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Item 2. Management’s Discussion and Analysis

2022-05-13 compared with 2021-11-12 · 521 added, 486 removed, 172 unchanged (85% of the section changed)

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL

CONDITION AND RESULTS OF OPERATION

MANAGEMENT’S DISCUSSION

AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION

FORWARD-LOOKING STATEMENT NOTICE

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be deemed to be forward-looking statements.

Without limiting the foregoing, words such as “may,” “will,” “expect,”

“believe,” “anticipate,” “estimate” or “continue” or comparable terminology are intended

to identify forward-looking statements.

These statements by their nature involve substantial risks and uncertainties, and actual results

may differ materially depending on a variety of factors, many of which are not within our control.

These factors include but are not limited

to economic conditions generally and in the industries in which we may participate;

competition within our chosen industry, including

competition from much larger competitors;

technological advances and failure to successfully develop business relationships.

Without limiting the foregoing, words such as “may,” “will,”

“expect,” “believe,” “anticipate,” “estimate” or “continue” or comparable

terminology are intended to identify forward-looking statements.

These statements by their nature involve substantial risks and

uncertainties, and actual results may differ materially depending on a variety of factors, many of which are not within our control.

factors include but are not limited to economic conditions generally and in the industries in which we may participate;

competition within

our chosen industry, including competition from much larger competitors;

technological advances and failure to successfully develop business

relationships.

Description of Business

Pharmaceuticals, Inc.

is a clinical-stage, biopharmaceutical company applying its proprietary platform technology and deep

understanding of radiobiology to the development of novel targeted therapies known as Antibody Radiation-Conjugates

ARCs combine the cell-killing ability of radiation via a radioisotope payload with a targeting agent, such as

a monoclonal antibody, to deliver radiation in a precise manner inside the body to specific, targeted cells, to potentially achieve

greater efficacy with lower toxicity than with external beam radiation.

ARCs enable a broader usage of radiation than external beam

radiation as they can be used in the treatment of both solid tumors and blood cancers.

Blood or hematologic cancers are known to be

highly sensitive to radiation.

Our clinical pipeline is focused on ARCs targeting the antigens CD45 and CD33, both of which are

expressed in multiple hematologic cancers.

Actinium Pharmaceuticals, Inc.

is a clinical-stage, biopharmaceutical company applying its proprietary platform technology and deep understanding of radiobiology to

the development of novel targeted radiotherapies for patients with unmet needs.

Our targeted radiotherapies combine the cell-killing ability

of radiation via a radioisotope payload with a targeting agent, such as a monoclonal antibody, to deliver radiation in a precise manner

inside the body to specific, targeted cells, to potentially achieve greater efficacy with lower toxicity than with external beam radiation.

They also enable a broader usage of radiation than external beam radiation as they can be used in the treatment of both solid tumors and

blood cancers, which generally cannot be treated with external radiation given their diffuse nature.

Our clinical pipeline is focused

on targeting the antigens CD45 and CD33, both of which are expressed in multiple hematologic cancers, which are known to be highly sensitive

to radiation.

Our clinical programs are focused on two primary areas:

(1) targeted conditioning prior

to a bone marrow transplant (“BMT”), adoptive cell therapy (“ACT”) such as CAR-T or gene therapy and (2) ARC

therapeutic combinations with other agents.

Our product development strategy is actively informed by clinical data with our ARCs in

approximately 600 patients, including our ongoing Pivotal Phase 3 SIERRA trial, which completed enrollment of 150 patients in

September 2021.

Our clinical pipeline has emanated from our Antibody Warhead Enabling (“AWE”) technology platform, which

is protected by over 160 issued and pending patents, trade secrets and know-how and is being utilized in a collaborative research

partnership with Astellas Pharma, Inc.

(“Astellas”).

We are also utilizing our AWE technology platform to advance our

research objectives focused on developing next-generation targeted radiotherapies.

To accelerate development efforts we are

undertaking an expansion of our R&D organization and research laboratories to enable us to more effectively leverage our drug

development experience to advance candidates to clinical trials.

(1) targeted conditioning prior to a bone marrow transplant (“BMT”),

adoptive cell therapy (“ACT”) such as CAR-T or gene therapy with Iomab-B and (2) targeted radiotherapy combinations with Actimab-A

and other therapeutic agents.

Our product development strategy is actively informed by clinical data with Iomab-B and Actimab-A in approximately

600 patients, including our ongoing Pivotal Phase 3 SIERRA trial, which completed its targeted enrollment of 150 patients in the third

quarter of 2021, with the last patient receiving their BMT in the fourth quarter of 2021.

Our clinical pipeline has emanated from our

Antibody Warhead Enabling (“AWE”) technology platform, which is protected by over190 issued and pending patents, trade secrets

and know-how that we are applying to the development of targeted radiotherapies for blood and solid tumor indications, independently and

with collaborators.

Ongoing collaborations include a research partnership with Astellas Pharma, Inc.

(“Astellas”) focused

on the development of theranostics, which enable the diagnosis and treatment, for solid tumor indications, a collaboration with EpicentRx,

Inc, focused on a novel CD47 immunotherapy targeted radiotherapy combination, leveraging EpicentRx’s RRx-001, that is being studied

in a Phase 3 trial in non-small cell lung cancer, with our clinical stage Actimab-A in AML models, and a collaboration with AVEO Oncology,

focused on developing a HER3 targeting ARC or Antibody Radiation Conjugate for solid tumors leveraging with their clinical stage antibody.

We are also utilizing our AWE technology platform to advance our research objectives focused on developing next-generation targeted radiotherapies

with our expanded research and development organization and research laboratories leveraging our drug development experience.

Targeted Conditioning

To the best of our knowledge,

we are advancing the only multi-target, multi-indication, clinical-stage pipeline for targeted conditioning and the only ARC-based targeted

conditioning regimens in development.

Our ARCs for targeted conditioning are intended to potentially enable improved access and outcomes

to cell-based therapies with curative potential, including BMT, ACT, and gene therapy Conditioning in the context of BMT, ACT or gene

therapy is the act of depleting certain blood and immune-forming cells, including bone marrow stem cells and, in some cases, cancer cells

prior to transplanting new cells into a patient.

Currently, conditioning is accomplished using a combination of cytotoxic chemotherapeutic

agents and external radiation.

These non-targeted conditioning regimens are highly toxic and may prevent a patient from receiving a potentially

curative therapy and hinder outcomes.

ARCs have the potential to increase patient access and outcomes by way of their ability to selectively

deplete targeted cells while sparing normal healthy cells, resulting in potentially lower systemic and off-target toxicities.

our ARCs both at high isotope dose levels to achieve myeloablation, which fully depletes bone marrow stem cells and at lower isotope

dose levels to achieve lymphodepletion, which spares bone marrow stem cells from depletion.

In addition, dosing may be titrated downward

from myeloablative doses to achieve partial myeloablation, which may be appropriate for certain gene therapy programs.

we are advancing the only multi-target, multi-indication, clinical-stage pipeline for targeted conditioning.

Our targeted conditioning

agents are intended to potentially enable improved access and outcomes to cell-based therapies with curative potential, including BMT,

ACT, and gene therapy.

Conditioning in the context of BMT, ACT or gene therapy is the act of depleting certain blood and immune-forming

cells, including bone marrow stem cells and, in some cases, cancer cells prior to transplanting new cells into a patient.

Currently, conditioning

is accomplished using a combination of cytotoxic chemotherapeutic agents and external radiation.

These non-targeted conditioning regimens

are highly toxic and may prevent a patient from receiving a potentially curative therapy and hinder outcomes.

We believe our targeted

conditioning agents have the potential to increase patient access and outcomes by way of their ability to selectively deplete targeted

cells while sparing normal healthy cells, resulting in potentially lower systemic and off-target toxicities.

We use our ARCs both at high

isotope dose levels to achieve myeloablation, which fully depletes bone marrow stem cells and at lower isotope dose levels to achieve

lymphodepletion, which spares bone marrow stem cells from depletion.

In addition, dosing may be titrated downward from myeloablative doses

to achieve partial myeloablation, which may be appropriate for certain gene therapy programs.

CD45 Targeted Conditioning Program

Our CD45 ARC is comprised

of the anti-CD45 monoclonal antibody known as apamistamab (formerly BC8) and the radioisotope Iodine-131 (“I-131”).

an antigen expressed on leukemia, lymphoma and myeloma cancer cells, as well as nucleated immune cells including bone marrow stem cells,

but is not expressed outside of the hematopoietic, or blood forming, system.

This unique expression on blood cancer and immune cells enables

simultaneous depletion of both cell types, making CD45 an optimal antigen for targeted conditioning applications.

CD45 is a cell surface

antigen with an average expression of 200,000 copies per cell, however, it only internalizes at a rate of 10-15%.

We believe our ARC approach

is the most effective method to target CD45 positive cells, as the radioisotope payload linear energy transfer can readily ablate a targeted

cell without requiring payload internalization like an antibody drug conjugate or without relying on biological effector function processes

like a naked antibody.

Furthermore, since CD45 expression level varies from low to high antigen density as the immune cells become more

terminally differentiated, we can selectively condition depending on the therapeutic application, from full myeloablation to transient

lymphodepletion, by adjusting the dose or intensity of the I-131 isotope payload.

Full myeloablation can be achieved with high doses of

I-131, as its energy pathlength and crossfire effect can penetrate into bone marrow niches to target and deplete blood and immune system

forming bone marrow stem cells.

Myeloablation is applicable to autologous or allogeneic BMT and to autologous gene-edited or modified

therapies that can reconstitute a patient’s blood and immune systems.

Alternatively, low doses of I-131 can be transiently lymphodepleting

and spare a patient’s bone marrow stem cells, which we believe is ideal for ACT applications such as CAR-T.

We intend to develop

our CD45 targeted conditioning program for BMT, ACT and gene therapy applications for malignant and non-malignant diseases and believe

that multiple radioisotopes beyond I-131 may be utilized including alpha and beta emitters.

Our lead CD45 targeted conditioning

product candidate is Iomab-B, which uses high doses of I-131 to achieve myeloablative conditioning prior to a BMT, is currently being

studied in the pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory AML (“SIERRA”), clinical trial for targeted

conditioning prior to an allogeneic BMT for patients with active, relapsed or refractory (“r/r”) Acute Myeloid Leukemia, (“AML”),

who are age 55 or older.

Enrollment of the planned 150 patients in the SIERRA trial was completed in September 2021.

Patients with active,

r/r AML are not normally considered eligible for BMT and the SIERRA trial is the only randomized Phase 3 trial to offer BMT as a treatment

option for this patient population.

The SIERRA trial compares outcomes of patients randomized to receive Iomab-B and a BMT (the “study

arm”) to those patients randomized to receive physician’s choice of salvage therapy (the “control arm”).

arm is also defined as conventional care, as no standard of care exists for this patient population and includes over 20 agents that may

be used as single agents or in combination including venetoclax, a targeted Bcl-2 inhibitor, Midostaurin and Sorafenib, targeted FLT3

inhibitors, hypomethylating agents and cytotoxic chemotherapies.

Patients who fail to achieve a Complete Remission (“CR”)

on the control arm are ineligible to proceed to a BMT, but the trial design permits these patients to “cross over” to receive

the study arm treatment if they meet the eligibility criteria.

The primary endpoint of the SIERRA trial is durable Complete Remission

(“dCR”) of 180 days and the secondary endpoint is Overall Survival (“OS”).

When the crossover patients receive

Iomab-B and BMT, they have not achieved remission with their salvage therapy and are considered to be failures for the primary endpoint

of the study.

The SIERRA trial recruited patients at 24 sites in the United States and Canada, which includes many of the leading BMT

sites based on volume.

If approved, we expect our initial commercial launch would target the leading 50-100 BMT and medical centers that

perform the vast majority of BMT’s in the United States.

In the European Union (“EU”), we received favorable feedback

from the European Medicines Agency (“EMA”) via their scientific advice program that the trial design, primary endpoint and

planned statistical analysis from the SIERRA trial are acceptable as the basis for a Marketing Authorization Application, or MAA.

Additionally,

the EMA commented that it does not anticipate the need for further standalone preclinical toxicology or safety studies.

Overall, transplant

procedures in the EU are approximately fifty percent higher than in the United States with a similar market dynamic, with a majority of

BMT volume being conducted in a concentrated number of leading medical centers.

Currently we intend to secure a partner for Iomab-B in

Data from the first 113 patients

enrolled in the SIERRA trial, which represents 75% of the total of 150 patients that were enrolled in the trial, was presented in oral presentations

at the American Society of Hematology (“ASH”) Annual Meeting in December 2020 and at the Transplantation & Cellular

Therapy (“TCT”) Meetings of the American Society for Transplantation and Cellular Therapy (“ASTCT”) and Center

for International Bone & Marrow Transplant Research (“CIBMTR”) in February 2021.

It was reported that 100% of patients

Iomab-B (I-131 apamistamab),

our lead candidate and targeted conditioning agent is comprised of the anti-CD45 monoclonal antibody known as apamistamab (formerly BC8)

and the radioisotope Iodine-131 (“I-131”).

CD45 is an antigen expressed on leukemia, lymphoma and myeloma cancer cells, as

well as nucleated immune cells including bone marrow stem cells, but is not expressed outside of the hematopoietic, or blood forming,

This unique expression on blood cancer and immune cells enables simultaneous depletion of both cell types, making CD45 an optimal

antigen for targeted conditioning applications.

CD45 is a cell surface antigen with an average expression of 200,000 copies per cell,

however, it only internalizes at a rate of 10-15%.

We believe our ARC approach is the most effective method to target CD45 positive cells,

as the radioisotope payload linear energy transfer can readily ablate a targeted cell without requiring payload internalization like an

antibody drug conjugate or without relying on biological effector function processes like a naked antibody.

Furthermore, since CD45 expression

level varies from low to high antigen density as the immune cells become more terminally differentiated, we can selectively condition

depending on the therapeutic application, from full myeloablation to transient lymphodepletion, by adjusting the dose or intensity of

the I-131 isotope payload.

Full myeloablation can be achieved with high doses of I-131, as its energy pathlength and crossfire effect

can penetrate into bone marrow niches to target and deplete blood and immune system forming bone marrow stem cells.

Myeloablation is applicable

to autologous or allogeneic BMT and to autologous gene-edited or modified therapies that can reconstitute a patient’s blood and

immune systems.

Alternatively, low doses of I-131 can be transiently lymphodepleting and spare a patient’s bone marrow stem cells,

which we believe is ideal for ACT applications such as CAR-T.

We intend to develop our CD45 targeted conditioning program for BMT, ACT

and gene therapy applications for malignant and non-malignant diseases and believe that multiple radioisotopes beyond I-131 may be utilized

including alpha and beta emitters.

Iomab-B uses high doses of

I-131 to achieve myeloablative conditioning prior to a BMT.

Iomab-B is currently being studied in the pivotal Phase 3 Study of Iomab-B

in Elderly Relapsed or Refractory AML (“SIERRA”), clinical trial for targeted conditioning prior to an allogeneic BMT for

patients with active, relapsed or refractory (“r/r”) Acute Myeloid Leukemia, (“AML”), who are age 55 or older.

Enrollment of the planned 150 patients in the SIERRA trial was completed in the third quarter of 2021 with the last patient receiving

their BMT in the fourth quarter of 2021.

Patients with active, r/r AML are not normally considered eligible for BMT and the SIERRA trial

is the only randomized Phase 3 trial to offer BMT as a treatment option for this patient population.

The SIERRA trial compares outcomes

of patients randomized to receive Iomab-B and a BMT (the “study arm”) to those patients randomized to receive physician’s

choice of salvage therapy (the “control arm”).

The control arm is also defined as conventional care, as no standard of care

exists for this patient population and includes over 20 agents that may be used as single agents or in combination including venetoclax,

a targeted Bcl-2 inhibitor, Midostaurin and Sorafenib, targeted FLT3 inhibitors, hypomethylating agents and cytotoxic chemotherapies.

Patients who fail to achieve a Complete Remission (“CR”) on the control arm are ineligible to proceed to a BMT, but the trial

design permits these patients to “cross over” to receive the study arm treatment if they meet the eligibility criteria.

primary endpoint of the SIERRA trial is durable Complete Remission (“dCR”) of 180 days and the secondary endpoint is Overall

Survival (“OS”).

When the crossover patients receive Iomab-B and BMT, they have not achieved remission with their salvage

therapy and are considered to be failures for the primary endpoint of the study.

The SIERRA trial recruited patients at 24 sites in the

United States and Canada, which includes many of the leading BMT sites based on volume.

If approved, we expect our

initial commercial launch would target the leading 50-100 BMT and medical centers that perform the vast majority of BMT’s in the

United States.

In the European Union (“EU”), we received favorable feedback from the European Medicines Agency (“EMA”)

via their scientific advice program that the trial design, primary endpoint and planned statistical analysis from the SIERRA trial are

acceptable as the basis for a Marketing Authorization Application, or MAA.

Additionally, the EMA commented that it does not anticipate

the need for further standalone preclinical toxicology or safety studies.

Overall, transplant procedures in the EU are approximately fifty

percent higher than in the United States with a similar market dynamic, with a majority of BMT volume being conducted in a concentrated

number of leading medical centers.

In April 2022, we entered into a license and supply agreement with Immedica Pharma AB, or Immedica,

pursuant to which Immedica licensed the exclusive product rights for commercialization of Iomab-B in the European Economic Area, Middle

East and North Africa.

including Algeria, Andorra, Bahrain, Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya.

Morocco, Oman, Palestine, Qatar, San Marino, Saudi Arabia, Switzerland, Syria, Tunisia, Turkey, the United Arab Emirates, the United Kingdom,

the Vatican City and Yemen.

Upon signing, we are entitled to an upfront payment of $35 million from Immedica, which we received in May 2022.

Under the terms of the agreement,

we are eligible to receive aggregate regulatory and commercial milestone payments of up to approximately $417 million, subject to future

currency exchange rates.

Additionally, we are entitled to receive royalties in the mid-20 percent range on net sales of the product in

certain countries that may result from the License Agreement.

We will continue to be responsible for certain clinical development activities

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

and rest of the world.

Data from full patient enrollment

in the SIERRA trial (153 patients), was presented at the Transplantation & Cellular Therapy (TCT) Tandem Meetings of ASTCT and CIBMTR,

the combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International

Blood & Marrow Transplant Research (CIBMTR) in April 2022.

The data presented includes rates of BMT access and engraftment, 100-day

non-relapse transplant-related mortality (100-day TRM) and adverse events, which has been reported from interim analyses conducted at

25%, 50%, 75% and 100% of patient enrollment pursuant to the study protocol.

The data presented at ASH highlighted that 100% of patients

(66/66) on the study arm that received a therapeutic dose of Iomab-B received a BMT, with a median time to BMT of 30 days, and all patients

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median blast count of 20%.

Of the 82% of patients failing to achieve a CR with conventional care (47/57), 30 patients were eligible to

cross over to receive Iomab-B followed by transplant.

These patients are considered as having failed the primary endpoint of the study.

All crossover patients who received the therapeutic dose of Iomab-B (30/30) received a BMT, with a median time to BMT of 24 days and they

achieved engraftment in a median time of 19 days despite high median blast count of 22% at time of crossover.

It was also reported that

100-day non-relapse transplant-related mortality (100-day TRM) of the study or Iomab-B arm was only 4% (2/45) of patients that received

a BMT compared to 20% of patients (2/10) who received a BMT after salvage therapy on the control arm.

The universal engraftment rate and

low 100-day TRM rate of the Iomab-B arm resulted in 43 patients potentially evaluable for the primary endpoint compared to 8 patients

in the control arm, a greater than five times difference.

Data from SIERRA trial has been accepted for presentation at the American

Society of Hematology (ASH) annual meeting in December 2021 where we expect to present interim data from full trial enrollment.

data for the primary endpoint of durable Complete Remission is expected to be presented in mid-2022 (late 2Q/3Q:2022)..

We believe topline

data from SIERRA will support the submission of a Biologics License Application (“BLA”) with the U.S.

Food and Drug Administration

(“FDA”), which we expect to file toward the end of 2022.

Our Iomab-ACT program is intended

for targeted conditioning prior to ACT or gene therapy and uses the same I-131-apamistamab ARC construct as Iomab-B at varying doses.

Of the 82% of patients failing to achieve a complete remission (“CR”) with conventional care (63/77),

40 patients were eligible and elected to cross over to receive Iomab-B followed by transplant.

These patients are considered as having

failed the primary endpoint of the study.

All crossover patients who received the therapeutic dose of Iomab-B (40/40) received a BMT,

with a median time to BMT of 24 days and they achieved engraftment in a median time of 19 days despite high median blast count of 35%

at time of crossover.

It was also reported that 100-day TRM of the study or Iomab-B arm was 09% (6/65) of patients that received a BMT

compared to 14% of patients (2/14) who received a BMT after salvage therapy on the control arm.

The universal engraftment rate and low

100-day TRM rate of the Iomab-B arm resulted in 59 patients potentially evaluable for the primary endpoint compared to 12 patients in

the control arm, an approximate five times difference.

At each of the interim analyses throughout the SIERRA trial, this approximate five

times difference has been consistent in favor of the Iomab-B arm as a result of higher rates of BMT engraftment and lower rates of 100-day

Top-line data for the primary endpoint of durable Complete Remission is expected to be presented in the fourth quarter of 2022 based

on the current status of the data collection and data query process with certain SIERRA trial sites.

We believe topline data from SIERRA

will support the submission of a Biologics License Application (“BLA”) with the FDA, which we expect to file in the first

half of 2023.

Our Iomab-ACT program is

intended for targeted conditioning prior to ACT or gene therapy and uses the same I-131-apamistamab construct as Iomab-B at varying doses.

At lower doses of one-eighth to one-sixth of the myeloablative dose, it is applicable for lymphodepletion prior to CAR-T or certain gene

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stem cell myeloablation is necessary.

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 the standard of practice today for lymphodepletion prior to CAR-T.

CD45 is an antigen expressed on certain immune cell

types that are relevant to the mechanism of CAR-T therapies including lymphocytes, regulatory T-cells and macrophages that have been associated

with clinical responses that may limit the safety, efficacy and durability of response of these CAR-T therapies including cytokine release

syndrome (“CRS”) and neurotoxicity.

Some of these limitations may be attributable to the chemotherapy-based conditioning agents

that are being used prior to CAR-T therapies.

Preclinical data supporting the rational for our Iomab-ACT program was presented at multiple

medical conferences in 2019.

Unlike chemotherapy, Iomab-ACT is targeted in nature and, due to this CD45-directed targeting, we expect

we can improve CAR-T cell expansion, potentially resulting in responses that are more durable, but also resulting in reduced CAR-T related

Importantly, we expect the Iomab-ACT program construct to enable lymphodepletion through a single-dose, outpatient administration

versus Flu/Cy or other chemotherapy-based lymphodepletion regimens that can require multiple infusion cycles over several days.

of this potentially superior profile, the Iomab-ACT construct could result in improved access to CAR-T therapy and better outcomes.

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 the standard of practice today for lymphodepletion prior to CAR-T.

CD45 is an antigen expressed on certain

immune cell types that are relevant to the mechanism of CAR-T therapies including lymphocytes, regulatory T-cells and macrophages that

have been associated with clinical responses that may limit the safety, efficacy and durability of response of these CAR-T therapies

including cytokine release syndrome (“CRS”) and neurotoxicity.

Some of these limitations may be attributable to the chemotherapy-based

conditioning agents that are being used prior to CAR-T therapies.

Preclinical data supporting the rational for our Iomab-ACT program

was presented at multiple medical conferences in 2019.

Unlike chemotherapy, Iomab-ACT is targeted in nature and, due to this CD45-directed

targeting, we expect we can improve CAR-T cell expansion, potentially resulting in responses that are more durable, but also resulting

in reduced CAR-T related toxicities.

Importantly, we expect the Iomab-ACT program construct to enable lymphodepletion through a single-dose,

outpatient administration versus Flu/Cy or other chemotherapy-based lymphodepletion regimens that can require multiple infusion cycles

over several days.

Because of this potentially superior profile, the Iomab-ACT construct could result in improved access to CAR-T therapy

and better outcomes.

We are studying Iomab-ACT

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to fund this trial with MSKCC being a co-recipient on this grant.

This is a first of its kind study to use an ARC-based conditioning regimen

with CAR-T therapy.

This is a first of its kind study to use an ARC-based conditioning

regimen with CAR-T therapy.

The hypothesized rationale for this study is that Iomab-ACT will exert an anti-tumor effect on the chemotherapy-refractory

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patient population.

Median event-free survival (EFS) was 6.1 months and median overall survival (OS) was 12.9 months at a median follow

up period of 29 months (range 1 – 65 months).

There was a 26% (14/53) rate of Grade 3 or greater CRS and a 42% rate of Grade 3 or

4 neurotoxicity reported.

The study will evaluate the feasibility of using an ARC-based conditioning regimen with CAR-T therapy and will

evaluate safety measures including incidence of CRS and neurotoxicity and efficacy measures including responses and survival outcomes.

In March 2021, we announced that patient enrollment was initiated, and the first patient was administered Iomab-ACT followed by their

19-28z CAR-T therapy.

We expect proof of concept data from this study in 2022.

Median event-free survival (“EFS”) was 6.1 months and median overall survival (“OS”) was

12.9 months at a median follow up period of 29 months (range 1 – 65 months).

There was a 26% (14/53) rate of Grade 3 or greater

CRS and a 42% rate of Grade 3 or 4 neurotoxicity reported.

The study will evaluate the feasibility of using an ARC-based conditioning

regimen with CAR-T therapy and will evaluate safety measures including incidence of CRS and neurotoxicity and efficacy measures including

responses and survival outcomes.

We expect proof of concept data from this study in the second half of 2022.

In addition, we are working

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with multiple academic or industry developers to establish Iomab-ACT as a non-chemotherapy universal targeted conditioning solution.

We are also exploring an Ac-225-based

CD45 ARC, as a potential next-generation targeted conditioning agent.

Dosimetry results with this Ac-225-based alpha emitting ARC showed

selective accumulation in immune cell target organs such as bone marrow, spleen, and liver with the potential for lower exposure to non-target

tissues from longer path length beta emitter radioisotopes like Iodine-131 and Lutetium-177 (“Lu-177”).

Preclinical data demonstrated

that conditioning with this Ac-225-based CD45-targeting agent result in depletion of peripheral immune cells and hematopoietic progenitor

cells, thereby enabling engraftment of donor cells.

A dose dependent response was observed with low doses depleting white blood cells

without affecting hematopoietic progenitor cells, representing a lymphodepletive dose that is relevant for adoptive cell therapies such

as CAR-T, while higher doses eliminated peripheral immune cells and hematopoietic progenitor cells, which is applicable to ex vivo gene

therapies and BMT.

CD33 Program:

and Therapeutics

Combinations and Therapeutics

Our CD33 program is evaluating

the clinical utility of Actimab-A, an ARC comprised of the anti-CD33 mAb lintuzumab linked to the potent alpha-emitting radioisotope Actinium-225

the clinical utility of Actimab-A, comprised of the anti-CD33 mAb lintuzumab linked to the potent alpha-emitting radioisotope Actinium-225

CD33 is expressed in the majority of patients with AML and myelodysplastic syndrome (“MDS”) as well

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Ac-225 emits four alpha particles and can kill a cell with one alpha-particle

hit, making it one of the most powerful cell-killing agents with no know resistance mechanism to the double strand DNA breaks it can cause.

We source Ac-225 from the Department of Energy’s Oak Ridge National Laboratory through an annual supply agreement, which we expect

to renew annually.

hit, making it one of the most powerful cell-killing agents with no know resistance mechanism to the double strand DNA breaks it can

We source Ac-225 from the Department of Energy’s Oak Ridge National Laboratory.

Our CD33 development program

is driven by data obtained from nearly one hundred fifty treated patients, including results from a Phase 1/2 trial that was conducted

in 58 patients with newly diagnosed AML, which was completed in 2018.

This clinical data, as well as our experience with Iomab-B, is shaping

a two-pronged approach with our CD33 program, where at high doses we are exploring its use for targeted conditioning and at low doses

we are exploring its use for therapeutic combinations with other treatment modalities.

is driven by data obtained from nearly one hundred fifty treated patients, including results from a Phase 1/2 trial that studied Actimab-A

as a single agent at multiple dose levels in 58 patients with newly diagnosed AML, which was completed in 2018, as well as trials studying

Actimab-A in combination with other agents.

We believe that radiation

via an ARC can be synergistic when used in combination with chemotherapy, targeted agents and immunotherapy based on mechanistic rationales

supported by our own clinical data, preclinical research and scientific and clinical evidence in the literature.

We have prioritized our

efforts and resources in favor of combination trials for our CD33 program development strategy rather than single agent trials at this

time as we believe Actimab-A can be a backbone therapy in AML when combined with other therapeutic modalities.

Our CD33 ARC development

program encompasses the following ongoing trials:

Combination Trials :

Phase 1 investigator initiated Actimab-A + CLAG-M combination trial with the salvage chemotherapy regimen CLAG-M (cladribine, cytarabine, filgrastim and mitoxantrone) for fit patients age 18 and above with relapsed or refractory AML at the Medical College of Wisconsin (“MCW”).

The combination of Actimab-A + CLAG-M is supported by mechanistic rationale for combining inhibitors of DNA replication and/or repair processes such as mitoxantrone, a topoisomerase-II inhibitor, and radiation, as imparted by tumor-targeting of Ac-225 with Actimab-A.

Thus far, we have reported preliminary data from dose cohorts one, two and the third and planned final dose cohort of 0.75 µCi/kg of Actimab-A.

At the 2020 American Society of Hematology Annual Meeting, it was reported that 100% of patients (3/3) receiving 0.75 µCi/kg of Actimab-A, and CLAG-M achieved a complete remission, which is nearly 85% greater than the 55% remission rate observed in a study of CLAG-M alone conducted at MCW in the same r/r AML patient population.

Complete Remission or Complete Remission with Incomplete blood count recovery (“CRi”) were observed in all dose cohorts (0.25, 0.50 and 0.75 µCi/kg) with 67% of patients (10/15) achieving CR or CRi.

The 0.25 and 0.50 µCi/kg doses of Actimab-A have been shown to be subtherapeutic as a single agent.

Of the 10 patients achieving CR or Cri, 70% achieved negative minimal residual disease (“MRD”) status with no detectable disease via flow cytometry, indicating that these are deep remissions.

No dose-limiting toxicities (“DLTs”) were reported in the third dose cohort of 0.75 µCi/kg and therefore maximum tolerable dose (“MTD”) was not reached.

As a result, MCW amended the study protocol to allow for continued dose escalation and the trial is now enrolling patients at a dose of 1.0 µCi/kg.

Upon completion of this Phase 1 trial, we will work to develop a regulatory and development pathway that can potentially support a registration for the Actimab-A + CLAG-M combination.

In addition, the Actimab-A + CLAG-M combination study has provided proof of principle that the addition of subtherapeutic doses of Actimab-A to other AML therapies can lead to well-tolerated regimens with improved responses.

In November 2021, we announced that we completed enrollment of the fourth and planned final dose cohort in this Phase 1 dose escalation study and that we will present data from this trial including additional patients from the fourth dose cohort of 1.0 µCi/kg of Actimab-A at ASH in December 2021.

Phase 1/2 Actimab-A + Ven combination trial with the BCL-2 inhibitor Venetoclax (“ven”) for fit and unfit patients age 18 and above with relapsed or refractory AML.

delivered internally via a targeting moiety can be synergistic when used in combination with chemotherapy, targeted agents and immunotherapy

based on mechanistic rationales supported by our own clinical data, preclinical research and scientific and clinical evidence in the

We have prioritized our efforts and resources in favor of combination trials for our CD33 program development strategy rather

than single agent trials at this time as we believe Actimab-A can be a backbone therapy in AML when combined with other therapeutic modalities.

Our CD33 development program encompasses the following ongoing trials:

Actimab -A Combination Trials :

Actimab-A + CLAG-M

The combination of Actimab-A

with CLAG-M has been studied in a Phase 1 combination trial that was conducted in collaboration with the Medical College of Wisconsin

(“MCW”) in patients age 18 and above with r/r AML who are fit for intensive therapy.

Patient enrollment was completed in

November 2021.

CLAG-M (cladribine, cytarabine, filgrastim and mitoxantrone) is a salvage chemotherapy regimen that produced a 55% remission

rate in patients with r/r AML in a previous study conducted by MCW that compared outcomes of patients receiving either CLAG-M, MEC or

CLAG salvage therapy regimens.

Data from the Phase 1 combination trial of Actimab-A + CLAG-M were presented at ASH in December 2021.

After completion of dose-escalation in the Phase 1 trial, the recommended Phase 2 dose was determined to be 0.75 µCi/kg of Actimab-A.

3 patients were enrolled in the 0.75 µCi/kg dose cohort, which had a 100% remission rate comprised of 1 complete remission (“CR”)

and 2 complete remissions with incomplete platelet recovery (“CRp”), there were no dose limiting toxicities (“DLTs”)

or 30-day mortality reported.

Overall, a 67% (12/18) overall response rate (“ORR”) was reported across all dose cohorts (0.25

– 1.0 µCi/kg) and remissions were achieved in every dose cohort including the 0.25 and 0.50 µCi/kg doses of Actimab-A,

which have been shown to be subtherapeutic as a single agent.

In addition, there was a 72% minimal residual disease (“MRD”)

negativity rate, which compares favorably to the 39% MRD negativity rate reported by MCW with CLAG-M alone.

This study enrolled patients

who previously failed Venetoclax, a targeted Bcl-2 inhibitor, and efficacy was similar in patients Venetoclax naïve and those that

previously failed Venetoclax, with a 60% response rate in previous Venetoclax failures.

We are working to develop a regulatory and development

pathway for the Actimab-A CLAG-M combination and will be evaluating potential registration enabling strategies.

In addition, we believe

this Actimab-A + CLAG-M combination study has provided proof of principle that the addition of Actimab-A to other AML therapies can lead

to well-tolerated regimens with improved responses, which supports our Actimab-A backbone therapy in AML strategy.

Actimab-A + Venetoclax

We are also conducting a Phase

1/2 Actimab-A combination trial with the Bcl-2 inhibitor Venetoclax in fit and unfit patients age 18 and above with relapsed or refractory

This multi-center trial is being led by UCLA Medical Center.

This combination is supported by mechanistic evidence in preclinical studies using ven-resistant AML tumor cell lines.

In these models, we have demonstrated that Actimab-A can deplete Mcl-1 and Bcl-XL, two proteins implicated in mediating resistance to venetoclax, in addition to causing potentially lethal double-stranded DNA breaks in these CD33 expressing cells.

Furthermore, in vivo studies in animal models of ven-resistant AML demonstrated robust tumor regression and improved survival in cohorts receiving the Actimab-A ven combination compared to ven alone.

The rationale for this clinical study is that the addition of Actimab-A will;

1) have a direct anti-tumor effect via double-stranded DNA breaks and 2) deplete Mcl-1 and BCL-XL making the AML cells more susceptible to ven.

At the 2020 ASH annual meeting, data from the first dose cohort of 0.50 µCi/kg Actimab-A in combination with ven were presented.

There was a 67% overall response rate (2/3 patients), including one CR and one partial response (“PR”) with blast count reduction of 50%.

All 3 patients were poor risk with adverse cytogenetics and each patient had an additional high-risk marker (FLT3-ITD+, antecedent JAK2+ myelofibrosis, or TP53 mutation).

The patient achieving a CR was in second relapse and a TP53 mutation as well as multiple other high-risk markers.

The trial is now active and recruiting at 4 trial sites in dose escalation cohorts.

We will present data from additional dose cohorts of 0.75 and 1.0 µCi/kg of Actimab-A from the Phase 1 portion of this novel combination study at ASH in December 2021.

In addition to these active

trials, we actively seek and evaluate additional modalities and agents that can be the basis for Actimab-A therapeutic combinations such

as the CD47 combinations we announced in October 2021 to leverage our clinical experience, supply chain and AWE technology platform.

This combination is supported by mechanistic evidence in preclinical

studies using Venetoclax -resistant AML tumor cell lines.

In these models, we have demonstrated that Actimab-A can deplete Mcl-1 and Bcl-XL,

two proteins implicated in mediating resistance to Venetoclax, in addition to causing potentially lethal double-stranded DNA breaks in

these CD33 expressing cells.

Furthermore, in vivo studies in animal models of Venetoclax-resistant AML demonstrated robust tumor regression

and improved survival in cohorts receiving the Actimab-A Venetoclax combination compared to Venetoclax alone.

The rationale for this clinical

study is that the addition of Actimab-A will;

1) have a direct anti-tumor effect via double-stranded DNA breaks and 2) deplete Mcl-1 and

Bcl-XL making the AML cells more susceptible to Venetoclax.

Updated data from the Phase 1 dose escalation portion of this study was presented

at ASH in December 2021 from three dose cohorts of 0.50, 0.75 and 1.0 µCi/kg of Actimab-A in a total of 12 patients.

50% of patients

received Venetoclax therapy prior to enrollment on the Actimab-A combination trial.

And 67% of patients had poor risk cytogenetics, of

which, 3 had a TP53 mutation, which is associate with poorer response rates and survival outcomes.

Of the patients with a TP53 mutation,

67% achieved a remission including a patient that achieved a CR who remained in follow-up 230 days (~7.5 months) at the time of data cutoff

The combination of Actimab-A with Venetoclax was reported to be well-tolerated with no 30-day mortality.

The data to date support

advancing to the Phase 2 portion of the trial and we expect to provide an update on the development strategy, including consideration

of patients with a TP53 mutation, after the Phase 1 dose finding portion of the trial is complete and the recommended Phase 2 dose is

In addition to these ongoing trials,

we actively seek and evaluate additional modalities and agents that can be the basis for Actimab-A therapeutic combinations such as the

CD47 immunotherapy magrolimab combinations we announced at the Society for Immunotherapy of Cancer (“SITC”) in November 2021

to leverage our clinical experience, supply chain and AWE technology platform.

CD47 Based ARC Combinations in Solid Tumors

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To explore this synergy and the potential to improve patient outcomes and we have initiated a program in AML with our Actimab-A ARC, consistent

with our strategy to establish Actimab-A a backbone AML therapy, and in solid tumors with a HER-2 targeting ARC, which emanated from our

AWE technology platform.

To our knowledge, these are the first and only ARC-based targeted radiotherapy combinations with CD47 immunotherapy.

Data from these novel combinations were presented at the 36 th Annual Meeting of the Society for Immunotherapy for Cancer.

with our strategy to establish Actimab-A as a backbone AML therapy, and in solid tumors with a HER2 and HER3 targeting ARCs, which emanated

from our AWE technology platform.

To our knowledge, these are the first and only ARC-based targeted radiotherapy combinations with CD47

immunotherapy.

Data from the novel HER2 magrolimab combination was presented at the 36 th Annual SITC Meeting in April 2022

and at the HER3 magrolimab combination was presented American Association for Cancer Research (“AACR”) Annual Meeting in April

2022 that showed a significant increase in tumor control compared to magrolimab alone in preclinical non-small cell lung cancer (“NSCLC”)

The most advanced CD47 development

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models of AML.

In preclinical models, it was shown that in multiple AML cell lines, the combination of Actimab-A with magrolimab led to

increased phagocytosis of AML cells compared to magrolimab alone.

In preclinical models, it was shown that in multiple AML cell lines, the combination of Actimab-A with magrolimab led

to increased phagocytosis of AML cells compared to magrolimab alone.

Our studies also demonstrated that AML cell lines exposed to Actimab-A

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with the goal of advancing to human clinical trials.

In addition, we are studying an

anti-HER2 ARC using the antibody Trastuzumab with either Ac-225 or Lu-177 radioisotopes, which was developed using our AWE technology

platform, in combination with magrolimab in solid tumor preclinical models.

Anti-CD47 monotherapies have not shown meaningful responses

in clinical studies of solid tumors.

We hypothesized that an ARC would upregulate calreticulin, a pro-phagocytic “eat me”

signal that when combined with an anti-CD47 blockade therapy would enhance antitumor activity.

Data from this combination was presented

at the 36 th Annual Meeting of the Society for Immunotherapy for Cancer.

In vitro studies showed that HER2 ARC immunogenicity,

determined by binding to HER2 expressing cells, remained intact after radiolabeling with Ac-225 or Lu-177.

In multiple cells lines HER2-ARCs

increased cell surface calreticulin and the combination with magrolimab increased phagocytosis.

The combination of the Ac-225 or Lu-117

HER2-ARCs with magrolimab slowed tumor growth in animal models of solid tumors compared to either the HER2 ARC or magrolimab as single

We are continuing to evaluate this combination in additional tumor models, and we intend to continue to study this combination

with the goal of advancing to human clinical trials.

In January 2022, we announced a research collaboration

with EpicentRx that will evaluate Actimab-A in combination with EpicentRx’s RRx-001in AML.

EpicentRx’s RRx-001, currently

under investigation in a Phase 3 trial for Small Cell Lung Cancer and in other oncology and non-oncology indications, is a versatile

next generation small molecule immunotherapeutic that targets the CD47-SIRPα axis and the NLRP3 inflammasome to alter the

tumor microenvironment and optimize immune response.

This collaboration will explore the mechanistic synergy of RRx-001’s CD47–SIRPα

downregulation with Actinium’s targeted radiotherapy calreticulin upregulation to increase the immune detection and destruction

of cancer cells.

Preclinical experiments have begun exploring this combination in AML models.

We intend to leverage our experience with

CD47 targeting agents such as magrolimab in this collaboration.

Based on Actimab-A and RRx-001 both being clinical-stage assets, we believe

there is a potentially faster pathway to clinical trials with this novel combination, particularly if the preclinical safety and efficacy

profile are in line with what was observed with Actimab-A and magrolimab.

Antibody Warhead Enabling Technology Platform

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platform is supported by intellectual property, know-how and trade secrets that cover the generation, development, methods of use and

manufacture of ARCs and certain of their components.

Our AWE technology patent portfolio presently includes 38 patent families comprised

of 168 issued patents and pending patent applications, of which 8 are issued and 31 are pending in the United States, and 131 are issued

or pending internationally.

The effective life of the patents in our portfolio range from expirations between 2021 and 2040.

Our technology

enables the direct labeling, or conjugation and labeling, of a biomolecular targeting agent to a radionuclide warhead and its development

and use as a therapeutic regimen for the treatment of diseases such as cancer.

Our AWE intellectual property covers various methods of

use for ARCs in multiple diseases, including indication, dose and scheduling, radionuclide warhead, and therapeutic combinations.

particular expertise in the area of ARCs utilizing the alpha emitting isotope Ac-225 including clinical experience in treating approximately

150 patients with our alpha-emitter ARCs, “gold standard” linker technology and 5 issued patents in the United States 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.

We have enhanced our research

and development capabilities around AWE by securing and staffing research facilities.

Our research laboratories are focused on applying

our AWE technology platform to the development of radiation conjugates and to execute on research collaborations.

Our R&D efforts

employ a multidisciplinary approach leveraging our team’s knowledge and experience in cancer cell biology, radiochemistry, radiation

sciences, immunology and oncology drug development.

We intend to focus on generating ARCs using our existing intellectual property, evaluating

assets for in-licensing to complement our existing clinical pipeline and securing collaborations and partnerships with biopharmaceutical

By adding research and development capabilities to our clinical development and clinical supply chain capabilities, we seek

to enable the rapid translation of radiotherapies.

We have formed a wholly owned research subsidiary for the purposes of advancing certain

of our R&D objectives.

Our AWE technology platform is being utilized in our ongoing research

collaboration with Astellas to arm select targeting agents owned by Astellas with the alpha-emitting radioisotope Ac-225 for the development

of theranostics for solid tumor indications, which combine the ability of radioisotopes to be used for both diagnostic and therapeutic

manufacture of targeted radiotherapies and certain of their components.

Our AWE technology patent portfolio presently includes 43 patent

families comprised of over 190 issued patents and pending patent applications, of which 10 are issued and 37 are pending in the United

States, and 144 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 2042.

Our technology enables the direct

labeling, or conjugation and labeling, of a biomolecular targeting agent to a radionuclide warhead and its development and use as a therapeutic

regimen for the treatment of diseases such as cancer.

Our AWE intellectual property covers various methods of use in multiple diseases,

including indication, dose and scheduling, radionuclide warhead, and therapeutic combinations.

We have particular 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 5 issued patents in the United States 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

Our research is focused on

applying our AWE technology platform to the development of radiation conjugates and to execute on research collaborations.

efforts employ a multidisciplinary approach leveraging our team’s knowledge and experience in cancer cell biology, radiochemistry,

radiation sciences, immunology and oncology drug development.

We intend to focus on generating targeted radiotherapies using our existing

intellectual property, evaluating assets for in-licensing to complement our existing clinical pipeline and securing collaborations and

partnerships with biopharmaceutical companies.

By adding research and development capabilities to our clinical development and clinical

supply chain capabilities, we seek to enable the rapid translation of radiotherapies.

Our AWE technology platform

is being utilized in our ongoing research collaboration with Astellas to arm select targeting agents owned by Astellas with the alpha-emitting

radioisotope Ac-225 for the development of theranostics for solid tumor indications, which combine the ability of radioisotopes to be

used for both diagnostic and therapeutic purposes.

We also utilized AWE to create

a HER2-targeting radiotherapy using the antibody Trastuzumab with either Ac-225 or Lu-177 radioisotopes to study in combination with

magrolimab for solid tumors.

Anti-CD47 monotherapies, such as magrolimab, have not shown meaningful responses in clinical studies in

solid tumors.

We hypothesized that radiation directed at HER2 expressing cells would upregulate cell surface calreticulin, a pro-phagocytic

“eat me” signal, that when combined with an anti-CD47 blockade therapy would enhance antitumor activity.

Data from this combination

was presented at the Annual Meeting of the Society for Immunotherapy for Cancer in November 2021.

In vitro studies showed that immunogenicity,

determined by binding to HER2 expressing cells, remained intact after radiolabeling Trastuzumab with Ac-225 or Lu-177.

In multiple cells

lines radiolabeled Trastuzumab increased cell surface calreticulin and the combination with magrolimab increased phagocytosis.

The combination

of the Ac-225 or Lu-117 Trastuzumab with magrolimab slowed tumor growth in animal models of solid tumors compared to either the radiolabeled

Trastuzumab or magrolimab as single agents.

We are continuing to evaluate this combination in additional tumor models, and we intend

to continue to study this combination with the goal of advancing to human clinical trials.

We are also collaborating

with AVEO Oncology (“AVEO”) to develop a targeted radiotherapy against ErbB3, also known as HER3, with the Ac-225 isotope

for solid tumor indications.

HER3 is overexpressed in several solid tumor indications with high unmet needs, including colorectal, gastric,

head and neck, breast, ovarian, melanoma, prostate and bladder cancers with HER3 agents under development demonstrating activity in preclinical

and clinical studies.

To our knowledge, this is the first HER3 targeting radiotherapy in development.

AVEO is developing high affinity

antibodies including HER3 targeting AV-203, which has demonstrated preclinical activity across a number of solid tumor indications and

was studied in a Phase 1 open-label trial in patients with advanced solid tumors where it was found to be safe and generally well tolerated.

In April 2022, we presented data at the AACR Annual Meeting showing potent tumor cell cytotoxicity, enhanced antitumor effects and significantly

improved survival with an Ac-225 radiolabeled HER3 antibody compared to a naked HER3 antibody in a preclinical NSCLC model.

these preliminary results support our collaboration with AVEO and given that AV-203 has clinical safety data, a potentially accelerated

regulatory pathway to clinical studies with an Ac-225 HER3 targeted radiotherapy.

Recent Developments

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The global health crisis

caused by the novel coronavirus COVID-19 pandemic and its resurgences has and may continue to negatively impact global economic

activity, which, despite progress in vaccination efforts, remains uncertain and cannot be predicted with confidence.

the Delta variant of COVID-19, which appears to be the most transmissible variant to date, has spread globally.

The full impact of

the Delta variant cannot be predicted at this time, and could depend on numerous factors, including vaccination rates among the

population, the effectiveness of COVID-19 vaccines against the Delta variant and the response by governmental bodies and regulators.

Given the ongoing and dynamic nature of the circumstances, it is difficult to predict the impact of the COVID-19 pandemic on our

caused by the novel coronavirus COVID-19 pandemic and its resurgences has and may continue to negatively impact global economic activity,

which, despite progress in vaccination efforts, remains uncertain and cannot be predicted with confidence.

In addition, the Omicron variants

of COVID-19, which appears to be the most transmissible variants to date, has spread globally.

The full impact of the Omicron variants,

or any subsequent variants, cannot be predicted at this time, and could depend on numerous factors, including vaccination rates among

the population, the effectiveness of COVID-19 vaccines against the Omicron variants and the response by governmental bodies and regulators.

Given the ongoing and dynamic nature of the circumstances, it is difficult to predict the impact of the COVID-19 pandemic on our business.

Many countries around the

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our ability to continue to operate our business may also be limited.

Such events may result in a period of business, supply and drug product

manufacturing disruption, and in reduced operations, any of which could materially affect our business, financial condition and results

of operations.

In response to COVID-19, we implemented remote working and thus far have not experienced a significant disruption or delay

in our operations as it relates to the clinical development of our drug candidates.

Such government-imposed precautionary measures may

have been relaxed in certain countries or states, but there is no assurance that more strict measures will be put in place again due to

a resurgence in COVID-19 cases, including those involving new variants of the coronavirus, which may be more contagious and deadly than

prior strains.

Therefore, the COVID-19 pandemic may continue to affect our operation, may further divert the attention and efforts of

the medical community to coping with COVID-19 and disrupt the marketplace in which we operate and may have a material adverse effect on

our operations.

Such events may result in a period of business, supply and drug

product manufacturing disruption, and in reduced operations, any of which could materially affect our business, financial condition and

results of operations.

In response to COVID-19, we implemented hybrid working for our office-based staff, while our research staff has

been actively working in our laboratory throughout the pandemic and thus far have not experienced a significant disruption or delay in

our operations as it relates to the clinical development, preclinical research or manufacturing of our drug candidates.

Such government-imposed

precautionary measures may have been relaxed in certain countries or states, but there is no assurance that more strict measures will

be put in place again due to a resurgence in COVID-19 cases, including those involving new variants of the coronavirus, which may be

more contagious and deadly than prior strains.

Therefore, the COVID-19 pandemic may continue to affect our operation, may further divert

the attention and efforts of the medical community to coping with COVID-19 and disrupt the marketplace in which we operate and may have

a material adverse effect on our operations.

A continuation or worsening

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COVID-19 could materially affect our business and the value of our common stock.

The Phase 3 SIERRA trial for our lead program, Iomab-B, remained active

at a majority of our clinical trial sites, with investigators providing feedback that recruitment and enrollment would remain active because

of the acute nature of the disease, the high unmet needs of patients with relapsed or refractory AML, the potentially curative nature

of BMT and the differentiated profile of Iomab-B.

Certain Phase 3 SIERRA trial sites that had not been actively enrolling due to COVID-19

at the initial outbreak of the pandemic resumed recruitment and enrollment in mid-2020, and we completed patient recruitment in September

We also believe our earlier stage CD33 clinical trials will continue to recruit and enroll patients given the acute nature of relapsed

or refractory AML.

The continuation of the pandemic could adversely affect our planned clinical trial operations, including our ability

to conduct the trials on the expected timelines and recruit and retain patients and principal investigators and site staff who, as healthcare

providers, may have heightened exposure to COVID-19 if their geography is impacted by the pandemic.

Further, the continuation and/or resurgence

of the COVID-19 pandemic could result in delays in our clinical trials due to prioritization of hospital resources toward the pandemic,

restrictions in travel, potential unwillingness of patients to enroll in trials at this time, or the inability of patients to comply with

clinical trial protocols if quarantines or travel restrictions impede patient movement or interrupt healthcare services.

we rely on independent clinical investigators, contract research organizations and other third-party service providers to assist us in

managing, monitoring and otherwise carrying out our preclinical studies and clinical trials, and the pandemic may affect their ability

to devote sufficient time and resources to our programs or to travel to sites to perform work for us.

We believe our earlier stage

CD33 clinical trials will continue to recruit and enroll patients given the acute nature of relapsed or refractory AML.

The continuation

of the pandemic could adversely affect our planned clinical trial operations, including our ability to conduct the trials on the expected

timelines and recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened

exposure to COVID-19 if their geography is impacted by the pandemic.

Further, the continuation and/or resurgence of the COVID-19 pandemic

could result in delays in our clinical trials due to prioritization of hospital resources toward the pandemic, restrictions in travel,

potential unwillingness of patients to enroll in trials at this time, or the inability of patients to comply with clinical trial protocols

if quarantines or travel restrictions impede patient movement or interrupt healthcare services.

In addition, we rely on independent clinical

investigators, contract research organizations and other third-party service providers to assist us in managing, monitoring and otherwise

carrying out our preclinical studies and clinical trials, and the pandemic may affect their ability to devote sufficient time and resources

to our programs or to travel to sites to perform work for us, which may result in delays or hinder our ability to collect data from our

clinical trials.

Additionally, COVID-19 may

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the new variants of the virus, the pace at which governmental and private travel restrictions and public concerns about public gatherings

will ease, the rate at which historically large increases in unemployment rates will decrease, if at all, and whether, and the speed with

which the economy recovers.

will ease, the rate at which historically large increases in unemployment rates will decrease, if at all, and whether, and the speed

with which the economy recovers.

We are not able to fully quantify the impact that these factors will have on our financial results during

2022 and beyond.

Results of Operations – Three Months

Ended September 30, 2021 Compared to Three Months Ended September 30, 2020

The following table sets forth,

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

September 30,

(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 three months ended September 30, 2021 and September 30, 2020.

Other revenue

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 revenue of $0.2 million from this grant

during the three months ended September 30, 2021.

Research and development expense

Research and development expenses

increased $0.9 million to $4.7 million for the three months ended September 30, 2021 compared to $3.8 million for the three months ended

September 30, 2020.

The increase was primarily due to higher expenses from our CD45 program, our research activities at our new laboratory

space and our government grant program, mostly offset by lower expenses on our CD33 program.

General and administrative expense

General and administrative

expenses of $2.0 million for the three months ended September 30, 2021 increased $0.2 million compared to $1.8 million for the three months

ended September 30, 2020, primarily attributable to higher professional fees.

Other income is comprised

of net interest income in both reporting periods.

The amount for the three months ended September 30, 2021 of $46 thousand decreased from

$73 thousand for the three months ended September 30, 2020 due to a lower average interest rate.

Net loss of $6.4 million for

the three months ended September 30, 2021 increased by $0.9 million from $5.5 million for the three months ended September 30, 2020, primarily

due to higher research and development expenses and higher general and administrative expenses, partially offset by other revenue.

Results of Operations – Nine months Ended

September 30, 2021 Compared to Nine months Ended September 30, 2020

The following table sets forth,

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

September 30,

Results of Operations

– Three Months Ended March 31, 2022 Compared to Three Months Ended March 31, 2021

The following table sets

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

Three Months Ended

(in thousands)

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We recorded no commercial

revenue for the nine months ended September 30, 2021 and September 30, 2020.

revenue for the three months ended March 31, 2022 and March 31, 2021.

Other revenue

In addition to the recognized

revenue of $0.2 million from our grant with the National Institute of Health, we determined that certain collaborations with a third-party

are within the scope of ASC 606.

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.

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.

We recognized revenue during the nine months

ended September 30, 2021 of $0.9 million from these collaborations.

While the third party has

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

services within each module for which we receive monetary consideration.

Other revenue recognized during the three months ended March

31, 2022 and March 31, 2021 was $0.8 million and $0.6 million respectively.

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 during the

three months ended March 31, 2022 of $0.1 million.

Research and development expense

Research and development expenses

increased $1.2 million to $12.6 million for the nine months ended September 30, 2021 compared to $11.4 million for the nine months ended

September 30, 2020.

The increase was primarily due to higher compensation expense resulting from the hiring of additional employees and

expenses related to our research activities at our laboratory space and government grant program, mostly offset by lower expenses on our

CD33 program.

Research and development expenses of $4.4 million for the three months

ended March 31, 2022 increased $0.1 million from $4.3 million for the three months ended March 31, 2021.

Higher expenses related to our

research activities at our laboratory space and government grant program were mostly offset by lower expenses on our CD45 program resulting

from the completion of enrollment in the SIERRA trial.

General and administrative expense

General and administrative

expenses of $5.4 million for the nine months ended September 30, 2021 increased $0.9 million compared to $4.5 million for the nine months

ended September 30, 2020, primarily attributable to higher professional fees.

expenses of $1.7 million for the three months ended March 31, 2022 were unchanged from $1.7 million for the three months ended March

Other income is comprised

of net interest income in both reporting periods.

The amount for the nine months ended September 30, 2021 of $152 thousand increased from

$123 thousand for the nine months ended September 30, 2020, as a higher average balance of cash and cash equivalents offset a lower average

interest rate.

Net loss of $16.8 million

for the nine months ended September 30, 2021 increased $1.0 million from $15.8 million in the prior-year comparison period, primarily

due to higher research and development expenses and higher general and administrative expenses being partially offset by other revenue.

The amount for the three months ended March 31, 2022 of $35 thousand decreased from

$52 thousand for the three months ended March 31, 2021 due to a lower average interest rate.

Net loss of $5.1 million for

the three months ended March 31, 2022 decreased by $0.2 million from $5.3 million for the three months ended March 31, 2021 primarily

due to the increase in other revenue recognized during the respective periods.

Liquidity and Capital Resources

We have financed our operations

primarily through sales of shares of our common stock and warrants.

The following tables sets forth selected cash flow information for

the periods indicated:

Nine months Ended

September 30,

Historically, we have financed

our operations primarily through sales of shares of our stock.

The following tables sets forth selected cash flow information for the

periods indicated:

Three Months Ended

(in thousands)

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Cash used in investing activities

Cash provided by financing activities

Cash used in /provided by financing activities

Net change in cash, cash equivalents and restricted cash

Net cash used in operating

activities for the nine months ended September 30, 2021 of $15.8 million increased by $0.4 million from $15.4 million in the prior-year

period, primarily due to the increased spending on our research activities and professional fees.

Net cash used in investing

activities for the nine months ended September 30, 2021 of $133 thousand was primarily due to the purchase of equipment for our laboratory

Net cash provided by financing

activities for the nine months ended September 30, 2021 was $34.4 million, primarily from the sale of shares of our common stock.

2020 we entered into the Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC, or JonesTrading, pursuant

to which we may sell, from time to time, through or to JonesTrading, up to an aggregate of $200 million of our common stock.

common stock are offered pursuant to our shelf registration statement on Form S-3 filed with the United States Securities and Exchange

Commission, or SEC, on August 7, 2020.

As of December 31, 2020, we had sold 2.1 million shares of common stock, resulting in gross proceeds

of $22.6 million and net proceeds of $21.7 million.

For the nine months ended September 30, 2021, we sold 4.5 million shares of common

stock, resulting in gross proceeds of $35.6 million and net proceeds of $34.5 million.

During the nine months ended

September 30, 2020, net cash provided by financing activities was $54.3 million, including sale of shares of our common stock and pre-funded

On April 24, 2020, we issued and sold 4.3 million shares of common stock and pre-funded warrants to purchase 2.8 million shares

of common stock.

The price to the public for each share of common stock sold in the offering was $4.50, and the price to the public for

each pre-funded warrant sold in the offering was $4.497.

The pre-funded warrants were exercisable at an exercise price of $0.003 per share.

Gross proceeds from this offering were $31.6 million, before deducting underwriting discounts and commissions and other offering expenses

payable by us.

Net proceeds from the offering were approximately $29.1 million.

On June 19, 2020, we issued

and sold 1.9 million shares of common stock and pre-funded warrants to purchase 0.7 million shares of common stock.

The price to the public

in this offering for each share of common stock was $9.75 and for each pre-funded warrant was $9.747.

Each pre-funded warrant had an exercise

price of $0.003 per share.

Gross proceeds from this offering to us were $25.0 million, before deducting underwriting discounts and commissions

and other offering expenses payable us.

Net proceeds from this offering were approximately $23.0 million.

Off-Balance Sheet Arrangements

We do not have any off-balance

sheet arrangements that have, or are reasonably likely to have a current or future effect on our financial condition, changes in financial

condition, revenue or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.

activities for the three months ended March 31, 2022 of $5.8 million increased by $0.2 million from $5.6 million in the prior-year period.

A lower net loss of $0.2 million was more than offset by $0.9 million in receipts for other revenue that were received in 2021 and recognized

in the three months ended March 31, 2022.

Net cash used in financing

activities for the three months ended March 31, 2022 was $22 thousand of payments of finance leases.

During the three months ended March

31, 2021, net cash provided by financing activities was $14.3 million, primarily from the sale of shares of our common stock.

In August 2020 we entered

into the Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC, or JonesTrading, pursuant to which we

may sell, from time to time, through or to JonesTrading, up to an aggregate of $200 million of our common stock.

Shares of common stock

are offered pursuant to our shelf registration statement on Form S-3 filed with the SEC on August 7, 2020.

As of December 31, 2021, we

had sold 6.7 million shares of common stock, resulting in gross proceeds of $59.1 million and net proceeds of $57.0 million.

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

For the three months ended March 31, 2021, we sold

1.7 million shares of common stock, resulting in gross proceeds of $14.8 million and net proceeds of $14.4 million.

As of the date of filing

this report, we expect that our existing resources will be more than 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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and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared

in accordance with accounting principles generally accepted in the United States, or GAAP.

The preparation of these financial statements

requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure of

contingent assets and liabilities in our consolidated financial statements during the reporting periods.

These items are monitored and

analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future.

estimates on historical experience, known trends and events, and on various other factors that we believe are reasonable under the circumstances,

the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent

from other sources.

in accordance with accounting principles generally accepted in the United States, (“GAAP”).

The preparation of these financial

statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure

of contingent assets and liabilities in our consolidated financial statements during the reporting periods.

These items are monitored

and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future.

our estimates on historical experience, known trends and events, and on various other factors that we believe are reasonable under the

circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not

readily apparent from other sources.

Changes in estimates are reflected in reported results for the period in which they become known.

Actual results may

differ materially from these estimates under different assumptions or conditions.

Actual results may differ materially from these estimates under different assumptions or conditions.

Our significant accounting

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Fair Value of Financial Instruments

Fair value is defined as the

price that would be received to sell an asset, or paid to transfer a liability, in an orderly transaction between market participants.

Fair value is defined as

the price that would be received to sell an asset, or paid to transfer a liability, in an orderly transaction between market participants.

A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted prices in active markets for

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with ASC 606.

Under ASC 606, we recognize revenue when our customer obtains control of promised goods or services, in an amount that reflects

the consideration that we expect to receive in exchange for those goods or services.

Under ASC 606, we recognize revenue when our customer obtains control of promised goods or services, in an amount that

reflects the consideration that we expect to receive in exchange for those goods or services.

To determine revenue recognition for arrangements

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We only apply

the five-step model to contracts when it is probable that we will collect the consideration to which we are entitled in exchange for the

goods or services we transfer to the customer.

the five-step model to contracts when it is probable that we will collect the consideration to which we are entitled in exchange for

the goods or services we transfer to the customer.

At contract inception, once

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Collaborative Arrangements

We follow the accounting guidance

for collaboration agreements, which requires that certain transactions between us and collaborators be recorded in our consolidated statements

of operations and comprehensive loss on either a gross basis or net basis, depending on the characteristics of the collaborative relationship,

and requires enhanced disclosure of collaborative relationships.

We evaluate our collaboration agreements for proper classification in

our consolidated statements of operations and comprehensive loss based on the nature of the underlying activity.

When we conclude that

we have a customer relationship with one of our collaborators, we follow the guidance of ASC 606 .

Research and Development Costs

We follow the accounting

guidance for collaboration agreements, which requires that certain transactions between us and collaborators be recorded in our consolidated

statements of operations and comprehensive loss on either a gross basis or net basis, depending on the characteristics of the collaborative

relationship, and requires enhanced disclosure of collaborative relationships.

We evaluate our collaboration agreements for proper classification

in our consolidated statements of operations and comprehensive loss based on the nature of the underlying activity.

When we conclude

that we have a customer relationship with one of our collaborators, we follow the guidance of ASC 606 .

Research and Development Costs

are expensed as incurred.

Research and development

costs are expensed as incurred.

These costs include the costs of manufacturing drug product, the costs of clinical trials, costs of employees

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The fair value determined represents the

cost for the award and is recognized over the vesting period during which an employee is required to provide service in exchange for the

cost for the award and is recognized over the vesting period during which an employee is required to provide service in exchange for

We account for forfeitures of stock options as they occur.

Accounting Standards Recently Adopted

In August 2020, FASB issued

ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s

Own Equity (Subtopic 815-40):

Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity , which, among other

things, provides guidance on how to account for contracts on an entity’s own equity.

This ASU simplifies the accounting for certain

financial instruments with characteristics of liabilities and equity.

Specifically, the ASU eliminated the need for us to assess whether

a contract on our own equity (1) permits settlement in unregistered shares, (2) whether counterparty rights rank higher than shareholder’s

rights, and (3) whether collateral is required.

In addition, the ASU requires incremental disclosure related to contracts on our own equity

and clarifies the treatment of certain financial instruments accounted for under this ASU on earnings per share.

This ASU may be applied

on a full retrospective of modified retrospective basis.

This ASU is effective January 1, 2022 and interim periods presented, although

early adoption of this ASU was permitted effective January 1, 2021.

We early adopted this standard effective January 1, 2021 and the standard

did not have a significant impact on our financial statements.

Accounting Standards Recently Issued

In May 2021, FASB issued ASU

2021-04, Earnings Per Share (topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation – Stock

Compensation (Topic 718) and Derivatives and Hedging – Contracts in an Entity’s Own Equity (Subtopic 815-40) – Issuer’s

Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options , which provides guidance

of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification

or exchange as (1) an adjustment to equity and, if so, the related earnings per share (EPS) effects, if any, or (2) an expense and, if

so, the manner and pattern of recognition.

In May 2021, FASB issued

ASU 2021-04, Earnings Per Share (topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation –

Stock Compensation (Topic 718) and Derivatives and Hedging – Contracts in an Entity’s Own Equity (Subtopic 815-40) –

Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options , which provides

guidance of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after

modification or exchange as (1) an adjustment to equity and, if so, the related earnings per share (EPS) effects, if any, or (2) an expense

and, if so, the manner and pattern of recognition.

The amendments in this ASU are effective January 1, 2022, including interim periods.

adoption is permitted.

We will apply the amendments prospectively to modifications or exchanges occurring on or after January 1, 2022.

We will evaluate the impact of ASU 2017-09 on any future changes to the terms and conditions of its warrants.

We adopted this standard effective January 1, 2022 and the standard did not have a material effect on our financial statements.

In November 2021, the FASB

issued ASU 2021-10, Government Assistance (Topic 832), Disclosures by Business Entities about Government Assistance , which provides

guidance on disclosure requirements to entities other than not-for-profit entities about transaction with a government that are accounted

for by applying a grant or contribution accounting model by analogy.

ASU 2021-10 requires an entity to make annual disclosures related

to (1) the nature of the transactions and the related accounting policy used to account for the government transactions, (2) quantification

and disclosure of amounts related to the government transactions included in balance sheet and income statement financial statement line

items, and (3) significant terms and conditions of the government transactions, including commitments and contingencies.

The amendments

of ASU 2021-10 are effective January 1, 2022, including interim periods.

We adopted this standard effective January 1, 20212 and the

standard did not have a material impact on our financial statements.

Accounting Standards Recently Issued

In October 2021, FASB issued

ASU 2021-08, Business Combinations (Topic 805), Account for Contract Assets and Contract Liabilities from Contracts with Customers ,

which provides guidance on accounting for contract assets and contract liabilities acquired in a business combination in accordance ASC

To achieve this, an acquirer may assess how the acquiree applied ASC 606 to determine what to record for the acquired revenue contracts.

Generally, this should result in an acquirer recognizing and measuring the acquired contract assets and contract liabilities consistent

with how they were recognized and measured in the acquiree’s financial statements.

The amendments of ASU 2021-08 are effective

January 1, 2023, including interim periods.

Early adoption is permitted, including adoption in an interim period.

We will evaluate the

impact of ASU 2021-08 on any future business combinations that we may enter in the future.

Subsequent Events

On April 7, 2022, we entered into

a license and supply agreement (the “License Agreement”) with Immedica Pharma AB (“Immedica”), pursuant to which

Immedica licensed the exclusive product rights for commercialization of Iomab-B (I-131 apamistamab) in the European Economic Area, Middle

East and North Africa (EUMENA) including Algeria, Andorra, Bahrain, Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya.

Monaco, Morocco, Oman, Palestine, Qatar, San Marino, Saudi Arabia, Switzerland, Syria, Tunisia, Turkey, the United Arab Emirates, the

United Kingdom, the Vatican City and Yemen.

Upon signing, we were entitled to an upfront payment of $35 million from Immedica, which was

received in May 2022.

Under the terms of the License Agreement, we are eligible to receive aggregate regulatory and commercial milestone

payments of up to approximately $417 million, subject to future currency exchange rates.

Additionally, we are entitled to receive royalties

in the mid-20 percent range on net sales of the product in certain countries that may result from the License Agreement.

We will continue

to be responsible for certain clinical development activities and the manufacturing of Iomab-B and will retain commercialization rights

and rest of the world.

Since March 31, 2022, we

have sold 1.6 million shares of common stock under our Capital on Demand™ Sales Agreement with JonesTrading, resulting in net proceeds

of $11.1 million.

The cumulative effect of these

subsequent events has been to increase our cash position by $46.1 million, resulting in an unaudited cash position as of May 13, 2022,

of approximately $115 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