What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-11-02 compared with 2023-08-14 · 437 added, 397 removed, 745 unchanged (53% of the section changed)

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Description of Business

Pharmaceuticals, Inc.

(“Actinium”) develops targeted radiotherapies intended to meaningfully improve survival for

patients with relapsed or refractory cancer who have failed existing therapies.

Our vision is to build a specialty,

hospital-focused, radiotherapeutics company that develops and markets medicines for patients who are treated primarily in large

quaternary care hospitals and their catchment areas.

Actinium Pharmaceuticals,

(“Actinium”) develops targeted radiotherapies intended to meaningfully improve survival for patients with relapsed or

refractory cancer who have failed existing therapies.

Our vision is to build a specialty, hospital-focused, radiotherapeutics company

that develops and markets medicines for patients who are treated primarily in large quaternary care hospitals and their catchment areas.

Pipeline Highlights

We intend to leverage the

clinical data of our lead product candidates, Iomab-B and Actimab-A, to improve outcomes in patients with relapsed or refractory acute

myeloid leukemia (“r/r AML”) by launching two radiotherapy drugs over the next several years to address the significant need

for better outcomes from treatment with therapeutics or from undergoing a bone marrow transplant (“BMT”).

We intend to leverage the clinical data of our lead product candidates,

Iomab-B and Actimab-A, to potentially improve outcomes in patients with relapsed or refractory acute myeloid leukemia (“r/r AML”)

by launching two radiotherapy drugs over the next several years to address the significant need for better outcomes from treatment with

therapeutics or from undergoing a bone marrow transplant (“BMT”).

We also intend to further

advance Iomab-B outside of acute myeloid leukemia (“AML”) based on promising data as a disease control and conditioning agent

advance Iomab-B beyond acute myeloid leukemia (“AML”) based on promising data as a disease control and conditioning agent

for various other blood cancers.

Based on early promising clinical trial results, we are also working on a lower dose, next generation

conditioning program, Iomab-ACT, for rapidly growing cell and gene therapies.

Based on early clinical trial results, we are also working on a lower dose, next generation conditioning

program, Iomab-ACT, for rapidly growing cell and gene therapies.

Our Clinical Pipeline

AML is an aggressive, heterogeneous

disease that is difficult-to-treat.

Most AML patients develop relapsed or refractory disease within one year of being afflicted and have

an extremely poor prognosis and dismal survival.

Currently, a BMT is the only curative regimen available for AML patients, however, access

is limited to AML patients who are fit enough to withstand the challenges associated with this treatment.

The majority of AML patients

are considered not transplantable in routine clinical practice as they are not fit enough to withstand the rigors of the patient journey

which includes therapy to attain a remission, conditioning regimens to destroy diseased marrow, challenge of the transplant itself or

post-transplant complications.

Our Iomab-B and

Actimab-A product candidates potentially fill the major unmet medical needs in r/r AML in a complementary fashion as they are

directed at different parts of the patient journey.

Iomab-B is being developed as a targeted bridging therapy candidate that we

believe could provide both disease control and conditioning in one agent.

We believe results from our Phase 3 SIERRA trial

demonstrate the possibility for unprecedented access to a BMT and improved survival in unfit patients who are currently not

considered transplantable in routine clinical practice.

We are developing Actimab-A as a targeted therapy candidate for fit

Actimab-A has demonstrated an extension in survival in a proof-of-concept study and is poised for advanced development in

collaboration with the NCI, or National Cancer Institute (“NCI”).

Together, we believe these two product candidates

could provide us the opportunity to transform the treatment of AML, especially in the relapsed and refractory segment which

represents over 50% of AML patients.

We announced in October 2022

that Iomab-B met the primary endpoint of durable Complete Remission (“dCR”) with a high degree of statistical significance

(p<0.0001) in the pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractor AML, or “SIERRA trial.” In February

2023, we announced full trial results, demonstrating unprecedented transplant access and improved outcomes in patients with r/r AML, with

double 1-year and median overall survival (“OS”) compared to control arm patients.

These data were presented at the 2023 Tandem

Meetings aka the Transplantation & Cellular Therapy (“TCT”) Meetings of the American Society for Transplantation and Cellular

Therapy (“ASTCT”) and the Center for International Blood & Marrow Transplant Research (“CIBMTR”).

these results from the SIERRA trial may provide the opportunity, if we are able to obtain U.S.

Food and Drug Administration (“FDA”)

approval, to establish Iomab-B as a new standard of care.

The results from the

SIERRA trial were recently presented and discussed at major bone marrow transplant and hematology medical conferences, nuclear

medicines conference and nursing congress, which is helping to broaden the awareness of Iomab-B among members of the relevant

medical and scientific communities as we prepare for potential commercialization if we achieve FDA approval.

Including TCT, the

SIERRA Phase 3 results have now been highlighted in oral presentations at four international medical conferences in the U.S.

attended by key Iomab-B stakeholders including bone marrow transplant physicians, hematologists and nuclear medicine physicians.

April 27, 2023, the results from the SIERRA trial were also showcased at the European Society for Blood and Marrow Transplantation

(“EBMT”) 49 th Annual Meeting, which was well-attended by the European transplant community.

Also in April

2023, two posters that detailed clinical findings from the SIERRA trial sites were presented at the 48 th Annual Oncology

Nursing Society (“ONS”) Congress.

We believe that the scientific community present at such events took note of the

successful administration of Iomab-B infusions at various BMT centers, which was done without increasing radiation exposure risks to

treating nursing staff.

SIERRA results were also awarded an oral presentation at the European Hematology Association

(“EHA”) 2023 Hybrid Congress and presented in Frankfurt, Germany on June 10, 2023.

The SIERRA results were also

presented at the Society for Nuclear Medicine and Molecule Imaging (“SNMMI”) annual meeting on June 26, 2023 and was

awarded the Henry N.

Wagner, Jr., Abstract of the Year award, which represents the top selection out of more than 1,500 abstracts

accepted for presentation.

We are actively working on

launching an early access program (“EAP”) for Iomab-B.

We are also working towards completing and submitting our Biologics

License Application (“BLA”) for Iomab-B to the FDA by the end of 2023 and if approved, we intend to commercialize Iomab-B

We are committed to bringing Iomab-B to patients globally and are working with Immedica AB (“Immedica”), our

European, Middle East and North Africa (“EUMENA”) partner, for the subsequent marketing authorization application (“MAA”)

of Iomab-B with the European Medicines Agency (“EMA”).

Europe represents a large commercial market opportunity with approximately

twice as many transplants performed in Europe compared to the U.S.

AML is an aggressive, heterogeneous disease that is difficult-to-treat.

Over 50% of AML patients develop relapsed or refractory disease within one year of being afflicted and have an extremely poor prognosis

and dismal survival.

Currently, a BMT is regarded as being able to provide the best treatment outcomes and is the only curative regimen

available for AML patients, however, access is limited to AML patients who are fit enough to withstand the challenges associated with

this treatment.

The majority of AML patients are considered not transplantable in routine clinical practice as they are not fit enough

to withstand the rigors of the patient journey, which includes therapy to attain a remission, conditioning regimens to destroy diseased

marrow, challenge of the transplant itself or post-transplant complications.

Our Iomab-B and Actimab-A

product candidates have the potential to fill the major unmet medical needs in r/r AML in a complementary fashion as they are directed

at different parts of the patient journey.

Iomab-B is being developed as a targeted bridging therapy candidate that we believe could provide

both disease control and conditioning in one agent.

We believe results from our Phase 3 SIERRA trial demonstrate the possibility for unprecedented

access to a BMT and improved survival in unfit patients who are currently not considered transplantable in routine clinical practice.

We are developing Actimab-A as a targeted therapy candidate for fit patients.

Actimab-A has demonstrated an extension in survival in a

proof-of-concept study and is poised for advanced development in collaboration with the NCI, or National Cancer Institute (“NCI”).

Together, we believe these two product candidates could provide us the opportunity to transform the treatment of AML, especially in the

relapsed and refractory segment which represents over 50% of AML patients.

Iomab-B was evaluated in the

pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractor AML, or “SIERRA trial” with Iomab-B meeting the primary

endpoint of durable Complete Remission (“dCR”) with a high degree of statistical significance (p<0.0001).

In February 2023,

we announced full SIERRA trial results, demonstrating unprecedented transplant access and improved outcomes in patients with r/r AML,

with double 1-year and median overall survival (“OS”) compared to control arm patients.

These data were presented at the 2023

Tandem Meetings aka the Transplantation & Cellular Therapy (“TCT”) Meetings of the American Society for Transplantation

and Cellular Therapy (“ASTCT”) and the Center for International Blood & Marrow Transplant Research (“CIBMTR”).

We believe these results from the SIERRA trial may provide the opportunity, if we are able to obtain U.S.

Food and Drug Administration

(“FDA”) approval, to establish Iomab-B as a potentially new standard of care.

The results from the SIERRA trial have been and are expected to be

presented at the most prestigious and high-impact bone marrow transplant and hematology medical conferences, nuclear medicine conferences

and nursing congresses.

This wide exposure is helping broaden the awareness of Iomab-B among members of these relevant medical and scientific

communities as we prepare for potential commercialization subject to FDA approval.

Including TCT, the SIERRA Phase 3 results have now been

highlighted in oral presentations at seven international medical conferences in the U.S.

and EU attended by key Iomab-B stakeholders including

bone marrow transplant physicians, hematologists and nuclear medicine physicians.

Previous and expected Iomab-B SIERRA trial data presentations

● Oral Presentation:

European Society for Blood

and Marrow Transplantation (“EBMT”) 49 th Annual Meeting, April 2023

● Oncology Nursing Society (“ONS”)

48 th Annual Congress, April 2023

● Oral Presentation:

European Hematology Association

(“EHA”) 2023 Hybrid Congress, June 2023

● Oral Presentation:

Society for Nuclear Medicine

and Molecule Imaging (“SNMMI”) Annual Meeting, June 2023

We believe that the medical

and scientific communities present at these events took note of the positive SIERRA clinical trial results, safety and tolerability of

Iomab-B and the successful administration of Iomab-B infusions at various BMT centers, which was done without increasing radiation exposure

risks to treating nursing staff.

The SIERRA results were awarded the Henry N.

Wagner, Jr., Abstract of the Year award at SNMMI, representing

the top selection out of more than 1,500 abstracts accepted for presentation, which we believe highlights the recognition by the nuclear

medicine community.

Recent Iomab-B SIERRA trial data presentations

● Oral Presentation:

European Association of Nuclear

Medicine (“EANM”) 2023 Congress, September 10, 2023

● Society of Hematologic Oncology

(“SOHO”) 2023 Annual Meeting, September 6, 2023

Upcoming Iomab-B SIERRA trial data presentations

● Oral Presentation:

American Society of Hematology

Annual Meeting & Exposition, December 10, 2023

The data accepted for oral

presentation at ASH on December 10, 2023, will detail survival outcomes of patients with a TP53 mutation enrolled on the SIERRA trial,

highlighting improved survival in patients who received Iomab-B.

As disclosed in the ASH abstract published on November 2, 2023, a total

of 37 patients (24.2%) enrolled on the SIERRA trial had a TP53 mutation with 17 patients randomized to the Iomab-B arm and 20 patients

randomized to the control arm of the study.

Median Overall Survival for TP53 negative patients receiving Iomab-B was 6.37 months and 5.72

months for TP53 positive patients, demonstrating Iomab-B’s ability to overcome TP53 gene mutations.

The median overall survival

of TP53 positive patients on the control arm, including patients who crossed over and received Iomab-B, was 2.96 months.

When analyzing

all TP53 positive patients who received Iomab-B, either after initial randomization or crossover, median overall survival was 5.49 months

compared to 1.66 months in patients that did not receive Iomab-B, hazard ratio= 0.23 (p=0.0002).

We are working towards completing

and submitting our Biologics License Application (“BLA”) for Iomab-B to the FDA, and if approved, we intend to commercialize

Iomab-B in the U.S.

We have been meeting with the FDA regarding our BLA strategies, and have received positive feedback regarding the

Chemistry, Manufacturing and Controls (“CMC”) package for Iomab-B.

The Company, as a continuation of our regulatory interactions

with the FDA, will request a meeting prior to completion of the CMC package to further discuss the clinical and non-clinical modules that

will determine the finalization and timing of our planned BLA filing.

As a result of the CMC meeting, as well as updated project timelines

necessitated by the now complete facility modifications at one of our third-party manufacturers, the Company is progressing with completion

of CMC activities and believes it is on track to complete the CMC modules and be in a position to submit a BLA filing in the first half

The Early Access Program for Iomab-B is also anticipated to start post completion of these activities.

We simultaneously plan

to bring Iomab-B to patients globally and are working with Immedica Pharma AB (“Immedica”), our European, Middle East and

North Africa (“EUMENA”) partner, for the marketing authorization application (“MAA”) of Iomab-B with the European

Medicines Agency (“EMA”).

Europe represents a large commercial market opportunity with approximately twice as many transplants

performed in Europe compared to the U.S.

Actimab-A is being developed

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energy transfer emitted by Ac-225 has no known resistance mechanism.

Actimab-A is being developed in combination with other regimens to

exploit mechanistic synergies and leverage the mutation-agnostic mechanism of action of Ac-225 with the objective of establishing it as

a backbone therapy in AML, an extremely heterogenous disease.

We believe our Actimab-A + CLAG-M therapeutic combination trial results

in r/r AML provide validation of this approach.

Such results were presented at the American Society of Hematology (“ASH”)

2022 Annual Meeting & Exposition in December 2022.

Phase 1 results from the Actimab-A + CLAG-M combination trial showed high response

rates and minimal residual disease (“MRD”) negativity, translating to a survival benefit of 53% and 32% at one and two years

in patients who are typically expected to live two to four months.

At the same meeting, we shared Phase 1 data showing that the combination

of Actimab-A + venetoclax was well-tolerated with responses, including a Complete Remission (“CR”) and a partial response

in early dose escalation cohorts.

We believe the promise of these results have paved the way for the NCI Cooperative Research and Development

Agreement (“CRADA”), announced on February 6, 2023, to develop Actimab-A for the treatment of patients with AML and other

hematologic malignancies.

Under the CRADA, Actinium expects to initiate the late-stage development of Actimab-A, including a potential

pivotal trial, in combination as a backbone therapy for r/r AML and expects to update on the program and timing by end of the second half of 2023.

Actimab-A is being developed in combination with other regimens including

chemotherapies and targeted agents to exploit potential mechanistic synergies and leverage the mutation-agnostic mechanism of action of

Ac-225 with the objective of establishing it as a backbone therapy in AML, an extremely heterogenous disease.

We believe our Actimab-A +

CLAG-M therapeutic combination trial results in r/r AML, presented in an oral presentation at ASH in December 2022 validate this approach.

Phase 1 results from the Actimab-A + CLAG-M combination trial showed high response rates and minimal residual disease (“MRD”)

negativity, translating to a survival benefit of 53% and 32% at one and two years in patients who are typically expected to live two to

On September 6, 2023, updated survival data from the Actimab-A + CLAG-M combination trial was presented at SOHO with 30-month

median Overall Survival (“OS”) reported in patients with prior venetoclax treatment who proceeded to BMT and 24-month median

OS in all patients who proceeded to BMT following Actimab-A + CLAG-M treatment.

We have also presented Phase 1 data showing that

the combination of Actimab-A + venetoclax was well-tolerated with responses, including a Complete Remission (“CR”) and a partial

response in early dose escalation cohorts.

We believe the promise of these results paved the way for the NCI Cooperative Research and

Development Agreement (“CRADA”), announced in February 2023, to develop Actimab-A for the treatment of patients with AML and

other hematologic malignancies.

Additionally, we presented the first-ever preclinical data demonstrating the potential synergy of Actimab-A

with FLT3 inhibitors gilteritinib and midostaurin at SOHO.

FLT3 is one of the most commonly mutated genes in AML and is associated with

aggressive disease with poor outcomes.

Actimab-A was shown to have single-agent activity against FLT3 mutant AML cell lines, supporting

its mutation agnostic mechanism, and enhanced the anti-leukemic activity of the FLT3 inhibition in vitro.

We believe these results support

continued evaluation of the combination with the goal of advancing to clinical trials.

Based on this data update, Actinium expects to

initiate the late-stage development of Actimab-A, including a potential pivotal trial, in combination as a backbone therapy for r/r AML

under the CRADA with the NCI and the NCI expects to meet with the FDA in the first quarter of 2024 to finalize a pivotal trial design.

To explore the potential for

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and exert immunosuppressive effects.

On April 18, 2023, we presented preclinical data at the Association for Cancer Research (“AACR”)

In April 2023, we presented preclinical data at the Association for Cancer Research (“AACR”)

Annual Meeting that depicted Actimab-A’s role in the tumor microenvironment to overcome immunosuppression driven by MDSCs.

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cancer (p<0.01), highlighting the powerful cytotoxicity and potential therapeutic benefit of radiotherapy compared to naked antibodies

We believe that the data we have gathered to-date continues to support our objective to demonstrate the potential for Actimab-A

to be a backbone therapy to broadly improve antitumor activity of immunotherapies and other therapeutic modalities.

Additional preclinical data evaluating Actimab-A for the targeting of MDSCs has been accepted for presentation at the Society

of Immunotherapy of Cancer (“SITC”) 38 th Annual Meeting on November 4, 2023.

We believe that the data we have

gathered to-date continues to support our objective to demonstrate the potential for Actimab-A to be a backbone therapy to broadly improve

antitumor activity of immunotherapies and other therapeutic modalities.

Our differentiated R&D

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with investigational new drug (“IND”) enabling studies underway.

Our platform has been used

to develop a pipeline of novel radiotherapeutic assets to drive company growth.

Preclinical pharmacology studies with our targeted radiotherapeutics,

such as HER3-ARC, HER2-ARC or CD33-ARC, have shown strong improvement in tumor growth inhibition in various preclinical tumor models as

single agents or in combination with immunotherapy such as magrolimab, an anti-CD47 monoclonal antibody.

These results have prompted the

Our platform has been

used to develop a pipeline of novel radiotherapeutic assets to drive company growth.

Preclinical pharmacology studies with our

targeted radiotherapeutics directed at validated cancer targets including HER3, HER2, CD33 and CD38, have shown strong improvement

in tumor growth inhibition in various preclinical tumor models as single agents or in combination with targeted agents and

immunotherapy such as checkpoint inhibitors including magrolimab, an anti-CD47 monoclonal antibody.

These results have prompted our

team to spearhead efforts in multiple solid tumor programs.

Actinium’s lead solid

tumor program is a targeted radiotherapy against HER3, a pan-cancer target that is overexpressed in several solid tumor indications with

high unmet need.

We have aligned our R&D strategy of advancing solid tumors into the clinic with our Actimab-A program.

presented pre-clinical data at the AACR 2023 Annual Meeting, highlighting this opportunity.

We believe the results support further testing

to evaluate the anti-tumor effects of HER3-targeted radiotherapy.

HER3 conjugated to either alpha-emitting Ac-225 or beta-emitting Lutetium-177

(“Lu-177”) displayed anticancer activity in ovarian and colorectal cancer preclinical models.

The consistent overexpression

of HER3 in multiple solid tumor types, including ovarian, renal, prostate, urothelial, breast, and lung cancers suggests broad utility

of a HER3-targeted agent in a clinical setting, which we intend to explore further.

Our intellectual

property (“IP”) portfolio includes over 200 issued patents and pending patent applications worldwide.

With the approximately $91.2

million cash on hand as of June 30, 2023, we expect to fund operations through 2025 as we continue to drive ahead in executing our strategy

Our intellectual property

(“IP”) portfolio includes over 220 issued patents and pending patent applications worldwide.

With approximately $82.9 million

cash on hand as of September 30, 2023, we expect to fund operations through 2025 as we continue to drive ahead in executing our strategy

to realize our vision.

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to treat both newly diagnosed or r/r AML patients, with the potential addressable population comparable to the prevalence of patients

Today, less than 20% of AML

patients are able to access a BMT, currently the only potentially curative option.

These patients are usually younger, fit, and able to

withstand the challenges associated with this treatment, leaving the large majority of AML patients ineligible for transplant.

This provides

an opportunity for Iomab-B, which has demonstrated the ability to enable unfit patients to benefit from a BMT.

Thus Iomab-B can potentially

expand the market from the approximately 400 r/r AML patients who are transplanted currently to approximately 8,000 unfit patients that

could be eligible for transplant.

Iomab-B has also demonstrated the ability to improve BMT access with extended survival and potentially

curative outcomes in several other hematological diseases outside of AML.

Several clinical trials in over 300 patients with myelodysplastic

syndromes (“MDS”), acute lymphocytic leukemia (“ALL”), Hodgkin’s lymphoma (“HL”), Non-Hodgkin

lymphoma (“NHL”) and multiple myeloma (“MM”) have demonstrated the same value proposition as in AML.

provides a potential opportunity to expand the market for Iomab-B beyond AML via label expansion.

In the U.S., there are approximately

185,000 patients diagnosed annually with blood cancers (e.g., leukemia, lymphoma, and myeloma) that are treatable with BMT, of which,

approximately 20,000 are transplanted, leaving greater than 165,000 patients who could potentially benefit from transplant.

These patients

do not receive a BMT today primarily because they are unfit with active disease and are not considered eligible, as they cannot tolerate

the rigors of therapy required to induce a remission and the conditioning agents required to ablate the marrow prior to a BMT.

Today, less than 20% of all

AML patients and less than 5% of r/r AML patients are able to access a BMT, currently the only potentially curative option.

Most patients

receiving BMT are fit, in remission and able to withstand the challenges associated with this treatment, leaving the large majority of

AML patients ineligible for transplant.

This provides an opportunity for Iomab-B, which has demonstrated the ability to enable unfit patients

to benefit from a BMT.

Thus Iomab-B can potentially expand the market from the approximately 400 r/r AML patients who are transplanted

currently to approximately 8,000 unfit patients that could be eligible for transplant.

Iomab-B has also demonstrated the ability to improve

BMT access with extended survival and potentially curative outcomes in several other hematological diseases outside of AML.

Several clinical

trials in over 300 patients with myelodysplastic syndromes (“MDS”), acute lymphocytic leukemia (“ALL”), Hodgkin’s

lymphoma (“HL”), Non-Hodgkin lymphoma (“NHL”) and multiple myeloma (“MM”) have demonstrated the same

value proposition as in AML.

This data provides a potential opportunity to expand the market for Iomab-B beyond AML via label expansion.

In the U.S., there are approximately 185,000 patients diagnosed annually with blood cancers (e.g., leukemia, lymphoma, and myeloma) that

are treatable with BMT, of which, approximately 20,000 are transplanted, leaving greater than 165,000 patients who could potentially benefit

from transplant.

These patients do not receive a BMT today primarily because they are unfit with active disease and are not considered

eligible, as they cannot tolerate the rigors of therapy required to induce a remission and the conditioning agents required to ablate

the marrow prior to a BMT.

Beyond BMT, the opportunity

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a therapeutic agent, and Iomab-B for induction and conditioning, can be used in a complementary fashion as depicted in the diagram below.

Based on solid clinical evidence with these product candidates, we intend to develop and commercialize these two radiotherapy drugs, starting

with Iomab-B in 2024 and Actimab-A in 2027, if approved, to improve survival in patients with r/r AML.

Iomab-B and Actimab-A have the potential

to significantly improve r/r AML outcomes in a complementary manner

Based on the clinical evidence with these product candidates, we intend to develop and commercialize these two radiotherapy drugs, starting

with Iomab-B and followed by Actimab-A, if approved, with the goal of improving survival in patients with r/r AML.

Iomab-B and Actimab-A have the potential to significantly improve

r/r AML outcomes in a complementary manner

The operating model

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significant overlap in the healthcare providers and ecosystem required to diagnose, treat and care for r/r AML patients within these

hospitals, which will enable us to deploy a relatively small commercial organization and operate a supply chain without the need for

large investments.

hospitals, which we believe will enable us to deploy a relatively small commercial organization and operate an appropriately sized

supply chain.

Our product pipeline is targeting

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Our strategic priorities are to:

Establish Iomab-B as the standard of care to improve BMT access and survival outcomes in r/r AML patients who are currently not considered transplantable in routine clinical practice:

We intend to file a BLA in the second half of 2023 based on the positive results from the Pivotal Phase 3 SIERRA trial and leverage our operating track record at key cancer centers to build an organization that can effectively commercialize Iomab-B.

By virtue of the SIERRA trial, we have established operations at 24 leading BMT centers in the U.S (22) and Canada (2) that represent about 30% of transplant volume and have strong working partnership with Key Opinion Leaders (“KOLs”) and their teams.

The SIERRA results demonstrating unprecedented access to BMT and outcomes along with our commitment to operational excellence provides a strong foundation for our commercial team in the U.S.

We will also work with our partner Immedica to file the MAA for the EU and support Iomab-B’s potential approval and launch with our expertise, as well as supply drug product for commercialization.

Iomab-B as the standard of care to improve BMT access and survival outcomes in r/r AML patients

who are currently not considered transplantable in routine clinical practice:

intend to file a BLA in the first half of 2024 based on the positive results from the Pivotal

Phase 3 SIERRA trial and successful regulatory interactions with the FDA.

We intend to leverage

our operating track record at key cancer centers to build an organization that can effectively

commercialize Iomab-B.

By virtue of the SIERRA trial, we have established operations at 24

leading BMT centers in the U.S (22) and Canada (2) that represent about 30% of transplant

volume and have strong working partnership with Key Opinion Leaders (“KOLs”)

and their teams.

The SIERRA results demonstrating unprecedented access to BMT and outcomes

along with our commitment to operational excellence provides a strong foundation for our

commercial team in the U.S.

We will also work with our partner Immedica to support the MAA

for the EU and support Iomab-B’s potential approval and launch with our expertise,

as well as supply drug product for commercialization.

Advance Actimab-A in combinations as a backbone therapy for r/r AML:

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The number of patients potentially eligible for Iomab-ACT is growing with increased availability of commercial cell and gene therapy products, as well as the expanding number of indications.

We are studying Iomab-ACT in conditioning prior to CAR-T cellular therapy via a National Institutes of Health (“NIH”) funded clinical trial with Memorial Sloan Kettering Cancer Center (“MSKCC”).

We expect to present proof-of-concept data from this study in the second half of 2023 and announce further development of this program in the CAR-T space.

Leverage our R&D capabilities and technological prowess to advance our solid tumor programs and partnerships:

We intend to continue to direct our R&D effort to advance our solid tumor programs into the clinic and support life cycle management for Iomab-B and Actimab-A.

Our solid tumor programs and technological capabilities are validated by our partnerships with Astellas, LG Chem, and EpicentRx.

Our R&D capability is demonstrated by our patent portfolio with over 200 issued and pending patent applications worldwide which include protection for Iomab-B into 2037.

Our IP portfolio also includes several patent families to manufacture Ac-225 in a cyclotron and includes valuable know-how.

In keeping with our strategic

vision over the next five years, we plan to first focus on ensuring an Iomab-B approval and successful launch into core BMT centers

to support commercial success.

We intend to expand the Iomab-B label and revenue stream while progressing the development of Actimab-A

by leveraging the NCI CRADA.

We will progress the development of Iomab-ACT to proof-of-concept and explore potential partnerships

as a means to achieve commercialization.

Our solid tumor programs will progress toward the clinic as we continue to build out our

commercial footprint into the top 100 hospitals leaving us positioned to develop them in line with our vision.

With commercial dynamics

aligning favorably for a successful Iomab-B launch and with late-stage development of Actimab-A in collaboration with the NCI, we

plan to deliver on our mission to transform the treatment of AML and patient outcomes, and create a highly differentiated, specialty

radiotherapeutics company focused on the top 100 large hospitals.

We are studying Iomab-ACT in conditioning prior to CAR-T cellular therapy via a National Institutes of Health (“NIH”) grant that was recently extended to the Phase 2 portion to fund the ongoing clinical trial with Memorial Sloan Kettering Cancer Center (“MSKCC”).

We expect to present proof-of-concept data from this study and announce further development of this program in the CAR-T space by the end of 2023.

Leverage our R&D capabilities

and technological prowess to advance our solid tumor programs and partnerships:

to continue to direct our R&D effort to advance our solid tumor programs into the clinic and

support life cycle management for Iomab-B and Actimab-A.

Our solid tumor programs and technological

capabilities are validated by our partnerships with Astellas, LG Chem, and EpicentRx.

capability is demonstrated by our patent portfolio with over 220 issued and pending patent applications

worldwide which include protection for Iomab-B into 2037.

Our IP portfolio also includes several

patent families to manufacture Ac-225 in a cyclotron and includes valuable know-how.

In keeping with our strategic vision over the next five years, we plan to first focus on ensuring an Iomab-B approval and successful launch into core BMT centers to support commercial success.

We intend to expand the Iomab-B label and revenue stream while progressing the development of Actimab-A by leveraging the NCI CRADA.

We will progress the development of Iomab-ACT to proof-of-concept and explore potential partnerships as a means to achieve commercialization.

Our solid tumor programs will progress toward the clinic as we continue to build out our commercial footprint into the top 100 hospitals leaving us positioned to develop them in line with our vision.

With commercial dynamics aligning favorably for a successful Iomab-B launch and with late-stage development of Actimab-A in collaboration with the NCI, we plan to deliver on our mission to transform the treatment of AML and patient outcomes, and create a highly differentiated, specialty radiotherapeutics company focused on the top 100 large hospitals.

Our Product Pipeline

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for Accessing a BMT and Improving Outcomes

The current approach in preparing

patients for a BMT is to first induce a remission with therapeutic agents to reduce the disease burden and then suppress or destroy the

patient’s immune system, including the diseased bone marrow, with conditioning regimens prior to transplanting the healthy donor

hematopoietic stem cells, which are expected to restore normal bone marrow function following engraftment.

As this approach requires patients

to withstand multiple challenges from non-targeted therapies, which include chemotherapy agents and/or total body irradiation that are

highly toxic, BMT is typically limited to FIT patients.

Iomab-B is a targeted therapy that provides both disease control (induction) and

conditioning in one agent and is well-tolerated even by UNFIT patients who typically are not transplanted in routine practice today.

SIERRA trial was designed to demonstrate that UNFIT patients with active disease could be administered Iomab-B and proceed directly to

a BMT without the need for inducing a remission and that this approach could result in improved survival and curative outcomes.

by the positive results of the SIERRA trial detailed below, Iomab-B represents an exciting new paradigm in the management of AML patients

and establishes a potential new standard of care especially for UNFIT patients in the relapsed or refractory setting.

approach has also been tried in the Phase 3 ASAP trial but with FIT patients.

However, to avoid confusion between the potential of the

approaches used in the ASAP and SIERRA trials, important distinctions between these trials are depicted in the graphic below.

trial sought to demonstrate non-inferiority between two non-novel approaches and found that outcomes similar to those of current practice

could be achieved without first getting a patient into remission before taking them to BMT by giving them sequential conditioning or treating

them twice with non-targeted chemotherapy agents that are typically used in this setting.

The ASAP approach is

limited to only FIT patients as the UNFIT patients treated in SIERRA could not tolerate ASAP’s highly toxic sequential

conditioning approach.

Sequential conditioning is not novel as a similar trial to ASAP was conducted by the UK National Cancer

Research Institute in 2019, which did not show any benefit from this approach in high-risk AML and MDS patients (Craddock et al.

Augmented Reduced Intensity Regimen Does Not Improve Post allogeneic Transplant Outcomes in Acute Myeloid Leukemia.

The current approach in

preparing patients for a BMT is to first induce a remission with therapeutic agents to reduce the disease burden and then suppress

or destroy the patient’s immune system, including the diseased bone marrow, with conditioning regimens prior to transplanting

the healthy donor hematopoietic stem cells, which are expected to restore normal bone marrow function following engraftment.

approach requires patients to withstand multiple challenges from non-targeted therapies, which include chemotherapy agents and/or

total body irradiation that are highly toxic, BMT is typically limited to FIT patients.

Iomab-B is a targeted therapy that provides

both disease control (induction) and conditioning in one agent and is well-tolerated even by UNFIT patients who typically are not

transplanted in routine practice today.

The SIERRA trial was designed to demonstrate that UNFIT patients with active disease could

be administered Iomab-B and proceed directly to a BMT without the need for inducing a remission and that this approach could result

in improved survival and curative outcomes.

As seen by the positive results of the SIERRA trial detailed below, Iomab-B represents

an exciting new potential paradigm in the management of AML patients and establishes a potential new standard of care especially for

UNFIT patients in the relapsed or refractory setting.

A similar approach has also

been tried in the Phase 3 ASAP trial but with FIT patients.

However, to avoid confusion between the potential of the approaches used in

the ASAP and SIERRA trials, important distinctions between these trials are depicted in the graphic below.

The ASAP trial sought to demonstrate

non-inferiority between two non-novel approaches and found that outcomes similar to those of current practice could be achieved without

first getting a patient into remission before taking them to BMT by giving them sequential conditioning or treating them twice with non-targeted

chemotherapy agents that are typically used in this setting.

The ASAP approach is limited

to only FIT patients as the UNFIT patients treated in SIERRA could not tolerate ASAP’s highly toxic sequential conditioning approach.

Sequential conditioning is not novel as a similar trial to ASAP was conducted by the UK National Cancer Research Institute in 2019, which

did not show any benefit from this approach in high-risk AML and MDS patients (Craddock et al.

Augmented Reduced Intensity Regimen Does

Not Improve Post allogeneic Transplant Outcomes in Acute Myeloid Leukemia.

J Clin Oncol.

The SIERRA trial results therefore can change the paradigm in transplant because non-transplantable patients in routine

clinical practice can benefit from a transplant with Iomab-B and have superior outcomes.

While both approaches in these trials

support increased access to BMT, only Iomab-B is applicable to the unfit patients who comprise approximately 80% of r/r AML patients

and can potentially expand the market for transplant.

The SIERRA trial results therefore

can change the paradigm in transplant because non-transplantable patients in routine clinical practice can benefit from a transplant with

Iomab-B and have superior outcomes.

While both approaches in these trials support increased access to BMT, only Iomab-B is applicable

to the unfit patients who comprise approximately 80% of r/r AML patients and can potentially expand the market for transplant.

Schetelig et al.

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Unfortunately, approximately 30%

of patients with AML have primary refractory disease while 50% relapse quickly after achieving initial remission.

Getting these patients

with primary r/r AML into remission is very challenging due to characteristics such as age, comorbidities, and disease features such as

high-risk mutations that contribute to lack of response to salvage therapies and limit treatment options.

of patients with AML have primary refractory disease while approximately 50% relapse quickly after achieving initial remission.

these patients with primary r/r AML into remission is very challenging due to characteristics such as age, comorbidities, and disease

features such as high-risk mutations that contribute to lack of response to salvage therapies and limit treatment options.

Patients must be able to overcome

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a patient not achieving CR/CRp or crossing over, patient not receiving

BMT, a patient relapsing or death.

BMT, or a patient relapse or death.

In the figure below comparing

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an Iomab-B led regimen, an unprecedented number of patients were able to access transplant and were able to do so with active disease,

eliminating need for achieving a CR in order to transplant the patient.

eliminating the need for achieving a CR in order to transplant the patient.

Thus, patients are also able to access BMT faster with Iomab-B,

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standard of care for patients with r/r AML.

We are actively working to launch an EAP and successfully file a BLA in the second half of

2023, and if approved, we anticipate the commercial launch for Iomab-B in 2024.

We intend to commercialize

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AML in EUMENA, two times that of the U.S., performed in a concentrated number of centers.

The incidence rate of AML in Europe is 3.7

per 100,000, or ~27,500 new patients per year.

The incidence rate of AML in Europe is 3.7 per

100,000, or ~27,500 new patients per year.

Actinium received an upfront payment of $35 million USD with the potential for an additional

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Background on Iomab-B

Iomab-B is a first-in-class targeted radiotherapy consisting of apamistamab,

an anti-CD45 mouse antibody conjugated to radioactive iodine 131 (“I-131”) designed to deliver targeted myeloablative radiation

to malignant and hematopoietic cells prior to allogeneic BMT.

CD45 is uniquely expressed on blood cancer, immune and bone marrow stem

cells at high levels.

Targeting CD45 enables delivery of high radiation doses directly to the bone marrow, with a median of 16 gray and

as high as 44.6 gray in the SIERRA trial, while minimizing radiation exposure to vital organs such as lungs, heart and gastrointestinal

tract, thereby producing myeloablative outcomes with an overall better safety profile and the tolerability of a reduced intensity regimen.

I-131 is a beta- and gamma-emitting radioisotope that works on the cell surface and does not need to be internalized.

Developed at the

Fred Hutchinson Cancer Research Center (“FHCRC”), Iomab-B has been studied in multiple disease indications including leukemias,

lymphomas, MDS, and MM.

Over 300 patients received Iomab-B through prior studies, demonstrating the potential for unprecedented access

to BMT, improved survival and tolerability, and we intend to leverage these data as we plan for label expansion of Iomab-B.

been granted Orphan Drug Designation from the FDA and has patent protection into 2037.

Iomab-B is a first-in-class

targeted radiotherapy consisting of apamistamab, an anti-CD45 mouse antibody conjugated to radioactive iodine 131 (“I-131”)

designed to deliver targeted myeloablative radiation to malignant and hematopoietic cells prior to allogeneic BMT.

CD45 is uniquely expressed

on blood cancer, immune and bone marrow stem cells at high levels.

Targeting CD45 enables delivery of high radiation doses directly to

the bone marrow, with a median of 16 gray and as high as 44.6 gray in the SIERRA trial, while minimizing radiation exposure to vital organs

such as lungs, heart and gastrointestinal tract, thereby producing myeloablative outcomes with an overall better safety profile and the

tolerability of a reduced intensity regimen.

I-131 is a beta- and gamma-emitting radioisotope that works on the cell surface and does

not need to be internalized.

Developed at the Fred Hutchinson Cancer Research Center (“FHCRC”), Iomab-B has been studied in

multiple disease indications including leukemias, lymphomas, MDS, and MM.

Over 300 patients received Iomab-B through prior studies, demonstrating

the potential for unprecedented access to BMT, improved survival and tolerability, and we intend to leverage these data as we plan for

label expansion of Iomab-B.

Iomab-B has been granted Orphan Drug Designation from the FDA and has patent protection into 2037.

Actimab-A – CD33 targeting radiotherapeutic

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In collaboration with the

Medical College of Wisconsin, the Actimab-A + CLAG-M Phase 1 trial was conducted in r/r AML patients.

These patients had a median age

of 63, failed two or more lines of therapy, which includes 57% having received prior treatment with venetoclax, a BCL-2 inhibitor.

Medical College of Wisconsin, the Actimab-A + CLAG-M Phase 1 trial was conducted in r/r AML patients fit for intensive therapy.

patients had a median age of 63, failed two or more lines of therapy, which includes 57% having received prior treatment with venetoclax,

a BCL-2 inhibitor.

67% of these patients had adverse cytogenetics, 52% had a TP53 mutation, and 57% had a prior BMT.

Median OS is typically two to four months

for this patient population, with a median OS of less than 3 months for patients who relapsed following venetoclax and a median OS less

than 2 months for those with a TP53 mutation.

Median OS is typically

two to four months for this patient population, with a median OS of less than 3 months for patients who relapsed following venetoclax

and a median OS less than 2 months for those with a TP53 mutation.

These trial results were presented

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have dismal outcomes.

Actimab-A + CLAG-M – Impressive Response

and Survival Benefit in r/r AML

Actimab-A + CLAG-M –Response and Survival

Benefit in r/r AML

Actimab-A + CLAG-M Compared to CLAG-M Alone

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survival of 32% in patients who failed prior venetoclax-based therapy, which compares very favorably to the traditional outcomes in these

On September 6, 2023, updated survival data from the Actimab-A + CLAG-M combination trial was presented at SOHO with 30-month

median Overall Survival (“OS”) reported in patients with prior venetoclax treatment who proceeded to BMT and 24-month median

OS in all patients who proceeded to BMT following Actimab-A + CLAG-M treatment.

Actimab-A + venetoclax Phase 1/2 Study Results

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as well as the dosing regimen of the combination.

We expect to present proof-of-concept of this study in the second half of 2023.

Further Development for Actimab-A

On February 6, 2023, we announced

In February 2023, we announced

that we entered into a CRADA with the NCI, part of the NIH, to develop Actimab-A for the treatment of patients with AML and other hematologic

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The NCI will serve as the regulatory sponsor for any clinical trials mutually approved by both parties to study Actimab-A,

and the CRADA will provide extensive support for and accelerate the development of Actimab-A alone or in combination with chemotherapy,

and the CRADA is expected to provide extensive support for and accelerate the development of Actimab-A alone or in combination with chemotherapy,

immunotherapy, targeted agents and other novel combinations.

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and its Myelomatch program.

Later this year, we will provide updates on our progress as we move into late-stage development with Actimab-A

By year-end we expect to provide updates on our progress as we move into late-stage development with Actimab-A

+ CLAG-M, as well as other developments with our venetoclax combination trial as part of our backbone development strategy.

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role in the tumor microenvironment by depleting MDSCs in a targeted manner.

On April 19, 2023, we presented data at the AACR Annual Meeting,

In April 2023, we presented data at the AACR Annual Meeting

that we believe support the potential role of Actimab-A to overcome immunosuppression by MDSCs in the tumor microenvironment.

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tumor indications.

Additional preclinical data evaluating Actimab-A for the targeting of MDSCs has been accepted for presentation at the

Society of Immunotherapy of Cancer (“SITC”) 38 th Annual Meeting on November 4, 2023.

Background on Actimab-A

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We have completed treatment of an initial cohort of three

patients and will expand to a second cohort.

This study was presented at the ASH Annual Meeting in December 2022 as a trial-in-progress.

We expect to present proof-of-concept data from this study in the second half of 2023 and look forward to sharing more on our Iomab-ACT

trial with MSKCC, along with future development plans in the CAR-T space.

patients and have begun treating patients in expand to a second cohort that is being funded by our recently extended NIH grant.

was presented at the ASH Annual Meeting in December 2022 as a trial-in-progress.

We expect to present an update on our Iomab-ACT program,

along with future development plans in the CAR-T space by year end.

R&D and Preclinical Programs

Our R&D efforts yield

differentiated, high-value programs that demonstrate our experience across multiple validated cancer targets and isotopes and cover broad

areas of focus leveraging our clinical development experience across hematology, targeted conditioning, solid tumors, and next generation

radiotherapies.

Our R&D capabilities have

the potential to yield differentiated, high-value programs that demonstrate our experience across multiple validated cancer targets and

isotopes and cover broad areas of focus leveraging our clinical development experience across hematology, targeted conditioning, solid

tumors, and next generation radiotherapies.

Our programs also inform the advancement of our Iomab-B, Actimab-A, and Iomab-ACT programs.

We have utilized our technology

platform to develop our clinical portfolio in hematology – Iomab-B and Actimab-A, in conditioning for transplant and as a therapeutic,

respectively.

Our research collaborations with Astellas, LG Chem, and EpicentRx establish our work with immunotherapies and in solid tumors.

We are working on several preclinical programs which include novel approaches to established targets such as HER2 and HER3, as well as

novel targets that show immense potential for radiotherapeutic approaches.

Underpinning our development programs is our expanded patent

portfolio of over 200 issued patents and pending patent applications worldwide.

We have utilized our technology platform to develop our clinical portfolio in hematology – Iomab-B and Actimab-A, in conditioning

for transplant and as a therapeutic, respectively.

Our research collaborations with Astellas, LG Chem, and EpicentRx have established

our work with immunotherapies and in solid tumors.

We are working on several preclinical programs which include novel approaches to validated

cancer targets such as HER2 and HER3, as well as novel targets that show immense potential for radiotherapeutic approaches.

our development programs is our expanded patent portfolio of over 220 issued patents and pending patent applications worldwide.

Our platform has been used

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Preclinical pharmacology studies with our targeted radiotherapeutics,

such as HER3-ARC, HER2-ARC or CD33-ARC, have shown strong improvement in tumor growth inhibition in various preclinical tumor models as

single agents or in combination with immunotherapy such as magrolimab, an anti-CD47 monoclonal antibody.

These results have prompted the

team to spearhead efforts in multiple solid tumor programs.

Actinium’s lead solid

tumor program is a targeted radiotherapy against HER3, a pan-cancer target that is overexpressed in several solid tumor indications with

high unmet need.

The HER3-targeted radiotherapeutic agent showed potent tumor cell cytotoxicity, enhanced antitumor effects and significantly

improved survival with an Ac-225 radiolabeled HER3 antibody compared to a naked HER3 antibody in a preclinical non-small cell lung cancer

(“NSCLC”) model.

We have also demonstrated the direct impact of targeted radiotherapy in modulating immune signals such as

calreticulin upregulation to enhance tumor cell killing.

Further, we have leveraged the immunomodulatory effect(s) of targeted radiotherapy

in combination with CD47 targeting agents such as magrolimab for sustained tumor growth inhibition in mouse models of AML and NSCLC.

We have also aligned our R&D

strategy of advancing solid tumors with HER3 into the clinic with our Actimab-A program.

On April 19, 2023, we announced encouraging preclinical

proof-of-concept data at the AACR 2023 Annual Meeting showcasing the anti-tumor effects of HER3-targted radiotherapy using multiple therapeutic

radionuclides in preclinical models of high unmet need malignancies.

Actinium’s HER3-ARC conjugated to either Ac-225 or Lu-177 showed

highly significant tumor growth suppression (p<0.0001) in an ovarian cancer model compared to bevacizumab, an anti-VEGF monoclonal

antibody indicated in ovarian cancer.

Data presented also showed promising antitumor activity in a preclinical model of colorectal cancer,

a highly aggressive malignancy, including a significant reduction in tumor growth (p<0.0001), when dosed with 225Ac-HER3-ARC.

HER3-targeted radiotherapy displayed strong anticancer activity when conjugated to either alpha-emitting Actinium-225 or beta-emitting

Lutetium-177 in models of two high unmet need cancers, highlighting its therapeutic potential for HER3+ malignancies.

The consistent overexpression

of HER3 in multiple solid tumor types, including ovarian, renal, prostate, urothelial, breast, and lung cancers suggests broad utility

of a HER3-targeted agent in a clinical setting.

such as HER3, HER2, CD33 and CD38, have shown strong improvement in tumor growth inhibition in various preclinical tumor models as single

agents or in combination with immunotherapy such as magrolimab, an anti-CD47 monoclonal antibody.

These results have prompted the team

to spearhead efforts in multiple solid tumor programs.

We continue to expand on capabilities

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clinical and preclinical programs, we have utilized multiple isotopes including Ac-225, I-131 and Lu-177 directed at multiple targets

in oncology and hematology such as CD45, CD33, HER3, among others.

Our targeted radiotherapies combine the cell-killing ability of radiation

via a radioisotope payload with a targeting agent, such as a monoclonal antibody.

in oncology and hematology such as CD45, CD33, CD38, HER2, among others.

Our targeted radiotherapies combine the cell-killing ability

of radiation via a radioisotope payload with a targeting agent, such as a monoclonal antibody.

In addition to developing

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Manufacturing

For Iomab-B, we have

established an actively managed end-to-end supply chain that encompasses isotope sourcing through drug administration at the point

Our end-to-end supply chain did not miss a patient dose in our international, 24-site SIERRA Phase 3 clinical trial

including 40 additional patients that crossed over from the control arm to receive Iomab-B.

We have scaled up and have commercially

viable manufacturing operations in place to support U.S.

For Iomab-B, we have established

an actively managed end-to-end supply chain that encompasses isotope sourcing through drug administration at the point of care.

Our end-to-end

supply chain did not miss a patient dose in our international, 24-site SIERRA Phase 3 clinical trial including 40 additional patients

that crossed over from the control arm to receive Iomab-B.

We have scaled up and have commercially viable manufacturing operations in

place to support U.S.

and international commercial sales.

Actinium has commercial agreements with Contract Development and Manufacturing

Organizations (“CDMOs”) with significant experience in monoclonal antibodies (“mAbs”) and final radio-labeled

drug products.

The CDMO we have selected to manufacture the finished drug product to support our commercial activity has been previously

inspected by the FDA and EMA.

We have scaled deliberately for manufacturing flexibility to ensure readily available drug product

upon FDA approval and the ability to ramp up rapidly to meet commercial demand.

We have multiple isotope

supply agreements and qualified vendors in place to supply isotopes for commercial production.

Actinium has commercial agreements

with Contract Development and Manufacturing Organizations (“CDMOs”) with significant experience in monoclonal antibodies (“mAbs”)

and final radio-labeled drug products.

The CDMO we have selected to manufacture the finished drug product to support our commercial activity

has been previously inspected by the FDA and EMA.

We have scaled deliberately for manufacturing flexibility to ensure readily available

drug product upon FDA approval and the ability to ramp up rapidly to meet commercial demand.

We have multiple isotope supply

agreements and qualified vendors in place to supply isotopes for commercial production.

Intellectual Property

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scheduling, radionuclide warhead, and therapeutic combinations.

As of August 2023, our patent portfolio is comprised of over 200 issued

patents and pending patent applications worldwide, which we believe constitutes a valuable business asset.

Our IP includes 45 patent families,

including key patents that relate primarily to our radiotherapeutic candidates.

Our patent portfolio includes 12 issued patents and 39

pending patent applications in the U.S., and 151 that are issued or pending internationally.

The effective lives of the issued patents

in our portfolio, or patents that may issue from the pending applications in our portfolio, ranges from expirations between 2024 and 2043.

As of November 2023, our patent

portfolio is comprised of over 220 issued patents and pending patent applications worldwide, which we believe constitutes a valuable business

Our IP includes 47 patent families, including key patents that relate primarily to our radiotherapeutic candidates.

portfolio includes 13 issued patents and 47 pending patent applications in the U.S., and 162 that are issued or pending internationally.

The effective lives of the issued patents in our portfolio, or patents that may issue from the pending applications in our portfolio,

ranges from expirations between 2024 and 2043.

For our Iomab-B product candidate,

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currently utilized methods.

These patents will expire in the years 2024 through 2027.

These patents expire in the years 2024 through 2027.

In addition, we also own U.S.

and international

patents and pending patent applications that relate to the manufacturing of Actimab-A and its use in the treatment of cancers.

and international patents

and pending patent applications that relate to the manufacturing of Actimab-A and its use in the treatment of cancers.

Results of Operations –

Three Months Ended June 30, 2023 Compared to Three Months Ended June 30, 2022

Three Months Ended September 30, 2023 Compared to Three Months Ended September 30, 2022

The following table sets forth,

for the periods indicated, data derived from our statements of operations:

Three Months Ended

For the Three

September 30,

(in thousands)

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We recorded no commercial

revenue for the three months ended June 30, 2023 and June 30, 2022.

revenue for the three months ended September 30, 2023 and September 30, 2022.

Other revenue

We determined that

certain collaborations with a third-party were within the scope of Topic ASC 606, Revenue Recognition from Contracts with

Customers, or ASC 606.

The collaboration agreement was made up of multiple modules related to various research activities.

the third party had the option to terminate the agreement at the conclusion of any module, we identified a single performance

obligation to provide research services within each module for which we received monetary consideration.

The consideration was

recognized to revenue over each module and revenue of $45 thousand was recognized during the three months ended June 30, 2022.

was no corresponding revenue recognized from a collaboration during the three months ended June 30, 2023.

On April 7, 2022, we

entered into a license and supply agreement with Immedica Pharma AB, or Immedica, pursuant to which Immedica licensed the exclusive product

rights for commercialization of Iomab-B in the European Economic Area, Middle East and North Africa (EUMENA) including Algeria, Andorra,

Bahrain, Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Monaco, Morocco, Oman, Palestine, Qatar, San Marino, Saudi

Arabia, Switzerland, Syria, Tunisia, Turkey, the United Arab Emirates, the United Kingdom, the Vatican City and Yemen.

Upon signing, we

were entitled to an upfront payment of $35 million from Immedica, which was received in May 2022.

Under the terms of the License Agreement,

we are eligible to receive regulatory and commercial milestone payments and are entitled to receive royalties in the mid-20 percent range

on net sales of the product in certain countries that may result from the License Agreement.

We will continue to be responsible for certain

clinical development activities and the manufacturing of Iomab-B and will retain commercialization rights in the U.S.

and rest of the

We determined that certain

collaborations with a third-party were within the scope of Topic ASC 606, Revenue Recognition from Contracts with Customers, or

The collaboration agreement were made up of multiple modules related to various research activities.

While the third party had

the option to terminate the agreement at the conclusion of any module, we identified a single performance obligation to provide research

services within each module for which we received monetary consideration.

The consideration is recognized to revenue over each module

and revenue of $45 thousand was recognized during the three months ended September 30, 2022.

There was no corresponding revenue recognized

from a collaboration during the three months ended September 30, 2023.

On April 7, 2022, we entered

into a license and supply agreement with Immedica Pharma AB, or Immedica, pursuant to which Immedica licensed the exclusive product rights

for commercialization of Iomab-B in the European Economic Area, Middle East and North Africa (EUMENA) including Algeria, Andorra, Bahrain,

Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Monaco, Morocco, Oman, Palestine, Qatar, San Marino, Saudi Arabia,

Switzerland, Syria, Tunisia, Turkey, the United Arab Emirates, the United Kingdom, the Vatican City and Yemen.

Upon signing, we were entitled

to an upfront payment of $35 million from Immedica, which was received in May 2022.

Under the terms of the License Agreement, we are eligible

to receive regulatory and commercial milestone payments and are entitled to receive royalties in the mid-20 percent range on net sales

of the product in certain countries that may result from the License Agreement.

We will continue to be responsible for certain clinical

development activities and the manufacturing of Iomab-B and will retain commercialization rights in the U.S.

and rest of the world.

Our contract liabilities are

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advanced payments from licensees.

There was no Other revenue deferred-current liability at June 30, 2023 and December 31, 2022.

license revenue deferred was $35.0 million at June 30, 2023 and December 31, 2022, resulting from the receipt from Immedica;

this deferred

revenue will be recognized upon European Union regulatory approval of Iomab-B.

There was no Other revenue deferred-current liability at September 30, 2023 and December 31, 2022.

license revenue deferred was $35.0 million at September 30, 2023 and December 31, 2022, resulting from the receipt from Immedica;

deferred revenue will be recognized upon European Union regulatory approval of Iomab-B.

Research and Development Expense, net of reimbursements

Research and development expenses

of $11.1 million for the three months ended June 30, 2023 increased $6.4 million from $4.7 million for the three months ended June 30,

Higher research and development expenses were primarily due to increased CMC activity related to the planned BLA filing for Iomab-B

in the second half of 2023, as well as increased compensation of $1.5 million resulting from higher headcount.

of $11.6 million for the three months ended September 30, 2023 increased $4.8 million from $6.8 million for the three months ended September

Higher research and development expenses were primarily due to increased CMC activity related to the planned BLA-enabling work

Once complete, CMC expenses are expected to decrease in 2024 as we expect to use final drug product material produced to

support the BLA filing and to supply initial Iomab-B commercialization.

In addition, increased compensation of $1.1 million resulted due

to higher headcount necessary to support BLA-enabling CMC activity.

General and administrative expense

General and administrative

expenses of $4.6 million for the three months ended June 30, 2023 increased by $1.4 million from $3.2 million for the three months ended

June 30, 2022.

Higher expenses were primarily due to increased compensation of $0.5 million resulting from higher headcount, higher non-cash

equity compensation of $0.5 million, as well as higher professional and consulting fees, including recruiting fees.

expenses of $2.7 million for the three months ended September 30, 2023 decreased by $0.4 million from $3.1 million for the three months

ended September 30, 2022.

Lower professional and consulting fees of $0.5 million, lower legal fees of $0.1 million and lower non-cash

equity compensation of $0.1 million were partially offset by increased compensation of $0.3 million as a result of higher headcount.

Other income is comprised

of net interest income in both reporting periods.

The amount for the three months ended June 30, 2023 of $0.5 million increased from $0.1

million for the three months ended June 30, 2022 due to a higher average interest rate.

The amount for the three months ended September 30, 2023 of $1.1 million increased from

$0.3 million for the three months ended September 30, 2022 due to a higher average interest rate.

Net loss of $13.3 million

for the three months ended June 30, 2023 increased by $7.4 million from $7.8 million for the three months ended June 30, 2022 primarily

due to higher research and development expenses and general and administrative expenses.

for the three months ended September 30, 2023 increased by $3.8 million from $9.5 million for the three months ended September 30, 2022

primarily due to higher research and development expenses, partially offset by lower general and administrative expenses and higher other

Results of Operations –

– Six Months Ended June 30, 2023 Compared to Six Months Ended June 30, 2022

Nine months Ended September 30, 2023 Compared to Nine months Ended September 30, 2022

The following table sets forth,

for the periods indicated, data derived from our statements of operations:

Six Months Ended

September 30,

(in thousands)

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We recorded no commercial

revenue for the six months ended June 30, 2023 and June 30, 2022.

revenue for the nine months ended September 30, 2023 and September 30, 2022.

Other revenue

We determined that

certain collaborations with a third-party were within the scope of ASC 606.

The collaboration agreement was made up of multiple

modules related to various research activities.

While the third party had the option to terminate the agreement at the conclusion of

any module, we identified a single performance obligation to provide research services within each module for which we receive

monetary consideration.

Other revenue of $0.9 million was recognized during the six months ended June 30, 2022.

corresponding revenue recognized from a collaboration during the six months ended June 30, 2023.

The National Institutes of Health awarded us a Small Business Technology

Transfer cost reimbursable grant to support a clinical collaboration with Memorial Sloan Kettering Cancer Center, or MSK, to study Iomab-ACT,

our CD45-targeted conditioning program to achieve lymphodepletion prior to administration of a CD19-targeted CAR T-cell therapy developed

We recognized other revenue from this grant for the six months ended June 30, 2022 of $0.1 million.

There was no corresponding

revenue recognized for the six months ended June 30, 2023.

We determined that certain

collaborations with a third-party were within the scope of ASC 606.

The collaboration agreement is made up of multiple modules related

to various research activities.

While the third party has the option to terminate the agreement at the conclusion of any module, we identified

a single performance obligation to provide research services within each module for which we receive monetary consideration.

Other revenue

of $0.9 million was recognized during the nine months ended September 30, 2022.

There was no corresponding revenue recognized from a collaboration

during the nine months ended September 30, 2023.

The National Institutes of

Health awarded us a Small Business Technology Transfer cost reimbursable grant to support a clinical collaboration with Memorial Sloan

Kettering Cancer Center, or MSK, to study Iomab-ACT, our CD45-targeted conditioning program to achieve lymphodepletion prior to administration

of a CD19-targeted CAR T-cell therapy developed at MSK.

We recognized other revenue from this grant for the nine months ended September

30, 2022 of $0.1 million.

There was no other revenue recognized for the nine months ended September 30, 2023.

Research and Development Expense, net of reimbursements

Research and development expenses

of $18.9 million for the six months ended June 30, 2023 increased $9.9 million from $9.0 million for the six months ended June 30, 2022.

Higher research and development expenses were primarily due to increased CMC activity related to the planned BLA filing for Iomab-B in

the second half of 2023, as well as increased compensation of $2.5 million resulting from higher headcount.

of $30.6 million for the nine months ended September 30, 2023 increased $14.8 million from $15.8 million for the nine months ended September

Higher research and development expenses were primarily due to increased CMC activity related to the planned BLA-enabling work

for Iomab-B, which once complete, we expect to decrease in 2024 as we expect to use final drug product material produced to support the

BLA filing and to supply initial Iomab-B commercialization.

In addition, increased compensation of $3.2 million resulted due to higher

headcount primarily to support BLA-enabling CMC activity.

General and administrative expense

General and administrative

expenses of $8.3 million for the six months ended June 30, 2023 increased by $3.3 million from $5.0 million for the six months ended June

Higher expenses were primarily due to increased compensation of $0.9 million due to higher headcount, higher non-cash equity

compensation of $0.9 million, and higher professional and consulting fees, including recruiting fees.

expenses of $11.0 million for the nine months ended September 30, 2023 increased by $3.0 million from $8.0 million for the nine months

ended September 30, 2022.

Higher expenses were primarily due to increased compensation of $1.1 million due to higher headcount, higher

non-cash equity compensation of $0.8 million, and higher professional and consulting fees, including recruiting fees.

Other income is comprised

of net interest income in both reporting periods.

The amount for the six months ended June 30, 2023 of $1.0 million increased from $0.1

million for the six months ended June 30, 2022 due to a higher average interest rate.

The amount for the nine months ended September 30, 2023 of $2.1 million increased from

$0.4 million for the nine months ended September 30, 2022 due to a higher average interest rate.

Net loss of $39.5 million

for the six months ended June 30, 2023 increased by $13.3 million from $12.9 million for the six months ended June 30, 2022 primarily

due to higher research and development expenses and general and administrative expenses.

for the nine months ended September 30, 2023 increased by $17.1 million from $22.4 million for the nine months ended September 30, 2022

primarily due to higher research and development expenses and general and administrative expenses.

Liquidity and Capital Resources

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selected cash flow information for the periods indicated:

Six Months Ended

For the Nine months Ended

September 30,

(in thousands)

4 unchanged sentences

Net cash used in operating

activities for the six months ended June 30, 2023 of $28.7 million increased by $50.8 million from the prior-year period of $22.1 million,

as a result of the higher net loss of $13.3 million and the receipt of the $35.0 million up-front payment from Immedica included in the

prior-year period.

activities for the nine months ended September 30, 2023 of $39.8 million increased by $56.2 million from the prior-year period of $16.4

million provided by operating activities, as a result of the higher net loss of $17.1 million and the receipt of the $35.0 million up-front

payment from Immedica included in the prior-year period.

Net cash used in investing

activities was $0.1 million and $0.3 million for the six months ended June 30, 2023 and 2022, respectively, due to the purchase of equipment.

activities was $0.1 million and $0.4 million for the nine months ended September 30, 2023 and 2022, respectively, due to the purchase

of equipment.

Net cash provided by financing

activities for the six months ended June 30, 2023 of $10.8 million and for the six months ended June 30, 2022 of $16.6 million was primarily

from the sale of shares of our common stock.

activities for the nine months ended September 30, 2023 of $13.7 million and for the nine months ended September 30, 2022 of $18.2 million

was primarily from the sale of shares of our common stock.

In August 2020 we entered

8 unchanged sentences

with the SEC on August 7, 2020.

For the six months ended June 30, 2023, we sold 1.3 million shares of common stock, resulting in gross

proceeds of $10.9 million and net proceeds of $10.6 million.

For the six months ended June 30, 2022, we sold 2.7 million shares of common

stock, resulting in gross proceeds of $17.2 million and net proceeds of $16.7 million.

For the nine months ended September 30, 2023, we sold 1.7 million shares of common stock, resulting in

gross proceeds of $13.8 million and net proceeds of $13.4 million.

For the nine months ended September 30, 2022, we sold 3.0 million shares

of common stock, resulting in gross proceeds of $18.9 million and net proceeds of $18.3 million.

As of the date of filing this

66 unchanged sentences

Grant Revenue

We had a grant from the National Institutes of Health for research and development related activities that provided for payments for reimbursed costs, which included overhead and general

We had a grant from a government-sponsored

entity for research and development related activities that provided for payments for reimbursed costs, which included overhead and general

and administrative costs as well as an administrative fee.

6 unchanged sentences

licensing agreement whereby we allowed a third party to commercialize a certain product in specified territories using our trademarks.

The terms of this arrangement include payment to us for a combination of one or more of the following:

The terms of this arrangement includes payment to us for a combination of one or more of the following:

upfront license fees;

80 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis