OTC: ABPWW

After
giving effect to the Merger, Legacy Abpro became a wholly owned subsidiary of the Company. The Merger was accounted for as a reverse
recapitalization in accordance with U.S. GAAP, and under this method of accounting, ACAB was treated as the acquired company for financial
reporting purposes and Legacy Abpro was treated as the acquirer. Operations prior to the Merger are those of Legacy Abpro. Unless otherwise
noted, the Company has retroactively adjusted all common and preferred share and related price information to give effect to the Exchange
Ratio as set forth in the Merger Agreement (see Note 3 to the consolidated financial statements). The “Company” refers to
Abpro Holdings, Inc. and its subsidiaries, including Legacy Abpro. Legacy Abpro was the accounting acquirer in the Merger and, as such,
the consolidated financial statements for the year ended December 31, 2024 includes operations of Legacy Abpro prior to the Merger Date.

Reverse
Stock Split

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 (the “Effective Time”),
to effect a one-for-thirty (1:30) reverse stock split (the “Reverse Stock Split”), of the shares of the Company’s Common
Stock, par value $0.0001 per share. The Reverse Stock Split was approved by the Company’s stockholders at the 2025 annual meeting
of the stockholders held on October 10, 2025. The Company’s Common Stock began trading on a reverse stock split-adjusted basis
upon market opening on November 3, 2025.

As
a result of the Reverse Stock Split, every 30 shares of issued and outstanding Common Stock were combined into one (1) issued and outstanding
share of Common Stock, without any change in the par value per share or total Common Stock authorized under the Certificate of Amendment.
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.

All
of the Company’s historical share and per share information related to issued and outstanding Common Stock, restricted stock units,
and options and warrants exercisable for Common Stock in this Annual Report on Form 10-K and in its consolidated financial statements
have been adjusted, on a retroactive basis, to reflect this 1:30 Reverse Stock Split.

Lead
Product Candidates

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.

1

ABP-102

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 in the first half of 2026.

ABP-102
is being developed and commercialized through a worldwide strategic partnership with Celltrion Inc. (“Celltrion”) (KRX:068270),
a leading Korean biopharmaceutical company headquartered in Incheon, South Korea, under a Collaboration Agreement entered into in September
2022 and amended in October 2024. We received an initial milestone payment of $2.0 million from Celltrion in 2022 in connection with
this agreement. In addition, we are eligible for net sales milestone payments of up to $1.75 billion and development milestone payments
of up to $4.0 million under that agreement.

On
January 6, 2026, the Company, together with its co-development partner Celltrion, Inc., was notified that the U.S. Food and Drug Administration
(FDA) has cleared the Investigational New Drug (IND) application for ABP-102 / CT-P72, The Company’s lead multispecific antibody
oncology program. The IND clearance enables the initiation of a Phase 1 clinical trial evaluating the safety, tolerability, pharmacokinetics,
and preliminary efficacy of ABP-102 / CT-P72 in patients with HER2-positive solid tumors. The Phase 1 clinical study will be led by Celltrion
as part of the ongoing joint strategic collaboration to ensure the robust progression of the ABP-102 / CT-P72 program.

ABP-201

ABP
201 is being developed and commercialized through a territorial partnership with Abpro Bio, a subsidiary of Abpro Bio Co. Ltd (KOSDAQ:195990),
a company formerly named Ugint Co Ltd with diversified holdings in precision machine tools, equipment and biotechnology headquartered
in Daegu, South Korea, under a collaboration and license agreement entered into in January 2020 that granted Abpro Bio exclusive development
and commercialization rights in the People’s Republic of China, Japan, South Korea, Southeast Asia (which for the purposes hereof
means Philippines, Indonesia, Taiwan, Pakistan, India, Vietnam, Laos, Cambodia, Thailand, Myanmar and West Malaysia), the Middle East
(which for the purposes hereof means Bahrain, Cyprus, Egypt, Iraq, Israel, Jordan, Kuwait, Lebanon, Northern Cyprus, Oman, Palestine,
Qatar, Saudi Arabia, Syria, Turkey, United Arab Emirates and Yemen), and the Commonwealth of Independent States (CIS) (which for the
purposes hereof means Armenia, Azerbaijan, Belarus, Estonia, Georgia, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, Moldova, Russia, Tajikistan,
Turkmenistan, Ukraine and Uzbekistan). We are potentially eligible for net sales milestones of up to $485 million and development milestones
of up to $56.5 million.

In
connection with the Merger, all previously issued and outstanding Convertible Preferred Stock (Series A-F) was converted into the aggregate
number of shares of New Abpro’s Common Stock that would be issued upon conversion of the shares of Legacy Abpro preferred stock
based on the applicable conversion ratio immediately prior to the effective time, multiplied by approximately 0.068 (the “Exchange
Ratio”), and the remaining amount was reclassified to additional paid-in capital.

Our
Platforms

We
have developed two proprietary antibody platforms that we believe provide competitive advantages:

DiversImmune®
is our antibody discovery platform that rapidly generates a diverse collection of proprietary antibodies against both clinically validated
and novel targets that have been traditionally difficult to access. This provides us with high affinity and high specificity antibody
building blocks with drug-like properties that we then use to engineer novel therapeutics.

MultiMab™
is our engineering platform that provides us with the flexibility to combine these antibody building blocks in different combinations
and orientations to rapidly create “fit for purpose” novel full-length multi-specific antibody constructs. Our antibody constructs,
including our TetraBi antibody format, can potentially benefit patients with the goal of improved efficacy, better safety profiles, and
more convenient dosing regimens relative to current standard-of-care therapies. Furthermore, in contrast to single-format bispecific
antibody platforms that are only able to provide a single solution to different biological problems, our platform enables us to design
a diverse suite of full-length multi-specific antibody formats to address new problems in medicine. Our approach is designed to result
in therapeutic candidates with differentiated characteristics, including potentially stronger binding affinity, improved safety, more
convenient dosing regimens and streamlined manufacturing processes.

2

ABP-102:
Next generation T-cell engager targeting HER2 and CD3 for HER2+ solid tumors

ABP-102

Key Characteristics
of ABP-102

●
Dual-arm affinity-tuned construct for selective
killing and cytokine release on HER2-high target cells, with reduced killing and cytokine release on HER2-low target cells to reduce
“on-target, off-tumor” toxicity

●
Bivalent HER2 binding to promote more selective
HER2-high target cell engagement

●
TetraBiTM IgG-[L]-scFv format with functionally
monovalent CD3 binding at the hinge region to prevent T cell activation in the absence of tumor cells

●
Cross-reactivity to human and cynomolgus
CD3 for toxicity assessment

●
Engineered for reduced Fc receptor engagement

●
Symmetrical structure with natural antibody
features for efficient manufacturing and a potentially improved dosing profile

Our
lead product candidate, ABP-102, is a next generation immuno-oncology TetraBi antibody targeting HER2 and CD3 being developed for the
treatment of HER2+ solid tumors, including breast and gastric cancers. ABP-102 features bivalent HER2 binding sites and is engineered
through affinity tuning to selectively target tumor cells expressing high and intermediate levels of HER2, with reduced activity on cells
expressing low-to-negative levels of HER2. ABP-102 also features an affinity-tuned CD3 binding domain to provide enhanced potential for
safety. ABP-102 harnesses the power of the immune system by redirecting and activating cytotoxic T cells to attack tumor tissue. ABP-102
may provide an improved therapeutic window to attack tumor cells while reducing systemic toxicity by promoting “on-target, on-tumor”
effects, with reduced potential for “on-target, off-tumor” toxicity toward endogenous tissues.

In
pre-clinical in vitro studies, ABP-102 has demonstrated selectivity in both cytokine secretion and cytotoxicity with HER2-high and intermediate
breast, ovarian, and gastric cancer cell lines, including those that are resistant to Herceptin (trastuzumab), with reduced activity
on HER2-low and negligible activity on HER2-negative cell lines. We plan to initiate a Phase 1/2 clinical trial of ABP-102 with our partner
Celltrion in the first half of 2026, focusing on HER2+ breast and gastric cancers.

On
January 6, 2026, the Company, together with its co-development partner Celltrion, Inc., was notified that the U.S. Food and Drug Administration
(FDA) has cleared the Investigational New Drug (IND) application for ABP-102 / CT-P72, Abpro’s lead multispecific antibody oncology
program. The IND clearance enables the initiation of a Phase 1 clinical trial evaluating the safety, tolerability, pharmacokinetics,
and preliminary efficacy of ABP-102 / CT-P72 in patients with HER2-positive solid tumors. The Phase 1 clinical study will be led by Celltrion
as part of the ongoing joint strategic collaboration to ensure the robust progression of the ABP-102 / CT-P72 program.

We
believe ABP-102 is an improvement over currently approved HER2-targeting agents such as Herceptin, Perjeta (pertuzumab), and Kadcyla
(T-DM1), as well as other HER2-targeting agents currently in development, because it relies on the redirection of cytotoxic T cells to
selectively target and eliminate tumor cells, while sparing endogenous HER2-expressing cells. Current HER2-directed therapies, which
are designed either to block HER2 function or deliver toxic payloads to the tumor, are only effective in a subset of HER2+ patients,
cause undesirable side effects, and are limited by the onset of drug resistance.

3

It
is management’s belief that ABP-102 has the potential to provide longer lasting or even curative results in a broader set of patients
than are currently addressed by HER2-directed therapies. The global HER2+ market is forecast to grow to $12.1 billion by 2030, at a CAGR
of 1.5%, according to Research and Markets.

We
believe the TetraBi antibody format of ABP-102 provides a potentially transformative approach to immuno-oncology. The TetraBi antibody
format features two affinity-tuned binding sites, and thus bivalent binding for the tumor antigen, creating a stronger connection to
the tumor cell compared to monovalent binding. In addition, the placement of the CD3 binding domain in the middle, or hinge region, of
the TetraBi antibody format results in a therapeutic candidate that, in pre-clinical studies, selectively activates T cells only in the
presence of tumor cells. We have designed ABP-102 with the goal of a favorable safety profile and potential for an enhanced therapeutic
window.

We
are leveraging the TetraBi antibody format of ABP-102 to pursue a broad pipeline of immuno-oncology agents that target highly expressed
antigens on a diverse range of tumor types, as depicted in the following chart. Our platform of T cell engagers has the potential to
translate into an industry-leading pipeline of therapeutic agents with the goal of improving the treatment of patients.

TetraBi
series of CD3-targeting T-cell engagers

ABP-201:
Ligand trap targeting VEGF and ANG-2 for vascular diseases of the eye

ABP-201

Key
characteristics of ABP-201

●
Dual inhibition of VEGF and ANG-2 to block
angiogenesis

●
Four high-affinity binding sites for increased
potential potency

●
Dual targeting in single molecule

●
Natural antibody structure for potentially
improved dosing

●
Symmetrical structure for efficient manufacturing

4

ABP-201
is a different TetraBi antibody format, designed to simultaneously inhibit VEGF and ANG-2 for the potential treatment of vascular diseases
of the eye, including diabetic macular edema, or DME, and wet age-related macular degeneration, or Wet AMD. In both DME and Wet AMD,
blood vessels form abnormally and leak fluid, resulting in vision loss. Whereas VEGF drives new blood vessel formation, ANG-2 acts to
destabilize blood vessels and contributes to vessel leakage. The current standard of care for DME and Wet AMD includes intravitreal injections
of VEGF-targeted agents, including Eylea (aflibercept), Lucentis (ranibizumab), and Avastin (bevacizumab, used off-label). However, these
drugs require eye injections every one to two months and are only effective in a subset of patients, many of whom eventually develop
resistance. Because ABP-201 has a high binding capacity, with a total of four binding sites per molecule, we believe ABP-201 could be
administered less frequently than current agents. Recently, the VEGF and ANG-2 co-targeting agent Vabysmo (faricimab), was approved by
the FDA, and clinical trial results showed a dose-dependent improvement in best-corrected visual acuity relative to Lucentis, providing
strong support for this approach. In 2022, the combined worldwide sales of Eylea and Lucentis exceeded $10.5 billion according to company
filings. Through our AbMed subsidiary, we have in-licensed certain intellectual property rights relating to ABP-201 from MedImmune (now
AstraZeneca) and are in breach of the terms of our license agreement with MedImmune/AstraZeneca. See “Risk Factors - Risks Relating
to Abpro’s Business and Industry”.

Clinical
Development Plan

We
plan to conduct a Phase 1, multiple-ascending dose evaluation of the safety and initial efficacy of ABP-201 in patients with wet age-related
macular degeneration (Wet AMD). Following the identification of the maximum tolerated dose (MTD) or the safety and tolerability of the
maximum administered dose (MAD), a larger randomized phase 2 study is planned.

We
have an experienced leadership team with significant industry know-how and deep experience in antibody discovery and development, biomarker
discovery and validation, clinical development and regulatory approval, partnerships, operations, and corporate finance. Our leadership
team has broad industry experience from working at pharmaceutical and biotech companies. We also have a group of scientific advisors
comprised of leaders in our industry across various disciplines.

Our Pipeline

Our
DiversImmune® and MultiMabTM platforms and licensing strategy have generated a pipeline
of next-generation antibody product candidates, as reflected in the following table:

5

ABP-201
is held through our majority-owned subsidiary AbMed Corporation, or AbMed. AstraZeneca (formerly MedImmune) owns a minority stake in
AbMed and, with respect to Asia, the Middle East and certain other countries, ABP-201 is being developed and commercialized through a
territorial partnership with Abpro Bio, with our company retaining rights in the rest of the world. ABP-102 is being developed and commercialized
through our world-wide strategic partnership with Celltrion. We hold world-wide exclusive rights to ABP-110 under a patent license granted
by the National Cancer Institute, or NCI, a division of the NIH. ABP-150 is being developed under a collaboration agreement with Nanjing
Chia Tai Tianqing Pharmaceutical Co., Ltd (“NJCTTQ”), pursuant to which NJCTTQ has exclusive commercialization rights in
China and Thailand and we retain commercialization rights in the rest of the world.

Our Strategy

Our
mission is to develop next-generation antibody therapeutics with the goal of improving the lives of patients with severe and life-threatening
diseases. Traditionally, creating antibodies against targets and validating them as potential therapies has been time consuming and labor-intensive.
We believe that our proprietary antibody platforms and approach overcome these limitations, however, we have yet to (i) produce antibodies
on a scale needed for clinical trials or commercialization or (ii) evaluate any of our product candidates in a patient. By leveraging
the speed, quality, and target-access of our DiversImmune® platform, we have generated a proprietary collection
of antibody building blocks that enable us to establish our own pipeline of next-generation antibody product candidates. We believe our
ability to leverage our MultiMabTM platform to design novel bi-and multi-specific antibody constructs with natural,
antibody-like structures presents a significant opportunity to unleash the immune system’s natural ability to fight disease and
to elicit responses from broader patient populations.

Our
key strategies to achieve this mission are:

●
Aggressively advance our lead product
candidates, ABP-102 and ABP-201, into the clinic. We plan to initiate a Phase 1/2 clinical trial of ABP-102 in the first half
of 2026, focusing on HER2+ breast and gastric cancers. Additionally, we are planning to advance ABP-201 into Phase 1 clinical trials
in the second half of 2026 for the treatment of Wet AMD. We believe that the development of our lead antibody product candidates,
if successful, will generate substantial value and provide us with differentiated products to pursue in large markets with significant
unmet medical needs. IND-enabling studies are underway for both lead product candidates in preparation for final GLP toxicity studies
and GMP manufacturing for filing the IND and we will request Pre-IND meetings beforehand with the FDA when appropriate.

●
Rapidly follow ABP-102 with a broad pipeline
of CD3-targeting T-cell engagers and leverage this approach to other immune cell targets in multiple indications and disease areas.
We are building on the optimized format of ABP-102 to aggressively develop a suite of immuno-oncology agents that redirect T cells
to a diverse range of liquid and solid tumors. ABP-110, targeting GPC3 on hepatocellular carcinoma, and ABP-150, targeting Claudin
18.2 on gastric cancer, are currently in pre-clinical development. We may also use this “pipeline in a format” strategy
with other immune cell targets, including CD137 and CD47.

●
Leverage our DiversImmune®
and MultiMabTM platforms to grow our pipeline of antibody product candidates. We plan to continue
investing in our DiversImmune® and MultiMabTM platforms to maintain our competitive advantage.
We will continue to expand our collection of high affinity and high specificity antibody building blocks against both clinically
validated and novel therapeutic targets and apply our “fit for purpose” antibody engineering approach to construct novel
multi-valent, multi-specific therapeutic product candidates. We will continue to build on the success of existing immuno-oncology
or cell therapies that use the power of T cells to fight cancer, such as chimeric antigen receptor T-cell, or CAR T, therapy, but
will focus on simpler, more accessible, and less expensive approaches that provide a universal solution for large populations of
cancer patients.

6

●
Continue to explore and execute strategic
collaborations. In addition to the development and commercialization collaborations we have entered into with Celltrion and Abpro
Bio, we entered into a collaboration agreement in January 2019 with NJCTTQ, a pharmaceutical company specializing in research and
development, production and commercialization of drugs for cardiovascular diseases, tumors, perioperative care, gastrointestinal
disorders and urologic diseases headquartered in Nanjing, China, for the development of novel bispecific antibody therapies for immuno-oncology,
including potentially best in class T-cell engagers. Under that agreement, we are jointly developing ABP-150, a T-cell engager designed
to fight cancer through co-targeting CD3 and Claudin 18.2. NJCTTQ has exclusive commercialization rights in China and Thailand, and
we retain commercialization rights in the rest of the world. We will continue to explore strategic and geographic-oriented partnerships
that provide us with near-term economic benefits where we retain product rights to key strategic markets.

●
Build a leading fully integrated discovery-to-commercial
antibody therapeutics company. We have assembled an experienced scientific and business team and have built robust discovery
and antibody engineering platforms that allow us to create a broad pipeline of novel product candidates. As we advance our product
candidates into clinical development, we intend to complement our discovery and development strengths with clinical expertise and
commercial capabilities to build a fully integrated company.

Introduction
to Monoclonal and Dual-Targeting Antibodies

Antibodies
are large and diversified proteins produced by B cell immune responses to counter threats including infectious entities such as viruses,
bacteria, and fungi. Antibodies can be raised against antigens seen by the immune system as “non-self,” and therefore antibodies
against human proteins are often raised using a variety of immunization strategies in mice or other animals. The resulting antibodies
can then be used as building blocks to develop therapeutics for molecular targets, including proteins overexpressed on the surface of
cancer cells. Because they recognize their target antigens with high affinity and high specificity, and because they are natural elements
of the immune system, antibodies have been used effectively as drugs for over 30 years. Monoclonal antibodies are the largest and most
rapidly growing class of therapeutic proteins and have become a mainstay of therapeutic options for patients with cancer, autoimmune
disorders, and other diseases.

An
immunoglobulin G, or IgG, is the most common type of antibody and comprises two identical heavy chains and two identical light chains,
which assemble to form a Y-shaped molecule, as depicted in the following graphic. The bottom tail of the “Y” is called the
fragment crystallizable, or Fc, region, and is structurally constant across entire classes of antibodies. The Fc region of an antibody
interacts with a variety of receptors on immune cells and is also responsible for the long circulating half-life of an antibody. The
tips of the “Y” are called the fragment variable, or Fv, regions, and contain the antigen-binding sites. A natural antibody
recognizes a single target antigen and is therefore “monospecific.” Because it features two identical binding sites, however,
it is “bivalent” for that target. Bivalency is a critical feature of natural antibodies. Just as it is much easier to hang
from a bar with two arms rather than one, bivalent binding has been shown in pre-clinical studies to provide a much stronger connection
to the target antigen than would be possible with monovalent binding.

7

Although
natural antibodies recognize a single target, they can be engineered in different ways to bind two or more targets, resulting in a bispecific
or multispecific antibody. While there are many different types of dual-targeting antibodies, several mechanisms of action can be implemented
for a bispecific construct, including dual binding, cross-linking, and cell-cell bridging, as depicted in the following graphics.

Two
antibodies in one

●
Replaces a combination of two monospecific
antibodies

●
Simplifies the regulatory process, decreases
manufacturing costs, and provides more favorable reimbursement conditions

●
Ensures both targets are engaged in the
same place at the same time

Cross-linking

●
Cross-links two targets on the same cell

●
Physically connects two proteins and can
be used to activate pathways that are otherwise inactive or more potently inhibit pathways that are already active

●
Can produce a synergistic effect, where
the dual-targeting antibody out-performs the corresponding combination of two single-targeting antibodies

8

Cell-bridging

●
Bridges two cells, physically bringing them
into close proximity

●
Promote immune cell activation to kill the
tumor cells to which they are attached

Our Platforms

Our
approach consists of two technology platforms: our DiversImmune® platform, which we use to generate therapeutic
“building blocks,” which are high affinity and high specificity antibodies with functional activity against therapeutic targets;
and our MultiMabTM platform, which we use to construct therapeutic product candidates by assembling the building blocks
into different combinations of bi- and multi-specific antibodies. Together, these platforms support our strategy of building a broad
pipeline of next generation antibody therapeutics that are designed to address a wide range of human diseases.

DiversImmune®:
Our antibody discovery platform

Our
DiversImmune® platform was built to address a key bottleneck in the antibody therapeutics industry: the ability
to rapidly generate high affinity and high specificity antibodies against virtually any target of interest. Although in vitro
methods, such as phage and yeast display, have been developed to mimic the immune system, these methods typically rely on collections
of antibodies from unimmunized donors and as a result generally yield relatively low affinity antibodies. Improving these antibodies
through affinity maturation (i.e., mutation and selection) is often a lengthy process and is not always successful. In contrast,
the adaptive immune system of a mouse has a built-in mechanism called somatic hypermutation that improves the affinity of antibodies
up to one thousand times, yielding high affinity and high specificity antibodies suitable for therapeutic development.

The
Company does not hold issued patents or pending patent applications covering the Diversimmune or MultiMab platform technologies as platforms.
These platforms are protected through a combination of trade secret protection, proprietary know-how, customary confidentiality and invention
assignment agreements with employees and contractors, internal access controls, and registered and unregistered trademarks for the Diversimmune
and MultiMab names.

The
greatest challenge with mouse-based methods, however, lies in generating a strong and diverse immune response to the target of interest.
The mammalian immune system has a mechanism called tolerance that prevents it from making antibodies against proteins that are perceived
as “self.” Thus, to generate a strong immune response against a target that is difficult to access, either because the target
is not particularly immunogenic, or capable of producing an immune response, or because the target, a human protein, is very similar
to the corresponding mouse protein, it is necessary to “break tolerance.” A key component of our DiversImmune®
platform is our genetically engineered hyperimmune mouse which seeks to solve this problem in two ways. First, the mouse has been genetically
engineered so that more of its antibody-generating B cells survive and proliferate than in a non-engineered mouse. This results in a
larger and more diverse collection of high affinity antibodies. Second, the mouse has a hyperactive immune system in which its tolerance
to self-antigens has been “broken.” This enables us to generate a diverse array of antibodies against a wide range of targets,
including targets that are very similar between mouse and human.

9

The
DiversImmune® platform comprises three key steps, all focused on generating a diverse collection of high-quality
antibodies:

1.
Immunization. We have developed an
integrated collection of immunization methods, termed Raptor, which includes purified proteins, engineered cells, viral-like particles,
and DNA. These methods all work in concert with the goal of eliciting a strong and diverse immune response.

2.
Diversification. We have developed
a hyperimmune mouse, combined with a variety of co-stimulation methods, to optimize the immune response to each target and yield
a diverse collection of antibodies that recognize different epitopes, or binding regions, on the same target protein. This is a critical
component of our discovery process as we believe it greatly increases the probability of identifying antibodies with the desired
functional properties necessary for therapeutic development.

3.
Optimization. We have streamlined
the processes of humanization and optimization so that we can rapidly advance antibodies with the desired functional properties to
fully developed building blocks. These building blocks can then be assembled into novel therapeutic product candidates using our
MultiMabTM platform.

To
date, our DiversImmune® platform has been used to generate antibodies for pharmaceutical and biotechnology companies.
We are now using this platform internally to create what management believes to be an industry-leading collection of building blocks
to support a growing pipeline of therapeutic product candidates.

10

MultiMabTM:
Our antibody engineering platform

Our
MultiMabTM platform enables us to build a diverse array of bi-and multi-specific antibody formats, allowing us to optimize
the format of our product candidates. Because biology is diverse and complex, there is no “one size fits all” solution to
engineering multi-specific antibodies. Instead, different problems call for different solutions. We draw from a suite of different antibody
formats to choose the one that we believe best suits the disease and mechanism we are targeting. Despite having multiple formats from
which to choose, our formats typically contain two key features:

1.
Bivalent binding. Bivalent binding,
or binding with two points of contact, takes advantage of the concept of avidity, specifically that multipoint connections are much
stronger than single point connections. In order to maximize efficacy, we build bivalent binding into our therapeutic product candidates
where increased strength of binding is desirable. For example, ABP-102 features two identical binding sites for HER2, rather than
one. This enables the molecule to bind tightly to HER2+ tumor cells, forming a strong immunological synapse, or cell-to-cell interaction,
between the tumor cell and the cytotoxic T cell. We believe this is critical to generating a strong and sustained immune response
and differentiates ABP-102 from other T-cell engaging bispecific antibodies that only feature a single binding site for the tumor-specific
antigen.

2.
Fc region. The Fc region of an antibody
interacts with various receptors on immune cells to control both the immune response to antibody binding and the circulating half-life
of an antibody. To take advantage of these natural functions, we build Fc regions into all our therapeutic product candidates. For
example, ABP-102 features a human IgG1 Fc region that promotes a long circulating half-life and has been further engineered to reduce
or eliminate antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) to reduce potentially
harmful side-effects associated with inflammation and cytokine release. Similarly, ABP-201 features an Fc region that results in
greater stability and, due to its size, a longer ocular half-life, potentially enabling more convenient dosing for patients.

Both
of our lead product candidates, ABP-102 and ABP-201, are TetraBi antibodies that feature two high affinity binding sites for each of
their targets and Fc regions for longer half-lives. In addition, both product candidates are symmetrical, with two identical heavy chains
and two identical light chains. Many bispecific antibody formats are asymmetrical, featuring two different heavy chains. This creates
the possibility of chain mispairing, which complicates the manufacturing process as it is necessary to rigorously characterize each batch
and minimize the presence of mispaired species. With our TetraBi antibody format, this allows for straightforward manufacturing, as there
is no possibility of chain mispairing.

MultiMabTM
antibody engineering platform

11

Other
programs

Additional
TetraBi antibody T-cell engagers

Building
on the CD3-directed TetraBi antibody format of ABP-102, we are using our DiversImmune® and MultiMabTM platforms
to develop a broad pipeline of immuno-oncology agents that target highly expressed antigens on a diverse range of tumor types.

ABP-110

ABP-110 is
a TetraBi antibody targeting GPC3 and CD3 for the potential treatment of hepatocellular carcinoma, or HCC, the major form of liver cancer. ABP-110 is
designed to bind bivalently to GPC3 on HCC cells and CD3 on cytotoxic T cells, bringing these two cell types into close proximity and
triggering sustained T-cell activation and tumor cell killing. GPC3 is an onco-fetal antigen that is only expressed during
fetal development and on HCC cells, making it an ideal tumor antigen target. GPC3 expression is also prognostic of poor overall survival
in HCC, suggesting that ABP-110 may be most effective in the patients at highest risk and most in need of novel therapeutic
interventions. Targeting this patient population may provide for a relatively rapid path to approval given the unmet medical need in
HCC.

Source:
Abpro internal data.

We
have generated three lead candidates that have displayed potent T cell-mediated killing of GPC3-positive tumor cells. The next steps
are to assess the pharmacokinetics and in vivo efficacy in pre-clinical GPC3-positive tumor models. We expect to initiate clinical trials
for ABP-110 in the first half of 2027. According to SNS Insider, the global liver cancer therapeutics market is projected to
reach $12.9 billion by 2030.

12

ABP-150

ABP-150 is
a TetraBi antibody targeting claudin 18.2 and CD3 for the potential treatment of gastric cancers. Like our other T cell engagers, ABP-150 is
designed to bind bivalently to claudin 18.2 on gastric cancer cells and to CD3 on cytotoxic T cells, leading to T cell-mediated killing
of gastric tumor cells. Claudin 18.2 is exclusively expressed on gastric tissue, a tissue with a high physiological turnover rate, making
it tolerant of even moderate acute toxicity without unacceptable or chronic toxic effects.

Source:
Abpro internal data.

Source:
Abpro internal data.

Pre-clinically, ABP-150 shows
potent killing in in vitro T cell-mediated killing assays. In both mouse syngeneic tumor models using human CD3-transgenic mice
and human tumor xenograft models using human peripheral blood mononuclear cells as a source of T cells, ABP-150 shows potent
efficacy. As ABP-150 cross-reacts with mouse claudin 18.2, but not mouse CD3, we demonstrated in a human CD3-transgenic mouse
toxicity model that ABP-150 is well tolerated, with little impact on body weight, appetite (food consumption) or body temperature. IL-6, a
key cytokine for the initiation of cytokine release syndrome, saw little increase over vehicle (placebo) control. The next steps are
to evaluate toxicity in a non-human primate model. We expect to initiate clinical trials for ABP-150 in the first
half of 2027. According to Data Bridge Market Research, the global gastric cancer market is projected to reach $13.1 billion by
2029.

13

SARS-CoV-2 neutralizing
antibody program

As
of October 2023, according to data published by the World Health Organization, the COVID pandemic had resulted in over 771 million
confirmed cases and over 6 million deaths had been reported globally. While vaccination efforts have made tremendous strides in
bringing the pandemic under control, vaccination is contraindicated in some individuals, such as the immunocompromised. For these patients,
there are no currently available prophylactic therapies. The only therapies available are Nirmatrelvir/ritonavir, molnupiravir, and remdesivir.
While these are effective therapies, their toxicities preclude them from being used as prophylactics. Monoclonal antibodies are ideal
molecules to serve as prophylactic therapies as they can effectively neutralize the SARS-CoV-2 virus and have a proven safety
profile and can be engineered to extend their half-lives. However, all antibody therapies and prophylactics to date have become ineffective
due to SARS-CoV-2 viral mutation. In response to the global pandemic, Abpro sought to develop COVID antibodies targeting highly
conserved (resistant to mutation) areas of the virus with highly potent neutralizing antibodies engineered to have extended half-lives
to allow for dosing intervals of greater than six months, through collaborations with third parties in the form of in-license agreements.
Several candidate molecules were evaluated through different stages of development. The most advanced molecule was developed through
GMP manufacturing and evaluated in a clinical trial. Although the clinical trial was not successful, Abpro has developed significant
capabilities in the infectious disease area and may leverage such capabilities into novel therapeutics.

Recent
Developments

The following
is a summary of significant recent developments:

SEPA and
Convertible Notes

On
November 13, 2024, the Company entered into a Standby Equity Purchase Agreement (“SEPA”) with YA II PN, Ltd. (“YA”),
a fund managed by Yorkville Advisors Global LP. Under the SEPA, the Company has the right to sell to YA up to $50 million of shares of
its Common Stock, subject to certain limitations and conditions. The Company has utilized its Standby Equity Purchase Agreement with
YA II PN, Ltd. (“YA”) as a primary source of financing. During 2025, the First Convertible Note (principal balance of $3.0
million) and Second Convertible Note (principal balance of $2.0 million) were both fully converted into shares of Common Stock resulting
in the aggregate of 881,472 shares of Common Stock being issued thereunder. Between July and December 2025, the Company issued seven
advance notices to YA, raising aggregate net proceeds of approximately $1.0 million. In January and February 2026, the Company issued
twenty advance notices for an aggregate of 3,162,785 shares of Common Stock for net proceeds of approximately $6.7 million (gross proceeds
of approximately $7.3 million, net of fees of approximately $0.6 million) under the SEPA, increasing total shares outstanding to approximately
5,896,048 from 2,733,263 shares outstanding at December 31, 2025.

On
February 23, 2026, the Common Stock was delisted from NASDAQ. The delisting of the Common Stock from NASDAQ is a Material Outside Event
under the SEPA, which results in the Company being unable to use the SEPA to issue shares of Common Stock to YA.

Personnel

On
September 30, 2025, the Company furloughed Robert J. Markelewicz, Jr., M.D., M.M.Sc., its Chief Medical Officer, effective September
30, 2025 until November 30, 2025. During the furlough period, Dr. Markelewicz did not perform any duties or responsibilities associated
with his role. Dr. Markelewicz’s employment was terminated effective November 30, 2025. The Company will hire additional research
and development personnel as funding becomes available.

CEO
Transition

Effective
March 3, 2025, Miles Suk was appointed as Chief Executive Officer. On July 20, 2025, the Company entered into a consulting agreement
with Mr. Suk (retroactive to March 3, 2025) pursuant to which Mr. Suk serves as the full-time CEO on a consulting basis.

Our Collaborations

We
are developing next generation antibodies both independently and in collaboration with leading global biopharmaceutical companies and
non-profit and government research institutions. We in-license some of the technology that we use in the ABP-110 and ABP-201 molecules.

14

In-licensing
agreements

We
in-license rights to intellectual property relevant or potentially relevant to our development and commercialization plans in the ordinary
course of business. We have in-licensed rights to certain intellectual property from the National Institutes of Health, or NIH, and from
AstraZeneca (formerly Medimmune).

National
Institutes of Health-ABP-110

In
September 2017 we entered into a patent license agreement effective as of August 1, 2017 with the National Cancer Institute, or NCI,
a division of the NIH, pursuant to which we received an exclusive, worldwide license, with the right to sublicense (subject to certain
conditions), under certain patent rights to make, have made, use, have used, sell, have sold, offer to sell and import products covered
by the licensed patents in the field of using certain monoclonal antibodies as monospecific or bispecific antibodies for the treatment
of liver cancer. The license was amended in May 2020 and October 2023 and the field of use was narrowed to the development and commercialization
of a bispecific antibody for the treatment of GPC-3 expressing liver cancer using a particular moiety for targeting GPC3 and the timeline
for development and commercialization was extended. We agreed to pay NCI a $25,000 issuance fee in connection with the October 2023 amendment
to the patent license agreement. Under the amended patent license agreement, we are obligated to pay a $25,000 minimum annual royalty,
creditable against any earned royalties, and to pay royalties of a single digit percentage based on net sales of licensed products. We
also agreed to pay up to an aggregate of approximately $16.0 million of benchmark royalties, which are payable upon achieving certain
clinical, regulatory and commercial milestones. We also agreed to pay sublicense royalties ranging from a mid-single digit percentage
to a low-double digit percentage based on the fair value of the consideration we receive from any sublicensees. The royalty term expires
on a licensed patent-to-licensed patent and country-by-country basis upon the earliest of (i) the date an application in the licensed
patents has been abandoned, (ii) the date a licensed patent expires or (iii) the date a licensed patent has been held invalid or unenforceable
by a court of competent jurisdiction or administrative agency. Unless earlier terminated, our agreement with NCI will expire upon expiration
of all licensed patent rights. NCI may terminate our agreement upon the occurrence of specified bankruptcy events for us or if we are
in material default or breach of the agreement and do not cure within a specified notice and cure period. NCI may terminate the agreement
if necessary to meet the public use requirement specified by federal regulations and we are not reasonably satisfying such requirements.
We may also terminate the agreement as to any licenses in any country or territory upon 60 days written notice. Upon expiration or termination
of the agreement, we are required to return to NCI or destroy all licensed products and other materials in the licensed patents.

Our
license is subject to the reserved rights of NCI and the U.S. government. Additionally, all licensed products used or sold in the United
States are required to be manufactured substantially within the United States.

AstraZeneca

In
August 2016, we entered into a collaboration and license agreement through our majority-owned subsidiary, AbMed Corporation, or AbMed,
and MedImmune (now AstraZeneca), pursuant to which MedImmune granted AbMed an exclusive, worldwide, royalty-bearing, sublicensable (subject
to certain conditions) license under specified patent rights and know-how to make, use, sell certain of its proprietary ANG-2/VEGF-H1RK
bispecific antibodies. We hold 82% of the capital stock of AbMed, and MedImmune (now AstraZeneca) holds the remainder. We are responsible
for the operational activities of AbMed and bear all costs necessary to operate AbMed.

Under
the agreement, AbMed agreed to pay milestone and royalty payments, including up to $244.0 million in milestone payments, which are comprised
of $14.0 million upon meeting certain clinical development milestones, $80.0 million upon achieving certain regulatory events and $150.0
million upon meeting certain worldwide commercial sales thresholds; and tiered high-single digit to low double-digit percentage royalties
based on annualized net sales of each product commercialized from our collaboration on a country-by-country basis.

Unless
earlier terminated in accordance with its terms, the agreement with AbMed and AstraZeneca remains in effect on a country-by-country basis
until the latest of (i) the expiration of patent claims that cover the licensed product in a country, (ii) 10 years after the first commercial
sale of a licensed product in a country, and (iii) the expiration of regulatory exclusivity for a licensed product in a country. AbMed
could be required to redeem AstraZeneca’s equity stake in certain circumstances. We are in breach of the terms of our license agreement
with AstraZeneca. See “Risk Factors - Risks Relating to Abpro’s Business and Industry”. 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.” AstraZeneca may terminate our agreement on
the basis of this breach, or upon the occurrence of specified bankruptcy events for us or if we are in material default or breach of
the agreement and do not cure within a specified notice and cure period. We may also terminate the agreement upon 90 days written notice.

15

In
November 2016, we entered into an amendment to this agreement pursuant to which Medimmune granted us a non-exclusive sublicense to certain
additional intellectual property rights held by Medimmune under an agreement with EMD Millipore Corporation and the know-how included
under the agreement was amended. In August 2017, we entered into a side letter with MedImmune to clarify our agreement regarding the
timing of our required contribution to AbMed and the issuance of MedImmune’s equity stake. The agreement was further amended in
November 2017, March 2018 and December 2019 to modify the dates for the achievement of certain development and commercialization milestones
and AbMed agreed to use commercially reasonable efforts to reach these development and commercialization milestones within specified
timeframes. The development may resume upon receipt of sufficient funding however the exact timing is uncertain.

Partnerships

Celltrion

ABP-102
is being developed and commercialized through a worldwide strategic partnership with Celltrion, a leading Korean and global biopharmaceutical
company headquartered in Incheon, South Korea, under a Collaboration Agreement entered into in September 2022 and amended in October
2024. We received an initial milestone payment of $2.0 million from Celltrion in connection with this agreement in 2022. We also received
an equity investment in our Series F preferred stock of $2.0 million from Celltrion.

We
agreed to form a joint steering committee to oversee the collaboration that includes representatives from both our company and Celltrion.
Celltrion agreed to use commercially reasonable efforts to develop and commercialize a licensed product, including the achievement of
certain milestones by certain dates.

Under
the Collaboration Agreement, our company is responsible for certain in vitro pre-clinical work, and Celltrion is responsible for in vivo
pre-clinical work, CMC, clinical development and commercialization on a worldwide basis. All costs and expenses for future development
and commercialization of the molecule are required to be paid initially by Celltrion. The proceeds from commercialization are subject
to a 50/50 profit split. Amounts that may be paid by third party collaborators, for example upfronts, milestones and/or royalty payments
from territorial commercialization partners, are also subject to a 50/50 split. Following commercial approval of ABP-102, we have agreed
to reimburse Celltrion 250% of its direct and certain indirect costs and expenses incurred through first commercial sale. Celltrion is
entitled to offset amounts otherwise due to us under the agreement until our share of these costs has been paid back; provided that we
are entitled to a minimum 50% of profit from commercial sales and from third party collaborators regardless of the amount of unreimbursed
development costs outstanding (and then 50% once the reimbursement has been made in full). In addition, we are entitled to up to over
$1.75 billion in development and sales milestones. We are responsible for world-wide patent prosecution, with Celltrion reimbursing 50%
of our out-of-pocket costs.

Unless
earlier terminated, our agreement with Celltrion will remain in effect so long as ABP-102 is being developed or commercialized anywhere
in the world. Either party may terminate our agreement upon the occurrence of specified bankruptcy events relating to the other party.
We may terminate the agreement if Celltrion is in material default or breach of the agreement and does not cure within a specified notice
and cure period. Celltrion may also terminate the agreement upon 180 days written notice.

On
January 6, 2026, the Company, together with its co-development partner Celltrion, Inc., was notified that the U.S. Food and Drug Administration
(FDA) has cleared the Investigational New Drug (IND) application for ABP-102 / CT-P72, Abpro’s lead multispecific antibody oncology
program. The IND clearance enables the initiation of a Phase 1 clinical trial evaluating the safety, tolerability, pharmacokinetics,
and preliminary efficacy of ABP-102 / CT-P72 in patients with HER2-positive solid tumors. The Phase 1 clinical study will be led by Celltrion
as part of the ongoing joint strategic collaboration to ensure the robust progression of the ABP-102 / CT-P72 program.

Abpro
Bio

ABP-201
is being developed and commercialized through a territorial partnership with Abpro Bio, a subsidiary of Abpro Bio Co. Ltd (KOSDAQ:195990),
a company formerly named Ugint Co Ltd. with diversified holdings in precision machine tools, equipment and biotechnology headquartered
in Daegu, South Korea granting Abpro Bio exclusive development and commercialization rights under a Collaboration and License agreement
entered into in January 2020, in the People’s Republic of China, Japan, South Korea, Southeast Asia (which for the purposes hereof
means Philippines, Indonesia, Taiwan, Pakistan, India, Vietnam, Laos, Cambodia, Thailand, Myanmar and West Malaysia), the Middle East
(which for the purposes hereof means Bahrain, Cyprus, Egypt, Iraq, Israel, Jordan, Kuwait, Lebanon, Northern Cyprus, Oman, Palestine,
Qatar, Saudi Arabia, Syria, Turkey, United Arab Emirates and Yemen), and the Commonwealth of Independent States (CIS) (which for the
purposes hereof means Armenia, Azerbaijan, Belarus, Estonia, Georgia, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, Moldova, Russia, Tajikistan,
Turkmenistan, Ukraine and Uzbekistan), if we have proper local partners in the territories and market opportunity justifies the local
clinical study costs.

16

Abpro
Corporation, through its majority owned subsidiary, AbMed Corporation, received an initial equity investment in our Series E preferred
stock of $30 million from Abpro Bio in connection with this agreement. Under the Collaboration and License Agreement, we granted Abpro
Bio an exclusive, royalty-bearing sublicenseable (subject to certain restrictions) license under specified patent rights and know-how
to make, use, sell certain proprietary ANG-2/VEGF-H1RK bispecific antibodies in China, Japan, South Korea and certain other countries
in Southeast Asia, the Middle East and the Commonwealth of Independent States (CIS).

We
agreed to form a joint steering committee to oversee the collaboration that includes representatives from both AbMed Corporation and
Abpro Bio. Abpro Bio agreed to use commercially reasonable efforts to develop and commercialize a licensed product, including the achievement
of certain milestones by certain dates. Under the agreement, Abpro Bio agreed to pay us a double-digit percentage royalty in the low
teens, tiered based on cumulative net sales by Abpro Bio, its affiliates or sublicensees beginning with the first commercial sale of
a licensed product in its territory. We are also entitled to payments totaling approximately $540 million subject to the satisfaction
of certain development and sales milestones. We are responsible for patent prosecution and Abpro Bio has agreed to reimburse us for patent
costs in its licensed territory. Unless earlier terminated in accordance with its terms, the agreement with Abpro Bio remains in effect
on a country-by-country basis until the latest of (i) the expiration of patent claims that cover the licensed product in a country, (ii)
10 years after the first commercial sale of a licensed product in a country, and (iii) the expiration of regulatory exclusivity for a
licensed product in a country. We may terminate the agreement upon the occurrence of specified bankruptcy events relating to Abpro Bio
or if Abpro Bio is in material default or breach of the agreement and does not cure within a specified notice and cure period. Abpro
Bio may also terminate the agreement upon 90 days written notice.

NJCTTQ

We
entered into a collaboration agreement in January 2019 with NJCTTQ, a pharmaceutical company specializing in research and development,
production and commercialization of drugs for cardiovascular diseases, tumors, perioperative care, gastrointestinal disorders and urologic
diseases headquartered in Nanjing, China.

We
agreed to form a joint steering committee to oversee the collaboration that includes representatives from both our company and NJCTTQ.
NJCTTQ paid a technology access fee to us and agreed to reimburse our pre-clinical research and development costs for the selected program
up to CMC stage. Under the agreement, CMC development costs and GLP toxicology costs are shared equally, with each party thereafter being
responsible for its own development and commercialization costs in its territory, with the NJCTTQ territory being China and Thailand
and our company retaining rights to the rest of the world. The parties agreed to pay reciprocal royalties, with each of them paying the
other party low single-digit royalties, tiered based on net sales per calendar year in its territory. In addition, NJCTTQ agreed to pay
us milestones based on commercial approval and sales in its territory of up to $405 million and we agreed to pay NJCTTQ a milestone based
on commercial approval in our territory of $5 million. ABP-150 is being developed under this agreement.

Unless
earlier terminated in accordance with its terms, the initial term of this agreement is five years from its effective date, with automatic
renewals for an additional five years unless objected to in writing by a party at least six months prior to expiration of the initial
term. If no joint development program gets to clinical stage within the first five years of the collaboration, then the agreement by
its terms will not be renewed after expiration. Either party has the right to terminate in the case of material default or breach of
the agreement by the other party not cured within a specified period, in which case the parties’ rights and obligations under the
agreement are terminated, except for rights accrued prior to termination and customary survival clauses. If the agreement is terminated
other than for cause, the territorial rights and payment obligations of each party relating to the development and commercialization
of a licensed product in its territory survive such termination.

The
agreement remains unrenewed at this time after the expiration of its initial term. However, notwithstanding the agreement’s expiration,
the low single-digit royalties and the $5 million milestone payable to NJCTTQ based on commercial approval in our territory, as described
above, will continue to apply.

Manufacturing

We
do not have, and we do not currently plan to acquire or develop, the infrastructure, facilities or capabilities to manufacture current
Good Manufacturing Practices, or cGMP, bulk drug substance or filled drug product for use in human clinical trials. We intend to utilize
third-party manufacturers such as contract manufacturing organizations, or CMOs, to produce, test and release cGMP bulk drug substance
and drug product for our planned clinical trials. We expect to continue to rely on such third parties to manufacture clinical trial material
for the foreseeable future.

17

Competition

The
biotechnology and biopharmaceutical industries, and the immuno-oncology and ophthalmology subsectors, are characterized by rapid evolution
of technologies, fierce competition and strong defense of intellectual property. Any product candidates that we successfully develop
and commercialize will have to compete with existing therapies and new therapies that may become available in the future. While we believe
that our proprietary DiversImmune® and MultiMabTM platforms, along with our scientific expertise
in the field of biologics and immuno-oncology, provide us with competitive advantages, a wide variety of institutions, including large
biopharmaceutical companies, specialty biotechnology companies, academic research departments and public and private research institutions,
are actively developing potentially competitive products and technologies. Our competitors generally fall within the following categories:

●Immune-based
treatments for cancer, such as T-cell engager, CAR T and TCR therapies. Such as Amgen,
Bristol-Myers Squibb Company, Janux, J&J, Genentech, Inc. (a member of the Roche Group,
or Genentech/Roche), Vir Bio and Xencor.

●Treatments
for Ophthalmology related indications. Such as Allergan plc, Genentech/Roche, Novartis
International AG, and Regeneron Pharmaceuticals, Inc.

Many
of our competitors, either alone or with strategic partners, have substantially greater financial, technical and human resources than
we do. Accordingly, our competitors may be more successful than us in obtaining approval for treatments and achieving widespread market
acceptance, rendering our treatments obsolete or non-competitive.

Accelerated
merger and acquisition activity in the biotechnology and pharmaceutical industries may result in even more resources being concentrated
among a smaller number of our competitors. These companies also compete with us in recruiting and retaining qualified scientific and
management personnel, establishing clinical study sites and patient registration for clinical studies and acquiring technologies complementary
to, or necessary for, our programs. Smaller or early-stage companies may also prove to be significant competitors, particularly through
collaborative arrangements with large and established companies.

Our
commercial opportunity could be substantially limited in the event that our competitors develop and commercialize products that are more
effective, safer, less toxic, more convenient or less expensive than our comparable products. Competitors may also obtain regulatory
approvals before us, resulting in our competitors building a strong market position in advance of our products’ entry, if any.
We believe the factors determining the success of our product pipeline will be the efficacy, safety and convenience of our product candidates.

Intellectual
Property

Our
commercial success will depend significantly on our and our licensors’ ability to obtain and maintain patent and other proprietary
protection for our product candidates and the other technology, inventions and improvements we consider important to our business, defend
any patents we obtain or in-license, preserve the confidentiality of our trade secrets and operate without infringing the patents
and proprietary rights of third parties. Our policy is to seek to protect our proprietary and intellectual property position by, among
other methods, filing and in-licensing U.S., international (under Patent Cooperation Treaty, or PCT) and foreign patent applications
related to our product candidates and other proprietary technology, inventions and improvements that we consider are important to the
development and implementation of our business. We also rely on trade secrets, know-how and continuing technological innovation
to develop and maintain our proprietary and intellectual property position.

ABP-102

As
of April 13, 2026, we own two patent families that cover compositions of matter, methods of use, and methods of manufacture for our ABP-102 product
candidate, a bispecific HER2 and CD3 binding antibody. The first and second families each consist of pending patent applications in Australia,
Canada, China, Europe, Hong Kong, Japan, South Korea, and the United States. Any patents resulting from these applications would be expected
to expire in 2042, excluding any patent term adjustments and/or extensions.

18

ABP-110

As
of April 13, 2026, we have licensed one patent family from the U.S. Department of Health and Human Services that covers compositions
of matter, methods of use, and methods of manufacture related to our ABP-110 product candidate, a tetravalent bispecific glypican-3 (GPC3)
and CD3 binding antibody. This family includes one issued patent in the United States and issued patents in China, Japan, South Korea,
and Singapore. The patents in this family are expected to expire in 2033, excluding any patent term adjustments and/or extensions.

ABP-150

As
of April 13, 2026, we own one patent family that covers compositions of matter, methods of use, and methods of manufacture for our ABP-150 product
candidate, a bispecific Claudin18.2 and CD3 binding antibody. This family includes one issued patent in Japan and applications that are
currently pending in the United States, China, Europe, Hong Kong, Japan, South Korea, and Thailand. The patents in this family are expected
to expire in 2041, excluding any patent term adjustments and/or extensions.

ABP-201

As
of April 13, 2026, we own one patent family that covers compositions of matter, methods of use, and methods of manufacture for our ABP-201 product
candidate, which binds to both angiopoietin-2, or ANG-2, and vascular endothelial growth factor, or VEGF. This family
includes pending applications in the United States, China, Europe, and Hong Kong. Any patents resulting from that application would be
expected to expire in 2042, excluding any patent term adjustments and/or extensions.

Through
our majority-owned subsidiary AbMed Corporation, we have also exclusively licensed from MedImmune/AstraZeneca certain intellectual property
originally entered in connection with ABP-200, which we are no longer developing. As of April 13, 2026, we have licensed three patent
families from MedImmune/AstraZeneca comprised of pending and/or issued U.S. and foreign patents and applications. The patents in these
families are not expected to cover ABP-201, have expired, and/or are expected to expire before commercialization of ABP-201, excluding
any patent term adjustments and/or extensions. We believe that we do not need the intellectual property licensed under this agreement
for the development and eventual commercialization of ABP-201.

As
of April 13, 2026, one of these licensed patent families includes three issued U.S. patents, and issued patents in Australia, Brazil,
China, Hong Kong, Japan, Mexico, Russia, South Korea, as well as pending applications in Europe and India. The patents and applications
in this family expired in 2025, excluding any patent term adjustments and/or extensions.

As
of April 13, 2026, the second family of these licensed patent families includes two issued patents in the United States and issued patents
in Australia, Canada, China, Hong Kong, Israel, Japan, and South Korea, as well as pending applications in Europe and Hong Kong. Any
patents resulting from that application would be expected to expire in 2037, excluding any patent term adjustments and/or extensions.

As
of April 13, 2026, the third family of these licensed patents includes two issued patents in the United States, and issued patents in
Australia, Canada, China, Europe, Hong Kong, Israel, Japan, and South Korea, as well as a pending application in Hong Kong. Any patents
resulting from that application would be expected to expire in 2037, excluding any patent term adjustments and/or extensions.

19

Regulatory
framework

The
term of individual patents depends upon the legal term for patents in the countries in which they are obtained. In most countries, including
the United States, the patent term is 20 years from the earliest filing date of a non-provisional patent application. In the United States,
a patent’s term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the USPTO
in examining and granting a patent, or may be shortened if a patent is terminally disclaimed over an earlier filed co-owned patent. The
term of a patent that covers a drug or biological product may also be eligible for patent term extension when FDA approval is granted,
provided statutory and regulatory requirements are met. However, as to the FDA component, the restoration period cannot be longer than
five years and the total patent term including the restoration period must not exceed 14 years following the FDA approval. Additionally,
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. The duration of foreign patents varies in accordance with provisions of applicable local law but typically is also
20 years from the earliest effective filing date. In the future, if and when our product candidates receive approval by the FDA or foreign
regulatory authorities, we expect to apply for patent term extensions on issued patents covering those products, depending upon the length
of the clinical studies for each product and other factors. There can be no assurance that any of our pending patent applications will
issue or that we will benefit from any patent term extension or favorable adjustments to the terms of any of our patents. 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 also not be granted because of, for example, 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 the expiration of relevant patents, or otherwise
failing to satisfy applicable requirements. The actual protection afforded by a patent varies on a product-by-product basis, from country-to-country,
and depends upon many factors, including the type of patent, the scope of its coverage, the availability of regulatory-related extensions,
the availability of legal remedies in a particular country, and the validity and enforceability of the patent. In addition to patents,
we rely upon unpatented trade secrets and know-how and continuing technological innovation to develop and maintain our competitive position.
We seek to protect our proprietary information, in part, by executing confidentiality agreements with our collaborators and scientific
advisors, and non-competition, non-solicitation, confidentiality and invention assignment agreements with our employees and consultants.
We also have or intend to implement executed agreements requiring assignment of inventions with selected scientific advisors and collaborators.
These confidentiality agreements are designed to protect our proprietary information and, in the case of invention assignment agreements,
to grant us ownership of technologies that are developed through a relationship with a third party. However, these agreements may be
breached, and we may not have adequate remedies for any breach, with a third party. In addition, our trade secrets may otherwise become
known or be independently discovered by competitors. To the extent that our commercial partners, collaborators, employees and consultants
use intellectual property owned by others in their work for use, disputes may arise as to the rights in related or resulting know-how
and inventions.

We
also seek to preserve the integrity and confidentiality of our proprietary technology and processes by maintaining physical security
of our premises and physical and electronic security of our information technology systems. Although we have confidence in these individuals,
organizations, and systems, agreements or security measures may be breached and we may not have adequate remedies for any breach. To
the extent that our employees, contractors, consultants, collaborators, and advisors use intellectual property owned by others in their
work for us, disputes may arise as to the rights in related or resulting know-how and inventions. For more information regarding the
risks related to our intellectual property, proprietary technology, inventions, improvements, platforms and product candidates, please
see the section entitled “Risk Factors - Risks Related to Intellectual Property.”

Government
regulation and product approval

Governmental
authorities in the United States, at the federal, state, and local level, and other countries extensively regulate, among other things,
the research, development, testing, manufacture, labeling, packaging, promotion, storage, advertising, distribution, marketing, and export
and import of products such as those we are developing. Our therapeutic product candidates must be approved by the FDA through the Biologics
License Application, or BLA, process before they may be legally marketed in the United States and will be subject to similar requirements
in other countries prior to marketing in those countries. The process of obtaining regulatory approvals and the subsequent compliance
with applicable federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial
resources.

20

U.S. Government
regulation

In
the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and, in the case of therapeutic biologics,
the Public Health Service Act, or PHSA, and implementing regulations of each. Failure to comply with the applicable U.S. requirements
at any time during the product development or approval process, or after approval, may subject an applicant to administrative or judicial
sanctions, any of which could have a material adverse effect on us. These sanctions could include:

●
refusal to approve pending applications;

●
withdrawal of an approval;

●
imposition of a clinical hold;

●
warning or untitled letters;

●
seizures or administrative detention of
product;

●
total or partial suspension of production
or distribution; or

●
injunctions, fines, disgorgement, or civil
or criminal penalties.

BLA approval
process

The
process required by the FDA before a therapeutic biologic may be marketed in the United States generally involves the following:

●
completion of nonclinical laboratory tests,
animal studies and formulation studies conducted according to Good Laboratory Practices, or GLPs, and other applicable regulations;

●
submission to the FDA of an IND, which must
become effective before human clinical trials may begin, and applicable institutional review boards (IRBs)/ ethics committee approvals;

●
performance of adequate and well-controlled
human clinical trials according to Good Clinical Practices, or GCPs, to establish the safety and efficacy of the product candidate
for its intended use;

●
submission to the FDA of a BLA;

●
satisfactory completion of an FDA inspection
of the manufacturing facility or facilities at which the product candidate is produced to assess readiness for commercial manufacturing
and conformance to the manufacturing-related elements of the application, to conduct a data integrity audit, and to assess compliance
with cGMPs to assure that the facilities, methods, and controls are adequate to preserve the product candidate’s identity,
strength, quality, and purity;

●
satisfactory completion of an FDA inspection
at selected clinical research sites, the contract research organization if the monitoring of the study was outsourced, and/or inspection
of the Sponsor organization to assess GCP compliance may also be required; and

●
FDA review and approval of the BLA.

Once
a biopharmaceutical candidate is identified for development, it enters the pre-clinical or nonclinical testing stage. Nonclinical tests
include laboratory evaluations of product chemistry, toxicity, and formulation, as well as animal studies. An IND sponsor must submit
the results of the nonclinical tests, together with manufacturing information and analytical data, to the FDA as part of the IND. Some
nonclinical testing may continue even after the IND is submitted. In addition to including the results of the nonclinical studies, the
IND will also include a protocol detailing, among other things, the objectives of the clinical trial, the parameters to be used in monitoring
safety, and the effectiveness criteria to be evaluated if the first phase lends itself to an efficacy determination. The IND automatically
becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, places the IND on clinical hold. In
such a case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can begin. A clinical hold may
occur at any time during the life of an IND and may affect one or more specific studies or all studies conducted under the IND.

All
clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with GCPs. They must be
conducted under protocols detailing the objectives of the trial, dosing procedures, research subject selection and exclusion criteria,
and the safety and effectiveness criteria to be evaluated. Each protocol, and any subsequent material amendment to the protocol, must
be submitted to the FDA as part of the IND, and progress reports detailing the status of the clinical trials must be submitted to the
FDA annually. Sponsors also must report to the FDA serious and unexpected suspected adverse reactions in a timely manner, any clinically
important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigation brochure or
any findings from other studies or animal or in vitro testing that suggest a significant risk in humans exposed to the product
candidate. An IRB at each institution participating in the clinical trial must review and approve the protocol before a clinical trial
commences at that institution and must also approve the information regarding the trial and the informed consent form that must be provided
to each research subject or the subject’s legal representative, monitor the study until completed and otherwise comply with IRB
regulations. There are also requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public
registries.

21

Human
clinical trials are typically conducted in three sequential phases that may overlap or be combined.

●
Phase 1-The product candidate
is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution,
and elimination. In the case of some therapeutic candidates for severe or life-threatening diseases, such as cancer, especially when
the product candidate may be inherently too toxic to ethically administer to healthy volunteers, the initial human testing is often
conducted in patients.

●
Phase 2-Clinical trials are
performed on a limited patient population intended to identify possible adverse effects and safety risks, to preliminarily evaluate
the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.

●
Phase 3-Clinical trials are
undertaken to further evaluate dosage, clinical efficacy, and safety in an expanded patient population at geographically dispersed
clinical study sites. These studies are intended to establish the overall risk-benefit ratio of the product and provide an adequate
basis for product labeling.

A
pivotal study is a clinical study that adequately meets regulatory agency requirements for the evaluation of a product candidate’s
efficacy and safety such that it can be used to justify the approval of the product. Generally, pivotal studies are also Phase 3 studies
but may be Phase 2 studies if the trial design provides a reliable assessment of clinical benefit, particularly in situations where there
is an unmet medical need. Human clinical trials are inherently uncertain, and Phase 1, Phase 2, and Phase 3 testing may not be successfully
completed. The FDA or the sponsor may suspend a clinical trial at any time for a variety of reasons, including a finding that the research
subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical
trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the product
candidate has been associated with unexpected serious harm to patients.

During
the development of a new product candidate, sponsors are given opportunities to meet with the FDA at certain points; specifically, prior
to the submission of an IND, at the end of Phase 2 and before a BLA or New Drug Application, or NDA, is submitted. Meetings at other
times may be requested. These meetings can provide an opportunity for the sponsor to share information about the data gathered to date
and for the FDA to provide advice on the next phase of development.

Post-approval
trials, sometimes referred to as “Phase 4” clinical trials, may be conducted after initial marketing approval. These trials
are used to gain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, FDA
may mandate the performance of such “Phase 4” clinical trials.

Concurrently
with clinical trials, sponsors usually complete additional animal safety studies, develop additional information about the chemistry
and physical characteristics of the product candidate, and finalize a process for manufacturing commercial quantities of the product
candidate in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of
the product candidate and the manufacturer must develop methods for testing the quality, purity, and potency of the product candidate.
To help reduce the risk of the introduction of adventitious agents with use of biological products, the PHSA emphasizes the importance
of manufacturing control for products whose attributes cannot be precisely defined. The manufacturing process must be capable of consistently
producing quality batches of the product candidate and, among other criteria, the sponsor must develop methods for testing the identity,
strength, quality, potency, and purity of the final biological product. Additionally, appropriate packaging must be selected and tested,
and stability studies must be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration
over its proposed shelf life.

The
results of product development, nonclinical studies, and clinical trials, along with descriptions of the manufacturing process, analytical
tests and other control mechanisms, proposed labeling, and other relevant information are submitted to the FDA as part of a BLA requesting
approval to market the product. Under the Prescription Drug User Fee Act, or PDUFA, as amended, each BLA must be accompanied by a significant
user fee. The FDA adjusts the PDUFA user fees on an annual basis. PDUFA also imposes an annual product fee for products and an annual
establishment fee on facilities used to manufacture prescription biological or drug products. Fee waivers or reductions are available
in certain circumstances, such as where a waiver is necessary to protect the public health, where the fee would present a significant
barrier to innovation, or where the applicant is a small business submitting its first human therapeutic application for review.

Within
60 days following submission of the application, the FDA reviews a BLA submitted to determine if it is substantially complete before
the agency accepts it for filing. The FDA may refuse to accept for filing any BLA that it deems incomplete or not properly reviewable
at the time of submission and may request additional information. In this event, the BLA must be resubmitted with the additional information.
The resubmitted application also is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing,
the FDA begins an in-depth substantive review of the BLA. The FDA reviews the BLA to determine, among other things, whether the proposed
product is safe, potent, and/or effective for its intended use, and has an acceptable purity profile and whether the product is being
manufactured in accordance with cGMP. The FDA may refer applications for novel products or products that present difficult questions
of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation,
and a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations
of an advisory committee, but it considers such recommendations carefully when making decisions.

22

During
the product approval process, the FDA also will determine whether a Risk Evaluation and Mitigation Strategy, or REMS, plan is necessary
to assure the safe use of the product. If the FDA concludes a REMS plan is needed, the sponsor of the BLA must submit a proposed REMS
plan. The FDA will not approve a BLA without a REMS plan, if required. The FDA has authority to require a REMS plan to ensure that the
benefits of a drug or therapeutic biologic outweigh the risks. Before approving a BLA, the FDA will inspect the facilities at which the
product is manufactured. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are
in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally,
before approving a BLA, the FDA will typically inspect one or more clinical sites to assure that the clinical trials were conducted in
compliance with IND trial requirements and GCP requirements. To assure cGMP and GCP compliance, an applicant must incur significant expenditure
of time, money, and effort in the areas of training, record keeping, production, and quality control. Notwithstanding the submission
of relevant data and information, the FDA may ultimately decide that the BLA does not satisfy its regulatory criteria for approval and
deny approval. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than we interpret
the same data. If the agency decides not to approve the BLA in its present form, the FDA will issue a complete response letter that describes
all of the specific deficiencies in the BLA identified by the FDA. The deficiencies identified may be minor, for example, requiring labeling
changes, or major, for example, requiring additional clinical trials. Additionally, the complete response letter may include recommended
actions that the applicant might take to place the application in a condition for approval. If a complete response letter is issued,
the applicant may either resubmit the BLA, addressing all of the deficiencies identified in the letter, or withdraw the application.
Even if a product receives regulatory approval, the approval may be significantly limited to specific indications and dosages or the
indications for use may otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require
that certain contraindications, warnings, or precautions be included in the product labeling. The FDA may impose restrictions and conditions
on product distribution, prescribing, or dispensing in the form of a risk management plan or otherwise limit the scope of any approval.

Post-approval
requirements

Once
an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements is not maintained or if problems
occur after the product candidate reaches the market. Later discovery of previously unknown problems with a product candidate may result
in restrictions on the product candidate or even complete withdrawal of the product candidate from the market. After approval, some types
of changes to the approved product candidate, such as adding new indications, manufacturing changes, and additional labeling claims,
are subject to further FDA review and approval. In addition, the FDA may under some circumstances require testing and surveillance programs
to monitor the effect of approved therapeutic candidates that have been commercialized, and the FDA under some circumstances has the
power to prevent or limit further marketing of a product candidate based on the results of these post-marketing programs.

Any
therapeutic candidates manufactured or distributed by us pursuant to FDA approvals are subject to continuing regulation by the FDA, including,
among other things:

●
record-keeping requirements;

●
reporting of adverse experiences with the
product candidate;

●
providing the FDA with updated safety and
efficacy information;

●
product sampling and distribution requirements;

●
notifying the FDA and gaining its approval
of specified manufacturing or labeling changes; and

●
complying with FDA promotion and advertising
requirements, which include, among other things, standards for direct-to-consumer advertising, restrictions on promoting products
for uses or in patient populations that are not described in the product’s approved labeling, limitations on industry-sponsored
scientific and educational activities and requirements for promotional activities involving the internet.

23

Therapeutic
manufacturers and other entities involved in the manufacture and distribution of approved therapeutic products are required to register
their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and some
state agencies for compliance with cGMPs and other laws. The FDA periodically inspects manufacturing facilities to assess compliance
with cGMP, which imposes extensive procedural, substantive, and record-keeping requirements. In addition, changes to the manufacturing
process are strictly regulated, and, depending on the significance of the change, may require FDA approval before being implemented.
FDA regulations would also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements
upon us and any third-party manufacturers that we may decide to use if our product candidates are approved. Accordingly, manufacturers
must continue to expend time, money, and effort in the area of production and quality control to maintain compliance with cGMP and other
aspects of regulatory compliance.

The Orphan
Drug Act

Under
the Orphan Drug Act, the FDA may grant Orphan Drug Designation to drugs intended to treat a rare disease or condition - generally a disease
or condition that affects fewer than 200,000 individuals in the United States. Orphan Drug Designation must be requested before submitting
a BLA. After the FDA grants Orphan Drug Designation, the generic identity of the drug and its potential orphan use are disclosed publicly
by the FDA. Orphan Drug Designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval
process. The first BLA applicant to receive FDA approval for a particular active ingredient to treat a particular disease with FDA Orphan
Drug Designation is entitled to a seven-year exclusive marketing period in the United States for that product, for that indication. During
the seven-year exclusivity period, the FDA may not approve any other applications to market the same drug for the same disease, except
in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. Orphan drug exclusivity
does not prevent the FDA from approving a different drug for the same disease or condition, or the same drug for a different disease
or condition. Among the other benefits of Orphan Drug Designation are tax credits for certain research and a waiver of the BLA application
user fee.

New legislation
and regulations

From
time to time, legislation is drafted, introduced, and passed in Congress that could significantly change the statutory provisions governing
the testing, approval, manufacturing, and marketing of products regulated by the FDA. In addition to new legislation, FDA regulations,
guidance documents, and policies are often revised or interpreted by the agency in ways that may significantly affect our business and
our products. It is impossible to predict whether further new legislation will be enacted, or whether FDA regulations, guidance documents,
policies, or interpretations will be changed or what the effect of such changes, if any, may be.

Review
and approval of drug products outside the United States

In
order to market any drug product outside of the United States, a company must also comply with numerous and varying regulatory requirements
of other countries and jurisdictions regarding quality, safety and efficacy and governing, among other things, clinical trials, marketing
authorization, commercial sales, and distribution of drug products. Whether or not it obtains FDA approval for a product, the company
would need to obtain the necessary approvals by the comparable foreign regulatory authorities before it can commence clinical trials
or marketing of the product in those countries or jurisdictions. The approval process ultimately varies between countries and jurisdictions
and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other
countries and jurisdictions might differ from and be longer than that required to obtain FDA approval. Regulatory approval in one country
or jurisdiction does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country
or jurisdiction may negatively impact the regulatory process in others.

Pharmaceutical
coverage, pricing and reimbursement

In
the United States and markets in other countries, patients who are prescribed treatments for their conditions and providers performing
the prescribed services generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Significant
uncertainty exists as to the coverage and reimbursement status of products approved by the FDA and other government authorities. Thus,
even if a product candidate is approved, sales of the product will depend, in part, on the extent to which third-party payors, including
government health programs in the United States such as Medicare and Medicaid, commercial health insurers and managed care organizations,
provide coverage, and establish adequate reimbursement levels for, the product. The process for determining whether a payor will provide
coverage for a product may be separate from the process for setting the price or reimbursement rate that the payor will pay for the product
once coverage is approved. Third-party payors are increasingly challenging the prices charged, examining the medical necessity, and reviewing
the cost-effectiveness of medical products and services and imposing controls to manage costs. Third-party payors may limit coverage
to specific products on an approved list, also known as a formulary, which might not include all of the approved products for a particular
indication. Moreover, on July 4, 2025, the President signed into law the One Big Beautiful Bill Act (“OBBBA”). Under the
OBBBA, coverage availability itself may shrink, not merely coverage decisions for a given product and government program retrenchment
(especially Medicaid) may reduce the addressable reimbursed patient population, even for FDA-approved products. OBBBA represents a shift
from previous measures in that cost-containment is no longer only a policy priority but a legislated fiscal requirement. Because of OBBBA,
reimbursement reductions may result indirectly from Medicare sequestration, Medicaid enrollment caps, or State-level payment reductions.
Favorable coverage decisions may be short-lived or reversed. OBBBA-mandated coverage changes could have a material adverse effect on
reimbursement for use of the Company’s product candidates even if they become commercially viable.

24

In
order to secure coverage and reimbursement for any product that might be approved for sale, a company may need to conduct expensive pharmacoeconomic
studies in order to demonstrate the medical necessity and cost-effectiveness of the product, in addition to the costs required to obtain
FDA or other comparable marketing approvals. Nonetheless, product candidates may not be considered medically necessary or cost effective.
A decision by a third-party payor not to cover a product candidate could reduce physician utilization once the product is approved and
have a material adverse effect on sales, results of operations and financial condition. Additionally, a payor’s decision to provide
coverage for a product does not imply that an adequate reimbursement rate will be approved. Further, one payor’s determination
to provide coverage for a drug product does not assure that other payors will also provide coverage and reimbursement for the product,
and the level of coverage and reimbursement can differ significantly from payor to payor. For example, as a result of the OBBBA’s
cost-saving mandates, payors may apply more stringent cost-effectiveness thresholds, coverage decisions may be revisited more frequently
or revoked, and administrative barriers may reduce utilization even when nominal coverage exists.

The
containment of healthcare costs also has become a priority of federal, state and foreign governments and other third-party payors, and
the prices of drugs have been a focus in this effort. Governments have shown significant interest in implementing cost-containment programs,
including price controls, restrictions on reimbursement, and requirements for substitution of generic products. Adoption of price controls
and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could
further limit a company’s revenue generated from the sale of any approved products. Coverage policies and third-party reimbursement
rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which a company
or its collaborators receive marketing approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
Moreover, as a result of OBBBA’s mandates, even significant investment in pharmacoeconomic data may not be sufficient. Utilization
may decline due to eligibility barriers and cost-sharing, without regard to clinical merit, and coverage determinations may vary sharply
by state post-OBBBA.

Outside
the United States, ensuring adequate coverage and payment for a product also involves challenges. Pricing of prescription pharmaceuticals
is subject to governmental control in many countries. Pricing negotiations with governmental authorities can extend well beyond the receipt
of regulatory marketing approval for a product and may require a clinical trial that compares the cost effectiveness of a product to
other available therapies. The conduct of such a clinical trial could be expensive and result in delays in commercialization.

Healthcare
law and regulation

Healthcare
providers and third-party payors play a primary role in the recommendation and prescription of drug products that are granted marketing
approval. Arrangements with providers, consultants, third-party payors, and customers are subject to broadly applicable fraud and abuse,
anti-kickback, false claims laws, reporting of payments to physicians and teaching physicians, patient privacy laws and regulations,
and other healthcare laws and regulations that may constrain business and/or financial arrangements. Restrictions under applicable federal
and state healthcare laws and regulations include the following:

●
the federal Anti-Kickback Statute, which
prohibits, among other things, a person or entity from knowingly and willfully soliciting, offering, paying, receiving, or providing
remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase,
lease, order, arrange for or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in
part, by a federal healthcare program such as Medicare or Medicaid. A person or entity does not need to have actual knowledge of
the statute or specific intent to violate it in order to have committed a violation. Violation of the federal Anti-Kickback Statue
carries criminal penalties and fines as well as administrative sanctions under the Civil Money Penalties Law. In addition, a violation
of the Anti-Kickback Statute can form the basis for a violation of the federal False Claims Act;

25

●
federal civil and criminal false claims
laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit an individual or entity from, among
other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false, fictitious,
or fraudulent or knowingly making, using, or causing to be made or used a false record or statement to avoid, decrease, or conceal
an obligation to pay money to the federal government;

●
the federal Health Insurance Portability
and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for executing a scheme to defraud any healthcare
benefit program, or knowingly and willingly falsifying, concealing, or covering up a material fact or making any materially false
statement in connection with the delivery of or payment for healthcare benefits, items, or services. Similar to the federal Anti-Kickback
Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have
committed a violation;

●
HIPAA, as amended by the Health Information
Technology for Economic and Clinical Health Act, and their respective implementing regulations, including the Final Omnibus Rule
published in January 2013, which impose obligations on certain covered entity healthcare providers, health plans, and healthcare
clearinghouses as well as their business associates that perform certain services involving the use or disclosure of individually
identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security, and transmission
of individually identifiable health information, and require notification to affected individuals and regulatory authorities of certain
breaches of security of individually identifiable health information;

●
the federal false statements statute, which
prohibits knowingly and willfully falsifying, concealing, or covering up a material fact, or making any materially false statement
in connection with the delivery of or payment for healthcare benefits, items, or services;

●
the federal transparency requirements known
as the federal Physician Payments Sunshine Act, created by the Patient Protection and Affordable Care Act, as amended by the Health
Care Education Reconciliation Act, or the ACA, which requires certain manufacturers of drugs, devices, biologics, and medical supplies
for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to the
Centers for Medicare & Medicaid Services, or CMS, information related to payments and other transfers of value made to physicians
and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and

●
analogous local, state, and foreign laws
and regulations, such as state anti-kickback and false claims laws that may apply to healthcare items or services that are reimbursed
by third-party payors, including private insurers; local, state, and foreign transparency laws that require manufacturers to report
information related to payments and transfers of value to other health care providers and health care entities, or marketing expenditures;
state laws that require pharmaceutical companies to register certain employees engaged in marketing activities in the locale and
comply with the pharmaceutical industry’s voluntary compliance guidelines or relevant compliance guidance promulgated by the
federal government; and state and foreign laws that govern the privacy and security of health information in some circumstances,
many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

If
our operations are found to be in violation of any such requirements, we may be subject to sanctions, including criminal fines, significant
civil monetary penalties, individual imprisonment, disgorgement, contractual damages, reputational harm, exclusion from participation
in government healthcare programs, integrity obligations, injunctions, recall or seizure of products, total or partial suspension of
production, denial or withdrawal of pre-marketing product approvals, private qui tam actions brought by individual whistleblowers in
the name of the government, refusal to allow us to enter into supply contracts, including government contracts, and the curtailment or
restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.
Although effective compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, these risks
cannot be entirely eliminated. Any action against us for an alleged or suspected violation could cause us to incur significant legal
expenses and could divert our management’s attention from the operation of our business, even if our defense is successful. In
addition, achieving and sustaining compliance with applicable laws and regulations may be costly to us in terms of money, time and resources.

26

Healthcare
reform

In
both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health
care system that could impact our ability to sell our products profitably. In particular, in 2010, the ACA was enacted, which, among
other things, addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated
for drugs and biologics; increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; extended
the Medicaid Drug Rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations; subjected
manufacturers to new annual fees and taxes for certain branded prescription drugs; created a new Medicare Part D coverage gap discount
program, in which manufacturers must agree to offer 50% (increased to 70% as of January 1, 2019 and further revised, effective January
1, 2025 under the IRA), point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their
coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; and provided incentives
to programs that increase the federal government’s comparative effectiveness research. Effective January 1, 2025, certain provisions
of the Inflation Reduction Act of 2022 will reduce Medicare Part D beneficiaries’ annual out-of-pocket maximum from $7,050 to $2,000,
thereby effectively eliminating the coverage gap. In addition, on July 4, 2025, the President signed into law the OBBBA, which includes
significant changes to federal health care programs, particularly Medicaid and the Affordable Care Act marketplaces, that are expected
to reduce coverage availability and increase reimbursement pressure. The OBBBA’s cost-containment mandates, including restrictions
on eligibility, enrollment, and state financing mechanisms, may further limit the addressable reimbursed patient population and adversely
affect pricing, coverage, and utilization of pharmaceutical products.

Since
its enactment, there have been numerous judicial, administrative, executive and legislative challenges to certain aspects of the ACA.
On June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically
ruling on the constitutionality of the ACA. Prior to the Supreme Court’s decision, President Biden issued an executive order to
initiate a special enrollment period from February 15, 2021 through August 15, 2021, for purposes of obtaining health insurance coverage
through the ACA marketplace. The executive order also instructed certain governmental agencies to review and reconsider their existing
policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs
that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through
Medicaid or the ACA. It is unclear how other healthcare reform measures of the Biden administration or other efforts, if any, to challenge,
repeal or replace the ACA will impact our business.

Other
legislative changes have been proposed and adopted in the United States since the ACA was enacted:

●
In August 2011, the Budget Control Act of
2011 and subsequent legislation, among other things, created measures for spending reductions by Congress, including a reduction
of Medicare payments to providers up to 2% per fiscal year, and, due to subsequent legislative amendments, this will remain in effect
through 2030 unless additional Congressional action is taken.

●
The U.S. American Taxpayer Relief Act of
2012 was signed into law in 2013, which among other things, further reduced Medicare payments to several types of providers.

●
On May 30, 2018, the Right to Try Act was
signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigational
new drug products that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval. Under certain
circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under
the FDA expanded access program. There is no obligation for a pharmaceutical manufacturer to make its drug products available to
eligible patients as a result of the Right to Try Act.

●
The Further Consolidated Appropriations
Act, signed into law in 2019, repealed the Cadillac tax, the health insurance provider tax, and the medical device excise tax. It
is impossible to determine whether similar taxes could be instituted in the future.

There
has been increasing legislative and enforcement interest in the United States with respect to product pricing practices. Specifically,
there have been several recent U.S. Congressional inquiries and proposed federal and state legislation designed to, among other things,
bring more transparency to drug pricing, reduce the cost of therapies under Medicare, review the relationship between pricing and manufacturer
patient programs, and reform government program reimbursement methodologies for drug products. The HHS has already started the process
of soliciting feedback on some of these measures and, at the same time, is immediately implementing others under its existing authority.
It is unclear what effect such legislative and enforcement interest may have on our product candidates.

27

Further,
on December 13, 2016, President Obama signed the 21st Century Cures Act, or Cures Act, into law. Among other provisions, the Cures Act
reauthorized the existing priority review voucher program for certain drugs intended to treat rare pediatric diseases until 2020; created
a new priority review voucher program for drug applications determined to be material national security threat medical countermeasure
applications; revised the FDCA to streamline review of combination product applications; required the FDA to evaluate the potential use
of “real world evidence” to help support approval of new indications for approved drugs; provided a new “limited population”
approval pathway for antibiotic and antifungal drugs intended to treat serious or life-threatening infections; and authorized the FDA
to designate a drug as a “regenerative advanced therapy,” thereby making it eligible for certain expedited review and approval
designations.

We
expect that these and other healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria
and in additional downward pressure on the price that we receive for any approved product, which could have an adverse effect on customers
for our product candidates. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction
in payments from private payers.

There
have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels in the U.S.
directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. The implementation of cost containment
measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our products.
Such reforms could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which
we may obtain regulatory approval and may affect our overall financial condition and ability to develop products. If we, or any third
parties we may engage, are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies,
or if we or such third parties are not able to maintain regulatory compliance, our current or any future product candidates we may develop
may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.

Employees

As
of March 30, 2026, we had one full-time employee and two part-time employees. None of our employees are represented by a labor union
or covered by a collective bargaining agreement.

Facilities

We
occupy shared office space in Burlington, Massachusetts, under a lease that expires in August 2026, which we use for our corporate headquarters.

Available
Information

We
are required to file Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those
reports pursuant to Section 13(a) or Section 15(d) of the Exchange Act with the SEC. The SEC maintains an internet site that contains
reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at http://www.sec.gov.