What changed in this filing

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Item 1. Financial Statements

2020-10-23 compared with 2020-08-14 · 869 added, 859 removed, 235 unchanged (88% of the section changed)

FINANCIAL STATEMENTS

The accompanying consolidated financial statements

have been prepared by the Company and are unaudited.

In the opinion of management, all adjustments (which include only normal recurring

adjustments) necessary to present fairly the financial position at June 30, 2020 and December 31, 2019, and the results of operations

and cash flows for the three and six months ended June 30, 2020 and 2019, respectively, have been made.

Certain information and

footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted

in the United States of America have been condensed or omitted.

It is suggested that these financial statements be read in conjunction

with the financial statements and notes thereto included in the Company’s audited financial statements for the year ended

December 31, 2019 in the Company’s Annual Report on Form 10-K.

The results of operations for the three and six months ended

June 30, 2020 are not necessarily indicative of the operating results for the full year.

Actinium Pharmaceuticals, Inc.

Consolidated Balance Sheets

(amounts in thousands, except share and per

accompanying consolidated financial statements have been prepared by the Company and are unaudited.

In the opinion of management,

all adjustments (which include only normal recurring adjustments) necessary to present fairly the financial position at September

30, 2020 and December 31, 2019, and the results of operations and cash flows for the three and nine months ended September 30,

2020 and 2019, respectively, have been made.

Certain information and footnote disclosures normally included in financial statements

prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted.

It is suggested that these financial statements be read in conjunction with the financial statements and notes thereto included

in the Company’s audited financial statements for the year ended December 31, 2019 in the Company’s Annual Report

on Form 10-K.

The results of operations for the three and nine months ended September 30, 2020 are not necessarily indicative

of the operating results for the full year.

Pharmaceuticals, Inc.

Balance Sheets

in thousands, except share and per share data)

September 30,

Current Assets:

28 unchanged sentences

Total Liabilities and Stockholders’

See accompanying notes to the consolidated financial

Actinium Pharmaceuticals, Inc.

Consolidated Statements of Operations

(amounts in thousands, except share and per

accompanying notes to the consolidated financial statements.

Pharmaceuticals, Inc.

Statements of Operations

in thousands, except share and per share data)

For the Three Months Ended

For the Six Months Ended

September 30,

For the Nine Months Ended

September 30,

Operating expenses:

12 unchanged sentences

basic and diluted

See accompanying notes to the consolidated financial

Actinium Pharmaceuticals, Inc.

Consolidated Statement of Changes in Stockholders’

For the Three and Six Months Ended June 30,

(amounts in thousands, except share amounts)

accompanying notes to the consolidated financial statements.

Pharmaceuticals, Inc.

Statement of Changes in Stockholders’

the Three and Nine Months Ended September 30, 2020

in thousands, except share amounts)

Additional Paid-In

9 unchanged sentences

Balance, June 30, 2020

See accompanying notes to the consolidated financial

Actinium Pharmaceuticals, Inc.

Consolidated Statement of Changes in Stockholders’

For the Three and Six Months Ended June 30,

(amounts in thousands, except share amounts)

Stock-based compensation

Issuance of common stock from exercise of warrants and stock options

Issuance of common stock from exercise of pre-funded warrants

Costs related to prospectus filed on Form S-3

Balance, September 30, 2020

accompanying notes to the consolidated financial statements.

Pharmaceuticals, Inc.

Statement of Changes in Stockholders’

the Three and Nine Months Ended September 30, 2019

in thousands, except share amounts)

Additional Paid-In

10 unchanged sentences

Balance, June 30, 2019

See accompanying notes to the consolidated financial

Actinium Pharmaceuticals, Inc.

Consolidated Statements of Cash Flows

(amounts in thousands)

For the Six Months Ended

Stock-based compensation

Sale of common stock and warrants, net of offering costs

Balance, September 30, 2019

accompanying notes to the consolidated financial statements.

Pharmaceuticals, Inc.

Statements of Cash Flows

in thousands)

For the Nine Months

September 30,

Cash Flows From Operating Activities:

16 unchanged sentences

Proceeds from exercise of pre-funded warrants

Proceeds from exercise of warrants

Proceeds from exercise of warrants and stock options

Net Cash Provided By Financing Activities

3 unchanged sentences

Supplemental disclosure of cash flow information:

Cash paid for interest on note payable

Cash paid for taxes

Cash paid for interest

Cash paid for income taxes

Supplemental disclosure of non-cash flow information:

Deemed dividend for warrant down-round protection provision

See accompanying notes to the consolidated financial

Actinium Pharmaceuticals, Inc.

Notes to Consolidated Financial Statements

Note 1 - Description of Business and Summary

of Significant Accounting Policies

Nature of Business -

Actinium Pharmaceuticals, Inc.

(the “Company”, “Actinium”, or “We”) is a clinical-stage, biopharmaceutical

company applying its proprietary platform technology and deep understanding of radioimmunobiology to the development of novel targeted

therapies known as ARCs or Antibody Radiation-Conjugates.

Basis of Presentation

- Unaudited Interim Financial Information - The accompanying unaudited interim consolidated financial statements and related

notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S.

GAAP”) for interim financial information, and in accordance with the rules and regulations of the United States Securities

and Exchange Commission (the “SEC”) with respect to Form 10-Q and Article 10 of Regulation S-X.

Accordingly, they do

not include all of the information and footnotes required by U.S.

accompanying notes to the consolidated financial statements.

Pharmaceuticals, Inc.

to Consolidated Financial Statements

1 - Description of Business and Summary of Significant Accounting Policies

of Business - Actinium Pharmaceuticals, Inc.

(the “Company”, “Actinium”, or “We”) 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 ARCs, or Antibody Radiation-Conjugates.

of Presentation - Unaudited Interim Financial Information - The accompanying unaudited interim consolidated financial statements

and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America

GAAP”) for interim financial information, and in accordance with the rules and regulations of the United States

Securities and Exchange Commission (the “SEC”) with respect to Form 10-Q and Article 10 of Regulation S-X.

they do not include all of the information and footnotes required by U.S.

GAAP for complete financial statements.

The unaudited interim

consolidated financial statements furnished reflect all adjustments (consisting of normal recurring adjustments) which are, in

the opinion of management, necessary for a fair statement of the results for the interim periods presented.

Interim results are

not necessarily indicative of the results for the full year.

These unaudited interim consolidated financial statements should be

read in conjunction with the audited consolidated financial statements and notes thereto contained in the Company’s annual

The unaudited

interim consolidated financial statements furnished reflect all adjustments (consisting of normal recurring adjustments) which

are, in the opinion of management, necessary for a fair statement of the results for the interim periods presented.

Interim results

are not necessarily indicative of the results for the full year.

These unaudited interim consolidated financial statements should

be read in conjunction with the audited consolidated financial statements and notes thereto contained in the Company’s annual

report on Form 10-K for the year ended December 31, 2019.

Reverse Stock Split

- On April 29, 2020, the Company received a deficiency letter from the NYSE American LLC, or NYSE American, indicating that

the Company was not in compliance with the NYSE American continued listing standard set forth in Section 1003(f)(v) of the NYSE

American Company Guide because its shares of common stock had been selling for a substantial period of time at a low price per

Stock Split - On April 29, 2020, the Company received a deficiency letter from the NYSE American LLC, or NYSE American, indicating

that the Company was not in compliance with the NYSE American continued listing standard set forth in Section 1003(f)(v) of the

NYSE American Company Guide because its shares of common stock had been selling for a substantial period of time at a low price

Pursuant to Section 1003(f)(v) of the NYSE American Company Guide, the NYSE American staff determined that the Company’s

continued listing is predicated on the Company effecting a reverse stock split of its common stock or otherwise demonstrating sustained

price improvement within a reasonable period of time, which the staff determined to be no later than October 29, 2020.

On October 18, 2019, the

Company’s board of directors, or the Board, unanimously approved, subject to stockholder approval, an amendment to the Company’s

certificate of incorporation to effect a reverse stock split of its outstanding common stock by combining outstanding shares of

common stock into a lesser number of outstanding shares of common stock by a ratio of not more than 1-for-75 prior to December

18, 2020, with the exact ratio to be set within this range by the Board at its sole discretion.

At its Annual Meeting of Stockholders

held on December 18, 2019, the Company’s stockholders approved such amendment to its certificate of incorporation.

On August 7, 2020, the Board unanimously approved a reverse

stock split of its outstanding common stock by combining outstanding shares of common stock into a lesser number of outstanding

shares of common stock by a ratio of 1-for-30, and on August 10, 2020, the Company filed with the Secretary of State of Delaware

a certificate of amendment to its certificate of incorporation to effect the reverse stock split.

The reverse stock split became

effective as of 5:00 p.m.

Eastern Time on August 10, 2020, and the Company’s common stock began trading on a split-adjusted

basis when the market opened on August 11, 2020.

Accordingly, all common share and per common share data in these consolidated

financial statements and related notes hereto have been retroactively adjusted to account for the effect of this reverse stock

split for all periods presented.

In addition, at the effective time of the reverse stock split, the number of shares of our common

stock reserved for issuance upon exercise of all options and warrants to acquire common stock have been proportionally decreased,

and the exercise price of all options and warrants to acquire common stock have been proportionally increased.

Principles of Consolidation

- The consolidated financial statements include the Company’s accounts and those of the Company’s wholly owned

Use of Estimates in

Financial Statement Presentation - The preparation of these consolidated financial statements in conformity with U.S.

requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of

the consolidated financial statements and the reported amounts of expenses during the reporting period.

Actual results could differ

from those estimates.

Impact of COVID–19

Pandemic on Financial Statements

In December 2019, a novel

strain of COVID-19 was reported in China.

continued listing is predicated on the Company effecting a reverse stock split of its common stock or otherwise demonstrating

sustained price improvement within a reasonable period of time, which the staff determined to be no later than October 29, 2020.

October 18, 2019, the Company’s board of directors, or the Board, unanimously approved, subject to stockholder approval,

an amendment to the Company’s certificate of incorporation to effect a reverse stock split of its outstanding common stock

by combining outstanding shares of common stock into a lesser number of outstanding shares of common stock by a ratio of not more

than 1-for-75 prior to December 18, 2020, with the exact ratio to be set within this range by the Board at its sole discretion.

At its Annual Meeting of Stockholders held on December 18, 2019, the Company’s stockholders approved such amendment to its

certificate of incorporation.

August 7, 2020, the Board unanimously approved a reverse stock split of its outstanding common stock by combining outstanding

shares of common stock into a lesser number of outstanding shares of common stock by a ratio of 1-for-30, and on August 10, 2020,

the Company filed with the Secretary of State of Delaware a certificate of amendment to its certificate of incorporation to effect

the reverse stock split.

The reverse stock split became effective as of 5:00 p.m.

Eastern Time on August 10, 2020, and the Company’s

common stock began trading on a split-adjusted basis when the market opened on August 11, 2020.

Accordingly, all common share

and per common share data in these consolidated financial statements and related notes hereto have been retroactively adjusted

to account for the effect of this reverse stock split for all periods presented.

In addition, at the effective time of the reverse

stock split, the number of shares of our common stock reserved for issuance upon exercise of all options and warrants to acquire

common stock have been proportionally decreased, and the exercise price of all options and warrants to acquire common stock have

been proportionally increased.

of Consolidation - The consolidated financial statements include the Company’s accounts and those of the Company’s

wholly owned subsidiary.

of Estimates in Financial Statement Presentation - The preparation of these consolidated financial statements in conformity

GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities

at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period.

results could differ from those estimates.

of COVID–19 Pandemic on Financial Statements - In

December 2019, a novel strain of COVID-19 was reported in China.

Since then, COVID-19 has spread globally.

The spread of COVID-19 from China to other

countries has resulted in the World Health Organization (“WHO”) declaring the outbreak of COVID-19 as a “pandemic,”

or a worldwide spread of a new disease, on March 11, 2020.

Many countries around the world have imposed quarantines and restrictions

on travel and mass gatherings to slow the spread of the virus and have closed non-essential businesses, and many local jurisdictions

continue to have such restrictions in place.

As local jurisdictions

continue to put restrictions in place, the Company’s ability to continue to operate its business may also be limited.

events may result in a period of business, supply and drug product manufacturing disruption, and in reduced operations, any of

which could materially affect the Company’s business, financial condition and results of operations.

In response to COVID-19,

the Company implemented remote working and thus far, has not experienced a significant disruption or delay in its operations as

it relates to the clinical development or drug production of our drug candidates.

The spread of COVID-19

which has caused a broad impact globally, may materially affect the Company economically.

While the ultimate economic impact brought

by, and the duration of, the COVID-19 pandemic may be difficult to assess or predict, including new information which may emerge

concerning the severity of COVID-19 and the actions to contain COVID-19 or treat its impact, among others, the pandemic has resulted

significant disruptions in the general commercial activity and the global economy and caused financial market volatility and uncertainty

in significant and unforeseen ways in the recent months.

A continuation or worsening of the levels of market disruption and volatility

seen in the recent past could have an adverse effect on the Company’s ability to access capital, which could in the future

negatively affect the Company’s liquidity.

In addition, a recession or market correction resulting from the spread of COVID-19

could materially affect the Company’s business and the value of the Company’s common stock.

Additionally, COVID-19

may result in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions

with IRB’s or Institutional Review Boards, local and foreign regulators, ethics committees and other important agencies and

contractors due to limitations in employee resources or forced furlough of government employees.

To date, COVID-19 has not

had a financial impact on the Company.

However, COVID-19 has caused severe disruptions in transportation and limited access to

the Company’s facility, resulting in limited support from its staff and professional advisors.

Cash, Cash Equivalents

and Restricted Cash - The Company considers all highly liquid accounts with original maturities of three months or less to

be cash equivalents.

Balances held by the Company are typically in excess of Federal Deposit Insurance Corporation insured limits.

The following is a summary

of cash, cash equivalents and restricted cash at June 30, 2020 and December 31, 2019:

from China to other countries has resulted in the World Health Organization (“WHO”) declaring the outbreak of COVID-19

as a “pandemic,”

or a worldwide spread of a new disease, on March 11, 2020.

Many countries around the world have imposed

quarantines and restrictions on travel and mass gatherings to slow the spread of the virus and have closed non-essential businesses,

and many local jurisdictions continue to have such restrictions in place.

local jurisdictions continue to put restrictions in place, the Company’s ability to continue to operate its 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 the Company’s business, financial condition and results of operations.

In response to COVID-19, the Company implemented remote working and thus far, has not experienced a significant disruption or

delay in its operations as it relates to the clinical development or drug production of our drug candidates.

spread of COVID-19, which has caused a broad impact globally, may materially affect the Company economically.

ultimate economic impact brought by, and the duration of, the COVID-19 pandemic may be difficult to assess or predict,

including new information which may emerge concerning the severity of COVID-19 and the actions to contain COVID-19 or treat

its impact, among others, the pandemic has resulted in significant disruptions in the general commercial activity and the

global economy and caused financial market volatility and uncertainty in significant and unforeseen ways in the recent

A continuation or worsening of the levels of market disruption and volatility seen in the recent past could have an

adverse effect on the Company’s ability to access capital, which could in the future negatively affect the

Company’s liquidity.

In addition, a recession or market correction resulting from the spread of COVID-19 could

materially affect the Company’s business and the value of the Company’s common stock.

Additionally,

COVID-19 may result in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions

with IRB’s or Institutional Review Boards, local and foreign regulators, ethics committees and other important agencies

and contractors due to limitations in employee resources or forced furlough of government employees.

date, COVID-19 has not had a financial impact on the Company.

However, COVID-19 has caused severe disruptions in transportation

and limited access to the Company’s facility, resulting in limited support from its staff and professional advisors.

Cash Equivalents and Restricted Cash - The Company considers all highly liquid accounts with original maturities of three

months or less to be cash equivalents.

Balances held by the Company are typically in excess of Federal Deposit Insurance Corporation

insured limits.

following is a summary of cash, cash equivalents and restricted cash at September 30, 2020 and December 31, 2019:

(in thousands)

September 30,

Cash and cash equivalents

2 unchanged sentences

Cash, cash equivalents and restricted cash

Current restricted cash

relates to credit card accounts, while long-term restricted cash relates to a certificate of deposit held as collateral for a letter

of credit issued in connection with the Company’s lease for corporate office space.

Leases –

Company has operating and finance leases for corporate office space, office equipment and furniture located at the corporate office

restricted cash relates to credit card accounts, while long-term restricted cash relates to a certificate of deposit held as collateral

for a letter of credit issued in connection with the Company’s lease for corporate office space.

The Company has operating and finance leases for corporate office space, office equipment and furniture located at

the corporate office space.

Leases with an initial term of 12 months or less are not recorded on the balance sheet;

lease expense for these leases is

recognized on a straight-line basis over the lease term.

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.

A fair value hierarchy has been established for valuation inputs that gives

the highest priority to quoted prices in active markets for identical assets or liabilities and the lowest priority to unobservable

Research and Development

Costs - 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 and associated overhead, and depreciation and amortization costs related to facilities

and equipment.

Research and development reimbursements are recorded by the Company as a reduction of research and development costs.

Share-Based Payments

- The Company estimates the fair value of each stock option award at the grant date by using the Black-Scholes option pricing

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 award.

The Company accounts for forfeitures of stock options as they occur.

Net Loss Per Common

Share - Basic loss per common share is computed by dividing the net loss available to common stockholders by the weighted

average number of common shares outstanding during the reporting period.

For periods of net income, and when the effects are not

anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted-average

number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common shares underlying

common stock options and warrants using the treasury stock method.

The Company issued pre-funded warrants in April 2020 and June

2020 that are considered outstanding shares for the purposes of calculating net loss per common share, see Note 4 for additional

Since the shares underlying the outstanding 2.3 million pre-funded warrants are issuable for negligible consideration

and are fully vested and exercisable, they are considered outstanding for the calculations of both basic and diluted loss per

For periods of net loss,

diluted loss per share is calculated similarly to basic loss per share because the impact of all potential dilutive common shares

is anti-dilutive.

For the six months ended June 30, 2020 and 2019, the Company’s potentially dilutive shares, which include

outstanding common stock options and warrants have not been included in the computation of diluted net loss per share as the result

would have been anti-dilutive.

lease expense

for these leases is recognized on a straight-line basis over the lease term.

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.

A fair value hierarchy has been established for valuation

inputs that gives the highest priority to quoted prices in active markets for identical assets or liabilities and the lowest priority

to unobservable inputs.

and Development Costs - 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 and associated overhead, and depreciation and amortization costs

related to facilities and equipment.

Research and development reimbursements are recorded by the Company as a reduction of research

and development costs.

Payments - The Company estimates the fair value of each stock option award at the grant date by using the Black-Scholes option

pricing model.

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 award.

The Company accounts for forfeitures of stock options as

Loss Per Common Share - Basic loss per common share is computed by dividing the net loss available to common stockholders

by the weighted average number of common shares outstanding during the reporting period.

For periods of net income, and when the

effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders

by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily

of common shares underlying common stock options and warrants using the treasury stock method.

The Company issued pre-funded warrants

in April 2020 and June 2020 that are considered outstanding shares for the purposes of calculating net loss per common share,

see Note 4 for additional information.

Since the shares underlying the outstanding 1.8 million pre-funded warrants are issuable

for negligible consideration and are fully vested and exercisable, they are considered outstanding for the calculations of both

basic and diluted loss per share.

periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all potential

dilutive common shares is anti-dilutive.

For the nine months ended September 30, 2020 and 2019, the Company’s potentially

dilutive shares, which include outstanding common stock options and warrants have not been included in the computation of diluted

net loss per share as the result would have been anti-dilutive.

(in thousands)

Accounting Standards

Recently Adopted

In August 2018, FASB issued

ASU 2018-13, Fair Value Measurement - Disclosure Framework (Topic 820).

The updated guidance improves the disclosure requirements

on fair value measurements, primarily associated with Level 3 fair value measurements and is effective for fiscal years, and interim

periods within those fiscal years, beginning after December 15, 2019.

Early adoption is permitted upon issuance of the standard

for disclosures modified or removed with a delay of adoption of the additional disclosures until their effective date.

adopted this standard effective January 1, 2020 and the standard did not have a significant impact to the Company’s financial

In November 2018, FASB

issued ASU 2018-18, C ollaborative Arrangements (Topic 808):

Clarifying the Interaction Between Topic 808 and Topic 606, which,

among other things, provides guidance on how to assess whether certain collaborative arrangement transactions should be accounted

for under Topic 606.

The amendments in this ASU are effective for fiscal years, and interim periods within those fiscal years,

beginning after December 15, 2019, with early adoption permitted.

The Company adopted this standard effective January 1, 2020

and the standard did not have a significant impact to the Company’s financial statements.

Note 2 - Commitments and Contingencies

The Company has entered

into agreements with third parties for the rights to certain intellectual property, manufacturing and clinical trial services under

which the Company may incur obligations to make payments including upfront payments as well as milestone and royalty payments.

September 30,

Standards Recently Adopted

August 2018, FASB issued ASU 2018-13, Fair Value Measurement - Disclosure Framework (Topic 820).

The updated guidance improves

the disclosure requirements on fair value measurements, primarily associated with Level 3 fair value measurements and is effective

for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019.

Early adoption is permitted

upon issuance of the standard for disclosures modified or removed with a delay of adoption of the additional disclosures until

their effective date.

The Company adopted this standard effective January 1, 2020 and the standard did not have a significant

impact to the Company’s financial statements.

November 2018, FASB issued ASU 2018-18, C ollaborative Arrangements (Topic 808):

Clarifying the Interaction Between Topic 808

and Topic 606, which, among other things, provides guidance on how to assess whether certain collaborative arrangement transactions

should be accounted for under Topic 606.

The amendments in this ASU are effective for fiscal years, and interim periods within

those fiscal years, beginning after December 15, 2019, with early adoption permitted.

The Company adopted this standard effective

January 1, 2020 and the standard did not have a significant impact to the Company’s financial statements.

Standards Recently Issued

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

This ASU simplifies the accounting for certain financial instruments with characteristics of liabilities and equity.

Specifically, the ASU eliminated the need for the Company to assess whether a contract on the entity’s own equity (1) permits

settlement in unregistered shares, (2) whether counterparty rights rank higher shareholder’s rights, and (3) whether collateral

In addition, the ASU requires incremental disclosure related to contracts on the entity’s 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.

adoption of the ASU is permitted by the Company effective January 1, 2021.

The Company is in the process of assessing the adoption

of the ASU on the Company’s financial statements.

2 - Commitments and Contingencies

Company has entered into agreements with third parties for the rights to certain intellectual property, manufacturing and clinical

trial services under which the Company may incur obligations to make payments including upfront payments as well as milestone

and royalty payments.

Notable inclusions in this category are:

Oak Ridge National Laboratory (“ORNL”) –

The Company is contracted to purchase radioactive material to be used for research and development, with a renewal option at the contract end.

During the six months ended June 30, 2020 and 2019, the Company purchased material from ORNL of $0.1 million in each period.

In November 2019, the Company signed a contract with ORNL to purchase $0.3 million of radioactive material during calendar year 2020.

On June 15, 2012, the Company entered into a license and sponsored research agreement with Fred Hutchinson Cancer Research Center (“FHCRC”) to build upon previous and ongoing clinical trials with BC8 (licensed antibody).

FHCRC has completed both a Phase 1 and Phase 2 clinical trial with BC8.

The Company has been granted exclusive rights to the BC8 antibody and related master cell bank developed by FHCRC.

A milestone payment of $1 million will be due to FHCRC upon FDA approval of the first drug utilizing the licensed BC 8 antibody.

Upon commercial sale of the drug, royalty payments of 2% of net sales will be due to FHCRC.

Collaborative Agreement

In March 2018, the

Company entered into a research and option agreement with Astellas Pharma Inc.

(“Astellas”) to develop ARCs using the

Company’s AWE Technology Platform.

Under this collaboration, the Company will utilize its AWE Platform to conjugate and label

selected Astellas targeting agents with an Actinium-225 payload.

The Company is also responsible for conducting preclinical validation

studies on any ARCs generated.

Payments from Astellas under this agreement are accounted for as a reduction to research and development

Note 3 - Leases

The Company adopted ASC

842 as of January 1, 2019, using a modified retrospective approach and applying the standard’s transition provisions at January

1, 2019, the effective date.

The Company made an accounting policy election to exclude from balance sheet reporting those leases

with initial terms of 12 months or less.

The Company determines

if an arrangement is a lease at inception.

This determination generally depends on whether the arrangement conveys to the Company

the right to control the use of a fixed asset for a period of time in exchange for consideration.

Control of an underlying asset

is conveyed to the Company if the Company obtains the rights to direct the use of and to obtain substantially all of the economic

benefits from using the underlying asset.

The Company has lease agreements which include lease and non-lease components, which

the Company has elected to account for as a single lease component for all classes of underlying assets.

Lease expense for variable

lease components are recognized when the obligation is probable.

Right-of-use assets and

liabilities are recognized at commencement date based on the present value of lease payments over the lease term.

ASC 842 requires

a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily

determined, its incremental borrowing rate.

As an implicit interest rate is not readily determinable in the Company’s leases,

the incremental borrowing rate is used based on the information available at commencement date in determining the present value

of lease payments.

The lease term for all

of the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered by either a

Company option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option to extend

(or not to terminate) the lease controlled by the lessor.

Options for lease renewals have been excluded from the lease term (and

lease liability) for the majority of the Company’s leases as the reasonably certain threshold is not met.

At June 30, 2020, the Company

has an operating lease for corporate office space and two finance leases for office equipment and furniture located in the corporate

office space.

In addition, the Company has auxiliary corporate office space that it rents on a month-to-month basis;

is accounted for as an operating lease with the same term as the Company’s main office in the same building.

The components of lease expense are as follows:

Ridge National Laboratory (“ORNL”) –

The Company is contracted to purchase radioactive material to be used

for research and development, with a renewal option at the contract end.

During the nine months ended September 30, 2020 and

2019, the Company purchased material from ORNL of $0.2 million and $0.2 million, respectively.

In November 2019, the Company

signed a contract with ORNL to purchase $0.3 million of radioactive material during calendar year 2020.

June 15, 2012, the Company entered into a license and sponsored research agreement with Fred Hutchinson Cancer Research Center

(“FHCRC”) to build upon previous and ongoing clinical trials with BC8 (licensed antibody).

FHCRC has completed

both a Phase 1 and Phase 2 clinical trial with BC8.

The Company has been granted exclusive rights to the BC8 antibody and

related master cell bank developed by FHCRC.

A milestone payment of $1 million will be due to FHCRC upon FDA approval of the

first drug utilizing the licensed BC 8 antibody.

Upon commercial sale of the drug, royalty payments of 2% of net sales will

be due to FHCRC.

Collaborative

March 2018, the Company entered into a research and option agreement with Astellas Pharma Inc.

(“Astellas”) to develop

ARCs using the Company’s AWE Technology Platform.

Under this collaboration, the Company will utilize its AWE Platform to

conjugate and label selected Astellas targeting agents with an Actinium-225 payload.

The Company is also responsible for conducting

preclinical validation studies on any ARCs generated.

Payments from Astellas under this agreement are accounted for as a reduction

to research and development expense.

Company adopted ASC 842 as of January 1, 2019, using a modified retrospective approach and applying the standard’s transition

provisions at January 1, 2019, the effective date.

The Company made an accounting policy election to exclude from balance sheet

reporting those leases with initial terms of 12 months or less.

Company determines if an arrangement is a lease at inception.

This determination generally depends on whether the arrangement

conveys to the Company the right to control the use of a fixed asset for a period of time in exchange for consideration.

of an underlying asset is conveyed to the Company if the Company obtains the rights to direct the use of and to obtain substantially

all of the economic benefits from using the underlying asset.

The Company has lease agreements which include lease and non-lease

components, which the Company has elected to account for as a single lease component for all classes of underlying assets.

expense for variable lease components are recognized when the obligation is probable.

assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term.

842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot

be readily determined, its incremental borrowing rate.

As an implicit interest rate is not readily determinable in the Company’s

leases, the incremental borrowing rate is used based on the information available at commencement date in determining the present

value of lease payments.

lease term for all of the Company’s leases includes the non-cancellable period of the lease plus any additional periods

covered by either a Company option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise,

or an option to extend (or not to terminate) the lease controlled by the lessor.

Options for lease renewals have been excluded

from the lease term (and lease liability) for the majority of the Company’s leases as the reasonably certain threshold is

September 30, 2020, the Company has an operating lease for corporate office space and two finance leases for office equipment

and furniture located in the corporate office space.

In addition, the Company has auxiliary corporate office space that it rents

on a month-to-month basis;

this rental is accounted for as an operating lease with the same term as the Company’s main office

in the same building.

components of lease expense are as follows:

Three months ended

Six months ended

Nine months ended

(in thousands)

September 30,

Operating lease expense

3 unchanged sentences

Total finance lease cost

Supplemental cash flow information related to

leases are as follows:

cash flow information related to leases are as follows:

Cash flow information:

Six months ended

Nine months ended

(in thousands)

September 30,

Cash paid for amounts included in the measurement of lease liabilities:

6 unchanged sentences

Finance Leases

Weighted average remaining lease terms are as

follows at June 30, 2020:

average remaining lease terms are as follows at September 30, 2020:

Weighted average remaining lease term:

1 unchanged sentence

Finance Leases

As the Company’s

leases do not provide an implicit rate, the Company used its incremental borrowing rate based on the information available at adoption

date in determining the present value of lease payments.

Below is information on the weighted average discount rates used:

Weighted average discount rates:

Operating leases

Finance Leases

Maturities of lease liabilities

are as follows:

the Company’s leases do not provide an implicit rate, the Company used its incremental borrowing rate based on the information

available at adoption date in determining the present value of lease payments.

Below is information on the weighted average discount

average discount rates:

of lease liabilities are as follows:

(in thousands)

Year ending December 31,

2020 (excluding six months

ended June 30, 2020)

2020 (excluding nine months ended September 30, 2020)

Total lease payments

1 unchanged sentence

Present value of lease liabilities

Note 4 - Equity

On August 7, 2020,

the Board unanimously approved a reverse stock split of its outstanding common stock by combining outstanding shares of common

stock into a lesser number of outstanding shares of common stock by a ratio of 1-for-30, and on August 10, 2020, the Company filed

with the Secretary of State of Delaware a certificate of amendment to its certificate of incorporation to effect the reverse stock

Accordingly, all common share and per common share data in these consolidated financial statements and related notes hereto

have been retroactively adjusted to account for the effect of this reverse stock split for all periods presented.

On April 24, 2020,

the Company issued and sold 4.3 million shares of common stock and 2.8 million pre-funded warrants to purchase shares of common

The price to the public in this offering for each share of common stock was $4.50 and for each pre-funded warrant was $4.497.

In August 2020, the Company entered into the Capital on Demand™

Sales Agreement with JonesTrading Institutional Services LLC (“JonesTrading”), pursuant to which the Company may sell,

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

Shares of common stock are

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

As of September

30, 2020, $200 million of common stock remained available for issuance under the program.

August 7, 2020, the Board unanimously approved a reverse stock split of its outstanding common stock by combining outstanding

shares of common stock into a lesser number of outstanding shares of common stock by a ratio of 1-for-30, and on August 10, 2020,

the Company filed with the Secretary of State of Delaware a certificate of amendment to its certificate of incorporation to effect

the reverse stock split.

Accordingly, all common share and per common share data in these consolidated financial statements and

related notes hereto have been retroactively adjusted to account for the effect of this reverse stock split for all periods presented.

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

shares of common stock.

The price to the public in this offering for each share of common stock was $4.50 and for each pre-funded

warrant was $4.497.

Each pre-funded warrant has an exercise price of $0.003 per share and is exercisable immediately upon issuance.

The pre-funded

warrants are subject to certain limitations on beneficial ownership.

Gross proceeds from this offering to Actinium were $31.6 million,

before deducting underwriting discounts and commissions and other offering expenses payable by the Company.

Net proceeds from this

offering were $29.1 million.

In June 2020, holders

of 1.2 million pre-funded April 2020 warrants exercised their warrants at $0.003 per share and received 1.2 million shares of common

On June 19, 2020, the

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

pre-funded warrant has an exercise price of $0.003 per share and is exercisable immediately upon issuance.

The pre-funded warrants

are subject to certain limitations on beneficial ownership.

Gross proceeds from this offering to Actinium were $25.0 million, before

deducting underwriting discounts and commissions and other offering expenses payable by the Company.

Net proceeds from this offering

were $23.0 million.

In December 2018, the

Company entered into the Amended and Restated At Market Issuance Sales Agreement with B.

The pre-funded warrants are subject to certain limitations on beneficial ownership.

Gross proceeds from this offering to Actinium

were $31.6 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company.

Net proceeds from this offering were $29.1 million.

the nine months ended September 30, 2020, holders of 1.4 million pre-funded April 2020 warrants exercised their warrants at $0.003

per share and received 1.4 million shares of common stock.

June 19, 2020, the Company issued and sold 1.9 million shares of common stock and 0.7 million pre-funded warrants to purchase

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 has an exercise price of $0.003 per share and is exercisable immediately upon issuance.

The pre-funded warrants are subject to certain limitations on beneficial ownership.

Gross proceeds from this offering to Actinium

were $25.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company.

Net proceeds from this offering were $23.0 million.

During the nine months

ended September 30, 2020, holders of 0.2 million pre-funded June 2020 warrants exercised their warrants at $0.003 per share and

received 0.2 million shares of common stock and holders of April 2019 warrants exercised their warrants at $15.00 per share and

received 2 thousand shares of common stock.

In December 2018, the Company entered into the Amended and Restated

At Market Issuance Sales Agreement with B.

Riley FBR, Inc.

and JonesTrading Institutional

Services LLC, pursuant to which the Company conducted its at-the market program.

During the six months ended June 30, 2020, the

Company sold 0.3 million common shares through its at-the-market program, resulting in net proceeds of $2.5 million.

In October 2018, the

Company and Lincoln Park Capital Fund, LLC (“Lincoln Park”) entered into a purchase agreement and a registration rights

agreement, pursuant to which the Company has the right to sell to Lincoln Park shares of the Company’s common stock having

an aggregate value of up to $32.5 million, subject to certain limitations and conditions set forth in the agreement.

six months ended June 30, 2020, the Company elected to sell to Lincoln Park 27 thousand shares and received $0.2 million.

In June 2020, the Company

issued 5 thousand shares of restricted common stock, valued at $30 thousand, for consulting services.

For the six months

ended June 30, 2019, holders of March 2018 series A warrants exercised 83 thousand shares, resulting in the Company receiving $1.5

and JonesTrading, pursuant to which the Company conducted its at-the

market program.

During the nine months ended September 30, 2020, the Company sold 0.3 million shares of common stock through its

at-the-market program, resulting in net proceeds of $2.5 million.

October 2018, the Company and Lincoln Park Capital Fund, LLC (“Lincoln Park”) entered into a purchase agreement and

a registration rights agreement, pursuant to which the Company has the right to sell to Lincoln Park shares of the Company’s

common stock having an aggregate value of up to $32.5 million, subject to certain limitations and conditions set forth in the

During the nine months ended September 30, 2020, the Company elected to sell to Lincoln Park 27 thousand shares and

received $0.2 million.

June 2020, the Company issued 5 thousand shares of restricted common stock, valued at $30 thousand, for consulting services.

the nine months ended September 30, 2019, holders of March 2018 series A warrants exercised 83 thousand shares, resulting in the

Company receiving $1.5 million.

The remaining March 2018 series A warrants expired in March 2019.

The Company has outstanding

warrants to purchase 1,907 shares of common stock that include down-round protection.

For warrants with down-round protection,

a deemed dividend is recorded for the change in fair value of the warrants when the down-round provision is triggered.

of the April 2019 offering, the exercise price of the warrant was reset from $37.50 per share to $26.40 per share.

of the April 2020 offering and June 2020 offering, the exercise price of the warrant was reset from $26.40 per share to $15.60

The down-round protection provision in the above warrants created a deemed dividend to common stockholders of $1 thousand

in the six months ended June 30, 2020 and 2019, which are reflected in the accompanying consolidated statement of operations and

consolidated statement of changes in stockholders’

Stock Options

The following is a summary

of stock option activity for the six months ended June 30, 2020:

The Company has an outstanding warrant to purchase 1,907 shares

of common stock, issued on March 14, 2017 to Sandesh Seth, the Company’s Chairman and Chief Executive Officer.

included down-round protection up until it was amended on August 11, 2020.

For warrants with down-round protection, a deemed dividend

is recorded for the change in fair value of the warrants when the down-round provision is triggered.

As a result of the April 2019

offering, the exercise price of the warrant was reset from $37.50 per share to $26.40 per share.

As a result of the April 2020

offering and June 2020 offering, the exercise price of the warrant was reset from $26.40 per share to $15.61515 per share.

down-round protection provision in the above warrants created a deemed dividend to common stockholders of $1 thousand in the nine

months ended September 30, 2020 and 2019, which are reflected in the accompanying consolidated statement of operations and consolidated

statement of changes in stockholders’

On August 11, 2020, the Company and Mr.

Seth agreed to amend the warrant to

remove the anti-dilution provision that had been in the warrant.

Accordingly, pursuant to the amendment, as of August 11, 2020,

the exercise price of the warrant will no longer be subject to a proportional adjustment if and when the Company issues any shares

of its common stock for a consideration less than the exercise price of the warrant.

All other terms of the warrant remained the

following is a summary of stock option activity for the nine months ended September 30, 2020:

(in thousands, except for per-share amounts)

1 unchanged sentence

Outstanding, December 31, 2019

Outstanding, June 30, 2020

Exercisable, June 30, 2020

During the six months

ended June 30, 2020, options to purchase 15 thousand shares were cancelled upon the termination of employment for several employees.

The fair values of all

options issued and outstanding are being amortized over their respective vesting periods.

The unrecognized compensation expense

at June 30, 2020 was $1.5 million related to unvested options, which is expected to be expensed over a weighted average of 2.8

During the six months ended June 30, 2020 and 2019, the Company recorded compensation expense related to stock options of

$0.5 million and $0.3 million, respectively.

Pre-funded Warrants

As part of the April

2020 offering and the June 2020 offering, the Company issued pre-funded warrants.

Each pre-funded warrant has an exercise price

of $0.003 per share and is exercisable immediately upon issuance.

The pre-funded warrants are subject to certain limitations on

beneficial ownership.

Outstanding, September 30, 2020

Exercisable, September 30, 2020

the nine months ended September 30, 2020, the Company granted its employees 0.4 million options to purchase the Company’s

common stock with an exercise price ranging from $9.55 to $17.70 per share, a term of 10 years, and a vesting period of 4 years.

The options have an aggregated fair value of $2.6 million that was calculated using the Black-Scholes option-pricing model.

used in the Black-Scholes option-pricing model include:

(1) discount rate range from 0.34% to 0.41% (2) expected life of 6 years,

(3) expected volatility range from 83.6% to 84.7%, and (4) no expected dividends.

During the nine months ended September 30, 2020,

options to purchase 20 thousand shares were cancelled upon the termination of employment for several employees.

fair values of all options issued and outstanding are being amortized over their respective vesting periods.

The unrecognized

compensation expense at September 30, 2020 was $3.7 million related to unvested options, which is expected to be expensed over

a weighted average of 3.4 years.

During the nine months ended September 30, 2020 and 2019, the Company recorded compensation expense

related to stock options of $0.8 million and $0.9 million, respectively.

part of the April 2020 offering and the June 2020 offering, the Company issued pre-funded warrants.

Each pre-funded warrant has

an exercise price of $0.003 per share and is exercisable immediately upon issuance.

The pre-funded warrants are subject to certain

limitations on beneficial ownership.

The pre-funded warrants do not have an expiration date.

Management determined that the pre-funded warrants

are freestanding instruments and that the pre-funded warrants should be classified as permanent equity in accordance with authoritative

Following is a summary

of pre-funded warrant activity for the six months ended June 30, 2020.

Management determined that the pre-funded

warrants are freestanding instruments and that the pre-funded warrants should be classified as permanent equity in accordance

with authoritative guidance.

is a summary of pre-funded warrant activity for the nine months ended September 30, 2020.

(in thousands, except for per-share amounts)

1 unchanged sentence

Outstanding, December 31, 2019

Outstanding, June 30, 2020

Exercisable, June 30, 2020

Following is a summary

of warrant activity for the six months ended June 30, 2020:

Outstanding, September 30, 2020

Exercisable, September 30, 2020

is a summary of warrant activity for the nine months ended September 30, 2020:

(in thousands, except for per-share amounts)

2 unchanged sentences

Cancelled/Expired

Outstanding, June 30, 2020

Exercisable, June 30, 2020

Subsequent Events

In July 2020, holders

of 0.4 million pre-funded April 2020 and June 2020 warrants exercised their warrants at $0.003 per share and received 0.4 million

shares of common stock.

Holders of 2 thousand April 2019 warrants exercised their warrants at $15.00 per share and received 2 thousand

In August 2020, the

Company filed a registration statement including a base prospectus which covers the offering, issuance and sale of up to $500 million

of common stock, preferred stock, warrants, units and/or subscription rights;

and a sales agreement prospectus covering the offering,

issuance and sale of up to a maximum aggregate offering price of $200 million of common stock that may be issued and sold under

the Capital on Demand™

Sales Agreement with JonesTrading Institutional Services LLC.

Since June 30, 2020, the

Company has issued stock options for 357,189 shares to employees and 33,332 shares to non-employee directors.

MANAGEMENT’S DISCUSSION

AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION

FORWARD-LOOKING STATEMENT NOTICE

This Form 10-Q contains

certain forward-looking statements.

For this purpose, any statements contained in this Form 10-Q that are

not statements of historical fact may be deemed to be forward-looking statements.

Outstanding, September 30, 2020

Exercisable, September 30, 2020

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION

FORWARD-LOOKING

STATEMENT NOTICE

Form 10-Q contains certain forward-looking statements.

For this purpose, any statements contained in this Form 10-Q that are not

statements of historical fact may be deemed to be forward-looking statements.

Without limiting the foregoing, words such

14 unchanged sentences

technological advances and failure to successfully develop business relationships.

Description of Business

Actinium Pharmaceuticals,

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

to the development of novel targeted therapies known as ARCs or Antibody Radiation-Conjugates.

Radiation is an effective therapeutic

modality that is used in the treatment of over fifty percent of all cancer patients and often combined with chemotherapy and immunotherapy

for greater therapeutic effect.

Radiation is typically administered from outside the body, which constrains the amount that can

be administered to patients due to dose-limiting toxicities.

In addition, due to the diffuse nature of the external radiation beam,

its usage is limited to solid tumors and cannot be used in blood cancers, which are diffuse.

ARCs combine the cell-killing ability

of a radioisotope payload with a targeting agent, such as a monoclonal antibody, or mAb, to deliver radiation inside the body to

specific cells, to potentially generate greater efficacy and less toxicity.

ARCs usage is broader than external delivered radiation

as they can be used for both solid tumors and blood cancers.

Blood or hematologic cancers are highly sensitive to radiation and

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 Radio-Conjugates (“ARCs”).

Radiation is an effective

therapeutic modality that is used in the treatment of over fifty percent of all cancer patients and is often combined with chemotherapy,

immunotherapy and other treatments for greater therapeutic effect.

Radiation is typically administered via an external beam source

from outside the body, leading to off-target exposure to normal healthy tissue and organs, which can constrain the amount of radiation

that can be administered to patients due to associated dose-limiting toxicities.

In addition, use of external beam radiation is

largely limited to solid tumors and cannot be used in blood cancers, which are diffuse throughout the body of a patient.

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

Our clinical programs are focused on two primary areas:

targeted conditioning prior to a cell or gene therapy procedure

and therapeutics, either in combination with other agents or as a monotherapy.

Our product development strategy is actively informed

by clinical data with our ARCs in over 500 patients, including the ongoing SIERRA trial.

Our clinical pipeline has emanated from

our AWE, or Antibody Warhead Enabling technology platform, which is protected by over 120 issued and pending patents, trade secrets

and know-how and is being utilized in a collaborative research partnership with Astellas Pharma, Inc.

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 to cell-based therapies with

curative potential, including BMT, or bone marrow transplant, ACT, or adoptive cell therapy such as CAR-T, and Gene Therapy, as

well as improved outcomes.

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, diseased cells prior to transplanting new cells into a patient.

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

These non-targeted conditioning

regimens may prevent a patient from receiving a potentially curative therapy and hinder outcomes due to their toxicities.

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

sparing normal healthy cells.

We use our ARCs 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.

addition, dosing may be titrated downward from myeloablative doses to achieve partial myeloablation, which may be appropriate for

certain gene therapy programs.

(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 over 500 patients, including the ongoing

SIERRA trial.

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

is protected by over 130 issued and pending patents, trade secrets and know-how and is being utilized in a collaborative research

partnership with Astellas Pharma, Inc.

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 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

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

CD45 Targeted Conditioning Program

Our CD45 ARC is comprised

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

CD45 is an antigen

expressed on leukemia, lymphoma and myeloma cancer cells, as well as nucleated immune cells, but is not expressed outside of the

hematopoietic, or blood, 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 rely 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.

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, 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

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.

Our lead CD45 targeted

1 unchanged sentence

Iomab-B is currently being studied in the pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory AML, or SIERRA, clinical

trial for targeted conditioning prior to an allogeneic BMT for patients with active, relapsed or refractory (r/r) Acute Myeloid

Leukemia, or AML, who are age 55 or older.

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 chemotherapy (the control arm).

Salvage chemotherapy is also defined as conventional care, as no standard of

care exists for this patient population.

Patients who fail to achieve a CR or Complete Response 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, or dCR, of six months

and the secondary endpoint is one-year Overall Survival, or 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.

SIERRA trial is currently active at 20 sites in the United States and Canada, which includes many of the leading BMT sites based

We expect to complete enrollment of the SIERRA trial and have topline data that we believe will support the submission

of a Biologics License Application, or BLA, with the U.S.

Food and Drug Administration, or FDA, in 2021.

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 or EU, we received favorable feedback from the European Medicines Agency or 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.

We intend to secure a partner for Iomab-B in the EU.

trial for targeted conditioning prior to an allogeneic BMT for patients with active, relapsed or refractory (“R/R”)

Acute Myeloid Leukemia, or AML, who are age 55 or older.

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.

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 chemotherapy (the control arm).

Salvage chemotherapy is also defined as conventional

care, as no standard of care exists for this patient population.

Patients who fail to achieve a CR or Complete Response on the

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

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 one-year 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 is currently active at 20 sites in the United States and Canada, which

includes many of the leading BMT sites based on volume.

We expect to complete enrollment of the SIERRA trial and have topline data

that we believe will support the submission of a Biologics License Application, or BLA, with the U.S.

Food and Drug Administration,

or FDA, in 2021.

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,

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

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.

secure a partner for Iomab-B in the EU.

Safety and feasibility

data from the first 75 patients enrolled on the SIERRA trial, which represents 50% of the total of 150 patients to be enrolled

in the trial, was presented in an oral presentation at the Transplantation & Cellular Therapy Meetings of the American Society

for Transplantation and Cellular Therapy (ASTCT) and Center for International Bone & Marrow Transplant Research (CIBMTER) in

February 2020.

It was reported that 100% of patients (31/31) 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 achieved neutrophil and platelet engraftment in a median time of

20 days despite a high median blast count of 30%.

On the control arm, only 18% of patients (7/38) achieved remission after salvage

therapy, and then received a BMT with a median time to BMT of 67 days and median blast count of 26%.

Of the 82% of patients failing

to achieve a CR with conventional care (31/38), 20 patients were eligible to cross over to the study arm.

These patients are considered

as having failed the primary endpoint of the study.

All crossover patients who received the therapeutic dose of Iomab-B (20/20)

received a BMT, with a median time to BMT of 64 days and all patients 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 non-relapse transplant-related mortality

(100-day TRM) of the study or Iomab-B arm was 6% (2/31) of patients that received a BMT compared to 29% of patients (2/7) 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 29 patients potentially evaluable for the primary endpoint compared to 5 patients in the control arm, a nearly six times difference.

The SIERRA trial is

powered for up to two interim analyses of the primary endpoint of dCR of 180 days exercisable at our discretion and triggered by

an enrollment range of 70 to 110 patients.

We exercised a single ad-hoc analysis in the second quarter of 2020, based on the data

reported from SIERRA thus far and the status of enrollment at the time of triggering our ad hoc analysis.

The ad hoc analysis is

expected to be completed by the end of 2020, which could generate topline data for the primary endpoint and early termination of

the trial if positive.

Based on the statistical plan of the study, a single ad-hoc analysis would result in a minimal alpha spend

of no more than 0.00925, depending on the number of patients included in the ad-hoc analysis.

Our Iomab-ACT program is

intended for targeted conditioning prior to ACT or Gene Therapy and uses the same 131 I-apamistamab ARC 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 Therapy applications where stem cell myeloablation is not necessary.

in the trial, was presented in an oral presentation 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 2020.

It was reported that 100% of patients (31/31) 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 achieved

neutrophil and platelet engraftment in a median time of 20 days despite a high median blast count of 30%.

On the control arm, only

18% of patients (7/38) achieved remission after salvage therapy, and then received a BMT with a median time to BMT of 67 days and

median blast count of 26%.

Of the 82% of patients failing to achieve a CR with conventional care (31/38), 20 patients were eligible

to cross over to receive Iomab-B followed by transplant.

These patients are considered as having failed the primary endpoint of

All crossover patients who received the therapeutic dose of Iomab-B (20/20) received a BMT, with a median time to BMT

of 64 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 non-relapse transplant-related mortality (100-day TRM) of the study or Iomab-B arm was only 6%

(2/31) of patients that received a BMT compared to 29% of patients (2/7) who received a BMT after salvage therapy on the control

The universal engraftment rate and low 100-day TRM rate of the Iomab-B arm resulted in 29 patients potentially evaluable for

the primary endpoint compared to 5 patients in the control arm, a nearly six times difference.

We have reached 75% enrollment

in the SIERRA trial.

We expect to present safety and feasibility data including rates of BMT engraftment, 100-day TRM and key safety

metrics from 113 patients, representing 75% of the planned 150-patient enrollment, as we did on the first 25% and 50% of patients.

In addition, rates of CR and rates of patients that did not achieve CR who then received Iomab-B, defined as failures for the primary

endpoint, will be reported for patients randomized to the control arm.

The SIERRA trial is powered

to show a two-times difference in the primary endpoint of dCR at 180 days at full enrollment of the study.

The SIERRA trial design

allowed for up to two ad hoc interim analyses of the primary endpoint exercisable at our discretion and triggered by an enrollment

range of 70 to 110 patients.

We exercised a single ad hoc interim analysis in the second quarter of 2020 based on the data reported

from SIERRA thus far that is consistent with prior findings with Iomab-B and have updated and shared the updated SIERRA trial protocol

and statistical analysis plan with the FDA to reflect the single ad hoc interim analysis.

With a single ad hoc interim analysis

exercised, the final analysis on full enrollment of 150 patients would be conducted with a p-value of 0.046 defining success of

The interim analysis is expected to be completed in the fourth quarter of 2020 and could result in a recommendation

for early termination of the trial for futility of one of the arms, or a continuation of the trial.

The company intends to consult

with the FDA should the recommendation be to terminate the study due to futility of the control arm.

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.

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 Therapy applications where stem cell myeloablation is not necessary.

At higher doses it is applicable

for Gene Therapy applications where stem cell myeloablation is necessary.

In January 2020, we announced

a collaboration with University of California Davis to utilize Iomab-ACT conditioning in an ongoing Phase 1/2 trial with a novel

anti-HIV autologous stem cell gene therapy for patients with HIV-related lymphoma.

We believe this to be the first Gene Therapy

trial to use an ARC-based conditioning regimen.

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 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.

In October 2020, we announced

a clinical collaboration with Memorial Sloan Kettering Cancer Center (“MSK”) to use our Iomab-ACT for targeted conditioning

prior to administration of MSK’s 19-28z CD19 targeting CAR-T in patients with relapsed or refractory B-cell acute lymphoblastic

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

We have been awarded Small Business Technology

Transfer (“STTR”) Fast-Track grant funding from the National Institutes of Health (“NIH”) to fund this

trial with MSK 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.

The hypothesized rationale for this study is that Iomab-ACT depletes CD45 expressing immune cells implicated in

CAR-T related toxicities, resulting in an optimal homeostatic environment for the CAR-T cells and possibly exerts an anti-tumor

effect on the chemotherapy-refractory B-ALL cells that are sensitive to radiation, resulting in reduced disease burden prior to

CAR-T administration.

Results with MSKCC’s 19-28z CD-19 CAR-T in 53 patients with R/R B-ALL published in the New England

Journal of Medicine reported complete remissions in 83% (44/53) of patients, which compares favorably to standard chemotherapy

regimens that have complete remission rates of 18% - 45% in this 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 –

a 26% (14/53) rate of Grade 3 or greater cytokine release syndrome (“CRS”) and a 42% rate of Grade 3 or 4 neurotoxicity

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.

of concept data from this study is expected in 2021.

In January 2020, we

announced a collaboration with University of California Davis to utilize Iomab-ACT conditioning in an ongoing Phase 1/2 trial with

a novel anti-HIV autologous stem cell gene therapy for patients with HIV-related lymphoma.

We believe this to be the first Gene

Therapy trial to use an ARC-based conditioning regimen.

I-131-Apamistamab has clinical proof of concept as a targeted conditioning

12 unchanged sentences

expect to have clinical proof of concept data in 2021.

We believe our Iomab-ACT

program is highly differentiated when compared to Fludarabine and Cyclophosphamide or 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, or 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, preclinical data suggests Iomab-ACT is targeted in

nature and, due to this targeted effect, we expect we can improve CAR-T cell expansion more efficiently, 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 intend to begin a clinical trial

with 131 I-apamistamab as a targeted conditioning agent prior to CAR-T, subject to identifying a suitable partner and

we expect to have Phase 1 clinical proof of concept data in 2021.

CD33 Program:

Targeted Conditioning, Combinations

and Therapeutics

Our CD33 program is evaluating

the clinical utility of an ARC 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, or MDS, as well as approximately

one third of patients with multiple myeloma.

Our CD33 development program is driven by data obtained from over one hundred treated

patients, including results from a Phase 1/2 trial that was conducted in 58 patients with newly diagnosed AML, which was completed

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 purposes

in combination with other modalities, such as chemotherapy, targeted agents or immunotherapy.

Actimab-MDS is our second

clinical trial focused on targeted conditioning, in this case for patients with high-risk MDS and is our second pivotal program.

Actimab-MDS is informed by prior experience with our CD33 ARC in multiple trials for patients with AML, MDS and for patients that

have progressed from MDS to AML, which is also known as secondary AML.

Data from these trials showed that our CD33 ARC had single-agent

activity capable of producing complete remissions (CRs) in certain patients at varying dose levels with minimal non-hematologic

Therapeutic Combinations

and Targeted Conditioning

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 (“Ac-225”).

CD33 is expressed in the majority of patients with AML and myelodysplastic syndrome

(“MDS”) as well as approximately one-third of patients with multiple myeloma.

Our CD33 development program is driven

by data obtained from over one hundred 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.

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.

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.

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.

In September 2020, we announced that we completed the planned enrollment of the Phase 1 trial and expect to have data from the third and final dose cohort of 0.75 µCi/kg of Actimab-A with CLAG-M by the end of 2020.We will continue development of this program as efficiently as possible upon taking into consideration results from the entire Phase 1 trial.

At the 2019 American Society of Hematology Annual Meeting, it was reported that 86% of patients (6/7) receiving 0.50 µCi/kg of Actimab-A, and CLAG-M achieved a complete remission after receiving Actimab-A + CLAG-M, which is nearly 60% 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.

In addition, 71% of these patients (5/7) achieved negative minimal residual disease status, indicating that these are deep remissions.

The 0.50 µCi/kg dose of Actimab-A was shown to be subtherapeutic as a single agent.

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.

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.

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.

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

In September 2020, we announced that we successfully completed enrollment of the first dose cohort and are continuing to advance to the next cohort of this dose-escalation trial.

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.

Additional clinical trial sites are being activated and we expect to have first in-human data from this combination trial by year-end and Phase 1 proof-of-concept data from this combination study in 2021.

In addition to these

active trials, we are working to identify additional modalities and agents that can be the basis for Actimab-A therapeutic combination

by leveraging our expertise in radioimmunobiology.

Targeted Conditioning :

Actimab-MDS is our

second clinical trial focused on targeted conditioning, in this case for patients with high-risk MDS and is our second pivotal

Actimab-MDS is informed by prior experience with our CD33 ARC in multiple trials for patients with AML, and for patients

that have progressed from MDS to AML, which is also known as secondary AML.

Data from these trials showed that our CD33 ARC had

single-agent activity capable of producing complete remissions (CRs) in certain patients at varying dose levels with minimal non-hematologic

extramedullary toxicities.

13 unchanged sentences

with the FDA.

We are also studying our

CD33 ARC construct at various dose levels and dosing regimens in combination with other therapeutic modalities such as chemotherapy,

targeted agents or immunotherapy in CD33 expressing hematologic disease indications.

We believe that radiation can be synergistic

when used in combination with these modalities based on mechanistic rationale 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, which we are no longer advancing at this time.

ARC development program encompasses the following ongoing and planned 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 patients with relapsed or refractory AML at the Medical College of Wisconsin.

In addition, 71% of these patients (5/7) achieved negative minimal residual disease status, indicating that these are deep remissions.

The 0.50 µCi/kg dose of Actimab-A was shown to be subtherapeutic as a single agent.

Since the combination to date has been well tolerated, the study progressed to the third and final cohort for the study of Actimab-A at a dose of 0.75 µCi/kg in March 2020 and we expect to complete this trial by the end of 2020.

Upon completion, we intend to explore a regulatory pathway for a pivotal trial that could potentially support a registration.

Phase 1 Actimab-A + Ven combination trial with the BCL-2 inhibitor Venetoclax (Ven) for patients with relapsed or refractory AML.

This trial will be led by UCLA Medical Center and will be conducted at three additional trial sites.

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

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.

We expect to initiate the trial and have preliminary proof of concept clinical data from this combination study by the end of 2020.

Phase 1 Actimab-A + 7+3 combination trial in patients with newly diagnosed AML with intermediate or high-risk cytogenetics or molecular markers.

In February 2020, we announced plans to initiate this combination trial to add Actimab-A to 7+3, which is the standard of care chemotherapy regimen comprised of cytarabine and daunorubicin for patients with newly diagnosed AML who are fit for intensive therapy.

As we have seen with the combination of Actimab-A + CLAG-M chemotherapy, we believe that Actimab-A will have synergistic and potentiating properties when added to 7+3, which causes DNA damage and has radiation sensitizing properties since daunorubicin is an anthracycline antibiotic that cytotoxically inhibits DNA replication and repair and RNA synthesis through inhibition of topoisomerase II.

The rationale for studying Actimab-A in combination with 7+3 is the potential for both additive and synergistic effects due to the interplay of various mechanisms including DNA damage from alpha radiation and the chemotherapy combination, radiation sensitization, and prevention of DNA damage repair.

We expect to initiate this Phase 1 trial by the end of 2020 and have proof of concept data in 2021.

Antibody Warhead Enabling Technology Platform

Antibody Warhead Enabling Technology

Our proprietary Antibody

Warhead Enabling, or AWE, Technology 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

includes 29 patent families comprised of over 120 issued and pending patent applications, of which 9 are issued and 25 pending

in the United States, and 92 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.

Recent Developments

Impact of COVID–19 Pandemic

In December 2019, a novel

strain of COVID-19 was reported in China.

Warhead Enabling (“AWE”) Technology 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 includes 29 patent families comprised of over 130 issued and pending patent applications, of which 10 are issued and

31 pending in the United States, and 97 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

Our AWE intellectual property covers various methods of use for ARCs in multiple diseases, including indication, dose

and scheduling, radionuclide warhead, and therapeutic combinations.

We recently enhanced

our research and development capabilities by securing research facilities where we will focus on applying our AWE technology platform

and radiobiology capabilities to the development of ARCs.

Our R&D efforts will employ a multidisciplinary approach leveraging

our team’s knowledge and experience in cancer cell biology, radiochemistry, radiation sciences, immunology and oncology drug

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 companies.

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

the rapid translation of radiotherapies.

of COVID–19 Pandemic

December 2019, a novel strain of COVID-19 was reported in China.

Since then, COVID-19 has spread globally.

The spread of COVID-19 from China to other

countries has resulted in the World Health Organization (WHO) declaring the outbreak of COVID-19 as a “pandemic,”

a worldwide spread of a new disease, on March 11, 2020.

Many countries around the world have imposed quarantines and restrictions

on travel and mass gatherings to slow the spread of the virus and have closed non-essential businesses, and as of the date of this

prospectus, many local jurisdictions continue to have such restrictions in place.

As many local jurisdictions

continue to have such restrictions in place, 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.

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.

The spread of COVID-19

which has caused a broad impact globally, may materially affect us economically.

While the ultimate economic impact brought by,

and the duration of, the COVID-19 pandemic may be difficult to assess or predict, including new information which may emerge concerning

the severity of COVID-19 and the actions to contain COVID-19 or treat its impact, among others, the pandemic has resulted significant

disruptions in the general commercial activity and the global economy and caused financial market volatility and uncertainty in

significant and unforeseen ways in the recent months.

A continuation or worsening of the levels of market disruption and volatility

seen in the recent past could have an adverse effect on our ability to access capital, which could in the future negatively affect

our liquidity.

In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect our

business and the value of our common stock.

from China to other countries has resulted in the World Health Organization (WHO) declaring the outbreak of COVID-19 as a “pandemic,”

or a worldwide spread of a new disease, on March 11, 2020.

Many countries around the world have imposed quarantines and restrictions

on travel and mass gatherings to slow the spread of the virus and have closed non-essential businesses, and as of the date of

this prospectus, many local jurisdictions continue to have such restrictions in place.

many local jurisdictions continue to have such restrictions in place, our ability to continue to operate our business may also

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

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.

spread of COVID-19, which has caused a broad impact globally, may materially affect us economically.

While the ultimate economic

impact brought by, and the duration of, the COVID-19 pandemic may be difficult to assess or predict, including new information

which may emerge concerning the severity of COVID-19 and the actions to contain COVID-19 or treat its impact, among others, the

pandemic has resulted in significant disruptions in the general commercial activity and the global economy and caused financial

market volatility and uncertainty in significant and unforeseen ways in the recent months.

A continuation or worsening of the

levels of market disruption and volatility seen in the recent past could have an adverse effect on our ability to access capital,

which could in the future negatively affect our liquidity.

In addition, a recession or market correction resulting from the spread

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

Currently, the Phase 3

3 SIERRA trial for our lead program, Iomab-B, continues to remain active at a majority of our clinical trial sites, with investigators

providing feedback that recruitment and enrollment will 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 sites that had not been actively enrolling due to COVID-19 have resumed recruitment and enrollment, and we currently anticipate

that other sites that have not been actively enrolling due to COVID-19 will likely resume recruitment and enrollment in the summer

We also believe our earlier stage clinical trials for our CD33 program will also 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.

Additionally, COVID-19

may result in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions

with IRB’s or Institutional Review Boards, local and foreign regulators, ethics committees and other important agencies and

contractors due to limitations in employee resources or forced furlough of government employees.

To date, COVID-19 has not

had a financial impact on our company.

However, COVID-19 has caused severe disruptions in transportation and limited access to

our facility, resulting in limited support from our staff and professional advisors.

The ultimate impact from

COVID-19 on our business operations and financial results during 2020 will depend on, among other things, the ultimate severity

and scope of the pandemic, 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.

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

results during 2020 and beyond, but developments related to COVID-19 may materially affect us in 2020.

Reverse Stock Split

On April 29, 2020, we received

a deficiency letter from the NYSE American LLC, or the NYSE American, indicating that we are not in compliance with certain NYSE

American continued listing standards.

The deficiency letter stated that our shares of common stock have been selling for a low

price per share for a substantial period of time.

Pursuant to Section 1003(f)(v) of the Company Guide, the NYSE American staff

determined that our continued listing is predicated on us effecting a reverse stock split of our common stock or otherwise demonstrating

sustained price improvement within a reasonable period of time, which the staff determined to be until October 29, 2020.

The letter further stated

that as a result of the foregoing, we have become subject to the procedures and requirements of Section 1009 of the NYSE American

Company Guide, which could, among other things, result in the initiation of delisting proceedings, unless we cure the deficiency

in a timely manner.

Our common stock will continue to be listed on the NYSE American while we attempt to regain compliance with

the listing standards, subject to our compliance with other continued listing requirements.

In addition, the NYSE American

has advised us that its policy is to immediately suspend trading in shares of, and commence delisting procedures with respect to,

a listed company if the market price of its shares falls below $0.06 per share at any time during the trading day.

On October 18, 2019, our

board of directors unanimously approved, subject to stockholder approval, an amendment to our certificate of incorporation to effect

a reverse stock split of our outstanding common stock by combining outstanding shares of common stock into a lesser number of outstanding

shares of common stock by a ratio of not more than 1-for-75 prior to December 18, 2020, with the exact ratio to be set within this

range by our board of directors at its sole discretion.

On December 18, 2019, at our 2019 Annual Meeting of Stockholders, our stockholders

approved such proposed amendment to our certificate of incorporation.

The primary intent of effecting the reverse stock split,

would be to ensure that we are able to maintain compliance with the listing standards of the NYSE American.

On August 7, 2020,

the Board unanimously approved a reverse stock split of its outstanding common stock by combining outstanding shares of common

stock into a lesser number of outstanding shares of common stock by a ratio of 1-for-30, and on August 10, 2020, we filed with

the Secretary of State of Delaware a certificate of amendment to its certificate of incorporation to effect the reverse stock split.

The reverse stock split became effective as of 5:00 p.m.

Eastern Time on August 10, 2020, and our common stock began trading on

a split-adjusted basis when the market opened on August 11, 2020.

all common share and per common share data in these

consolidated financial statements and related notes hereto have been retroactively adjusted to account for the effect of this reverse

stock split for all periods presented.

In addition, at the effective time of the reverse stock split, the number of shares of our

common stock reserved for issuance upon exercise of all options and warrants to acquire common stock have been proportionally decreased,

and the exercise price of all options and warrants to acquire common stock have been proportionally increased.

SIERRA trial for our lead program, Iomab-B, continues to remain active at a majority of our clinical trial sites and no sites are

inactive due to COVID-19, with investigators providing feedback that recruitment and enrollment will 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.

We also believe our earlier stage clinical trials for our CD33 program will also

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

adjusted and proportionately decreased the total number of shares of our common stock that may be the subject of the future grants

under our stock plans.

Results of Operations

Three Months Ended June 30, 2020 Compared to Three Months Ended June 30, 2019

The following table sets

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

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.

Additionally,

COVID-19 may result in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions

with IRB’s or Institutional Review Boards, local and foreign regulators, ethics committees and other important agencies

and contractors due to limitations in employee resources or forced furlough of government employees.

date, COVID-19 has not had a financial impact on our company.

However, COVID-19 has caused severe disruptions in transportation

and limited access to our facility, resulting in limited support from our staff and professional advisors.

ultimate impact from COVID-19 on our business operations and financial results during 2020 will depend on, among other things,

the ultimate severity and scope of the pandemic, 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.

We are not able to fully quantify the impact that these factors will

have on our financial results during 2020 and beyond, but developments related to COVID-19 may materially affect us in 2020.

of Operations –

Three Months Ended September 30, 2020 Compared to Three Months Ended September 30, 2019

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

For the Three Months Ended

September 30,

(in thousands)

6 unchanged sentences

Total other income

We recorded no commercial

revenue for the three months ended June 30, 2020 and 2019.

Research and Development Expense

Research and development

expenses decreased $0.5 million to $3.5 million for the three months ended June 30, 2020 compared to $4.0 million for the three

months ended June 30, 2019.

The decrease in expenses was primarily due to manufacturing related to the antibody component of Iomab-B,

as in prior periods we have manufactured sufficient antibody supply for the SIERRA trial and other planned trials.

General and Administrative Expenses

General and administrative

expenses of $1.2 million for the three months ended June 30, 2020 increased $0.1 million from the $1.1 million recorded for the

three months ended June 30, 2019, 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 June 30, 2020 of $37 thousand fell from

$59 thousand for the three months ended June 30, 2019, primarily due to lower interest rates.

Net loss of $4.6 million

for the three months ended June 30, 2020 decreased by $0.4 million from the prior-year comparison period due to lower research

and development expenses.

Results of Operations

Six Months Ended June 30, 2020 Compared to Six Months Ended June 30, 2019

The following table sets

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

For the Six Months Ended

recorded no commercial revenue for the three months ended September 30, 2020 and 2019.

and Development Expense

and development expenses decreased $1.0 million to $3.8 million for the three months ended September 30, 2020 compared to $4.8

million for the three months ended September 30, 2019.

The decrease in expenses was primarily due to manufacturing related to

the antibody component of Iomab-B, as in prior periods we have manufactured sufficient antibody supply for the SIERRA trial and

other planned trials.

and Administrative Expenses

and administrative expenses of $1.8 million for the three months ended September 30, 2020 were virtually unchanged from the prior-year

three-month period.

income is comprised of net interest income in both reporting periods.

The amount for the three months ended September 30, 2020

of $73 thousand increased from $53 thousand for the three months ended September 30, 2019, as a result of higher cash balances

due to our stock and warrant offerings in April and June 2020, partially offset by lower interest rates.

loss of $5.5 million for the three months ended September 30, 2020 decreased by $1.1 million from the prior-year comparison period

due to lower research and development expenses.

Results of Operations –

Ended September 30, 2020 Compared to Nine Months Ended September 30, 2019

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

For the Nine Months Ended

September 30,

(in thousands)

6 unchanged sentences

Total other income

We recorded no commercial

revenue for the six months ended June 30, 2020 and 2019.

Research and Development Expense

Research and development

expenses decreased $0.6 million to $7.7 million for the six months ended June 30, 2020 compared to $8.3 million for the six months

ended June 30, 2019.

The decrease in expenses was primarily due to manufacturing related to the antibody component of Iomab-B,

as in prior periods we have manufactured sufficient antibody supply for the SIERRA trial and other planned trials.

General and Administrative

General and administrative

expenses of $2.7 million for the six months ended June 30, 2020 increased $0.3 million compared to $2.4 million for the six months

ended June 30, 2019, primarily attributable to higher professional fees.

Other income is comprised

of net interest income in both reporting periods.

The amount for the six months ended June 30, 2020 of $50 thousand fell from $88

thousand for the six months ended June 30, 2019 primarily due to lower interest rates.

Net loss of $10.3 million

for the six months ended June 30, 2020 decreased $0.4 million from $10.7 million reported in the prior-year comparison period,

primarily due to lower research and development expenses, slightly offset by higher general and administrative expenses.

Liquidity and Capital Resources

We have financed our

operations primarily through sales of our common stock and warrants.

The following tables sets forth selected cash flow information

for the periods indicated:

For the Six Months Ended

recorded no commercial revenue for the nine months ended September 30, 2020 and 2019.

and Development Expense

and development expenses decreased $1.7 million to $11.5 million for the nine months ended September 30, 2020 compared to $13.2

million for the nine months ended September 30, 2019.

The decrease in expenses was primarily due to manufacturing related to the

antibody component of Iomab-B, as in prior periods we have manufactured sufficient antibody supply for the SIERRA trial and other

planned trials.

and Administrative Expenses

and administrative expenses of $4.5 million for the nine months ended September 30, 2020 increased $0.2 million compared to $4.3

million for the nine months ended September 30, 2019, primarily attributable to higher professional fees.

income is comprised of net interest income in both reporting periods.

The amount for the nine months ended September 30, 2020

of $123 thousand fell from $141 thousand for the nine months ended September 30, 2019 due to lower interest rates.

loss of $15.8 million for the nine months ended September 30, 2020 decreased $1.5 million from $17.3 million reported in the prior-year

comparison period, primarily due to lower research and development expenses, slightly offset by higher general and administrative

and Capital Resources

have financed our operations primarily through sales of our common stock and warrants.

The following table sets forth selected

cash flow information for the periods indicated:

For the Nine Months Ended

September 30,

(in thousands)

3 unchanged sentences

Net change in cash, cash equivalents and restricted cash

Net cash used in operating

activities for the six months ended June 30, 2020 of $10.4 million decreased by $0.5 million from $10.9 million in the prior-year

period, reflecting the lower net loss due to lower research and development expenses, as well as the timing of payments to vendors.

Net cash provided by financing

activities was $54.6 million for the six months ended June 30, 2020, reflecting sales of common stock and pre-funded warrants.

During the six months ended June 30, 2019, net cash provided by financing activities was $16.8 million, reflecting $15.5 million

in proceeds from the sale of common stock, plus $1.5 million in proceeds from the exercise of warrants.

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

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.

cash used in operating activities for the nine months ended September 30, 2020 of $15.4 million decreased by $1.1 million from

$16.5 million in the prior-year period, reflecting the lower net loss due to lower research and development expenses, as well

as the timing of payments to vendors.

cash provided by financing activities was $54.3 million for the nine months ended September 30, 2020, reflecting sales of common

stock and pre-funded warrants in April and June 2020.

During the nine months ended September 30, 2019, net cash provided by financing

activities was $17.2 million, reflecting $15.9 million in proceeds from the sale of common stock, plus $1.5 million in proceeds

from the exercise of warrants.

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 are exercisable at an exercise price of $0.003

per share and are subject to certain limitations on beneficial ownership.

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.

In June 2020, holders of 1.2 million pre-funded April 2020 warrants exercised

their warrants and received 1.2 million shares of common stock.

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.

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.

pre-funded warrant has an exercise price of $0.003 per share and is exercisable immediately upon issuance.

Gross proceeds from

this offering to us were $25.0 million, before deducting underwriting discounts and commissions and other offering expenses payable

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

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

Each pre-funded warrant has an exercise price of $0.003 per share and is exercisable immediately upon issuance.

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.

In December 2018, we

entered into the Amended and Restated At Market Issuance Sales Agreement with B.

In December 2018, we entered into the Amended and Restated

At Market Issuance Sales Agreement with B.

Riley FBR, Inc.

and JonesTrading Institutional

Services LLC, pursuant to which we conducted our at-the market program.

During the six months ended June 30, 2020, we sold 0.3

million common shares through its at-the-market program, resulting in net proceeds of $2.5 million.

In October 2018,

we and Lincoln Park Capital Fund, LLC (“Lincoln Park”) entered into a purchase agreement and a registration rights

agreement, pursuant to which we have the right to sell to Lincoln Park shares of our common stock having an aggregate value of

up to $32.5 million, subject to certain limitations and conditions set forth in the agreement.

During the six months ended June

30, 2020, we elected to sell to Lincoln Park 27 thousand shares and received $0.2 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.

Critical Accounting Policies and Use of Estimates

Our management’s

discussion 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

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.

We base 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.

Our significant accounting

policies are described in detail in the notes to our consolidated financial statements appearing in our Annual Report filed on

Form 10-K for the year ended December 31, 2019.

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.

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

for identical assets or liabilities and the lowest priority to unobservable inputs.

Research and Development Costs

Research and development

costs are expensed as incurred.

These costs include the costs of manufacturing drug components and final drug product, the costs

of clinical trials, costs of employees and associated overhead, and depreciation and amortization costs related to facilities and

Research and development reimbursements are recorded by us as a reduction of research and development costs.

Share-Based Payments

We estimate the fair value

of each stock option award at the grant date by using the Black-Scholes option pricing model.

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 award.

and JonesTrading Institutional Services LLC, or JonesTrading, pursuant

to which we conducted our at-the market program.

During the nine months ended September 30, 2020, we sold 0.3 million shares of

common stock through our at-the-market program, resulting in net proceeds of $2.5 million.

In October 2018, we and Lincoln Park Capital Fund, LLC,

or Lincoln Park entered into a purchase agreement and a registration rights agreement, pursuant to which we have the right to sell

to Lincoln Park shares of our common stock having an aggregate value of up to $32.5 million, subject to certain limitations and

conditions set forth in the agreement.

During the nine months ended September 30, 2020, we elected to sell to Lincoln Park 27 thousand

shares and received $0.2 million.

In connection with the

Company’s June 2020 public offering, the Company suspended, and during the duration of the June 2020 public offering, did

not offer, any securities pursuant to the Lincoln Park Agreement and the ATM Sales Agreement.

The Company will not make any sales

of securities pursuant to the Lincoln Park Agreement and the ATM Sales Agreement unless and until a new prospectus supplement is

filed with the SEC;

however, the Lincoln Park Agreement and the ATM Sales Agreement remain in full force and effect.

In August 2020, we entered into the Capital on Demand™

Sales Agreement with 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 filed with

the SEC on August 7, 2020.

As of September 30, 2020, $200 million of common stock remained available for issuance under the program.

Sheet Arrangements

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.

Accounting Policies and Use of Estimates

management’s discussion 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.

We base 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.

significant accounting policies are described in detail in the notes to our consolidated financial statements appearing in our

Annual Report filed on Form 10-K for the year ended December 31, 2019.

Value of Financial Instruments

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 identical assets or liabilities and the lowest priority to unobservable inputs.

and Development Costs

and development costs are expensed as incurred.

These costs include the costs of manufacturing drug components and final drug

product, the costs of clinical trials, costs of employees and associated overhead, and depreciation and amortization costs related

to facilities and equipment.

Research and development reimbursements are recorded by us as a reduction of research and development

estimate the fair value of each stock option award at the grant date by using the Black-Scholes option pricing model.

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 award.

We account for forfeitures of stock options as they occur.

Accounting Standards

Recently Adopted -

In August 2018, FASB issued

ASU 2018-13, Fair Value Measurement - Disclosure Framework (Topic 820).

The updated guidance improves the disclosure requirements

on fair value measurements, primarily associated with Level 3 fair value measurements and is effective for fiscal years, and interim

periods within those fiscal years, beginning after December 15, 2019.

Early adoption is permitted upon issuance of the standard

for disclosures modified or removed with a delay of adoption of the additional disclosures until their effective date.

this standard effective January 1, 2020 and the standard did not have a significant impact to our financial statements.

In November 2018, FASB

issued ASU 2018-18, C ollaborative Arrangements (Topic 808):

Clarifying the Interaction Between Topic 808 and Topic 606,

which, among other things, provides guidance on how to assess whether certain collaborative arrangement transactions should be

accounted for under Topic 606.

The amendments in this ASU are effective for fiscal years, and interim periods within those fiscal

years, beginning after December 15, 2019, with early adoption permitted.

We adopted this standard effective January 1, 2020 and

the standard did not have a significant impact to our financial statements.

QUANTITATIVE AND QUALITATIVE

DISCLOSURES ABOUT MARKET RISK.

Not applicable.

Accounting Standards Recently Adopted

August 2018, FASB issued ASU 2018-13, Fair Value Measurement - Disclosure Framework (Topic 820).

The updated guidance improves

the disclosure requirements on fair value measurements, primarily associated with Level 3 fair value measurements and is effective

for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019.

Early adoption is permitted

upon issuance of the standard for disclosures modified or removed with a delay of adoption of the additional disclosures until

their effective date.

We adopted this standard effective January 1, 2020 and the standard did not have a significant impact to

our financial statements.

November 2018, FASB issued ASU 2018-18, C ollaborative Arrangements (Topic 808):

Clarifying the Interaction Between Topic 808

and Topic 606, which, among other things, provides guidance on how to assess whether certain collaborative arrangement transactions

should be accounted for under Topic 606.

The amendments in this ASU are effective for fiscal years, and interim periods within

those fiscal years, beginning after December 15, 2019, with early adoption permitted.

We adopted this standard effective January

1, 2020 and the standard did not have a significant impact to our financial statements.

Standards Recently Issued

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

This ASU simplifies the accounting for certain financial instruments with characteristics of liabilities and equity.

Specifically, the ASU eliminates the need for us to assess whether a contract on the entity’s own equity (1) permits settlement

in unregistered shares, (2) whether counterparty rights rank higher shareholder’s rights, and (3) whether collateral is

In addition, the ASU requires incremental disclosure related to contracts on the entity’s 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.

adoption of the ASU is permitted by us effective January 1, 2021.

We are in the process of assessing the adoption of the ASU on

our financial statements.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

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 1. Financial Statements