NASDAQ: ACTU

Figure 1 shows the broad therapeutic
potential of elraglusib where evidence of preclinical and clinical activity has been observed.

Figure 1: GSK-3β inhibitors and elraglusib’s
potential to treat numerous cancer histologies.

1

Significant Clinical Experience and Promising
Phase 2 Data in mPDAC

To date, we have treated over
500 patients with elraglusib as an IV injection (“Elraglusib Injection”) in Phase 1 and Phase 2 studies.

Our most advanced clinical
indication is first-line metastatic pancreatic ductal adenocarcinoma (“mPDAC”). Our Phase 2 study in mPDAC, known as Actuate-1801
Part 3B study, is a randomized, controlled Phase 2 trial that enrolled 286 patients with no prior systemic treatment for metastatic disease.
The primary endpoint for this study was median overall survival (“mOS”), with overall survival (“OS”) summarized
throughout the study by estimates of 1-year survival. Updated data results presented at the American Society of Clinical Oncology (“ASCO”)
Genitourinary Cancers Symposium (“ASCO GI”) in January 2026 utilizing a data cutoff as of November 22, 2025 showed that the
trial met its primary endpoint, demonstrating a statistically significant improvement in mOS with elraglusib plus gemcitabine/nab-paclitaxel
(“GnP”) versus GnP alone.

Data presented at ASCO GI
included:

·Statistically significant benefit in mOS in the
elraglusib/GnP arm vs GnP control arm (mOS 10.1 months vs. 7.2 months, p=0.02, HR=0.62);

·Near doubling of the 12-month survival rate,
from 22.3% in the GnP arm to 44.4% in the elraglusib/GnP arm; and

·Almost fivefold increase in 24-month survival
rate, from 2.6% in the GnP control arm to 12.9% in the elraglusib/GnP arm, emphasizing the potential for long-term clinical benefit.

Elraglusib Injection Shows Promise in the Treatment
of Pediatric Cancers

In addition to mPDAC, Elraglusib
Injection is also being evaluated in pediatric cancer patients with recurrent/refractory solid cancers. This study, Actuate-1902, is a
Phase 1/2 study that evaluated escalating doses of elraglusib as a single agent as well as in combination with irinotecan or cyclophosphamide/topotecan
in the Phase 1 portion of the trial. Patients in this Actuate-1902 study also experienced a number of objective responses in the combination
chemotherapy arms, and based on this data, we identified Ewing sarcoma and neuroblastoma as new indications for further development of
Elraglusib Injection, further expanding the potential of elraglusib.

Elraglusib Oral Dose Tablet Allows Us to Expand
into New Indications

We have developed several
oral dosage forms of elraglusib, which we believe will allow us to expand the number of cancer indications that we are able to target
and allow us to further explore more convenient dose delivery options for patients. A clinical candidate tablet, the Elraglusib Oral Tablet,
has been selected for further development and, subject to future funding, we are planning a Phase 1 study to identify the maximum tolerated
dose and recommended Phase 2 dose (“RP2D”) for Elraglusib Oral Tablet in adult patients with advanced, refractory cancers.
Once we have determined a RP2D, several Phase 2 studies have been identified for further clinical development of Elraglusib Oral Tablet,
subject to additional funding, based on data from previous studies, including but not limited to, refractory, metastatic melanoma and
refractory, metastatic colorectal cancer, and non-small cell lung cancer.

Pancreatic Cancer Represents a High Unmet Need
with Limited Treatment Options for Patients

According to the American
Cancer Society, the annual incidence of pancreatic cancer is expected to exceed 67,000 patients in the United States in 2026. Pancreatic
ductal adenocarcinoma (“PDAC”) is considered one of the most aggressive malignancies, with approximately 90% of patients presenting
with advanced disease. Despite advances in the treatment therapies over the last 30 years, the 5-year survival rate for Stage IV disease
is less than 5%. The standard of care for first-line treatment of mPDAC generally includes one of the following two chemotherapy regimens:

·FOLFIRINOX: A combination of 5-fluorouracil,
irinotecan, and oxaliplatin, which has been established as the new standard of care for advanced or mPDAC. It achieved a mOS of 11.1 months
in the ACCORD/PRODIGE Phase 3 trial.

·GnP: This regimen achieved a mOS of 8.5 months
with GnP compared to 6.7 months with gemcitabine alone in the MPACT Phase 3 trial.

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A recent review of clinical
trials in Future Oncology1 showed that the mOS in patients with mPDAC treated with GnP ranged from approximately 3.6
to 9.8 months with an unweighted mOS of 6.9 months. Therefore, we believe the ability to extend survival by even a few months would be
considered meaningful in this patient population.

Our Strategy and Strengths

We believe that we have several
strengths that support our vision of developing therapies for the treatment of high impact, difficult to treat cancers through the inhibition
of GSK-3β, including:

·Advancing a potentially class-leading GSK-3β
inhibitor, elraglusib with a novel, multimodal mechanisms of action (“MOA”) profile, in multiple advanced trials for the treatment
of cancer.

·Broad potential with clinical responses (complete
responses and partial responses) and extended disease control observed across multiple cancer histologies.

·Extended survival and increased responses observed
in mPDAC, relapsed/refractory Ewing sarcoma, and neuroblastoma.

·Preliminary evidence of clinical benefit has
also been observed in patients with metastatic melanoma and relapsed/refractory colorectal and lung cancer.

·Elraglusib Oral Tablet developed and ready for
Phase 1/2 study in advanced cancer patients.

·Broad composition of matter intellectual property
protection and development incentives.

·Orphan Drug Designations for pancreatic and other
cancer types; Fast Track Designation for pancreatic cancer.

Our strategy is to develop
elraglusib for multiple advanced cancer indications with high unmet medical need and significant commercial potential, initially in patients
with metastatic pancreatic cancer, pediatric cancers, and metastatic melanoma, subject to available financing and/or funding from potential
strategic collaborations. We believe that our two product candidates, Elraglusib Injection and Elraglusib Oral Tablet, will provide us
with two different dosage forms of drug product with different attributes that will allow us to tailor each dosage form to a specific
cancer type to potentially improve outcomes and compliance. Key elements of our strategy to accomplish this objective include:

·Build
a Sustainable Oncology Company. Our vision is to build a leading oncology company with a sustainable pipeline of target
indications revolving around a patented, active product candidate, elraglusib, that can be delivered in different ways to potentially
treat a wide variety of cancers. To accomplish this, we are focused on rapid advancement of our currently active clinical trials while
curating and preparing additional indications for future expansion of elraglusib development. This effort is led by Daniel Schmitt, our
president, chief executive officer and founder, and Dr. Andrew Mazar, our scientific co-founder and chief operating officer. Together,
they bring more than 60 years of combined experience in biotechnology management and healthcare investing. Mr. Schmitt has led and
contributed to the successful development and launch of multiple pharmaceutical and health technology products and executed licensing,
acquisition, and development transactions totaling over approximately $1.0 billion in milestone value. Dr. Mazar has founded
seven start-ups and is the co-founder, former chief scientific officer and director of Monopar Therapeutics, Inc. (Nasdaq: MNPR) as well
as the former chief scientific officer of Attenuon, LLC. Dr. Mazar has shepherded eleven drugs from discovery stage through Phase 2
and Phase 3 trials.

·Advance
Our Lead Product Candidate, Elraglusib, Through Clinical Trials. We have generated clinical data from over 500 patients
who have been treated with elraglusib to date. Under the innovative seamless study design of our Actuate-1801 Master Protocol, we have
reported promising top-line data from our Phase 2 trial testing Elraglusib Injection in combination with GnP in mPDAC. We are also
considering advancing the development of elraglusib in pediatric cancers, including Ewing sarcoma and neuroblastoma, based on promising
data from the Phase 1 portion of the Actuate-1902 study, pending additional internal or external funding support. We also intend
to explore strategically identified investigator-initiated trials (“IITs”) that may identify additional indications and standard
of care products to combine with elraglusib in indications that go beyond those already identified, which would allow us to further leverage
our pipeline in a molecule. By collaborating with our network of oncology Key Opinion Leaders (“KOLs”), we anticipate partnering
to access non-dilutive funding for our IITs, to the extent available.

_______________________

1 Cockrum P, Dennen S, Brown A,
Briggs J, Paluri R. Real-world clinical outcomes and economic burden of metastatic pancreatic ductal adenocarcinoma: a systematic review.
Future Oncol. 2025; 21: 241-260. doi: 10.1080/14796694.2024.2435253. Epub 2024 Dec 8.

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·Obtain
Regulatory Development Incentives to Accelerate the Path to Potential Approval of Elraglusib. One of our strategic objectives
is to obtain development incentives in the United States and in other countries that we believe may accelerate our path to drug approval:
Orphan Drug Designation (“ODD”), Fast Track Designation (“FTD”) and Breakthrough Therapy Designation (“BTD”)
in the United States; Orphan and priority medicines (“PRIME”) designations in the EU; and Orphan designations in Japan and
Australia. There is no guarantee that any such designation, if received, will lead to a faster development, regulatory review or approval
process; or increase the likelihood that a product candidate will receive FDA approval.

·Explore
Strategic Partnerships That Can Accelerate and Maximize the Potential of GSK-3 Inhibitors. We will evaluate potential strategic
partnering opportunities with pharmaceutical companies which could further help us to accelerate development of elraglusib by providing
expertise, guidance, and funding to expand the pipeline into different tumors and other disease areas that could benefit from GSK-3 inhibitor
therapy. We may also broaden the reach of our platform by selectively in-licensing technologies or novel product candidates, pending
the availability of the necessary funding. In addition, we will consider potentially out-licensing certain geographic rights to elraglusib
or other product candidates in our target indications or for indications and industries that we are not currently pursuing ourselves.

·Leverage
Our Academic and Research Partnerships. We are actively engaging with regulators, KOLs, advocates and other stakeholders
early and throughout the development process in each cancer indication being considered for development to enhance the probability of
technical success. We currently have clinical partnerships with investigators conducting IITs where we provide elraglusib drug product
and input into study design while retaining the rights to any preexisting intellectual property and the right for exclusively licensing
any joint inventions resulting from the studies. We also have a research and development collaboration with Lantern Pharma Inc. to leverage
their artificial intelligence platform to further understand the effects of elraglusib and identify patient subtypes that are particularly
susceptible to GSK-3 inhibition. We expect to continue to leverage these partnerships and establish others to hone and expand our research
and development efforts.

Our Solution

Elraglusib represents a broad
opportunity for us to potentially initiate and advance multiple drug development programs around our lead asset based on data emerging
from completed or ongoing Phase 1/2 trials. Our lead program is developing Elraglusib Injection for the first-line treatment of mPDAC.
Despite advances in the treatment therapies over the last 30 years, the 5-year survival rate for Stage IV mPDAC remains at less than 5%,
representing one of the lowest of any cancer type.

Our Advancing Pipeline

Our initial focus is on the
development of GSK-3 inhibitors for the treatment of cancers with ineffective treatment options and poor overall survival. Given our ability
to formulate elraglusib in both the Elraglusib Injection and Elraglusib Oral Tablet forms, and given the potential to administer this
molecule as an IV or oral formulation depending on the cancer type and existing standard of care, we believe that elraglusib represents
a pipeline in a molecule that can be broadly developed if adequate funding is secured. We are focused on advancing trials in mPDAC, Ewing
sarcoma, and neuroblastoma with Elraglusib Injection while also advancing the Elraglusib Oral Tablet in a Phase I trial in advanced solid
tumors. Our ability to advance our ongoing and planned clinical trials listed in Figure 2 will depend on whether we can raise sufficient
capital to support those trials, including potential support from strategic collaborations.

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Figure 2: Ongoing and planned clinical trials.

Developing Elraglusib Injection for the Treatment
of mPDAC

Our lead clinical program
is focused on evaluating Elraglusib Injection for the treatment of first-line mPDAC. The Phase 2 trial is a randomized, controlled Phase
2 trial of elraglusib in combination with GnP versus GnP alone in first-line mPDAC. The trial enrolled 286 patients with mPDAC and no
prior systemic treatment for metastatic disease. Patients were randomized 2:1 to the elraglusib/GnP combination arm or the GnP arm, respectively.
This study included a run-in to explore two different dosing schedules of elraglusib/GnP (once weekly versus twice weekly) to evaluate
the potential of moving to a more convenient, commercially viable elraglusib dosing schedule. The Phase 2 trial enrolled its first patient
in October 2021 and the run-in part of the trial demonstrated that the weekly dosing of elraglusib was equivalent to twice weekly dosing
of elraglusib with no meaningful clinical difference in safety or efficacy. After the dose run-in part of the trial, all patients that
were randomized to the elraglusib/GnP arm received weekly elraglusib in addition to GnP. Last patient was enrolled in the first quarter
of 2024.

Key inclusion criteria included
patients that were 18 years or older with metastatic pancreatic adenocarcinoma and no prior therapy with measurable disease as defined
by RECIST1.1.

The primary endpoint for this
study was mOS, with OS summarized throughout the study by estimates of 1-year survival. Secondary endpoints were overall response rates
(“ORR”), median progression-free survival (“mPFS”), disease control rate (“DCR”) and adverse events.

Updated study results were
presented at the ASCO GI conference in January 2026 utilizing a data cutoff of November 22, 2025. Log-rank analysis was used to determine
statistical significance when comparing the two arms of the study. Data presented in the pre-specified safety population showed that the
trial met its primary endpoint of improved mOS in patients in the elraglusib/GnP arm versus the GnP control arm. The analysis of updated
data demonstrated treatment with elraglusib/GnP resulted in statistically significant increases in 1-year survival rate (p-value of 0.0004)
and mOS (10.1 months vs 7.2 months, HR=0.62, log-rank p=0.02) with a 38% reduction in the risk of death versus treatment with GnP alone.

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The following table provides
additional Phase 2 study results as of the November 22, 2025 cutoff date:

Safety Population

Elraglusib/GnP

(n=155)

GnP

(n=78)

Primary Endpoint: mOS (months)

HR=0.62; log-rank p=0.02*

10.1

7.2

12-month OS (%) p=0.0004*

44.4

22.3

Number (%) of death events

128 (82.6)

74 (94.9)

18-month OS (%)

22.9

6.6

24-month OS (%)

12.9

2.6

_____________________

*statistically significant

In addition, updated data showed there were numerically
improved ORR, mPFS, and DCR in the elraglusib/GnP combination arm versus the GnP arm as noted in the below table.

Safety Population

Elraglusib/GnP

(n=155)

GnP

(n=78)

ORR (%)

28.4

21.8

mPFS (months)

5.6

5.1

DCR (%)

39.4

29.5

Figure 3 depicts the interim
Kaplan-Meier estimate for mOS as of November 22, 2025 cutoff and other endpoints in the study, including primary and secondary endpoints
and patients remaining on study for each treatment arm as well as landmark OS endpoints at 18- and 24-months.

Figure 3: Unaudited Phase 2 data of elraglusib
in mPDAC (data as of November 22, 2025 cutoff).

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As with all preliminary analyses
of interim data, this data should not be relied upon as a final analysis and is subject to change once full data analysis is complete.

Treatment-emergent adverse
events (“TEAEs”) and Serious Adverse Events (“SAEs”) in the elraglusib/GnP combination arm were similar to those
observed in the GnP arm, indicating a favorable risk-benefit profile for the elraglusib/GnP combination. TEAEs broadly encompass all
adverse events observed while a patient is on study and could be due to the drug or drugs (if used in combination), the disease or something
specific to a particular patient such as other diseases or illness. It is then up to the individual clinical investigator to decide which
toxicities are due to elraglusib. The most common TEAEs attributed to elraglusib were transient visual disturbance and fatigue across
both study parts, and the majority of TEAEs that occurred in ≥ 20% of patients were reported as Grade 1 or 2 (Figure 4). Visual disturbance
affected 68.4% of patients (n=106/155) receiving elraglusib/GnP and 9.0% of patients (n=7/78) receiving GnP alone. Commonly reported
symptoms were darkened vision, where patients described lights visually appearing brighter and skin tones visually appearing darker.
Greater than 99% of visual disturbance cases were reported as mild or moderate (Grade 1 or 2). All cases of visual disturbance were transient,
resolved completely, and lacked any associated retinal, ocular, or systemic toxicity. Fatigue, while also observed in ≥ 20% of patients,
was also reported as mild or moderate (Grade 1 or 2) and did not interfere with daily life.

Figure 4 below is a summary
of TEAEs of any grade reported in ≥20% of patients treated with elraglusib/GnP versus GnP alone as of November 22, 2025 data cutoff.

Patients,
n (%)

Adverse Event

Elraglusib/GnP

(n=155)

GnP

(n=78)

Any Grade
Grade ≥3
Any Grade
Grade ≥3

Any TEAE
155 (100)
140 (90.3)
77 (98.7)
62 (79.5)

Serious TEAE
87 (56.1)
82 (52.9)
44 (56.4)
43 (55.1)

Leading to Stoppage of Any Study Drug
43 (27.7)
26 (16.8)
22 (28.2)
17 (21.8)

Resulting in death
19 (12.3)
19 (12.3)
13 (16.7)
13 (16.7)

TEAEs
of any Grade in ³20%
of Patients

Visual Impairment
106 (68.4)
1 (0.6)
7 (9.0)
0

Fatigue
97 (62.6)
26 (16.8)
40 (51.3)
4 (5.1)

Neutropenia
97 (62.6)
83 (53.6)
32 (41.0)
25 (32.1)

Diarrhea
92 (59.4)
15 (9.7)
38 (48.7)
6 (7.7)

Nausea
90 (58.1)
11 (7.1)
38 (48.7)
4 (5.1)

Alopecia
71 (45.8)
0
27 (34.6)
0

Anemia
70 (45.2)
39 (25.2)
37 (47.4)
26 (33.3)

Decreased appetite
66 (42.6)
9 (5.8)
19 (24.4)
6 (6.7)

Thrombocytopenia
58 (37.4)
17 (11.0)
25 (32.1)
6 (7.7)

Vomiting
59 (38.1)
5 (3.2)
30 (38.5)
1 (1.3)

Edema peripheral
57 (38.1)
3 (1.9)
26 (33.3)
0

Constipation
49 (31.6)
3 (1.9)
24 (30.8)
1 (1.3)

Pyrexia
44 (28.4)
2 (1.3)
20 (25.6)
1 (1.3)

Abdominal pain
46 (29.7)
14 (9.0)
16 (20.5)
2 (2.6)

Weight decreased
46 (29.7)
5 (3.2)
17 (21.8)
3 (3.8)

Peripheral sensory neuropathy
40 (25.8)
4 (2.6)
18 (23.1)
0

Hypokalemia
35 (22.6)
8 (5.2)
24 (30.8)
4 (5.1)

Asthenia
33 (21.3)
9 (5.8)
19 (24.4)
5 (6.4)

Dysgeusia
32 (20.6)
0
16 (20.5)
0

Leukopenia
31 (20.0)
22 (14.2)
12 (15.4)
9 (11.5)

Neuropathy peripheral
21 (13.5)
1 (0.6)
18 (23.1)
0

Figure 4: TEAEs
of Any Grade Reported in ≥20% of Patients Treated.

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Additional updated data
as of November 22, 2025 are shown in Figures 5 and 6. As with all interim data, this data should not be relied upon as a
final analysis and is subject to change once full data analysis is complete.

Figure 5 summarizes
additional details regarding the demographics and disease history of the enrolled patient population in each arm of the study.

Demographics

GnP
(n=78)
Elraglusib
/GnP (n=155)

Sex

Female
35 (44.9%)
75 (48.4%)

Male
43 (55.1%)
80 (51.6%)

Age (years)

n (%)
78 (100%)
155 (100%)

Mean (S.D.)
66.2 (9.9)
65.1 (9.1)

Median
68.0
65.0

Min, Max
42.0, 85.0
42.0, 86.0

Race

Asian
2 (2.6%)
5 (3.2%)

Black or African American
6 (7.7%)
7 (4.5%)

White
65 (83.3%)
128 (82.6%)

Multiracial
0
1 (0.6%)

Unknown/Not Reported
5 (6.4%)
14 (9.0%)

Ethnicity

Hispanic or Latino
0
8 (5.2%)

Not Hispanic or Latino
77 (98.7%)
141 (91.0%)

Unknown/Not Reported
1 (1.3%)
6 (3.9%)

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Body Surface Area (BSA) (m2)

n (%)
78 (100%)
155 (100%)

Mean (S.D.)
1.83 (0.26)
1.83 (0.23)

Median
1.82
1.81

Min, Max
1.31, 2.77
1.30, 2.62

Eastern Cooperative Oncology Group Performance Status

0
31 (39.7%)
64 (41.3%)

1
45 (57.7%)
89 (57.4%)

2
2 (2.6%)
2 (1.3%)

Disease Status

Metastatic at Initial Diagnosis
60 (76.9%)
108 (69.7%)

Metastatic at Study Entry
77 (98.7%)
154 (99.4%)

Site of Metastases

Pancreas
68 (87.2%)
123 (79.4%)

Liver
61
(78.2%)
112 (72.3%)

Lymph
Node
27 (34.6%)
69 (44.5%)

Lung
26 (33.3%)
59
(38.1%)

Figure 5: Patient demographics and disease history
as of November 22, 2025 cutoff.

Figure 6 below is a
graphical representation of survival (“mOS Swim Plot’”) of each patient enrolled in the Phase 2 study in the
elraglusib/GnP arm versus the GnP control arm.

Figure
6: mOS Swim Plot as of November 22, 2025.

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During the first half of 2026,
we plan to meet with the FDA and EMA to discuss the design and execution of a Phase 3 global registration study to support potential
product registration.

Elraglusib Injection for the Treatment of Pediatric
Cancers

Elraglusib Injection is also
being evaluated in pediatric cancer patients with recurrent/refractory solid cancers. The Actuate-1902 study was an open-label, multicenter
Phase 1/2 study evaluating the safety and efficacy of elraglusib in 40 pediatric patients ages 3 – 21 with relapsed (>2 remissions)/refractory
cancers, including EWS, neuroblastoma, Central Nervous System (“CNS”) tumors, non-EWS sarcomas, and other refractory pediatric
malignancies. This trial evaluated escalating doses of elraglusib as a single agent as well as in combination with irinotecan or cyclophosphamide/topotecan
in the Phase 1 portion of the trial. The Phase 1 dose escalation portion of the trial was designed primarily to determine the maximum
tolerated dose (“MTD”) and/or RP2D of elraglusib as a single agent and in combination with chemotherapy. While an MTD was
not reached, initial evidence of anti-tumor activity was observed, particularly when elraglusib was administered with a standard cyclophosphamide
and topotecan regimen. Two Complete Metabolic Responses (“CMRs”) were observed in patients with relapsed/refractory metastatic
EWS and one Complete Response (“CR”) was observed in a patient with relapsed/refractory metastatic neuroblastoma. The Phase
1 portion of this study was closed in July 2025. Key highlights from the Actuate-1902 study include:

Elraglusib in combination with cyclophosphamide
and topotecan regimen:

·Clinical responses and disease control observed
in 10 of 19 patients with relapsed/refractory EWS or neuroblastoma.

oOne patient with six prior treatments for EWS achieved a CMR with a 60% reduction in tumor size of a lung
target lesion. This patient completed 30 weeks (Cycle 10) on treatment with long term treatment with elraglusib monotherapy continuing
without disease progression outside of the study.

oOne patient with four prior treatments for EWS (+EWSR1 translocation or Ewing sarcoma breakpoint region
1) was identified as a CR (BOR) at week 9 (Cycle 3) with CT scan showing a 100% decrease in piriformis muscle tumor compared to baseline
(CMR by Positron Emission Tomography or PET).

oOne patient with six prior treatments for unfavorable neuroblastoma histology (Indeterminate MYCN, ALK
(anaplastic lymphoma kinase), and ploidy) had a first response at week 9 (Cycle 3) of stable disease (“SD”), with a BOR of
a complete bone marrow response identified at week 27 (Cycle 9).

oOne patient with 10 prior treatments for DSRCT (Desmoplastic Small Round Cell Tumor) achieved a PR (52.6%
decrease in liver/lung target lesions compared to baseline). Non-target lesions included multiple lung and liver lesions, which were not
present at the end of treatment.

oSix patients with prior treatments ranging from 2 to 11, achieved a BOR of stable disease.

Elraglusib in combination with irinotecan regimen:

·Four patients (neuroblastoma, ganglioneuroblastoma
(a high-risk variant with an unfavorable prognosis)) achieved BOR of stable disease.

·One patient with neuroblastoma achieved a 35%
reduction in tumor burden between baseline and week 9 (Cycle 3).

·One patient with ependymoma experienced stable
disease with a prolonged time to progression of 54 weeks.

Based on these data, we identified
Ewing sarcoma and neuroblastoma as new indications for further development of Elraglusib Injection. Given that Ewing sarcoma and neuroblastoma
are very rare pediatric cancer indications, an international consortium of investigators and sites will be needed to advance this program
to registration. In addition, we plan to pursue a number of development incentives in the United States and parallel programs in the EU.
In July 2024, we received ODD from the FDA for elraglusib for the treatment of soft tissue sarcomas in the United States and Orphan Medical
Product Designation from the EMA for the treatment of sarcoma. In October 2024, we received Rare Pediatric Disease Designation (“RPDD”)
from the FDA for the treatment of EWS. The ability to engage in further development in pediatric cancers will depend on our ability to
raise sufficient additional capital to support this path. We believe that pursuing this development could be an efficient and rapid path
to registration in the United States and Marketing Authorization in the EU.

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Elraglusib Oral Tablet for the Treatment of
Solid Tumors

We initially developed an
oral liquid that was evaluated for bioavailability in a Phase 1 healthy volunteer study (Actuate-2203) in a single dose cross-over
design such that each subject on the study received IV, oral liquid after fasting and oral liquid with food. Elraglusib oral liquid was
greater than 50% bioavailable when given with food and was very well tolerated by healthy volunteers.

Consequently, we developed several oral tablet prototype formulations that were evaluated for bioavailability in dogs, and an oral tablet
candidate was identified with greater than 95% orally bioavailable when given with food. In the study, the oral drug had an AUC24 (Area
Under the serum Concentration vs. time curve for 0-24 hours) of 77,000 ng•h/mL (nanograms times hours per milliliter) after a single
250 mg oral tablet and 137,000 ng•h/mL after oral administration of 500 mg (2 x 250 mg tablets). We expect that steady state exposures
of 77,000 ng•h/mL or greater will be possible with the Elraglusib Oral Tablet at well-tolerated doses in humans. We believe that
we will be able to administer the Elraglusib Oral Tablet daily, which may allow the drug to achieve steady state levels in plasma in
patients resulting in continuous inhibition of the target GSK-3 in the tumor and tumor-associated cells. Based on the potential for daily
dosing, we believe this will allow for additional opportunities to explore the anti-tumor activity of elraglusib with the oral tablet
that could not be achieved with Elraglusib Injection.

Our lead clinical candidate
tablet, the Elraglusib Oral Tablet, has been selected for further development, and we are planning a Phase 1/2 dose escalation study to
identify the MTD and RP2D for Elraglusib Oral Tablet in adult patients with advanced, refractory cancers, subject to future funding. Once
we have determined a RP2D, several Phase 2 studies have been identified for further clinical development of Elraglusib Oral Tablet based
on data from the Actuate-1801 study in indications, including but not limited to, refractory, metastatic melanoma and refractory, metastatic
colorectal cancer, and non-small lung cancer.

Investigator-Initiated Trials

In addition to company-sponsored
trials, we have collaborated with a number of investigators through investigator-initiated trials (“IIT”) to evaluate elraglusib
in new indications and with new drug combinations. Two of these IITs will provide exploratory data on the combination of elraglusib and
FOLFIRINOX as a first-line treatment for mPDAC and may provide a rationale for developing elraglusib in combination with FOLFIRINOX or
NALIRIFOX as another first-line treatment for mPDAC. Since either GnP or FOLFIRINOX are currently used to treat the majority of patients
with mPDAC, we believe that elraglusib has the potential to treat a large segment of patients diagnosed with mPDAC.

In August 2025, we supported
commencement of a Phase 1b IIT with UPMC Hillman Cancer Center. The trial is evaluating elraglusib in combination with Incyte’s
PD-1 inhibitor, retifanlimab, and modified FOLFIRINOX (“mFOLFIRINOX”) as front-line therapy in advanced pancreatic adenocarcinoma
in up to 12 patients. This IIT is an open-label, single-arm RiLEY (NCT06896188) trial, led by Anwaar Saeed, MD, Associate Professor of
Medicine, and Chief of the Gastrointestinal Medical Oncology at UPMC Hillman Cancer Center. The primary objective of the trial is to determine
the RP2D for the combination regimen, while the secondary objectives include evaluation of ORR, DCR, mPFS, OS, and assessment of safety
and tolerability. The trial is currently open for enrollment, and four patients have been enrolled as of February 28, 2026.

In February 2022, we supported
commencement of a Phase 2 IIT to determine the safety, tolerability, and progression-free survival of the combination of elraglusib with
FOLFIRINOX and losartan in adults with untreated metastatic pancreatic adenocarcinoma. The IIT is being led by Colin Weekes, MD Ph.D.
at Massachusetts General Hospital and is supported by us and the Lustgarten Foundation. Additional sites participating in the study include
The University of Colorado and the University of Washington’s Fred Hutchinson Cancer Center. This study administers elraglusib by
IV infusion twice weekly in combination with FOLFIRINOX administered once every 14 days and daily losartan in adults with pancreatic
cancer who have not received any prior systemic therapy for advanced disease. A total of 49 patients have been enrolled in the study.
We expect to receive all final data from this study, which is considered exploratory and may inform future development of elraglusib in
2026.

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Our Market Opportunity

Treatment of Metastatic Pancreatic Ductal Adenocarcinoma
(“mPDAC”)

According to the American
Cancer Society, the annual incidence of pancreatic cancer is expected to exceed 67,000 patients in the United States in 2026, and the
majority of these patients will present with metastatic disease. The Pancreatic Cancer Treatment Market Size Report, 2030 by Grand View
Research, estimates the current global market for treating pancreatic cancer was approximately $2.9 billion in 2024 and is expected to
grow to $5.8 billion by 2030 based on the growing aging population and associated rise in lifestyle-related diseases.

Current first-line therapies
for mPDAC consist of GnP, FOLFIRINOX, or irinotecan liposomal injection given with oxaliplatin, fluorouracil, and leucovorin (“NALIRIFOX”).
NALIRIFOX was approved in February 2024 and may provide an alternative to FOLFIRINOX with a somewhat improved safety profile.

We are developing elraglusib
for patients in mPDAC who have not previously received systemic treatment for their metastatic disease. Due to lack of early symptoms,
approximately 80-90% of all patients with pancreatic cancer are unresectable, and present with advanced or metastatic disease. In addition,
80-90% of PDAC cases do not have a high tumor mutational burden in general, and are unlikely to respond to checkpoint inhibitors such
as pembrolizumab. Pembrolizumab has been approved for patients with metastatic solid cancer with high tumor burden but is rarely used
in metastatic pancreatic cancer for this reason. However, frequent mutations in KRAS and TP53 oncogenes drive pancreatic tumor growth
and treatment resistance, often making PDAC refractory to chemotherapy.

A recent review of real-world
clinical trials in Future Oncology showed
that the mOS in patients with mPDAC treated with GnP ranged from approximately 3.6 to 9.8 months with an unweighted mOS of 6.9 months.
Therefore, we believe the ability to extend survival by even a few months would be considered meaningful in this patient population.

We believe elraglusib may
improve outcomes in first-line mPDAC regardless of the chemotherapy backbone used by doctors. Patients with mPDAC are often resistant
or become resistant to the first-line chemotherapy backbones currently used to treat them. One of the mechanisms of action of elraglusib
is the ability to enhance chemotherapy activity even in resistant tumors, and we believe this has been demonstrated in multiple animal
tumor models. Elraglusib has shown the ability to enhance the activity of several chemotherapy drugs that comprise the current first-line
backbones in mPDAC including gemcitabine, nab-paclitaxel and irinotecan, suggesting the potential for elraglusib to be used in combination
with multiple first-line mPDAC treatments.

Treatment of Pediatric Cancers

EWS is a rare malignancy that
occurs primarily in the bone or in the soft tissue around a bone. The tumor is most common in older children and adolescents, but it can
occur at any age. According to American Cancer Society, Ewing sarcoma accounts for about 1% of all childhood cancers and approximately
200 children and adolescents in the United States are diagnosed annually with EWS. Treatment options include surgery, radiotherapy, chemotherapy,
and tyrosine kinase inhibitors. The response to therapy is dependent on the stage of the tumor. Overall, the 5-year survival rates range
from 81% for patients with localized disease to 41% for patients with metastatic disease. The five-year survival rate for patients who
have recurrent (relapsed) disease is <30% with no known treatment regimens that meaningfully extend life in Ewing sarcoma patients
with metastatic, refractory disease.

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Neuroblastoma is a rare cancer
of the early nerve cells, called neuroblasts, that make up the nerves in our bodies. According to American Cancer Society, neuroblastoma
is the most common cancer in infants who are less than 1 year old. There are about 600 to 800 new cases of neuroblastoma each year in
the United States. The 5-year survival rates range from 95% for lower risk patients to 60% for patients with higher risk disease per the
American Cancer Society, and neuroblastoma claims more lives of children under the age of 5 than any other cancer.

The FDA has granted RPDD to
elraglusib for our treatment of EWS and neuroblastoma. Rare Pediatric Disease Designation is granted by the FDA for serious or life-threatening
diseases that affect fewer than 200,000 people in the United States and in which the serious or life-threatening manifestations primarily
affect individuals less than 18 years of age. If, in the future, a New Drug Application (“NDA”) for elraglusib for the treatment
of Ewing sarcoma or neuroblastoma is approved by the FDA, we may be eligible to receive a Priority Review Voucher (“PRV”)
that could be utilized by us or potentially sold to another company for its use.

About GSK-3β

There are no approved high-affinity
inhibitors of GSK-3β, and we believe elraglusib is one of the most advanced GSK-3β inhibitors in clinical development.

GSK-3β inhibition may
exert anticancer activity through a variety of mechanisms that may be context and cancer type specific. For example, GSK-3β mediates
signaling of oncogenic PI-3K but if this oncogene is not expressed in a particular tumor, this would not be a pathway that could be targeted
by elraglusib in that tumor. Potential antitumor activity through GSK-3β inhibition may occur through multimodal mechanisms of action,
including:

(1)Immune modulation;

(2)Inhibiting cell proliferation;

(3)Reducing tumor fibrosis;

(4)Decreasing immune evasion;

(5)Increasing apoptosis and disrupting DNA damage repair; and

(6)Inhibition of epithelial-mesenchymal transitions (“EMT”).

GSK-3β plays an important
role in immune cell function, as inhibition of GSK-3β can facilitate immune cell expansion, differentiation and activation including
T and natural killer (“NK”) cells. Inhibition of GSK-3β leads to inhibition of tumor cell proliferation as shown in multiple
tumor model systems using elraglusib. A number of pathways have been implicated in the inhibition of cell proliferation mediated by GSK-3β
inhibitors including MYC, Cyclin D1, TGFα, epidermal growth factor receptor, Ras, PI3K/Akt, and NF-κB. Also, a chronic inflammatory
microenvironment is conducive to tumorigenesis (e.g., pancreatitis patients are known to have increased risk of pancreatic cancer), and
tumors can undergo EMT, leading to increased metastasis, under inflammatory conditions. Further, GSK-3β has also been demonstrated
to be a mediator of EMTs. Therefore, the inflammatory response designed to fight tumor progression also ends up promoting metastasis and
tumor-associated fibrosis. In addition, a number of studies have suggested that the primary mechanism of GSK-3β -mediated apoptosis
is through the NF-κB pathway. Studies have shown that eliminating or inhibiting GSK-3β in cancer cells is able to restore apoptosis
to cells, leading to tumor cell death. These findings support GSK-3β as a potential therapeutic target to potentiate apoptosis in
cancer cells. GSK-3β has been shown to be a mediator of a number of signaling pathways that regulate the transition of tumor cells
from an epithelial to mesenchymal phenotype potentially contributing to tumor progression, a process known as EMT. Signaling through Wnt,
Notch, TGF-β and Snail are known mediators of EMT, and their signaling is regulated through GSK-3β. Several toolkit GSK-3β
inhibitors have been shown to inhibit EMT in tumor models suggesting that this is a class effect and highlighting a similar mechanism
for elraglusib.

13

License Agreements

Northwestern University License Agreement

We licensed the exclusive
worldwide rights to materials and non-exclusive rights to certain know-how relating to the use for therapeutic, diagnostic and commercial
research purposes of elraglusib and related compounds in cancer and combination therapies from NU pursuant to that certain royalty-free
license agreement between us and NU dated March 31, 2015, as amended on April 29, 2019 (as amended, the “NU License Agreement”).

Pursuant to the NU License
Agreement, NU granted us (i) a nonexclusive license to certain technical information developed in the laboratory of Dr. Mazar,
and (ii) an exclusive license to all results obtained by Dr. Mazar and his collaborators at NU on the use of the GSK-3β
inhibitor 9-ING-41 and related compounds used for the treatment of cancer and combination therapies. The term of the NU License Agreement
continues in effect until the expiration of the last to expire of patent rights covering 9-ING-41 and related GSK-3 inhibitors (see the
discussion under “Intellectual Property” below for a discussion of our expected patent terms), unless earlier
terminated by NU due to our making a general assignment for the benefit of creditors, initiation of bankruptcy proceedings by or against
us or the appointment of a receiver or trustee to take possession of our property, or by either party following 90 days’ notice
of a material breach of the NU License Agreement that is not then cured. The NU License Agreement terms are subject to the provisions
of the Bayh-Dole Act, including requiring us to substantially manufacture products related to the license in the United States, unless
waived. While the drug substance (“DS”) for elraglusib is manufactured by a supplier in China, the end drug product is substantially
manufactured in the United States.

In consideration of the license
granted by NU, we issued 27,778 shares of our common stock to NU, which represented 5% of our then-outstanding fully-diluted shares and
agreed to customary confidentiality and progress update obligations and to indemnify NU for any claims arising from our use of the licensed
rights under the NU License Agreement.

UIC Exclusive License Agreement with Equity

The exclusive rights to Patent
Rights (as defined in the UIC License Agreement and described further below) and Technical Information (as defined in the UIC License
Agreement) surrounding GSK-3 inhibitors for Neurodegenerative Disorders were licensed through an Exclusive License Agreement with Equity
between us and UIC, dated April 6, 2015, as amended on April 24, 2019 (as amended, the “UIC License Agreement”).
Under the UIC License Agreement, the Patent Rights relate to certain patents relating to 3-Benzofuranyl-4-Indolyl Maleimides, the last
of which is scheduled to expire on March 16, 2028, not including any Patent Term Extension (“PTE”), which we may apply
for under Title II of the Drug Price Competition and Patent Term Restoration Act of 1984 (“Hatch-Waxman”), 35 U.S.C. §156.
The following summarizes the key terms set forth in the UIC License Agreement.

Pursuant to the UIC License
Agreement, UIC granted us (i) an exclusive, nontransferable license, with the right to sublicense under UIC’s rights in the
Patent Rights, and (ii) a non-exclusive, non-transferable license, with the right to sublicense, to use UIC’s rights in the
Technical Information within the specified territory (which is where the Patent Rights exist for such rights and worldwide for the Technical
Information) for all uses other than rights reserved by UIC for non-commercial purposes, including teaching, research and public service
and publishing information included in the Patent Rights and the Technical Information. The term of the UIC License Agreement continues
in effect until the later of (x) expiration of the last to expire of the Patent Rights, (y) notice from us that the use of the
Technical Information has ceased, and (z) the expiration of the last form of market exclusivity for products using the licensed technology.
The UIC License Agreement may also be earlier terminated by UIC in the event of certain breaches of its terms that are not cured following
a notice period or initiation of bankruptcy proceedings by or against us or the imposition of any lien or encumbrance on the licensed
technology. We may also terminate the UIC License Agreement for any reason following 90 days’ notice.

14

In consideration of the license
granted under the UIC License Agreement, we issued 46,528 shares of our common stock to UIC, which represented 5% of our capital stock
on a fully-diluted basis as defined in the UIC License Agreement, and agreed to pay UIC (i) development milestones of up to $1.25 million,
of which, up to $0.25 million is due upon the progress of clinical trials and $1.0 million is due upon the initiation of commercial
sales (ii) increasing annual minimum royalty payments reaching $50,000 in year six and thereafter, (iii) royalty on net sales
for product covered under the Patent Rights in the low single digits with a 50% reduction in royalties for products solely utilizing Technical
Information, (iv) a declining percentage of sublicensing revenue based on the escalating stage of development upon a sublicensing
event, and (v) the reimbursement of all patent and related expenses incurred by UIC covering the Patent Rights. We also agreed to
customary confidentiality and progress update obligations, to indemnify UIC for any claims arising from our use of the licensed rights
under the UIC License Agreement.

The UIC License Agreement
obligates us or a sublicensee to commercialize the licensed technology, including to achieve the development events specified in the agreement,
including progress through clinical trials and achieving commercialization. UIC may also identify feasible uses of the licensed technology
and, unless we demonstrate that we are pursuing such development or such development is not feasible within a specified period, UIC may
terminate the UIC License Agreement or the exclusivity of the licensed rights. As of the date hereof, we have met all existing milestones
as provided for in the UIC License Agreement. We are also responsible for the prosecution and maintenance of the licensed patents, at
our expense and using commercially reasonable efforts. We have the sole right to enforce the licensed patents, at our expense. The UIC
License Agreement terms are subject to the provisions of the Bayh-Dole Act, including requiring us to substantially manufacture products
related to the license in the United States, unless waived. While the DS for elraglusib is manufactured by a supplier in China, the end
drug product is substantially manufactured in the United States.

In addition, we entered into
a sublicense and collaboration agreement dated August 28, 2017 with an unrelated entity that was covered under the UIC License Agreement,
which sublicense agreement was later terminated on January 31, 2018. Under the UIC License Agreement, the Company owed UIC a certain percentage
of amounts received under the sublicense agreement in the amount of $449,990. The Company paid UIC 10% of the sublicense fees in the amount
of $44,999 and the remaining unpaid balance of $404,991 (“Deferred Amount”) was originally due and payable to UIC in two installments:
50% due and payable on the one-year anniversary from the first commercial sale and 50% due on the second-year anniversary from the first
commercial sale. The Deferred Amount is treated as debt and continues to accrue interest at a rate of five percent (5%) per annum, representing
the prime rate as of the date of the agreement plus 1%, payable annually within 30 days following the second anniversary of the closing
of the IPO and annually thereafter. On July 16, 2024, the Company and UIC entered an amendment to the UIC License Agreement (“UIC
Amendment”). Pursuant to the UIC Amendment, the payment of the Deferred Amount and any accrued interest thereon is due upon the
sooner of (i) termination of the UIC License Agreement by the Company, (ii) the Company ceases development of the licensed UIC technology,
(iii) the Company consummates a Change in Control (as defined in the UIC License Agreement), (iv) the Company sublicenses the licensed
technology or the developed product, (v) the one-year anniversary following approval of a NDA of a licensed product, or (vii) the Company
executes a partnership agreement with any entity resulting in the payment to us above a specified milestone amount or the Company secures
cumulative financing equal to or exceeding $200 million. In addition, the UIC Amendment provides that to the extent the Company secures
equity financing equal to or exceeding $85 million through its IPO or otherwise, 50% of the Deferred Amount is due and payable within
30 days. The remaining 50% of the Deferred Amount shall be due and payable upon the first to occur of any of the events noted above in
clauses (i) through (vii). Finally, the UIC Amendment provides that for as long as the Company or a sublicensee is selling the licensed
product, the Company will pay all consideration provided for in the original UIC License Agreement and described above until the last
to expire market exclusivity date, the period of which for all products in a jurisdiction will not exceed a total of seven (7) years beginning
with the date regulatory approval is granted for the first licensed product in the jurisdiction, and such obligation will survive termination
of the UIC License Agreement.

15

Collaboration Agreement

We entered into a Collaboration
Agreement with Lantern Pharma in 2021 under which the parties are collaborating on utilization of Lantern Pharma’s platform to develop
novel biomarker-derived signatures for use with our product candidates. As part of the collaboration, Lantern Pharma received 13,889 restricted
shares of our common stock, which vested upon meeting certain conditions of the collaboration, as well as the potential to receive additional
shares if results from the collaboration are utilized in future development efforts. Certain affiliates of the Bios Equity Affiliated
Funds (as defined below), which is our largest stockholder, beneficially owned greater than 10% of Lantern Pharma’s common stock
as of December 31, 2025. Through December 31, 2025, no revenue has been recognized by either party under this agreement.

Intellectual Property

The proprietary nature of,
and protection for, our product candidates and their methods of use and compositions of matter are an important part of our strategy to
develop and commercialize novel medicines, as described in more detail below. Our policy is to file patent applications to protect technology,
inventions and improvements to inventions that are commercially important to the development of our product candidates and our business.
We seek U.S. and foreign patent protection for a variety of technologies. We also intend to seek patent protection or rely upon trade
secret rights to protect other technologies that may be used to discover and validate targets and identify and develop novel products.
We seek protection, in part, through confidentiality and proprietary information agreements. We are a party to various other license agreements
that give us rights to use specific technologies in our research and development.

As of December 31, 2025,
we own or have licensed 119 issued patents and pending patent applications worldwide, including four pending international Patent Cooperation
Treaty (“PCT”) patent applications, which are material to the programs described in this Report. Three of these issued worldwide
patents are owned by UIC, which has granted us exclusive license rights to the technology.

With respect to our elraglusib
program, as of December 31, 2025, we own or exclusively in-license one patent family focused on the elraglusib molecule and/or related
compounds. The exclusively in-licensed patent family for elraglusib and related compounds (the original patent in-licensed from UIC) includes
one granted U.S. patent, one granted European patent (with validation in 5 countries) and one granted Canadian patent, which are directed
to 3-Benzofuranyl-4-Indolyl Maleimides compounds. The U.S. patent is expected to expire in 2028.

Actuate subsequently discovered
that elraglusib exists as only two polymorphs and filed composition of matter patents covering both polymorphs. The patent family covering
“Polymorph I” is based on PCT/US2018/046203 9-ING-41 Polymorph I Composition of Matter and includes two granted patents in
the U.S. (US 11,136,334 and 12,145,943) and three granted patents in Mexico, and two granted patents in Australia and Japan, one granted
patent in each of China, Europe (with validation in 18 countries), Israel, and South Korea, and pending patent applications in Australia,
Brazil, Canada, China, Hong Kong, Israel, Japan, Macao, South Korea, South Africa and the U.S., which are directed to a polymorph of a
GSK-3β inhibitor, compounds, pharmaceutical compositions, methods of preparing and uses for treating cancers. The U.S. patent is
expected to expire in 2038.

The patent family we own that
covers elraglusib “Polymorph II” is based on PCT/US2018/056083 9-ING-41 Polymorph II Composition of Matter and includes two
granted U.S. patents (US 11,407,759 and 12,116,374), one granted patent in each of Europe (validated in France, Austria, Belgium, Switzerland,
Germany, Denmark, Spain, Finland, the United Kingdom, Greece, Ireland, and Italy) Australia, China, Mexico and Macao, South Korea, Japan,
and Israel, and pending patent applications in Brazil, Canada, the European Patent Office, Japan, South Africa and the U.S., which are
directed to a polymorph of a GSK-3β inhibitor, compounds, pharmaceutical compositions, methods of preparing and uses for treating
cancers. The U.S. patent is expected to expire in 2038.

The patent family we own that
covers oral dosage forms of elraglusib is based on PCT/US2023/069158. Patent applications are pending in Australia, Brazil, Canada, China,
Europe, Israel, India, Japan, South Korea, Mexico, Hong Kong, South Africa, and the U.S.

16

The term of individual patents
depends upon the legal term of the patents in the countries in which they are obtained. In the United States, the patent term is 20 years
from the earliest date of filing a non-provisional patent application. In the United States, a patent’s term may be shortened if
a patent is terminally disclaimed over another patent or as a result of delays in patent prosecution by the patentee, and a patent’s
term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the USPTO in granting a patent.
Patent term may also be extended up to five years due to regulatory delay (Patent Term Extension or “PTE”). We may apply
for PTE under Title II of the Hatch-Waxman Act for any one of the U.S. Patents, however there is no guarantee that PTE would be granted
for any patent.

We intend to continue to regularly
assess opportunities for seeking patent protection for those aspects of our discoveries that we believe provide a meaningful competitive
advantage. However, because patent filings can be time-consuming and expensive, our ability to do so may be limited until such time as
we are able to generate cash flow from operations or otherwise raise sufficient capital to continue to invest in our intellectual property.
For example, maintaining patents in the United States and other countries requires the payment of maintenance fees which, if we are unable
to pay, may result in loss of our patent rights. If we are unable to do so, our ability to protect our intellectual property or prevent
others from infringing our proprietary rights may be impaired.

Commercial Plan

We intend to retain significant
development and commercialization rights to our product candidates and, if marketing approval is obtained, to commercialize our product
candidates on our own, or potentially with a partner, in the United States and other regions. We currently have no sales, marketing and
commercial product distribution capabilities. We intend to build the necessary infrastructure and capabilities over time for the United
States, and potentially other regions, in connection with the advancement of our product candidates. Clinical data, the size of the addressable
patient population, the size of the commercial infrastructure and manufacturing needs, the status of our pipeline and other factors, may
all influence or alter our commercialization plans.

Manufacturing

We work with third-party suppliers
and manufacturers to support the manufacturing of elraglusib for clinical studies and our research activities and, if we receive regulatory
approval, we intend to rely on such third parties for commercial manufacture. We do not own or operate, and currently have no plans to
establish any manufacturing facilities. We currently obtain our investigational product from these third-party manufacturers on a purchase
order basis and do not have any long-term supply agreements in place. In order to de-risk our supply chain, and as we advance toward potential
commercialization, we may enter into long-term supply agreements as well as evaluate additional product manufacturing sources.

Competition

The biotechnology and pharmaceutical
industries, and the oncology sector in particular, are characterized by rapid evolution of technologies, fierce competition and strong
defense of intellectual property rights. While we believe that our development programs, technology, knowledge, experience and scientific
resources provide us with competitive advantages, we face competition from major pharmaceutical and biotechnology companies, academic
institutions, government agencies and public and private research institutions, among others.

Any product candidates that
we successfully develop and potentially commercialize will compete with currently approved therapies and new therapies that may become
available in the future. Key product features that would affect our ability to effectively compete with other therapeutics include the
efficacy, safety and convenience of our products.

Our most advanced clinical
asset, Elraglusib Injection (“elraglusib”) is being evaluated in a Phase 2 clinical trial as a first-line treatment for mPDAC.
The current standard first-line treatments for mPDAC include GnP, FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin)
or NALIRIFOX (liposomal irinotecan, 5-fluorouracil, leucovorin and oxaliplatin), and are associated with modest overall survival benefit.

17

We are developing elraglusib
in combination with GnP as a first-line treatment for mPDAC. In addition, we are also supporting an ongoing IIT that will provide exploratory
data on the combination of elraglusib and FOLFIRINOX as a first-line treatment for mPDAC. This may provide a rationale for developing
elraglusib in combination with FOLFIRINOX or NALIRIFOX as another first-line treatment for mPDAC. Patients with mPDAC either have primary
resistance to these chemotherapy backbones (e.g., do not respond when treated) or develop resistance quickly (responses with GnP, FOLFIRINOX
and NALIRIFOX are transient and not very durable in most patients). Our management believes that elraglusib may improve outcomes in first-line
mPDAC regardless of the chemotherapy backbone used, although the clinical data does not yet support this hypothesis. Nevertheless, since
either GnP or FOLFIRINOX are currently used to treat the majority of patients with mPDAC and there is potential for combining elraglusib
with either of these chemotherapy regimens based on our ongoing clinical studies, we believe that elraglusib has the potential to treat
a large segment of patients diagnosed with mPDAC. Thus, our plan is to develop elraglusib in combination with the present first-line chemotherapy
regimens used in the treatment of mPDAC, as exemplified by its lead program of elraglusib/GnP and later moving to combinations with either
FOLFIRINOX or NALIRIFOX pending results of the IIT. If shown to be clinically meaningful, elraglusib plus standard of care chemotherapy
combinations could eventually be used to treat a large segment of patients with mPDAC. In addition, we are also supporting a recently
initiated Phase 1b IIT trial of elraglusib in combination with Incyte’s PD-1 inhibitor, retifanlimab, and modified FOLFIRINOX (“mFOLFIRINOX’)
as a frontline therapy in advanced PDAC, representing another combination therapy that could expand the potential of elraglusib in first-line
mPDAC.

Several other targeted therapies
are also being evaluated in Phase 3 in mPDAC. The panRAS inhibitor daraxonrasib (RMC-6236, Revolution Medicines, Inc.) is being evaluated
as a single agent in a Phase 3 trial (RASolute 303) in patients with previously untreated mPDAC. Arcus Biosciences, Inc. is also evaluating
their small molecule inhibitor of CD73 (quemliclustat) in combination with GnP in a Phase 3 trial (PRISM-1) also in patients with previously
untreated mPDAC. There are other studies combining immune checkpoint inhibitors, PARP inhibitors, various chemotherapies and other RAS
inhibitors in patients with mPDAC including second-line studies. Ongoing studies with many of these agents in mPDAC are generally non-randomized
at one or a limited number of sites, are too early to assess for commercial potential and may not represent a substantial competitive
threat to elraglusib because of their lack of broad suitability for most mPDAC patients. For example, the PARP inhibitor Lynparza (olaparib)
was recently approved as a maintenance therapy as it has been shown to significantly improve PFS and duration of response in patients
with BRCA-mutated mPDAC who have not progressed following first-line platinum-based chemotherapy. However, BRCA mutations are only present
in 4-7% of all PDAC patients. Olaparib is currently being evaluated as a therapeutic intervention in combination with a checkpoint inhibitor,
pembrolizumab, in patients with mPDAC in BRCA1 mutated patients.

Despite these efforts, the
vast majority of mPDAC patients still do not have an approved targeted therapy that can treat pancreatic cancer. If successful, we believe
the elraglusib/chemotherapy combination would introduce the first broadly targeted agent, elraglusib, as a treatment option for patients
with mPDAC and would have the potential to treat the majority of patients with mPDAC. A review of clinicaltrials.gov reveals that there
are several randomized studies for any novel drug or drug combination (not just targeted) in patients with mPDAC previously untreated
for metastatic disease, including the following:

·Onivyde® (Ipsen Pharma): Recently approved
for first-line mPDAC when used as part of the NALIRIFOX regimen based on an improvement in mOS of 1.9 months (NALIRIFOX mOS of 11.1 months
vs GnP mOS of 9.2 months).

·SBP-101 (Panbela Therapeutics, Inc.): A randomized,
double-blind, placebo-controlled, multicenter study (ASPIRE) of standard treatment with GnP with or without SBP-101 in subjects previously
untreated for mPDAC.

·Zolbetuximab and setidegrasib (Astellas): A randomized , open-label, Phase
2 study (8951-CL-5201) to assess the efficacy and safety of zolbetuximab (IMAB362) in combination with GnP as first-line treatment in
subjects with claudin 18.2 (cldn18.2) positive, metastatic pancreatic adenocarcinoma. Astellas is also planning a Phase 3 trial in 2026
of setidegrasib combined with mFOLFIRINOX in first-line mPDAC.

·Mitazalimab (Alligator Pharmaceuticals): An open-label,
multi-center Phase 1b/2 study (OPTIMIZE-1) to assess the clinical efficacy of mitazalimab in combination with chemotherapy in patients
with mPDAC. Mitazalimab is a CD40 agonist hypothesized to overcome the suppressive immune environment in PDAC. OPTIMIZE-1 evaluated the
combination of mitazalimab with mFOLFIRINOX in a single arm study in patients with previously untreated mPDAC and met its primary endpoint
with an ORR of 42.1% and OS of 14.9 months. Previous clinical studies using the CD40 agonist sotigalimab combined with GnP in patients
with previously untreated mPDAC did not meet their primary endpoint of 1 year OS compared to a historical 1-year OS of 35%.

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·Daraxonrasib (Revolution Medicines, Inc.): A
randomized Phase 3 trial (RASolute 303) in patients with first-line mPDAC that will evaluate daraxonrasib monotherapy and the combination
of daraxonrasib plus GnP, each compared to a control arm with GnP treatment. This study was recently initiated in the fourth quarter of
2025.

·Quemliclustat (Arcus Biosciences, Inc.): A randomized,
placebo-controlled, double-blind, Phase 3 trial (PRISM-1) of quemliclustat and chemotherapy versus placebo and chemotherapy in patients
with treatment-naive mPDAC.

·Atebimetinib (Immuneering Corporation): A randomized,
Phase 3 trial (MAPKeeper 301) of atebimetinib in combination with modified gemcitabine and nab-paclitaxel. This study is set to dose the
first patient in mid-2026.

·Certepetide (Lisata Therapeutics): A randomized,
placebo-controlled, Phase 2b trial (ASCEND) to measure the effect of adding certepetide,
compared to placebo, to chemotherapy (gemcitabine and nab-paclitaxel) in patients who have untreated mPDAC.

·Zabilugene almadenorepvec (Theriva Biologics):
A multicenter, open label, randomized, 2-parallel arm, Phase 2b trial (VIRAGE) evaluating intravenous zabilugene almadenorepvec in combination
with first-line standard of care chemotherapy in patients with newly-diagnosed mPDAC.

·Pelareorep (Oncolytics
Biotech): An open label, multi-indication biomarker, safety, and efficacy Phase 2 trial (GOBLET Cohort 5) to explore the safety and efficacy
of pelareorep and mFOLFIRINOX with or without atezolizumab in patients with mPDAC.

There are several other treatments
in development for locally advanced or mPDAC. The information cited above focuses only on select first-line treatments that are in clinical
trials in mPDAC. Quite a few of these are very early stage and therefore little information is available on clinical activity to date.
With the initial success of biomarker-driven targeted therapies, there is an effort to test additional targeted agents in mPDAC patients
to determine if there is any synergy with standard chemotherapy regimens in the first-line setting. For instance, KRAS is mutated in over
90% of pancreatic cancer patients and there are several KRAS targeted agents in development. Other agents are being tested in KRAS mutant
cancers more broadly by targeting other MAPK pathway members such as MEK and ERK1/2, though treatment-related toxicity has been reported
with these agents. Additionally, these MAPK targeted agents are currently being evaluated in second-line and later settings. In the future,
targeted agents may be able to be combined or used in series to provide a more flexible and tailored therapeutic approach for each individual
patient. Additionally, the multifaceted and differentiated mechanism of action of elraglusib is likely to be synergistic with both cytotoxic
and immunomodulatory therapeutics that may be approved in the future. Our management believes that this potential for combining elraglusib
with future multi-therapy regimens is also feasible given the favorable safety profile of elraglusib as a single agent observed to date.
Mechanistically, some of the targets inhibited by competitors (e.g., KRAS) intersect with the GSK-3 pathways and provide a rationale for
potentially prioritizing these combinations with elraglusib in the future.

The above information includes
corporate competitors that we are currently aware of and are currently conducting clinical trials or marketing in geographies where we
currently anticipate conducting clinical trials for our product candidate. However, companies operating in other geographies and smaller
and other early-stage companies may also prove to be significant competitors. In addition, academic research departments and public and
private research institutions may be conducting research on compounds that could prove to be competitive.

Finally, many of the companies
against which we may compete have significantly greater financial resources and expertise in research and development, manufacturing,
preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Smaller or
early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established
companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel, establishing
clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary
for, our programs.

Government Regulation and Product Approval

Government 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, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution,
post-approval monitoring and reporting, marketing and export and import of products such as those we are developing. The pharmaceutical
product candidates that we develop must be approved by the FDA before they may be legally marketed in the United States.

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U.S. Pharmaceutical Product Development Process

In the United States, the
FDA regulates pharmaceutical products under the Federal Food, Drug and Cosmetic Act (“FDCA”) and implementing regulations.
Pharmaceutical products are also subject to other federal, state and local statutes and regulations. The process of obtaining regulatory
approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure
of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development
process, approval process or after approval, may subject an applicant to administrative or judicial enforcement. Any regulatory enforcement
action could have a material adverse effect on us. The process required by the FDA before a non-biological pharmaceutical product may
be marketed in the United States generally involves the following:

·Completion
of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices (“GLP”), and
other applicable regulations;

·Submission
of an Investigational New Drug application (“IND”), which must become effective before human clinical studies may begin;

·Conduct
of adequate and well-controlled human clinical studies according to current Good Clinical Practices (“GCP”), to establish
the safety and efficacy of the proposed pharmaceutical product for its intended use;

·Submission
to the FDA of an NDA for a new pharmaceutical product;

·Satisfactory
completion of an FDA inspection of the manufacturing facility or facilities where the pharmaceutical product is produced to assess compliance
with current Good Manufacturing Practice standards (“cGMP”), to assure that the facilities, methods and controls are adequate
to preserve the pharmaceutical product’s identity, strength, quality and purity;

·Potential
FDA inspection of the preclinical and clinical study sites that generated the data in support of the NDA; and

·FDA
review and approval of the NDA.

The lengthy process of seeking required
approvals and the continuing need for compliance with applicable statutes and regulations require the expenditure of substantial resources
and approvals are inherently uncertain.

Before testing any pharmaceutical
product with potential therapeutic value in humans, the pharmaceutical product candidate enters the preclinical testing stage. Preclinical
tests include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies to assess the potential
safety and activity of the pharmaceutical product candidate. These early studies are conducted using sound scientific procedures and require
thorough documentation. The conduct of a single and repeat dose toxicology and toxicokinetic studies in animals must comply with federal
regulations and requirements including GLP. The pharmaceutical product sponsor must submit the results of the preclinical tests, together
with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA
as part of the IND. The IND becomes effective 30 days after receipt by the FDA, unless the FDA has concerns and notifies the sponsor.
In such a case, the IND sponsor must resolve any outstanding concerns before the clinical study can begin. If resolution cannot be reached
within the 30-day review period, the FDA can place the IND on clinical hold or the sponsor may withdraw the application. The FDA may also
impose clinical holds on a pharmaceutical product candidate at any time before or during clinical studies due to safety concerns or regulatory
non-compliance. Accordingly, it is not certain that submission of an IND will result in the FDA allowing clinical studies to begin, or
that, once begun, issues will not arise that can lead to suspension or termination of such clinical studies.

During the development of
a new drug, sponsors are given opportunities to meet with the FDA to discuss progress. These formal meetings may occur prior to submission
of an IND, at the end of Phase 1 clinical development (for certain investigational products), at the end of Phase 2 clinical development,
and before an 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, for the sponsor to ask specific questions of the FDA, for the FDA to provide advice,
and for the sponsor and FDA to reach agreement on the next phase of development. Sponsors typically use the end of Phase 2 meeting
to discuss their Phase 2 clinical results and present their plans for the pivotal Phase 3 clinical (registration) trial(s) that
they believe will support approval of the new drug. A sponsor may be able to request a Special Protocol Assessment (“SPA”),
the purpose of which is to reach agreement with the FDA on the Phase 3 clinical trial protocol design and analyses that will form
the primary basis of an efficacy claim.

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Conducting Clinical Studies

Clinical studies are voluntary
research studies involving the administration of the pharmaceutical product candidate to healthy volunteers or patients under the supervision
of qualified investigators, typically physicians independent of the clinical study sponsor’s control. Clinical studies are conducted
according to protocols detailing, among other things, the objectives of the clinical study, dosing procedures, subject selection and exclusion
criteria, how the results will be analyzed and presented and the parameters to be used to monitor subject safety. Each protocol must be
submitted to the FDA as part of the IND. Clinical studies must be conducted in accordance with GCP requirements. Further, each clinical
study must be reviewed and approved by an independent institutional review board (“IRB”), at, or servicing, each institution
at which the clinical study will be conducted. An IRB is charged with protecting the welfare and rights of study participants and is tasked
with considering such items as whether the safety risks to individuals participating in the clinical studies are minimized and are reasonable
in relation to anticipated benefits. The IRB approves the informed consent that must be provided to each clinical study subject or his
or her legal representative and will also monitor the clinical study to ensure patient safety until completed.

Human clinical studies are
typically conducted in three sequential phases that may overlap or be combined:

·Phase 1. The pharmaceutical product
is initially administered to healthy volunteers and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion.

·Phase 2. The pharmaceutical product
is studied in a limited patient population with the disease or condition to evaluate its effectiveness for a particular indication or
indications and to determine the common short-term side effects and risks associated with the product.

·Phase 3. Clinical studies are undertaken
to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical study
sites. These clinical studies are intended to establish the overall risk/benefit of the product and provide an adequate basis for product
labeling. The studies must be well-controlled and usually include a control arm for comparison. One or two Phase 3 studies may be
required by the FDA for an NDA, depending on the disease severity and other available treatment options.

·Post-approval studies, or Phase 4 clinical
studies, may be conducted after initial marketing approval. These studies are used to gain additional experience from the treatment of
patients in the intended therapeutic indication.

·Progress reports detailing the results of the
clinical studies must be submitted at least annually to the FDA and written IND safety reports must be submitted to the FDA and the investigators
for serious and unexpected adverse events or any finding from tests in laboratory animals that suggests a significant risk for human subjects.
Phase 1, Phase 2 and Phase 3 clinical studies may not be completed successfully within any specified period, if at all.
The FDA, the sponsor or its data safety monitoring board may suspend a clinical study at any time on various grounds, 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 study at its institution if the clinical study is not being conducted in accordance with the IRB’s requirements or
if the pharmaceutical product has been associated with unexpected serious harm to patients.

Concurrent with clinical studies,
companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics
of the pharmaceutical product as well as finalize a process for manufacturing the product in commercial quantities in accordance with
cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the pharmaceutical product candidate
and, among other things, must include methods for testing the identity, strength, quality and purity of the final pharmaceutical product.
Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the pharmaceutical
product candidate does not undergo unacceptable deterioration over its shelf-life.

U.S. Review and Approval Processes

The results of product development,
preclinical studies and clinical studies, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry
of the pharmaceutical product, proposed labeling and other relevant information are submitted to the FDA as part of an NDA requesting
approval to market the product. The submission of an NDA is subject to the payment of substantial user fees; a waiver of such fees may
be obtained under certain limited circumstances.

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In addition, under the Pediatric
Research Equity Act (“PREA”), an NDA or a supplement thereof must contain data to assess the safety and effectiveness of the
pharmaceutical product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for
each pediatric subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission of data or full or
partial waivers. Unless otherwise required by regulation, PREA does not apply to any pharmaceutical product for an indication for which
orphan designation has been granted. The FDA reviews all NDAs submitted before it accepts them for filing and may request additional information
rather than accepting an NDA for filing. Once the submission is accepted for filing, the FDA begins an in-depth review of the NDA. Under
the goals and policies agreed to by the FDA under the Prescription Drug User Fee Act (“PDUFA”), the FDA has 10 months
in which to complete its initial review of a standard NDA and respond to the applicant, and six months for a priority NDA. The FDA
does not always meet its PDUFA goal dates for standard and priority NDAs. The review process and the PDUFA goal date may be extended by
three months if the FDA requests or if the NDA sponsor otherwise provides additional information or clarification regarding information
already provided in the submission within the last three months before the PDUFA goal date.

After the NDA submission is
accepted for filing, the FDA reviews the NDA application to determine, among other things, whether the proposed product is safe and effective
for its intended use, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s
identity, strength, quality and purity. The FDA may refer applications for novel pharmaceutical products or pharmaceutical products which
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. During the
pharmaceutical product approval process, the FDA also will determine whether a risk evaluation and mitigation strategy (“REMS”),
is necessary to assure the safe use of the pharmaceutical product. If the FDA concludes that a REMS is needed, the sponsor of the NDA
must submit a proposed REMS; the FDA will not approve the NDA without a REMS, if required.

Before approving an NDA, 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 ensure consistent production of the product
within required specifications.

Additionally, before approving
an NDA, the FDA will typically inspect one or more clinical study sites to assure compliance with GCPs. If the FDA determines the application,
manufacturing process or manufacturing facilities, or clinical study sites are not acceptable, it will outline the deficiencies in the
submission and often will request additional testing or information. In addition, the FDA will require the review and approval of product
labeling.

The NDA review and approval
process is lengthy and involved and the FDA may refuse to approve an NDA if the applicable regulatory criteria are not satisfied or may
require additional clinical data or other data and information. Even if such data and information are submitted, the FDA may ultimately
decide that the NDA does not satisfy the criteria for approval. Data obtained from clinical studies are not always conclusive and the
FDA may interpret data differently than the sponsor interprets the same data. The FDA will issue a complete response letter if the agency
decides not to approve the NDA. The complete response letter usually describes all of the specific deficiencies in the NDA identified
by the FDA. The deficiencies identified may be minor, for example, requiring labeling changes, or major, for example, requiring additional
clinical studies.

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 NDA, addressing all of the deficiencies identified in the
letter, or withdraw the application.

If a product receives regulatory
approval, the approval may be significantly limited to specific diseases 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. In addition, the FDA may require Phase 4 testing which involves clinical studies designed to
further assess pharmaceutical product safety and effectiveness and may require testing and surveillance programs to monitor the safety
of approved products that have been commercialized.

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Expedited Development and Review Programs; Fast-Track Designation
(“FTD”) and Breakthrough Therapy Designation (“BTD”)

The FDA has a Fast Track program
that is intended to expedite or facilitate the process for reviewing new pharmaceutical products that meet certain criteria. Specifically,
new pharmaceutical products are eligible for Fast Track designation if they are intended to treat a serious or life-threatening condition
and demonstrate the potential to address unmet medical needs for the condition. The Fast Track designation must be requested by the sponsor.
Fast Track designation applies to the combination of the product and the specific indication for which it is being studied. With a Fast
Track designated product, the FDA may consider for review sections of the NDA on a rolling basis before the complete application is submitted,
if the sponsor provides a schedule for the submission of the sections of the NDA, if the FDA agrees to accept sections of the NDA and
determines that the schedule is acceptable and if the sponsor pays any required user fees upon submission of the first section of the
NDA.

Any product submitted to the
FDA for marketing approval, including a Fast Track program, may also be eligible for other types of FDA programs intended to expedite
development and review, such as priority review and accelerated approval. Any product is eligible for priority review if it has the potential
to provide safe and effective therapy where no satisfactory alternative therapy exists or a significant improvement in the treatment,
diagnosis or prevention of a disease compared to marketed products. The FDA will attempt to direct additional resources to the evaluation
of an application for a new pharmaceutical product designated for priority review in an effort to facilitate the review. Additionally,
a product may be eligible for accelerated approval. Pharmaceutical products studied for their safety and effectiveness in treating serious
or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval,
which means that the products may be approved on the basis of adequate and well-controlled clinical studies establishing that the product
has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit, or on the basis of an effect on a clinical
endpoint other than survival or irreversible morbidity. As a condition of approval, the FDA may require that a sponsor of a pharmaceutical
product receiving accelerated approval perform adequate and well-controlled post-marketing clinical studies. In addition, the FDA currently
requires as a condition for accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the
commercial launch of the product. Fast Track designation, priority review and accelerated approval do not change the standards for approval
but may expedite the development or approval process.

The FDA is also required to
expedite the development and review of the application for approval of drugs that are intended to treat a serious or life-threatening
disease or condition where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing
therapies on one or more clinically significant endpoints. Under the breakthrough therapy program, the sponsor of a new product candidate
may request that the FDA designate the product candidate for a specific indication as a breakthrough therapy concurrent with, or after,
the filing of the IND for the product candidate. The FDA must determine if the product candidate qualifies for breakthrough therapy designation
within 60 days of receipt of the sponsor’s request. Elraglusib IV and elraglusib oral dosage forms may all be eligible for
breakthrough therapy designation depending on the indication and pending clinical additional data.

Orphan Drug Designation

Under the Orphan Drug Act,
the FDA may grant orphan designation (“ODD”) to a drug intended to treat a rare disease or condition affecting fewer than
200,000 individuals in the United States, or in other limited cases. ODD provides for seven years of market exclusivity, independent
of patent protection, to the company with ODD that brings a particular product to market. In addition, companies developing orphan drugs
are eligible for certain incentives, including tax credits for qualified clinical testing.

To gain exclusivity, if a
product that has ODD subsequently receives the first FDA approval for the disease or condition for which it has such designation, the
product is entitled to the orphan drug exclusivity, which means that the FDA may not approve any other applications to market the same
active moiety for the same indication for seven years, except in limited circumstances, such as another drug’s showing of clinical
superiority over the drug with orphan exclusivity. In addition, doctors may prescribe products for off-label uses and undermine our exclusivity.
Orphan drug exclusivity could block the approval of one of our product candidates for seven years if a competitor obtains approval
for the same active moiety for the same indication before we do, unless we are able to demonstrate that our product is clinically superior.

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A sponsor may request ODD
of a previously unapproved product or new orphan indication for an already marketed product. In addition, a sponsor of a product that
is otherwise the same product as an already approved orphan drug may seek and obtain ODD for the subsequent product for the same rare
disease or condition if it can present a plausible hypothesis that its product may be clinically superior to the first, approved product.
More than one sponsor may receive ODD for the same product for the same rare disease or condition, but each sponsor seeking ODD must file
a complete request for designation, and only the first sponsor that obtains approval for that drug for the orphan indication will obtain
market exclusivity, effectively preventing the FDA from approving products under development by competitors for the same drug and same
indication, unless the competitor is able to demonstrate that the product under development is clinically superior to the approved product
or the approved product is not available in sufficient quantities. To permit the FDA to end another manufacturer’s orphan exclusivity
period, the FDA must determine that the manufacturer has demonstrated clinical superiority by showing the later drug is safer, more effective,
or otherwise makes a major contribution to patient care.

We may plan to pursue ODD
and exclusivity for some of our product candidates in the United States, the EU, and other geographies of interest for specific products.
ODD neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review
or approval process. We cannot guarantee that we will obtain ODD for any products in any jurisdiction. Even if we are able to acquire
ODD for a product, we cannot be sure that such product will be approved, that we will be able to obtain orphan drug exclusivity upon approval,
if ever, or that we will be able to maintain any exclusivity that is granted.

Regulation Outside the United States

To market any medicinal product
outside of the U.S., similar regulatory requirements, including adherence to GLP, Good Clinical Practices (“GCP”) and Good
Manufacturing Practice (“GMP”), collectively referred to as GxP to initiate clinical trials and, subsequently, to obtain marketing
approval of a new pharmaceutical product are in place in each jurisdiction and vary country to country. Each regulatory jurisdiction will
apply these regulations in their assessment of clinical trial applications and marketing authorization applications. The foreign regulatory
approval process includes all the risks associated with FDA approval set forth above, as well as additional country-specific regulation.
Failure to comply with applicable foreign regulatory requirements may be subject to, among other things, fines, suspension or withdrawal
of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

Non-clinical Studies, Clinical Trials, and
Manufacturing

Similarly to the United States,
the various phases of non-clinical and clinical research in the European Union (“EU”), United Kingdom (“UK”) and
Canada are subject to significant regulatory controls.

Non-clinical studies are performed
to demonstrate the health or environmental safety of new biological substances. Non-clinical studies (pharmaco-toxicological) must be
conducted in compliance with the principles of GLP, as set forth in EU Directive 2004/10/EC. Non-clinical studies, both in vitro and in
vivo, must be planned, performed, monitored, recorded, reported and archived in accordance with the GLP principles, which define a set
of rules and criteria for a quality system for the organizational process and the conditions for non-clinical studies. These GLP standards
reflect the Organization for Economic Co-operation and Development requirements.

Clinical trials of medicinal
products humans must be conducted in accordance with national regulations and the International Council for Harmonization of Technical
Requirements for Pharmaceuticals for Human Use (“ICH”) guidelines on GCP as well as the applicable regulatory requirements
and the ethical principles that have their origin in the Declaration of Helsinki. Clinical trials involve the administration of the investigational
new drug or biological product to healthy volunteers or patients under the supervision of a qualified investigator. Clinical trials must
be conducted: (i) in compliance with federal regulations; (ii) in compliance with GCP, which is an international standard meant to protect
the rights and health of patients and to define the roles of clinical trial sponsors, administrators and monitors; as well as (iii) under
protocols detailing the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated.
Each protocol involving testing on patients and subsequent protocol amendments must be submitted to regulatory authorities for review
and approval. Medicines used in clinical trials must be manufactured in accordance with regulatory requirements under GMP.

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Legislation in EU, UK, and Canada

In the EU, the EMA conducts
the scientific evaluation, supervision and safety monitoring of our innovative medicinal products that are eligible for the centralized
marketing authorization procedure. Through the centralized procedure, pharmaceutical companies may submit to the EMA a single application
for a marketing authorization valid in all the EU and the European Economic Area (“EEA”) countries. The European Community
(“EC”) makes a legally binding decision based on the EMA’s recommendation. The centralized procedure is mandatory for certain
new products and optional for others.

In the UK, we are subject
to rigorous and evolving regulation and standards in the UK, overseen primarily by the Medicines and Healthcare products Regulatory Agency
(“MHRA”). In 2026, the UK will require a new, independent framework for the authorization and surveillance of medicinal products.
This includes mandatory compliance with revised standards governing clinical trials, patient protections and the new International Reliance
Framework for marketing authorizations.

In April 2026, clinical trials
in the UK will be subject to the Medicines for Human Use (Clinical Trials) Amendment Regulations 2025, which introduced revised classification
for trial modifications, enhanced transparency, and extended data retention requirements. We are also subject to ICH E6(R3) standards
and, the UK’s Cyber Security and Resilience Bill. The regulations are intended to protect the rights, safety and wellbeing of research
participants and to simplify and harmonize regulatory processes. They apply to trials designed to generate information on the efficacy
or safety of medicine.

In Canada, we are subject
to rigorous and evolving regulation and standards by Health Canada under the Food and Drugs Act and the Food and Drug Regulations. Before
receiving marketing authorization, we must conduct extensive preclinical and clinical trials, demonstrating safety, efficacy, and quality
to Health Canada. The regulatory approval process is lengthy, expensive, and uncertain. Even if we obtain approval, our products remain
subject to ongoing post-marketing surveillance, and failure to comply with Health Canada requirements, such as GMP and GCP, could result
in product recalls, suspension of approvals, or penalties.

Marketing Authorization in the EU

The EMA is the scientific
agency of the EU that coordinates the evaluation and monitoring of new and approved medicinal products such as drugs and biologics. It
is responsible for the scientific evaluation of applications for EU marketing authorizations, as well as the development of technical
guidance and the provision of scientific advice to sponsors.

In the EU, we are required
to apply for marketing authorizations under the centralized procedure to the EMA as the centralized procedure is mandatory for certain
medicines, such as t orphan medicinal products, and advanced therapy medicinal products and those containing a new active substance indicated
for the treatment of cancer. The marketing authorization granted under the centralized procedure by the EMA will be valid in all EEA Member
States. The evaluation of a marketing authorization application by the EMA’s Committee for Medicinal Products for Human Use (“CHMP:)
takes up to 210 “active” days (excluding all “clock stops” for an applicant to address questions by the EMA–there
are usually one or two clock stops that last three to six months and one to two months, respectively) but can be extended, should additional
information be required by the CHMP. The European Commission makes the final decision to grant a marketing authorization, which is issued
within 67 days of receipt of the EMA’s positive opinion.

An accelerated assessment
procedure of 150 days may be implemented for drugs considered to be of major public health interest. There is also an internal re-examination
procedure available in case the applicant disagrees with the CHMP opinion.

Regulatory Submissions

The EU Clinical Trials Regulation
(“CTR”) which was adopted in April 2014 and repeals the EU Clinical Trials Directive and went into full effect on January
31, 2025. Unlike directives, the CTR is directly applicable in all EU member states without the need for member states to further implement
it into national law. The CTR harmonizes the assessment and supervision processes for clinical trials throughout the EU via a Clinical
Trials Information System, which contains a centralized EU portal and database.

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The CTR introduces a centralized
process and only requires the submission of a single application for multi-center trials. The CTR allows sponsors to make a single submission
to both the competent authority and an ethics committee in each member state, leading to a single decision per member state. The clinical
trial application (“CTA”) must include, among other things, a copy of the trial protocol and an investigational medicinal
product dossier containing information about the manufacture and quality of the medicinal product under investigation. The assessment
procedure of the CTA has been harmonized as well, including a joint assessment by all member states concerned, and a separate assessment
by each member state with respect to specific requirements related to its own territory, including ethics rules. Each member state’s
decision is communicated to the sponsor via the centralized EU portal.

Conditional Approval

In specific circumstances,
EU legislation (Article 14(7) Regulation (EC) No. 726/2004 and Regulation (EC) No. 507/2006 on Conditional Marketing Authorizations for
Medicinal Products for Human Use) enables applicants to obtain a conditional marketing authorization prior to obtaining the comprehensive
clinical data required for an application for a full marketing authorization. Such conditional approvals may be granted for products (including
medicines designated as orphan medicinal products), if (1) the risk-benefit balance of the product is positive, (2) it is likely
that the applicant will be in a position to provide the required comprehensive clinical trial data, (3) the product fulfills unmet medical
needs, and (4) the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the
risk inherent in the fact that additional data are still required. A conditional marketing authorization may contain specific obligations
to be fulfilled by the marketing authorization holder, including obligations with respect to the completion of ongoing or new studies,
and with respect to the collection of pharmacovigilance data. Conditional marketing authorizations are valid for one year, and may be
renewed annually, if the risk-benefit balance remains positive, and after an assessment of the need for additional or modified conditions
and/or specific obligations. The timelines for the centralized procedure described above also apply with respect to the review by the
CHMP of applications for a conditional marketing authorization.

Marketing Authorization Under Exceptional Circumstances

Marketing Authorization Under
Exceptional Circumstances is a regulatory pathway in the EU allowing early access to medicines for rare diseases, emergencies, or ethical
constraints preventing comprehensive data collection. It enables approval without a full efficacy/safety dossier, provided the benefit-risk
balance is positive. Per Article 14(8) Regulation (EC) No 726/2004, products for which the applicant can demonstrate that comprehensive
data (in line with the requirements laid down in Annex I of Directive 2001/83/EC, as amended) cannot be provided (due to specific reasons
foreseen in the legislation) might be eligible for marketing authorization under exceptional circumstances. This type of authorization
is reviewed annually to reassess the risk-benefit balance. The fulfillment of any specific procedures/obligations imposed as part of the
marketing authorization under exceptional circumstances is aimed at the provision of information on the safe and effective use of the
product and will normally not lead to the completion of a full dossier/approval.

Accelerated Approval Pathways

The EU and UK operate accelerated
evaluation and assessment schemes, which include, at EU level, Priority Medicines (“PRIME”) scheme and, at UK level, the Early
Access to Medicines Scheme (“EAMS”), which may be granted in exceptional cases, often when there is unmet medical need for
a life-threatening or serious debilitating condition and existing data show a positive benefit/risk balance that means the medicinal product
is of a major public health interest. The CHMP of the EMA or the MHRA (or other national competent authority) will make this determination
on a case-by-case basis and subject to meeting eligibility criteria. Accelerated assessment takes place within 150 days. Other regulatory
facilitations for these pathways include additional scientific advice at key development milestones and frequent guidance and discussions
throughout the approval process.

In the UK, the MHRA has launched
the Innovative Licensing and Access Pathway (ILAP), a new accelerated assessment procedure for marketing authorization applications that
enables companies to enter the UK market faster. The MHRA launched an International Recognition Procedure for Great Britain (England,
Scotland and Wales) marketing authorization applications whereby the MHRA will, when considering such applications, recognize the approval
of medicines by trusted reference regulators in Australia, Canada, Switzerland, Singapore, Japan, United States and EU following its own
abbreviated assessment.

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Pediatric Development

In the EEA, MAAs for new medicinal
products must include the results of studies conducted in the pediatric population, in compliance with a pediatric investigation plan
(“PIP”), agreed with the EMA’s Pediatric Committee (“PDCO”). The PIP sets out the timing and measures proposed
to generate data to support a pediatric indication of the drug for which MA is being sought. The PDCO can grant a deferral of the obligation
to implement some or all the measures of the PIP until there are sufficient data to demonstrate the efficacy and safety of the product
in adults. Further, the obligation to provide pediatric clinical trial data can be waived by the PDCO when these data are not needed or
appropriate because the product is likely to be ineffective or unsafe in children, the disease or condition for which the product is intended
occurs only in adult populations, or when the product does not represent a significant therapeutic benefit over existing treatments for
pediatric patients. We have received a class waiver for pediatric data in mPDAC.

Orphan Medicinal Products

In the EU and UK, under Regulation
(EC) 141/2000 and the UK Human Medicines Regulations 2012 SI 2012 No. 1916 (as amended), respectively, medicinal products may be granted
an orphan drug designation if they are used to treat or prevent life-threatening or chronically debilitating conditions that affect no
more than five in 10,000 people in the EU/UK and for which there is no satisfactory method of diagnosis, prevention or treatment when
the application is made, or when the medicinal product is of significant benefit to those affected by the condition. In addition, orphan
drug designation can be granted to drugs used to treat or prevent life-threatening or chronically debilitating conditions which, for economic
reasons, would be unlikely to be developed without incentives.

The application for orphan
designation must be submitted to and approved by the EMA in respect of the EU or to the MHRA for Great Britain before an application is
made for marketing authorization for the product. Medicinal products which benefit from orphan status can benefit from up to ten years
of market exclusivity in respect of the approved indication. This prevents regulatory authorities in the EU or Great Britain from granting
marketing authorizations for similar medicinal products for the same therapeutic indication, unless another applicant can show that the
similar medicinal product in question is safer, more effective or clinically superior to the orphan-designated product or if the marketing
authorization holder consents to the second orphan medicinal product application, or were the marketing authorization holder cannot supply
the needs of the market.

The ten-year market exclusivity
may be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan
designation, for example, if the product is sufficiently profitable not to justify the maintenance of market exclusivity. Conversely,
the 10- year exclusivity period can be further extended by two years, when pediatric studies are conducted in accordance with an agreed
pediatric investigation plan (“PIP”) and in completion of all the legal requirements. Orphan designation does not convey any
advantage in, or shorten the duration of, the regulatory review and approval process.

It is noted that the general
pharmaceutical legislative framework, as well as the framework applicable to orphan and pediatric medicinal products in the EU, is under
review. On April 26, 2023, the European Commission adopted a proposal for a new Regulation set to replace Regulation (EC) No 726/2004
and a new Directive to replace Directive 2001/83 on the Community Code relating to medicinal products for human use. Initial framework
agreement was reached in December 2025; however, final legislation is undergoing final formal review by the European Parliament and Council.
If made into law, this proposal will revise the existing general pharmaceutical legislation with new measures to encourage pediatric research,
including incentives for completing pediatric investigation plans (PIPs) and introducing more flexible paths for pediatric medicines;
however, may reduce applicable regulatory exclusivities which will significantly affect all medicinal products that will be authorized
after the legislative changes have taken effect.

We have received Orphan Designation
from the EMA for mPDAC and sarcoma in pediatric patients.

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Period of Authorization and Renewals

A marketing authorization
will be valid for five years in principle, and the marketing authorization may be renewed after five years on the basis of a re-evaluation
of the risk-benefit balance by the EMA or by a national authority. To this end, the marketing authorization holder must provide the EMA
or the competent authority with a consolidated version of the file in respect of quality, safety and efficacy, including all variations
introduced since the marketing authorization was granted, at least nine months before the marketing authorization ceases to be valid.
Once renewed, the marketing authorization will be valid for an unlimited period, unless the European Commission or the national authority
decides on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal. Any authorization that is
not followed by the actual placing of the drug on the EU market (in case of centralized procedure) or on the market of the authorizing
member state within three years after authorization will cease to be valid, the so-called “sunset clause.”

Regulatory Data Protection

EU legislation also provides
for a system of regulatory data and market exclusivity. Upon receiving marketing authorization, new chemical entities approved on the
basis of complete independent data package benefit from eight years of data exclusivity and an additional two years of market exclusivity.
Data exclusivity prevents regulatory authorities in the EU from referencing the innovator’s data to assess a generic or biosimilar
(abbreviated) application. During the additional two-year period of market exclusivity, a generic or biosimilar marketing authorization
can be submitted, and the innovator’s data may be referenced, but no generic or biosimilar medicinal product can be marketed until
the expiration of the market exclusivity. The overall 10-year period will be extended to a maximum of 11 years if, during the first 8
years of those 10 years, the marketing authorization holder (“MAH”) obtains an authorization for one or more new therapeutic
indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in
comparison with existing therapies. Even if a compound is considered to be a new chemical entity and the innovator is able to gain the
period of data exclusivity, another company nevertheless could also market another version of the drug if such company obtained marketing
authorization based on an MAA with a complete independent data package of pharmaceutical test, preclinical tests and clinical trials.
However, products designated as orphan medicinal products enjoy, upon receiving marketing authorization, a period of 10 years of orphan
market exclusivity. Depending upon the timing and duration of the EU marketing authorization process, products may be eligible for up
to five years’ supplementary protection certificates (“SPCs”). Such SPCs extend the rights under the basic patent for
the drug.

Clinical Trials Regulation and Data Sharing
in the EU

In the EU/EEA, all initial
clinical trial applications (“CTA”) must be submitted through the Clinical Trials Information System (“CTIS”)
and ethics approval must be sought from an independent Ethics Committee. Under the EU Clinical Trials Regulation 536/2014, which has been
in effect since January 31, 2022, replacing the EU Clinical Trials Directive 2001/20/EC, suspected unexpected serious adverse reactions
to the drug during the clinical trial must be reported via the EudraVigilance database.

In the EU, Transparency Regulation
No 1049/ 2001, EMA Policy 0043, EMA Policy 0070, as well as the Clinical Trials Regulation No 536/2014 set out the obligation for sponsors
to make publicly available certain information stemming from clinical studies, whether proactively or in response to third party requests.
Interested parties based in the EU may submit a request to the EMA to access information included in the marketing authorization application
for authorized medicinal products. Commercially confidential information and protected personal data, however, may not be accessed.

The European Health Data Space
Regulations (the “EHDS Regulations”) came into force on March 26, 2025. The aims of the EHDS Regulations are to provide individuals
with more control over their electronic health data, enable cross-border sharing of European Health Data (EHD) between national EU healthcare
systems and facilitate the sharing of EHD for secondary research purposes. The EHDS Regulations impose new obligations but also create
opportunities for companies engaged in health-related research to share and access health data on a large scale. Although the EHDS Regulations
have come into force, key obligations will not apply until March 2029.

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Data Privacy

We are subject to extensive
privacy and data protection laws and regulations around the world concerning the collection, use and sharing of personal data. We are
subject to privacy laws in connection with our clinical trial activities outside the United States such as the EU and UK General Data
Protection Regulation (“GDPR”), non-compliance with which could result in administrative fines of up to the greater of 4%
of global annual revenues or €20.0 million (under the EU GDPR) or £17.5m (under the UK GDPR). The GDPR also confers a private
right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies and
obtain compensation for damages resulting from violations of the GDPR. We routinely collect and use sensitive personal information relating
to health. The legislative, regulatory and litigation landscape for privacy and data protection requirements is rapidly evolving and changing
and may limit our ability to use data globally or across borders. Data protection requirements are not universal and can conflict between
jurisdictions.

Compliance with local laws
and regulations is made more complex by the lack of consistent standards, common definitions, or clear regulatory expectations. At the
same time, enforcement of these laws and regulations is increasing and fines and penalties are also increasing. Any failure or perceived
failure by us to comply with applicable privacy and data protection laws and regulations, including cybersecurity breaches or incidents,
could subject us to significant fines and penalties, and/or litigation, as well as negatively impacting our reputation.

Regulatory Requirements After a Marketing Authorization
(“MA”) Has Been Obtained

Similar to the United States,
MA holders and manufacturers of medicinal products are subject to comprehensive regulatory oversight by the EMA, the European Commission
and/or the competent regulatory authorities of the EU member states. The holder of a MA must establish and maintain a pharmacovigilance
system and appoint an individual qualified person for pharmacovigilance (“QPPV”) who is responsible for the establishment
and maintenance of that system and oversees the safety profiles of medicinal products and any emerging safety concerns. Key obligations
include expedited reporting of suspected serious adverse reactions and submission of periodic safety update reports (“PSURs”).

All new MAA must include a
risk management plan (“RMP”) describing the risk management system that the company will put in place and documenting measures
to prevent or minimize the risks associated with the product. The regulatory authorities may also impose specific obligations as a condition
of the MA. Such risk-minimization measures or post-authorization obligations may include additional safety monitoring, more frequent submission
of PSURs, or the conduct of additional clinical trials or post-authorization safety studies.

The manufacturing of authorized
drugs, for which a separate manufacturer’s license is mandatory, must be conducted in compliance with the EMA’s GMP requirements
and comparable requirements of other national authorities, which mandate the methods, facilities and controls used in manufacturing, processing
and packing of drugs to assure their safety and identity. The EMA enforces its GMP requirements through mandatory registration of facilities
and inspections of those facilities. The EMA may have a coordinating role for these inspections while the responsibility for carrying
them out rests with the member states competent authority under whose responsibility the manufacturer falls. Failure to comply with these
requirements could interrupt supply and result in delays, unanticipated costs and lost revenues, and could subject the applicant to potential
legal or regulatory action, including but not limited to warning letters, suspension of manufacturing, seizure of product, injunctive
action or possible civil and criminal penalties.

The advertising and promotion
of medicinal products is also subject to laws concerning promotion of medicinal products, interactions with physicians, misleading and
comparative advertising and unfair commercial practices. All advertising and promotional activities for the product must be consistent
with the approved summary of product characteristics, and therefore all off-label promotion is prohibited. Direct-to-consumer advertising
of prescription medicines is also prohibited in the EU.

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Reimbursement of Medicines in Europe

In the EU, pricing and reimbursement
methods can differ in each Member State. Some Member States and the UK may require that health technology assessments (“HTA”)
be completed for the product to be recommended for funding under the NHS. The outcome of HTAs is decided on a national basis and some
Member States may decide not to reimburse the use of medicines or may reduce the rate of reimbursement. As of January 12, 2025, EU Health
Technology Regulation No. 2021/2282 has become applicable in respect of new oncology medicines. Regulation 2021/2282 imposes a new procedure,
a joint clinical assessment at a centralized level, as a mandatory step for the assessment of the pricing and reimbursement of medicinal
products by national authorities. It requires companies applying for products in scope to make relevant submissions for the joint clinical
assessment, in line with a number of prespecified criteria.

In the UK, NICE is the body
in England and Wales, which conducts HTAs and issues guidance on whether a product is considered to be “cost-effective” and
therefore recommended for use and reimbursement under the national health service. This means that if a positive recommendation has been
obtained, then the medicinal product will be widely available to patients in England and Wales. For avoidance of doubt, Scotland and Northern
Ireland have their own HTA bodies which will conduct their own assessment.

Other Healthcare Laws

In addition to FDA restrictions
on marketing of pharmaceutical products, several other types of state and federal laws have been applied to restrict certain business
practices in the biopharmaceutical industry. Applicable federal and state healthcare laws and regulations include the following:

·The federal healthcare Anti-Kickback Statute
of 1972 prohibits, among other things, persons from knowingly and willfully soliciting, offering, 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, order, or recommendation
of, any good or service, for which payment may be made under federal healthcare programs such as Medicare, Medicaid, or other governmental
programs. A person or entity does not need to have actual knowledge of the federal anti-kickback statute or specific intent to violate
it to have committed a violation; in addition, items or services resulting from a violation of the federal anti-kickback statute may constitute
a false or fraudulent claim for purposes of the False Claims Act;

·The federal False Claims Act of 1986 imposes
criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting,
or causing to be presented, to the federal government claims for payment that are false or fraudulent or making a false statement to avoid,
decrease, or conceal an obligation to pay money to the federal government;

·The Health Insurance Portability and Accountability
Act of 1996 (“HIPAA”), imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program
and also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission
of individually identifiable health information. This statute also 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;

·HIPAA, as amended by the Health Information Technology
for Economic and Clinical Health Act (“HITECH”) of 2009 and its implementing regulations, imposes certain requirements relating
to the privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’s
privacy and security standards directly applicable to “business associates” — independent contractors
or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of
a covered entity.

·The Medicare Prescription Drug, Improvement and
Modernization Act of 2003 (MMA) imposed new requirements for the distribution and pricing of prescription drugs for Medicare beneficiaries.
Under Part D, Medicare beneficiaries may enroll in prescription drug plans offered by private entities, which will provide coverage
of outpatient prescription drugs.

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·The American Recovery and Reinvestment Act of
2009 provides funding for the federal government to compare the effectiveness of different treatments for the same illness.

·The Physician Payments Sunshine Act of 2010 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, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services
(“CMS”) information related to payments or other transfers of value made to physicians and teaching hospitals, and applicable
manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by the physicians
and their immediate family members.

·The Patient Protection and Affordable Care Act
of 2010 (“PPACA”) includes measures to significantly change the way healthcare is financed by both governmental and private
insurers and significantly impacts the U.S. pharmaceutical industry. Among the provisions of the PPACA of importance to the pharmaceutical
and biotechnology industry are the following, among others: (i) extension of manufacturers’ Medicaid rebate liability to covered
drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; (ii) expansion of eligibility criteria for Medicaid
programs; and (iii) expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program.

·The Budget Control Act of 2011, which, among
other things, created the Joint Select Committee on Deficit Reduction, or joint committee, to recommend proposals in spending reductions
to Congress. The joint committee did not achieve its targeted deficit reduction of at least $1.2 trillion for the years 2013 through
2021, triggering automatic reductions to several government programs. These reductions include aggregate reductions to Medicare payments
to providers of up to 2% per fiscal year, starting in 2013.

·The American Taxpayer Relief Act of 2012, reduced
Medicare payments to several providers, among other things, and increased the statute of limitations period for the government to recover
overpayments to providers from three to five years. These new laws may result in additional reductions in Medicare and other healthcare
funding.

·Depending upon the timing, duration and specifics
of the FDA approval of the use of our pharmaceutical product candidates, some of our products to be licensed under U.S. patents may be
eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred
to as the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permits a patent restoration term of up to five years as compensation
for patent term lost during product development and the FDA regulatory review process.

·The Biologics Price Competition and Innovation
Act (“BPCI Act”) authorizes the FDA to license a biological product that is biosimilar to an FDA-licensed biologic through
an abbreviated pathway. The BPCI Act establishes criteria for determining that a product is biosimilar to an already-licensed biologic,
or reference product, and establishes a process by which an abbreviated BLA for a biosimilar product is submitted, reviewed and approved.

Coverage and Reimbursement

Sales of our product candidates
in the United States may depend, in part, on the extent to which the costs of the product candidates may be covered by third-party payers,
such as government health programs, commercial insurance and managed health care organizations. These third-party payers are increasingly
challenging the prices charged for medical products and services. Additionally, the containment of health care costs has become a priority
of federal and state governments, and the prices of drugs have been a focus in this effort. The United States government, state legislatures
and foreign 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 our net revenue and results.
If these third-party payers do not consider our product candidates to be cost-effective compared to other available therapies, they may
not cover our product candidates after approval as a benefit under their plans or, if they do, the level of payment may not be sufficient
to allow us to sell our product candidates on a profitable basis.

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In order to secure coverage
and reimbursement for any product that might be approved for sale, we 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, EMA or other
comparable regulatory approvals. Our product candidates may not be considered medically necessary or cost-effective. A payer’s decision
to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Third-party reimbursement
may not be sufficient to enable us to maintain price levels high enough to realize an appropriate return on our investment in product
development.

Pricing and reimbursement
schemes vary widely from country to country. Some countries provide that drug products may be marketed only after a reimbursement price
has been agreed. Some countries may require the completion of additional studies that compare the cost-effectiveness of a particular product
candidate to currently available therapies. The conduct of such studies could be expensive and result in delays in our commercializing
efforts. There can be no assurance that any country that has price controls or reimbursement limitations for drug products will allow
favorable reimbursement and pricing arrangements for any of our products.

The marketability of any products
for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate
coverage and reimbursement. In addition, emphasis on managed care in the United States has increased and we expect will continue to increase
the pressure on drug pricing. Coverage policies, third-party reimbursement rates and drug pricing regulation may change at any time. Even
if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable
coverage policies and reimbursement rates may be implemented in the future.

U.S. Healthcare Reform

In the United States, there
have been and continue to be a number of significant legislative initiatives to contain healthcare costs. The PPACA contains provisions
that may reduce the profitability of drug products, including, for example, increased rebates for drugs subject to the Medicaid Drug Rebate
Program, extension of Medicaid rebates to Medicaid managed care plans, mandatory discounts for certain Medicare Part D beneficiaries
and annual fees based on pharmaceutical companies’ share of sales to federal health care programs.

Since its enactment, there
have been executive, judicial and Congressional challenges to certain aspects of the PPACA. On June 17, 2021, the U.S. Supreme Court
dismissed the most recent judicial challenge to the PPACA brought by several states without specifically ruling on the constitutionality
of the PPACA.

In addition, other legislative
changes have been proposed and adopted since PPACA was enacted. On March 11, 2021, President Biden signed the American Rescue Plan Act
of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, for single source and innovator multiple source drugs, beginning
January 1, 2024. The rebate was previously capped at 100% of a drug’s average manufacturer price. Additionally, there has been
heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription
drugs and biologics. Such scrutiny has resulted in several recent Congressional inquiries, presidential executive orders and proposed
and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship
between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. Additional
changes included aggregate reductions to Medicare payments to providers of 2% per fiscal year, effective April 1, 2013 and, due to
subsequent legislative amendments to the statute, will stay in effect through 2027, unless additional Congressional action is taken; however,
pursuant to the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) and subsequent legislation. In January 2013,
the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, reduced Medicare payments to several providers,
and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
These new laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect
on customers for our drugs, if approved, and, accordingly, our financial operations.

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Moreover, recently there has
been heightened governmental scrutiny over the manner in which manufacturers set prices for their commercial products. There have been
several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring
more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of drugs
under Medicare, and reform government program reimbursement methodologies for drugs. The FDA published a final rule on October 1,
2020, effective November 30, 2020, providing guidance for states to build and submit importation plans for drugs from Canada. Further,
on November 20, 2020, the U.S. Department of Health and Human Service (“HHS”) finalized a regulation removing safe harbor
protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy
benefit managers, unless the price reduction is required by law. The rule also creates a new safe harbor for price reductions reflected
at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and
biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and
marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk
purchasing.

Most recently, on August 16,
2022, the Inflation Reduction Act of 2022 (the “IRA”) was signed into law. Among other things, the IRA directs the HHS to
negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare. The negotiated prices, which
will first become effective in 2026, will be capped at a statutory ceiling price representing a significant discount from average prices
to wholesalers and direct purchasers. The law will also, beginning in 2023, penalize drug manufacturers that increase prices of Medicare
Part B and Part D drugs at a rate greater than the rate of inflation. Further, the IRA eliminates the “donut hole”
under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating
a new manufacturer discount program. The IRA permits the Secretary of the HHS to implement many of these provisions through guidance,
as opposed to regulation, for the initial years. HHS has and will continue to issue and update guidance as these programs are implemented,
although the IRA may be subject to legal challenges. It is currently unclear how the IRA will be implemented but it is likely to have
a significant impact on the pharmaceutical industry. In addition, in response to the Biden administration’s October 2022 executive
order, on February 14, 2023, HHS released a report outlining three new models for testing by the Center for Medicare and Medicaid
Innovation which will be evaluated on their ability to lower the cost of drugs, promote accessibility, and improve quality of care. It
is unclear whether the models will be utilized in any health reform measures in the future.

Although a number of these
and other proposed measures may require authorization through additional legislation to become effective, Congress has indicated that
it will continue to seek new legislative measures to control drug costs.

CMS issued a final rule, effective
on July 9, 2019, that requires direct-to-consumer advertisements of prescription drugs and biological products, for which payment
is available through or under Medicare or Medicaid, to include in the advertisement the Wholesale Acquisition Cost, or list price, of
that drug or biological product if it is equal to or greater than $35 for a monthly supply or usual course of treatment. Prescription
drugs and biological products that are in violation of these requirements will be included on a public list.

Any adopted health reform
measure could reduce the ultimate demand for our products, if approved, or put pressure on our product pricing. Individual states in the
United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical
product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing
cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical
products and which suppliers will be included in their prescription drug and other healthcare programs. We expect that additional state
and federal healthcare reform measures will be adopted in the future.

We expect that additional
state and federal healthcare reform measures, as well as legal changes by foreign governments, will be adopted in the future, any of which
could limit the amounts that governments will pay for healthcare products and services, which could result in reduced demand for our product
candidates or additional pricing pressures.

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Employees and Human Capital Resources

As of December 31, 2025,
we had 12 full-time employees plus a number of contract workers, who manage and oversee all aspects of our operations, including
nonclinical development, manufacturing, clinical development, and general and administrative functions. Nine employees were engaged
in research and development activities. In addition, we currently work with numerous highly experienced consultants and contractors
who provide management and oversight in manufacturing, analytical, clinical supply chain, regulatory, pharmacovigilance and safety,
clinical operations, data management, statistics, non-clinical toxicology, nonclinical and clinical pharmacology, and medical
affairs. Thus, we currently operate as a semi-virtual pharmaceutical company with expertise in numerous aspects of preclinical and
clinical development.

None of our employees are
represented by a labor union or covered under a collective bargaining agreement. We consider our relationship with our employees to be
good.

Corporate Information

We are a Delaware corporation
formed on January 16, 2015 as Apotheca Therapeutics, Inc. and changed our name to Actuate Therapeutics, Inc. on October 1, 2015.
Our principal executive offices are located at 1751 River Run, Suite 400, Fort Worth, Texas 76107, and our telephone number is (817)
887-8455.

Our Internet address for corporate
and investor information is www.actuatetherapeutics.com. The information contained on our website or connected to our website is not incorporated
by reference into this Annual Report and should not be considered part of this Report.

Our annual reports on Form
10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports, filed or furnished pursuant to Section
13(a) or 15(d) of the Securities Exchange Act are available free of charge on or through our website at www.actuatetherapeutics.com under
the “SEC Filings” heading on the “Investors” page as soon as reasonably practicable after such reports have been filed
with or furnished to the SEC. They are also available for free on the SEC’s website at www.sec.gov.

In addition, we use our website
www.actuatetherapeutics.com as a means of disclosing material non-public information and for complying with our disclosure obligations
under the Regulation FD. Such disclosures will be included on the Company’s website under the heading “Investors.” We
also use social media accounts as a means of disclosing material non-public information, including accounts at:

·X account (formerly Twitter): @ActuateThera or https://x.com/ActuateThera

·LinkedIn: https://www.linkedin.com/company/actuate-therapeutics-inc./

·Facebook profile: https://www.facebook.com/profile.php?id=61572431561095

Accordingly, investors should
monitor such portions of the Company’s website and social media accounts, in addition to following the Company’s press releases,
SEC filings, corporate presentations, and public conference calls and webcasts (if any).

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