive, seek to enter into additional collaborations, including with major biotechnology or biopharmaceutical companies
or hospitals.
The competition for partners is intense, and the negotiation process is time-consuming and complex. Any new collaboration
may be on terms
that are not optimal for us, and we may not be able to maintain any new collaboration if, for example, development or
approval of a product
candidate is delayed, sales of an approved product candidate do not meet expectationsexpectations, or the partner terminates
the collaboration. Any
such collaboration, or other strategic transaction, may require us to incur non-recurring or other charges,
increase our near- and long-term
expenditures and pose significant integration or implementation challenges or disrupt our management
or business. These transactions
would entail numerous operational and financial risks, including:
Accordingly,
although there can be no assurance that we will undertake or successfully complete any transactions of the nature described above, and
any
such transactions that we do complete may be subject to the foregoing or other risks and have a material and adverse effect on our
business, business,
financial condition, results of operations and prospects. Conversely, any failure to enter any additional collaboration or
other strategic
transaction that would be beneficial to us could delay the development and potential commercialization of our product
candidates and
have a negative impact on the competitiveness of any product candidate that reaches market.
If
third parties on which we intend to rely on to conduct certain preclinicalpre-clinical studies, or any future clinical trials, do not perform as
contractually required, fail to satisfy regulatory or legal requirements or miss expected deadlines, our development program could be
delayed with material and adverse effects on our business, financial condition, results of operations and prospects.
We
intend to rely on third-party clinical investigators, contract research organizations (“CROs”), clinical data management
organizations and consultants to design, conduct, supervise and monitor certain preclinicalpre-clinical studies of our product candidates and will
do the same for any clinical trials. Because we intend to rely on these third parties and will not have the ability to conduct certain
preclinicalpre-clinical studies or clinical trials independently, we will have less control over the timing, quality and other aspects of such preclinicalpre-clinical
studies and clinical trials than we would have had we conducted them on our own. These investigators, CROs and consultants will not be
our employeesemployees, and we will have limited control over the amount of time and resources that they dedicate to our programs. These third
parties may have contractual relationships with other entities, some of which may be our competitors, which may draw time and resources
from our programs. The third parties with which we may contract might not be diligent, careful or timely in conducting our preclinicalpre-clinical
studies or clinical trials, resulting in the preclinicalpre-clinical studies or clinical trials being delayed or unsuccessful.
If
we cannot contract with acceptable third parties on commercially reasonable terms, or at all, or if these third parties do not carry
out their contractual duties, satisfy legal and regulatory requirements for the conduct of preclinicalpre-clinical studies or clinical trials or
meet expected deadlines, our clinical development programs could be delayed and otherwise adversely affected. In all events, we will
be responsible for ensuring that each of our preclinicalpre-clinical studies and clinical trials are conducted in accordance with the general investigationalinvestigation
plan and protocols for the trial. The FDA requires preclinicalpre-clinical studies to be conducted in accordance with good laboratory practices,
or GLPs, and clinical trials to be conducted in accordance with good clinical practices (“GCPs”), including for designing,
conducting, recording and reporting the results of preclinicalpre-clinical studies and clinical trials to ensure that data and reported results
are are
credible and accurate and that the rights, integrity and confidentiality of clinical trial participants are protected. Our reliance
on on
third parties that we do not control will not relieve us of these responsibilities and requirements. Any adverse development or delay
in our clinical trials could have a material and adverse effect on our business, financial condition, results of operations and prospects.
Because
we may rely on third-party manufacturing and supply partners for preclinicalpre-clinical and clinical development materials, our supply may become
limited or interrupted or may not be of satisfactory quantity or quality.
We
produce only small-scale quantities of our antibodies and reagents for characterization, in vivo and in vitro assessment. We may rely
on third-party contract manufacturers to manufacture our preclinicalpre-clinical and clinical trial product supplies. We do not currently own manufacturing
facilities for producing such supplies. There can be no assurance that our preclinicalpre-clinical or clinical development product supplies will
not be limited or interrupted,interrupted or will be of satisfactory quality or continue to be available at acceptable prices. In particular, any
replacement of our manufacturers could require significant effort and expertise because there may be a limited number of qualified replacements.
We
expect to rely on third-party manufacturers if we receive regulatory approval for any product candidate. To the extent that we then have existing,
or enter into future,existing manufacturing arrangements with third parties, we will depend on these third parties to perform their obligations
in a timely
manner consistent with contractual and regulatory requirements, including those related to quality control and assurance.
If we are unable
to obtain or maintain third-party manufacturing for product candidates, or to do so on commercially reasonable terms,
we may not be able
to develop and commercialize our product candidates successfully. Our failure or a third party’s failure to execute
on our manufacturing
requirements and comply with cGMPs could adversely affect our business in a number of ways, including:
Our
understanding of both the number of people who suffer from HER2+ breast and gastric cancers or other tumors that can be treated with
VEGF inhibitors, is based on estimates. These estimates may prove to be incorrectincorrect, and new studies may reduce the estimated incidence
or prevalence of these diseases. The number of patients in the United States, Europe, or elsewhere may turn out to be lower than expected,
may not be otherwise amenable to treatment with our product candidates or patients may become increasingly difficult to identify and
access, all of which would adversely affect our business, financial condition, results of operations and prospects.
We
are aware of several companies that are developing antibodies for the treatment of cancer and autoimmune diseases. Many of these companies
are well-capitalized and, in contrast to us, have significant clinical experience, and may include our existing or future partners. In
addition, these companies compete with us in recruiting scientific and managerial talent. Our success will partially depend on our ability
to develop and protect antibodies that are safer and more effective than competing products. Our commercial opportunity and success will
be reduced or eliminated if competing products that are safer, more effective, or less expensive than the antibodies we develop.
Many
of our competitors have significantly greater financial, technical, manufacturing, marketing, sales and supply resources or experience
than we do. If we successfully obtain approval for any product candidate, we will face competition based on many different factors, including
the safety and effectiveness of our products, the ease with which our products can be administered and the extent to which patients accept
relatively new routes of administration, the timing and scope of regulatory approvals for these products, the availability and cost of
manufacturing, marketing and sales capabilities, price, reimbursement coverage and patent position. Competing products could present
superior treatment alternatives, including by being more effective, safer, less expensive or marketed and sold more effectively than any
any products we may develop. Competitive products may make any products we develop obsolete or noncompetitive before we recover the expense
of developing and commercializing our product candidates. Such competitors could also recruit our employees, which could negatively impact
on our level of expertise and our ability to execute our business plan.
Our
success largely depends on the continued service of key management,
advisors and other specialized personnel, including Robert Markelewicz, our Chief Medical Officer. We have an offer letter with Robert
Markelewicz.personnel. The loss of one or more
members of our executive team, management team or other key employees or advisors could delay
our research and development programs and
have a material and adverse effect on our business, financial condition, results of operations
and prospects.
As
of theMarch date30, of this Annual Report,2026, we had sixone full-time employeesemployee and ninetwo furloughedpart-time employees. Our focus on the development
of our product candidates
will require adequate staffing. We may need to hire and retain new employees to execute our future
clinical development and manufacturing
plans. We cannot provide assurance that we will be able to hire and/or retain adequate
staffing levels to develop our product candidates
or run our operations and/ or to accomplish all of our objectives.
We
have limited experience in product development and have not begun clinical trials for any of our product candidates. As our product candidates
enter and advance through preclinicalpre-clinical studies and any clinical trials, we will need to expand our development, regulatory and manufacturing
capabilities or contract with other organizations to provide these capabilities for us. We may also experience difficulties in the discovery
and development of new antibody product candidates using our DiversImmune® and MultiMabTM platforms
if we are unable to meet demand as we grow our operations. In the future, we also expect to have to manage additional relationships with
collaborators, suppliers and other organizations. Our ability to manage our operations and future growth will require us to continue
to improve our operational, financial and management controls, reporting systems and procedures. We may not be able to implement improvements
to our management information and control systems in an efficient or timely manner and may discover deficiencies in existing systems
and controls.
We
currently have no sales, marketing or distribution capabilities or experience. If any of our product candidates is approved, we will
need to develop internal sales, marketing and distribution capabilities to commercialize such products, which would be expensive and
time-consuming, or enter into partnerships with third parties to perform these services. If we decide to market our products directly,
we will need to commit significant financial and managerial resources to develop a marketing and sales force with technical expertise
and supportingsupportive distribution, administration and compliance capabilities. If we rely on third parties with such capabilities to market
our products or decide to co-promote products with partners, we will need to establish and maintain marketing and distribution arrangements
arrangements with third parties, and there can be no assurance that we will be able to enter into such arrangements on acceptable terms
or at all.
In entering into third-party marketing or distribution arrangements, any revenue we receive will depend upon the efforts of
the third
parties and there can be no assurance that such third parties will establish adequate sales and distribution capabilities or
be successful
in gaining market acceptance of any approved product. If we are not successful in commercializing any product approved
in the future,
either on our own or through third parties, our business, financial condition, results of operations and prospects could
be materially
and adversely affected.
Undesirable
side effects caused by our product candidates could cause regulatory authorities to interrupt, delay or halt clinical trials and could
result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other regulatory authorities. While we
have not yet initiated clinical trials for any of our product candidates, it is likely that there may be side effects associated with
their use. Results of our trials could reveal a high and unacceptable severity and prevalence of these or other side effects. In such
an event, our trials could be suspended or terminatedterminated, and the FDA or comparable foreign regulatory authorities could order us to cease
further development of or deny approval of our product candidates for any or all targeted indications. Such side effects could also affect
patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of
these occurrences may materially and adversely affect our business, financial condition, results of operations and prospects.
As
we move into conducting clinical trials of our product candidates, we will be exposed to significant product liability risks inherent
in the development, testing, manufacturing and marketing of antibody treatments. Product liability claims could delay or prevent completion
of our development programs. If we succeed in marketing products, such claims could result in an FDA investigation of the safety and
effectiveness of our products, our manufacturing processes and facilities or our marketing programs and potentially a recall of our products
or more serious enforcement action, limitations on the approved indications for which they may be used or suspension or withdrawal of
approvals. Regardless of the merits or eventual outcome, liability claims may also result in decreased demand for our products, injury
to our reputation, costs to defend the related litigation, a diversion of management’s time and our resources, substantial monetary
awards to trial participants or patients and a decline in our stock price. We currently do not have product liability insurance and will
need to obtain such insurance prior to marketing any of our product candidates. Any insurance we have or may obtain may not provide sufficient
coverage against potential liabilities. Furthermore, clinical trial and product liability insuranceinsurances ismay be becoming increasingly expensive.expensive
As a result, our partners or we may be unable to obtain sufficient insurance at a reasonable cost to protect us against losses caused
by product liability claims that could have a material and adverse effect on our business, financial condition, results of operations
and prospects.
Our
employees, principal investigators, consultants and commercial partnerspartners, may engage in misconduct or other improper activities, including
noncompliance with regulatory standards and requirements.
Our
internal computer systems and those of CROs and other contractors and consultants we use or may use in the future, may be vulnerable
to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.
Such events could cause interruptions of our operations. For instance, the loss of preclinicalpre-clinical data or data from any future clinical
trial involving our product candidates could result in delays in our development and regulatory filing efforts and significantly increase
our costs. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data, or inappropriate
disclosure of confidential or proprietary information, we could incur liabilityliability, and the development of our product candidates could
be be
delayed.
Our
research, development and manufacturing involve the use of hazardous materials and various chemicals. We maintain quantities of various
flammable and toxic chemicals in our facilities that are required for our research, development and manufacturing activities. We are
subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous
materials. We believe our procedures for storing, handling and disposing these materials in our facilities comply with the relevant guidelines
of the Commonwealth of Massachusetts and the Occupational Safety and Health Administration of the U.S. Department of Labor. Although
we believe that our safety procedures for handling and disposing of these materials comply with the standards mandated by applicable
regulations, the risk of accidental contamination or injury from these materials cannot be eliminated. If an accident occurs, we could
be held liable for resulting damages, which could be substantial. We are also subject to numerous environmental, health and workplace
safety laws and regulations, including those governing laboratory procedures, exposure to blood-borne pathogens and the handling of animals
and biohazardous materials. Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur
due to injuries to our employees resulting from the use of these materials, this insurance may not provide adequate coverage against
potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us
in connection with our storage or disposal of biological or hazardous materials. Additional federal, state and local laws and regulations
affecting our operations may be adopted in the future. We may incur substantial costs to comply with, and substantial fines or penalties
if we violate,violate any of these laws or regulations.
OurWe
current operations are concentrated across two locations in close proximity, and we or the third parties upon whom we depend may be adversely
affected by natural disasters and we may not be adequately protected from a
serious disaster.
Our
current operations are concentrated across two locations in close proximitylocated outside of Boston, Massachusetts. Any unplanned event, such
as flood, fire, explosion, extreme weather
condition, medical epidemics, power shortage, telecommunication failure or other natural or
manmade accidents or incidents that result
in us being unable to fully utilize our facilities, or the manufacturing facilities of our
third-party contract manufacturers, may have
a material and adverse effect on our ability to operate our business, particularly on a
daily basis, and have significant negative consequences
on our financial and operating conditions. Loss of access to thesethis facilities
facility may result in increased costs, delays in the development of
our product candidates or interruption of our business operations. Natural
disasters such as snowstorms or hurricanes could further disrupt
our operations,operations and have a material and adverse effect on our business,
financial condition, results of operations and prospects. If a
natural disaster, power outage or other event occurred that prevented
us from using all or a significant portion of our headquarters,
that damaged critical infrastructure, such as our research facilities
or the manufacturing facilities of our third-party contract manufacturers, or that otherwise
disrupted operations, it may be difficult
or, in certain cases, impossible, for us to continue our business for a substantial period
of time. We do not currently have disaster
recovery and business continuity plans in placeplace, and this may have adverse consequences in
the event of a serious disaster or similar
event. As a result, we may incur substantial expenses, which could have a material adverse
effect on our business. As part of our risk
management policy, we maintain insurance coverage at levels that we believe are appropriate
for our business. However, in the event of
an accident or incident at thesethis facilities,facility or the facilities maintained and insured by our third
party vendors, contractors or development partners, we cannot assure you that the amounts of insurance will be sufficient to satisfy
any damages
and losses. If our facilities,offices or the manufacturing facilities of our third-party contract manufacturers, are unable to operate
because because
of an accident or incident or for any other reason, even for a short period of time, any or all of our research and development
programs programs
may be harmed. Any business interruption may have a material and adverse effect on our business, financial condition, results
of operations
and prospects.
We
are heavily reliant upon licenses to certain patent rights and proprietary technology from third parties that are important or necessary
to the development of our technologies and product candidates. Our current license agreements impose, and any future license agreements
we enter into are likely to impose, various development, commercialization, funding, milestone, royalty, diligence, sublicensing, insurance,
patent prosecution and enforcement and/or other obligations on us. We previously were party to an Exclusive License Agreement with Memorial
Sloan Kettering Cancer Center (“MSK”), which was terminated by MSK in September 2023 for our failure to fulfil our payment
obligations to MSK. MSK has demanded payments totaling approximately $1.2 million. We have contacted MSK about possible settlement
andsettlement, have
responded to a counterproposal received from MSK in February 2024,2024 and are continuing discussions. See “Legal Proceedings”
for more information. We are in breach of our obligations under our license agreement with MedImmune/AstraZeneca. See ” — Through
our AbMed subsidiary, we have in-licensed certain intellectual property rights relating to ABP-201 from MedImmune
Limited, or MedImmune (now AstraZeneca), and are in breach of the terms of our license agreement with MedImmune/AstraZeneca.”
Our breach of this license agreement or breach of any other license agreement, or the use of intellectual property licensed to
us in an unauthorized manner, may require us to pay damages and the licensor may have the right to terminate the license, which could
result in us being unable to develop, manufacture and sell products that are covered by the licensed technology or enable a competitor
to gain access to the licensed technology. In certain circumstances, our licensed patent rights are subject to our reimbursing our licensors
for their patent prosecution and maintenance costs.
We are in breach of our obligations under our license agreement with MedImmune/AstraZeneca. See ” - Through our AbMed subsidiary, we have in-licensed certain intellectual property rights relating to ABP-201 from MedImmune Limited, or MedImmune (now AstraZeneca), and are in breach of the terms of our license agreement with MedImmune/AstraZeneca.” Our breach of this license agreement or breach of any other license agreement, or the use of intellectual property licensed to us in an unauthorized manner, may require us to pay damages and the licensor may have the right to terminate the license, which could result in us being unable to develop, manufacture and sell products that are covered by the licensed technology or enable a competitor to gain access to the licensed technology. In certain circumstances, our licensed patent rights are subject to our reimbursing our licensors for their patent prosecution and maintenance costs.
Furthermore,
we may not have the right to control the preparation, filing, prosecution, maintenance, enforcement, and defense of patents and patent
applications that we license from third parties. For example, pursuant to each of our intellectual property licenses with MedImmune,
and NCI,the National Cancer Institute (“NCI”), our licensors retain control of preparation, filing, prosecution, and maintenance,
and, in certain circumstances, enforcement
and defense of the patents and patent applications. Therefore, we cannot be certain that these
patents and patent applications will be
prepared, filed, prosecuted, maintained, enforced, and defended in a manner consistent with the
best interests of our business. If our
licensors fail to prosecute, maintain, enforce, and defend such patents, or lose rights to those
patents or patent applications, the
rights we have licensed may be reduced or eliminated, and our right to develop and commercialize
any of our products or product candidates
that are subject of such licensed rights could be materially adversely affected.
In
addition, the agreements under which we currently license intellectual property or technology from third parties are complex, and certain
provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement
that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology,technology or increase
what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse
effect on our business, financial condition, results of operations, and prospects. Moreover, if disputes over intellectual property that
we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may
be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on our
business, financial conditions, results of operations, and prospects.
Patents
have a limited lifespan. In the United States, the standard expiration of a patent is generally 20 years after it is filed. Various extensions
may be available. However, the life of a patent and the protection it affords is limited. As a result, our owned and in-licensed patent
portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. For
example, given the large amount of time required for the research, development, testing and regulatory review of new product candidates,
patents protecting such candidates might expire before or shortly after such candidates are commercialized. In the United States, the
Drug Price Competition and Patent Term Restoration Act of 1984 permits a patent term extension of up to five years beyond the normal
expiration of the patent, which is limited to the approved indication (or any additional indications approved during the period of extension).
Additionally, a patent term extension cannot extend the remaining term of a patent beyond 14 years from the date of product approval,
only one patent may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing
it may be extended. However, the applicable authorities, including the FDA and the USPTO in the United States, and any equivalent regulatory
authority in other countries, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions
to our patents, or may grant more limited extensions than we request. An extension may not be granted or may be limited because of, for
exampleexample, a failure to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable
deadlines, failing to apply prior to expiration of relevant patents, or otherwise failing to satisfy applicable requirements. If this
occurs, our competitors may be able to take advantage of our investment in development and clinical trials by referencing our clinical
and preclinicalpre-clinical data and launchlaunching their product earlier than might otherwise be the case, which could have a material adverse effect
on on
our business, financial condition, results of operations and prospects.
The
U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain
circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our
and our licensors’ ability to obtain patents in the future, this combination of events has created uncertainty with respect to
the value of patents,patents once obtained. The recent decision by the Supreme Court in Association for Molecular Pathology v. Myriad Genetics,
Inc. precludes claims directed to a nucleic acid having a stated nucleotide sequence that is identical to a sequence found in nature
and that is unmodified. This decision has yet to be clearly interpreted by other courts and by the USPTO. We cannot assure you that the
interpretations of this decision or that subsequent rulings will not adversely impact on our owned or in-licensed patents or patent applications.
applications. Depending on decisions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents
could change
in unpredictable ways that would weaken our and our licensors’ ability to obtain new patents or to enforce our existing
owned or
in-licensed patents and patents that we might obtain or in-license in the future. Similarly, changes in
patent law and regulations in
other countries or jurisdictions or changes in the governmental bodies that enforce them or changes in
how the relevant governmental
authority enforces patent laws or regulations may have a material adverse effect on our and our licensors’
ability to obtain new
patents or to protect and enforce our owned or in-licensed patents or that we may obtain or in-license in
the future.
Filing,
prosecuting and defending patents on current or future technologies or product candidates in all countries throughout the world would
be prohibitively expensive. Competitors or other third parties may use our technologies in jurisdictions where we have not obtained patent
protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection
or licenseslicenses, but enforcement is not as strong as that in the United States. These products may compete with our products, and our patents
or other intellectual property rights may not be effective or sufficient to prevent them from competing.
Because
the antibody landscape is still evolving, it is difficult to conclusively assess our freedom to operate without infringing, misappropriating
or violating third-party rights. There are numerous companies that have pending patent applications and issued patents broadly covering
antibodies generally or covering antibodies directed against the same targets as, or targets similar to, those we are pursuing. Our competitive
position may materially suffer if patents issued to third parties or other third-party intellectual property rights cover our current
or future technologies or product candidates or elements thereof, or our manufacture or uses relevant to our development plans. In such
cases, we may not be in a position to develop or commercialize current or future technologies or product candidates unless we successfully
pursue litigation to nullify or invalidate the third-party intellectual property right concerned,concerned or enter into a license agreement with
the intellectual property right holder, if available on commercially reasonable terms. There may be issued patents of which we are not
aware, held by third parties that, if found to be valid and enforceable, could be alleged to be infringed by our current or future technologies
or product candidates. There also may be pending patent applications of which we are not aware that may result in issued patents, which
could be alleged to be infringed by our current or future technologies or product candidates. If such an infringement claim should be
brought and be successful,successfully, we may be required to pay substantial damages, be forced to abandon our current or future technologies or product
product candidates or seek a license from any patent holders. No assurances can be given that a license will be available on commercially reasonable
reasonable terms, if at all.
In
addition to seeking patent protection for certain aspects of our current or future technologies and product candidates, we also consider
trade secrets, including confidential and unpatented know-how, important to the maintenance of our competitive position. However, trade
trade secrets and know-how can be difficult to protect. We protect trade secrets and confidential and unpatented know-how, in
part, by entering
into non-disclosure and confidentiality agreements with parties who have access to such knowledge, such as
our employees, corporate collaborators,
outside scientific collaborators, CROs, contract manufacturers, consultants, advisors and other
third parties. We also enter into confidentiality
and invention or patent assignment agreements with our employees and consultants that
obligate them to maintain confidentiality and assign
their inventions to us. Despite these efforts, any of these parties may breach such
agreements and disclose our proprietary information,
including our trade secrets, and we may not be able to obtain adequate remedies
for such breaches. We may also become involved in inventorship
disputes relating to inventions and patents developed by our employees
or consultants under such agreements. Enforcing a claim that a
party illegally disclosed or misappropriated a trade secret,secret or securing
title to an employee-or consultant-developed invention if a dispute
arises, is difficult, expensive and time-consuming, and the outcome
is unpredictable. In addition, some courts in the United States and
certain foreign jurisdictions are less willing or unwilling to protect
trade secrets. If any of our trade secrets were to be lawfully
obtained or independently developed by a competitor, we would have no
right to prevent them from using that technology or information
to compete with us. If any of our trade secrets were to be disclosed
to or independently developed by a competitor, our competitive position
would be materially and adversely harmed.
Many
of our employees were previously employed at universities or biotechnology or biopharmaceutical companies, including our competitors
or potential competitors. We may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade
secrets or other proprietary information offrom their former employers. Litigation may be necessary to defend against these claims. If
we we
fail in defending such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel
or may be enjoined from using such intellectual property,property and would likely divert significant resources from our core business, including
distracting our technical and management personnel from their normal responsibilities. A loss of key research personnel or their work
product could limit our ability to commercialize, or prevent us from commercializing, our current or future technologies or product candidates,
which could materially harm our business. Even if we are successful in defending against these claims, litigation could result in substantial
costs and be a distraction to management.
If
our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interestinterest,
and our business may be adversely affected.
Our
trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
We may not be able to protect our rights to these trademarks and trade names or may be forced to stop using these names, which we need
for name recognition by potential partners or customers in our markets of interest. If we are unable to establish name recognition based
on our trademarks and trade names, we may not be able to compete effectivelyeffectively, and our business may be materially adversely affected.
The
degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations,limitations
and may not adequately protect our business. The following examples are illustrative:
All
of our product candidates are in preclinicalpre-clinical development and their risk of failure is high. It is impossible to predict when or if any
of our product candidates will prove effective and safe in humans or will receive regulatory approval. Before obtaining marketing approval
from regulatory authorities for the sale of any product candidate, we must complete preclinicalpre-clinical studies and then conduct extensive clinical
trials to demonstrate the safety and efficacy of our product candidates in humans. Clinical testing is expensive and can take many years
to complete, and its outcome is inherently uncertain. Failure can occur at any time during the development process. The results of preclinicalpre-clinical
studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials. Product
candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through
preclinicalpre-clinical studies and initial clinical trials. A number of companies in the pharmaceutical industry have suffered significant setbacks
in advanced clinical trials due to lack of efficacy or safety profiles, notwithstanding promising results in earlier trials.
We
expectare toplanning commencefor clinical trials of our two lead product candidates, ABP-102 for the treatment of breast and gastric cancers,
and ABP-201
for the treatment of wet age-related macular degeneration (Wet AMD) and diabetic macular edema (DME). We expect to initiate clinical
trials for ABP-102 in 2026.the first half of 2026 in conjunction with our Korean collaborators. The clinical trials for APB-201 are planned
for the second half of 2027 if appropriate funding is secured. . Commencing these clinical trials is subject to finalizing the trial
design and filing an IND or similar filing with the FDA
or similar foreign regulatory authority. Even after we file our IND or comparable
submissions in other jurisdictions, the FDA or other
regulatory authorities could disagree that we have satisfied their requirements
to commence our clinical trials or disagree with our
study design, which may require us to complete additional preclinicalpre-clinical studies or
amend our protocols or impose stricter conditions on
the commencement of clinical trials.
We
may experience delays in completing our preclinicalpre-clinical studies and initiating or completing clinical trials of our product candidates.
We We
do not know whether planned preclinicalpre-clinical studies and clinical trials will be completed on schedule or at all, or whether planned clinical
trials will begin on time, need to be redesigned, enroll patients on time or be completed on schedule, if at all. Our development programs
may be delayed for a variety of reasons, including delays related to:
Patient
enrollment, a significant factor in the timing of clinical trials, is affected by many factors including the size and nature of the patient
population, the proximity of patients to clinical sites, the eligibility criteria for the trial, the design of the clinical trial, the
severity of the disease under investigation, our payments for conducting clinical trials, competing clinical trials and clinicians’
and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available
therapies, including any new drugs or therapeutic biologics that may be approved for the indications we are investigating. Especially
because our product candidates may initially target indications that may be characterized as orphan markets, the clinical trial timeline
for the regulatory process could be prolonged if sufficient patients cannot be enrolled in a timely manner. Furthermore, we expect to
rely on our partners, CROs and clinical trial sitessites, to ensure the proper and timely conduct of our clinical trials and while we expect
to enter into agreements governing their committed activities, we have limited influence over their actual performance.
We
cannot commercialize a product until the appropriate regulatory authorities have reviewed and approved the product candidate. Our product
candidates are subject to extensive governmental regulations relating to, among other things, research, testing, development, manufacturing,
safety, efficacy, approval, recordkeeping, reporting, labeling, storage, packaging, advertising and promotion, pricing, marketing and
distribution of drugs and therapeutic biologics. Rigorous preclinicalpre-clinical testing and clinical trials and an extensive regulatory approval
process are required to be successfully completed in the U.S. and in many foreign jurisdictions before a new drug or therapeutic biologic
can be marketed. Satisfaction of these and other regulatory requirements is costly, time consuming,time-consuming, uncertain and subject to unanticipated
delays. It is possible that none of the product candidates we may develop will obtain the regulatory approvals necessary for us or our
existing or future partners to begin selling them. We have very limited experience in conducting and managing the clinical trials necessary
to obtain regulatory approvals, including approval by the FDA. The time required to obtain FDA and other approvals is unpredictable but
typically takes many years following the commencement of clinical trials, depending upon the type, complexity and novelty of the product
candidate. The standards that the FDA and its foreign counterparts use when regulating us require judgment and can change, which makes
it difficult to predict with certainty how they will be applied. Any analysis we perform of data from preclinicalpre-clinical and clinical activities
is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. We
may also encounter unexpected delays or increased costs due to new government regulations, for example, from future legislation or administrative
action, or from changes in FDA policy during the period of product development, clinical trials and FDA regulatory review. It is impossible
to predict whether legislative changes will be enacted, or whether FDA or foreign regulations, guidance or interpretations will be changed,
or what the impact of such changes, if any, may be.
The
FDA’s policies may changechange, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval
of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation
or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements
or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval
that we may have obtained and we may not achieve or sustain profitability, which would adversely affect our business.
We
may attempt to secure approval from the FDA through the use of accelerated approval pathways. If unable to obtain approval under an accelerated
pathway, we may be required to conduct additional preclinicalpre-clinical studies or clinical trials which could increase the expense of obtaining,
reduce the likelihood of obtaining and/or delay the timing of obtaining, necessary marketing approvals. Even if we receive accelerated
approval from the FDA, if our confirmatory trials do not verify clinical benefit, or if we do not comply with rigorous post-marketing
requirements, the FDA may seek to withdraw accelerated approval.
Management's Discussion & Analysis (MD&A)
New heading “Share-based Compensation”
Largest changes
“Economic uncertainty in various global markets caused by political instability and conflicts, such as the ongoing conflicts in the Ukraine, and Israel, and economic challenges have led to market disruptions, including significant volatility in commodity prices, credit and capital market instability and supply chain interruptions, which have caused record inflation globally. …”see in full comparison
“Our business and operations may be negatively affected by worldwide economic conditions, which may continue to be impacted by global macroeconomic challenges such as changes in trade policies, including sanctions, treaties, tariffs, regulatory requirements, and other limitations on cross-border operations, changes in inflation and fluctuations in interest rates, instability in the banking and financial services sector, declines in consumer confidence, declines in economic growth, uncertainty in the markets, geo-political and economic instability, and tensions in U.S.-China relations. …”see in full comparison
“In this Annual Report, we have restated our previously issued consolidated financial statements for the years ended December 31, 2023 and 2022, and our interim reporting period for the nine months ended September 30, 2024. See the “Explanatory Note” preceding Cautionary Note Regarding Forward-Looking Statements for background on the restatement, the fiscal periods impacted, control considerations, and other information. …”see in full comparison
“On February 18, 2026, the Company received written notification from the Nasdaq Listings Qualifications Panel that the Company’s securities were to be delisted from Nasdaq, effective February 23, 2026. Following the delisting, our securities are currently quoted on the OTC Markets Pink Limited tier (the “OTC Pink”) under the symbol “ABPO.” Trading on the OTC Pink may result in reduced liquidity, fewer market makers for our Common Stock, greater volatility in the market price of our Common Stock, and reduced ability for us to raise additional capital.”see in full comparison
“In determining the exercise prices of options granted, our Board has considered the fair value of the common stock as of the measurement date. …”see in full comparison
“Accordingly, based on the considerations discussed above, management has concluded there is substantial doubt as to the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. The Company plans to continue to fundraise, as well as seek alternate revenues from collaboration and license agreements. If adequate funds are not available, the Company may be required to initiate steps to slow cash burn, extending the cash runway until financing can be secured. …”see in full comparison
Full comparison: every changed paragraph (52)
Unless
otherwise indicated or the context otherwise
requires, references in this section to “New Abpro,” “we,” “us,”
“our,” “the “Company,”
and other similar terms refer to Abpro Holdings, Inc. and its subsidiaries.
In this Annual Report, we have restated our previously
issued consolidated financial statements for the years ended December 31, 2023 and 2022, and our interim reporting period for the nine
months ended September 30, 2024. See the “Explanatory Note” preceding Cautionary Note Regarding Forward-Looking Statements
for background on the restatement, the fiscal periods impacted, control considerations, and other information. As a result, we have also
restated our previously issued financial information as of and for the year ended December 31, 2023 in this Part II, Item 7, “Management’s
Discussion and Analysis of Financial Condition and Results of Operations”, to conform the discussion with the appropriate restated
amounts. See Note 2 to our Consolidated Financial Statements included within Part II, Item 8 contained in this Annual Report for additional
information related to the restatement including descriptions of the errors and the impact to our consolidated financial statements. As
a result of the restatement, it was determined that the Company’s disclosure controls and procedures were not effective as of December
31, 2024, and that the Company had identified material weaknesses in its internal controls over financial reporting, as referenced in
Item 9A.
We have not amended and do not plan to amend our
previously filed reports for the periods affected by the restatement. The information that has been previously filed or otherwise reported
for these periods is superseded by the information in this Annual Report. Accordingly, the consolidated financial statements and related
financial information contained in such previously filed or furnished reports should no longer be relied upon.
Abpro
Holdings, Inc. and(together with its subsidiaries, (the “Company”) is a biotechnology company headquartereddedicated in Woburn, Massachusetts, dedicated
to developing next-generation
antibody therapeutics to improve the lives of patients with severe and life-threatening diseases. The Company
is focused on the development
of novel antibodies using its proprietary discovery and engineering platforms, primarily in the areas of
immuno-oncology, ophthalmology
and infectious disease. By leveraging our proprietary DiversImmune® and MultiMabTM antibody discovery and engineering platforms,
we are developing a pipeline of antibodies, both independently and through collaborations with global pharmaceutical and research institutions.
Our two lead product candidates, ABP-102 and ABP-201, feature our next generation tetravalent antibody format, or TetraBi antibody format, which binds to two different targets with two distinct binding sites per target.
By
leveraging our proprietary DiversImmune® and MultiMabTM antibody discovery and engineering platforms, we are developing a pipeline
of antibodies, both independently and through collaborations with global pharmaceutical and research institutions.
Our
two lead product candidates, ABP-102 and ABP-201, feature our next generation tetravalent antibody format, or TetraBi antibody format,
which binds to two different targets with two distinct binding sites per target. ABP-102 is designed to redirect a patient’s immune
system to fight cancer by engaging T cells through co-targeting human epidermal growth factor receptor 2, or HER2, and cluster of differentiation
3, or CD3, T-cell co-receptor. We plan initially to develop ABP-102 for difficult to treat HER2+ solid tumors, focusing on orphan indications.
ABP-201 is designed to block blood vessel formation and normalize damaged vessels through co-targeting vascular endothelial growth factor,
or VEGF, and angiopoietin-2, or ANG-2. We plan to develop ABP-201 to treat vascular disease of the eye, focusing on wet age-related macular
degeneration (Wet AMD). We intend to follow these two lead product candidates with a broad pipeline of CD3-targeting T-cell engagers
based on the differentiated format of ABP-102. We expect to initiate clinical trials for ABP-102 and ABP-201 in 2026.
On
November 13, 2024 (the “Closing Date”), Atlantic Costal
Coastal Acquisition Corp. II (“ACAB”) consummated a merger (the
“Merger”) pursuant to the terms of the Merger Agreement,
dated as of December 11, 2023 (the “Merger Agreement”)
by and among Abpro Corporation (“Legacy Abpro”), ACAB,
and Abpro Merger Sub Corp., a Delaware corporation (“Merger
Sub”) and wholly owned subsidiary of ACAB prior to the Closing.
Pursuant to the Merger Agreement, on the Closing Date, (i) ACAB
changed its name to “Abpro Holdings, Inc.”, (“New Abpro”),
and (ii) Merger Sub merged with and into Legacy Abpro, with Legacy Abpro as the
surviving company in the Merger (such transactions, the
“Merger,” and, collectively with the other transactions described
in the Merger Agreement, the “Reverse Recapitalization”).
After giving effect to the Merger, Legacy Abpro became a wholly
owned subsidiary of the Company. Shares of the New AbproCompany commenced trading
on the Nasdaq Global Market on November 14, 2024.
Our business and operations may be negatively affected by worldwide economic conditions, which may continue to be impacted by global macroeconomic challenges such as changes in trade policies, including sanctions, treaties, tariffs, regulatory requirements, and other limitations on cross-border operations, changes in inflation and fluctuations in interest rates, instability in the banking and financial services sector, declines in consumer confidence, declines in economic growth, uncertainty in the markets, geo-political and economic instability, and tensions in U.S.-China relations. The extent, severity, and duration of the impact of these events and conditions on our business cannot be predicted and may not be fully reflected in our results of operations until future periods. If economic uncertainty continues or increases, or if the global economy worsens, our business, financial condition, and results of operations may be harmed.
Economic
uncertainty in various global markets caused by political instability and conflicts, such as the ongoing conflicts in the Ukraine, and
Israel, and economic challenges have led to market disruptions, including significant volatility in commodity prices, credit and capital
market instability and supply chain interruptions, which have caused record inflation globally. Our business, financial condition, and
results of operations could be materially and adversely affected by further negative impacts on the global economy and capital markets
resulting from these global economic conditions, particularly if such conditions are prolonged or worsen. Although, to date, our results
of operations have not been materially impacted by these global economic and geopolitical conditions, it is impossible to predict the
extent to which our operations may be impacted in the short and long term. The extent and duration of these market disruptions, whether
as a result of the military conflict between Russia and Ukraine, the effects of the Russian sanctions, the conflict between Israel and
Hamas, geopolitical tensions, record inflation, or otherwise, are impossible to predict. Any such disruptions may also magnify the impact
of other risks described or incorporated by reference in this Annual Report.
On October 16, 2025, the Company filed with the Delaware Secretary of State a Certificate of Amendment to the Certificate of Incorporation of the Company (the “Certificate of Amendment”), which became effective on October 31, 2025, to effect a one-for-thirty (1:30) reverse stock split (the “Reverse Stock Split”), of the shares of the Company’s Common Stock. The Reverse Stock Split was approved by the Company’s stockholders at the 2025 annual meeting of the stockholders on October 10, 2025.
As a result of the Reverse Stock Split, every 30 shares of issued and outstanding Common Stock were automatically combined into one (1) issued and outstanding share of Common Stock, without any change in the par value per share. No fractional shares were issued as a result of the Reverse Stock Split. Instead, stockholders who otherwise would have been entitled to receive fractional shares because they held a number of shares not evenly divisible by the Reverse Stock Split ratio were entitled to receive an additional fraction of a share of Common Stock to round up to the next whole share.
Following the Reverse Stock Split, the number of shares of Common Stock outstanding were proportionally reduced from 81,150,000 shares to approximately 2,705,061 shares. The shares of Common Stock underlying the Company’s outstanding stock options and warrants were similarly adjusted along with corresponding adjustments to their exercise prices. Unless we indicate otherwise or the context otherwise requires, all information in this section gives effect to this Reverse Stock Split.
The Common Stock began trading on a reverse stock split-adjusted basis upon market open on November 3, 2025. The ticker symbol for the Common Stock remained “ABP” under CUSIP number (following the Reverse Stock Split) 000847202. Following the Nasdaq delisting of our securities on the Nasdaq Capital Market, effective February 23, 2026, our securities are trading on the OTC Pink Limited Market under the ticker symbol “ABPO”.
On March 3, 2025, the Board removed Ian Chan as Chief Executive Officer
of the Company for cause, and Miles Suk was appointed as Chief Executive Officer of the Company. In addition, pursuant to Mr. Chan’s
employment agreement with the Company’s wholly-owned subsidiary, Abpro Corporation, Mr. Chan was notified that he was terminated
as Chief Executive Officer and director of Abpro Corporation, effective March 3, 2025.
We
did not generate any material revenues during the years ended December 31, 20242025 and 2023.2024. Our research and development services revenue
increaseddecreased by $0.2 million during the year ended December 31, 20242025 as compared to the year ended December 31, 2023,2024, due to the revenue
earned from the research and development services performed for Celltrion related to ABP-102 development. TheNo collaborationsuch revenuesresearch and development
ofservices $0.1 millionrevenue was recognizedearned during the year ended December 31, 2023 under the collaboration agreement with Celltrion related to ABP-102
entered into during 2022 with no further revenues in 2024.2025. Our ability to generate product revenues in the future will depend
almost entirely on our ability to successfully develop, obtain regulatory approval for, and then successfully commercialize a drug candidate,
or enter into collaborations that provide for payments to us.
The
following table summarizes our research and development expenses by product candidate and program for the year ended December 31, 2024
and 2023 (in thousands):
Unallocated
research and development expenses include engineering platform-related expenses that are not allocable to a specific product candidate
or program, as well as stock-based compensation, other employee-related expenses that are not related to a specific product candidate
or program, and facilities and depreciation expenses.
Research
and development expenses decreased by
$1.3 $2.0 million for the year ended December 31, 2024,2025, as compared to the year ended December 31, 2023 2024,
primarily due to athe decreasemajority of research and development personnel being on furlough since October 2024 and then subsequently terminated
in expenses
associated with the SARS-CoV-2fourth neutralizing antibody program, partially offset by increased expenses associated with the developmentquarter of
ABP-102. 2025. The overall decrease in expenses attributable to specific product candidates or programs was a result of the decrease in research
and development activities while
raising additional capital necessary to restartresume our research and development programs.
General
and administrative expenses consist primarily
of compensation and benefits to our personnel, including the costs related to our
management services agreements, directors, and senior
advisors; professional service fees, including accounting, legal, and other
consulting services. General and administrative expenses decreased
increased by $0.5$0.3 million for the year ended December 31, 2024,2025, as compared
to the year ended December 31, 2023,2024, primarily due to the
increase cancellationin costs of operating as a public company, including legal, accounting advisory, and insurance expenses, since the closing date
of the accrued bonuses related to prior years during
the fourth quarter of 2024 of $0.9 million, offset by the bonuses approved during the year ended December 31, 2024 of $0.6 million.
The remaining decreaseMerger in payrollNovember and benefits expenses was due to the reduction in employee headcount.2024.
Other income, net increased to $5.6 million for the year ended December 31, 2025, from $2.7 million in other income for the year ended December 31, 2024. The other income realized for the year ended December 31, 2025 is primarily related to the derecognition of a $4.4 million liability for excise taxes payable and of a $3.3 million derecognition of Mabwell liability, partially offset by $1.1 million in interest expenses and $0.8 million loss on the change in fair value of embedded derivative liability related the convertible notes. The other income for the year ended December 31, 2024 was primarily due to the reversal of another $3.5 million liability to Mabwell during 2024, partially offset by $0.4 million in interest expense related to various notes payable in place throughout 2024, $0.3 million loss on the change in fair value of the forward purchase agreement and $0.3 million loss on the change in the fair value of the SEPA put rights assets (as defined in the notes to the consolidated financial statements).
Other income, net increased to $2.7 million for
the year ended December 31, 2024, from $40 thousand in other income for the year ended December 31, 2023. This change is primarily due
to the reversal of the approximately $3.5 million liability to one of the Company’s research and development providers as this provider
informed the Company they are not pursuing collection on this liability. This increase in other income was partially offset by $0.3 million
loss on the change in the fair value of the SEPA put rights asset (as defined in the notes to the consolidated financial statements),
$0.3 million loss on the change in the fair value of the Forward Purchase Agreement asset related to the financing arrangements entered
into in November 2024, and $0.4 million increase in interest expense due to the promissory notes which were issued in October 2023, December
2023, and April 2024.
On
October 18, 2023, we entered into a promissory note agreement with ABI, a significant investor in Legacy Abpro’s Series E and F
convertible preferred stock, to receive up to $6,000. We received $4,225 through the Closing Date under this note. The outstanding principal
amount on this note was settled in connection with the PIPE Financing.
On
April 18, 2024, we entered into a promissory note agreement with one
of our executives, as amended, to receive up to $2,158 in funding. We received $1,997 through the Closing Date. The principal amount of
this note was converted into 600,000 shares of common stock at the Closing Date.
On
October 7, 2024, we entered into an additional promissory note with
ABI to receive up to $1,000, all of which was received in 2024, in weekly installments of $250. The note accrued 10% interest and had
a maturity date of 5 business days after receipt of the proceeds under the PIPE Financing. The Company repaid the $1,000 balance at the
Closing out of the proceeds from the PIPE Financing.
We received $5.7 million in net proceeds from the
Merger and related PIPE Financing, net of ACAB’s transaction costs and liabilities settled at the Closing. We incurred $2.1 million
in transaction costs and $0.9 million in issuance costs related to the PIPE Financing, consisting of banking, legal, investment advisory
and other professional fees, of which were recorded as a reduction of proceeds to additional paid-in capital. At the Closing Date, we
assumed $6.6 million of net liabilities, including tax liabilities and legal fees of ACAB, of which $1.0 million was included in accrued
expenses, $4.4 million in excise tax payable and $0.4 million in income tax payable as of December 31, 2024.
On November 14, 2024, the Company entered into
a convertible promissory note with YA (the “Convertible Note”) (see the notes to the audited financial statements) for $3
million and received net proceeds of $2.755 million, which were net of the original issuance discount of 8% (the “Convertible Note
Discount”). The Convertible Note has a maturity of November 13, 2025 (subject to earlier repayments based on Amortization Event
described below), incurs interest at a rate of 0% (or 18% upon the occurrence of an uncured Event of Default).
On
April 2, 2025, the Company received written
notice (the “Notice”) from the Listing Qualifications Department staff (the “Staff”)
of the Nasdaq Stock Market (“Nasdaq”) notifying the Company that, based on the closing
bid price of the Company’s common
stock for the last 30 consecutive business days, the Company no longer complies with the minimum
bid price requirement for continued
listing on The Nasdaq Stock Market LLC. Nasdaq Listing Rule 5450(a)(1) requires listed securities
to maintain a minimum bid price of
$1.00 per share (the “Minimum Bid Price Requirement”), and Nasdaq Listing Rule 5810(c)(3)(A)
provides that a failure
to meet the Minimum Bid Price Requirement exists if the deficiency continues for a period of 30 consecutive business
days. Pursuant to
the Nasdaq Listing Rules, the Company has been provided an initial compliance period of 180 calendar days to regain
compliance with the
Minimum Bid Price Requirement. ToThe regainletter compliance,stated that the closingCompany bidhad price180 ofcalendar thedays, Company’sor common stock must
be at least $1.00 per share for a minimum of 10 consecutive business days prior tountil September 29, 2025.2025, to regain compliance.
On April 10, 2025, the Company received two letters from the Staff of Nasdaq. One letter (the “MVPHS Notice”) indicated that based upon Nasdaq’s review of the Company’s Market Value of Publicly Held Shares (“MVPHS”) for the last 30 consecutive business days prior to the date of the MVPHS Notice, the Company no longer meets the requirements of Nasdaq Listing Rule 5450(b)(2)(C), which requires listed securities to maintain a minimum MVPHS of $15,000,000 (the “MVPHS Requirement”). The second letter notified the Company that from February 20, 2025, to April 9, 2025, the Company’s Market Value of Listed Securities (“MVLS”) was below the minimum of $50 million required for continued listing on The Nasdaq Global Market pursuant to Nasdaq Listing Rule 5450(b)(2)(A) (the “MVLS Requirement”). Each letter stated that the Company had 180 calendar days, or until October 7, 2025, to regain compliance.
On September 30, 2025, the Company received a letter from Nasdaq notifying the Company that it had not regained compliance with the Minimum Bid Price Requirement during the compliance period. Accordingly, the Company timely requested a hearing before the appeal panel (the “Panel”), which stayed the suspension of the Company’s securities with Nasdaq pending the Panel’s decision or any extension of time provided by the Panel to regain compliance.
On October 14, 2025, the Company received a letter (the “Notice”) from Nasdaq notifying the Company that it had not regained compliance with either the MVPHS Requirement or the MVLS Requirement during the compliance period.
The Hearing was held on October 30, 2025. During the Hearing, the Company presented its plans to regain compliance with the Minimum Bid Price Requirement, the MVPHS Requirement and the MVLS Requirement. On November 10, 2025, the Company received a decision letter from the Panel granting the Company’s request for continued listing on The Nasdaq Stock Market, subject to the Company’s strict adherence to certain interim deadlines and conditions.
On February 18, 2026, the Company received written notification from the Nasdaq Listings Qualifications Panel that the Company’s securities were to be delisted from Nasdaq, effective February 23, 2026. Following the delisting, our securities are currently quoted on the OTC Markets Pink Limited tier (the “OTC Pink”) under the symbol “ABPO.” Trading on the OTC Pink may result in reduced liquidity, fewer market makers for our Common Stock, greater volatility in the market price of our Common Stock, and reduced ability for us to raise additional capital.
On March 18, 2026, we filed an appeal of the Nasdaq Stock Market de-listing determination. We can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our shares to become listed again, stabilize the market price or improve the liquidity of our shares, prevent our shares from dropping below Nasdaq’s Minimum Bid Price Requirement or prevent future non-compliance with Nasdaq’s listing requirements.
If we are unsuccessful in our appeal to Nasdaq and do not regain listing on the Nasdaq or another national exchange, we could face significant material adverse consequences, including the loss of federal preemption of state securities laws (blue sky laws) that will make certain finance and securities transactions more costly and involve increase complexities, along with the costs associated with trading on the Over-the-Counter, as well as the following:
As of December 31, 2025, the Company had cash of $67 thousand. On June 23, 2025, the Company received net proceeds of $1.8 million the Second Convertible Note pursuant to the SEPA (see Note 13 to the consolidated financial statements).
Between July and December 2025, the Company issued seven Advance Notices to YA (see Note 13) in accordance with the terms of the SEPA, under which YA purchased from the Company the total of 152,377 common stock shares, raising approximately $1 million in total net proceeds.
In January and February 2026, the Company issued 3,162,785 shares of common stock with the aggregate gross purchase price of $7.3 million under an Advance Notice to YA in accordance with the terms of the SEPA.
Due to its current liabilities and considering its future cash needs to cover both research and development activities and administrative expenses, the cash available to the Company will not be sufficient to allow the Company to operate for at least 12 months from the date these consolidated financial statements are issued. The future viability of the Company is largely dependent on its ability to raise additional capital to finance its operations. The Company expects to seek additional funding through equity and debt financings, collaboration agreements and research grants. Although the Company has been successful in raising capital in the past, there is no assurance that it will be successful in obtaining such additional financing on terms acceptable to the Company, if at all. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects.
Accordingly, based on the considerations discussed above, management has concluded there is substantial doubt as to the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. The Company plans to continue to fundraise, as well as seek alternate revenues from collaboration and license agreements. If adequate funds are not available, the Company may be required to initiate steps to slow cash burn, extending the cash runway until financing can be secured. The consolidated financial statements included elsewhere in this filing do not include any adjustments with respect to the carrying amounts of assets and liabilities and their classification that might result from the outcome of this uncertainty.
Current amounts of cash and cash equivalents will
be insufficient to fund our operations, including our projected clinical trial expenses and capital expenditure requirements, for at least
the next 12 months from the issuance date of our consolidated financial statements as of December 31, 2024. We have concluded that these
circumstances raise substantial doubt about our ability to continue as a going concern within one year after the original issuance date
of our annual financial statements. We are planning to raise additional capital through equity or debt financing to meet our operating
cash needs. If we had based this estimate on assumptions that may prove to be wrong, we could exhaust our available capital resources
sooner than we expect. There can be no assurance that any required future funding can be successfully completed on a timely basis or terms
acceptable to us.
Until
such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity
offerings, debt financings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements with third parties.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, our ownership interest may
be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely affect the rights
of our stockholders and the rights of the stockholders of the combined organizationCompany following the Closing of the merger.Merger. Debt financing
and preferred
equity financing, if available, may involve agreements that include restrictive covenants that limit our ability to take
specified actions,
such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, strategic
strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights
to our technologies,
future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable
to us. If we are
unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required
to delay, scale
back or discontinue the development and commercialization of one or more of our product candidates or delay our pursuit
of potential
in-licenses or acquisitions.
The
following table summarizes our cash flows for the years ended December 31, 20242025 and 20232024 (in thousands):
Net
cash used in operating activities for the
year ended December 31, 2024,2025, increaseddecreased by $1.6$3.0 million as compared to the year ended December
31, 2023.2024. The increasedecrease in net cash used
for operating activities was primarily due to a $1.0 million decrease in operating cash collectionsspent
driven by a decrease in research and development activities, with approximately $1.0 million of $1.9additional expenses incurred in excess
of payments in 2025, approximately $0.8 million duringof the year ended December 31, 2023 related to revenue
recognizedpayments in 2022excess butof collectedexpenses duringincurred thein year ended December 31, 2023 under the collaboration agreement with Celltrion.2024.
Net
cash usedprovided inby investing activities decreased
increased by $48$26 thousand for the year ended December 31, 2024,2025, as compared to the year ended December
31, 2023.2024. The Company purchasedsold laboratory
equipment during the year ended December 31, 2023.2025. No property or equipment was purchasedsold during the
year ended December 31, 2024.
Net
cash provided by financing activities increased
decreased by $10.3$8.1 million for the year ended December 31, 2024,2025, as compared to the year ended December
31, 2023.2024. During the year ended December 31, 2025, the Company received net proceeds of $1.8 million from the Second Convertible Note,
$1.1 million in net proceeds from the issuance of shares under the SEPA arrangement, and $0.1 million from the settlement of the Forward
Purchase Agreement. During the year ended December 31, 2024, the Company received grossnet proceeds of $10.4 million from the PIPE Financing,
$2.8 million in net proceeds from the First Convertible
Note, and $0.5 million from the Merger (which includes $2.4 million proceeds
from the trust account, less $1.9 million used to settle
the ACAB liabilities at the closing of the Merger). These proceeds were partially
offset by the payments of $1.4 million in offering costs
and $1.1 million cash transferred into escrow pursuant to the Forward Purchase
Agreement. During the year ended December 31, 2023, the
Company received proceeds of $1.4 million from the issuance of notes payable to related parties, which were partially offset by the payments
of $0.4 million in offering costs and $0.2 million remaining payment on finance lease liabilities.
This
discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which
have been prepared in accordance with USU.S. GAAP. The preparation of these consolidated financial statements 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 consolidated financial statements, as well as the reported expenses and net loss incurred during the reporting periods.
Our estimates are based on our historical experience and various other factors that we believe are reasonable under the circumstances,
the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent
from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Share-based Compensation
Our share-based compensation program awards include stock options and restricted stock awards. The fair value of stock option grants is estimated as of the date of the grant using the Black-Scholes option pricing model. The fair value of restricted stock units is based on the fair value of our common stock on the date of the grant. The fair value of the awards is then expensed over the requisite service period, generally the vesting period, for each award as compensation expense.
We do not have sufficient history of market prices of its common stock, and as such, volatility is estimated using historical volatilities of similar public entities. The peer group was developed based on companies in the biotechnology industry. We will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. The expected term of the awards is estimated based on the simplified method for grants to employees and is based on the contractual term for non-employee awards. The risk-free interest rate assumption is based on observed interest rates appropriate for the terms of the awards. The dividend yield assumption is based on history and expectation of paying no dividends.
In determining the exercise prices of options granted, our Board has considered the fair value of the common stock as of the measurement date. As Legacy Abpro’s common stock was not traded prior to the Merger, the fair value of the common stock was determined by the Board at each award grant date based upon a variety of factors, including the results obtained from an independent third-party valuation, our financial position and historical financial performance, the status of technological developments within our proposed products, an evaluation or benchmark of our competition, the current business climate in the marketplace, the illiquid nature of the common stock, arm’s length sales of our capital stock, including convertible preferred stock, the effect of the rights and preferences of the preferred stockholders, and then prospects of a liquidity event, among others.
See
Note 2, Summary of Significant Accounting Policies of the Notes to theConsolidated Financial Statements for a discussion of recent
accounting accounting
pronouncements.
What changed in the latest 10-Q
Risk Factors
New heading “Our failure to meet Nasdaq’s continued listing requirements could result in a further delisting of our shares.”
New heading “We will need substantial additional funds to advance development of our product candidates, and we cannot guarantee that we will have sufficient funds available in the future to develop and commercialize our current or future product candidates.”
New heading “Should we pursue a deregistration or be involuntarily deregistered, resulting in “going dark”, this may limit our ability to raise capital on favorable terms as a private company.”
Largest changes
“Our failure to meet Nasdaq’s continued listing requirements could result in a further delisting of our shares.”see in full comparison
“If we are unable to obtain funding on a timely basis or on acceptable terms, we may have to delay, reduce or terminate our research and development programs and pre-clinical studies or clinical trials, if any, limit strategic opportunities or other corporate restructuring activities. We also could be required to seek funds through arrangements with partners or others that may require us to relinquish rights to some of our technologies or product candidates that we would otherwise pursue on our own. …”see in full comparison
“The delisting does not affect the Company’s operations, but may have, among other material adverse effects, an adverse impact on the liquidity and market price of the Common Stock and on the Company’s ability to raise capital, including under the SEPA (see Note 10 of the Notes to the Unaudited Condensed Consolidated Financial Statements) and on favorable terms, if at all, in the future.”see in full comparison
“Additionally, any residual OTC trading will feature extremely limited liquidity, wider bid-ask spreads, and heightened price volatility. …”see in full comparison
“If we are involuntarily deregistered by the SEC or if we complete a voluntary deregistration under the Exchange Act (referred to as “going dark”), we will cease filing public financial reports. Following any such transition to a private non-reporting company, our access to traditional capital markets may be constrained since any future debt or equity financings we pursue will likely rely entirely on private placement markets. …”see in full comparison
“The Company did not meet the required equity standard by the deadline, and on February 18, 2026, the Panel notified the Company that its securities would be delisted. Trading of the Company’s stock on Nasdaq was suspended on February 23, 2026, and the shares began trading on the OTC Pink Limited Market tier under the ticker symbol “ABPO.” Although the Company appealed the delisting decision, on May 28, 2026, the Nasdaq Listing and Hearing Review Council upheld the Panel’s ruling. …”see in full comparison
Full comparison: every changed paragraph (16)
Factors that could cause our actual results to
differ materially from
those in this report include the risk factors described in our Annual Report on Form 10-K filed with the SEC for
the year ended December
31, 2025.2025, Thereas may be updated in subsequent periodic reports we file with the SEC. Other than as set forth below,
there have been no material changes to the risk factors described in our most recent Form 10-K.
Our failure to meet Nasdaq’s continued listing requirements could result in a further delisting of our shares.
In April 2025, the Company received multiple notices from the Listing Qualifications Department staff of the Nasdaq Stock Market (“Nasdaq”) indicating that it no longer met several continued listing requirements. Specifically, its stock price had remained below Nasdaq’s $1.00 minimum bid price requirement for 30 consecutive business days, and it failed to meet the required minimum levels for both Market Value of Publicly Held Shares (the “MVPHS requirement”) and Market Value of Listed Securities (the “MVLS requirement”). Nasdaq granted compliance periods through September and October 2025 to allow the Company time to regain compliance.
After failing to satisfy the minimum bid price requirement by the September 2025 deadline, the Company requested a hearing before a Nasdaq Hearings Panel (the “Panel”). At an October 2025 hearing, management presented its plan to regain compliance with the minimum bid price, MVPHS, and MVLS requirements. Nasdaq subsequently allowed the Company to remain listed temporarily, subject to strict conditions and deadlines, including demonstrating compliance with Nasdaq’s minimum equity standard by February 16, 2026.
The Company did not meet the required equity standard by the deadline, and on February 18, 2026, the Panel notified the Company that its securities would be delisted. Trading of the Company’s stock on Nasdaq was suspended on February 23, 2026, and the shares began trading on the OTC Pink Limited Market tier under the ticker symbol “ABPO.” Although the Company appealed the delisting decision, on May 28, 2026, the Nasdaq Listing and Hearing Review Council upheld the Panel’s ruling. The Company expects that Nasdaq may file a Form 25 with the SEC to delist the securities from Nasdaq and deregister the securities under Section 12(b) of the Securities Exchange Act of 1934, in the coming days.
The delisting does not affect the Company’s operations, but may have, among other material adverse effects, an adverse impact on the liquidity and market price of the Common Stock and on the Company’s ability to raise capital, including under the SEPA (see Note 10 of the Notes to the Unaudited Condensed Consolidated Financial Statements) and on favorable terms, if at all, in the future.
Following the above-referenced suspension of trading on Nasdaq, the Company expects its common stock will continue to be eligible for quotation on the OTC Pink Limited Market under the ticker symbol “ABPO” and its public warrants under the existing symbol “ABPWW.” The Company can provide no assurances that any broker-dealer will make a market in its common stock or public warrants or that trading levels, liquidity, or quotation prices will be maintained. The Company also cautions its stockholders and public warrant holders that trading on the OTC Pink Limited Market may be subject to limited availability of information, reduced transparency and liquidity and greater volatility.
We can provide no assurance that any action taken by us in the future to restore compliance with listing requirements would allow our shares to become listed again, stabilize the market price or improve the liquidity of our shares or prevent future non-compliance with Nasdaq’s listing requirements.
Following the unsuccessful appeal to Nasdaq we expect to face significant material adverse consequences, including the loss of federal preemption of state securities laws (blue sky laws) that will make certain finance and securities transactions more costly, ineligible and/or involve increased complexities, along with the costs associated with trading on the OTC Market, as well as the following:
We will need substantial additional funds to advance development of our product candidates, and we cannot guarantee that we will have sufficient funds available in the future to develop and commercialize our current or future product candidates.
The development of biopharmaceutical product candidates is capital-intensive. If our product candidates enter and advance through pre-clinical studies and clinical trials, we will need substantial additional funds to expand our development, regulatory, manufacturing, marketing and sales capabilities. We have used substantial funds to develop our technology and product candidates and will require significant additional funds to conduct further research and development and pre-clinical testing and clinical trials of our product candidates, to seek regulatory approvals for our product candidates and to manufacture and market products, if any, that are approved for commercial sale. In addition, we expect to incur additional costs associated with operating as a public company, which will require additional funding to operate in parallel with and in addition to our clinical and development costs of our assets.
Because the length of time and activities associated with successful research and development of our product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any approved marketing and commercialization activities. The timing and amount of our operating expenditures will depend largely on:
If we are unable to obtain funding on a timely basis or on acceptable terms, we may have to delay, reduce or terminate our research and development programs and pre-clinical studies or clinical trials, if any, limit strategic opportunities or other corporate restructuring activities. We also could be required to seek funds through arrangements with partners or others that may require us to relinquish rights to some of our technologies or product candidates that we would otherwise pursue on our own. We do not expect to realize revenue from sales of products or royalties from licensed products in the foreseeable future, if at all, and unless and until our product candidates are clinically tested, approved for commercialization and successfully marketed. To date, we have primarily financed our operations through equity and debt financings, payments received under collaboration agreements, and research grants We will be required to seek additional funding in the future and currently intend to do so through additional collaborations, public or private equity offerings or debt financings, credit or loan facilities or a combination of one or more of these funding sources. Our ability to raise additional funds will depend on financial, economic and other factors, many of which are beyond our control. Additional funds may not be available to us on acceptable terms or at all. If we raise additional funds by issuing equity securities, our stockholders will suffer dilution, and the terms of any financing may adversely affect the rights of our stockholders. In addition, as a condition to providing additional funds to us, future investors may demand, and may be granted, rights superior to those of existing stockholders. Debt financing, if available, is likely to involve restrictive covenants limiting our flexibility in conducting future business activities, and, in the event of insolvency, debt holders would be repaid before holders of our equity securities received any distribution of our corporate assets.
Should we pursue a deregistration or be involuntarily deregistered, resulting in “going dark”, this may limit our ability to raise capital on favorable terms as a private company.
If we are involuntarily deregistered by the SEC or if we complete a voluntary deregistration under the Exchange Act (referred to as “going dark”), we will cease filing public financial reports. Following any such transition to a private non-reporting company, our access to traditional capital markets may be constrained since any future debt or equity financings we pursue will likely rely entirely on private placement markets. Private investors and lenders often demand higher yields, stricter financial covenants, greater board representation, or significant liquidation preferences to compensate for the lack of liquidity and mandatory and more stringent public disclosure requirements. We cannot assure you that private financing will be available when needed, or that the commercial terms will be acceptable to us.
Additionally, any residual OTC trading will feature extremely limited liquidity, wider bid-ask spreads, and heightened price volatility. As a result of the lack of an active public trading market, private financing rounds often suffer from a steep “illiquidity discount.” While the Company believes that its stock price per share has been severely undervalued and, therefore, capital raising terms may ultimately prove more favorable on a private company financing basis, there remains the possibility that financing raised after going dark may result in greater equity dilution for existing stockholders than an equivalent public capital raise, especially if the Company’s common stock were still listed and traded on Nasdaq under ordinary and non-distressed circumstances. Further, such a structural shift may result in increased stockholder skepticism, damage to our reputation among alternative lenders, and potentially trigger costly stockholder litigation regarding the loss of liquidity and perceived reduction in fiduciary transparency. Any ongoing litigation or negative market perception will further depress our corporate valuation and complicate our efforts to finalize essential private financings.
Management's Discussion & Analysis (MD&A)
New heading “Other Income (Expense), Net”
New heading “Results of Operations for the Six Months Ended June 30, 2026 and 2025”
New heading “Operating Expenses”
New heading “Research and Development Expenses”
New heading “General and Administrative Expenses”
New heading “Other Income (Expense), Net”
Removed heading “Impact of Macroeconomic Events”
Removed heading “Other Expense, Net”
Largest changes
“Our business and operations may be negatively affected by worldwide economic conditions, which may continue to be impacted by global macroeconomic challenges such as changes in trade policies, including sanctions, treaties, tariffs, regulatory requirements, and other limitations on cross-border operations, changes in inflation and fluctuations in interest rates, instability in the banking and financial services sector, declines in consumer confidence, declines in economic growth, uncertainty in the markets, geo-political and economic instability, and tensions in U.S.-China relations. …”see in full comparison
“On February 18, 2026, the Company received written notification from the Panel stating that, due to the Company not having met the terms of the Panel’s November 10, 2025 decision that the Company demonstrate compliance with the minimum equity standard requirement under Nasdaq Listing Rule 5550(b)(1) by February 16, 2026, the Company’s securities were to be delisted from Nasdaq. …”see in full comparison
“The Company did not meet the required equity standard by the deadline, and on February 18, 2026, the Panel notified the Company that its securities would be delisted. Trading of the Company’s stock on Nasdaq was suspended on February 23, 2026, and the shares began trading on the OTC Pink Limited Market tier under the ticker symbol “ABPO.” Although the Company appealed the delisting decision, on May 28, 2026, the Nasdaq Listing and Hearing Review Council upheld the Panel’s ruling. …”see in full comparison
“On May 28, 2026, the Company received written notification from the Nasdaq Listing and Hearing Review Council (the “Council”) that the Council had reviewed the decision of the Nasdaq Hearings Panel (the “Panel”) of the Nasdaq Stock Market LLC (“Nasdaq”) and had determined to reaffirm the Panel’s decision that due to the Company not having met the terms of the Panel’s November 10, 2025 decision that the Company demonstrate compliance with the minimum equity standard requirement under Nasdaq Listing Rule 5550(b)(1) by February 16, 2026, the Company’s securities will be delisted from Nasdaq.”see in full comparison
see in full comparisonIfThewedelistingare unsuccessful in our appeal to Nasdaq and dodoes notregain listing onaffect theNasdaqCompany’soroperations,anotherbut resultsnational exchange, we could facein significant material adverse consequences, including the loss of federal preemption of state securities laws (blue sky laws) that will make certain finance and securities transactions more costly and involveincreaseincreased complexities, along with the costs associated with trading on theOver-the-Counter,Over-the-Counter market, as well as the following:
“The Company expects that Nasdaq may file a Form 25 with the SEC to delist the securities from Nasdaq and deregister the securities under Section 12(b) of the Securities Exchange Act of 1934, as amended (potentially) in the coming days.”see in full comparison
Full comparison: every changed paragraph (51)
Unless
otherwise indicated or the context otherwise
requires, references in this section to ” “Abpro,” “we,” “us,”
“our,” “the Company,”
and other similar terms refer to Abpro Holdings, Inc. and its subsidiaries.
Our two lead product candidates, ABP-102 and ABP-201, feature our next generation tetravalent antibody format, or TetraBi antibody format, which binds to two different targets with two distinct binding sites per target. ABP-102 is designed to redirect a patient’s immune system to fight cancer by engaging T cells through co-targeting human epidermal growth factor receptor 2, or HER2, and cluster of differentiation 3, or CD3, T-cell co-receptor. The Phase 1 clinical trials for ABP-102 are led by Celltrion and aim to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with HER2-positive solid tumors (such as breast and gastric cancers). ABP-201 is designed to block blood vessel formation and normalize damaged vessels through co-targeting vascular endothelial growth factor, or VEGF, and angiopoietin-2, or ANG-2. We plan to develop ABP-201 to treat vascular disease of the eye, focusing on wet age-related macular degeneration (Wet AMD).
Our two lead product candidates, ABP-102 and ABP-201,
feature our next generation tetravalent antibody format, or TetraBi antibody format, which binds to two different targets with two distinct
binding sites per target.
On November 13, 2024 (the “Closing Date”),
Abpro Corporation (“Legacy Abpro”) completed the merger with Atlantic Coastal Acquisition Corp. II (“ACAB”) (the
“Merger”). At the Closing Date, ACAB changed its name to “Abpro Holdings, Inc.”
Impact of Macroeconomic Events
Our business and operations may be negatively
affected by worldwide economic conditions, which may continue to be impacted by global macroeconomic challenges such as changes in trade
policies, including sanctions, treaties, tariffs, regulatory requirements, and other limitations on cross-border operations, changes in
inflation and fluctuations in interest rates, instability in the banking and financial services sector, declines in consumer confidence,
declines in economic growth, uncertainty in the markets, geo-political and economic instability, and tensions in U.S.-China relations.
The extent, severity, and duration of the impact of these events and conditions on our business cannot be predicted and may not be fully
reflected in our results of operations until future periods. If economic uncertainty continues or increases, or if the global economy
worsens, our business, financial condition, and results of operations may be harmed.
On October 16, 2025, the Company filed with the
Delaware Secretary of State a Certificate of Amendment to the Certificate of Incorporation of the Company (the “Certificate of Amendment”),
which became effective on October 31, 2025, to effect a one-for-thirty (1:30) reverse stock split (the “Reverse Stock Split”),
of the shares of the Company’s Common Stock. The Reverse Stock Split was approved by the Company’s stockholders at the 2025
annual meeting of the stockholders on October 10, 2025.
As a result of the Reverse Stock Split, every
30 shares of issued and outstanding Common Stock were automatically combined into one (1) issued and outstanding share of Common Stock,
without any change in the par value per share. No fractional shares were issued as a result of the Reverse Stock Split. Instead, stockholders
who otherwise would have been entitled to receive fractional shares because they held a number of shares not evenly divisible by the Reverse
Stock Split ratio were entitled to receive an additional fraction of a share of Common Stock to round up to the next whole share.
Following the Reverse Stock Split, the number
of shares of Common Stock outstanding were proportionally reduced from 81,150,000 shares to approximately 2,705,061 shares. The shares
of Common Stock underlying the Company’s outstanding stock options and warrants were similarly adjusted along with corresponding
adjustments to their exercise prices. Unless we indicate otherwise or the context otherwise requires, all information in this section
gives effect to this Reverse Stock Split.
The Common Stock began trading on a reverse stock split-adjusted basis
upon market open on November 3, 2025. The ticker symbol for the Common Stock remained “ABP” under CUSIP number (following
the Reverse Stock Split) 000847202. Following the Nasdaq delisting of our securities onfrom the Nasdaq Capital
Market, effective February
23, 2026, our securities are trading on the OTC Pink Limited Market under the ticker symbol “ABPO”.
The delisting does not
affect the Company’s operations, but may have, among other material adverse effects, an adverse impact on
the liquidity and market
price of the Common Stock and on the Company’s ability to raise capital, including under the SEPA and on
favorable terms, if at
all, in the future.
On May 28, 2026, the Company received written notification from the Nasdaq Listing and Hearing Review Council (the “Council”) that the Council had reviewed the decision of the Nasdaq Hearings Panel (the “Panel”) of the Nasdaq Stock Market LLC (“Nasdaq”) and had determined to reaffirm the Panel’s decision that due to the Company not having met the terms of the Panel’s November 10, 2025 decision that the Company demonstrate compliance with the minimum equity standard requirement under Nasdaq Listing Rule 5550(b)(1) by February 16, 2026, the Company’s securities will be delisted from Nasdaq.
The Company expects that Nasdaq may file a Form 25 with the SEC to delist the securities from Nasdaq and deregister the securities under Section 12(b) of the Securities Exchange Act of 1934, as amended (potentially) in the coming days.
The Company expects its common stock will continue to be eligible for quotation on the OTC Pink Limited Market under its existing symbol, “ABP” and its public warrants under the existing symbol “ABPWW.” The Company can provide no assurances that any broker-dealer will make a market in its common stock or public warrants or that trading levels, liquidity, or quotation prices will be maintained. The Company also cautions its stockholders and public warrant holders that trading on the OTC Pink Limited Market may be subject to limited availability of information, reduced transparency and liquidity and greater volatility.
Results
of Operations for the Three
Months Ended MarchJune 31,30, 2026 and 2025
The
following is a comparative discussion of our
results of operations for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):
We
did not generate revenue during the three months
ended MarchJune 31,30, 2026 and 2025. Our ability to generate product or license revenue in
the future will depend almost entirely on our ability to successfully
develop, obtain regulatory approval for, and then successfully
commercialize a drug candidate, or enter into collaborations that provide
for license and royalty payments to us.
Research
and development expenses decreased by
$0.3 million for the three months ended MarchJune 31,30, 2026, as compared to the three months ended March 31,June
30, 2025, primarily due to the majority
of research and development personnel being on furlough since October 2024 and then subsequently
terminated in the fourth quarter of 2025.
The overall decrease in expenses was a result of the decrease in research and development activities
while raising additional capital
necessary to resume our research and development programs.
General
and administrative expenses consist primarily of compensation
and benefits to our personnel not involved in research and development
efforts, costs related to our directors, and senior advisors; professional
service fees, including accounting and legal services and
other consulting services. General and administrative expenses decreased by
$1.7 million for the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, primarily due to the decrease
of approximately $0.8 million in legal and accounting expenses, approximately $0.3 million in facilities and supplies costs, approximately
$0.4 million decrease in estimated liability under the litigation with the former director and $0.2 million in share-based compensation
expense as a result of the cost reduction efforts implemented in the second half of 2025.
Other Expense, Net
OtherGeneral
and expense,administrative netexpenses improveddecreased by $0.8 million for the three months ended
March 31,June 30, 2026, as compared to the three months ended
June March30, 31, 2025. This change is2025, primarily relateddue to the interestdecrease of approximately $0.3 million in legal and accounting expenses, approximately $0.2 million
in facilities and supplies costs and $0.2 million in share-based compensation expense foras the
one-timea charge for the fair valueresult of the warrantscost issuedreduction underefforts the promissory note with an executive implemented
in the amountsecond half of approximately $0.7
million during the three months ended March 31, 2025, in which there was no similar interest expense activity during the three months
ended March 31, 2026.2025.
Other Income (Expense), Net
Other income (expense), net improved by $1.0 million for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. This change is primarily due to the loss of approximately $0.6 million on the change in the fair value of the embedded derivative liabilities and the loss on the settlement of the convertible notes of approximately $0.1 million recognized during the three months ended June 30, 2025, as well as the decrease in interest expense of approximately $0.2 million.
Results of Operations for the Six Months Ended June 30, 2026 and 2025
The following is a comparative discussion of our results of operations for the six months ended June 30, 2026 and 2025 (in thousands):
Revenue
We did not generate revenue during the six months ended June 30, 2026 and 2025. Our ability to generate product or license revenue in the future will depend almost entirely on our ability to successfully develop, obtain regulatory approval for, and then successfully commercialize a drug candidate, or enter into collaborations that provide for license and royalty payments to us.
Operating Expenses
Research and Development Expenses
Research and development expenses decreased by $0.6 million for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, primarily due to the majority of research and development personnel being on furlough since October 2024 and then subsequently terminated in the fourth quarter of 2025. The overall decrease in expenses was a result of the decrease in research and development activities while raising additional capital necessary to resume our research and development programs.
General and Administrative Expenses
General and administrative expenses decreased by $2.5 million for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, primarily due to the decrease of approximately $1.2 million in legal and accounting expenses, approximately $0.4 million in facilities and supplies costs, approximately $0.4 million reversal of expenses upon settlement of outstanding liabilities to a former director and $0.5 million in executive and share-based compensation expenses as a result of the cost reduction efforts implemented in the second half of 2025.
Other Income (Expense), Net
Other income (expense), net improved by $1.8 million for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. This change is primarily related to the interest expense for the one-time charge for the fair value of the warrants issued under the promissory note with an executive in the amount of approximately $0.7 million during the six months ended June 30, 2025, in which there was no similar interest expense activity during the six months ended June 30, 2026. The remaining change is due to the loss of approximately $0.6 million on the change in the fair value of the embedded derivative liabilities during the six months ended June 30, 2025, the decrease in interest expense of approximately $0.2 million, and the loss of approximately $0.2 million for the change in fair value of the SEPA Put Rights asset and the loss on the settlement of the convertible notes of approximately $0.1 million recognized during the six months ended June 30, 2025.
To date, we have financed our operations primarily
through the sale of equity securities and convertible debt, proceeds from the Merger and related PIPE financing, borrowings under loan
facilities and, to a lesser extent, through payments received in connection with collaboration and license agreements. Since our
inception, we incurred significant recurring losses, including net losses of $1.0$2.0 million and $3.9$6.9 million for the threesix months ended June
March 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $120.0$121.0 million. We expect to incur operating losses
losses in the foreseeable future.
In April 2025, the Company received multiple notices from the Listing Qualifications Department staff of the Nasdaq Stock Market (“Nasdaq”) indicating that it no longer met several continued listing requirements. Specifically, its stock price had remained below Nasdaq’s $1.00 minimum bid price requirement for 30 consecutive business days, and it failed to meet the required minimum levels for both Market Value of Publicly Held Shares (the “MVPHS requirement”) and Market Value of Listed Securities (the “MVLS requirement”). Nasdaq granted compliance periods through September and October 2025 to allow the Company time to regain compliance.
After failing to satisfy the minimum bid price requirement by the September 2025 deadline, the Company requested a hearing before a Nasdaq Hearings Panel (the “Panel”). At an October 2025 hearing, management presented its plan to regain compliance with the minimum bid price, MVPHS, and MVLS requirements. Nasdaq subsequently allowed the Company to remain listed temporarily, subject to strict conditions and deadlines, including demonstrating compliance with Nasdaq’s minimum equity standard by February 16, 2026.
The Company did not meet the required equity standard by the deadline, and on February 18, 2026, the Panel notified the Company that its securities would be delisted. Trading of the Company’s stock on Nasdaq was suspended on February 23, 2026, and the shares began trading on the OTC Pink Limited Market tier under the ticker symbol “ABPO.” Although the Company appealed the delisting decision, on May 28, 2026, the Nasdaq Listing and Hearing Review Council upheld the Panel’s ruling. The Company expects that Nasdaq may file a Form 25 with the SEC to delist the securities from Nasdaq and deregister the securities under Section 12(b) of the Securities Exchange Act of 1934, in the coming days.
On April 2, 2025, the Company received written notice from the Listing
Qualifications Department staff (the “Staff”) of the Nasdaq Stock Market (“Nasdaq”) notifying the Company that,
based on the closing bid price of the Company’s common stock for the last 30 consecutive business days, the Company no
longer complies with the minimum bid price requirement for continued listing on The Nasdaq Stock Market LLC. Nasdaq Listing Rule 5450(a)(1)
requires listed securities to maintain a minimum bid price of $1.00 per share (the “Minimum Bid Price Requirement”),
and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the Minimum Bid Price Requirement exists if the deficiency continues
for a period of 30 consecutive business days. Pursuant to the Nasdaq Listing Rules, the Company has been provided an initial
compliance period of 180 calendar days to regain compliance with the Minimum Bid Price Requirement. The letter stated that the Company
had 180 calendar days, or until September 29, 2025, to regain compliance.
On April 10, 2025, the Company received two letters
from the Staff of Nasdaq. One letter (the “MVPHS Notice”) indicated that based upon Nasdaq’s review of the Company’s
Market Value of Publicly Held Shares (“MVPHS”) for the last 30 consecutive business days prior to the date of the
MVPHS Notice, the Company no longer meets the requirements of Nasdaq Listing Rule 5450(b)(2)(C), which requires listed securities to maintain
a minimum MVPHS of $15,000,000 (the “MVPHS Requirement”). The second letter notified the Company that from February 20,
2025, to April 9, 2025, the Company’s Market Value of Listed Securities (“MVLS”) was below the minimum of $50 million
required for continued listing on The Nasdaq Global Market pursuant to Nasdaq Listing Rule 5450(b)(2)(A) (the “MVLS Requirement”).
Each letter stated that the Company had 180 calendar days, or until October 7, 2025, to regain compliance.
On September 30, 2025, the Company received a
letter from Nasdaq notifying the Company that it had not regained compliance with the Minimum Bid Price Requirement during the compliance
period. Accordingly, the Company timely requested a hearing before the appeal panel (the “Panel”), which stayed the suspension
of the Company’s securities with Nasdaq pending the Panel’s decision or any extension of time provided by the Panel to regain
compliance.
On October 14, 2025, the Company received a letter from Nasdaq notifying
the Company that it had not regained compliance with either the MVPHS Requirement or the MVLS Requirement during the compliance period.
The hearing was held on October 30, 2025. During
the hearing, the Company presented its plans to regain compliance with the Minimum Bid Price Requirement, the MVPHS Requirement and the
MVLS Requirement. On November 10, 2025, the Company received a decision letter from the Panel granting the Company’s request for
continued listing on The Nasdaq Stock Market, subject to the Company’s strict adherence to certain interim deadlines and conditions.
On February 18, 2026, the Company received written notification from
the Panel stating that, due to the Company not having met the terms of the Panel’s November 10, 2025 decision that the Company demonstrate
compliance with the minimum equity standard requirement under Nasdaq Listing Rule 5550(b)(1) by February 16, 2026, the Company’s
securities were to be delisted from Nasdaq. The trading of the Company’s common stock was suspended at the open of trading on NASDAQ
on February 23, 2026 and the Company’s securities now trade on the OTCQB, Pink Limited tier of the OTC Markets under the ticker
symbol “ABPO”. The Company was provided fifteen (15) days from receipt of the aforementioned notice of the Panel’s decision
to request that the Nasdaq Listing and Hearing Review Council (the “Council”) review the decision. The delisting does not
affect the Company’s operations, but may have, among other material adverse effects, an adverse impact on the liquidity and market
price of the Common Stock and on the Company’s ability to raise capital, including under SEPA (see Note 10 of the Notes to the Unaudited
Condensed Consolidated Financial Statements) and on favorable terms, if at all, in the future.
On March 18, 2026, the Company formally appealed
the delisting determination and is expecting the response in June 2026.
IfThe wedelisting are unsuccessful in our appeal to Nasdaq
and dodoes not regain listing onaffect the NasdaqCompany’s oroperations, anotherbut
results national exchange, we could facein significant material adverse consequences, including
the loss of federal preemption of state securities laws (blue sky laws)
that will make certain finance and securities transactions more
costly and involve increaseincreased complexities, along with the costs associated
with trading on the Over-the-Counter,Over-the-Counter market, as well as the following:
As of MarchJune 31,30, 2026, the Company had cash of
$4.2 $5,398.million. Due to its current
liabilities, the cash available to the Company will not be sufficient to allow the Company to operate
for at least 12 months from the
date that the unaudited condensed consolidated financial statements are issued. The future viability
of the Company is largely dependent
on its ability to raise additional capital to finance its operations. The Company expects to seek
additional funding through equity and
debt financings, collaboration agreements and research grants. If the Company is unable to obtain
funding, the Company could be forced
to further delay, reduce or eliminate its research and development programs, product portfolio expansion
or commercialization efforts, which could
adversely affect its business prospects.
Accordingly, based on the considerations discussed above, management
has concluded there is substantial doubt as to the Company’s ability to continue as a going concern within one year after
the date these unaudited condensed consolidated financial statements are issued. The Company plans to continue to fundraise, as well
as as
seek alternate revenues from collaboration and license agreements. If adequate funds are not available, the Company may be required
to to
initiate steps to further slow cash burn, extending the cash runway until financing can be secured. The condensed consolidated financial
statements statements
do not include any adjustments with respect to the carrying amounts of assets and liabilities and their classification that
might result
from the outcome of this uncertainty.
Until
such time, if ever, as we can generate substantial
product revenue, we expect to finance our cash needs through a combination of
equity offerings, debt financings, collaborations, strategic
alliances, and marketing, distribution or licensing arrangements with
third parties. To the extent that we raise additional capital through
the sale of equity or convertible debt securities, our
ownership interest may be materially diluted, and the terms of such securities
could include liquidation or other preferences that
adversely affect the rights of our stockholders. Debt financing and preferred equity
financing, if available, may involve agreements
that include restrictive covenants that limit our ability to take specified actions, such
as incurring additional debt, making
capital expenditures or declaring dividends. If we raise funds through collaborations, strategic
alliances or marketing,
distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future
future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are
unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to further
delay, scale
back or discontinue the development and commercialization of one or more of our product candidates or delay our pursuit
of potential in-licenses
or acquisitions.
The
following table summarizes our cash flows
for the threesix months ended MarchJune 31,30, 2026 and 2025 (in thousands):
Net
cash used in operating activities for the threesix months ended March
31,June 30, 2026, increased by $0.6 million as compared to the threesix months ended
June March 31,30, 2025. Although the operating expenses, excluding non-cash
items, decreased by $1.6$2.8 million for the threesix months ended MarchJune 31, 30,
2026 as compared to the threesix months ended MarchJune 31,30, 2025, the cash
used in operating activities increased by $3.4 million due to the timing
of disbursements, net of disbursementscollections with $0.6 million increase in prepaids and $1.6 million decrease
inon accounts payable and accrued expensesreceivable, in the first quarterhalf of 2026 as compared to the first quarterhalf of 2025.
Net
cash provided by financing activities increased by $7.3$5.7 million for the six months ended June 30, 2026 as compared to the six months
ended June 30, 2025. The cash provided during the six months ended June 30, 2026 is primarily from the sale of the common stock shares
to YA in accordance with the terms of the SEPA for gross cash proceeds of $7.3 million. The cash provided during the threesix months ended
June March30, 31,2025 2026,is as
compareddue to theproceeds threereceived monthsfrom endedissuances Marchof 31,debt 2025.of During the three months ended March 31, 2025, the Company made $0.2$1.8 million payments
on the Note Payable which were partially offset by theand proceeds of $0.1 million from the settlement of
the Forward Purchase Agreement.Agreement which were partially offset by $0.3 million of payments made on notes payable.
ABPO insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. 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.
No Form 4 stock transactions in this period.
Well-known investors holding ABPO (13F)
None of the 59 investors we track reported a position in their latest 13F.