What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-08-14 compared with 2023-05-15 · 577 added, 511 removed, 565 unchanged (66% of the section changed)

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Pharmaceuticals, Inc.

(“Actinium”) is a biopharmaceutical company developing targeted radiotherapies to deliver

cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs.

Our vision is to build a

specialty, hospital focused, radiotherapeutics company that develops and markets medicines for relapsed or refractory cancer

patients who are treated primarily in large quaternary care hospitals and their catchment areas.

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”).

(“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 also intend to further

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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 a Phase 3 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 that 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.

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

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.

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(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 relapsed/refractory

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 Meetings of the American Society for Transplantation and Cellular

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 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 oncology medical and nursing congresses, 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.

On 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 is well-attended by the European transplant community.

On April 28, 2023, we

announced that 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

On May 11, 2023, we announced that these results were also accepted for oral presentation at the European Hematology Association

(“EHA”) 2023 Hybrid Congress to be held in Frankfurt, Germany on June 8-11, 2023.

We are working towards completing

and submitting our Biologics License Application (“BLA”) for Iomab-B to the U.S.

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

Food and Drug Administration (“FDA”)

in the second half of 2023 and if approved, we intend to commercialize Iomab-B in the U.S.

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

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.

Actimab-A is being developed

under what we believe to be the current industry-leading clinical-study program utilizing the potent alpha radiation emitting isotope

Actinium-225 (“Ac-225”) with clinical data in approximately 150 patients treated over 6 clinical trials.

Actinium-225 (“Ac-225”) with clinical data in approximately 150 patients treated over six clinical trials.

The potent linear

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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, which 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 may pave 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.

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.

To explore the potential for

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

In addition, our intellectual property (“IP”)

portfolio includes over 200 issued patents and pending patent applications worldwide

We are actively working on

launching an early access program (“EAP”) for Iomab-B and intend to file a BLA by year-end while preparing for a U.S.

launch, if such BLA is approved by FDA, and working with our partner Immedica to support the Marketing Authorization Application (“MAA”)

and, if approved by EMA, commercialization in the EU.

Late-stage Actimab-A development is expected to begin in the second half of 2023

under the NCI CRADA.

With the approximately $94.5 million cash on hand as of March 31, 2023, we expect to fund operations through 2025

as we continue to drive ahead with realizing our five-year plan.

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

to realize our vision.

Market Opportunity

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could be eligible for transplant.

Iomab-B has 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.

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

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.

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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We believe our

focus on relapsed and refractory disease in cancer indications with high unmet medical need, with limited or no competition, and where

focus on relapsed or refractory disease in cancer indications with high unmet medical need, with limited or no competition, and where

the primary delivery of care occurs in large comprehensive cancer care centers, is the appropriate strategy for our company.

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

The operating model required to achieve our vision

is attractive for several reasons, including the concentrated point of care;

the top 50 transplant centers account for approximately 75%

of BMTs and the top 100 hospitals treat over 50 percent of r/r AML patients.

Further, there is 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.

Our product pipeline is targeting a broader

opportunity in conditioning via label expansion of Iomab-B into BMT for other blood cancers and with Iomab-ACT, our next generation conditioning

program for rapidly growing cell and gene therapies.

Further, our solid tumor programs are initially directed at relapsed or refractory

cancers, a stage of disease where treatment is again concentrated in large hospitals, which account for a significant portion of patients.

We believe our strategy will enable us to build a successful company with high operating efficiencies and is feasible to achieve without

requiring a commercial partner.

The operating model

required to achieve our vision is attractive for several reasons, including the concentrated point of care;

the top 50 transplant

centers account for approximately 75% of BMTs and the top 100 hospitals treat over 50% of r/r AML patients.

Further, there is

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.

Our product pipeline is targeting

a broader opportunity in conditioning via label expansion of Iomab-B into BMT for other blood cancers and with Iomab-ACT, our next generation

conditioning program for rapidly growing cell and gene therapies.

Further, our solid tumor programs are initially directed at r/r cancers,

a stage of disease where treatment is again concentrated in large hospitals, which account for a significant portion of patients.

our strategy will enable us to build a successful company with high operating efficiencies and is feasible to achieve without requiring

a commercial partner.

Our strategic priorities are to:

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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 that represent about 30% of transplant volume in the U.S.

and have strong working partnership with Key Opinion Leaders and their teams.

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.

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

We intend to progress late-stage development of Actimab-A to leverage its mutation-agnostic mechanism of action and exploit synergies in combination with other treatments to develop it as an AML backbone therapy.

We intend to progress late-stage development of Actimab-A to leverage its mutation-agnostic mechanism of action (“MOA”) and exploit synergies in combination with other treatments to develop it as an AML backbone therapy.

This approach is validated by proof-of-concept data from our Actimab-A + CLAG-M combination trial in r/r AML, which included 57% of patients who had failed venetoclax and are expected to live two to four months on average.

The results demonstrated high response rates overall and in these venetoclax failed patients’ median OS was 59% at one year and thirty-two percent at two years.

The results demonstrated high response rates overall and in these venetoclax failed patients’ median OS was 59% at one year and 32% at two years.

Our collaboration with the NCI under the CRADA could provide broad support for late-stage development of Actimab-A + CLAG-M and also other clinical trials to broaden use of Actimab-A.

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We plan to develop Iomab-ACT to be used for either lymphodepletion or reduced intensity conditioning prior to CAR-T and gene therapies.

Similar to BMT, access and outcomes of patients who might benefit from these therapies is limited by sub-optimal chemotherapy-based conditioning agents.

Similar to BMT, access and outcomes of patients who might benefit from these therapies is currently limited by sub-optimal chemotherapy-based conditioning agents.

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.

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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, which are focused on solid tumors and immunotherapies.

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

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

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.

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

We have strategically focused our development

efforts in areas where there is a significant unmet medical need.

We are developing a portfolio of novel radiotherapeutics that has the

potential to positively impact the outcomes of people living with hard-to-treat diseases such as r/r AML via both a therapeutic and induction/conditioning

Outside of AML, our pipeline development offers the opportunity to enhance the value proposition of cell and gene therapies with

our targeted conditioning programs.

We have strategically focused

our development efforts in areas where there is a significant unmet medical need.

We are developing a portfolio of novel radiotherapeutics

that has the potential to positively impact the outcomes of people living with hard-to-treat diseases such as r/r AML via both a therapeutic

and induction/conditioning agent.

Outside of AML, our pipeline development offers the opportunity to enhance the value proposition of

cell and gene therapies with our targeted conditioning programs.

AML Focused Programs – Iomab-B

and Actimab-A

Our Iomab-B and Actimab-A product candidates are

focused on addressing the major unmet medical needs in r/r AML in a complementary manner and are directed at different parts of the patient

Our Iomab-B and Actimab-A

product candidates are focused on addressing the major unmet medical needs in r/r AML in a complementary manner and are directed at different

parts of the patient journey.

Iomab-B – Targeted Radiotherapeutic

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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 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 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 Postallogeneic

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.

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.

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

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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Pivotal Phase 3 SIERRA Trial for Iomab-B ( 131 Iodine-apamistamab)

The SIERRA trial was designed to demonstrate the

ability of Iomab-B to overcome challenges related to patient access to curative BMT.

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.

Patients must be able to overcome several challenges

related to curative BMT.

The first access challenge is that the patient needs to be in complete remission prior to BMT.

The current clinical

practice is not to transplant patients with active AML as outcomes are poor due to high relapse rates.

The National Comprehensive Cancer

Network (“NCCN”) guidelines also recommend treatment to achieve remission prior to transplant in patients with relapsed AML.

The SIERRA trial was designed

to demonstrate the ability of Iomab-B to overcome challenges related to patient access to curative BMT.

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.

Patients must be able to overcome

several challenges related to curative BMT.

The first access challenge is that the patient needs to be in complete remission prior to

The current clinical practice is not to transplant patients with active AML as outcomes are poor due to high relapse rates.

Comprehensive Cancer Network (“NCCN”) guidelines also recommend treatment to achieve remission prior to transplant in patients

with relapsed AML.

The second challenge to access is tolerance to current conditioning regimens.

For older patients, myeloablative regimens are not an option

due to intense toxicity and mortality.

The third challenge is the ability to achieve post-BMT remission and successful engraftment.

conditioning can lead to graft failure, which is associated with very high mortality.

Patients who fail to achieve a CR post-transplant

have extremely poor outcomes and a survival of a few weeks.

The fourth challenge relates to BMT tolerability and post-BMT complications.

The conditioning and immunosuppressive regimens given to these patients put them at high risk for infectious complications and toxicity.

In the SIERRA trial, Iomab-B addresses all four of these challenges.

Access to BMT is improved as CR is not needed pre-BMT given effective

disease control and targeted myeloablation.

With better post-BMT engraftment, CR and lower complications, the SIERRA trial also addressed

the challenges related to improved outcomes through Iomab-B.

The SIERRA results, presented in the late-breaker

session at the 2023 Tandem Meetings:

Transplantation & Cellular Therapy Meetings of the ASTCT and the CIBMTR, support Iomab-B’s

value proposition of enabling both improved access and outcomes of a BMT, thereby providing a significant curative option for r/r patients,

a segment that represents approximately 50% of all AML patients and the majority not transplanted today.

The design of the SIERRA trial

is provided in the figure below.

For older patients, myeloablative regimens

are not an option due to intense toxicity and mortality.

The third challenge is the ability to achieve post-BMT remission and successful

Inadequate conditioning can lead to graft failure, which is associated with very high mortality.

Patients who fail to achieve

a CR post-transplant have extremely poor outcomes and a survival of a few weeks.

The fourth challenge relates to BMT tolerability and

post-BMT complications.

The conditioning and immunosuppressive regimens given to these patients put them at high risk for infectious complications

and toxicity.

In the SIERRA trial, Iomab-B addressed all four of these challenges.

Access to BMT is improved as CR is not needed pre-BMT

given effective disease control and targeted myeloablation.

With better post-BMT engraftment, CR and lower complications, the SIERRA trial

also addressed the challenges related to improved outcomes through Iomab-B.

The SIERRA results, presented

in the late-breaker session at the 2023 Tandem Meetings:

Transplantation & Cellular Therapy Meetings of the ASTCT and the CIBMTR,

support Iomab-B’s value proposition of enabling both improved access and outcomes of a BMT, thereby providing a significant curative

option for r/r AML patients, a segment that represents approximately 50% of all AML patients and the majority not transplanted today.

The design of the SIERRA trial is provided in the figure below.

A Novel, Pivotal Phase 3 Study of

Iomab-B in r/r AML

The pivotal Phase 3 SIERRA trial is a 153-patient,

randomized, multi-center, controlled trial of Iomab-B in patients aged 55 and above with active r/r AML, who were heavily pre-treated

and had high-risk characteristics.

Patients enrolled had blast counts of 5% or greater in the marrow or circulating blasts suggestive

of active AML.

In this study, Iomab-B was compared to the control arm that allowed physician’s choice of over 20 available agents,

including chemotherapies and/or targeted therapies such as venetoclax (BCL-2 inhibitor), FLT3 inhibitors, IDH inhibitors and Mylotarg,

reflecting current best treatment practices attempting to get patients to CR.

The control arm included recently approved AML therapies

that were added to the SIERRA protocol as they became available.

The crossover arm was designed in SIERRA for an equipoise that offered

Iomab-B to patients failing to achieve a CR on the control arm with an intent to rescue them by taking them to transplant.

Of note, SIERRA

had highly restrictive optionality for post-transplant maintenance.

Patients with active, r/r AML are not considered eligible for BMT

with current approaches and the SIERRA trial was the only randomized Phase 3 trial to offer BMT as a treatment option for this patient

These patients would not be offered BMT in standard practice and therefore have dismal survival outcomes of two to three months.

The primary endpoint of the SIERRA trial was dCR of 180 days and the secondary endpoints are OS and Event-Free Survival (“EFS”).

The comparison of OS in subjects randomized to the control arm who crossed over to receive Iomab-B versus all others in the control group

was an exploratory efficacy endpoint.

The pivotal Phase 3 SIERRA

trial was a 153-patient, randomized, multi-center, controlled trial of Iomab-B in patients aged 55 and above with active r/r AML, who

were heavily pre-treated and had high-risk characteristics.

Patients enrolled had blast counts of 5% or greater in the marrow or circulating

blasts suggestive of active AML.

In this study, Iomab-B was compared to the control arm that allowed physician’s choice of over

20 available agents, including chemotherapies and/or targeted therapies such as venetoclax (BCL-2 inhibitor), FLT3 inhibitors, IDH inhibitors

and Mylotarg, reflecting current best treatment practices attempting to get patients to CR.

The control arm included recently approved

AML therapies that were added to the SIERRA protocol as they became available.

The crossover arm was designed in SIERRA for an equipoise

that offered Iomab-B to patients failing to achieve a CR on the control arm with an intent to rescue them by taking them to transplant.

Of note, SIERRA had highly restrictive optionality for post-transplant maintenance.

Patients with active, r/r AML are not considered eligible

for BMT with current approaches and the SIERRA trial was the only randomized Phase 3 trial to offer BMT as a treatment option for this

patient population.

These patients would not be offered BMT in standard practice and therefore have dismal survival outcomes of two to

three months.

The primary endpoint of the SIERRA trial was dCR of 6-months and the secondary endpoints are OS and Event-Free Survival

The comparison of OS in subjects randomized to the control arm who crossed over to receive Iomab-B versus all others

in the control group was an exploratory efficacy endpoint.

As seen in the graphic below,

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22% of the patients

receiving Iomab-B maintained dCR lasting 180 days or more despite limited optionality for post-transplant maintenance, while none of the

receiving Iomab-B maintained dCR lasting 6-months or more despite limited optionality for post-transplant maintenance, while none of the

patients on the control arm achieved dCR.

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with High Significance (p<0.0001)

As demonstrated in the OS graph below, patients

who achieved 6-month dCR had 92.3% 1-year survival and 59.9% 2-year survival.

Median OS had not been reached in these patients.

worth noting that two years in CR is a significant milestone in this patient population, highly indicative of long-term survival and a

possible curative outcome.

As demonstrated in the OS

graph below, patients who achieved 6-month dCR had 92.3% 1-year survival and 59.9% 2-year survival.

Median OS had not been reached in

these patients.

It is worth noting that two years in CR is a significant milestone in this patient population, highly indicative of long-term

survival and a possible curative outcome.

Overall Survival for Patients who Achieved

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was not met in the ITT analysis.

In order to isolate the true impact of Iomab-B

on OS, one of the exploratory efficacy endpoints was the comparison of OS in subjects randomized to the control arm who crossed over to

receive Iomab-B versus all others in the control arm, as well as the control arm patients who did not crossover versus the Iomab-B arm.

The Kaplan-Meier plot of OS in the graphic below shows that this exploratory analysis demonstrated the clear benefit of Iomab-B over the

The median OS for the Iomab-B group was 6.4 months which was double the 3.2 months for the non-crossover patients in the

Patients who crossed over from the control arm to receive Iomab-B had a median OS of 7.1 months demonstrating further the

ability of Iomab-B to treat patients who are non-treatable by conventional means.

A similar pattern favoring the Iomab-B group was

seen across the pre-defined subgroups, where 1-year OS for Iomab-B was 26.1% compared with 13.1% for the non-crossover control arm.

1-year OS for patients in the crossover arm was 35.8%.

This clearly demonstrates the OS benefit of Iomab-B over the control arm and two

to three-fold improvement in survival outcomes possible with its use.

In order to isolate the true

impact of Iomab-B on OS, one of the exploratory efficacy endpoints was the comparison of OS in subjects randomized to the control arm

who crossed over to receive Iomab-B versus all others in the control arm, as well as the control arm patients who did not crossover versus

the Iomab-B arm.

The Kaplan-Meier plot of OS in the graphic below shows that this exploratory analysis demonstrated the clear benefit

of Iomab-B over the control arm.

The median OS for the Iomab-B group was 6.4 months which was double the 3.2 months for the non-crossover

patients in the control arm.

Patients who crossed over from the control arm to receive Iomab-B had a median OS of 7.1 months demonstrating

further the ability of Iomab-B to treat patients who are non-treatable by conventional means.

A similar pattern favoring

the Iomab-B group was seen across the pre-defined subgroups, where 1-year OS for Iomab-B was 26.1% compared with 13.1% for the non-crossover

The 1-year OS for patients in the crossover arm was 35.8%.

This clearly demonstrates the OS benefit of Iomab-B over the control

arm and two to three-fold improvement in survival outcomes possible with its use.

Kaplan-Meier Plot of Overall Survival ‒

Iomab-B, Crossover, and Non-Crossover Control Arm

Iomab-B produced a significant and clinically

meaningful improvement in the secondary endpoint of EFS, with a 78% reduction in the probability of an event (Hazard Ratio=0.22, p<0.0001

for both per protocol and ITT basis).

EFS at 180 days for the Iomab-B arm was 28% compared to 0.2% for the control arm.

In the SIERRA

trial, an event is defined as one of the following:

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

relapsing or death.

In the figure below comparing EFS with Iomab-B

versus the control arm, the initial vertical drop in the curve in the Iomab-B arm represents those patients who did not achieve a remission

after Iomab-B or those who did not proceed to transplant, while the initial vertical drop in the curve in the control arm mainly represents

patients who did not achieve a remission with salvage therapy and either crossed over to Iomab-B or went onto best supportive care.

Iomab-B produced a significant

and clinically meaningful improvement in the secondary endpoint of EFS, with a 78% reduction in the probability of an event (Hazard Ratio=0.22,

p<0.0001 for both per protocol and ITT basis).

EFS at 6-months for the Iomab-B arm was 28% compared to 0.2% for the control arm.

the SIERRA trial, an event is defined as one of the following:

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

BMT, a patient relapsing or death.

In the figure below comparing

EFS with Iomab-B versus the control arm, the initial vertical drop in the curve in the Iomab-B arm represents those patients who did not

achieve a remission after Iomab-B or those who did not proceed to transplant, while the initial vertical drop in the curve in the control

arm mainly represents patients who did not achieve a remission with salvage therapy and either crossed over to Iomab-B or went onto best

supportive care.

Event-Free Survival with Iomab-B Versus Control

The table below shows relevant adverse events

in transplanted Iomab-B patients.

In these patients, incidence of sepsis was four times lower in the Iomab-B arm than the control arm

In addition, rates of other treatment related adverse events were lower in favor of Iomab-B, including febrile neutropenia

The table below shows relevant

adverse events in transplanted Iomab-B patients.

In these patients, incidence of sepsis was four times lower in the Iomab-B arm than the

control arm (6.1% vs.

In addition, rates of other treatment related adverse events were lower in favor of Iomab-B, including febrile

neutropenia (43.9% vs.

50.0%), mucositis (15.2% vs.

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in Transplanted Patients Through Day 100 Post-HCT

With current treatment practice, patients who

have r/r AML with active disease, utilizing current conditioning agents have poor outcomes and very low survival rates.

Using 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.

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

half the time compared to conventional care.

Iomab-B represents an exciting new paradigm with the potential to establish a new standard

of care in r/r AML setting, making it possible for most patients to get to a successful transplant with Iomab-B with a portion of these

patients having a long-term survival benefit.

As shown below, with an Iomab-B led regimen, the majority of patients who are non-transplantable

in routine clinical practice can be successfully transplanted, administering myeloablative radiation with reduced intensity conditioning

tolerability to ultimately achieve transformative survival outcome, changing the treatment paradigm for r/r AML patients.

With current treatment practice,

patients who have r/r AML with active disease, utilizing current conditioning agents have poor outcomes and very low survival rates.

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.

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

in less than half the time compared to conventional care.

Iomab-B represents an exciting new paradigm with the potential to establish

a new standard of care in r/r AML setting, making it possible for most patients to get to a successful transplant with Iomab-B with a

portion of these patients having a long-term survival benefit.

As shown below, with an Iomab-B led regimen, the majority of patients who

are non-transplantable in routine clinical practice can be successfully transplanted, administering myeloablative radiation with reduced

intensity conditioning tolerability to ultimately achieve transformative survival outcome, changing the treatment paradigm for r/r AML

Iomab-B – New Paradigm to Upend BMT

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Future Development and Life Cycle Management

The results of the Pivotal Phase 3 SIERRA trial

validate the value proposition of Iomab-B, and we believe it could establish unprecedented access to transplant (currently the only curative

option) with better safety and tolerability and improved outcomes, all of which could potentially make Iomab-B the new 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 Iomab-B in the U.S.

The results of the Pivotal

Phase 3 SIERRA trial validate the value proposition of Iomab-B, and we believe it could establish unprecedented access to transplant (currently

the only curative option) with better safety and tolerability and improved outcomes, all of which could potentially make Iomab-B the new

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

Iomab-B in the U.S.

The commercial opportunity is supported by favorable dynamics, summarized by the “Three Ps and Two Cs”:

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Our goal is to help physicians make BMT an option for a vast majority of r/r AML patients who currently are unable to access transplant without disruption to current practice.

Patients are able to return to their referring physicians for post-BMT follow-up, long-term care

Patients are able to return to their referring physicians for post-BMT follow-up, and long-term care

Iomab-B potentially unlocks value through getting patients safely to effective, potentially curative transplants, with improved outcomes and a manageable safety and tolerability profile

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These factors allow for commercialization delivered by a focused 35–50-person commercial organization.

The favorable commercial dynamics for Iomab-B

are further supported by the strong foundation of core competencies developed during the successful execution of the SIERRA

trial at leading high-volume BMT centers.

We established and actively managed end-to-end supply chain, never missing a patient dose, and

were able to treat 60% more patients than expected due to the high number of crossover patients.

We focused on operational excellence

at the point of care, working in partnership with leading Key Opinion Leaders and their teams to successfully execute SIERRA at a wide

array of centers.

As a result, we have broad reach across leading BMT centers that account for 30% of BMT volume, which speaks to the

concentration of the BMT market.

The positive SIERRA results of unprecedented access and outcomes along with our commitment to operational

excellence provide a strong foundation for our commercial team.

In April 2022, Actinium licensed the EUMENA commercial

rights for Iomab-B to Immedica, an independent pharmaceutical company headquartered in Sweden.

Immedica has significant know-how and experience

in commercializing niche and specialty care products across Europe and the Middle East, with extensive regulatory and commercial expertise

and capabilities.

Actinium will continue to be responsible for certain clinical development activities and Iomab-B manufacturing and will

retain commercialization rights in the U.S.

The favorable commercial dynamics

for Iomab-B in the U.S.

are further supported by the strong foundation of core competencies developed during the successful execution

of the SIERRA trial at leading high-volume BMT centers.

We established and actively managed an end-to-end supply chain, never missing

a patient dose, and were able to treat 60% more patients than expected due to the high number of crossover patients.

We focused on operational

excellence at the point of care, working in partnership with leading KOLs and their teams to successfully execute SIERRA at a wide array

As a result, we have broad reach across leading BMT centers that account for 30% of BMT volume, which speaks to the concentration

of the BMT market.

The positive SIERRA results of unprecedented access and outcomes along with our commitment to operational excellence

provide a strong foundation for our commercial team.

In April 2022, Actinium licensed

the EUMENA commercial rights for Iomab-B to Immedica, an independent pharmaceutical company headquartered in Sweden.

Immedica has significant

know-how and experience in commercializing niche and specialty care products across Europe and the Middle East, with extensive regulatory

and commercial expertise and capabilities.

Actinium will continue to be responsible for certain clinical development activities and Iomab-B

manufacturing and will retain commercialization rights in the U.S.

and rest of the world.

Currently, there an estimated ~7,200 BMTs for AML in EUMENA, two times

that of the U.S., performed in a concentrated of number of centers.

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 $417 million USD in

regulatory and sales milestones and mid-twenty percent royalties.

Iomab-B has been granted Orphan Drug Designation by the EMA and has

received positive Scientific Advice from EMA that the SIERRA trial can support a marketing authorization with filing expected in 2024.

Currently, there an estimated ~7,200 BMTs for

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.

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

$417 million USD in regulatory and sales milestones and mid-twenty percent royalties.

Iomab-B has been granted Orphan Drug Designation

by the EMA and has received positive Scientific Advice from EMA that the SIERRA trial can support a marketing authorization with filing

expected in 2024.

Background on Iomab-B

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Actimab-A + CLAG-M Phase 1 Study Results

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.

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.

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.

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.

These trial results were presented

as an oral presentation at the ASH Annual Meeting in December 2022.

In this difficult-to-treat r/r AML population, the results demonstrate

its high potential.

We reported 1-year survival of 53% and 2-year survival of 32%, which are as much as double what can be expected with

currently available therapies.

The trial showed an Overall Response Rate (“ORR”) of 65% across all dose cohorts, 52% complete

remission rate, and a 75% MRD negativity rate.

As highlighted in the figure below, the results are highly encouraging and show that the

high rates of responses and MRD negativity are translating to a meaningful survival benefit in these difficult-to-treat patients, who

would otherwise have dismal outcomes.

as an oral presentation at the 2022 ASH Annual Meeting.

In this difficult-to-treat r/r AML population, the results demonstrate its high

We reported 1-year survival of 53% and 2-year survival of 32%, which are as much as double what can be expected with currently

available therapies.

The trial showed an Overall Response Rate (“ORR”) of 65% across all dose cohorts, 52% complete remission

rate, and a 75% MRD negativity rate.

As highlighted in the figure below, the results are highly encouraging and show that the high rates

of responses and MRD negativity are translating to a meaningful survival benefit in these difficult-to-treat patients, who would otherwise

have dismal outcomes.

Actimab-A + CLAG-M – Impressive Response

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

Efficacy of CLAG-M has been reported in older

studies (Halpern and Walter.

Efficacy of CLAG-M has been

reported in older studies (Halpern and Walter.

CLAG-M with dose-escalated mitoxantrone for adults with acute myeloid leukemia.

Oncotarget 2018 and Mushtaq

2018 and Mushtaq et al.

Comparison of Salvage Chemotherapy Regimens in Relapsed/Refractory Acute Myeloid Leukemia.

ASH 2018) in patients with r/r AML,

however, almost all of these studies were conducted in the pre-targeted therapy era where no patients enrolled had prior venetoclax-based

therapy, thus efficacy data of CLAG-M in the current era, in patients exposed to prior venetoclax, or with other high-risk features, is

ASH 2018) in patients

with r/r AML, however, almost all of these studies were conducted in the pre-targeted therapy era where no patients enrolled had prior

venetoclax-based therapy, thus efficacy data of CLAG-M in the current era, in patients exposed to prior venetoclax, or with other high-risk

features, is limited.

When combined with Actimab-A, the combination has demonstrated a clinically significant survival benefit in a proof-of-concept

study irrespective of prior targeted treatment.

Relapsed or refractory AML after failing venetoclax-based therapy is associated with dismal

survival outcomes, with a median OS of less than 3 months.

In comparison, the combination trial of Actimab-A + CLAG-M led to 1-year survival

of 59% and 2-year survival of 32% in patients who failed prior venetoclax-based therapy, which compares very favorably to the traditional

outcomes in these patients.

R/R AML after failing venetoclax-based therapy is associated with dismal survival outcomes,

with a median OS of less than 3 months.

In comparison, the combination trial of Actimab-A + CLAG-M led to 1-year survival of 59% and 2-year

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

Actimab-A + venetoclax Phase 1/2 Study Results

We are conducting a

Phase 1/2 multi-center trial combining Actimab-A + venetoclax in both fit and unfit patients 18 years and older with r/r AML led by

UCLA Medical Center.

We are conducting a Phase

1/2 multi-center trial combining Actimab-A + venetoclax in both fit and unfit patients 18 years and older with r/r AML led by UCLA Medical

Data from our Actimab-A + venetoclax combination trial was presented at the 2022 ASH Annual Meeting.

demonstrated preclinically that combinations of Actimab-A and venetoclax have mechanistic synergies.

Overexpression of MCL-1, an

anti-apoptotic protein, is associated with resistance to venetoclax in AML.

Actimab-A kills tumors cells with DNA double-strand

breaks and downregulates MCL-1, which can (re-)sensitize AML cells or reduce tumor resistance to venetoclax.

The Actimab-A +

venetoclax combination has been well-tolerated with responses, including a CR and a partial response in early dose escalation

In our ongoing clinical trial, we are exploring the optimal dose of Actimab-A, as well as the dosing regimen of the

We have demonstrated preclinically

that combinations of Actimab-A and venetoclax have mechanistic synergies.

Overexpression of MCL-1, an anti-apoptotic protein, is associated

with resistance to venetoclax in AML.

Actimab-A kills tumors cells with DNA double-strand breaks and downregulates MCL-1, which can (re-)sensitize

AML cells or reduce tumor resistance to venetoclax.

The Actimab-A + venetoclax combination has been well-tolerated with responses, including

a CR and a partial response in early dose escalation cohorts.

In our ongoing clinical trial, we are exploring the optimal dose of Actimab-A,

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 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 malignancies.

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, immunotherapy,

targeted agents and other novel combinations.

The CRADA studies will be overseen by the NCI in collaboration with Actinium’s clinical

development team, where Actinium has the right to review and approval all protocols and has full right to all data.

This broad collaboration

may accelerate our Actimab-A development efforts with access to NCI’s vast network of over 2,000 clinical trial sites and its Myelomatch

Later this year, we will 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.

On February 6, 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

malignancies.

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,

immunotherapy, targeted agents and other novel combinations.

The CRADA studies will be overseen by the NCI in collaboration with Actinium’s

clinical development team, where Actinium has the right to review and approval all protocols and has full right to all data.

collaboration may accelerate our Actimab-A development efforts with access to NCI’s vast network of over 2,000 clinical trial sites

and its Myelomatch program.

Later this year, we will 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.

We are exploring the broader

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of broad applicability, a differentiated mechanism of action, and targeted precision that is well-tolerated with minimal toxicity.

CD33 development program is driven by data obtained from approximately 150 AML patients in 6 trials and demonstrated single agent activity

CD33 development program is driven by data obtained from approximately 150 AML patients in six trials and demonstrated single agent activity

with high response rates, but was also associated with prolonged neutropenia.

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Conditioning Focused Programs

We will further expand the Iomab-B franchise by

focusing on lifecycle management for label enhancement and indication expansion.

Iomab-B data in five additional hematologic indications

(i.e., MDS, ALL, HL, NHL, and MM) provide the foundation to explore indication expansion opportunities to increase the total addressable

market for Iomab-B.

We will further expand the

Iomab-B franchise by focusing on lifecycle management for label enhancement and indication expansion.

Iomab-B data in five additional

hematologic indications (i.e., MDS, ALL, HL, NHL, and MM) provide the foundation to explore indication expansion opportunities to increase

the total addressable market for Iomab-B.

Across early trials at the FHCRC, Iomab-B demonstrated similar improved access to BMT and outcomes.

We will leverage

these data with strong results from the pivotal Phase 3 SIERRA trial to execute a comprehensive life cycle management strategy to further

expand Iomab-B’s role in a variety of malignant and non-malignant hematological disorders.

We will continue to develop the Iomab-B

franchise to potentially address a broader market opportunity to address the over 165,000 patients diagnosed with cancers (e.g., leukemia,

lymphoma, and myeloma), who could potentially benefit from transplant, but are unable to access one today.

Iomab-ACT is comprised of apamistamab, the same

anti-CD45 antibody as Iomab-B, but utilizes lower, nonmyeloablative levels of I-131 to achieve lymphodepletion for cellular therapies

such as CAR-T or reduced intensity conditioning for gene therapies.

We intend to continue to develop the Iomab-ACT program designed specifically

for use prior to CAR-T and gene therapies, ultimately with a value proposition of improving overall access and outcomes for patients who

need cellular or gene therapies.

Preclinical data showed a single, low-dose of

Iomab-ACT demonstrated lymphodepletion and as CD45 positive immune cells are implicated in major CAR-T side effects, i.e., cytokine release

syndrome ("CRS") and immune effector cell–associated neurotoxicity syndrome (“ICANS"), Iomab-ACT has the potential

to be developed as a conditioning agent for CAR-T therapies.

CRS and ICANS remain two most common toxicities of CAR-T therapies with severe

cases (>Grade 3) seen in >20% of patients and fatality rates between 0-10%.

Due to its effect on host monocytes/macrophages, we

believe conditioning with Iomab-ACT will potentially reduce the incidence of CRS and ICANS.

Unlike chemotherapy, Iomab-ACT is targeted in

nature, and we expect it to potentially promote improved CAR-T cell expansion, resulting in responses that are higher and more durable.

We believe our Iomab-ACT program is highly differentiated when compared to fludarabine and cyclophosphamide (“Flu/Cy”) or

other chemotherapy-based regimens that are used as standard practice today for lymphodepletion prior to cell therapy.

We are studying

Iomab-ACT in collaboration with MSKCC, for conditioning prior to CAR-T therapy for patients with relapsed or refractory B-cell acute

lymphoblastic leukemia (“B-ALL”) or diffuse large B-cell lymphoma (“DLBCL”).

This study funded by a NIH

grant is the first-of-its-kind study to use a radiotherapeutic-based conditioning regimen with CAR-T therapy.

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.

We will leverage these data with strong results from the pivotal Phase 3 SIERRA trial to execute a comprehensive life cycle management

strategy to further expand Iomab-B’s role in a variety of malignant and non-malignant hematological disorders.

We will continue

to develop the Iomab-B franchise to potentially address a broader market opportunity to address the over 165,000 patients diagnosed with

cancers (e.g., leukemia, lymphoma, and myeloma), who could potentially benefit from transplant, but are unable to access one today.

Iomab-ACT is comprised of

apamistamab, the same anti-CD45 antibody as Iomab-B, but utilizes lower, nonmyeloablative levels of I-131 to achieve lymphodepletion for

cellular therapies such as CAR-T or reduced intensity conditioning for gene therapies.

We intend to continue to develop the Iomab-ACT

program designed specifically for use prior to CAR-T and gene therapies, ultimately with a value proposition of improving overall access

and outcomes for patients who need cellular or gene therapies.

Preclinical data showed a

single, low-dose of Iomab-ACT demonstrated lymphodepletion and as CD45 positive immune cells are implicated in major CAR-T side effects,

i.e., cytokine release syndrome (“CRS”) and immune effector cell–associated neurotoxicity syndrome (“ICANS”),

Iomab-ACT has the potential to be developed as a conditioning agent for CAR-T therapies.

CRS and ICANS remain two most common toxicities

of CAR-T therapies with severe cases (>Grade 3) seen in >20% of patients and fatality rates between 0-10%.

Due to its effect on

host monocytes/macrophages, we believe conditioning with Iomab-ACT will potentially reduce the incidence of CRS and ICANS.

Unlike chemotherapy, Iomab-ACT

is targeted in nature, and we expect it to potentially promote improved CAR-T cell expansion, resulting in responses that are higher and

more durable.

We believe our Iomab-ACT program is highly differentiated when compared to fludarabine and cyclophosphamide (“Flu/Cy”)

or other chemotherapy-based regimens that are used as standard practice today for lymphodepletion prior to cell therapy.

We are studying Iomab-ACT

in collaboration with MSKCC, for conditioning prior to CAR-T therapy for patients with relapsed or refractory B-cell acute lymphoblastic

leukemia (“B-ALL”) or diffuse large B-cell lymphoma (“DLBCL”).

This study funded by a NIH grant is the first-of-its-kind

study to use a radiotherapeutic-based conditioning regimen with CAR-T therapy.

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.

R&D and Preclinical Programs

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respectively.

Our research collaborations with Astellas, LG Chem (formerly AVEO Oncology), 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.

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 team to spearhead efforts in multiple solid tumor

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.

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

team to spearhead efforts in multiple solid tumor programs.

Actinium’s lead solid

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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.

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

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.

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of a HER3-targeted agent in a clinical setting.

We continue to expand on capabilities and technologies across therapeutic

modalities, linker technologies and in vivo cancer models, and build visibility through presentations at key conferences and publications

in journals of high impact.

Our R&D efforts are centered on the advancement of our key programs with a robust “fast-to-clinic”

approach in niche indications.

Underpinning our development programs is our expanded patent portfolio of over 200 issued patents and pending

patent applications worldwide.

We continue to expand on capabilities

and technologies across therapeutic modalities, linker technologies and in vivo cancer models, and build visibility through presentations

at key conferences and publications in journals of high impact.

Our R&D efforts are centered on the advancement of our key programs

with a robust “fast-to-clinic” approach in niche indications.

Underpinning our development programs is our expanded patent

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

Our Platform Technology

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

In addition to developing targeted radiotherapies,

we also own patents related to the manufacturing of Ac-225 in a cyclotron.

We have expertise in utilizing the alpha emitting isotope Ac-225

including clinical experience in treating approximately 150 patients with our alpha-emitter-based therapies, “gold standard”

linker technology and five issued patents in the U.S.

and 49 patents internationally related to the manufacturing or Ac-225 in a cyclotron,

which we believe has the potential to produce higher quantities of highly pure Ac-225 than current methods.

When appropriate, we are well-positioned

to leverage this technology to produce Ac-225.

In addition to developing

targeted radiotherapies, we also own patents related to the manufacturing of Ac-225 in a cyclotron.

We have expertise in utilizing the

alpha emitting isotope Ac-225 including clinical experience in treating approximately 150 patients with our alpha-emitter-based therapies,

“gold standard” linker technology and five issued patents in the U.S.

and 49 patents internationally related to the manufacturing

or Ac-225 in a cyclotron, which we believe has the potential to produce higher quantities of highly pure Ac-225 than current methods.

When appropriate, we are well-positioned to leverage this technology to produce Ac-225.

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.

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.

Intellectual Property

Our proprietary technology platform is supported

by IP, know-how and trade secrets that cover the generation, development, methods of use and manufacture of targeted radiotherapies and

their select components.

Our IP covers various methods of use in multiple diseases, including indication, dose and scheduling, radionuclide

warhead, and therapeutic combinations.

As of March 2023, we have expanded our patent

portfolio to 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.

For our Iomab-B product candidate, we have four

issued patents in the U.S.

Our proprietary technology

platform is supported by IP, know-how and trade secrets that cover the generation, development, methods of use and manufacture of targeted

radiotherapies and their select components.

Our IP covers various methods of use in multiple diseases, including indication, dose and

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.

For our Iomab-B product candidate,

we have four issued patents in the U.S.

and issued patents in Canada, Europe and Japan that relate to the composition.

The basic patent terms of these

patents expire in 2036 and 2037.

The basic patent

terms of these patents expire in 2036 and 2037.

Related patent applications are also currently pending in the U.S.

and internationally.

we own both U.S.

and international pending patent applications that relate to the use of Iomab-B or Iomab-ACT in the treatment of cancers

and non-malignant conditions.

Our patents also cover key areas of our business

such as manufacturing key components of our product candidate, Actimab-A, including Ac-225 in a cyclotron.

We have expertise in utilizing

the alpha emitting isotope Ac-225 including clinical experience in treating approximately 150 patients with our alpha-emitter-based therapies,

“gold standard” linker technology and five issued patents in the U.S.

and 49 patents internationally related to the manufacturing

or Ac-225 in a cyclotron, which we believe has the potential to produce higher quantities of Ac-225 than currently utilized methods.

patents will expire in the years 2024 through 2027.

In addition, we own both U.S.

and international pending patent applications that relate to the use of Iomab-B or Iomab-ACT in the treatment

of cancers and non-malignant conditions.

Our patents also cover key

areas of our business such as manufacturing key components of our product candidate, Actimab-A, including Ac-225 in a cyclotron.

expertise in utilizing the alpha emitting isotope Ac-225 including clinical experience in treating approximately 150 patients with our

alpha-emitter-based therapies, “gold standard” linker technology and five issued patents in the U.S.

and 49 patents internationally

related to the manufacturing or Ac-225 in a cyclotron, which we believe has the potential to produce higher quantities of Ac-225 than

currently utilized methods.

These patents will 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 March 31, 2023 Compared to Three Months Ended March 31, 2022

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

The following table sets forth,

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We recorded no commercial

revenue for the three months ended March 31, 2023 and March 31, 2022.

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

Other revenue

We determined that certain

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

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.

The consideration is recognized to revenue over each module and

revenue of $0.8 million was recognized during the three months ended March 31, 2022.

There was no other revenue recognized from a collaboration

during the three months ended March 31, 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-targeting Antibody Radio-Conjugate, for targeted conditioning 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 three months ended March 31, 2022 of $0.1 million.

There was no other revenue recognized from a grant from a government-sponsored

entity for the three months ended March 31, 2023.

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

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advanced payments from licensees.

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

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

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

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Research and development expenses

of $7.8 million for the three months ended March 31, 2023 increased $3.4 million from $4.4 million for the three months ended March 31,

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.

The CMC expenses associated

with the planned BLA filing are expected to be one-time in nature and incurred in the first half of 2023, with a decrease in CMC expenses

expected in the second half of 2023 with submission of the BLA for Iomab-B.

General and administrative expense

General and administrative expenses of $3.7 million for the three months

ended March 31, 2023 increased by $2.0 million from $1.7 million for the three months ended March 31, 2022.

Higher expenses were primarily

due to higher professional and consulting fees, as well as legal fees, which as we detail in our subsequent risk factors herein, were

related to obtaining a permanent injunction against a former employee who violated the non-compete provision of their employment agreement,

increased compensation of $0.3 million and non-cash equity compensation of $0.5 million.

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.

Other income is comprised

of net interest income in both reporting periods.

The amount for the three months ended March 31, 2023 of $0.5 million increased from

$35 thousand for the three months ended March 31, 2022 due to a higher average interest rate, as well as a higher average cash balance.

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.

Net loss of $15.2 million

for the three months ended March 31, 2023 increased by $5.9 million from $5.1 million for the three months ended March 31, 2022 primarily

due to higher research and development expenses, of which certain CMC expenses are expected to be one-time in nature and incurred in the

first half of 2023, as well as general and administrative expenses.

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.

Results of Operations

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

The following table sets forth,

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

Six Months Ended

(in thousands)

Other revenue

Total revenue

Operating expenses:

Research and development, net of reimbursements

General and administrative

Total operating expenses

Other income:

Interest income – net

Total other income

We recorded no commercial

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

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.

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.

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.

Net loss of $26.2 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.

Liquidity and Capital Resources

Historically, we have financed

our operations primarily through sales of shares of our stock.

The following table sets forth selected cash flow information for the

periods indicated:

Three Months Ended

The following table sets forth

selected cash flow information for the periods indicated:

Six Months Ended

(in thousands)

Cash used in operating activities

Cash (used in)/provided by operating activities

Cash used in investing activities

Cash provided by / used in financing activities

Cash provided by financing activities

Net change in cash, cash equivalents and restricted cash

Net cash used in operating

activities for the three months ended March 31, 2023 of $15.1 million increased by $9.3 million from $5.8 million in the prior-year period,

primarily as a result of a higher net loss of $5.9 million, and compared to the prior-year period, a reduction in accounts payable and

accrued expenses of $2.5 million and an increase in prepaid expenses of $1.9 million.

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.

Net cash used in investing

activities was $76 thousand and $7 thousand for the three months ended March 31, 2023 and 2022, respectively, due to the purchase of equipment.

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.

Net cash provided by financing

activities for the three months ended March 31, 2023 was $0.8 million from the sale of common stock.

During the three months ended March

31, 2022, net cash used in financing activities was $22 thousand of payments of finance leases.

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.

In August 2020 we entered

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On June 28, 2022, we

entered into an Amended and Restated Capital on Demand™ Sales Agreement, or the Amended Sales Agreement, with JonesTrading and

entered into an Amended and Restated Capital on Demand™ Sales Agreement, or the Amended Sales Agreement, with JonesTrading and B.

Riley Securities, Inc.

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with the SEC on August 7, 2020.

For the three months ended March 31, 2023, we sold 0.1 million shares of common stock, resulting in gross

proceeds and net proceeds of $0.8 million.

For the three months ended March 31, 2022, there were no sales of common stock.

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.

As of the date of filing this

report, we expect that our existing resources will be sufficient to fund our planned operations for more than 12 months following

the date of this report.

report, we expect that our existing resources will be sufficient to fund our planned operations for more than 12 months following the

date of this report.

Critical Accounting Policies and Use of Estimates

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Grant Revenue

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

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

and administrative costs as well as an administrative fee.

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

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

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

upfront license fees;

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on our financial statements.

Subsequent Event

Since March 31, 2023, we have

sold 0.6 million shares of common stock under our A&R Sales Agreement, resulting in net proceeds of $5.6 million.

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