−Removed: MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDERS MATTERS, AND ISSUER PURCHASE OF EQUITY SECURITIES.
−Removed: common stock is listed for quotation on the NYSE AMERICAN under the symbol “ATNM”.
−Removed: of May 7, 2020, there were 303,343,699 shares of common stock issued and outstanding, which were held by approximately 99 holders
−Removed: There are no shares of preferred stock outstanding.
−Removed: On May 7, 2020, the closing price of our common stock as reported
−Removed: on the NYSE AMERICAN was $0.19 per share.
−Removed: Authorized for Issuance under Equity Compensation Plans
−Removed: currently have three equity compensation plans defined as follows:
−Removed: our Annual Meeting of Stockholders held on December 18, 2019, our stockholders authorized the implementation of a 2019 Stock Plan,
−Removed: to be implemented at the discretion of our Board before December 18, 2020.
−Removed: The 2019 Stock Plan as authorized, if implemented,
−Removed: would have 10,000,000 shares to be issued, in addition to the shares remaining to be issued under our 2013 Stock Plan.
−Removed: date of this report, the 2019 Stock Plan has not been implemented.
−Removed: Company’s 2013 Stock Plan has an expiration date of September 9, 2023 and the total number of shares of our common stock
−Removed: available for grant to employees, directors and consultants under the plan is currently 22,750,000 shares.
−Removed: Company’s 2013 Equity Incentive Plan has an expiration date of September 9, 2023 and the total number of shares of our common
−Removed: stock available for grant to employees, directors and consultants under the plan is 1,000,000 shares.
−Removed: following table indicates shares of common stock authorized for issuance under our equity compensation plans as of December 31,
+Added: MARKET FOR REGISTRANT’S COMMON
+Added: EQUITY, RELATED STOCKHOLDERS MATTERS, AND ISSUER PURCHASE OF EQUITY SECURITIES.
+Added: Market Information
+Added: Our common stock is listed
+Added: for quotation on the NYSE AMERICAN under the symbol “ATNM”.
+Added: As of March 31, 2021, there
+Added: were 19,245,638 shares of common stock issued and outstanding, which were held by approximately 99 holders of record.
+Added: no shares of preferred stock outstanding.
+Added: Securities Authorized for Issuance under
+Added: Equity Compensation Plans
+Added: We currently have three
+Added: equity compensation plans defined as follows:
+Added: The Company’s 2019
+Added: Amended and Restated Stock Plan has an expiration date of October 18, 2029 and the number of shares of our common stock available
+Added: for grant to employees, directors and consultants authorized under the plan is 3,083,333 shares.
+Added: The Company’s 2013
+Added: Amended and Restated Stock Plan has an expiration date of September 9, 2023 and after a number of amendments approved by stockholders,
+Added: the number of shares of our common stock available for grant to employees, directors and consultants authorized under the plan
+Added: is 758,333 shares.
+Added: The Company’s 2013
+Added: Equity Incentive Plan has an expiration date of September 9, 2023 and the number of shares of our common stock available for grant
+Added: to employees, directors and consultants under the plan is 33,333 shares.
+Added: The following table indicates
+Added: shares of common stock authorized for issuance under our equity compensation plans as of December 31, 2020:
Plan category
5 unchanged sentences
SELECTED FINANCIAL DATA.
−Removed: following selected financial data should be read in conjunction with our consolidated financial statements and related notes and
−Removed: the “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
−Removed: financial data included elsewhere in this Form 10-K.
−Removed: The selected statements of operations and the selected balance sheet data
−Removed: are derived from our consolidated audited financial statements.
+Added: The following selected
+Added: financial data should be read in conjunction with our consolidated financial statements and related notes and the “Management’s
+Added: Discussion and Analysis of Financial Condition and Results of Operations”
+Added: and other financial data included elsewhere
+Added: in this Form 10-K.
+Added: The selected statements of operations and the selected balance sheet data are derived from our consolidated
+Added: audited financial statements.
+Added: (in thousands, except for number of shares and per share data)
Year ended December 31,
1 unchanged sentence
Loss from operations
−Removed: $ (22,071,447 )
−Removed: $ (23,827,322 )
−Removed: $ (21,899,054 )
−Removed: $ (23,653,963 )
Net loss per common share:
2 unchanged sentences
Basic and diluted
+Added: (in thousands)
As of December 31,
3 unchanged sentences
Stockholders’
−Removed: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION.
−Removed: information and financial data discussed below is derived from the audited consolidated financial statements of Actinium Pharmaceuticals,
−Removed: for its fiscal years ended December 31, 2019 and 2018.
−Removed: The consolidated financial statements of Actinium
−Removed: Pharmaceuticals, Inc.
−Removed: were prepared and presented in accordance with generally accepted accounting principles in the United States.
−Removed: The information and financial data discussed below is only a summary and should be read in conjunction with the historical financial
−Removed: statements and related notes of Actinium Pharmaceuticals, Inc.
+Added: MANAGEMENT’S DISCUSSION AND
+Added: ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION.
+Added: The information and financial data discussed
+Added: below is derived from the audited consolidated financial statements of Actinium Pharmaceuticals, Inc.
+Added: for its fiscal years ended
+Added: December 31, 2020 and 2019.
+Added: The consolidated financial statements of Actinium Pharmaceuticals, Inc.
+Added: were prepared
+Added: and presented in accordance with generally accepted accounting principles in the United States.
+Added: The information and financial data
+Added: discussed below is only a summary and should be read in conjunction with the historical financial statements and related notes
+Added: of Actinium Pharmaceuticals, Inc.
contained elsewhere in this Report.
−Removed: The financial statements
−Removed: contained elsewhere in this Report fully represent Actinium Pharmaceuticals, Inc.’s financial condition and operations;
−Removed: however, they are not indicative of the Company’s future performance.
−Removed: See “Cautionary Note Regarding Forward-Looking
−Removed: Statements”
−Removed: above for a discussion of forward-looking statements and the significance of such statements in the context
−Removed: of this Report.
+Added: The financial statements contained elsewhere in this
+Added: Report fully represent Actinium Pharmaceuticals, Inc.’s financial condition and operations;
+Added: however, they are not indicative
+Added: of the Company’s future performance.
+Added: See “Cautionary Note Regarding Forward-Looking Statements”
+Added: above for a discussion
+Added: of forward-looking statements and the significance of such statements in the context of this Report.
Actinium Pharmaceuticals,
−Removed: is a clinical-stage biopharmaceutical company developing ARCs or Antibody Radiation-Conjugates, which combine the targeting
−Removed: ability of antibodies with the cell killing ability of radiation.
−Removed: Actinium’s lead application for our ARCs is targeted conditioning,
−Removed: which is intended to selectively kill patient’s cancer cells and certain immune cells prior to a Bone Marrow Transplant,
−Removed: or BMT, CAR-T and other cell therapies.
−Removed: With our ARC approach, we seek to improve patient outcomes and access to these potentially
−Removed: curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice
−Removed: Our lead product candidate, Iomab-B is being studied in the ongoing pivotal Phase 3 Study of Iomab-B in Elderly Relapsed
−Removed: or Refractory Acute Myeloid Leukemia (“SIERRA”) trial for BMT conditioning.
−Removed: The SIERRA trial achieved fifty percent
−Removed: patient enrollment in July 2019 and is our leading clinical priority.
−Removed: Beyond Iomab-B, we are developing a multi-disease, multi-target
−Removed: pipeline of clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in
−Removed: combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies
−Removed: including AML or Acute Myeloid Leukemia, MDS or Myelodysplastic Syndrome, and MM or Multiple Myeloma.
−Removed: Underpinning our clinical
−Removed: programs is our proprietary AWE or Antibody Warhead Enabling technology platform.
−Removed: This is where our intellectual property portfolio
−Removed: of over 100 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel
−Removed: ARCs and ARC combinations to bolster our pipeline and for strategic purposes.
−Removed: Our AWE technology platform is currently being utilized
−Removed: in a collaborative research partnership with Astellas Pharma, Inc.
−Removed: On April 24, 2020,
−Removed: we issued and sold 210.8 million shares of common stock (or pre-funded warrants to purchase shares of common stock in lieu thereof).
−Removed: The price to the public in this offering for each share of common stock was $0.15, and the price to the public in this offering
−Removed: for each pre-funded warrant was $0.1499.
−Removed: Each pre-funded warrant has an exercise price of $0.0001 per share.
−Removed: The pre-funded warrants
−Removed: are exercisable immediately upon issuance until all of the pre-funded warrants are exercised in full.
−Removed: The warrants are subject
−Removed: to certain limitations on beneficial ownership.
−Removed: Gross proceeds from this offering to us were $31.6 million, before deducting underwriting
−Removed: discounts and commissions and other offering expenses payable by us.
−Removed: As of the date of filing this report, we expect that our existing
−Removed: resources will be more than sufficient to fund our planned operations for more than 12 months following the date of this report.
−Removed: On April 29, 2020,
−Removed: we 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 our
−Removed: common shares have been selling for a substantial period of time at a low price per share.
−Removed: The letter did not result in the immediate
−Removed: delisting of our common shares from the NYSE American Market.
−Removed: to Section 1003(f)(v) of the NYSE American Company Guide, the NYSE American staff determined that the Company’s continued
−Removed: listing is predicated on our effecting a reverse stock split of our common shares or otherwise demonstrating sustained price improvement
−Removed: within a reasonable period of time, which the staff determined to be no later than October 29, 2020.
−Removed: If we do not effectuate
−Removed: a reverse stock split to maintain compliance with NYSE American listing requirements, we could be delisted from the exchange.
−Removed: We may elect to seek approval for and if authorized, effectuate a reverse stock split to increase the price of our common stock
−Removed: so that our stock is no longer considered a penny stock and to make our stock more marketable to institutional investors that
−Removed: cannot buy stocks below certain prices.
−Removed: our Annual Meeting of Stockholders held on December 18, 2019, our stockholders approved an amendment to our certificate of incorporation
−Removed: to effect a reverse stock split of our outstanding common stock by combining outstanding shares of common stock into a lesser
−Removed: number of outstanding shares of common stock by a ratio of not more than 1-for-75 prior to December 18, 2020, with the exact ratio
−Removed: to be set within this range by our Board of Directors, or Board, at its sole discretion.
−Removed: The Board may alternatively elect to
−Removed: abandon such proposed amendment and not effect the reverse stock split authorized by stockholders, in its sole discretion.
−Removed: the effectiveness of the amendment to our certificate of incorporation effecting the reverse stock split, the outstanding shares
−Removed: of our common stock will be reclassified and combined into a lesser number of shares such that one share of our common stock will
−Removed: be issued for a specified number of shares.
−Removed: Board has the sole discretion to effect the amendment and reverse stock split, and to fix the specific ratio for the reverse stock
−Removed: split, provided that the ratio would be not be more than 1-for-75.
−Removed: The reverse stock split would become effective upon the filing
−Removed: of an amendment to our 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 our Board based on its evaluation as to when
−Removed: such action will be the most advantageous to us and our stockholders.
−Removed: In addition, our Board reserves the right, notwithstanding
−Removed: stockholder approval and without further action by our stockholders, to abandon the amendment and the reverse stock split if,
−Removed: at any time prior to the effectiveness of the filing of the amendment with the Secretary of State, our Board determines that it
−Removed: is no longer in our best interest and the best interests of our stockholders to proceed.
−Removed: of Operations –
−Removed: Year Ended December 31, 2019 Compared to the Year Ended December 31, 2018
−Removed: following table sets forth, for the periods indicated, data derived from our statements of operations:
+Added: is a clinical-stage, biopharmaceutical company applying its proprietary platform technology and deep understanding of radiobiology
+Added: to the development of novel targeted therapies known as Antibody Radiation-Conjugates, or ARCs.
+Added: Radiation is an effective therapeutic
+Added: modality that is used in the treatment of over fifty percent of all cancer patients and is often combined with chemotherapy, immunotherapy
+Added: and other treatments for greater therapeutic effect.
+Added: Radiation is typically administered via an external beam source from outside
+Added: the body, leading to off-target exposure to normal healthy tissue and organs, which can constrain the amount of radiation that
+Added: can be administered to patients due to associated dose-limiting toxicities.
+Added: In addition, use of external beam radiation is largely
+Added: limited to solid tumors and cannot be used in blood cancers, which are diffuse throughout the body of a patient.
+Added: ARCs combine the
+Added: cell-killing ability of radiation via a radioisotope payload with a targeting agent, such as a monoclonal antibody to deliver radiation
+Added: in a precise manner inside the body to specific, targeted cells, to potentially achieve greater efficacy with lower toxicity than
+Added: with external beam radiation.
+Added: ARCs enable a broader usage of radiation than external beam radiation as they can be used in the
+Added: treatment of both solid tumors and blood cancers.
+Added: Blood or hematologic cancers are known to be highly sensitive to radiation.
+Added: clinical pipeline is focused on ARCs targeting the antigens CD45 and CD33, both of which are expressed in multiple hematologic
+Added: Our clinical programs are focused on two primary areas:
+Added: (1) targeted conditioning prior to a bone marrow transplant, or
+Added: BMT, adoptive cell therapy, or ACT, such as CAR-T or gene therapy and (2) ARC therapeutic combinations with other agents.
+Added: development strategy is actively informed by clinical data with our ARCs in over 500 patients, including our ongoing Pivotal Phase
+Added: 3 SIERRA trial.
+Added: Our clinical pipeline has emanated from our Antibody Warhead Enabling, or AWE technology platform, which is protected
+Added: by over 140 issued and pending patents, trade secrets and know-how and is being utilized in a collaborative research partnership
+Added: with Astellas Pharma, Inc.
+Added: Recent Developments
+Added: Impact of COVID–19 Pandemic
+Added: In December 2019, a
+Added: novel strain of COVID-19 was reported in China.
+Added: Since then, COVID-19 has spread globally.
+Added: The spread of COVID-19 from China to
+Added: other countries has resulted in the World Health Organization (WHO) declaring the outbreak of COVID-19 as a “pandemic,”
+Added: or 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: report, 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, including those
+Added: involving new variants of the coronavirus, which may be more contagious and deadly than prior strains.
+Added: Therefore, the COVID-19
+Added: pandemic may continue to affect our operation, may further divert the attention and efforts of the medical community to coping with COVID-19 and
+Added: 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 in 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 3
+Added: 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 at the initial outbreak of the pandemic resumed recruitment
+Added: and enrollment in mid-2020, and we currently do not have any sites that are not recruiting and enrolling patients due to COVID-19.
+Added: We also believe our earlier stage clinical trials for our CD33 program will also continue to recruit and enroll patients given
+Added: the acute nature of relapsed or refractory AML.
+Added: The continuation of the pandemic could adversely affect our planned clinical trial
+Added: operations, including our ability to conduct the trials on the expected timelines and recruit and retain patients and principal
+Added: investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19 if their geography is impacted
+Added: by the pandemic.
+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 with
+Added: IRB’s or Institutional Review Boards, local and foreign regulators, ethics committees and other important agencies and contractors
+Added: 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: We continue to monitor
+Added: the impacts of COVID-19 on the global economy and on our business operations.
+Added: However, the ultimate impact from COVID-19 on our
+Added: business operations and financial results during 2021 will depend on, among other things, the ultimate severity and scope of the
+Added: pandemic, the pace at which governmental and private travel restrictions and public concerns about public gatherings will ease,
+Added: the rate at which historically large increases in unemployment rates will decrease, if at all, and whether, and the speed with
+Added: which the economy recovers.
+Added: We are not able to fully quantify the impact that these factors will have on our financial results
+Added: during 2021 and beyond, but developments related to COVID-19 may materially affect us in 2021.
+Added: Results of Operations – Year Ended
+Added: December 31, 2020 Compared to the Year Ended December 31, 2019
+Added: The following table sets
+Added: forth, for the periods indicated, data derived from our statements of operations:
For the year ended
+Added: (in thousands)
Operating expenses:
4 unchanged sentences
Total other income
−Removed: $ (21,899,054 )
−Removed: $ (23,653,963 )
−Removed: recorded no commercial revenues for the years ended December 31, 2019 and 2018, respectively.
−Removed: and Development Expense
−Removed: and development expenses declined by $0.6 million to $16.5 million for the year ended December 31, 2019 compared to $17.1 million
−Removed: for the year ended December 31, 2018.
−Removed: The decrease was primarily attributable to lower expenses related to our CD33 program.
−Removed: and Administrative Expenses
−Removed: and administrative expenses declined by $1.2 million to $5.5 million for the year ended December 31, 2019 compared to $6.7 million
−Removed: for the year ended December 31, 2018, primarily attributable to lower professional fees and lower non-cash stock-based compensation
−Removed: income of $0.2 million for both time periods was attributable to interest income - net.
−Removed: loss decreased by $1.8 million to $21.9 million for the year ended December 31, 2019 compared to $23.7 million for the year ended
−Removed: December 31, 2018.
−Removed: The decrease was primarily due to lower general and administrative expenses and research and development expenses.
−Removed: and Capital Resources
−Removed: have financed our operations primarily through sales of our stock and warrants.
−Removed: following tables sets forth selected cash flow information for the periods indicated:
+Added: We recorded no commercial
+Added: revenues for the years ended December 31, 2020 and 2019, respectively.
+Added: Research and Development Expense
+Added: Research and development
+Added: expenses declined by $0.5 million to $16.1 million for the year ended December 31, 2020 compared to $16.6 million for the year
+Added: ended December 31, 2019.
+Added: The decrease was primarily attributable to lower expenses related to our CD33 program, mostly offset by
+Added: higher expenses on our CD45 program.
+Added: General and Administrative Expenses
+Added: General and administrative
+Added: expenses increased by $0.8 million to $6.3 million for the year ended December 31, 2020 compared to $5.5 million for the year ended
+Added: December 31, 2019, primarily attributable to higher third-party professional fees, including consultants, investor relations and
+Added: Other income of $0.2 million
+Added: for both time periods was attributable to interest income - net.
+Added: Net loss increased by $0.3
+Added: million to $22.2 million for the year ended December 31, 2020 compared to $21.9 million for the year ended December 31, 2019, primarily
+Added: due to higher general and administrative expenses.
+Added: Liquidity and Capital Resources
+Added: We have financed our operations
+Added: primarily through sales of our stock, pre-funded warrants and warrants.
+Added: The following tables sets
+Added: forth selected cash flow information for the periods indicated:
For the year ended
+Added: (in thousands)
Cash used in operating activities
−Removed: $ (21,461,449 )
−Removed: $ (20,571,056 )
Cash used in investing activities
1 unchanged sentence
Net change in cash, cash equivalents and restricted cash
−Removed: $ (4,411,264 )
−Removed: $ (3,686,062 )
−Removed: cash used in operating activities for the year ended December 31, 2019 of $21.5 million increased by $0.9 million from $20.6 million
+Added: Net cash used in operating
+Added: activities for the year ended December 31, 2020 of $21.6 million increased by $0.1 million from $21.5 million used in operations
for the prior year, primarily due to the timing of payments to vendors.
−Removed: cash used in investing activities of $64 thousand and $96 thousand for the years ended December 31, 2019 and December 31, 2018,
−Removed: respectively, was for the purchase of equipment.
−Removed: cash provided by financing activities was mainly generated by the sale of shares of common stock and warrants and proceeds from
−Removed: the exercise of warrants.
−Removed: On April 24, 2020,
−Removed: we issued and sold 210.8 million shares of common stock (or pre-funded warrants to purchase shares of common stock in lieu thereof).
−Removed: Gross proceeds from this offering to us were $31.6 million, before deducting underwriting discounts and commissions and other offering
−Removed: expenses payable by us.
−Removed: April 2019, we sold 42.9 million shares of common stock at an offering price of $0.385 per share and warrants to purchase up to
−Removed: 42.9 million shares of common stock at an exercise price of $0.50 per share and with a term of 5 years, resulting in gross proceeds
−Removed: of $16.5 million and net proceeds of $15.1 million after deducting underwriting and other offering expenses.
−Removed: 2019, we sold 2.8 million common shares through our at-the-market program with an investment bank, resulting in net proceeds of
−Removed: $0.8 million.
−Removed: October, 2018, we entered into a purchase agreement and a registration rights agreement with Lincoln Park Capital Fund, LLC or
−Removed: Lincoln Park, whereby we have the right to sell to Lincoln Park shares of common stock having an aggregate value of up to $32.5
−Removed: million, subject to certain limitations and conditions set forth in the agreements.
−Removed: As consideration for entering into the agreements,
−Removed: we issued to Lincoln Park 852,537 shares of common stock.
−Removed: to the purchase agreement, Lincoln Park initially purchased 3.4 million shares of common stock, at a price of $0.74 per share,
−Removed: for a total gross purchase price of $2.5 million.
−Removed: We have the right, from time to time, subject to certain daily limitations,
−Removed: to direct Lincoln Park to purchase up to an additional $30.0 million.
−Removed: We control the timing and amount of any sales of common
−Removed: stock to Lincoln Park.
−Removed: In all instances, we may not sell shares of common stock to Lincoln Park if it would result in Lincoln
−Removed: Park beneficially owning more than 9.99% of its common stock.
−Removed: purchase agreement does not limit our ability to raise capital from other sources, except that (subject to certain exceptions)
−Removed: we may not enter into any variable-rate transaction, including the issuance of any floating conversion rate or variable priced
−Removed: equity-like securities) during the 30 months after the date of the purchase agreement.
−Removed: We have the right to terminate the purchase
−Removed: agreement at any time, at no cost to us.
−Removed: December 31, 2018, we elected to sell to Lincoln Park an additional 1.0 million shares and received $0.7 million.
−Removed: March 2018, we sold an aggregate of 30.2 million units consisting of an aggregate of 30.2 million shares of common stock, 7.6
−Removed: million series A warrants and 22.7 million series B warrants, with each series A warrant having an exercise price of $0.60 per
−Removed: share and each series B warrant having an exercise price of $0.70 per share, resulting in gross proceeds of $15.1 million, (each
−Removed: unit was sold at $0.50 per unit), and net proceeds of $13.8 million after deducting expenses relating to dealer-manager fees and
−Removed: other offering expenses.
+Added: Net cash used in investing
+Added: activities of $253 thousand and $64 thousand for the years ended December 31, 2020 and December 31, 2019, respectively, was for
+Added: the purchase of equipment.
+Added: Net cash provided by financing
+Added: activities was mainly generated by the sale of shares of common stock, pre-funded warrants and warrants.
+Added: Net cash provided by financing
+Added: activities was $76.2 million for the year ended December 31, 2020, reflecting $76.6 million in proceeds from the sales of common
+Added: stock and pre-funded warrants in April and June 2020 and sales of common stock throughout 2020.
+Added: During 2019, net cash provided
+Added: by financing activities was $17.1 million, reflecting $15.9 million in proceeds from the sale of common stock and warrants, plus
+Added: $1.5 million in proceeds from the exercise of warrants.
+Added: On April 24, 2020, we issued
+Added: and sold 4.3 million shares of common stock and pre-funded warrants to purchase 2.8 million shares of common stock.
+Added: the public for each share of common stock sold in the offering was $4.50, and the price to the public for each pre-funded warrant
+Added: sold in the offering was $4.497.
+Added: The pre-funded warrants were exercisable at an exercise price of $0.003 per share and were exercisable
+Added: immediately upon issuance.
+Added: Gross proceeds from this offering were $31.6 million, before deducting underwriting discounts and commissions
+Added: and other offering expenses payable by us.
+Added: Net proceeds from the offering were approximately $29.1 million
+Added: On June 19, 2020, we issued
+Added: and sold 1.9 million shares of common stock and pre-funded warrants to purchase 0.7 million shares of common stock.
+Added: the public in this offering for each share of common stock was $9.75 and for each pre-funded warrant was $9.747.
+Added: Each pre-funded
+Added: warrant had an exercise price of $0.003 per share and were exercisable immediately upon issuance.
+Added: Gross proceeds from this offering
+Added: to us were $25.0 million, before deducting underwriting discounts and commissions and other offering expenses payable us.
+Added: from this offering were approximately $23.0 million.
+Added: During the year ended December
+Added: 31, 2020, holders of all 2.8 million pre-funded April 2020 warrants and 0.7 million pre-funded June 2020 warrants exercised their
+Added: pre-funded warrants at $0.003 per share and received 2.8 million shares of common stock and 0.7 million shares of common stock,
+Added: respectively.
+Added: In August 2020, we entered
+Added: a Capital on Demand™ Sales Agreement with JonesTrading, pursuant to which we may sell, from time to time, through or to JonesTrading,
+Added: up to an aggregate of $200 million of our common stock.
+Added: Shares of common stock are offered pursuant to our shelf registration statement
+Added: filed with the SEC on August 7, 2020.
+Added: As of December 31, 2020, we sold 2.1 million shares of common stock, resulting in gross proceeds
+Added: of $22.6 million and net proceeds of $21.7 million.
+Added: In December 2018, we entered
+Added: into the Amended and Restated At Market Issuance Sales Agreement with B.
+Added: Riley FBR, Inc.
+Added: and JonesTrading pursuant to which we
+Added: conducted our at-the market program.
+Added: In early 2020, we sold 0.3 million shares of common stock through our at-the-market program,
+Added: resulting in net proceeds of $2.5 million.
+Added: In October 2018,
+Added: we and Lincoln Park Capital Fund, LLC, or Lincoln Park entered into a purchase agreement and a registration rights agreement, pursuant
+Added: to which we have the right to sell to Lincoln Park shares of our common stock having an aggregate value of up to $32.5 million,
+Added: subject to certain limitations and conditions set forth in the agreement.
+Added: In early 2020, we elected to sell to Lincoln Park 27
+Added: thousand shares and received $0.2 million.
+Added: In April 2019, we sold
+Added: 1.4 million shares of common stock at an offering price of $11.55 per share and warrants to purchase 1.4 million shares of common
+Added: stock at an exercise price of $15.00 per share and with a term of 5 years, resulting in gross proceeds of $16.5 million and net
+Added: proceeds of $15.1 million after deducting underwriting and other offering expenses.
As of the date of filing
1 unchanged sentence
months following the date of this report.
−Removed: Impact of COVID–19 Pandemic
−Removed: In December 2019, a
−Removed: novel strain of COVID-19 was reported in China.
−Removed: Since then, COVID-19 has spread globally, to include Canada, the United States
−Removed: and several European countries.
−Removed: The spread of COVID-19 from China to other countries has resulted in the World Health Organization
−Removed: (WHO) declaring the outbreak of COVID-19 as a “pandemic,”
−Removed: or a worldwide spread of a new disease, on March 11, 2020.
−Removed: Many countries around the world have imposed quarantines and restrictions on travel and mass gatherings to slow the spread of the
−Removed: virus and have closed non-essential businesses.
−Removed: As local jurisdictions
−Removed: continue to put restrictions in place, our ability to continue to operate our business may also be limited.
−Removed: Such events may result
−Removed: in 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,
−Removed: which has caused a broad impact globally, may materially affect us economically.
−Removed: While the potential economic impact brought by,
−Removed: and the duration of, COVID-19 may be difficult to assess or predict, a widespread pandemic could result in significant disruption
−Removed: of global financial markets, reducing our ability to access capital, which could in the future negatively affect our liquidity.
−Removed: In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect our business and the
−Removed: value of our common shares.
−Removed: Currently, the Phase
−Removed: 3 SIERRA trial for our lead program, Iomab-B, continues to remain active at a majority of our clinical trial sites, with investigators
−Removed: providing feedback that recruitment and enrollment will remain active because of the acute nature of the disease, the high unmet
−Removed: needs of patients with relapsed or refractory AML, the potentially curative nature of BMT and the differentiated profile of Iomab-B.
−Removed: We currently anticipate that sites currently not actively enrolling due to COVID-19 will likely resume recruitment and enrollment
−Removed: in the summer timeframe.
−Removed: We also believe our earlier stage clinical trials for our CD33 program will also continue to recruit and
−Removed: enroll patients given the acute nature of relapsed or refractory AML.
−Removed: The continued spread of COVID-19 globally could adversely
−Removed: affect our planned clinical trial operations, including our ability to initiate the trials on the expected timelines and recruit
−Removed: and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19
−Removed: if an outbreak occurs in their geography.
−Removed: Further, the COVID-19 outbreak could result in delays in our clinical trials due to prioritization
−Removed: of hospital resources toward the outbreak, restrictions in travel, potential unwillingness of patients to enroll in trials at this
−Removed: time, or the inability of patients to comply with clinical trial protocols if quarantines or travel restrictions impede patient
−Removed: movement or interrupt healthcare services.
−Removed: In addition, we rely on independent clinical investigators, contract research organizations
−Removed: and other third-party service providers to assist us in managing, monitoring and otherwise carrying out our preclinical studies
−Removed: and clinical trials, and the outbreak 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
−Removed: may also result in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions
−Removed: with IRB’s or Institutional Review Boards, local and foreign regulators, ethics committees and other important agencies
−Removed: and contractors due to limitations in employee 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 our facility, resulting in limited support from our staff and professional advisors.
−Removed: The small size of our accounting staff
−Removed: and the additional responsibilities emanating from COVID-19 have presented difficulties to our ability to complete this Report
−Removed: on Form 10-K, resulting in its delay, and may continue to cause a delay in our ability to complete subsequent reports in a timely
+Added: Off-Balance Sheet Arrangements
+Added: We do not have any off-balance
sheet arrangements.
−Removed: do not have any off-balance sheet arrangements.
−Removed: Accounting Policies
−Removed: management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial
−Removed: statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP.
−Removed: The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of
−Removed: assets, liabilities and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements
−Removed: during the reporting periods.
−Removed: These items are monitored and analyzed by us for changes in facts and circumstances, and material
−Removed: changes in these estimates could occur in the future.
−Removed: We base our estimates on historical experience, known trends and events,
−Removed: and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making
−Removed: judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.
−Removed: Changes in estimates
−Removed: are reflected in reported results for the period in which they become known.
−Removed: Actual results may differ materially from these estimates
−Removed: under different assumptions or conditions.
−Removed: Value of Financial Instruments
−Removed: value is defined as the price that would be received to sell an asset, or paid to transfer a liability, in an orderly transaction
−Removed: between market participants.
−Removed: A fair value hierarchy has been established for valuation inputs that gives the highest priority
−Removed: to quoted prices in active markets for identical assets or liabilities and the lowest priority to unobservable inputs.
−Removed: and Development Costs
−Removed: and development costs are expensed as incurred.
−Removed: Research and development reimbursements and grants are recorded by us as a reduction
−Removed: of research and development costs.
−Removed: estimate the fair value of each stock option award at the grant date by using the Black-Scholes option pricing model.
−Removed: value determined represents the cost for the award and is recognized over the vesting period during which an employee is required
−Removed: to provide service in exchange for the award.
+Added: Critical Accounting Policies
+Added: Our management’s
+Added: discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which
+Added: have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP.
+Added: The preparation of
+Added: these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities
+Added: and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements during the reporting
+Added: These items are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates
+Added: could occur in the future.
+Added: We base our estimates on historical experience, known trends and events, and on various other factors
+Added: that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying
+Added: value of assets and liabilities that are not readily apparent from other sources.
+Added: Changes in estimates are reflected in reported
+Added: results for the period in which they become known.
+Added: Actual results may differ materially from these estimates under different assumptions
+Added: or conditions
+Added: Fair Value of Financial Instruments
+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.
+Added: Research and Development Costs
+Added: Research and development
+Added: costs are expensed as incurred.
+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.
+Added: Share-Based Payments
+Added: We estimate the fair value
+Added: of each stock option award at the grant date by using the Black-Scholes option pricing model.
+Added: The fair value determined represents
+Added: the cost for the award and is recognized over the vesting period during which an employee is required to provide service in exchange
+Added: for the award.
We account for forfeitures of stock options as they occur.
−Removed: use the asset and liability method to calculate deferred taxes.
−Removed: Deferred taxes are recognized based on the differences between
−Removed: the financial reporting and income tax bases of assets and liabilities using the enacted tax rates and laws that will be in effect
−Removed: when the differences are expected to reverse.
−Removed: We review deferred tax assets for a valuation allowance based upon whether it is
−Removed: more likely than not that the deferred tax asset will be fully realized.
−Removed: A valuation allowance, if necessary, is provided against
−Removed: deferred tax assets, based upon our assessment as to their realization.
−Removed: recognize tax when the positions meet a “more-likely-than-not”
+Added: We use the asset and liability
+Added: method to calculate deferred taxes.
+Added: Deferred taxes are recognized based on the differences between the financial reporting and
+Added: income tax bases of assets and liabilities using the enacted tax rates and laws that will be in effect when the differences are
+Added: expected to reverse.
+Added: We review deferred tax assets for a valuation allowance based upon whether it is more likely than not that
+Added: the deferred tax asset will be fully realized.
+Added: A valuation allowance, if necessary, is provided against deferred tax assets, based
+Added: upon our assessment as to their realization.
+Added: We recognize tax when the
+Added: positions meet a “more-likely-than-not”
recognition threshold.
−Removed: There were no tax positions
−Removed: for which it is considered reasonably possible that the total amounts of unrecognized tax benefits will significantly increase
−Removed: or decrease within the next year.
−Removed: We recognize interest related to unrecognized tax benefits in interest expense and penalties
−Removed: in operating expenses.
−Removed: Standards Recently Adopted
−Removed: Historically,
−Removed: we accounted for certain instruments, which do not have fixed settlement provisions, as derivative instruments in accordance with
−Removed: the Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, 815-40, Derivative and Hedging
−Removed: Contracts in Entity’s Own Equity .
−Removed: This was due to an anti-dilution provision for the warrants that provides
−Removed: for a reduction to the exercise price if we issue equity or equity-linked instruments in the future at an effective price per
−Removed: share less than the exercise price then in effect for the warrant (“down round provision”).
−Removed: As such, the warrants
−Removed: were re-measured at each balance sheet date based on estimated fair value.
−Removed: Changes in estimated fair value were recorded as non-cash
−Removed: adjustments within other income (expense), net, in our Consolidated Statements of Operations.
−Removed: In July 2017, FASB, issued Accounting
−Removed: Standard Update, or ASU, No.
−Removed: 2017-11, Earnings Per Share (Topic 260);
−Removed: Distinguishing Liabilities from Equity (Topic
−Removed: Derivatives and Hedging (Topic 815):
−Removed: (Part I) Accounting for Certain Financial Instruments with Down Round Features .
−Removed: These amendments simplify the accounting for certain financial instruments with down-round features.
−Removed: The amendments require companies
−Removed: to disregard the down-round feature when assessing whether the instrument is indexed to its own stock, for purposes of determining
−Removed: liability or equity classification.
−Removed: The guidance was adopted as of April 1, 2018 and did not have a significant impact to our
−Removed: financial statements.
−Removed: February 2016, FASB issued ASU No.
−Removed: 2016-02 Leases (Topic 842), which created new accounting and reporting guidelines for
−Removed: leasing arrangements.
−Removed: The standard requires that a lessee recognize the assets and liabilities that arise from operating leases.
−Removed: A lessee should recognize on its balance sheet a liability to make lease payments (the lease liability) and a right-of-use asset
−Removed: representing its right to use the underlying asset for the lease term.
−Removed: The guidance in ASU 2016-02 is effective for annual and
−Removed: interim reporting periods beginning after December 15, 2018.
−Removed: In July 2018, FASB issued ASU No.
−Removed: 2018-11 , Leases (Topic 842)
−Removed: -Targeted Improvements , providing an optional transition method that allows entities to initially apply the new leases standard
−Removed: at the adoption date.
−Removed: The Company adopted this Standard effective January 1, 2019, see Note 5.
−Removed: June 2018, FASB issued ASU 2018-07 to expand the scope of ASC Topic 718, Compensation - Stock Compensation , to include
−Removed: share-based payment transactions for acquiring goods and services from nonemployees.
−Removed: The standard is effective for fiscal years,
−Removed: and for interim periods within those fiscal years, beginning after December 15, 2018, with early adoption permitted.
−Removed: this Standard effective January 1, 2019.
−Removed: There was no material impact on our financial statements.
−Removed: Accounting Standards
−Removed: August 2018, FASB issued ASU 2018-13, Fair Value Measurement - Disclosure Framework (Topic 820).
−Removed: The updated guidance improves
−Removed: the disclosure requirements on fair value measurements and is effective for fiscal years, and interim periods within those fiscal
−Removed: years, beginning after December 15, 2019.
−Removed: Early adoption is permitted upon issuance of the standard for disclosures modified or
−Removed: removed with a delay of adoption of the additional disclosures until their effective date.
−Removed: We are in the process of evaluating
−Removed: the impact the standard will have on our financial statements.
−Removed: November 2018, FASB issued ASU 2018-18, C ollaborative Arrangements (Topic 808):
−Removed: Clarifying the Interaction Between Topic 808
−Removed: and Topic 606, which, among other things, provides guidance on how to assess whether certain collaborative arrangement transactions
−Removed: should be accounted for under Topic 606.
−Removed: The amendments in this ASU are effective for fiscal years, and interim periods within
−Removed: those fiscal years, beginning after December 15, 2019, with early adoption permitted.
−Removed: We are in the process of evaluating the
−Removed: impact the standard will have on our financial statements.
−Removed: Since December 31,
−Removed: 2019, we sold 9.5 million common shares through our at-the-market program and realized net proceeds of $2.6 million.
+Added: There were no tax positions for which it is considered
+Added: reasonably possible that the total amounts of unrecognized tax benefits will significantly increase or decrease within the next
+Added: We recognize interest related to unrecognized tax benefits in interest expense and penalties in operating expenses.
+Added: Accounting Standards Recently Adopted
+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.
+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,
+Added: which, among other things, provides guidance on how to assess whether certain collaborative arrangement transactions should be
+Added: accounted for under Topic 606.
+Added: The amendments in this ASU are effective for fiscal years, and interim periods within those fiscal
+Added: years, beginning after December 15, 2019, with early adoption permitted.
+Added: We adopted this standard effective January 1, 2020 and
+Added: the standard did not have a significant impact to our financial statements.
+Added: Recent Accounting Standards
+Added: In August 2020, FASB issued
+Added: ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts
+Added: in Entity’s Own Equity (Subtopic 815-40):
+Added: Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity ,
+Added: which, among other things, provides guidance on how to account for contracts on an entity’s own equity.
+Added: This ASU simplifies
+Added: the accounting for certain financial instruments with characteristics of liabilities and equity.
+Added: Specifically, the ASU eliminates
+Added: the need for us to assess whether a contract on the entity’s own equity (1) permits settlement in unregistered shares, (2)
+Added: whether counterparty rights rank higher shareholder’s rights, and (3) whether collateral is required.
+Added: In addition, the ASU
+Added: requires incremental disclosure related to contracts on the entity’s own equity and clarifies the treatment of certain financial
+Added: instruments accounted for under this ASU on earnings per share.
+Added: This ASU may be applied on a full retrospective of modified retrospective
+Added: This ASU is effective January 1, 2022 and interim periods presented.
+Added: Early adoption of the ASU is permitted by us effective
+Added: January 1, 2021.
+Added: We are in the process of assessing the adoption of the ASU on our financial statements.
+Added: Subsequent Events
Since December 31, 2020
−Removed: 2019, we elected to sell to Lincoln Park 0.8 million shares and received $0.2 million.
−Removed: On April 24, 2020, we issued and sold 210.8
−Removed: million shares of common stock (or pre-funded warrants to purchase shares of common stock in lieu thereof).
−Removed: The price to the public
−Removed: in this offering for each share of common stock was $0.15, and the price to the public in this offering for each pre-funded warrant
−Removed: Each pre-funded warrant has an exercise price of $0.0001 per share.
−Removed: The pre-funded warrants are exercisable immediately
−Removed: upon issuance until all of the pre-funded warrants are exercised in full.
−Removed: The warrants are subject to certain limitations on beneficial
−Removed: Gross proceeds from this offering to us were $31.6 million, before deducting underwriting discounts and commissions
−Removed: and other offering expenses payable by us.
−Removed: Net proceeds from this offering were $29.1 million.
+Added: we have sold 1.7 million shares of common stock under our Capital on Demand™
+Added: Sales Agreement with JonesTrading, resulting
+Added: in net proceeds of $14.4 million.
+Added: In January 2021, we announced
+Added: a collaborative research agreement with Astellas Pharma, Inc.
+Added: and began work on this project that will utilize our AWE technology
+Added: platform with select targeting agents owned by Astellas in the development of theranostics for solid tumor indications, which combine
+Added: the ability of radioisotopes to be used for both diagnostic and therapeutic purposes.
+Added: QUANTITATIVE AND QUALITATIVE DISCLOSURES
+Added: 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.