FINANCIAL STATEMENTS
−Removed: The accompanying consolidated financial
−Removed: statements have been prepared by the Company and are unaudited.
−Removed: In the opinion of management, all adjustments (which include only
−Removed: normal recurring adjustments) necessary to present fairly the financial position at March 31, 2020 and December 31, 2019, and the
−Removed: results of operations and cash flows for the three months ended March 31, 2020 and 2019, respectively, have been made.
−Removed: information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles
−Removed: generally accepted in the United States of America have been condensed or omitted.
−Removed: It is suggested that these financial statements
−Removed: be read in conjunction with the financial statements and notes thereto included in the Company’s audited financial statements
−Removed: for the year ended December 31, 2019 in the Company’s Annual Report on Form 10-K.
−Removed: The results of operations for the three
−Removed: months ended March 31, 2020 are not necessarily indicative of the operating results for the full year.
+Added: The accompanying consolidated financial statements
+Added: have been prepared by the Company and are unaudited.
+Added: In the opinion of management, all adjustments (which include only normal recurring
+Added: adjustments) necessary to present fairly the financial position at June 30, 2020 and December 31, 2019, and the results of operations
+Added: and cash flows for the three and six months ended June 30, 2020 and 2019, respectively, have been made.
+Added: Certain information and
+Added: footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted
+Added: in the United States of America have been condensed or omitted.
+Added: It is suggested that these financial statements be read in conjunction
+Added: with the financial statements and notes thereto included in the Company’s audited financial statements for the year ended
+Added: December 31, 2019 in the Company’s Annual Report on Form 10-K.
+Added: The results of operations for the three and six months ended
+Added: June 30, 2020 are not necessarily indicative of the operating results for the full year.
Actinium Pharmaceuticals, Inc.
Consolidated Balance Sheets
−Removed: (amounts in thousands, except share and per share data)
+Added: (amounts in thousands, except share and per
Current Assets:
28 unchanged sentences
Total Liabilities and Stockholders’
−Removed: See accompanying notes to the consolidated
−Removed: financial statements.
+Added: See accompanying notes to the consolidated financial
Actinium Pharmaceuticals, Inc.
Consolidated Statements of Operations
−Removed: (amounts in thousands, except share and
−Removed: per share data)
−Removed: Three Months Ended
+Added: (amounts in thousands, except share and per
+Added: For the Three Months Ended
+Added: For the Six Months Ended
Operating expenses:
6 unchanged sentences
Total other income
+Added: Deemed dividend for warrant down-round protection provision
+Added: Net loss applicable to common stockholders
Net loss per share of common stock –
−Removed: Weighted average
−Removed: shares of common stock outstanding –
basic and diluted
−Removed: See accompanying notes to the consolidated
−Removed: financial statements.
+Added: Weighted average shares of common stock outstanding, including outstanding pre-funded warrants–
+Added: basic and diluted
+Added: See accompanying notes to the consolidated financial
Actinium Pharmaceuticals, Inc.
−Removed: Consolidated Statement of Changes in
−Removed: Stockholders’
−Removed: For the Period from January 1, 2020
−Removed: to March 31, 2020
−Removed: (amounts in thousands, except
−Removed: share amounts)
+Added: Consolidated Statement of Changes in Stockholders’
+Added: For the Three and Six Months Ended June 30,
+Added: (amounts in thousands, except share amounts)
Additional Paid-In
4 unchanged sentences
Balance, March 31, 2020
−Removed: See accompanying notes to the consolidated
−Removed: financial statements.
+Added: Stock-based compensation
+Added: Issuance of common stock from exercise of pre-funded warrants
+Added: Sale of common stock and pre-funded warrants, net of offering costs
+Added: Deemed dividend for warrant down-round protection provision
+Added: Balance, June 30, 2020
+Added: See accompanying notes to the consolidated financial
Actinium Pharmaceuticals, Inc.
−Removed: Consolidated Statement of Changes in
−Removed: Stockholders’
−Removed: For the Period from January 1, 2019
−Removed: to March 31, 2019
−Removed: (amounts in thousands, except
−Removed: share amounts)
+Added: Consolidated Statement of Changes in Stockholders’
+Added: For the Three and Six Months Ended June 30,
+Added: (amounts in thousands, except share amounts)
+Added: Additional Paid-In
Stockholders’
4 unchanged sentences
Balance, March 31, 2019
−Removed: See accompanying notes to the consolidated
−Removed: financial statements.
+Added: Stock-based compensation
+Added: Issuance of common stock from exercise of warrants
+Added: Sale of common stock and warrants, net of offering costs
+Added: Deemed dividend for warrant down-round protection provision
+Added: Balance, June 30, 2019
+Added: See accompanying notes to the consolidated financial
Actinium Pharmaceuticals, Inc.
1 unchanged sentence
(amounts in thousands)
−Removed: Three Months Ended
+Added: For the Six Months Ended
Cash Flows From Operating Activities:
13 unchanged sentences
Payments on finance leases
−Removed: Sales of shares of common stock, net of costs
+Added: Sales of shares of common stock and pre-funded warrants, net of costs
+Added: Sales of shares of common stock and warrants, net of costs
+Added: Proceeds from exercise of pre-funded warrants
Proceeds from exercise of warrants
6 unchanged sentences
Cash paid for taxes
−Removed: See accompanying notes to the consolidated
−Removed: financial statements.
+Added: Supplemental disclosure of non-cash flow information:
+Added: Deemed dividend for warrant down-round protection provision
+Added: See accompanying notes to the consolidated financial
Actinium Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
−Removed: Note 1 - Description of Business and
−Removed: Summary of Significant Accounting Policies
+Added: Note 1 - Description of Business and Summary
+Added: of Significant Accounting Policies
Nature of Business -
Actinium Pharmaceuticals, Inc.
−Removed: (the “Company”, “Actinium”, or “We”) is a clinical-stage,
−Removed: biopharmaceutical company applying its proprietary platform technology and deep understanding of radioimmunobiology to the development
−Removed: of novel targeted therapies known as ARCs or Antibody Radiation-Conjugates.
−Removed: Radiation is an effective therapeutic modality that
−Removed: is used in the treatment of over fifty percent of all cancer patients and often combined with chemotherapy and immunotherapy for
−Removed: greater therapeutic effect.
−Removed: Radiation is typically administered from outside the body, which constrains the amount that can be
−Removed: administered to patients due to dose-limiting toxicities.
−Removed: In addition, due to the diffuse nature of the external radiation beam,
−Removed: its usage is limited to solid tumors and cannot be used in blood cancers, which are diffuse.
−Removed: ARCs combine the cell-killing ability
−Removed: of a radioisotope payload with a targeting agent, such as a monoclonal antibody, or mAb, to deliver radiation inside the body
−Removed: to specific cells, to potentially generate greater efficacy and less toxicity.
−Removed: ARCs usage is broader than external delivered radiation
−Removed: as they can be used for both solid tumors and blood cancers.
−Removed: Blood or hematologic cancers are highly sensitive to radiation and
−Removed: our clinical pipeline is focused on ARCs targeting the antigens CD45 and CD33, both of which are expressed in multiple hematologic
−Removed: Our clinical programs are focused on two primary areas:
−Removed: targeted conditioning prior to a cell or gene therapy procedure
−Removed: and therapeutics, either in combination with other agents or as a monotherapy.
−Removed: Our product development strategy is actively informed
−Removed: by clinical data with our ARCs in over 500 patients, including the ongoing SIERRA trial.
−Removed: Our clinical pipeline has emanated from
−Removed: our AWE, or Antibody Warhead Enabling technology platform, which is protected by over 110 issued and pending patents, trade secrets
−Removed: and know-how and is being utilized in a collaborative research partnership with Astellas Pharma, Inc.
+Added: (the “Company”, “Actinium”, or “We”) is a clinical-stage, biopharmaceutical
+Added: company applying its proprietary platform technology and deep understanding of radioimmunobiology to the development of novel targeted
+Added: therapies known as ARCs or Antibody Radiation-Conjugates.
Basis of Presentation
14 unchanged sentences
report on Form 10-K for the year ended December 31, 2019.
+Added: Reverse Stock Split
+Added: - On April 29, 2020, the Company received a deficiency letter from the NYSE American LLC, or NYSE American, indicating that
+Added: the Company was not in compliance with the NYSE American continued listing standard set forth in Section 1003(f)(v) of the NYSE
+Added: American Company Guide because its shares of common stock had been selling for a substantial period of time at a low price per
+Added: Pursuant to Section 1003(f)(v) of the NYSE American Company Guide, the NYSE American staff determined that the Company’s
+Added: continued listing is predicated on the Company effecting a reverse stock split of its common stock or otherwise demonstrating sustained
+Added: price improvement within a reasonable period of time, which the staff determined to be no later than October 29, 2020.
+Added: On October 18, 2019, the
+Added: Company’s board of directors, or the Board, unanimously approved, subject to stockholder approval, an amendment to the Company’s
+Added: certificate of incorporation to effect a reverse stock split of its outstanding common stock by combining outstanding shares of
+Added: 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
+Added: 18, 2020, with the exact ratio to be set within this range by the Board at its sole discretion.
+Added: At its Annual Meeting of Stockholders
+Added: held on December 18, 2019, the Company’s stockholders approved such amendment to its certificate of incorporation.
+Added: On August 7, 2020, the Board unanimously approved a reverse
+Added: stock split of its outstanding common stock by combining outstanding shares of common stock into a lesser number of outstanding
+Added: 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
+Added: a certificate of amendment to its certificate of incorporation to effect the reverse stock split.
+Added: The reverse stock split became
+Added: effective as of 5:00 p.m.
+Added: Eastern Time on August 10, 2020, and the Company’s common stock began trading on a split-adjusted
+Added: basis when the market opened on August 11, 2020.
+Added: Accordingly, all common share and per common share data in these consolidated
+Added: financial statements and related notes hereto have been retroactively adjusted to account for the effect of this reverse stock
+Added: split for all periods presented.
+Added: In addition, at the effective time of the reverse stock split, the number of shares of our common
+Added: stock reserved for issuance upon exercise of all options and warrants to acquire common stock have been proportionally decreased,
+Added: 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
−Removed: Use of Estimates
−Removed: in Financial Statement Presentation - The preparation of these consolidated financial statements in conformity with U.S.
+Added: Use of Estimates in
+Added: 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
4 unchanged sentences
Pandemic on Financial Statements
−Removed: In December 2019,
−Removed: a novel strain of COVID-19 was reported in China.
+Added: In December 2019, a novel
+Added: strain of COVID-19 was reported in China.
Since then, COVID-19 has spread globally.
−Removed: The spread of COVID-19 from China
−Removed: to other countries has resulted in the World Health Organization (“WHO”) declaring the outbreak of COVID-19 as a “pandemic,”
+Added: The spread of COVID-19 from China to other
+Added: 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.
2 unchanged sentences
continue to have such restrictions in place.
−Removed: As local jurisdictions continue to put restrictions in place,
−Removed: the Company’s ability to continue to operate its business may also be limited.
−Removed: Such events may result in a period of business,
−Removed: supply and drug product manufacturing disruption, and in reduced operations, any of which could materially affect the Company’s
−Removed: business, financial condition and results of operations.
−Removed: In response to COVID-19, the Company implemented remote working and thus
−Removed: far, has not experienced a significant disruption or delay in its operations as it relates to the clinical development or drug
−Removed: production of our drug candidates.
+Added: As local jurisdictions
+Added: continue to put restrictions in place, the Company’s ability to continue to operate its business may also be limited.
+Added: events may result in a period of business, supply and drug product manufacturing disruption, and in reduced operations, any of
+Added: which could materially affect the Company’s business, financial condition and results of operations.
+Added: In response to COVID-19,
+Added: the Company implemented remote working and thus far, has not experienced a significant disruption or delay in its operations as
+Added: it relates to the clinical development or drug production of our drug candidates.
The spread of COVID-19,
1 unchanged sentence
While the ultimate economic impact brought
−Removed: by, and the duration of, the COVID-19 pandemic may be difficult to assess or predict, the pandemic has resulted significant disruptions
−Removed: in the general commercial activity and the global economy and caused financial market volatility and uncertainty in significant
−Removed: and unforeseen ways in the recent months.
−Removed: A continuation or worsening of the levels of market disruption and volatility seen in
−Removed: the recent past could have an adverse effect on the Company’s ability to access capital, which could in the future negatively
−Removed: affect the Company’s liquidity.
−Removed: In addition, a recession or market correction resulting from the spread of COVID-19 could
−Removed: materially affect the Company’s business and the value of the Company’s common stock.
−Removed: Additionally, COVID-19 may also result in delays in receiving
−Removed: approvals from local and foreign regulatory authorities, delays in necessary interactions with IRB’s or Institutional Review
−Removed: Boards, local and foreign regulators, ethics committees and other important agencies and contractors due to limitations in employee
−Removed: resources or forced furlough of government employees.
−Removed: To date, COVID-19 has
−Removed: not had a financial impact on the Company.
−Removed: However, COVID-19 has caused severe disruptions in transportation and limited access
−Removed: to the Company’s facility, resulting in limited support from its staff and professional advisors.
−Removed: The small size of the Company’s
−Removed: accounting staff and the additional responsibilities emanating from COVID-19 have presented difficulties to the Company’s
−Removed: ability to complete this Report on Form 10-Q in a timely manner, resulting in its delay.
−Removed: NYSE American
−Removed: Notification and Potential Reverse Stock Split
−Removed: On April 29, 2020,
−Removed: the Company received a deficiency letter from the NYSE American LLC, or NYSE American, indicating that the Company is not in compliance
−Removed: with the NYSE American continued listing standard set forth in Section 1003(f)(v) of the NYSE American Company Guide because its
−Removed: shares of common stock have been selling for a substantial period of time at a low price per share.
−Removed: Pursuant to Section 1003(f)(v)
−Removed: of the NYSE American Company Guide, the NYSE American staff determined that the Company’s continued listing is predicated
−Removed: on the Company effecting a reverse stock split of its common stock or otherwise demonstrating sustained price improvement within
−Removed: a reasonable period of time, which the staff determined to be no later than October 29, 2020.
−Removed: If the Company does
−Removed: not effectuate a reverse stock split to maintain compliance with NYSE American listing requirements, it could be delisted from
−Removed: the exchange.
−Removed: On October 18, 2019, the Company’s board of directors, or the Board, unanimously approved, subject to stockholder
−Removed: approval, an amendment to the Company’s certificate of incorporation to effect a reverse stock split of its outstanding
−Removed: common stock by combining outstanding shares of common stock into a lesser number of outstanding shares of common stock by a ratio
−Removed: 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
−Removed: At its Annual Meeting of Stockholders held on December 18, 2019, the Company’s stockholders approved such amendment
−Removed: to its certificate of incorporation.
−Removed: Upon the effectiveness of the amendment to its certificate of incorporation effecting the
−Removed: reverse stock split, the outstanding shares of its common stock will be reclassified and combined into a lesser number of shares
−Removed: such that one share of common stock will be issued for a specified number of shares.
−Removed: The Board has the sole
−Removed: discretion to effect the amendment and reverse stock split, and to fix the specific ratio for the reverse stock split, provided
−Removed: that the ratio would be not be more than 1-for-75.
−Removed: The reverse stock split would become effective upon the filing of an amendment
−Removed: to the Company’s certificate of incorporation with the Secretary of State of the State of Delaware, or at the later time
−Removed: set forth in the amendment.
−Removed: The exact timing of the amendment will be determined by the Board based on its evaluation as to when
−Removed: such action will be the most advantageous to the Company and its stockholders.
+Added: by, and the duration of, the COVID-19 pandemic may be difficult to assess or predict, including new information which may emerge
+Added: concerning the severity of COVID-19 and the actions to contain COVID-19 or treat its impact, among others, the pandemic has resulted
+Added: significant disruptions in the general commercial activity and the global economy and caused financial market volatility and uncertainty
+Added: in significant and unforeseen ways in the recent months.
+Added: A continuation or worsening of the levels of market disruption and volatility
+Added: seen in the recent past could have an adverse effect on the Company’s ability to access capital, which could in the future
+Added: negatively affect the Company’s liquidity.
+Added: In addition, a recession or market correction resulting from the spread of COVID-19
+Added: could materially affect the Company’s business and the value of the Company’s common stock.
+Added: Additionally, COVID-19
+Added: may result in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions
+Added: with IRB’s or Institutional Review Boards, local and foreign regulators, ethics committees and other important agencies and
+Added: contractors due to limitations in employee resources or forced furlough of government employees.
+Added: To date, COVID-19 has not
+Added: had a financial impact on the Company.
+Added: However, COVID-19 has caused severe disruptions in transportation and limited access to
+Added: the Company’s facility, resulting in limited support from its staff and professional advisors.
Cash, Cash Equivalents
2 unchanged sentences
Balances held by the Company are typically in excess of Federal Deposit Insurance Corporation insured limits.
−Removed: The following is a
−Removed: summary of cash, cash equivalents and restricted cash at March 31, 2020 and December 31, 2019:
+Added: The following is a summary
+Added: of cash, cash equivalents and restricted cash at June 30, 2020 and December 31, 2019:
(in thousands)
3 unchanged sentences
Cash, cash equivalents and restricted cash
−Removed: Current restricted
−Removed: cash relates to credit card accounts, while long-term restricted cash relates to a certificate of deposit held as collateral for
−Removed: a letter of credit issued in connection with the Company’s lease for corporate office space.
+Added: Current restricted cash
+Added: relates to credit card accounts, while long-term restricted cash relates to a certificate of deposit held as collateral for a letter
+Added: of credit issued in connection with the Company’s lease for corporate office space.
Leases –
−Removed: The Company has operating and finance leases for corporate office space, office equipment and furniture located at the corporate
−Removed: office space.
+Added: Company has operating and finance leases for corporate office space, office equipment and furniture located at the corporate office
Leases with an initial term of 12 months or less are not recorded on the balance sheet;
−Removed: lease expense for these leases
−Removed: is recognized on a straight-line basis over the lease term.
+Added: lease expense for these leases is
+Added: recognized on a straight-line basis over the lease term.
Fair Value of Financial
14 unchanged sentences
The Company accounts for forfeitures of stock options as they occur.
−Removed: Common Share - Basic loss per common share is computed by dividing the net loss available to common stockholders by the
−Removed: weighted average number of common shares outstanding during the reporting period.
−Removed: For periods of net income, and when the
−Removed: effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders
−Removed: by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting
−Removed: primarily of common shares underlying common stock options and warrants using the treasury stock method.
−Removed: For periods of net
−Removed: loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all potential dilutive
−Removed: common shares is anti-dilutive.
−Removed: For the three months ended March 31, 2020 and 2019, the Company’s potentially dilutive
−Removed: shares, which include outstanding common stock options and warrants have not been included in the computation of diluted net
−Removed: loss per share as the result would have been anti-dilutive.
+Added: Net Loss Per Common
+Added: Share - Basic loss per common share is computed by dividing the net loss available to common stockholders by the weighted
+Added: average number of common shares outstanding during the reporting period.
+Added: For periods of net income, and when the effects are not
+Added: anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted-average
+Added: number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common shares underlying
+Added: common stock options and warrants using the treasury stock method.
+Added: The Company issued pre-funded warrants in April 2020 and June
+Added: 2020 that are considered outstanding shares for the purposes of calculating net loss per common share, see Note 4 for additional
+Added: Since the shares underlying the outstanding 2.3 million pre-funded warrants are issuable for negligible consideration
+Added: and are fully vested and exercisable, they are considered outstanding for the calculations of both basic and diluted loss per
+Added: For periods of net loss,
+Added: diluted loss per share is calculated similarly to basic loss per share because the impact of all potential dilutive common shares
+Added: is anti-dilutive.
+Added: For the six months ended June 30, 2020 and 2019, the Company’s potentially dilutive shares, which include
+Added: outstanding common stock options and warrants have not been included in the computation of diluted net loss per share as the result
+Added: would have been anti-dilutive.
(in thousands)
1 unchanged sentence
Recently Adopted
−Removed: In August 2018, FASB
−Removed: issued ASU 2018-13, Fair Value Measurement - Disclosure Framework (Topic 820).
−Removed: The updated guidance improves the disclosure
−Removed: requirements on fair value measurements, primarily associated with Level 3 fair value measurements and is effective for fiscal
−Removed: years, and interim periods within those fiscal years, beginning after December 15, 2019.
−Removed: Early adoption is permitted upon issuance
−Removed: of the standard for disclosures modified or removed with a delay of adoption of the additional disclosures until their effective
−Removed: The Company adopted this standard effective January 1, 2020 and the standard did not have a significant impact to the Company’s
−Removed: financial statements.
−Removed: In November 2018,
−Removed: FASB issued ASU 2018-18, C ollaborative Arrangements (Topic 808):
−Removed: Clarifying the Interaction Between Topic 808 and Topic 606,
−Removed: which, among other things, provides guidance on how to assess whether certain collaborative arrangement transactions should
−Removed: be accounted for under Topic 606.
−Removed: The amendments in this ASU are effective for fiscal years, and interim periods within those
−Removed: fiscal years, beginning after December 15, 2019, with early adoption permitted.
+Added: In August 2018, FASB issued
+Added: ASU 2018-13, Fair Value Measurement - Disclosure Framework (Topic 820).
+Added: The updated guidance improves the disclosure requirements
+Added: on fair value measurements, primarily associated with Level 3 fair value measurements and is effective for fiscal years, and interim
+Added: periods within those fiscal years, beginning after December 15, 2019.
+Added: Early adoption is permitted upon issuance of the standard
+Added: for disclosures modified or removed with a delay of adoption of the additional disclosures until their effective date.
+Added: adopted this standard effective January 1, 2020 and the standard did not have a significant impact to the Company’s financial
+Added: In November 2018, FASB
+Added: issued ASU 2018-18, C ollaborative Arrangements (Topic 808):
+Added: Clarifying the Interaction Between Topic 808 and Topic 606, which,
+Added: among other things, provides guidance on how to assess whether certain collaborative arrangement transactions should be accounted
+Added: for under Topic 606.
+Added: The amendments in this ASU are effective for fiscal years, and interim periods within those fiscal years,
+Added: beginning after December 15, 2019, with early adoption permitted.
The Company adopted this standard effective January 1, 2020
7 unchanged sentences
The Company is contracted to purchase radioactive material to be used for research and development, with a renewal option at the contract end.
−Removed: During the three months ended March 31, 2020 and 2019, the Company purchased material from ORNL of $0.1 million in each period.
+Added: 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.
4 unchanged sentences
Upon commercial sale of the drug, royalty payments of 2% of net sales will be due to FHCRC.
−Removed: On February 16, 2016, the Company entered into an agreement with Medpace, Inc.
−Removed: (“Medpace”), a contract research organization.
−Removed: Medpace provides project management services for the Iomab-B study.
−Removed: In January 2020, the Company and Medpace amended their agreement.
−Removed: The total project is currently estimated to cost $11.9 million.
−Removed: Medpace bills the Company when services are rendered and the Company records the related expense to research and development costs.
−Removed: During the three months ended March 31, 2020 and 2019, the Company paid Medpace $1.5 million and $0.4 million, respectively.
−Removed: These payments are for Medpace project management services and pass-through expenses incurred by investigators and clinical sites.
Collaborative Agreement
9 unchanged sentences
Note 3 - Leases
−Removed: The Company adopted
−Removed: ASC 842 as of January 1, 2019, using a modified retrospective approach and applying the standard’s transition provisions
−Removed: at January 1, 2019, the effective date.
−Removed: The Company made an accounting policy election to exclude from balance sheet reporting
−Removed: those leases with initial terms of 12 months or less.
+Added: The Company adopted ASC
+Added: 842 as of January 1, 2019, using a modified retrospective approach and applying the standard’s transition provisions at January
+Added: 1, 2019, the effective date.
+Added: The Company made an accounting policy election to exclude from balance sheet reporting those leases
+Added: with initial terms of 12 months or less.
The Company determines
9 unchanged sentences
lease components are recognized when the obligation is probable.
−Removed: Right-of-use assets
−Removed: and liabilities are recognized at commencement date based on the present value of lease payments over the lease term.
+Added: Right-of-use assets and
+Added: liabilities are recognized at commencement date based on the present value of lease payments over the lease term.
ASC 842 requires
4 unchanged sentences
of lease payments.
−Removed: The lease term for
−Removed: all of the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered by either
−Removed: a Company option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option to
−Removed: extend (or not to terminate) the lease controlled by the lessor.
−Removed: Options for lease renewals have been excluded from the lease term
−Removed: (and lease liability) for the majority of the Company’s leases as the reasonably certain threshold is not met.
−Removed: At March 31, 2020,
−Removed: the Company has an operating lease for corporate office space and two finance leases for office equipment and furniture located
−Removed: in the corporate office space.
−Removed: In addition, the Company has auxiliary corporate office space that it rents on a month-to-month
−Removed: this rental is accounted for as an operating lease with the same term as the Company’s main office in the same building.
+Added: The lease term for all
+Added: of the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered by either a
+Added: Company option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option to extend
+Added: (or not to terminate) the lease controlled by the lessor.
+Added: Options for lease renewals have been excluded from the lease term (and
+Added: lease liability) for the majority of the Company’s leases as the reasonably certain threshold is not met.
+Added: At June 30, 2020, the Company
+Added: has an operating lease for corporate office space and two finance leases for office equipment and furniture located in the corporate
+Added: office space.
+Added: In addition, the Company has auxiliary corporate office space that it rents on a month-to-month basis;
+Added: 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:
Three months ended
+Added: Six months ended
(in thousands)
−Removed: March 31, 2020
−Removed: March 31, 2019
Operating lease expense
3 unchanged sentences
Total finance lease cost
−Removed: Supplemental cash flow information related
−Removed: to leases are as follows:
+Added: Supplemental cash flow information related to
+Added: leases are as follows:
Cash flow information:
−Removed: Three months ended
+Added: Six months ended
(in thousands)
7 unchanged sentences
Finance Leases
−Removed: Weighted average remaining lease terms are as follows at March
+Added: Weighted average remaining lease terms are as
+Added: follows at June 30, 2020:
Weighted average remaining lease term:
8 unchanged sentences
Finance Leases
−Removed: Maturities of lease
−Removed: liabilities are as follows:
−Removed: (in thousands)
+Added: Maturities of lease liabilities
+Added: are as follows:
Year ending December 31,
−Removed: Operating Leases
−Removed: Finance Leases
−Removed: 2020 (excluding three months ended March 31, 2020)
+Added: 2020 (excluding six months
+Added: ended June 30, 2020)
Total lease payments
2 unchanged sentences
Note 4 - Equity
+Added: On August 7, 2020,
+Added: the Board unanimously approved a reverse stock split of its outstanding common stock by combining outstanding shares of common
+Added: 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
+Added: with the Secretary of State of Delaware a certificate of amendment to its certificate of incorporation to effect the reverse stock
+Added: Accordingly, all common share and per common share data in these consolidated financial statements and related notes hereto
+Added: have been retroactively adjusted to account for the effect of this reverse stock split for all periods presented.
+Added: On April 24, 2020,
+Added: the Company issued and sold 4.3 million shares of common stock and 2.8 million pre-funded warrants to purchase shares of common
+Added: 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.
+Added: Each pre-funded warrant has an exercise price of $0.003 per share and is exercisable immediately upon issuance.
+Added: The pre-funded
+Added: warrants are subject to certain limitations on beneficial ownership.
+Added: Gross proceeds from this offering to Actinium were $31.6 million,
+Added: before deducting underwriting discounts and commissions and other offering expenses payable by the Company.
+Added: Net proceeds from this
+Added: offering were $29.1 million.
+Added: In June 2020, holders
+Added: 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
+Added: On June 19, 2020, the
+Added: Company issued and sold 1.9 million shares of common stock and 0.7 million pre-funded warrants to purchase shares of common stock.
+Added: 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.
+Added: pre-funded warrant has an exercise price of $0.003 per share and is exercisable immediately upon issuance.
+Added: The pre-funded warrants
+Added: are subject to certain limitations on beneficial ownership.
+Added: Gross proceeds from this offering to Actinium were $25.0 million, before
+Added: deducting underwriting discounts and commissions and other offering expenses payable by the Company.
+Added: Net proceeds from this offering
+Added: were $23.0 million.
In December 2018, the
2 unchanged sentences
and JonesTrading Institutional
−Removed: Services LLC (the “ATM Sales Agreement”), pursuant to which the Company conducted its at-the market program.
−Removed: the three months ended March 31, 2020, the Company sold 9.3 million common shares through its at-the-market program, resulting
−Removed: in net proceeds of $2.5 million.
−Removed: During the three months ended March 31, 2019, the Company sold 0.9 million common shares through
−Removed: its at-the-market program, resulting in net proceeds of $0.4 million.
+Added: Services LLC, pursuant to which the Company conducted its at-the market program.
+Added: During the six months ended June 30, 2020, the
+Added: 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
−Removed: Company and Lincoln Park Capital Fund, LLC (“Lincoln Park”) entered into a purchase agreement (the “Lincoln
−Removed: Park Agreement”) and a registration rights agreement, pursuant to which the Company has the right to sell to Lincoln Park
−Removed: shares of the Company’s common stock having an aggregate value of up to $32.5 million, subject to certain limitations and
−Removed: conditions set forth in the agreement.
−Removed: During the three months ended March 31, 2020, the Company elected to sell to Lincoln Park
−Removed: 0.8 million shares and received $0.2 million.
−Removed: For the three months
−Removed: ended March 2019, holders of March 2018 series A warrants exercised 2.5 million shares, resulting in the Company receiving $1.5
+Added: Company and Lincoln Park Capital Fund, LLC (“Lincoln Park”) entered into a purchase agreement and a registration rights
+Added: agreement, pursuant to which the Company has the right to sell to Lincoln Park shares of the Company’s common stock having
+Added: an aggregate value of up to $32.5 million, subject to certain limitations and conditions set forth in the agreement.
+Added: six months ended June 30, 2020, the Company elected to sell to Lincoln Park 27 thousand shares and received $0.2 million.
+Added: In June 2020, the Company
+Added: issued 5 thousand shares of restricted common stock, valued at $30 thousand, for consulting services.
+Added: For the six months
+Added: ended June 30, 2019, holders of March 2018 series A warrants exercised 83 thousand shares, resulting in the Company receiving $1.5
The remaining March 2018 series A warrants expired in March 2019.
−Removed: Authorization for Reverse Stock Split
−Removed: At the Company’s
−Removed: Annual Meeting of Stockholders held on December 18, 2019, its stockholders approved an amendment to the Company’s certificate
−Removed: of incorporation to effect a reverse stock split of its outstanding common stock by combining outstanding shares of common stock
−Removed: 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
−Removed: the exact ratio to be set within this range by the Company’s Board of Directors, or Board, at its sole discretion.
−Removed: may alternatively elect to abandon such proposed amendment and not effect the reverse stock split authorized by stockholders,
−Removed: in its sole discretion.
−Removed: For more information on the potential reverse stock split, please see Note 1—Description of Business
−Removed: and Summary of Significant Accounting Policies herein.
+Added: The Company has outstanding
+Added: warrants to purchase 1,907 shares of common stock that include down-round protection.
+Added: For warrants with down-round protection,
+Added: a deemed dividend is recorded for the change in fair value of the warrants when the down-round provision is triggered.
+Added: of the April 2019 offering, the exercise price of the warrant was reset from $37.50 per share to $26.40 per share.
+Added: 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
+Added: The down-round protection provision in the above warrants created a deemed dividend to common stockholders of $1 thousand
+Added: in the six months ended June 30, 2020 and 2019, which are reflected in the accompanying consolidated statement of operations and
+Added: consolidated statement of changes in stockholders’
Stock Options
−Removed: The following is a
−Removed: summary of stock option activity for the three months ended March 31, 2020:
+Added: The following is a summary
+Added: of stock option activity for the six months ended June 30, 2020:
(in thousands, except for per-share amounts)
1 unchanged sentence
Outstanding, December 31, 2019
−Removed: Outstanding, March 31, 2020
−Removed: Exercisable, March 31, 2020
−Removed: During the three months
−Removed: ended March 31, 2020, options to purchase 0.3 million shares were cancelled upon the termination of employment for several employees.
−Removed: The fair values of
−Removed: all options issued and outstanding are being amortized over their respective vesting periods.
+Added: Outstanding, June 30, 2020
+Added: Exercisable, June 30, 2020
+Added: During the six months
+Added: ended June 30, 2020, options to purchase 15 thousand shares were cancelled upon the termination of employment for several employees.
+Added: The fair values of all
+Added: options issued and outstanding are being amortized over their respective vesting periods.
The unrecognized compensation expense
−Removed: at March 31, 2020 was $1.7 million related to unvested options, which is expected to be expensed over a weighted average of 3.0
−Removed: During the three months ended March 31, 2020 and 2019, the Company recorded compensation expense related to stock options
−Removed: of $0.4 million and $0.3 million, respectively.
+Added: 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
+Added: During the six months ended June 30, 2020 and 2019, the Company recorded compensation expense related to stock options of
+Added: $0.5 million and $0.3 million, respectively.
+Added: Pre-funded Warrants
+Added: As part of the April
+Added: 2020 offering and the June 2020 offering, the Company issued pre-funded warrants.
+Added: Each pre-funded warrant has an exercise price
+Added: of $0.003 per share and is exercisable immediately upon issuance.
+Added: The pre-funded warrants are subject to certain limitations on
+Added: beneficial ownership.
+Added: The pre-funded warrants do not have an expiration date.
+Added: Management determined that the pre-funded warrants
+Added: are freestanding instruments and that the pre-funded warrants should be classified as permanent equity in accordance with authoritative
Following is a summary
−Removed: of warrant activity for the three months ended March 31, 2020:
+Added: of pre-funded warrant activity for the six months ended June 30, 2020.
(in thousands, except for per-share amounts)
1 unchanged sentence
Outstanding, December 31, 2019
+Added: Outstanding, June 30, 2020
+Added: Exercisable, June 30, 2020
+Added: Following is a summary
+Added: of warrant activity for the six months ended June 30, 2020:
+Added: (in thousands, except for per-share amounts)
+Added: Number of Shares
+Added: Outstanding, December 31, 2019
Cancelled/Expired
−Removed: Outstanding, March 31, 2020
−Removed: Exercisable, March 31, 2020
+Added: Outstanding, June 30, 2020
+Added: Exercisable, June 30, 2020
Subsequent Events
−Removed: In April 2020, the
−Removed: Company sold 171 thousand shares of common stock through its at-the-market program and realized net proceeds of $35 thousand.
−Removed: On April 24, 2020,
−Removed: the Company issued and sold 128.3 million shares of common stock and 82.5 million pre-funded warrants to purchase shares of common
−Removed: The price to the public in this offering for each share of common stock was $0.15 and for each pre-funded warrant was $0.1499.
−Removed: Each pre-funded warrant has an exercise price of $0.0001 per share and is exercisable immediately upon issuance.
−Removed: are subject to certain limitations on beneficial ownership.
−Removed: Gross proceeds from this offering to Actinium were $31.6 million,
−Removed: before deducting underwriting discounts and commissions and other offering expenses payable by the Company.
−Removed: Net proceeds from
−Removed: this offering were $29.1 million.
−Removed: In June 2020, holders
−Removed: of 36.0 million pre-funded warrants exercised their warrants at $0.0001 per share and received 36.0 million shares of common stock.
−Removed: In June 2020, the
−Removed: Company issued 157 thousand shares of restricted common stock for consulting services.
−Removed: On June 19, 2020, the Company issued and sold 55.7 million shares of common stock and 21.3 million pre-funded warrants to
−Removed: purchase shares of common stock.
−Removed: The price to the public in this offering for each share of common stock was $0.325 and for
−Removed: each pre-funded warrant was $0.3249.
−Removed: Each pre-funded warrant has an exercise price of $0.0001 per share and is exercisable
−Removed: immediately upon issuance.
−Removed: The warrants are subject to certain limitations on beneficial ownership.
−Removed: Gross proceeds from this
−Removed: offering to Actinium were $25.0 million, before deducting underwriting discounts and commissions and other offering expenses
−Removed: payable by the Company.
−Removed: Net proceeds from this offering were $22.8 million.
−Removed: In connection with the Company’s June 2020 public offering,
−Removed: the Company suspended, and during the duration of the June 2020 public offering did not offer, any securities pursuant to the Lincoln
−Removed: Park Agreement and the ATM Sales Agreement.
−Removed: The Company will not make any sales of securities pursuant to the Lincoln Park Agreement
−Removed: and the ATM Sales Agreement unless and until a new prospectus supplement is filed with the SEC;
−Removed: however, the Lincoln Park Agreement
−Removed: and the ATM Sales Agreement remain in full force and effect.
+Added: In July 2020, holders
+Added: 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
+Added: shares of common stock.
+Added: Holders of 2 thousand April 2019 warrants exercised their warrants at $15.00 per share and received 2 thousand
+Added: In August 2020, the
+Added: Company filed a registration statement including a base prospectus which covers the offering, issuance and sale of up to $500 million
+Added: of common stock, preferred stock, warrants, units and/or subscription rights;
+Added: and a sales agreement prospectus covering the offering,
+Added: issuance and sale of up to a maximum aggregate offering price of $200 million of common stock that may be issued and sold under
+Added: the Capital on Demand™
+Added: Sales Agreement with JonesTrading Institutional Services LLC.
+Added: Since June 30, 2020, the
+Added: Company has issued stock options for 357,189 shares to employees and 33,332 shares to non-employee directors.
MANAGEMENT’S DISCUSSION
3 unchanged sentences
certain forward-looking statements.
−Removed: For this purpose, any statements contained in this Form 10-Q that are not statements of historical
−Removed: fact may be deemed to be forward-looking statements.
−Removed: Without limiting the foregoing, words such as “may,”
+Added: For this purpose, any statements contained in this Form 10-Q that are
+Added: not statements of historical fact may be deemed to be forward-looking statements.
+Added: Without limiting the foregoing, words such
+Added: as “may,”
“will,”
4 unchanged sentences
or “continue”
−Removed: or comparable
−Removed: terminology are intended to identify forward-looking statements.
−Removed: These statements by their nature involve substantial risks
−Removed: and uncertainties, and actual results may differ materially depending on a variety of factors, many of which are not within our
−Removed: These factors include but are not limited to economic conditions generally and in the industries in which we may
−Removed: competition within our chosen industry, including competition from much larger competitors;
−Removed: technological advances
−Removed: and failure to successfully develop business relationships.
+Added: or comparable terminology are intended to identify forward-looking statements.
+Added: These statements
+Added: by their nature involve substantial risks and uncertainties, and actual results may differ materially depending on a variety of
+Added: factors, many of which are not within our control.
+Added: These factors include but are not limited to economic conditions generally
+Added: and in the industries in which we may participate;
+Added: competition within our chosen industry, including competition from much larger
+Added: technological advances and failure to successfully develop business relationships.
Description of Business
Actinium Pharmaceuticals,
−Removed: 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.
−Removed: Radiation is an effective
−Removed: therapeutic modality that is used in the treatment of over fifty percent of all cancer patients and often combined with chemotherapy
−Removed: and immunotherapy for greater therapeutic effect.
−Removed: Radiation is typically administered from outside the body, which constrains
−Removed: the amount that can be administered to patients due to dose-limiting toxicities.
−Removed: In addition, due to the diffuse nature of the
−Removed: external radiation beam, its usage is limited to solid tumors and cannot be used in blood cancers, which are diffuse.
−Removed: the cell-killing ability of a radioisotope payload with a targeting agent, such as a monoclonal antibody, or mAb, to deliver radiation
−Removed: inside the body to specific cells, to potentially generate greater efficacy and less toxicity.
−Removed: ARCs usage is broader than external
−Removed: delivered radiation as they can be used for both solid tumors and blood cancers.
−Removed: Blood or hematologic cancers are highly sensitive
−Removed: to radiation and our clinical pipeline is focused on ARCs targeting the antigens CD45 and CD33, both of which are expressed in
−Removed: multiple hematologic cancers.
+Added: is a clinical-stage, biopharmaceutical company applying its proprietary platform technology and deep understanding of radioimmunobiology
+Added: to the development of novel targeted therapies known as ARCs or Antibody Radiation-Conjugates.
+Added: Radiation is an effective therapeutic
+Added: modality that is used in the treatment of over fifty percent of all cancer patients and often combined with chemotherapy and immunotherapy
+Added: for greater therapeutic effect.
+Added: Radiation is typically administered from outside the body, which constrains the amount that can
+Added: be administered to patients due to dose-limiting toxicities.
+Added: In addition, due to the diffuse nature of the external radiation beam,
+Added: its usage is limited to solid tumors and cannot be used in blood cancers, which are diffuse.
+Added: ARCs combine the cell-killing ability
+Added: of a radioisotope payload with a targeting agent, such as a monoclonal antibody, or mAb, to deliver radiation inside the body to
+Added: specific cells, to potentially generate greater efficacy and less toxicity.
+Added: ARCs usage is broader than external delivered radiation
+Added: as they can be used for both solid tumors and blood cancers.
+Added: Blood or hematologic cancers are highly sensitive to radiation and
+Added: 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:
−Removed: targeted conditioning prior to a cell or
−Removed: gene therapy procedure and therapeutics, either in combination with other agents or as a monotherapy.
−Removed: Our product development
−Removed: strategy is actively informed by clinical data with our ARCs in over 500 patients, including the ongoing SIERRA trial.
−Removed: pipeline has emanated from our AWE, or Antibody Warhead Enabling technology platform, which is protected by over 110 issued and
−Removed: pending patents, trade secrets and know-how and is being utilized in a collaborative research partnership with Astellas Pharma, Inc..
−Removed: We are advancing the
−Removed: only multi-target, multi-indication clinical-stage pipeline for targeted conditioning and the only ARC-based targeted conditioning
−Removed: regimens in development.
−Removed: Our ARCs for targeted conditioning are intended to potentially enable improved access to cell-based therapies
−Removed: with curative potential, including BMT, or bone marrow transplant, ACT, or adoptive cell therapy such as CAR-T, and Gene Therapy,
−Removed: as well as improved outcomes.
−Removed: Conditioning in the context of BMT, ACT or Gene Therapy is the act of depleting certain blood and
−Removed: immune-forming cells, including bone marrow stem cells and, in some cases, diseased cells prior to transplanting new cells into
−Removed: Currently, conditioning is accomplished using a combination of chemotherapeutic agents and external radiation.
−Removed: non-targeted conditioning regimens may prevent a patient from receiving a potentially curative therapy and hinder outcomes due
−Removed: to their toxicities.
−Removed: ARCs have the potential to increase patient access and outcomes by way of their ability to selectively deplete
−Removed: targeted cells while sparing normal healthy cells.
−Removed: We use our ARCs at high isotope dose levels to achieve myeloablation, which
−Removed: fully depletes bone marrow stem cells and at lower isotope dose levels to achieve lymphodepletion, which spares bone marrow stem
−Removed: cells from depletion.
−Removed: In addition, dosing may be titrated downward from myeloablative doses to achieve partial myeloablation, which
−Removed: may be appropriate for certain gene therapy programs.
+Added: targeted conditioning prior to a cell or gene therapy procedure
+Added: and therapeutics, either in combination with other agents or as a monotherapy.
+Added: Our product development strategy is actively informed
+Added: by clinical data with our ARCs in over 500 patients, including the ongoing SIERRA trial.
+Added: Our clinical pipeline has emanated from
+Added: our AWE, or Antibody Warhead Enabling technology platform, which is protected by over 120 issued and pending patents, trade secrets
+Added: and know-how and is being utilized in a collaborative research partnership with Astellas Pharma, Inc.
+Added: We are advancing the only
+Added: multi-target, multi-indication clinical-stage pipeline for targeted conditioning and the only ARC-based targeted conditioning regimens
+Added: in development.
+Added: Our ARCs for targeted conditioning are intended to potentially enable improved access to cell-based therapies with
+Added: curative potential, including BMT, or bone marrow transplant, ACT, or adoptive cell therapy such as CAR-T, and Gene Therapy, as
+Added: well as improved outcomes.
+Added: Conditioning in the context of BMT, ACT or Gene Therapy is the act of depleting certain blood and immune-forming
+Added: cells, including bone marrow stem cells and, in some cases, diseased cells prior to transplanting new cells into a patient.
+Added: conditioning is accomplished using a combination of chemotherapeutic agents and external radiation.
+Added: These non-targeted conditioning
+Added: regimens may prevent a patient from receiving a potentially curative therapy and hinder outcomes due to their toxicities.
+Added: have the potential to increase patient access and outcomes by way of their ability to selectively deplete targeted cells while
+Added: sparing normal healthy cells.
+Added: We use our ARCs at high isotope dose levels to achieve myeloablation, which fully depletes bone marrow
+Added: stem cells and at lower isotope dose levels to achieve lymphodepletion, which spares bone marrow stem cells from depletion.
+Added: addition, dosing may be titrated downward from myeloablative doses to achieve partial myeloablation, which may be appropriate for
+Added: certain gene therapy programs.
CD45 Targeted Conditioning Program
25 unchanged sentences
for malignant and non-malignant diseases.
−Removed: Our lead CD45
−Removed: targeted conditioning product candidate is Iomab-B, which uses high doses of I-131 to achieve myeloablative conditioning
−Removed: prior to a BMT.
−Removed: Iomab-B is currently being studied in the pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory
−Removed: AML, or SIERRA, clinical trial for targeted conditioning prior to an allogeneic BMT for patients with active, relapsed or
−Removed: refractory (r/r) Acute Myeloid Leukemia, or AML, who are age 55 or older.
−Removed: Patients with active, r/r AML are not normally
−Removed: considered eligible for BMT and the SIERRA trial is the only randomized Phase 3 trial to offer BMT as a treatment option for
−Removed: this patient population.
−Removed: The SIERRA trial compares outcomes of patients randomized to receive Iomab-B and a BMT (the study
−Removed: arm) to those patients randomized to receive physician’s choice of salvage chemotherapy (the control arm).
−Removed: chemotherapy is also defined as conventional care, as no standard of care exists for this patient population.
−Removed: fail to achieve a CR or Complete Response on the control arm are ineligible to proceed to a BMT, but the trial design permits
−Removed: these patients to “cross over”
−Removed: to receive the study arm treatment if they meet the eligibility criteria.
−Removed: primary endpoint of the SIERRA trial is durable Complete Remission, or dCR, of six months and the secondary endpoint is
−Removed: one-year Overall Survival, or OS.
−Removed: When the crossover patients receive Iomab-B and BMT, they have not achieved remission with
−Removed: their salvage therapy and are considered to be failures for the primary endpoint of the study.
−Removed: The SIERRA trial is currently
−Removed: active at 20 sites in the United States and Canada, which includes many of the leading BMT sites based on volume.
−Removed: to complete enrollment of the SIERRA trial and have topline data that we believe will support the submission of a Biologics
−Removed: License Application, or BLA, with the U.S.
+Added: Our lead CD45 targeted
+Added: conditioning product candidate is Iomab-B, which uses high doses of I-131 to achieve myeloablative conditioning prior to a BMT.
+Added: Iomab-B is currently being studied in the pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory AML, or SIERRA, clinical
+Added: trial for targeted conditioning prior to an allogeneic BMT for patients with active, relapsed or refractory (r/r) Acute Myeloid
+Added: Leukemia, or AML, who are age 55 or older.
+Added: Patients with active, r/r AML are not normally considered eligible for BMT and the SIERRA
+Added: trial is the only randomized Phase 3 trial to offer BMT as a treatment option for this patient population.
+Added: The SIERRA trial compares
+Added: outcomes of patients randomized to receive Iomab-B and a BMT (the study arm) to those patients randomized to receive physician’s
+Added: choice of salvage chemotherapy (the control arm).
+Added: Salvage chemotherapy is also defined as conventional care, as no standard of
+Added: care exists for this patient population.
+Added: Patients who fail to achieve a CR or Complete Response on the control arm are ineligible
+Added: to proceed to a BMT, but the trial design permits these patients to “cross over”
+Added: to receive the study arm treatment
+Added: if they meet the eligibility criteria.
+Added: The primary endpoint of the SIERRA trial is durable Complete Remission, or dCR, of six months
+Added: and the secondary endpoint is one-year Overall Survival, or OS.
+Added: When the crossover patients receive Iomab-B and BMT, they have
+Added: not achieved remission with their salvage therapy and are considered to be failures for the primary endpoint of the study.
+Added: SIERRA trial is currently active at 20 sites in the United States and Canada, which includes many of the leading BMT sites based
+Added: We expect to complete enrollment of the SIERRA trial and have topline data that we believe will support the submission
+Added: of a Biologics License Application, or BLA, with the U.S.
Food and Drug Administration, or FDA, in 2021.
−Removed: If approved, we expect our initial
−Removed: commercial launch would target the leading 50-100 BMT and medical centers that perform the vast majority of BMT’s in
−Removed: the United States.
+Added: If approved, we expect
+Added: our initial commercial launch would target the leading 50-100 BMT and medical centers that perform the vast majority of BMT’s
+Added: in the United States.
In the European Union or EU, we received favorable feedback from the European Medicines Agency or EMA via
−Removed: their scientific advice program that the trial design, primary endpoint and planned statistical analysis from the SIERRA
−Removed: trial are acceptable as the basis for a Marketing Authorization Application or MAA.
−Removed: Additionally, the EMA commented that it
−Removed: does not anticipate the need for further standalone preclinical toxicology or safety studies.
−Removed: Overall, transplant procedures
−Removed: in the EU are approximately fifty percent higher than in the United States with a similar market dynamic with a majority of
−Removed: BMT volume being conducted in a concentrated number of leading medical centers.
−Removed: We intend to secure a partner for Iomab-B in
+Added: their scientific advice program that the trial design, primary endpoint and planned statistical analysis from the SIERRA trial
+Added: are acceptable as the basis for a Marketing Authorization Application or MAA.
+Added: Additionally, the EMA commented that it does not
+Added: anticipate the need for further standalone preclinical toxicology or safety studies.
+Added: Overall, transplant procedures in the EU are
+Added: approximately fifty percent higher than in the United States with a similar market dynamic with a majority of BMT volume being
+Added: conducted in a concentrated number of leading medical centers.
+Added: We intend to secure a partner for Iomab-B in the EU.
Safety and feasibility
21 unchanged sentences
The SIERRA trial is
−Removed: powered for up to two interim analyses of the primary endpoint exercisable at our discretion and triggered by an enrollment range
−Removed: of 70 to 110 patients to evaluate, the primary endpoint of dCR of 180 days.
−Removed: We intend to exercise an ad-hoc analysis, basing our
−Removed: decision to do so on the data reported from SIERRA thus far and comfort with the pace and current status of enrollment as of April
−Removed: 2020, which could generate topline data for the primary endpoint in late 2020 and early termination of the trial if positive.
−Removed: 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
−Removed: on the number of patients included in the ad-hoc analysis.
−Removed: Our Iomab-ACT program
−Removed: is intended for targeted conditioning prior to ACT or Gene Therapy and uses the same 131 I-apamistamab ARC construct
−Removed: as Iomab-B at varying doses.
+Added: powered for up to two interim analyses of the primary endpoint of dCR of 180 days exercisable at our discretion and triggered by
+Added: an enrollment range of 70 to 110 patients.
+Added: We exercised a single ad-hoc analysis in the second quarter of 2020, based on the data
+Added: reported from SIERRA thus far and the status of enrollment at the time of triggering our ad hoc analysis.
+Added: The ad hoc analysis is
+Added: expected to be completed by the end of 2020, which could generate topline data for the primary endpoint and early termination of
+Added: the trial if positive.
+Added: Based on the statistical plan of the study, a single ad-hoc analysis would result in a minimal alpha spend
+Added: of no more than 0.00925, depending on the number of patients included in the ad-hoc analysis.
+Added: Our Iomab-ACT program is
+Added: intended for targeted conditioning prior to ACT or Gene Therapy and uses the same 131 I-apamistamab ARC construct as
+Added: Iomab-B at varying doses.
At lower doses of one-eighth to one-sixth of the myeloablative dose, it is applicable for lymphodepletion
2 unchanged sentences
for Gene Therapy applications where stem cell myeloablation is necessary.
−Removed: In January 2020,
−Removed: we announced a collaboration with University of California Davis to utilize Iomab-ACT conditioning in an ongoing Phase 1/2
−Removed: trial with a novel anti-HIV autologous stem cell gene therapy for patients with HIV-related lymphoma.
−Removed: We believe this to be
−Removed: the first Gene Therapy trial to use an ARC-based conditioning regimen.
−Removed: 131 I-Apamistamab has clinical proof of
−Removed: concept as a targeted conditioning regimen for patients with high-risk, relapsed or refractory lymphoma prior to an
−Removed: autologous stem cell transplant from a previous study, where a favorable safety profile with no dose-limiting toxicities and
−Removed: minimal non-hematologic toxicities were observed and promising efficacy with median overall survival not reached (range:
−Removed: months to not reached) and 31% of patients in prolonged remission at a median of 36 months follow up (range:
−Removed: In this study, Iomab-ACT is intended to replace the chemotherapy-based condition regimen known as BEAM
−Removed: (BCNU/carmustine, etoposide, cytarabine, and melphalan) to simultaneously kill the patient’s lymphoma cells and deplete
−Removed: the patient’s stem cells to make room for the transplant.
−Removed: Upon engraftment, the transplanted gene-modified autologous
−Removed: stem cells containing three anti-HIV genes are intended to equip the patient with a new immune system that is resistant to
−Removed: the HIV virus.
−Removed: Iomab-ACT will be substituted for BEAM in the ongoing Phase 1/2 trial and we expect to have clinical proof of
−Removed: concept data in 2021.
+Added: In January 2020, we announced
+Added: a collaboration with University of California Davis to utilize Iomab-ACT conditioning in an ongoing Phase 1/2 trial with a novel
+Added: anti-HIV autologous stem cell gene therapy for patients with HIV-related lymphoma.
+Added: We believe this to be the first Gene Therapy
+Added: trial to use an ARC-based conditioning regimen.
+Added: 131 I-Apamistamab has clinical proof of concept as a targeted conditioning
+Added: regimen for patients with high-risk, relapsed or refractory lymphoma prior to an autologous stem cell transplant from a previous
+Added: study, where a favorable safety profile with no dose-limiting toxicities and minimal non-hematologic toxicities were observed and
+Added: promising efficacy with median overall survival not reached (range:
+Added: 29 months to not reached) and 31% of patients in prolonged
+Added: remission at a median of 36 months follow up (range:
+Added: In this study, Iomab-ACT is intended to replace the
+Added: chemotherapy-based condition regimen known as BEAM (BCNU/carmustine, etoposide, cytarabine, and melphalan) to simultaneously kill
+Added: the patient’s lymphoma cells and deplete the patient’s stem cells to make room for the transplant.
+Added: Upon engraftment,
+Added: the transplanted gene-modified autologous stem cells containing three anti-HIV genes are intended to equip the patient with a new
+Added: immune system that is resistant to the HIV virus.
+Added: Iomab-ACT will be substituted for BEAM in the ongoing Phase 1/2 trial and we
+Added: expect to have clinical proof of concept data in 2021.
We believe our Iomab-ACT
21 unchanged sentences
CD33 Program:
−Removed: Targeted Conditioning,
−Removed: Combinations and Therapeutics
−Removed: Our CD33 program is
−Removed: evaluating the clinical utility of an ARC comprised of the anti-CD33 mAb lintuzumab linked to the potent alpha-emitting radioisotope
−Removed: Actinium-225 or Ac-225.
−Removed: CD33 is expressed in the majority of patients with AML and myelodysplastic syndrome, or MDS, as well as
−Removed: approximately one third of patients with multiple myeloma.
−Removed: Our CD33 development program is driven by data obtained from over one
−Removed: hundred treated patients, including results from a Phase 1/2 trial that was conducted in 58 patients with newly diagnosed AML,
−Removed: which was completed in 2018.
−Removed: This clinical data, as well as our experience with Iomab-B, is shaping a two-pronged approach with
−Removed: our CD33 program, where at high doses we are exploring its use for targeted conditioning and at low doses we are exploring its
−Removed: use for therapeutic purposes in combination with other modalities, such as chemotherapy, targeted agents or immunotherapy.
−Removed: Actimab-MDS is our
−Removed: second clinical trial focused on targeted conditioning, in this case for patients with high-risk MDS and is our second pivotal
−Removed: Actimab-MDS is informed by prior experience with our CD33 ARC in multiple trials for patients with AML, MDS and for patients
−Removed: that have progressed from MDS to AML, which is also known as secondary AML.
−Removed: Data from these trials showed that our CD33 ARC had
−Removed: single-agent activity capable of producing complete remissions (CRs) in certain patients at varying dose levels with minimal non-hematologic
+Added: Targeted Conditioning, Combinations
+Added: and Therapeutics
+Added: Our CD33 program is evaluating
+Added: the clinical utility of an ARC comprised of the anti-CD33 mAb lintuzumab linked to the potent alpha-emitting radioisotope Actinium-225
+Added: CD33 is expressed in the majority of patients with AML and myelodysplastic syndrome, or MDS, as well as approximately
+Added: one third of patients with multiple myeloma.
+Added: Our CD33 development program is driven by data obtained from over one hundred treated
+Added: patients, including results from a Phase 1/2 trial that was conducted in 58 patients with newly diagnosed AML, which was completed
+Added: This clinical data, as well as our experience with Iomab-B, is shaping a two-pronged approach with our CD33 program, where
+Added: at high doses we are exploring its use for targeted conditioning and at low doses we are exploring its use for therapeutic purposes
+Added: in combination with other modalities, such as chemotherapy, targeted agents or immunotherapy.
+Added: Actimab-MDS is our second
+Added: clinical trial focused on targeted conditioning, in this case for patients with high-risk MDS and is our second pivotal program.
+Added: Actimab-MDS is informed by prior experience with our CD33 ARC in multiple trials for patients with AML, MDS and for patients that
+Added: have progressed from MDS to AML, which is also known as secondary AML.
+Added: Data from these trials showed that our CD33 ARC had single-agent
+Added: activity capable of producing complete remissions (CRs) in certain patients at varying dose levels with minimal non-hematologic
extramedullary toxicities.
11 unchanged sentences
observed, may potentially serve as a pivotal trial to support the submission of a BLA.
−Removed: currently finalizing discussions with the FDA.
−Removed: We are also studying our CD33 ARC construct
−Removed: at various dose levels and dosing regimens in combination with other therapeutic modalities such as chemotherapy, targeted agents
−Removed: or immunotherapy in CD33 expressing hematologic disease indications.
−Removed: We believe that radiation can be synergistic when used in
−Removed: combination with these modalities based on mechanistic rationale supported by our own clinical data, preclinical research and scientific
−Removed: and clinical evidence in the literature.
−Removed: We have prioritized our efforts and resources in favor of combination trials for our CD33
−Removed: program development strategy rather than single agent trials, which we are no longer advancing at this time.
−Removed: Our CD33 ARC development
−Removed: program encompasses the following ongoing and planned trials:
+Added: We are currently finalizing discussions
+Added: with the FDA.
+Added: We are also studying our
+Added: CD33 ARC construct at various dose levels and dosing regimens in combination with other therapeutic modalities such as chemotherapy,
+Added: targeted agents or immunotherapy in CD33 expressing hematologic disease indications.
+Added: We believe that radiation can be synergistic
+Added: when used in combination with these modalities based on mechanistic rationale supported by our own clinical data, preclinical research
+Added: and scientific and clinical evidence in the literature.
+Added: We have prioritized our efforts and resources in favor of combination trials
+Added: for our CD33 program development strategy rather than single agent trials, which we are no longer advancing at this time.
+Added: ARC development program encompasses the following ongoing and planned trials:
Combination Trials :
20 unchanged sentences
We expect to initiate this Phase 1 trial by the end of 2020 and have proof of concept data in 2021.
−Removed: Antibody Warhead Enabling Technology
+Added: Antibody Warhead Enabling Technology Platform
Our proprietary Antibody
3 unchanged sentences
includes 29 patent families comprised of over 120 issued and pending patent applications, of which 9 are issued and 25 pending
−Removed: in the United States, and 81 are issued and pending internationally.
+Added: in the United States, and 92 are issued or pending internationally.
The effective life of the patents in our portfolio range from
−Removed: expirations between 2020 to 2039.
+Added: expirations between 2021 and 2040.
Our technology enables the direct labeling, or conjugation and labeling, of a biomolecular targeting
4 unchanged sentences
Impact of COVID–19 Pandemic
−Removed: In December 2019, a novel strain of COVID-19
−Removed: was reported in China.
+Added: In December 2019, a novel
+Added: strain of COVID-19 was reported in China.
Since then, COVID-19 has spread globally.
−Removed: The spread of COVID-19 from China to other countries has resulted
−Removed: in the World Health Organization (WHO) declaring the outbreak of COVID-19 as a “pandemic,”
−Removed: or a worldwide spread of
−Removed: a new disease, on March 11, 2020.
−Removed: Many countries around the world have imposed quarantines and restrictions on travel and mass
−Removed: gatherings to slow the spread of the virus and have closed non-essential businesses, and as of the date of this prospectus, many
−Removed: local jurisdictions continue to have such restrictions in place.
−Removed: As many local jurisdictions continue to
−Removed: have such restrictions in place, our ability to continue to operate our business may also be limited.
−Removed: Such events may result in
−Removed: a period of business, supply and drug product manufacturing disruption, and in reduced operations, any of which could materially
−Removed: affect our business, financial condition and results of operations.
−Removed: In response to COVID-19, we implemented remote working and
−Removed: thus far have not experienced a significant disruption or delay in our operations as it relates to the clinical development of
−Removed: our drug candidates.
−Removed: The spread of COVID-19, which has caused
−Removed: a broad impact globally, may materially affect us economically.
−Removed: While the ultimate economic impact brought by, and the duration
−Removed: of, the COVID-19 pandemic may be difficult to assess or predict, the pandemic has resulted significant disruptions in the general
−Removed: commercial activity and the global economy and caused financial market volatility and uncertainty in significant and unforeseen
−Removed: ways in the recent months.
−Removed: A continuation or worsening of the levels of market disruption and volatility seen in the recent past
−Removed: could have an adverse effect on our ability to access capital, which could in the future negatively affect our liquidity.
−Removed: a recession or market correction resulting from the spread of COVID-19 could materially affect our business and the value of our
−Removed: common stock.
−Removed: Currently, the Phase 3 SIERRA trial for
−Removed: our lead program, Iomab-B, continues to remain active at a majority of our clinical trial sites, with investigators providing feedback
−Removed: that recruitment and enrollment will remain active because of the acute nature of the disease, the high unmet needs of patients
−Removed: with relapsed or refractory AML, the potentially curative nature of BMT and the differentiated profile of Iomab-B.
−Removed: Certain sites
−Removed: that had not been actively enrolling due to COVID-19 have resumed recruitment and enrollment, and we currently anticipate that
−Removed: other sites that have not been actively enrolling due to COVID-19 will likely resume recruitment and enrollment in the summer timeframe.
−Removed: We also believe our earlier stage clinical trials for our CD33 program will also continue to recruit and enroll patients given
−Removed: the acute nature of relapsed or refractory AML.
−Removed: The continuation of the pandemic could adversely affect our planned clinical trial
−Removed: operations, including our ability to conduct the trials on the expected timelines and recruit and retain patients and principal
+Added: The spread of COVID-19 from China to other
+Added: countries has resulted in the World Health Organization (WHO) declaring the outbreak of COVID-19 as a “pandemic,”
+Added: a worldwide spread of a new disease, on March 11, 2020.
+Added: Many countries around the world have imposed quarantines and restrictions
+Added: 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
+Added: prospectus, many local jurisdictions continue to have such restrictions in place.
+Added: As many local jurisdictions
+Added: continue to have such restrictions in place, our ability to continue to operate our business may also be limited.
+Added: Such events may
+Added: result in a period of business, supply and drug product manufacturing disruption, and in reduced operations, any of which could
+Added: materially affect our business, financial condition and results of operations.
+Added: In response to COVID-19, we implemented remote working
+Added: and thus far have not experienced a significant disruption or delay in our operations as it relates to the clinical development
+Added: of our drug candidates.
+Added: Such government-imposed precautionary measures may have been relaxed in certain countries or states, but
+Added: there is no assurance that more strict measures will be put in place again due to a resurgence in COVID-19 cases.
+Added: Therefore, the
+Added: COVID-19 pandemic may continue to affect our operation, may further divert the attention and efforts of the medical community to
+Added: coping with COVID-19 and disrupt the marketplace in which we operate and may have a material adverse effect on our operations.
+Added: The spread of COVID-19,
+Added: which has caused a broad impact globally, may materially affect us economically.
+Added: While the ultimate economic impact brought by,
+Added: and the duration of, the COVID-19 pandemic may be difficult to assess or predict, including new information which may emerge concerning
+Added: the severity of COVID-19 and the actions to contain COVID-19 or treat its impact, among others, the pandemic has resulted significant
+Added: disruptions in the general commercial activity and the global economy and caused financial market volatility and uncertainty in
+Added: significant and unforeseen ways in the recent months.
+Added: A continuation or worsening of the levels of market disruption and volatility
+Added: seen in the recent past could have an adverse effect on our ability to access capital, which could in the future negatively affect
+Added: our liquidity.
+Added: In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect our
+Added: business and the value of our common stock.
+Added: Currently, the Phase
+Added: 3 SIERRA trial for our lead program, Iomab-B, continues to remain active at a majority of our clinical trial sites, with investigators
+Added: providing feedback that recruitment and enrollment will remain active because of the acute nature of the disease, the high unmet
+Added: needs of patients with relapsed or refractory AML, the potentially curative nature of BMT and the differentiated profile of Iomab-B.
+Added: Certain sites that had not been actively enrolling due to COVID-19 have resumed recruitment and enrollment, and we currently anticipate
+Added: that other sites that have not been actively enrolling due to COVID-19 will likely resume recruitment and enrollment in the summer
+Added: We also believe our earlier stage clinical trials for our CD33 program will also continue to recruit and enroll patients
+Added: given the acute nature of relapsed or refractory AML.
+Added: The continuation of the pandemic could adversely affect our planned clinical
+Added: 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.
−Removed: Further, the COVID-19 pandemic could result in delays in our clinical trials due to prioritization of hospital
−Removed: resources toward the pandemic, restrictions in travel, potential unwillingness of patients to enroll in trials at this time, or
−Removed: the inability of patients to comply with clinical trial protocols if quarantines or travel restrictions impede patient movement
−Removed: or interrupt healthcare services.
−Removed: In addition, we rely on independent clinical investigators, contract research organizations and
−Removed: other third-party service providers to assist us in managing, monitoring and otherwise carrying out our preclinical studies and
−Removed: clinical trials, and the pandemic may affect their ability to devote sufficient time and resources to our programs or to travel
−Removed: to sites to perform work for us.
−Removed: Additionally, COVID-19 may also result
−Removed: in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions with IRB’s
−Removed: or Institutional Review Boards, local and foreign regulators, ethics committees and other important agencies and contractors due
−Removed: to limitations in employee resources or forced furlough of government employees.
−Removed: To date, COVID-19 has not had a financial
−Removed: impact on our company.
−Removed: However, COVID-19 has caused severe disruptions in transportation and limited access to our facility, resulting
−Removed: in limited support from our staff and professional advisors.
−Removed: The ultimate impact from COVID-19 on our
−Removed: business operations and financial results during 2020 will depend on, among other things, the ultimate severity and scope of the
−Removed: pandemic, the pace at which governmental and private travel restrictions and public concerns about public gatherings will ease,
−Removed: the rate at which historically large increases in unemployment rates will decrease, if at all, and whether, and the speed with
−Removed: which the economy recovers.
−Removed: We are not able to fully quantify the impact that these factors will have on our financial results
−Removed: during 2020 and beyond, but developments related to COVID-19 may materially affect us in 2020.
−Removed: NYSE American Notification and
−Removed: Potential Reverse Stock Split
−Removed: On April 29, 2020, we received a deficiency
−Removed: letter from the NYSE American LLC, or the NYSE American, indicating that we are not in compliance with certain NYSE American continued
−Removed: listing standards.
−Removed: The deficiency letter states that our shares of common stock have been selling for a low price per share for
−Removed: a substantial period of time.
−Removed: Pursuant to Section 1003(f)(v) of the Company Guide, the NYSE American staff determined that our
−Removed: continued listing is predicated on us effecting a reverse stock split of our common stock or otherwise demonstrating sustained
−Removed: price improvement within a reasonable period of time, which the staff determined to be until October 29, 2020.
−Removed: The letter further stated that as a result
−Removed: of the foregoing, we have become subject to the procedures and requirements of Section 1009 of the NYSE American Company Guide,
−Removed: which could, among other things, result in the initiation of delisting proceedings, unless we cure the deficiency in a timely manner.
−Removed: Our common stock will continue to be listed on the NYSE American while we attempt to regain compliance with the listing standards,
−Removed: subject to our compliance with other continued listing requirements.
−Removed: In addition, the NYSE American has advised
−Removed: us that its policy is to immediately suspend trading in shares of, and commence delisting procedures with respect to, a listed
−Removed: company if the market price of its shares falls below $0.06 per share at any time during the trading day.
−Removed: We intend to regain compliance with the
−Removed: NYSE American’s continued listing standards by undertaking a measure or measures that are for the best interests of the Company
−Removed: and our stockholders.
−Removed: On October 18, 2019, our board of directors unanimously approved, subject to stockholder approval, an amendment
−Removed: to our certificate of incorporation to effect a reverse stock split of our outstanding common stock by combining outstanding shares
−Removed: 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
−Removed: 18, 2020, with the exact ratio to be set within this range by our board of directors at its sole discretion.
−Removed: On December 18, 2019,
−Removed: at our 2019 Annual Meeting of Stockholders, our stockholders approved such proposed amendment to our certificate of incorporation.
−Removed: The primary intent of effecting the reverse stock split, if our board of directors determines to do so, would be to ensure that
−Removed: we are able to maintain compliance with the listing standards of the NYSE American.
−Removed: The board of directors may alternatively elect
−Removed: to abandon such proposed amendment and not effect the reverse stock split authorized by stockholders, in its sole discretion.
−Removed: Although we expect that a reverse stock
−Removed: split will result in an increase in the market price of our common stock, such reverse stock split may not result in a permanent
−Removed: increase in the market price of our common stock, which is dependent on many factors, including general economic, market and industry
−Removed: conditions and other factors detailed from time to time in the reports we file with the Securities and Exchange Commission.
−Removed: If we implement the reverse stock split,
−Removed: the reverse stock split would affect all of our stockholders uniformly and will not affect any stockholder’s percentage ownership
−Removed: interest in our company, except to the extent that the reverse stock split results in any of our stockholders owning a fractional
−Removed: The reverse stock split would not change the terms of our common stock.
−Removed: After a reverse stock split, all shares of common
−Removed: stock would have the same voting rights and rights to dividends and distributions and will be identical in all other respects to
−Removed: the common stock now authorized, which is not entitled to preemptive or subscription rights, and is not subject to conversion,
−Removed: redemption or sinking fund provisions.
−Removed: As of the effective time of the reverse
−Removed: stock split, if any, we would adjust and proportionately decrease the number of shares of our common stock reserved for issuance
−Removed: upon exercise of, and adjust and proportionately increase the exercise price of, all options and warrants and other rights to acquire
−Removed: our common stock.
−Removed: In addition, as of the effective time of a reverse stock split, we would adjust and proportionately decrease
−Removed: the total number of shares of our common stock that may be the subject of the future grants under our stock plans.
−Removed: Issuances after March 31, 2020
−Removed: In April 2020, pursuant to the Amended
−Removed: and Restated At Market Issuance Sales Agreement by and among us, B.
−Removed: Riley FBR, Inc.
−Removed: and JonesTrading Institutional Services LLC
−Removed: , or the ATM Sales Agreement, pursuant to which we conduct our at-the market program, we sold 171 thousand shares of common stock
−Removed: and realized net proceeds of $35 thousand.
−Removed: In June 2020, we issued 157 thousand shares
−Removed: of restricted common stock for consulting services.
−Removed: The April 2020 Offering
−Removed: On April 24, 2020, we issued and sold 128,333,333
−Removed: shares of common stock and pre-funded warrants to purchase 82,500,001 shares of common stock.
−Removed: The price to the public for each
−Removed: share of common stock sold in the offering was $0.15, and the price to the public for each pre-funded warrant sold in the offering
−Removed: The pre-funded warrants are exercisable at an exercise price of $0.0001 per share and are subject to certain limitations
−Removed: on beneficial ownership.
−Removed: Gross proceeds from the April 2020 Offering to us were $31.6 million, before deducting underwriting discounts
−Removed: and commissions and other offering expenses payable by us.
−Removed: Net proceeds from the April 2020 Offering were $29.1 million.
−Removed: 2020, holders of 36.0 million pre-funded April 2020 warrants exercised their warrants and received shares of common stock.
−Removed: The June 2020 Offering
−Removed: On June 19, 2020, we issued and sold 55,653,846
−Removed: shares of common stock and pre-funded warrants to purchase 21,269,231 shares of common stock.
−Removed: The price to the public for each
−Removed: share of common stock sold in the offering was $0.3250, and the price to the public for each pre-funded warrant sold in the offering
−Removed: The pre-funded warrants are exercisable immediately upon issuance at an exercise price of $0.0001 per share and are
−Removed: subject to certain limitations on beneficial ownership.
−Removed: Gross proceeds from the June 2020 Offering to us were approximately $25
−Removed: million, before deducting underwriting discounts and commissions and other offering expenses payable by us.
−Removed: Net proceeds from the
−Removed: June 2020 Offering were $22.8 million.
−Removed: In connection with our June 2020 Offering,
−Removed: we suspended, and during the duration of the June 2020 Offering did not offer, any securities pursuant to the Lincoln Park Agreement
−Removed: and the ATM Sales Agreement.
−Removed: We will not make any sales of securities pursuant to the Lincoln Park Agreement and the ATM Sales
−Removed: Agreement unless and until a new prospectus supplement is filed with the SEC;
−Removed: however, the Lincoln Park Agreement and the ATM Sales
−Removed: Agreement remain in full force and effect.
+Added: Further, the continuation and/or resurgence of the COVID-19 pandemic could result in delays in our clinical trials
+Added: due to prioritization of hospital resources toward the pandemic, restrictions in travel, potential unwillingness of patients to
+Added: enroll in trials at this time, or the inability of patients to comply with clinical trial protocols if quarantines or travel restrictions
+Added: impede patient movement or interrupt healthcare services.
+Added: In addition, we rely on independent clinical investigators, contract
+Added: research organizations and other third-party service providers to assist us in managing, monitoring and otherwise carrying out
+Added: our preclinical studies and clinical trials, and the pandemic may affect their ability to devote sufficient time and resources
+Added: to our programs or to travel to sites to perform work for us.
+Added: Additionally, COVID-19
+Added: may result in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions
+Added: with IRB’s or Institutional Review Boards, local and foreign regulators, ethics committees and other important agencies and
+Added: contractors due to limitations in employee resources or forced furlough of government employees.
+Added: To date, COVID-19 has not
+Added: had a financial impact on our company.
+Added: However, COVID-19 has caused severe disruptions in transportation and limited access to
+Added: our facility, resulting in limited support from our staff and professional advisors.
+Added: The ultimate impact from
+Added: COVID-19 on our business operations and financial results during 2020 will depend on, among other things, the ultimate severity
+Added: and scope of the pandemic, the pace at which governmental and private travel restrictions and public concerns about public gatherings
+Added: will ease, the rate at which historically large increases in unemployment rates will decrease, if at all, and whether, and the
+Added: speed with which the economy recovers.
+Added: We are not able to fully quantify the impact that these factors will have on our financial
+Added: results during 2020 and beyond, but developments related to COVID-19 may materially affect us in 2020.
+Added: Reverse Stock Split
+Added: On April 29, 2020, we received
+Added: a deficiency letter from the NYSE American LLC, or the NYSE American, indicating that we are not in compliance with certain NYSE
+Added: American continued listing standards.
+Added: The deficiency letter stated that our shares of common stock have been selling for a low
+Added: price per share for a substantial period of time.
+Added: Pursuant to Section 1003(f)(v) of the Company Guide, the NYSE American staff
+Added: determined that our continued listing is predicated on us effecting a reverse stock split of our common stock or otherwise demonstrating
+Added: sustained price improvement within a reasonable period of time, which the staff determined to be until October 29, 2020.
+Added: The letter further stated
+Added: that as a result of the foregoing, we have become subject to the procedures and requirements of Section 1009 of the NYSE American
+Added: Company Guide, which could, among other things, result in the initiation of delisting proceedings, unless we cure the deficiency
+Added: in a timely manner.
+Added: Our common stock will continue to be listed on the NYSE American while we attempt to regain compliance with
+Added: the listing standards, subject to our compliance with other continued listing requirements.
+Added: In addition, the NYSE American
+Added: has advised us that its policy is to immediately suspend trading in shares of, and commence delisting procedures with respect to,
+Added: a listed company if the market price of its shares falls below $0.06 per share at any time during the trading day.
+Added: On October 18, 2019, our
+Added: board of directors unanimously approved, subject to stockholder approval, an amendment to our certificate of incorporation to effect
+Added: a reverse stock split of our outstanding common stock by combining outstanding shares of common stock into a lesser number of outstanding
+Added: 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
+Added: range by our board of directors at its sole discretion.
+Added: On December 18, 2019, at our 2019 Annual Meeting of Stockholders, our stockholders
+Added: approved such proposed amendment to our certificate of incorporation.
+Added: The primary intent of effecting the reverse stock split,
+Added: would be to ensure that we are able to maintain compliance with the listing standards of the NYSE American.
+Added: On August 7, 2020,
+Added: the Board unanimously approved a reverse stock split of its outstanding common stock by combining outstanding shares of common
+Added: 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
+Added: the Secretary of State of Delaware a certificate of amendment to its certificate of incorporation to effect the reverse stock split.
+Added: The reverse stock split became effective as of 5:00 p.m.
+Added: Eastern Time on August 10, 2020, and our common stock began trading on
+Added: a split-adjusted basis when the market opened on August 11, 2020.
+Added: all common share and per common share data in these
+Added: consolidated financial statements and related notes hereto have been retroactively adjusted to account for the effect of this reverse
+Added: stock split for all periods presented.
+Added: In addition, at the effective time of the reverse stock split, the number of shares of our
+Added: common stock reserved for issuance upon exercise of all options and warrants to acquire common stock have been proportionally decreased,
+Added: and the exercise price of all options and warrants to acquire common stock have been proportionally increased.
+Added: In addition, we
+Added: adjusted and proportionately decreased the total number of shares of our common stock that may be the subject of the future grants
+Added: under our stock plans.
Results of Operations
−Removed: Three Months Ended March 31, 2020 Compared to Three Months Ended March 31, 2019
−Removed: The following table
−Removed: sets forth, for the periods indicated, data derived from our statements of operations:
−Removed: Three Months Ended
+Added: Three Months Ended June 30, 2020 Compared to Three Months Ended June 30, 2019
+Added: The following table sets
+Added: forth, for the periods indicated, data derived from our statements of operations:
+Added: For the Three Months Ended
(in thousands)
7 unchanged sentences
We recorded no commercial
−Removed: revenue for the three months ended March 31, 2020 and 2019.
+Added: revenue for the three months ended June 30, 2020 and 2019.
Research and Development Expense
−Removed: In March 2018, we entered
−Removed: into a research and option agreement with Astellas to develop Actinium-225 Radio-Conjugates, or ARCs, using our Actinium Warhead
−Removed: Enabling, or AWE, Platform Technology.
−Removed: Under this collaboration, we will utilize our AWE Platform to conjugate and label selected
−Removed: Astellas targeting agents with an Actinium-225 payload.
−Removed: We will also be responsible for conducting preclinical validation studies
−Removed: on any ARCs generated.
Research and development
−Removed: expenses decreased $0.1 million to $4.2 million for the three months ended March 31, 2020 compared to $4.3 million for the three
−Removed: months ended March 31, 2019.
−Removed: The decrease was primarily due to lower expenses on our CD33 program, as our focus has been on Iomab-B
−Removed: and the SIERRA trial.
−Removed: In addition, we recognized a lower amount in March 2020 for payments received from Astellas compared to what
−Removed: was recognized in March 2019;
−Removed: these payments are accounted for as a reduction in research and development expenses.
−Removed: These declines
−Removed: were mostly offset by higher expenses incurred on our CD45 program.
+Added: 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
+Added: months ended June 30, 2019.
+Added: The decrease in expenses was primarily due to manufacturing related to the antibody component of Iomab-B,
+Added: 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
−Removed: expenses of $1.5 million for the three months ended March 31, 2020 increased $0.1 million compared to $1.4 million for the three
−Removed: months ended March 31, 2019, primarily attributable to higher professional fees.
+Added: 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
+Added: three months ended June 30, 2019, primarily attributable to higher professional fees.
Other income is comprised
of net interest income in both reporting periods.
−Removed: The amount for the three months ended March 31, 2020 of $13 thousand fell from
−Removed: $29 thousand for the three months ended March 31, 2019, due to a lower average balance of cash and cash equivalents and lower interest
+Added: The amount for the three months ended June 30, 2020 of $37 thousand fell from
+Added: $59 thousand for the three months ended June 30, 2019, primarily due to lower interest rates.
Net loss of $4.6 million
−Removed: for the three months ended March 31, 2020 was unchanged from the prior-year comparison period as lower research and development
−Removed: expenses were offset by higher general and administrative expenses and lower other income.
+Added: for the three months ended June 30, 2020 decreased by $0.4 million from the prior-year comparison period due to lower research
+Added: and development expenses.
+Added: Results of Operations
+Added: Six Months Ended June 30, 2020 Compared to Six Months Ended June 30, 2019
+Added: The following table sets
+Added: forth, for the periods indicated, data derived from our statements of operations:
+Added: For the Six Months Ended
+Added: (in thousands)
+Added: Operating expenses:
+Added: Research and development, net of reimbursements
+Added: General and administrative
+Added: Total operating expenses
+Added: Other income:
+Added: Interest income –
+Added: Total other income
+Added: We recorded no commercial
+Added: revenue for the six months ended June 30, 2020 and 2019.
+Added: Research and Development Expense
+Added: Research and development
+Added: 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
+Added: ended June 30, 2019.
+Added: The decrease in expenses was primarily due to manufacturing related to the antibody component of Iomab-B,
+Added: as in prior periods we have manufactured sufficient antibody supply for the SIERRA trial and other planned trials.
+Added: General and Administrative
+Added: General and administrative
+Added: 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
+Added: ended June 30, 2019, primarily attributable to higher professional fees.
+Added: Other income is comprised
+Added: of net interest income in both reporting periods.
+Added: The amount for the six months ended June 30, 2020 of $50 thousand fell from $88
+Added: thousand for the six months ended June 30, 2019 primarily due to lower interest rates.
+Added: Net loss of $10.3 million
+Added: for the six months ended June 30, 2020 decreased $0.4 million from $10.7 million reported in the prior-year comparison period,
+Added: primarily due to lower research and development expenses, slightly offset by higher general and administrative expenses.
Liquidity and Capital Resources
We have financed our
−Removed: operations primarily through sales of our stock and warrants.
−Removed: The following tables sets forth selected cash flow information for
−Removed: the periods indicated:
−Removed: Three Months Ended
+Added: operations primarily through sales of our common stock and warrants.
+Added: The following tables sets forth selected cash flow information
+Added: for the periods indicated:
+Added: For the Six Months Ended
(in thousands)
4 unchanged sentences
Net cash used in operating
−Removed: activities for the three months ended March 31, 2020 of $5.9 million increased by $0.4 million from $5.5 million in the prior-year
−Removed: period, primarily due to the timing of payments to vendors.
−Removed: Net cash provided by
−Removed: financing activities was $2.5 million for the three months ended March 31, 2020, reflecting $2.7 million from the sale of common
−Removed: During the three months ended March 31, 2019, net cash provided by financing activities was $1.8 million, reflecting $1.5
−Removed: million in proceeds from the exercise of warrants, plus $0.4 million from the sale of common stock.
−Removed: Subsequent Financings
−Removed: In April 2020, we sold 171 thousand common shares through our at-the-market program and realized net proceeds
−Removed: of $36 thousand.
−Removed: 2020, we issued and sold 210.8 million shares of common stock (or pre-funded warrants to purchase shares of common stock in
−Removed: lieu thereof).
−Removed: Gross proceeds from this offering to us were approximately $31.6 million, before deducting underwriting
−Removed: discounts and commissions and other offering expenses payable by us.
−Removed: Net proceeds from this offering were $29.1 million.
−Removed: On June 19, 2020, we issued and sold 55.7 million shares of common stock and 21.3 million pre-funded warrants to purchase
−Removed: shares of common stock.
−Removed: The price to the public in this offering for each share of common stock was $0.325 and for each pre-funded
−Removed: warrant was $0.3249.
−Removed: Each pre-funded warrant has an exercise price of $0.0001 per share and is exercisable immediately upon
−Removed: Gross proceeds from this offering to us were $25.0 million, before deducting underwriting discounts and commissions
−Removed: and other offering expenses payable us.
−Removed: Net proceeds from this offering were $22.8 million.
+Added: 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
+Added: period, reflecting the lower net loss due to lower research and development expenses, as well as the timing of payments to vendors.
+Added: Net cash provided by financing
+Added: activities was $54.6 million for the six months ended June 30, 2020, reflecting sales of common stock and pre-funded warrants.
+Added: During the six months ended June 30, 2019, net cash provided by financing activities was $16.8 million, reflecting $15.5 million
+Added: in proceeds from the sale of common stock, plus $1.5 million in proceeds from the exercise of warrants.
+Added: 2020, we issued and sold 4.3 million shares of common stock and pre-funded warrants to purchase 2.8 million shares of common
+Added: 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
+Added: each pre-funded warrant sold in the offering was $4.497.
+Added: The pre-funded warrants are exercisable at an exercise price of
+Added: $0.003 per share and are subject to certain limitations on beneficial ownership.
+Added: Gross proceeds from this offering were $31.6
+Added: million, before deducting underwriting discounts and commissions and other offering expenses payable by us.
+Added: Net proceeds from
+Added: the offering were approximately $29.1 million.
+Added: In June 2020, holders of 1.2 million pre-funded April 2020 warrants exercised
+Added: their warrants and received 1.2 million shares of common stock.
+Added: On June 19, 2020, we
+Added: issued and sold 1.9 million shares of common stock and pre-funded warrants to purchase 0.7 million shares of common stock.
+Added: 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.
+Added: pre-funded warrant has an exercise price of $0.003 per share and is exercisable immediately upon issuance.
+Added: Gross proceeds from
+Added: this offering to us were $25.0 million, before deducting underwriting discounts and commissions and other offering expenses payable
+Added: Net proceeds from this offering were approximately $23.0 million.
+Added: In December 2018, we
+Added: entered into the Amended and Restated At Market Issuance Sales Agreement with B.
+Added: Riley FBR, Inc.
+Added: and JonesTrading Institutional
+Added: Services LLC, pursuant to which we conducted our at-the market program.
+Added: During the six months ended June 30, 2020, we sold 0.3
+Added: million common shares through its at-the-market program, resulting in net proceeds of $2.5 million.
+Added: In October 2018,
+Added: we and Lincoln Park Capital Fund, LLC (“Lincoln Park”) entered into a purchase agreement and a registration rights
+Added: agreement, pursuant to which we have the right to sell to Lincoln Park shares of our common stock having an aggregate value of
+Added: up to $32.5 million, subject to certain limitations and conditions set forth in the agreement.
+Added: During the six months ended June
+Added: 30, 2020, we elected to sell to Lincoln Park 27 thousand shares and received $0.2 million.
Off-Balance Sheet Arrangements
−Removed: We do not have any
−Removed: off-balance sheet arrangements that have, or are reasonably likely to have a current or future effect on our financial condition,
−Removed: changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or capital resources
−Removed: that is material to investors.
+Added: We do not have any off-balance
+Added: sheet arrangements that have, or are reasonably likely to have a current or future effect on our financial condition, changes in
+Added: financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or capital resources that is material
+Added: to investors.
Critical Accounting Policies and Use of Estimates
18 unchanged sentences
Fair Value of Financial Instruments
−Removed: Fair value is defined
−Removed: as the price that would be received to sell an asset, or paid to transfer a liability, in an orderly transaction between market
−Removed: participants.
−Removed: A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted prices
−Removed: in active markets for identical assets or liabilities and the lowest priority to unobservable inputs.
+Added: Fair value is defined as
+Added: the price that would be received to sell an asset, or paid to transfer a liability, in an orderly transaction between market participants.
+Added: A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted prices in active markets
+Added: for identical assets or liabilities and the lowest priority to unobservable inputs.
Research and Development Costs
1 unchanged sentence
costs are expensed as incurred.
−Removed: These costs include the costs of manufacturing drug product, the costs of clinical trials, costs
−Removed: of employees and associated overhead, and depreciation and amortization costs related to facilities and equipment.
−Removed: development reimbursements are recorded by us as a reduction of research and development costs.
+Added: These costs include the costs of manufacturing drug components and final drug product, the costs
+Added: of clinical trials, costs of employees and associated overhead, and depreciation and amortization costs related to facilities and
+Added: Research and development reimbursements are recorded by us as a reduction of research and development costs.
Share-Based Payments
−Removed: We estimate the fair
−Removed: value of each stock option award at the grant date by using the Black-Scholes option pricing model.
+Added: We estimate the fair value
+Added: of each stock option award at the grant date by using the Black-Scholes option pricing model.
The fair value determined represents
4 unchanged sentences
Recently Adopted -
−Removed: In August 2018, FASB
−Removed: issued ASU 2018-13, Fair Value Measurement - Disclosure Framework (Topic 820).
−Removed: The updated guidance improves the disclosure
−Removed: requirements on fair value measurements, primarily associated with Level 3 fair value measurements and is effective for fiscal
−Removed: years, and interim periods within those fiscal years, beginning after December 15, 2019.
−Removed: Early adoption is permitted upon issuance
−Removed: of the standard for disclosures modified or removed with a delay of adoption of the additional disclosures until their effective
−Removed: We adopted this standard effective January 1, 2020 and the standard did not have a significant impact to our financial statements.
+Added: In August 2018, FASB issued
+Added: ASU 2018-13, Fair Value Measurement - Disclosure Framework (Topic 820).
+Added: The updated guidance improves the disclosure requirements
+Added: on fair value measurements, primarily associated with Level 3 fair value measurements and is effective for fiscal years, and interim
+Added: periods within those fiscal years, beginning after December 15, 2019.
+Added: Early adoption is permitted upon issuance of the standard
+Added: for disclosures modified or removed with a delay of adoption of the additional disclosures until their effective date.
+Added: this standard effective January 1, 2020 and the standard did not have a significant impact to our financial statements.
In November 2018, FASB
7 unchanged sentences
the standard did not have a significant impact to our financial statements.
+Added: QUANTITATIVE AND QUALITATIVE
+Added: DISCLOSURES ABOUT MARKET RISK.
+Added: Not applicable.
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.