2 unchanged sentences
CONDENSED CONSOLIDATED BALANCE SHEETS
−Removed: (Amounts in thousands, except share and
−Removed: per share amounts)
−Removed: September 30,
+Added: (Amounts in thousands, except share
+Added: and per share amounts)
Current assets:
5 unchanged sentences
Property, plant and equipment, net
−Removed: Research and development incentives receivable - long term
Restricted cash
15 unchanged sentences
Common stock, $0.001 par value;
−Removed: 150,000,000 shares authorized as of September 30, 2020 and March 31, 2020;
−Removed: 40,312,272 and 36,668,743 shares issued and outstanding as of September 30, 2020 and March 31, 2020, respectively
+Added: 150,000,000 shares authorized as of December 31, 2020 and March 31, 2020;
+Added: 46,384,675 and 36,668,743 shares issued and outstanding as of December 31, 2020 and March 31, 2020, respectively
Additional paid-in capital
7 unchanged sentences
CONDENSED CONSOLIDATED STATEMENTS OF
−Removed: (Amounts in thousands, except share and
−Removed: per share amounts)
+Added: (Amounts in thousands, except share
+Added: and per share amounts)
Three Months Ended
−Removed: Six Months Ended
−Removed: September 30,
−Removed: September 30,
+Added: Nine Months Ended
Operating expenses:
3 unchanged sentences
Loss from operations
−Removed: Other income:
+Added: Other income (expense):
Research and development incentives
2 unchanged sentences
Interest expense on debt obligations
−Removed: Total other income, net
+Added: Loss on extinguishment of debt
+Added: Other income (expense)
+Added: income (expense), net
Net loss attributable to common stockholders
8 unchanged sentences
Three Months Ended
−Removed: Six Months Ended
−Removed: September 30,
−Removed: September 30,
+Added: Nine Months Ended
Other comprehensive loss:
−Removed: Foreign currency translation loss
+Added: Foreign currency translation gain (loss)
Net unrealized gain (loss) on short-term investments, net of tax
3 unchanged sentences
REPLIMUNE GROUP, INC.
−Removed: CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
+Added: CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
(Amounts in thousands, except share amounts)
14 unchanged sentences
Balances as of September 30, 2020
+Added: Foreign currency translation adjustment
+Added: Unrealized loss on short-term investments
+Added: Exercise of stock options
+Added: Issuance of prefunded warrants to purchase common stock, net of $3,750 issuance costs
+Added: Issuance of common stock, net of issuance costs and underwriter fees of $13,775
+Added: Stock-based compensation expense
+Added: Balances as of December 31, 2020
Balances as of March 31, 2019
10 unchanged sentences
Balances as of September 30, 2019
+Added: Issuance of common stock through ATM sales, net of offering costs
+Added: Issuance of common shares upon closing of follow-on
+Added: public offering, net of issuance costs and underwriter fees of $4,017
+Added: Issuance of prefunded warrants to purchase common
+Added: stock, net of issuance costs and underwriter fees of $1,797
+Added: Foreign currency translation adjustment
+Added: Unrealized loss on short-term investments
+Added: Exercise of stock options
+Added: Stock-based compensation expense
+Added: Balances as of December 31, 2019
The accompanying notes are an integral part
3 unchanged sentences
(Amounts in thousands)
−Removed: Six Months Ended
−Removed: September 30,
+Added: Nine Months Ended
Cash flows from operating activities:
3 unchanged sentences
Noncash interest expense
+Added: Loss on extinguishment of debt
Net amortization of premiums and discounts on short-term investments
15 unchanged sentences
Cash flows from financing activities:
−Removed: Proceeds from long-term debt, net of debt issuance costs
−Removed: Proceeds from issuance of common stock in follow-on public offering, net of issuance costs
−Removed: Proceeds from issuance of prefunded warrants to purchase common stock, net of issuance costs
+Added: Proceeds from issuance of common stock in follow-on public offering, net of underwriting fees and discounts
+Added: Proceeds from issuance of prefunded warrants to purchase common stock, net of underwriting fees and discounts
+Added: Proceeds from issuance of common stock through ATM sales
+Added: Proceeds from long-term debt
+Added: Principal payment of long-term debt
+Added: Payment of long-term debt extinguishment costs
+Added: Payment of issuance costs
Principal payment of finance lease obligation
2 unchanged sentences
Effect of exchange rate changes on cash, cash equivalents and restricted cash
−Removed: Net increase in cash, cash equivalents and restricted cash
+Added: Net increase (decrease) in cash, cash equivalents and restricted cash
Cash, cash equivalents and restricted cash at beginning of period
4 unchanged sentences
Net unrealized gain (loss) on short-term investments
−Removed: Issuance costs included in accounts payable
Purchases of property and equipment included in accounts payable
5 unchanged sentences
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
−Removed: (Amounts in thousands, except share and
−Removed: per share amounts)
+Added: (Dollars in thousands, except share
+Added: and per share amounts)
Nature of the business
Replimune Group, Inc.
−Removed: (the “Company”)
−Removed: is a clinical-stage biotechnology company focused on the development of oncolytic immunotherapies to treat cancer.
−Removed: Replimune Group, Inc.,
−Removed: whose predecessor was founded in 2015, is the parent company of its wholly owned, direct and indirect subsidiaries:
−Removed: Replimune Limited
−Removed: (“Replimune UK”);
+Added: (the “Company”) is a clinical-stage biotechnology company focused on the development of oncolytic immunotherapies to
+Added: treat cancer.
+Added: Replimune Group, Inc., whose predecessor was founded in 2015, is the parent company of its wholly owned, direct
+Added: and indirect subsidiaries:
+Added: Replimune Limited (“Replimune UK”);
Replimune, Inc.
−Removed: (“Replimune US”);
−Removed: Replimune Securities Corporation;
−Removed: and Replimune
−Removed: (Ireland) Limited.
−Removed: The Company is subject to risks and uncertainties
−Removed: common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new
−Removed: technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations
−Removed: and the ability to secure additional capital to fund operations.
−Removed: Product candidates currently under development will require significant
−Removed: additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization.
−Removed: These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance
−Removed: and reporting capabilities.
−Removed: Even if the Company’s product development efforts are successful, it is uncertain when, if ever,
−Removed: the Company will realize significant revenue from product sales.
−Removed: Basis of presentation
−Removed: The accompanying consolidated financial
−Removed: statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities
−Removed: and commitments in the ordinary course of business.
−Removed: The Company has incurred recurring losses since its inception, including net
−Removed: losses of $20,095 and $11,139 for the three months ended September 30, 2020 and 2019, respectively and net losses of $37,588 and
−Removed: $20,647 for the six months ended September 30, 2020 and 2019, respectively.
−Removed: In addition, as of September 30, 2020, the Company
−Removed: had an accumulated deficit of $149,886.
−Removed: The Company expects to continue to generate operating losses for the foreseeable future.
−Removed: As of the issuance date of these consolidated financial statements, the Company expects that its cash and cash equivalents and
−Removed: short-term investments will be sufficient to fund its operating expenses and capital expenditure requirements through at least
−Removed: 12 months from the issuance of the consolidated financial statements.
−Removed: Impact of the COVID-19 coronavirus
−Removed: In December 2019, a novel strain of coronavirus,
−Removed: which causes the disease known as COVID-19, was reported to have surfaced in Wuhan, China.
−Removed: Since then, COVID-19 coronavirus has
−Removed: spread globally.
−Removed: In March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic and the U.S.
−Removed: imposed travel restrictions on travel between the United States, Europe and certain other countries.
−Removed: The impact of this pandemic
−Removed: has been, and will likely continue to be, extensive in many aspects of society, which has resulted, and will likely continue to
−Removed: result, in significant disruptions to the global economy as well as businesses and capital markets around the world.
−Removed: In response to public health
−Removed: directives and orders and to help minimize the risk of the virus to employees, the Company has taken precautionary measures,
−Removed: including implementing work-from-home policies for the Company’s employees, other than those in its laboratory, those
−Removed: performing manufacturing functions and certain other employees as deemed appropriate from time to time.
−Removed: For those employees,
−Removed: the Company has implemented stringent safety measures designed to comply with applicable federal, state and local guidelines
−Removed: instituted in response to the COVID-19 pandemic.
−Removed: The Company has taken these and other precautionary steps while maintaining
−Removed: business continuity in order to continue to progress its programs.
−Removed: While there has been no prolonged material disruption to
−Removed: the Company’s business to date, the impact of the virus, including work-from-home policies, may negatively impact
−Removed: productivity, disrupt the Company’s business, and delay its preclinical research and clinical trial activities and its
−Removed: development program timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions
−Removed: and other limitations on the Company’s ability to conduct its business in the ordinary course.
−Removed: Other impacts to the
−Removed: Company’s business may include temporary closures of its suppliers and disruptions or restrictions on its
−Removed: employees’ ability to travel.
−Removed: Any prolonged material disruption to the Company’s employees or suppliers could
−Removed: adversely impact the Company’s preclinical research and clinical trial activities, financial condition and results of
−Removed: operations, including its ability to obtain financing.
+Added: (“Replimune US”);
+Added: Securities Corporation;
+Added: and Replimune (Ireland) Limited.
+Added: The Company is subject
+Added: to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development
+Added: by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance
+Added: with government regulations and the ability to secure additional capital to fund operations.
+Added: Product candidates currently under
+Added: development will require significant additional research and development efforts, including preclinical and clinical testing and
+Added: regulatory approval, prior to commercialization.
+Added: These efforts require significant amounts of additional capital, adequate personnel
+Added: and infrastructure and extensive compliance and reporting capabilities.
+Added: Even if the Company’s product development efforts
+Added: are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
+Added: of presentation
+Added: The accompanying consolidated
+Added: financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of
+Added: liabilities and commitments in the ordinary course of business.
+Added: The Company has incurred recurring losses since its inception,
+Added: including net losses of $21,783 and $16,189 for the three months ended December 31, 2020 and 2019, respectively and net losses
+Added: of $59,371and $36,836 for the nine months ended December 31, 2020 and 2019, respectively.
+Added: In addition, as of December 31,
+Added: 2020, the Company had an accumulated deficit of $171,669.
+Added: The Company expects to continue to generate operating losses for the
+Added: foreseeable future.
+Added: As of the issuance date of these consolidated financial statements, the Company expects that its cash and cash
+Added: equivalents and short-term investments will be sufficient to fund its operating expenses and capital expenditure requirements through
+Added: at least 12 months from the issuance of the consolidated financial statements.
+Added: Impact of the
+Added: COVID-19 coronavirus
+Added: In December 2019,
+Added: a novel strain of coronavirus, which causes the disease known as COVID-19, was reported to have surfaced in Wuhan, China.
+Added: then, COVID-19 coronavirus has spread globally.
+Added: In March 2020, the World Health Organization declared the COVID-19 outbreak
+Added: a pandemic and the U.S.
+Added: government imposed travel restrictions on travel between the United States, Europe and certain other countries.
+Added: The impact of this pandemic has been, and will likely continue to be, extensive in many aspects of society, which has resulted,
+Added: and will likely continue to result, in significant disruptions to the global economy as well as businesses and capital markets
+Added: around the world.
+Added: In response to public
+Added: health directives and orders and to help minimize the risk of the virus to employees, the Company has taken precautionary measures,
+Added: including implementing work-from-home policies for the Company’s employees, other than those in its laboratory, those performing
+Added: manufacturing functions and certain other employees as deemed appropriate from time to time.
+Added: For those employees, the Company has
+Added: implemented stringent safety measures designed to comply with applicable federal, state and local guidelines instituted in response
+Added: to the COVID-19 pandemic.
+Added: The Company has taken these and other precautionary steps while maintaining business continuity in order
+Added: to continue to progress its programs.
+Added: While there has been no prolonged material disruption to the Company’s business to
+Added: date, the impact of the virus, including work-from-home policies, may negatively impact productivity, disrupt the Company’s
+Added: business, and delay its preclinical research and clinical trial activities and its development program timelines, the magnitude
+Added: of which will depend, in part, on the length and severity of the restrictions and other limitations on the Company’s ability
+Added: to conduct its business in the ordinary course.
+Added: Other impacts to the Company’s business may include temporary closures of
+Added: its suppliers and disruptions or restrictions on its employees’
+Added: ability to travel.
+Added: Any prolonged material disruption to the
+Added: Company’s employees or suppliers could adversely impact the Company’s preclinical research and clinical trial activities,
+Added: financial condition and results of operations, including its ability to obtain financing.
Summary of significant accounting policies
−Removed: Principles of consolidation
−Removed: The accompanying consolidated financial
−Removed: statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP,
−Removed: and include the accounts of the Company and its direct and indirect wholly owned subsidiaries, Replimune UK, Replimune US, Replimune
−Removed: Securities Corporation and Replimune (Ireland) Limited after elimination of all intercompany accounts and transactions.
−Removed: Use of estimates
−Removed: The preparation of consolidated financial
−Removed: statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets
−Removed: and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the
−Removed: reported amounts of expenses during the reporting periods.
−Removed: Significant estimates and assumptions reflected in these consolidated
−Removed: financial statements include, but are not limited to, the accrual for research and development expenses and the valuation of stock-based
−Removed: The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors
−Removed: that it believes to be reasonable under the circumstances.
−Removed: The full extent to which the COVID-19 pandemic
−Removed: will directly or indirectly impact our business, results of operations and financial condition, including, expenses, research and
−Removed: development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result
−Removed: of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19.
−Removed: We have made estimates
−Removed: of the impact of COVID-19 within our financial statements and there may be changes to those estimates in future periods.
−Removed: Estimates are periodically reviewed in light
−Removed: of reasonable changes in circumstances, facts and experience.
−Removed: Changes in estimates are recorded in the period in which they become
+Added: of consolidation
+Added: The accompanying consolidated
+Added: financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America,
+Added: or GAAP, and include the accounts of the Company and its direct and indirect wholly owned subsidiaries, Replimune UK, Replimune
+Added: US, Replimune Securities Corporation and Replimune (Ireland) Limited after elimination of all intercompany accounts and transactions.
+Added: The preparation of
+Added: consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the
+Added: reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated
+Added: financial statements and the reported amounts of expenses during the reporting periods.
+Added: Significant estimates and assumptions reflected
+Added: in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses and
+Added: the valuation of stock-based awards.
+Added: The Company bases its estimates on historical experience, known trends and other market-specific
+Added: or other relevant factors that it believes to be reasonable under the circumstances.
+Added: The full extent to
+Added: which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including,
+Added: expenses, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain,
+Added: including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19.
+Added: We have made estimates of the impact of COVID-19 within our financial statements and there may be changes to those estimates in
+Added: future periods.
+Added: Estimates are periodically
+Added: reviewed in light of reasonable changes in circumstances, facts and experience.
+Added: Changes in estimates are recorded in the period
+Added: in which they become known.
Actual results could differ from those estimates or assumptions.
−Removed: Unaudited interim financial information
−Removed: The accompanying consolidated balance sheet
−Removed: as of September 30, 2020, the consolidated statements of operations, of comprehensive loss and of stockholders’ equity for
−Removed: the three and six months ended September 30, 2020 and 2019 and the consolidated statements of cash flows for the six months ended
−Removed: September 30, 2020 and 2019 are unaudited.
−Removed: The unaudited interim consolidated financial statements have been prepared on the same
−Removed: basis as the audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which
−Removed: include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of
−Removed: September 30, 2020 and the results of its operations for the three and six months ended September 30, 2020 and 2019 and its cash
−Removed: flows for the six months ended September 30, 2020 and 2019.
−Removed: The financial data and other information disclosed in these consolidated
−Removed: notes related to the three and six months ended September 30, 2020 and 2019 are unaudited.
−Removed: The results for the three and six months
−Removed: ended September 30, 2020 are not necessarily indicative of results to be expected for the year ending March 31, 2021, any other
−Removed: interim periods or any future year or period.
−Removed: The financial information included herein should be read in conjunction with the
−Removed: financial statements and notes in the Company's Annual Report on Form 10-K for the year ended March 31, 2020.
−Removed: During the three and six months
−Removed: ended September 30, 2020, there have been no changes to the Company’s significant accounting policies as described
−Removed: in the Company's Annual Report on Form 10-K for the year ended March 31, 2020 which was filed with the Securities and Exchange
−Removed: Commission on June 3, 2020, except as described below.
−Removed: Recently adopted accounting
−Removed: pronouncements
−Removed: In August 2018, the FASB issued ASU
−Removed: 2018-13, Fair Value Measurement (Topic 820), Disclosure Framework- Changes to the Disclosure Requirements for
−Removed: Fair Value Measurement (“ASU 2018-13”).
−Removed: The amendments in this ASU require certain existing disclosure requirements
−Removed: in Topic 820 to be modified or removed, and certain new disclosure requirements to be added to the Topic.
−Removed: In addition, this ASU
−Removed: allows entities to exercise more discretion when considering fair value measurement disclosures.
−Removed: The Company adopted ASU 2018-13
−Removed: on April 1, 2020.
−Removed: The adoption of ASU 2018-13 did not have a material impact on the Company's consolidated financial statements.
−Removed: In November 2018, the FASB issued ASU No.
+Added: Unaudited interim financial
+Added: The accompanying consolidated
+Added: balance sheet as of December 31, 2020, the consolidated statements of operations, of comprehensive loss and of stockholders’
+Added: equity for the three and nine months ended December 31, 2020 and 2019 and the consolidated statements of cash flows for the
+Added: nine months ended December 31, 2020 and 2019 are unaudited.
+Added: The unaudited interim consolidated financial statements have been
+Added: prepared on the same basis as the audited annual consolidated financial statements and, in the opinion of management, reflect all
+Added: adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial
+Added: position as of December 31, 2020 and the results of its operations for the three and nine months ended December 31, 2020
+Added: and 2019 and its cash flows for the nine months ended December 31, 2020 and 2019.
+Added: The financial data and other information
+Added: disclosed in these consolidated notes related to the three and nine months ended December 31, 2020 and 2019 are unaudited.
+Added: The results for the three and nine months ended December 31, 2020 are not necessarily indicative of results to be expected
+Added: for the year ending March 31, 2021, any other interim periods or any future year or period.
+Added: The financial information included
+Added: herein should be read in conjunction with the financial statements and notes in the Company's Annual Report on Form 10-K for
+Added: the year ended March 31, 2020.
+Added: During the three and
+Added: nine months ended December 31, 2020, there have been no changes to the Company’s significant accounting policies as
+Added: described in the Company's Annual Report on Form 10-K for the year ended March 31, 2020 which was filed with the Securities
+Added: and Exchange Commission on June 3, 2020, except as described below.
+Added: adopted accounting pronouncements
+Added: In August 2018,
+Added: the FASB issued ASU No.
+Added: 2018-13, Fair Value Measurement (Topic 820), Disclosure Framework- Changes to the Disclosure
+Added: Requirements for Fair Value Measurement (“ASU 2018-13”).
+Added: The amendments in this ASU require certain existing
+Added: disclosure requirements in Topic 820 to be modified or removed, and certain new disclosure requirements to be added to the Topic.
+Added: In addition, this ASU allows entities to exercise more discretion when considering fair value measurement disclosures.
+Added: adopted ASU 2018-13 on April 1, 2020.
+Added: The adoption of ASU 2018-13 did not have a material impact on the Company's consolidated
+Added: financial statements.
+Added: In November 2018,
+Added: the FASB issued ASU No.
2018-18, Collaborative Arrangements (Topic 808):
−Removed: Clarifying the Interaction between Topic 808 and Topic 606 (“ASU2018-18”),
−Removed: which clarifies that certain transactions between collaborative arrangement participants should be accounted for as revenue under
−Removed: Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account.
−Removed: In those situations,
−Removed: all the guidance in Topic 606 should be applied, including recognition, measurement, presentation, and disclosure requirements.
−Removed: The standard adds unit-of-account guidance in Topic 808 to align with the guidance in Topic 606 (that is, a distinct good or service)
−Removed: when an entity is assessing whether the collaborative arrangement or a part of the arrangement is within the scope of Topic 606,
−Removed: and requires that in a transaction with a collaborative arrangement participant that is not directly related to sales to third
−Removed: parties, presenting the transaction together with revenue recognized under Topic 606 is precluded if the collaborative arrangement
−Removed: participant is not a customer.
−Removed: The standard is effective for interim and annual periods beginning after December 15, 2019,
−Removed: with early adoption permitted, including adoption in any interim period for public business entities for periods in which financial
−Removed: statements have not been issued.
−Removed: Amendments in the standard should be applied retrospectively to the date of initial application
−Removed: of Topic 606, but entities may elect to apply the amendments in this Update retrospectively either to all contracts or only to
−Removed: contracts that are not completed at the date of initial application of Topic 606, and should disclose the election.
−Removed: An entity may
−Removed: also elect to apply the practical expedient for contract modifications that is permitted for entities using the modified retrospective
−Removed: transition method in Topic 606.
+Added: Clarifying the Interaction between Topic 808 and
+Added: Topic 606 (“ASU 2018-18”), which clarifies that certain transactions between collaborative arrangement participants
+Added: should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context
+Added: of a unit of account.
+Added: In those situations, all the guidance in Topic 606 should be applied, including recognition, measurement,
+Added: presentation, and disclosure requirements.
+Added: The standard adds unit-of-account guidance in Topic 808 to align with the guidance in
+Added: Topic 606 (that is, a distinct good or service) when an entity is assessing whether the collaborative arrangement or a part of
+Added: the arrangement is within the scope of Topic 606, and requires that in a transaction with a collaborative arrangement participant
+Added: that is not directly related to sales to third parties, presenting the transaction together with revenue recognized under Topic
+Added: 606 is precluded if the collaborative arrangement participant is not a customer.
+Added: The standard is effective for interim and annual
+Added: periods beginning after December 15, 2019, with early adoption permitted, including adoption in any interim period for public
+Added: business entities for periods in which financial statements have not been issued.
+Added: Amendments in the standard should be applied
+Added: retrospectively to the date of initial application of Topic 606, but entities may elect to apply the amendments in this Update
+Added: retrospectively either to all contracts or only to contracts that are not completed at the date of initial application of Topic
+Added: 606, and should disclose the election.
+Added: An entity may also elect to apply the practical expedient for contract modifications that
+Added: is permitted for entities using the modified retrospective transition method in Topic 606.
The Company adopted ASU 2018-18 on April 1,
−Removed: The adoption of ASU 2018-18 did not have
−Removed: a material impact on the Company's consolidated financial statements.
−Removed: Recently issued accounting
−Removed: pronouncements
−Removed: In June 2016, the FASB issued ASU No.
−Removed: 2016-13, Financial
−Removed: Instruments- Credit Losses (Topic 326).
−Removed: The standard changes how entities will measure credit losses for most financial
−Removed: assets and certain other instruments that are not measured at fair value through net income.
−Removed: Financial assets measured at amortized
−Removed: cost will be presented at the net amount expected to be collected by using an allowance for credit losses.
−Removed: In April 2019,
+Added: The adoption of ASU 2018-18 did not have a material impact on the Company's consolidated financial statements.
+Added: issued accounting pronouncements
+Added: In June 2016,
the FASB issued ASU No.
−Removed: 2019-04, Codification Improvements to Topic 326, Financial Instruments - Credit
−Removed: Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, which clarifies and corrects certain
−Removed: unintended applications of the guidance contained in each of the amended Topics.
−Removed: Additionally, in May 2019, the FASB issued
−Removed: 2019-05, Financial Instruments - Credit Losses (Topic 326), which provides an option
−Removed: to irrevocably elect to measure certain individual financial assets at fair value instead of amortized cost.
−Removed: The standard is effective
−Removed: for fiscal years and interim periods beginning after December 15, 2023.
−Removed: Early adoption is permitted for all periods beginning
−Removed: after December 15, 2018.
−Removed: The adoption of ASU 2016-13 is not expected to have a material impact on the Company's consolidated
−Removed: financial statements.
+Added: 2016-13, Financial Instruments- Credit Losses (Topic 326).
+Added: The standard changes how
+Added: entities will measure credit losses for most financial assets and certain other instruments that are not measured at fair value
+Added: through net income.
+Added: Financial assets measured at amortized cost will be presented at the net amount expected to be collected by
+Added: using an allowance for credit losses.
+Added: In April 2019, the FASB issued ASU No.
+Added: 2019-04, Codification Improvements
+Added: to Topic 326, Financial Instruments - Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial
+Added: Instruments, which clarifies and corrects certain unintended applications of the guidance contained in each of the amended
+Added: Additionally, in May 2019, the FASB issued ASU No.
+Added: 2019-05, Financial Instruments - Credit
+Added: Losses (Topic 326), which provides an option to irrevocably elect to measure certain individual financial assets at fair
+Added: value instead of amortized cost.
+Added: The standard is effective for fiscal years and interim periods beginning after December 15,
+Added: Early adoption is permitted for all periods beginning after December 15, 2018.
+Added: The adoption of ASU 2016-13 is not expected
+Added: to have a material impact on the Company's consolidated financial statements.
+Added: In December 2019,
+Added: the FASB issued ASU No.
+Added: 2019-12 Income Taxes (Topic 740)-Simplifying the Accounting for Income Taxes (ASU 2019-12) ,
+Added: as part of its initiative to reduce complexity in the accounting standards.
+Added: The amendments in ASU 2019-12 eliminates certain exceptions
+Added: related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the
+Added: recognition of deferred tax liabilities for outside basis differences.
+Added: ASU 2019-12 also clarifies and simplifies other aspects
+Added: of the accounting for income taxes.
+Added: The standard is effective for fiscal years and interim periods beginning after December 15,
+Added: The Company is currently evaluating the impact of this new guidance on its financial statements and related disclosures
+Added: but does not expect the adoption of ASU 2019-12 to have a material impact on the Company's consolidated financial statements.
Fair value of financial assets and liabilities
The following tables present information
−Removed: about the Company’s financial assets and liabilities measured at fair value on a recurring basis:
+Added: about the Company’s financial assets and liabilities measured at fair value on a recurring basis:
Fair Value Measurements as of
−Removed: September 30, 2020 Using:
+Added: December 31, 2020 Using:
Money market funds
−Removed: US Treasury bonds
US Government Agency bonds
+Added: US Treasury bonds
Fair Value Measurements as of
7 unchanged sentences
market funds held by the Company are all government backed securities.
−Removed: During the three and six months ended September
+Added: During the three and nine months ended December 31,
2020 and 2019, there were no transfers between levels.
5 unchanged sentences
Cash equivalents consisted
−Removed: of money market funds at September 30, 2020 and March 31, 2020.
+Added: of money market funds at December 31, 2020 and March 31, 2020.
Short-term investments
1 unchanged sentence
consisted of the following:
−Removed: September 30, 2020
+Added: December 31, 2020
Gross unrealized
3 unchanged sentences
March 31, 2020
−Removed: Gross unrealized
−Removed: Gross unrealized
+Added: Amortized cost
+Added: Gross unrealized gains
+Added: Gross unrealized losses
Commercial paper
5 unchanged sentences
of the following:
−Removed: September 30,
Construction in progress
4 unchanged sentences
Accumulated depreciation and amortization
−Removed: Depreciation and amortization expense was
−Removed: $425 and $816 for the three and six months ended September 30, 2020, respectively, and $42 and $84 for the three and six months
−Removed: ended September 30, 2019, respectively.
−Removed: Depreciation and amortization expense are recorded within research and development and
−Removed: general and administrative expenses in the consolidated statement of operations.
+Added: Depreciation and amortization
+Added: expense was $402 and $1,217 for the three and nine months ended December 31, 2020, respectively, and $107 and $191 for the
+Added: three and nine months ended December 31, 2019, respectively.
+Added: Depreciation and amortization expense are recorded within research
+Added: and development and general and administrative expenses in the consolidated statement of operations.
Accrued expenses and other current liabilities
1 unchanged sentence
consisted of the following:
−Removed: September 30,
Accrued research and development costs
3 unchanged sentences
Long-term debt consisted of the following:
−Removed: September 30,
Principal amount of long-term debt
2 unchanged sentences
Hercules Loan Agreement
−Removed: On August 8, 2019, (the “Closing
−Removed: Date”) the Company and certain of its affiliates entered into a Loan and Security Agreement (as amended, the “Hercules
−Removed: Loan Agreement”) with Hercules Capital, Inc.
−Removed: (“Hercules”) pursuant to which Hercules agreed to make available
−Removed: to the Company a secured term loan facility in the amount of $30,000 (the “Term Loan Facility”), subject to certain
−Removed: terms and conditions.
−Removed: The Company borrowed $10,000 under the Hercules Loan Agreement in one advance as a single tranche Term Loan
−Removed: on the Closing Date upon which the Company paid a $225 facility charge and incurred $130 in additional closing and legal fees.
−Removed: The Company may borrow the unused $20,000 available under the Term Loan Facility in two separate advances.
−Removed: The second advance of
−Removed: up to $10,000 may be borrowed between January 1, 2020 and December 15, 2020 and the third advance of up to $10,000 may
−Removed: be borrowed between July 1, 2020 and June 30, 2021.
−Removed: June 1, 2020, the Company entered into the First Amendment to the Hercules Loan Agreement (the “Hercules First
−Removed: Amendment”), to, among other things, increase the aggregate principal amount of the secured term loan facility from
−Removed: $30,000 to $40,000 , by adding a fourth advance of up to $10,000.
−Removed: Pursuant to the Hercules First Amendment, the Company
−Removed: may borrow the second advance of $10,000 between October 1, 2020 and December 15, 2020.
−Removed: In the event the Company does not
−Removed: draw on the second advance or if the Term Loan Facility is terminated prior to a draw of the second advance, the Company
−Removed: shall pay Hercules a one-time facility charge fee of $100 on the earliest of (i) December 16, 2020 or (ii) the date the
−Removed: Company prepays the outstanding obligations.
−Removed: The third advance of up to $10,000 may be borrowed between July 1, 2020 and June
−Removed: The fourth advance of up to $10,000 may be borrowed between July 1, 2021 and December 15, 2021.
−Removed: incurred $100 in additional closing and legal fees in connection with Hercules First Amendment which were capitalized and
−Removed: will be amortized as part of the effective yield.
−Removed: Additionally, the Hercules First Amendment extended the interest only
−Removed: payment period from March 1, 2022 to September 1, 2022 (the “Amortization Date”).
−Removed: Advances under the Term Loan Facility bear
−Removed: interest at a rate per annum equal to the greater of either (i) the prime rate as reported in The Wall Street Journal plus
−Removed: 2.75%, or (ii) 8.75%.
−Removed: The Hercules Loan Agreement includes covenants, limitations, and events of default customary for similar
−Removed: The term of the Hercules Loan Agreement is four years, ending August 1, 2023.
−Removed: Interest is payable on a monthly basis until
−Removed: the Amortization Date.
−Removed: After the Amortization Date, payments shall consist of equal monthly installments of principal and interest
−Removed: payable until the secured obligations are repaid in full.
−Removed: At any time the Company may prepay the principal
−Removed: of any advance pursuant to the terms of the Term Loan Facility subject to a prepayment charge equal to:
−Removed: 3.0%, if such advance is
−Removed: prepaid within the first twelve months following the Closing Date, 2.0%, if such advance is prepaid after twelve months but prior
−Removed: to twenty four months following the Closing Date, and 1.0%, if such advance is prepaid anytime thereafter.
−Removed: The Company will also
−Removed: pay a charge equal to the product of 4.95% and the aggregate amount of any advance made pursuant to the terms of the Term Loan
−Removed: The Term Loan Facility is secured by substantially
−Removed: all of the Company’s assets, but excluding its intellectual property, and subject to certain exceptions and exclusions.
−Removed: The Hercules Loan Agreement contains customary
−Removed: covenants for transactions of this type and other covenants agreed to by the parties, including, among others, (i) the provision
−Removed: of delivery of annual and quarterly financial statements and insurance policies and restrictions on incurring debt, granting liens,
−Removed: making acquisitions, making loans, paying dividends, dissolving, and entering into leases and asset sales.
−Removed: The Hercules Loan Agreement
−Removed: also provides for customary events of default, including, among others, events of default relating to failure to make payment,
−Removed: bankruptcy, breach of covenants, breaches of representations and warranties, change of control, judgment and material adverse effects.
+Added: On August 8, 2019,
+Added: (the “Closing Date”) the Company and certain of its affiliates entered into a Loan and Security Agreement (as amended,
+Added: the “Hercules Loan Agreement”) with Hercules Capital, Inc.
+Added: (“Hercules”) pursuant to which Hercules
+Added: agreed to make available to the Company a secured term loan facility in the amount of $30,000 (the “Term Loan Facility”),
+Added: subject to certain terms and conditions.
+Added: The Company borrowed $10,000 under the Hercules Loan Agreement in one advance as a single
+Added: tranche term loan on the Closing Date upon which the Company paid a $225 facility charge and incurred $130 in additional closing
+Added: and legal fees.
+Added: On June 1, 2020,
+Added: the Company entered into the First Amendment to the Hercules Loan Agreement (the “Hercules First Amendment”), to, among
+Added: other things, increase the aggregate principal amount of the secured term loan facility from $30,000 to $40,000.
+Added: Pursuant to the
+Added: Hercules First Amendment, subject to the achievement of certain milestones, the Company could have borrowed three tranches of up
+Added: to $10,000 between October 1, 2020 and December 15, 2020, July 1, 2020 and June 30, 2021, and July 1,
+Added: 2021 and December 15, 2021, respectively.
+Added: The Company incurred $100 in additional closing and legal fees in connection with
+Added: Hercules First Amendment which were capitalized and will be amortized as part of the effective yield.
+Added: On December 15,
+Added: 2020, the Company entered into a Payoff Letter with respect to the Hercules Loan Agreement, which resulted in a loss on extinguishment
+Added: of debt of $913 including both cash and non-cash expense.
+Added: Pursuant to the Payoff Letter, the Company paid a total of $10,839 to
+Added: Hercules, representing $10,000 in outstanding principal, $495 end of term charge, $300 early termination fee due and $44 in accrued
+Added: interest owed to Hercules under the Hercules Loan Agreement.
+Added: In connection with the execution of the Payoff Letter and the repayment
+Added: of the Company’s outstanding obligations under the Hercules Loan Agreement, the Hercules Loan Agreement and the related loan
+Added: documents were terminated.
+Added: The Term Loan Facility
+Added: was secured by substantially all of the Company’s assets, but excluding its intellectual property, and subject to certain
+Added: exceptions and exclusions.
+Added: All liens on the Company’s assets held by Hercules were released in connection with the execution
+Added: of the Payoff Letter.
+Added: In connection with
+Added: entering into the Hercules Loan Agreement, the Company paid Hercules $355 of upfront fees, including closing costs and legal fees
+Added: associated with entering into the agreement, which were recorded as a debt discount.
In connection with entering into the Hercules
−Removed: Loan Agreement, the Company paid Hercules $355 of upfront fees, including closing costs and legal fees associated with entering
−Removed: into the agreement, which were recorded as a debt discount.
−Removed: In connection with entering into the Hercules First Amendment, the
−Removed: Company paid $100 of upfront fees, including closing costs and legal fees associated with entering into the amendment, which were
−Removed: recorded as debt discount, totaling the debt discount to $455 as of September 30, 2020.
−Removed: The debt discount is reflected as a reduction
−Removed: of the carrying value of long-term debt on the Company’s consolidated balance sheet and is being amortized to interest expense
−Removed: over the term of the loan using the effective interest method.
−Removed: Company recognized aggregate interest expense under the Hercules Loan Agreement of $286 and $570 during the three and six
−Removed: months ended September 30, 2020, respectively, which included non-cash interest expense of $63 and $126 for the three and six months
−Removed: ended September 30, 2020, respectively, $29 and $56 related to the accretion of the debt discount and $34 and $70 related to the
−Removed: accretion of the final payment for the three and six months ended September 30, 2020, respectively.
−Removed: The Company’s annual
−Removed: effective interest rate under the Hercules Loan Agreement (after giving effect to the Hercules First Amendment) was approximately
−Removed: 10.5% as of September 30, 2020.
−Removed: There were no principal payments due or
−Removed: paid under the Hercules Loan Agreement during the three and six months ended September 30, 2020.
−Removed: Future payments of long-term debt
−Removed: as of September 30, 2020 are as follows (fiscal years):
−Removed: Future long-term debt payments:
−Removed: 2021 (remaining six months) $
−Removed: Total debt payments $
−Removed: The table of future payments of long-term
−Removed: debt excludes the end of term charge of $495 as of September 30, 2020, which is due upon the maturity of the loan.
−Removed: Stockholders’ Equity
−Removed: As of September 30, 2020 and March 31, 2020,
−Removed: the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue up to 150,000,000 shares
−Removed: of common stock, par value $0.001 per share.
−Removed: As of September 30, 2020 and March 31, 2020,
−Removed: the Company had reserved 13,638,824 and 10,449,033 shares of common stock for the exercise of outstanding stock options, the number
−Removed: of shares remaining available for grant under the Company’s 2018 Omnibus Incentive Compensation Plan and the Company’s
−Removed: Employee Stock Purchase Plan (see Note 9) and the exercise of the outstanding warrants to purchase shares of common, respectively.
−Removed: Undesignated preferred
−Removed: As of September 30, 2020, the Company’s
−Removed: certificate of incorporation, as amended and restated, authorized the Company to issue up to 10,000,000 shares of undesignated
−Removed: preferred stock, par value $0.001 per share.
−Removed: There were no undesignated preferred shares issued or outstanding as of September 30,
−Removed: Convertible preferred stock and preferred
−Removed: stock warrants
−Removed: Prior to the IPO, the Company
−Removed: issued series seed convertible preferred stock (the “series seed preferred stock”), series A convertible preferred
−Removed: stock (the “series A preferred stock”) and series B convertible preferred stock (the “series B preferred stock”).
−Removed: The series seed preferred stock, series A preferred stock and series B preferred stock are collectively referred to as the “preferred
−Removed: stock.” In connection with the closing of the IPO, the preferred stock converted into 19,157,360 shares of common stock on
−Removed: a 1:9.94688 basis.
−Removed: There was no preferred stock outstanding as of September 30, 2020 and March 31, 2020.
−Removed: connection with the issuance of the series seed preferred stock, the Company issued to the holders of the series seed preferred
−Removed: stock warrants for the purchase of 50,000 shares of series seed preferred stock, which became fully vested and exercisable in the
−Removed: year of issuance.
−Removed: The warrants to purchase shares of series seed preferred stock were issued at an exercise price of $10.00 per
−Removed: share and expire on the earlier of September 16, 2025 or a qualified change of control event.
−Removed: In connection with the closing
−Removed: of the IPO , the series seed preferred stock warrants became exercisable for 497,344 shares of common stock and the exercise price
−Removed: was adjusted to $1.01 per share.
−Removed: Upon the closing of the IPO, the series seed preferred stock warrants and were reclassified to
−Removed: stockholders’ equity.
−Removed: The warrants to purchase 497,344 shares of common stock remain outstanding as of September 30,
−Removed: In August 2019, the
−Removed: Company entered into a Sales Agreement (as amended, the “2019 Sales Agreement”) with SVB Leerink LLC (the
−Removed: “Agent”), pursuant to which the Company could sell, from time to time, at its option, up to an aggregate amount
−Removed: of $75,000 of shares of the Company’s common stock, $0.001 par value per share, through the Agent, as the
−Removed: Company’s sales agent.
−Removed: In June 2020, the 2019 Sales Agreement was amended to reduce the aggregate offering amount under
−Removed: the 2019 Sales Agreement from $75,000 of shares to $30,000 of shares.
−Removed: On August 11, 2020, the 2019 Sales
−Removed: Agreement was terminated by the execution by the Company and the Agent of a new sales agreement (the “2020 Sales Agreement”).
−Removed: Under the 2020 Sales Agreement the Company may sell, from time to time, at its option, up to an aggregate of $75,000 of shares
−Removed: of the Company’s common stock, $0.001 par value per share (the “Shares”), through the Agent, as the Company’s
−Removed: On October 21, 2020, the 2020 Sales Agreement was amended to reduce the aggregate offering amount under the
−Removed: 2020 Sales Agreement from $75,000 of Shares to $62,500 of Shares (Note 14).
−Removed: Any Shares to be offered and sold
−Removed: under the 2020 Sales Agreement will be issued and sold (i) by methods deemed to be an “at the market offering” (“ATM”)
−Removed: as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended or in negotiated transactions, if authorized
−Removed: by the Company and (ii) pursuant to, and only upon the effectiveness of, a registration statement on Form S-3 filed by the Company
−Removed: with the Securities and Exchange Commission on August 11, 2020 for an offering of up to $350,000 of various securities, including
−Removed: shares of the Company’s common stock, preferred stock, debt securities, warrants and/or units for sale to the public in one
−Removed: or more public offerings.
−Removed: Subject to the terms of the 2020
−Removed: Sales Agreement, the Agent will use reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions
−Removed: (including any price, time or size limits or other customary parameters or conditions the Company may impose).
−Removed: The Company cannot
−Removed: provide any assurances that it will issue any Shares pursuant to the 2020 Sales Agreement.
−Removed: The Company will pay the Agent a commission
−Removed: of up to 3.0% of the gross proceeds from the sale of the Shares, if any.
−Removed: The Company has also agreed to provide the Agent with
−Removed: customary indemnification rights.
−Removed: During the year ended March 31,
−Removed: 2020, the Company issued and sold 287,559 shares of common stock under the 2019 Sales Agreement, for gross proceeds of $4,568 less
−Removed: offering fees of $137 for net proceeds of $4,431 under the ATM.
−Removed: The Company has not issued and sold any shares under the 2020 Sales
−Removed: Agreement as of September 30, 2020.
+Added: First Amendment, the Company paid $100 of upfront fees, including closing costs and legal fees associated with entering into the
+Added: amendment, which were recorded as debt discount.
+Added: The debt discount is reflected as a reduction of the carrying value of long-term
+Added: debt on the Company’s consolidated balance sheet and is being amortized to interest expense over the term of the loan using
+Added: the effective interest method.
+Added: The Company recognized
+Added: aggregate interest expense under the Hercules Loan Agreement of $247 and $817 during the three and nine months ended December 31,
+Added: 2020, respectively, which included non-cash interest expense of $55 and $181 for the three and nine months ended December 31,
+Added: 2020, respectively.
+Added: Non-cash interest expense related to the amortization of the debt discount of $26 and $82 and the accretion
+Added: of the final payment of $29 and $99 for the three and nine months ended December 31, 2020, respectively.
+Added: Stockholders’
+Added: As of December 31,
+Added: 2020 and March 31, 2020, the Company’s certificate of incorporation, as amended and restated, authorized the Company
+Added: to issue up to 150,000,000 shares of common stock, par value $0.001 per share.
+Added: As of December 31,
+Added: 2020 and March 31, 2020, the Company had reserved 14,753,921 and 10,449,033 shares of common stock for the exercise of outstanding
+Added: stock options, the number of shares remaining available for grant under the Company’s 2018 Omnibus Incentive Compensation
+Added: Plan and the Company’s Employee Stock Purchase Plan (see Note 9) and the exercise of the outstanding warrants to purchase
+Added: shares of common stock, respectively.
+Added: preferred stock
+Added: As of December 31,
+Added: 2020, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue up to 10,000,000
+Added: shares of undesignated preferred stock, par value $0.001 per share.
+Added: There were no undesignated preferred shares issued or outstanding
+Added: as of December 31, 2020.
+Added: Convertible preferred stock
+Added: and preferred stock warrants
+Added: The Company has issued
+Added: series seed convertible preferred stock (the “series seed preferred stock”), series A convertible preferred stock (the
+Added: “series A preferred stock”) and series B convertible preferred stock (the “series B preferred stock”).
+Added: The series seed preferred stock, series A preferred stock and series B preferred stock are collectively referred to as the “preferred
+Added: stock.”
+Added: In connection with the closing of the Company’s initial public offering (the “IPO”) in 2018, the
+Added: preferred stock converted into 19,157,360 shares of common stock on a 1:9.94688 basis.
+Added: There was no preferred stock outstanding
+Added: as of December 31, 2020 and March 31, 2020.
+Added: connection with the issuance of the series seed preferred stock, the Company issued to the holders of the series seed
+Added: preferred stock warrants for the purchase of 50,000 shares of series seed preferred stock, which became fully vested and
+Added: exercisable in the year of issuance.
+Added: The warrants to purchase shares of series seed preferred stock were issued at an
+Added: exercise price of $10.00 per share and expire on the earlier of September 16, 2025 or a qualified change of control
+Added: In connection with the closing of the IPO, the series seed preferred stock warrants became exercisable for 497,344
+Added: shares of common stock and the exercise price was adjusted to $1.01 per share.
+Added: Upon the closing of the IPO, the series seed
+Added: preferred stock warrants were reclassified to stockholders’
+Added: The warrants to purchase 497,344 shares of common
+Added: stock remain outstanding as of December 31, 2020.
+Added: In August 2019,
+Added: the Company entered into a Sales Agreement (as amended, the “2019 Sales Agreement”) with SVB Leerink LLC (the “Agent”),
+Added: pursuant to which the Company could sell, from time to time, at its option, up to an aggregate amount of $75,000 of shares of the
+Added: Company’s common stock, $0.001 par value per share, through the Agent, as the Company’s sales agent.
+Added: In June 2020,
+Added: the 2019 Sales Agreement was amended to reduce the aggregate offering amount under the 2019 Sales Agreement from $75,000 of shares
+Added: to $30,000 of shares.
+Added: On August 11,
+Added: 2020, the 2019 Sales Agreement was terminated by the execution by the Company and the Agent of a new sales agreement, which was
+Added: subsequently amended on October 21, 2020 (as amended, the “2020 Sales Agreement”).
+Added: Under the 2020 Sales Agreement
+Added: the Company may sell, from time to time, at its option, up to an aggregate of $62,500 of shares of the Company’s common stock,
+Added: $0.001 par value per share (the “Shares”), through the Agent, as the Company’s sales agent.
+Added: Any Shares to be offered
+Added: and sold under the 2020 Sales Agreement will be issued and sold (i) by methods deemed to be an “at the market offering”
+Added: (“ATM”) as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended or in negotiated
+Added: transactions, if authorized by the Company and (ii) pursuant to, and only upon the effectiveness of, a registration statement
+Added: on Form S-3 filed by the Company with the Securities and Exchange Commission on August 11, 2020 for an offering of up
+Added: to $350,000 of various securities, including shares of the Company’s common stock, preferred stock, debt securities, warrants
+Added: and/or units for sale to the public in one or more public offerings.
+Added: Subject to the terms
+Added: of the 2020 Sales Agreement, the Agent will use reasonable efforts to sell the Shares from time to time, based upon the Company’s
+Added: instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose).
+Added: Company cannot provide any assurances that it will issue any Shares pursuant to the 2020 Sales Agreement.
+Added: The Company will pay
+Added: the Agent a commission of up to 3.0% of the gross proceeds from the sale of the Shares, if any.
+Added: The Company has also agreed to
+Added: provide the Agent with customary indemnification rights.
+Added: During the year ended
+Added: March 31, 2020, the Company issued and sold 287,559 shares of common stock under the 2019 Sales Agreement, for gross proceeds
+Added: of $4,568 less offering fees of $137 for net proceeds of $4,431 under the ATM.
+Added: The Company has not issued and sold any shares under
+Added: the 2020 Sales Agreement as of December 31, 2020.
Equity offerings
−Removed: In November 2019, the Company
−Removed: entered into an Underwriting Agreement (the “November 2019 Underwriting Agreement”) with J.P.
−Removed: Morgan Securities LLC
−Removed: and SVB Leerink LLC, as representatives of the several underwriters named therein (the “November 2019 Underwriters”),
−Removed: relating to the issuance and sale of an aggregate of (a) 3,678,031 shares of the Company’s common stock (the “November
−Removed: 2019 Shares”), and (b) pre-funded warrants to purchase 2,200,000 shares of the Company’s common stock (the “November
−Removed: 2019 Pre-Funded Warrants”) to the Underwriters (the “November 2019 Offering”).
−Removed: The November 2019 Shares
−Removed: were sold to the purchasers at the public offering price of $13.61 per share.
−Removed: The November 2019 Pre-Funded Warrants were sold at
−Removed: a public offering price of $13.6099 per November 2019 Pre-Funded Warrant, which represents the per share public offering price
−Removed: for the Company’s common stock less a $0.0001 per share exercise price for each such November 2019 Pre-Funded Warrant.
−Removed: December 2019, the November 2019 Underwriters partially exercised their purchase option pursuant to the Underwriting Agreement,
−Removed: and the Company issued and sold an additional 838,530 shares of its common stock.
−Removed: The Company received aggregate net proceeds
−Removed: of approximately $85,598 in the November 2019 Offering, after deducting underwriting discounts, commissions and other
−Removed: offering expenses payable by the Company of approximately $5,814.
−Removed: Funds affiliated with Redmile Group,
−Removed: LLC purchased all of the November 2019 Pre-Funded Warrants.
−Removed: The November 2019 Pre-Funded Warrants are exercisable at any time after
−Removed: the date of issuance.
−Removed: A holder of November 2019 Pre-Funded Warrants may not exercise the November 2019 Pre-Funded Warrant if the
−Removed: holder, together with its affiliates, would beneficially own more than 9.99% of the number of shares of the Company’s common
−Removed: stock outstanding immediately after giving effect to such exercise.
−Removed: A holder of November 2019 Pre-Funded Warrants may increase
−Removed: or decrease this percentage to any other percentage by providing at least 61 days’ prior notice to the Company.
−Removed: September 30, 2020, none of the November 2019 Pre-Funded Warrants had been exercised.
−Removed: In June 2020, the Company entered
−Removed: into a separate Underwriting Agreement (the “June 2020 Underwriting Agreement”) with J.P.
−Removed: Morgan Securities LLC and
−Removed: SVB Leerink LLC, as representatives of the several underwriters named therein (the “June 2020 Underwriters”), relating
−Removed: to the issuance and sale of an aggregate of (a) 2,826,088 shares of the Company’s common stock (the “June 2020
−Removed: Shares”), and (b) pre-funded warrants to purchase 1,521,738 shares of the Company’s common stock (the “June
−Removed: 2020 Pre-Funded Warrants”) to the Underwriters (the “June 2020 Offering”).
−Removed: The June 2020 Shares were sold
−Removed: to the purchasers at the public offering price of $23.00 per share.
−Removed: The June 2020 Pre-Funded Warrants were sold at a public offering
−Removed: price of $22.9999 per June 2020 Pre-Funded Warrant, which represents the per share public offering price for the Company’s
−Removed: common stock less a $0.0001 per share exercise price for each such June 2020 Pre-Funded Warrant.
−Removed: The June 2020 Underwriters fully
−Removed: exercised their purchase option pursuant to the June 2020 Underwriting Agreement, and the Company issued and sold an additional
−Removed: 652,173 shares of its common stock.
+Added: In November 2019,
+Added: the Company entered into an underwriting agreement (the “November 2019 Underwriting Agreement”) with J.P.
+Added: Securities LLC and SVB Leerink LLC, as representatives of the several underwriters named therein (the “November 2019
+Added: Underwriters”), relating to the issuance and sale of an aggregate of (a) 3,678,031 shares of the Company’s common
+Added: stock (the “November 2019 Shares”), and (b) pre-funded warrants to purchase 2,200,000 shares of the Company’s
+Added: common stock (the “November 2019 Pre-Funded Warrants”) to the November 2019 Underwriters (the “November 2019
+Added: Offering”).
+Added: The November 2019 Shares were sold at the public offering price of $13.61 per share.
+Added: The November 2019
+Added: Pre-Funded Warrants were sold at a public offering price of $13.6099 per November 2019 Pre-Funded Warrant, which represented
+Added: the per share public offering price for the November 2019 Shares less a $0.0001 per share exercise price for each such November 2019
+Added: Pre-Funded Warrant.
+Added: In December 2019, the November 2019 Underwriters partially exercised their purchase option pursuant
+Added: to the November 2019 Underwriting Agreement, and the Company issued and sold an additional 838,530 shares of its common stock.
+Added: The Company received aggregate net proceeds of approximately $85,598 in the November 2019 Offering, after deducting
+Added: underwriting discounts, commissions and other offering expenses payable by the Company of approximately $5,814.
+Added: Funds affiliated with
+Added: Redmile Group, LLC purchased all of the November 2019 Pre-Funded Warrants.
+Added: The November 2019 Pre-Funded Warrants are
+Added: exercisable at any time after the date of issuance.
+Added: A holder of November 2019 Pre-Funded Warrants may not exercise the November 2019
+Added: Pre-Funded Warrants if the holder, together with its affiliates, would beneficially own more than 9.99% of the number of shares
+Added: of the Company’s common stock outstanding immediately after giving effect to such exercise.
+Added: In June 2020,
+Added: the Company entered into a separate underwriting agreement (the “June 2020 Underwriting Agreement”) with J.P.
+Added: Morgan Securities LLC and SVB Leerink LLC, as representatives of the several underwriters named therein (the “June 2020
+Added: Underwriters”), relating to the issuance and sale of an aggregate of (a) 2,826,088 shares of the Company’s common
+Added: stock (the “June 2020 Shares”), and (b) pre-funded warrants to purchase 1,521,738 shares of the Company’s
+Added: common stock (the “June 2020 Pre-Funded Warrants”) to the June 2020 Underwriters.
+Added: The June 2020
+Added: Shares were sold at the public offering price of $23.00 per share.
+Added: The June 2020 Pre-Funded Warrants were sold at a public
+Added: offering price of $22.9999 per June 2020 Pre-Funded Warrant, which represented the per share public offering price for the
+Added: June 2020 Shares less a $0.0001 per share exercise price for each such June 2020 Pre-Funded Warrant.
+Added: The June 2020
+Added: Underwriters fully exercised their purchase option pursuant to the June 2020 Underwriting Agreement, and the Company issued
+Added: and sold an additional 652,173 shares of its common stock.
The Company received aggregate net proceeds of approximately $107,782 after
deducting underwriting discounts, commissions and other offering expenses payable by the Company of approximately $7,217.
−Removed: Funds affiliated with Redmile Group,
−Removed: LLC and funds affiliated with a second institutional investor purchased all of the June 2020 Pre-Funded Warrants.
−Removed: The June 2020
−Removed: Pre-Funded Warrants are exercisable at any time after the date of issuance.
−Removed: A holder of June 2020 Pre-Funded Warrants may not exercise
−Removed: the June 2020 Pre-Funded Warrant if the holder, together with its affiliates, would beneficially own more than 9.99% of the number
−Removed: of shares of the Company’s common stock outstanding immediately after giving effect to such exercise.
−Removed: A holder of June 2020
−Removed: Pre-Funded Warrants may increase or decrease this percentage up to 19.99% by providing at least 61 days’ prior notice to
−Removed: As of September 30, 2020, none of the June 2020 Pre-Funded Warrants had been exercised.
−Removed: than as set forth in Note 10 to these consolidated financial statements, including in the calculation of basic and diluted
−Removed: net loss per share attributable to common stockholders, the 3,721,738 shares of the Company’s common stock into which the
−Removed: November 2019 Pre-Funded Warrants and the June 2020 Pre-Funded Warrants are exercisable are not included in the number of issued
−Removed: and outstanding shares of the Company’s common stock set forth herein.
+Added: Funds affiliated with
+Added: Redmile Group, LLC and funds affiliated with a second institutional investor purchased all of the June 2020 Pre-Funded Warrants.
+Added: The June 2020 Pre-Funded Warrants are exercisable at any time after the date of issuance.
+Added: A holder of June 2020 Pre-Funded
+Added: Warrants may not exercise the June 2020 Pre-Funded Warrants if the holder, together with its affiliates, would beneficially
+Added: own more than 9.99% of the number of shares of the Company’s common stock outstanding immediately after giving effect to
+Added: such exercise.
+Added: A holder of June 2020 Pre-Funded Warrants may increase or decrease this percentage up to 19.99% by providing
+Added: at least 61 days’
+Added: prior notice to the Company.
+Added: October 2020, pursuant to an underwriting agreement with J.P.
+Added: Morgan Securities LLC and SVB Leerink LLC, as
+Added: representatives of the several underwriters named therein, the Company issued and sold to the underwriters (a) 5,625,000
+Added: shares of the Company’s common stock, inclusive of the underwriters 30-day option to purchase up to an additional
+Added: 937,500 shares of the Company’s common stock, and (b) pre-funded warrants to purchase 1,562,500 shares of the
+Added: Company’s common stock (the “October 2020 Pre-Funded Warrants”).
+Added: The shares of the Company’s
+Added: common stock were sold to the underwriters at the public offering price of $40.00 per share and the pre-funded warrants were
+Added: sold at a public offering price of $39.99 per October 2020 Pre-Funded Warrant, which represented the per share public offering price
+Added: for the Company’s common stock less a $0.0001 per share exercise price for each such pre-funded warrant.
+Added: received aggregate net proceeds of approximately $269,975 after deducting underwriting discounts, commissions and
+Added: other offering expenses payable by the Company of approximately $17,525.
+Added: Funds affiliated with
+Added: Redmile Group, LLC and funds affiliated with a second institutional investor purchased all of the October 2020 Pre-Funded
+Added: The October 2020 Pre-Funded Warrants are exercisable at any time after the date of issuance.
+Added: A holder of October 2020
+Added: Pre-Funded Warrants may not exercise the October 2020 Pre-Funded Warrants if the holder, together with its affiliates, would
+Added: beneficially own more than 9.99% of the number of shares of the Company’s common stock outstanding immediately after giving
+Added: effect to such exercise.
+Added: A holder of October 2020 Pre-Funded Warrants may increase or decrease this percentage up to 19.99%
+Added: by providing at least 61 days’
+Added: prior notice to the Company.
+Added: Other than as set forth
+Added: in Note 10 to these consolidated financial statements, including in the calculation of basic and diluted net loss per share attributable
+Added: to common stockholders, the 5,284,238 shares of the Company’s common stock into which the November 2019 Pre-Funded Warrants,
+Added: the June 2020 Pre-Funded Warrants and October 2020 Pre-Funded Warrants are exercisable are not included in the number
+Added: of issued and outstanding shares of the Company’s common stock set forth herein.
+Added: As of December 31, 2020, none of the
+Added: November 2019 Pre-Funded Warrants, the June 2020 Pre-Funded Warrants, or the October 2020 Pre-Funded Warrants had
+Added: been exercised.
Stock-based compensation
−Removed: 2015 Enterprise Management
−Removed: Incentive Share Option Plan
−Removed: The 2015 Enterprise Management Incentive
−Removed: Share Option Plan of Replimune UK (the “2015 Plan”) provided for Replimune UK to grant incentive stock options, non-statutory
+Added: Enterprise Management Incentive Share Option Plan
+Added: The 2015 Enterprise
+Added: Management Incentive Share Option Plan of Replimune UK (the “2015 Plan”) provided for Replimune UK to grant incentive
+Added: stock options, non-statutory stock options, stock awards, stock units, stock appreciation rights and other stock-based awards.
+Added: Incentive stock options are granted only to the Company’s employees, including officers and directors who are also employees.
+Added: Non-statutory stock options are granted to employees, members of the board of directors, outside advisors and consultants of the
+Added: Equity Compensation Plan
+Added: In July 2017,
+Added: in conjunction with the Reorganization, the 2015 Plan was terminated, and all awards were cancelled with replacement awards issued
+Added: under the 2017 Equity Compensation Plan (the “2017 Plan”).
+Added: Subsequent to the Reorganization, no additional grants will
+Added: be made under the 2015 Plan and any outstanding awards under the 2015 Plan will continue with their original terms.
+Added: concluded that the cancellation of the 2015 Plan and issuance of replacement awards under the 2017 Plan was a modification with
+Added: no change in the material rights and preferences and therefore no recorded change in the fair value of each respective award.
+Added: The Company’s
+Added: 2017 Plan provides for the Company to grant incentive stock options or non-statutory stock options, stock awards, stock units,
+Added: stock appreciation rights and other stock-based awards.
+Added: Incentive stock options may be granted only to the Company’s employees,
+Added: including officers and directors who are also employees.
+Added: Restricted stock awards and non-statutory stock options may be granted
+Added: to employees, officers, members of the board of directors, advisors and consultants of the Company.
+Added: The maximum number of common
+Added: shares that may be issued under the 2017 Plan was 2,659,885, of which none remained available for future grants as of December 31,
+Added: Shares with respect to which awards have expired, terminated, surrendered or cancelled under the 2017 Plan without having
+Added: been fully exercised will be available for future awards under the 2017 Plan.
+Added: In addition, shares of common stock that are tendered
+Added: to the Company by a participant to exercise an award are added to the number of shares of common stock available for the grant
+Added: Omnibus Incentive Compensation Plan
+Added: On July 9, 2018,
+Added: the Company’s board of directors adopted, and the Company’s stockholders approved the 2018 Omnibus Incentive Compensation
+Added: Plan (the “2018 Plan”), which became effective immediately prior to the effectiveness of the registration statement
+Added: for the Company’s initial public offering.
+Added: The 2018 Plan provides for the issuance of incentive stock options, non-qualified
stock options, stock awards, stock units, stock appreciation rights and other stock-based awards.
−Removed: Incentive stock options are granted
−Removed: only to the Company’s employees, including officers and directors who are also employees.
−Removed: Non-statutory stock options are
−Removed: granted to employees, members of the board of directors, outside advisors and consultants of the Company.
−Removed: 2017 Equity Compensation
−Removed: In July 2017, in conjunction with the Reorganization,
−Removed: the 2015 Plan was terminated, and all awards were cancelled with replacement awards issued under the 2017 Equity Compensation Plan
−Removed: (the “2017 Plan”).
−Removed: Subsequent to the Reorganization, no additional grants will be made under the 2015 Plan and any
−Removed: outstanding awards under the 2015 Plan will continue with their original terms.
−Removed: The Company concluded that the cancellation of
−Removed: the 2015 Plan and issuance of replacement awards under the 2017 Plan was a modification with no change in the material rights and
−Removed: preferences and therefore no recorded change in the fair value of each respective award.
−Removed: The Company’s 2017 Plan provides
−Removed: for the Company to grant incentive stock options or non-statutory stock options, stock awards, stock units, stock
−Removed: appreciation rights and other stock-based awards.
−Removed: Incentive stock options may be granted only to the Company’s
−Removed: employees, including officers and directors who are also employees.
−Removed: Restricted stock awards and non-statutory stock options
−Removed: may be granted to employees, officers, members of the board of directors, advisors and consultants of the Company.
−Removed: maximum number of common shares that may be issued under the 2017 Plan was 2,659,885 of which 0 remained available for future
−Removed: grants as of September 30, 2020.
−Removed: Shares with respect to which awards have expired, terminated, surrendered or cancelled
−Removed: under the 2017 Plan without having been fully exercised will be available for future awards under the 2017 Plan.
−Removed: shares of common stock that are tendered to the Company by a participant to exercise an award are added to the number of
−Removed: shares of common stock available for the grant of awards.
−Removed: 2018 Omnibus Incentive
−Removed: Compensation Plan
−Removed: On July 9, 2018, the Company’s
−Removed: board of directors adopted, and the Company’s stockholders approved the 2018 Omnibus Incentive Compensation Plan (the “2018
−Removed: Plan”), which became effective immediately prior to the effectiveness of the registration statement for the Company’s
−Removed: initial public offering.
−Removed: The 2018 Plan provides for the issuance of incentive stock options, non-qualified stock options, stock
−Removed: awards, stock units, stock appreciation rights and other stock-based awards.
−Removed: The number of shares initially reserved for issuance
−Removed: under the 2018 Plan is 3,617,968 shares.
−Removed: If any options or stock appreciation rights, including outstanding options and stock appreciation
−Removed: rights granted under the 2017 Plan (up to 2,520,247 shares), terminate, expire, or are canceled, forfeited, exchanged, or surrendered
−Removed: without having been exercised, or if any stock awards, stock units or other stock-based awards, including outstanding awards granted
−Removed: under the 2017 Plan, are forfeited, terminated, or otherwise not paid in full in shares of common stock, the shares of the Company’s
−Removed: common stock subject to such grants will be available for purposes of our 2018 Plan.
−Removed: On April 1, 2020, the number of shares
−Removed: reserved for issuance under the 2018 Plan automatically increased by 1,466,749 shares pursuant to the terms of the 2018 Plan.
−Removed: April 1, 2019, the number of shares reserved for issuance under the 2018 Plan automatically increased by 1,266,278 shares
−Removed: pursuant to the terms of the 2018 Plan.
−Removed: As of September 30, 2020, 1,722,528 shares remained available for future grants under
−Removed: the 2018 Plan.
−Removed: The 2015 Plan, the 2017 Plan and the 2018
−Removed: Plan was administered by the board of directors or, at the discretion of the board of directors, by a committee of the board of
+Added: The number of shares initially
+Added: reserved for issuance under the 2018 Plan is 3,617,968 shares.
+Added: If any options or stock appreciation rights, including outstanding
+Added: options and stock appreciation rights granted under the 2017 Plan (up to 2,520,247 shares), terminate, expire, or are canceled,
+Added: forfeited, exchanged, or surrendered without having been exercised, or if any stock awards, stock units or other stock-based awards,
+Added: including outstanding awards granted under the 2017 Plan, are forfeited, terminated, or otherwise not paid in full in shares of
+Added: common stock, the shares of the Company’s common stock subject to such grants will be available for purposes of our 2018
+Added: On April 1, 2020, the number of shares reserved for issuance under the 2018 Plan automatically increased by 1,466,749
+Added: shares pursuant to the terms of the 2018 Plan.
+Added: On April 1, 2019, the number of shares reserved for issuance under the 2018
+Added: Plan automatically increased by 1,266,278 shares pursuant to the terms of the 2018 Plan.
+Added: As of December 31, 2020, 1,613,894
+Added: shares remained available for future grants under the 2018 Plan.
+Added: The 2015 Plan, the
+Added: 2017 Plan and the 2018 Plan was administered by the board of directors or, at the discretion of the board of directors, by a committee
+Added: of the board of directors.
However, the board of directors shall administer and approve all grants made to non-employee directors.
−Removed: prices, vesting and other restrictions are determined at the discretion of the board of directors, except that the exercise price
−Removed: per share of incentive stock options may not be less than 100% of the fair market value of the common stock on the date of grant
−Removed: (or 110% of fair value in the case of an award granted to employees who hold more than 10% of the total combined voting power of
−Removed: all classes of stock at the time of grant) and the term of stock options may not be greater than five years for an incentive stock
−Removed: option granted to a 10% stockholder and greater than ten years for all other options granted.
−Removed: Stock options awarded under both
−Removed: plans expire ten years after the grant date, unless the board of directors sets a shorter term.
−Removed: Vesting periods for both plans
−Removed: are determined at the discretion of the board of directors.
−Removed: Incentive stock options granted to employees and non-statutory options
−Removed: granted to employees, officers, members of the board of directors, advisors, and consultants of the Company typically vest over
−Removed: Employee Stock Purchase
−Removed: On July 9, 2018, the Company’s board
−Removed: of directors adopted and the Company’s stockholders approved the Employee Stock Purchase Plan (the “ESPP”), which
−Removed: became effective immediately prior to the effectiveness of the registration statement for the Company’s IPO.
−Removed: The total shares
−Removed: of common stock initially reserved for issuance under the ESPP is limited to 348,612 shares.
−Removed: In addition, as of the first trading
−Removed: day of each fiscal year during the term of the ESPP (excluding any extensions), an additional number of shares of the Company’s
−Removed: common stock equal to 1% of the total number of shares outstanding on the last trading day in the immediately preceding fiscal
−Removed: year or 697,224 shares, whichever is less (or such lesser amount as determined by the Company’s board of directors) will
−Removed: be added to the number of shares authorized under the ESPP.
−Removed: In accordance, on April 1, 2020 and 2019, the number of shares reserved
−Removed: for issuance under the ESPP automatically increased by 366,687 and 316,569 shares respectively, for a total of 1,031,868 shares
−Removed: reserved for the ESPP.
−Removed: If the total number of shares of common stock to be purchased pursuant to outstanding purchase rights on
−Removed: any particular date exceed the number of shares then available for issuance under the ESPP, then the plan administrator will allocate
−Removed: the available shares pro-rata and refund any excess payroll deductions or other contributions to participants.
−Removed: The Company’s
−Removed: ESPP is not currently active.
−Removed: Stock option valuation
−Removed: The fair value of stock option grants
−Removed: is estimated using the Black-Scholes option-pricing model.
+Added: The exercise prices, vesting and other restrictions are determined at the discretion of the board of directors, except that the
+Added: exercise price per share of incentive stock options may not be less than 100% of the fair market value of the common stock on the
+Added: date of grant (or 110% of fair value in the case of an award granted to employees who hold more than 10% of the total combined
+Added: voting power of all classes of stock at the time of grant) and the term of stock options may not be greater than five years for
+Added: an incentive stock option granted to a 10% stockholder and greater than ten years for all other options granted.
+Added: Stock options
+Added: awarded under both plans expire ten years after the grant date, unless the board of directors sets a shorter term.
+Added: Vesting periods
+Added: for both plans are determined at the discretion of the board of directors.
+Added: Incentive stock options granted to employees and non-statutory
+Added: options granted to employees, officers, members of the board of directors, advisors, and consultants of the Company typically vest
+Added: over four years.
+Added: Stock Purchase Plan
+Added: On July 9, 2018,
+Added: the Company’s board of directors adopted and the Company’s stockholders approved the Employee Stock Purchase Plan (the
+Added: “ESPP”), which became effective immediately prior to the effectiveness of the registration statement for the Company’s
+Added: The total shares of common stock initially reserved for issuance under the ESPP is limited to 348,612 shares.
+Added: as of the first trading day of each fiscal year during the term of the ESPP (excluding any extensions), an additional number of
+Added: shares of the Company’s common stock equal to 1% of the total number of shares outstanding on the last trading day in the
+Added: immediately preceding fiscal year or 697,224 shares, whichever is less (or such lesser amount as determined by the Company’s
+Added: board of directors) will be added to the number of shares authorized under the ESPP.
+Added: In accordance, on April 1, 2020 and 2019,
+Added: the number of shares reserved for issuance under the ESPP automatically increased by 366,687 and 316,569 shares respectively, for
+Added: a total of 1,031,868 shares reserved for the ESPP.
+Added: If the total number of shares of common stock to be purchased pursuant to outstanding
+Added: purchase rights on any particular date exceed the number of shares then available for issuance under the ESPP, then the plan administrator
+Added: will allocate the available shares pro-rata and refund any excess payroll deductions or other contributions to participants.
+Added: Company’s ESPP is not currently active.
+Added: option valuation
+Added: The fair value of stock
+Added: option grants is estimated using the Black-Scholes option-pricing model.
The Company lacks company-specific historical and implied
volatility information.
−Removed: Therefore, it estimated its expected stock volatility based on the historical volatility of a
−Removed: publicly traded set of peer companies.
−Removed: For options with service-based vesting conditions, the expected term of the
−Removed: Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as
−Removed: “plain-vanilla” options.
−Removed: The expected term of stock options granted to non-employees is equal to the contractual
−Removed: term of the option award.
−Removed: The risk-free interest rate is determined by reference to the U.S.
−Removed: Treasury yield curve in effect
−Removed: at the time of grant of the award for time periods approximately equal to the expected term of the award.
−Removed: Expected dividend
−Removed: yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in
−Removed: the foreseeable future.
−Removed: following table presents, on a weighted-average basis, the assumptions that the Company used to determine the grant-date fair value
−Removed: of stock options granted to employees and directors:
+Added: Therefore, it estimated its expected stock volatility based on the historical volatility of a publicly
+Added: traded set of peer companies.
+Added: For options with service-based vesting conditions, the expected term of the Company’s stock
+Added: options has been determined utilizing the “simplified”
+Added: method for awards that qualify as “plain-vanilla”
+Added: The expected term of stock options granted to non-employees is equal to the contractual term of the option award.
+Added: risk-free interest rate is determined by reference to the U.S.
+Added: Treasury yield curve in effect at the time of grant of the award
+Added: for time periods approximately equal to the expected term of the award.
+Added: Expected dividend yield is based on the fact that the Company
+Added: has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.
+Added: The following table
+Added: presents, on a weighted-average basis, the assumptions that the Company used to determine the grant-date fair value of stock options
+Added: granted to employees and directors:
Three Months Ended
−Removed: September 30,
−Removed: Six Months Ended
−Removed: September 30,
+Added: Nine Months Ended
Risk-free interest rate
2 unchanged sentences
Expected dividend yield
−Removed: Stock options
−Removed: following table summarizes the Company’s stock option activity:
+Added: The following table
+Added: summarizes the Company’s stock option activity:
Outstanding as of March 31, 2020
−Removed: Outstanding as of September 30, 2020
+Added: Outstanding as of December 31, 2020
Options exercisable as of March 31, 2020
−Removed: Options exercisable as of September 30, 2020
−Removed: The aggregate intrinsic value of stock options
−Removed: is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common
−Removed: stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock.
−Removed: The weighted average grant-date fair value
−Removed: per share of stock options granted during the six months ended September 30, 2020 and 2019 was $8.28 and $9.82, respectively.
−Removed: The total fair value of options vested during the three months and six months ended September 30, 2020 was $1,628 and $6,261, respectively.
−Removed: The total fair value of options vested during the three months and six months ended September 30, 2019 was $3,206 and $3,417, respectively.
−Removed: Stock-based compensation expense
−Removed: Stock-based compensation expense was classified
−Removed: in the consolidated statements of operations as follows:
+Added: Options exercisable as of December 31, 2020
+Added: The aggregate intrinsic
+Added: value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the
+Added: Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s
+Added: common stock.
+Added: The weighted average
+Added: grant-date fair value per share of stock options granted during the nine months ended December 31, 2020 and 2019 was $10.06
+Added: and $9.63, respectively.
+Added: The total fair value of options vested during the three months and nine months ended December 31,
+Added: 2020 was $2,069 and $8,330, respectively.
+Added: The total fair value of options vested during the three months and nine months ended
+Added: December 31, 2019 was $1,063 and $4,480, respectively.
+Added: Stock-based compensation
+Added: Stock-based compensation
+Added: expense was classified in the consolidated statements of operations as follows:
Three Months Ended
−Removed: Six Months Ended
−Removed: September 30,
−Removed: September 30,
+Added: Nine Months Ended
Research and development
General and administrative
−Removed: As of September 30, 2020, total unrecognized
−Removed: compensation cost related to the unvested stock-based awards was $29,049, which is expected to be recognized over a weighted average
−Removed: period of 2.96 years.
+Added: As of December 31,
+Added: 2020, total unrecognized compensation cost related to the unvested stock-based awards was $31,002, which is expected to be recognized
+Added: over a weighted average period of 2.95 years.
Net loss per share
−Removed: Basic and diluted net loss per share attributable
−Removed: to common stockholders was calculated as follows:
+Added: Basic and diluted net
+Added: loss per share attributable to common stockholders was calculated as follows:
Three Months Ended
−Removed: September 30,
−Removed: Six Months Ended
−Removed: September 30,
+Added: Nine Months Ended
Net loss attributable to common stockholders
1 unchanged sentence
Net loss per share attributable to common stockholders, basic and diluted
−Removed: November 2019 Pre-Funded Warrants and the June 2020 Pre-Funded Warrants are included in the calculation of basic and diluted
−Removed: net loss per share attributable to common stockholders.
−Removed: The Company’s potentially dilutive securities, which include stock
−Removed: options, preferred stock and warrants to purchase shares of series seed preferred stock, have been excluded from the computation
−Removed: of diluted net loss per share as the effect would be to reduce the net loss per share.
−Removed: Therefore, the weighted average number of
−Removed: common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the
−Removed: The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from
−Removed: the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them
−Removed: would have had an anti-dilutive effect:
−Removed: Three and Six Months Ended
−Removed: September 30,
+Added: The November 2019
+Added: Pre-Funded Warrants, the June 2020 Pre-Funded Warrants and October 2020 Pre-Funded Warrants are included as outstanding
+Added: common stock in the calculation of basic and diluted net loss per share attributable to common stockholders.
+Added: The Company’s
+Added: potentially dilutive securities, which include stock options and warrants to purchase shares of series seed preferred stock, have
+Added: been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share.
+Added: the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable
+Added: to common stockholders is the same.
+Added: The Company excluded the following potential common shares, presented based on amounts outstanding
+Added: at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated
+Added: because including them would have had an anti-dilutive effect:
+Added: Three and Nine Months Ended
Options to purchase common stock
1 unchanged sentence
Significant agreements
−Removed: Agreement with Bristol-Myers
−Removed: Squibb Company
−Removed: In February 2018, the Company entered into
−Removed: an agreement with Bristol-Myers Squibb Company (“BMS”).
−Removed: Pursuant to the agreement, BMS will provide to the Company,
−Removed: at no cost, a compound for use in the Company’s ongoing clinical trial.
−Removed: Under the agreement, the Company will sponsor, fund
−Removed: and conduct the clinical trial in accordance with an agreed-upon protocol.
−Removed: BMS granted the Company a non-exclusive, non-transferrable,
−Removed: royalty-free license (with a right to sublicense) under its intellectual property to its compound in the clinical trial and agreed
−Removed: to supply its compound, at no cost to the Company, for use in the clinical trial.
−Removed: In January 2020, this agreement was expanded
−Removed: to cover an additional cohort of 125 patients with anti-PD-1 failed melanoma.
−Removed: Unless earlier terminated, the agreement
−Removed: will remain in effect until (i) the completion of the clinical trial, (ii) all related clinical trial data have been
−Removed: delivered to both parties and (iii) the completion of any statistical analyses and bioanalyses contemplated by the clinical
−Removed: trial protocol or any analysis otherwise agreed upon by the parties.
+Added: with Bristol-Myers Squibb Company
+Added: In February 2018,
+Added: the Company entered into an agreement with Bristol-Myers Squibb Company (“BMS”).
+Added: Pursuant to the agreement, BMS will
+Added: provide to the Company, at no cost, a compound for use in the Company’s ongoing clinical trial of RP1.
+Added: Under the agreement,
+Added: the Company will sponsor, fund and conduct the clinical trial in accordance with an agreed-upon protocol.
+Added: BMS granted the Company
+Added: a non-exclusive, non-transferrable, royalty-free license (with a right to sublicense) under its intellectual property to its compound
+Added: in the clinical trial and agreed to supply its compound, at no cost to the Company, for use in the clinical trial.
+Added: In January 2020,
+Added: this agreement was expanded to cover an additional cohort of 125 patients with anti-PD-1 failed melanoma.
+Added: Unless earlier terminated,
+Added: the agreement will remain in effect until (i) the completion of the clinical trial, (ii) all related clinical trial data
+Added: have been delivered to both parties and (iii) the completion of any statistical analyses and bioanalyses contemplated by the
+Added: clinical trial protocol or any analysis otherwise agreed upon by the parties.
The agreement may be terminated by either party (i) in
1 unchanged sentence
proceedings or (iii) for safety reasons.
−Removed: Upon termination, the licenses granted to the Company to use BMS’s compound
+Added: Upon termination, the licenses granted to the Company to use BMS’s compound
in the clinical trial will terminate.
−Removed: In April 2019, the Company entered
−Removed: into a separate agreement with BMS on terms similar to the terms set forth in the agreement described above, pursuant to which
−Removed: BMS will provide to the Company, at no cost, nivolumab for use in the Company’s Phase 1 clinical trial of RP2 in combination
−Removed: with nivolumab.
−Removed: As of September 30, 2020, the Company had
−Removed: not incurred any costs and does not expect to incur future costs in connection with this agreement.
+Added: In April 2019,
+Added: the Company entered into a separate agreement with BMS on terms similar to the terms set forth in the agreement described above,
+Added: pursuant to which BMS will provide to the Company, at no cost, nivolumab for use in the Company’s Phase 1 clinical trial
+Added: of RP2 in combination with nivolumab.
+Added: As of December 31,
+Added: 2020, the Company had not incurred any costs and does not expect to incur future costs in connection with this agreement.
with Regeneron Pharmaceuticals, Inc .
−Removed: In May 2018, the Company entered into an
−Removed: agreement with Regeneron Pharmaceuticals, Inc.
−Removed: (“Regeneron”).
−Removed: The Company and Regeneron are each independently
−Removed: developing compounds for the treatment of certain tumor types.
−Removed: Pursuant to the agreement, the Company and Regeneron will undertake
−Removed: one or more clinical trials using a combination of the compounds being developed by each entity.
−Removed: Under the agreement, each study
−Removed: will be conducted under terms set out in a separately agreed upon study plan that will identify the name of the sponsor and which
−Removed: party will manage the particular clinical trial, and include the protocol, the budget and a schedule of clinical obligations.
−Removed: June 2018, under the terms of the agreement between the Company and Regeneron, the parties agreed to the first study plan.
−Removed: Company and Regeneron have agreed to the protocol, budget, sample testing and clinical obligations schedule under the study plan.
−Removed: Development and supply costs associated with the study plan will be split equally between the Company and Regeneron.
−Removed: Pursuant to the terms of the agreement,
−Removed: each party granted the other party a non-exclusive license under its respective intellectual property and agreed to contribute
−Removed: the necessary resources needed to fulfill its respective obligations, in each case, under the terms of the agreed-upon or to-be
−Removed: agreed upon study plans.
−Removed: Development costs of a particular clinical trial will be split equally between the Company and Regeneron.
−Removed: The agreement may be terminated by either
−Removed: party if (i) there is no active study plan for which a final study report has not been completed, (ii) the parties have
−Removed: not entered into a study plan for an additional clinical trial within a period of time after the delivery of the most recent final
−Removed: study report or (iii) in the event of a material breach.
−Removed: The Company will account for costs incurred
−Removed: as part of the study, including costs to supply compounds for use in the study, as research and development expenses within the
−Removed: consolidated statement of operations.
−Removed: The Company will recognize any amounts received from Regeneron in connection with this agreement
−Removed: as an offset to research and development expense within the consolidated statement of operations.
−Removed: Under the terms of the agreement, on a quarterly
−Removed: basis the Company and Regeneron true-up costs of the study and make corresponding payments to the party that incurred the majority
−Removed: of the costs.
−Removed: During the three and six months ended September 30, 2020 or 2019, the Company did not make any payments under
−Removed: the terms of the agreement to Regeneron.
−Removed: During the three and six months ended September 30, 2020, the Company received
−Removed: payments under the terms of the agreement to Regeneron of $1,433 and $2,404, respectively.
−Removed: During the three and six months
−Removed: ended September 30, 2019, the Company received payments under the terms of the agreement to Regeneron of $337 and $912, respectively.
−Removed: As of September 30, 2020 and March 31, 2020, the Company recorded $1,453 and $971 of receivables from Regeneron in connection
−Removed: with this agreement in prepaid expenses and other current assets in the consolidated balance sheet, respectively.
+Added: In May 2018, the
+Added: Company entered into an agreement with Regeneron Pharmaceuticals, Inc.
+Added: (“Regeneron”).
+Added: The Company and Regeneron
+Added: are each independently developing compounds for the treatment of certain tumor types.
+Added: Pursuant to the agreement, the Company and
+Added: Regeneron will undertake one or more clinical trials using a combination of the compounds being developed by each entity.
+Added: the agreement, each study will be conducted under terms set out in a separately agreed upon study plan that will identify the name
+Added: of the sponsor and which party will manage the particular clinical trial, and include the protocol, the budget and a schedule of
+Added: clinical obligations.
+Added: In June 2018, under the terms of the agreement between the Company and Regeneron, the parties agreed
+Added: to the first study plan.
+Added: The Company and Regeneron have agreed to the protocol, budget, sample testing and clinical obligations
+Added: schedule under the study plan.
+Added: Development and supply costs associated with the study plan will be split equally between the Company
+Added: and Regeneron.
+Added: Pursuant to the terms
+Added: of the agreement, each party granted the other party a non-exclusive license under its respective intellectual property and agreed
+Added: to contribute the necessary resources needed to fulfill its respective obligations, in each case, under the terms of the agreed-upon
+Added: or to-be agreed upon study plans.
+Added: Development costs of a particular clinical trial will be split equally between the Company and
+Added: Regeneron in accordance with the agreed upon study plan.
+Added: The agreement may be
+Added: terminated by either party if (i) there is no active study plan for which a final study report has not been completed, (ii) the
+Added: parties have not entered into a study plan for an additional clinical trial within a period of time after the delivery of the most
+Added: recent final study report or (iii) in the event of a material breach.
+Added: The Company will account
+Added: for costs incurred as part of the study, including costs to supply compounds for use in the study, as research and development
+Added: expenses within the consolidated statement of operations.
+Added: The Company will recognize any amounts received from Regeneron in connection
+Added: with this agreement as an offset to research and development expense within the consolidated statement of operations.
+Added: Under the terms
+Added: of the agreement, on a quarterly basis the Company and Regeneron true-up costs of the study and make corresponding payments
+Added: to the party that incurred the majority of the costs.
+Added: During the three and nine months ended December 31, 2020 or 2019,
+Added: the Company did not make any payments under the terms of the agreement from Regeneron.
+Added: During the three and nine months
+Added: ended December 31, 2020, the Company received payments under the terms of the agreement from Regeneron of $1,453 and
+Added: $3,857, respectively.
+Added: During the three and nine months ended December 31, 2019, the Company received payments under
+Added: the terms of the agreement from Regeneron of $760 and $2008, respectively.
+Added: As of December 31, 2020 and March 31,
+Added: 2020, the Company recorded $1,195 and $971 of receivables from Regeneron in connection with this agreement in prepaid
+Added: expenses and other current assets in the consolidated balance sheet, respectively.
Commitments and contingencies
−Removed: In April 2016, the Company entered into
−Removed: a lease agreement for office and laboratory space in Abingdon, England.
−Removed: On June 29, 2020 the Company modified the lease terms to
−Removed: extend the expiration date to April 3, 2031 and the lease modification was not accounted for as a separate contract.
−Removed: the lease modification, the lease liability was remeasured in accordance with the updated terms of the contract and the associated
−Removed: lease liability and right-of-use asset was increased by $1,580.
−Removed: The Company has the right to terminate the lease as of April 4,
−Removed: 2026 upon at least twelve months’ prior written notice.
−Removed: Monthly lease payments are inclusive of base rent, ancillary charges,
−Removed: non-rent shared tenant occupancy costs and the respective value added tax to be paid.
−Removed: Monthly lease payments include base rent
−Removed: of approximately $29 through June 23, 2020, $14 from June 24, 2020 through December 24, 2020, and $29 thereafter.
−Removed: rent is subject to increase after April 2021 in proportion to the Retail Price Index or market rates.
−Removed: The lease is classified as
−Removed: an operating lease.
−Removed: In June 2018, the Company entered into an
−Removed: agreement to lease approximately 63,000 square feet of office, manufacturing and laboratory space in Framingham, Massachusetts.
−Removed: Pursuant to the lease agreement, the lease term commenced in December 2018, subject to the landlord completing certain agreed upon
−Removed: landlord improvements.
+Added: In April 2016,
+Added: the Company entered into a lease agreement for office and laboratory space in Abingdon, England.
+Added: On June 29, 2020 the Company
+Added: modified the lease terms to extend the expiration date to April 3, 2031 and the lease modification was not accounted for as
+Added: a separate contract.
+Added: As part of the lease modification, the lease liability was remeasured in accordance with the updated terms
+Added: of the contract and the associated lease liability and right-of-use asset was increased by $1,580.
+Added: The Company has the right to
+Added: terminate the lease as of April 4, 2026 upon at least twelve months’
+Added: prior written notice.
+Added: Monthly lease payments are
+Added: inclusive of base rent, ancillary charges, non-rent shared tenant occupancy costs and the respective value added tax to be paid.
+Added: Monthly lease payments include base rent of approximately $29 through June 23, 2020, $14 from June 24, 2020 through December 24,
+Added: 2020, and $29 thereafter.
+Added: Monthly base rent is subject to increase after April 2021 in proportion to the Retail Price Index
+Added: or market rates.
+Added: The lease is classified as an operating lease.
+Added: In June 2018,
+Added: the Company entered into an agreement to lease approximately 63,000 square feet of office, manufacturing and laboratory space in
+Added: Framingham, Massachusetts.
+Added: Pursuant to the lease agreement, the lease term commenced in December 2018, subject to the landlord
+Added: completing certain agreed upon landlord improvements.
The rent commencement date started in August 2019.
−Removed: The initial lease term is ten years from the rent commencement
−Removed: date and includes two optional five-year extensions.
−Removed: Annual lease payments during the first year were $2,373 with increases of
−Removed: 3.0% each year thereafter until the expiration of the lease.
−Removed: Construction was completed associated with
−Removed: approximately 10,500 square feet of the leased space in Framingham, Massachusetts and the Company occupied the building as office
−Removed: space beginning August 1, 2019.
−Removed: The Company recorded a right-of-use asset and lease liability associated with the occupied
−Removed: space as of August 1, 2019.
−Removed: The Company recorded $2,368 in related construction costs to the right-of-use asset upon the lease
−Removed: commencement date which were reclassified from prepaid rent.
−Removed: The Company occupied the remainder of the facility, approximately
−Removed: 52,500 square feet used as laboratory space, on October 22, 2019.
−Removed: The Company recorded a right-of-use asset and lease
−Removed: liability associated with the remaining space as of October 22, 2019.
−Removed: The Company recorded $18,164 in related construction costs
−Removed: and $261 in rent payments made prior to the lease commencement date to the right-of-use asset upon the lease commencement date
−Removed: which were reclassified from prepaid rent.
+Added: The initial lease
+Added: term is ten years from the rent commencement date and includes two optional five-year extensions.
+Added: Annual lease payments during
+Added: the first year were $2,373 with increases of 3.0% each year thereafter until the expiration of the lease.
+Added: Construction was completed
+Added: associated with approximately 10,500 square feet of the leased space in Framingham, Massachusetts and the Company occupied the
+Added: building as office space beginning August 1, 2019.
+Added: The Company recorded a right-of-use asset and lease liability associated
+Added: with the occupied space as of August 1, 2019.
+Added: The Company recorded $2,368 in related construction costs to the right-of-use
+Added: asset upon the lease commencement date which were reclassified from prepaid rent.
+Added: The Company occupied the remainder of the facility,
+Added: approximately 52,500 square feet used as laboratory space, on October 22, 2019.
+Added: The Company recorded a right-of-use asset
+Added: and lease liability associated with the remaining space as of October 22, 2019.
+Added: The Company recorded $18,164 in related construction
+Added: costs and $261 in rent payments made prior to the lease commencement date to the right-of-use asset upon the lease commencement
+Added: date which were reclassified from prepaid rent.
The lease is classified as a financing lease.
−Removed: In June 2019, the Company entered into
−Removed: an agreement to lease approximately 18,700 square feet of office space in Woburn, Massachusetts.
−Removed: Pursuant to the lease agreement,
−Removed: the lease term commenced in August 2019.
+Added: In June 2019,
+Added: the Company entered into an agreement to lease approximately 18,700 square feet of office space in Woburn, Massachusetts.
+Added: to the lease agreement, the lease term commenced in August 2019.
The rent commenced in September 2019.
−Removed: The initial lease term is ten years from
−Removed: the rent commencement date and includes an optional five-year extension.
−Removed: Annual lease payments during the first year are $488 with
−Removed: increases of approximately 1.6% each year.
−Removed: The Company recorded a right-of-use asset and a lease liability of $4,363 upon the commencement
−Removed: date of the lease and the lease is classified as an operating lease.
−Removed: The Company determines if an arrangement
−Removed: is a lease at inception.
−Removed: Operating leases are included in our balance sheet as right-to-use—operating leases, operating lease
−Removed: liabilities, current and operating lease liabilities, non-current.
−Removed: Finance leases are included in the balance sheet as right-to-use
−Removed: asset—finance lease finance lease liabilities, current, and finance lease liabilities, non-current.
−Removed: Certain of the Company’s
−Removed: lease agreements contain renewal options;
−Removed: however, the Company does not recognize right-of-use assets or lease liabilities for
−Removed: renewal periods unless it is determined that the Company is reasonably certain of renewing the lease at inception or when a triggering
−Removed: event occurs.
−Removed: As the Company’s leases do not provide an implicit rate, the Company estimated the incremental borrowing rate
−Removed: in calculating the present value of the lease payments.
−Removed: Since the Company elected to account for each lease component and its associated
−Removed: non-lease components as a single combined lease component, all contract consideration was allocated to the combined lease component.
−Removed: Some of the Company’s lease agreements contain rent escalation clauses (including index-based escalations).
−Removed: The Company recognizes
−Removed: the minimum rental expense on a straight-line basis based on the fixed components of a lease arrangement.
−Removed: The Company amortizes
−Removed: this expense over the term of the lease beginning with the date of initial possession, which is the date the Company can enter
−Removed: the leased space and begin to make improvements in preparation for its intended use.
−Removed: Variable lease components represent amounts
−Removed: that are not fixed in nature and are not tied to an index or rate, and are recognized as incurred.
+Added: The initial lease
+Added: term is ten years from the rent commencement date and includes an optional five-year extension.
+Added: Annual lease payments during the
+Added: first year are $488 with increases of approximately 1.6% each year.
+Added: The Company recorded a right-of-use asset and a lease liability
+Added: of $4,363 upon the commencement date of the lease and the lease is classified as an operating lease.
+Added: The Company determines
+Added: if an arrangement is a lease at inception.
+Added: Operating leases are included in our balance sheet as right-to-use—operating leases,
+Added: operating lease liabilities, current and operating lease liabilities, non-current.
+Added: Finance leases are included in the balance
+Added: sheet as right-to-use asset—finance lease finance lease liabilities, current, and finance lease liabilities, non-current.
+Added: Certain of the Company’s lease agreements contain renewal options;
+Added: however, the Company does not recognize right-of-use assets
+Added: or lease liabilities for renewal periods unless it is determined that the Company is reasonably certain of renewing the lease at
+Added: inception or when a triggering event occurs.
+Added: As the Company’s leases do not provide an implicit rate, the Company estimated
+Added: the incremental borrowing rate in calculating the present value of the lease payments.
+Added: Since the Company elected to account for
+Added: each lease component and its associated non-lease components as a single combined lease component, all contract consideration was
+Added: allocated to the combined lease component.
+Added: Some of the Company’s lease agreements contain rent escalation clauses (including
+Added: index-based escalations).
+Added: The Company recognizes the minimum rental expense on a straight-line basis based on the fixed components
+Added: of a lease arrangement.
+Added: The Company amortizes this expense over the term of the lease beginning with the date of initial possession,
+Added: which is the date the Company can enter the leased space and begin to make improvements in preparation for its intended use.
+Added: lease components represent amounts that are not fixed in nature and are not tied to an index or rate, and are recognized as incurred.
Three Months Ended
−Removed: September 30,
−Removed: Six Months Ended
−Removed: September 30,
+Added: Nine Months Ended
Finance lease costs:
3 unchanged sentences
Total lease cost
−Removed: Finance lease costs of $89 and $60 are recognized
−Removed: in general and administrative expenses for the three months ended September 30, 2020 and 2019, respectively, and $179 and $149 for
−Removed: the six months ended September 30, 2020 and 2019, respectively.
−Removed: Finance lease costs of $518 and $0 are recognized in research and
−Removed: development expenses for the three months ended September 30, 2020 and 2019, respectively, and $1,035 and $0 for the six months
−Removed: ended September 30, 2020 and 2019, respectively.
−Removed: Operating leases costs are recognized in general and administrative expenses for
−Removed: the three and six months ended September 30, 2020 and 2019.
−Removed: The following table summarizes the maturity of the Company’s
−Removed: lease liabilities on an undiscounted cash flow basis and a reconciliation to the operating and financing lease liabilities recognized
−Removed: on our balance sheet as of September 30, 2020:
−Removed: lease liabilities
−Removed: September 30, 2020
−Removed: Operating leases
−Removed: Financing lease
−Removed: 2021 (remaining six months)
+Added: Finance lease costs
+Added: of $90 and $90 are recognized in general and administrative expenses for the three months ended December 31, 2020 and 2019,
+Added: respectively, and $268 and $149 for the nine months ended September 30, 2020 and 2019, respectively.
+Added: Finance lease costs of
+Added: $518 and $517 are recognized in research and development expenses for the three months ended December 31, 2020 and 2019, respectively,
+Added: and $1,553 and $517 for the nine months ended December 31, 2020 and 2019, respectively.
+Added: Operating leases costs are recognized
+Added: in general and administrative expenses for the three and nine months ended December 31, 2020 and 2019.
+Added: The following table
+Added: summarizes the maturity of the Company’s lease liabilities on an undiscounted cash flow basis and a reconciliation to the
+Added: operating and financing lease liabilities recognized on our balance sheet as of September 30, 2020:
+Added: December 31, 2020
+Added: 2021 (remaining three months)
Total lease payments
1 unchanged sentence
The following table provides lease disclosure
−Removed: as of September 30, 2020 and March 31, 2020:
−Removed: September 30, 2020
+Added: as of December 31, 2020 and March 31, 2020:
March 31, 2020
7 unchanged sentences
Total lease liabilities
−Removed: following table provides lease disclosure for the six months ended September 30, 2020 and 2019:
−Removed: September 30,
−Removed: paid for amounts included in the measurement of lease liabilities:
−Removed: cash flows from operating leases
−Removed: cash flows from finance leases
−Removed: cash flows from finance leases
−Removed: asset obtained in exchange for new operating lease liabilities
−Removed: Weighted-average
−Removed: remaining lease term - operating leases
−Removed: Weighted-average
−Removed: remaining lease term - financing leases
−Removed: Weighted-average
−Removed: discount rate - operating leases
−Removed: Weighted-average
−Removed: discount rate - financing leases
−Removed: The variable lease costs and short-term lease costs
−Removed: were insignificant for three and six months ended September 30, 2020 and 2019.
−Removed: Manufacturing commitments
−Removed: The Company has entered into an agreement
−Removed: with a contract manufacturing organization to provide clinical trial products.
−Removed: As of September 30, 2020 and March 31, 2020, the
−Removed: Company had committed to minimum payments under these arrangements totaling $2,137 and $3,569, respectively, through March 31,
−Removed: Indemnification agreements
−Removed: In the ordinary course of business, the
−Removed: Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect
−Removed: to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property
−Removed: infringement claims made by third parties.
−Removed: In addition, the Company has entered into indemnification agreements with members of
−Removed: its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may
−Removed: arise by reason of their status or service as directors or officers.
−Removed: The maximum potential amount of future payments the Company
−Removed: could be required to make under these indemnification agreements is, in many cases, unlimited.
−Removed: To date, the Company has not incurred
−Removed: any material costs as a result of such indemnifications.
−Removed: The Company is not aware of any claims under indemnification arrangements,
−Removed: and therefore it has not accrued any liabilities related to such obligations in its consolidated financial statements as of September
−Removed: 30, 2020 or March 31, 2020.
−Removed: Legal proceedings
−Removed: The Company is not a party to any litigation
−Removed: and does not have contingency reserves established for any litigation liabilities.
+Added: The following table provides
+Added: lease disclosure for the nine months ended December 31, 2020 and 2019:
+Added: Nine Months Ended
+Added: Other information
+Added: Cash paid for amounts included in the measurement of lease liabilities:
+Added: Operating cash flows from operating leases
+Added: Operating cash flows from finance leases
+Added: Financing cash flows from finance leases
+Added: Right-to-use asset obtained in exchange for new operating lease liabilities
+Added: Weighted-average remaining lease term - operating leases
+Added: Weighted-average remaining lease term - financing leases
+Added: Weighted-average discount rate - operating leases
+Added: Weighted-average discount rate - financing leases
+Added: The variable lease costs and short-term lease costs were insignificant
+Added: for three and nine months ended December 31, 2020 and 2019.
+Added: Manufacturing
+Added: The Company has entered
+Added: into an agreement with a contract manufacturing organization to provide clinical trial products.
+Added: As of December 31, 2020 and
+Added: March 31, 2020, the Company had committed to minimum payments under these arrangements totaling $1,622 and $3,569, respectively,
+Added: through March 31, 2021.
+Added: Indemnification
+Added: In the ordinary course
+Added: of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other
+Added: parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from
+Added: intellectual property infringement claims made by third parties.
+Added: In addition, the Company has entered into indemnification agreements
+Added: with members of its executive management team and its board of directors that will require the Company, among other things, to
+Added: indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers.
+Added: potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases,
+Added: To date, the Company has not incurred any material costs as a result of such indemnifications.
+Added: The Company is not aware
+Added: of any claims under indemnification arrangements, and therefore it has not accrued any liabilities related to such obligations
+Added: in its consolidated financial statements as of December 31, 2020 or March 31, 2020.
+Added: The Company is not
+Added: a party to any litigation and does not have contingency reserves established for any litigation liabilities.
Geographic information
1 unchanged sentence
the United States (Massachusetts) and the United Kingdom (Oxfordshire).
−Removed: Information about the Company’s long-lived assets
+Added: Information about the Company’s long-lived assets
held in different geographic regions is presented in the tables below:
−Removed: September 30, 2020
+Added: December 31, 2020
March 31, 2020
1 unchanged sentence
United Kingdom
−Removed: Subsequent events
−Removed: On October 26, 2020, pursuant to an underwriting
−Removed: agreement with J.P.
−Removed: Morgan Securities LLC and SVB Leerink LLC, as representatives of the several underwriters named therein, the
−Removed: Company issued and sold to the underwriters (a) 5,625,000 shares of the Company’s common stock, inclusive of the underwriters
−Removed: 30-day option to purchase up to an additional 937,500 shares of the Company’s common stock, and (b) pre-funded warrants
−Removed: to purchase 1,562,500 shares of the Company’s common stock.
−Removed: The shares of the Company’s common stock were sold to the
−Removed: underwriters at the public offering price of $40.00 per share and the pre-funded warrants were sold at a public offering price
−Removed: of $39.99 per warrant share, which represents the per share public offering price for the Company’s common stock less a $0.0001
−Removed: per share exercise price for each such pre-funded warrant.
−Removed: The Company received aggregate net proceeds
−Removed: of approximately $270 million after deducting underwriting discounts, commissions and other offering expenses payable by the
+Added: Management’s Discussion
+Added: and Analysis of Financial Condition and Results of Operations.
+Added: You should read
+Added: the following discussion and analysis of our financial condition and results of operations together with our unaudited consolidated
+Added: financial statements and related notes appearing in Part I, Item 1 of this Quarterly Report on Form 10-Q, or this
+Added: Quarterly Report, and with our audited consolidated financial statements and notes thereto for the year ended March 31, 2020,
+Added: included in our Annual Report on Form 10-K for the fiscal year ended March 31, 2020.
+Added: In addition to historical
+Added: information, some of the statements contained in this discussion and analysis or set forth elsewhere in this Quarterly Report,
+Added: including information with respect to our plans and strategy for our business, constitute forward-looking statements within the
+Added: meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
+Added: as amended, or the Exchange Act.
+Added: We have based these forward-looking statements on our current expectations and projections about
+Added: future events.
+Added: The following information and any forward-looking statements should be considered in light of factors discussed
+Added: elsewhere in this Quarterly Report, particularly including those risks identified in Part II, Item 1A “Risk Factors”
+Added: and our other filings with the SEC.
+Added: We caution you that
+Added: forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition
+Added: and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements
+Added: contained in this Quarterly Report.
+Added: Statements made herein are as of the date of the filing of this Quarterly Report with the Securities
+Added: Exchange Commission, or SEC, and should not be relied upon as of any subsequent date.
+Added: Even if our results of operations, financial
+Added: condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements
+Added: contained in this Quarterly Report, they may not be predictive of results or developments in future periods.
+Added: We disclaim any obligation,
+Added: except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect
+Added: any change in our expectations or in events, conditions or circumstances on which any such statements may be based or that may
+Added: affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
+Added: We are a clinical-stage
+Added: biotechnology company committed to applying our leading expertise in the field of oncolytic immunotherapy to transform the lives
+Added: of cancer patients.
+Added: We use our proprietary Immulytic platform to design and develop product candidates that are intended to maximally
+Added: activate the immune system against cancer.
+Added: Oncolytic immunotherapy
+Added: is an emerging drug class, which we intend to establish as the second cornerstone of immune-based cancer treatments, alongside
+Added: checkpoint blockade.
+Added: Oncolytic immunotherapy exploits the ability of certain viruses to selectively replicate in and directly kill
+Added: tumors, as well as induce a potent, patient-specific, anti-tumor immune response.
+Added: Our product candidates incorporate multiple mechanisms
+Added: of action into a practical “off-the-shelf”
+Added: approach that is intended to maximize the immune response against a patient’s
+Added: cancer and to offer significant advantages over personalized vaccine approaches.
+Added: We believe that the bundling of multiple approaches
+Added: for the treatment of cancer into single therapies will simplify the development path of our product candidates, while also improving
+Added: patient outcomes at a lower cost to the healthcare system than the use of multiple different drugs.
+Added: The foundation of our
+Added: Immulytic platform consists of a proprietary, engineered strain of herpes simplex virus 1, or HSV-1, that has been “armed”
+Added: with a fusogenic glycoprotein intended to substantially increase anti-tumor activity.
+Added: Our Immulytic platform enables us to incorporate
+Added: various genes into HSV-1 that are intended to further augment the inherent properties of HSV-1 in order to both directly destroy
+Added: tumor cells and induce an anti-tumor immune response.
+Added: We currently have three product candidates in our development pipeline:
+Added: our lead product candidate, RP2 and RP3.
+Added: We are conducting a
+Added: number of clinical trials of RP1, both as a monotherapy and in combination with anti-PD-1 therapy, with a focus on immune-responsive
+Added: We are actively enrolling patients in a randomized, controlled Phase 2 clinical trial of RP1 in up to approximately
+Added: 240 patients with cutaneous squamous cell carcinoma, or CSCC, RP1’s lead indication.
+Added: This registration-directed clinical
+Added: trial is evaluating RP1 in combination with cemiplimab, an anti-PD-1 therapy developed by Regeneron Pharmaceuticals, Inc.,
+Added: or Regeneron, versus cemiplimab alone.
+Added: Regeneron has granted to us a non-exclusive royalty-free license to cemiplimab for use in
+Added: this trial, is funding one-half of the clinical trial costs, and is supplying cemiplimab at no cost to us.
+Added: If this clinical trial
+Added: generates compelling clinical data demonstrating the benefits of the combined treatment, we believe the data could support a filing
+Added: with regulatory authorities seeking marketing approval.
+Added: We expect the primary data read-out from this Phase 2 clinical trial
+Added: will be in 2022.
+Added: We have also opened
+Added: for enrollment a Phase 1b clinical trial of single agent RP1 in solid organ transplant recipients with CSCC, which we believe
+Added: to be potentially registrational (in its own right or, subject to discussion with regulatory authorities, following enrollment
+Added: of additional patients, including as a potential label expansion after an initial approval of RP1 in a different indication).
+Added: are currently enrolling approximately 30 patients in this clinical trial to assess the safety and efficacy of RP1 in liver and
+Added: kidney transplant recipients with recurrent CSCC.
+Added: Progress in this clinical trial has been particularly impacted by COVID-19, as
+Added: the patient population is severely immune-compromised and considered very high risk if they were to contract COVID-19.
+Added: Nevertheless,
+Added: we expect to dose the first patient in this clinical trial in early 2021 and present initial data from this clinical trial in the
+Added: second half of the year.
+Added: We have also entered
+Added: into a collaboration with Bristol-Myers Squibb Company, or BMS, under which it has granted us a non-exclusive, royalty-free license
+Added: to, and is supplying at no cost, its anti-PD-1 therapy, nivolumab, for use in combination with RP1 in a multi-cohort Phase 1/2
+Added: clinical trial.
+Added: We are currently enrolling a 125-patient extension cohort of RP1 combined with nivolumab in anti-PD-1 failed cutaneous
+Added: We initiated this cohort after completing enrollment in a prior Phase 2 cohort in the same clinical trial of approximately
+Added: 30 patients with melanoma.
+Added: The data generated in the prior melanoma cohort demonstrated that RP1 combined with nivolumab has
+Added: the potential to treat anti-PD-1 failed melanoma.
+Added: We also believe this cohort to be potentially registrational (in its own right
+Added: or, subject to discussion with regulatory authorities, following enrollment of additional patients).
+Added: We expect that the primary
+Added: data read-out from this Phase 2 melanoma cohort will be in 2022.
+Added: In October 2020 we announced updated clinical data from
+Added: our multi-cohort Phase 1/2 clinical trial evaluating RP1 in combination with nivolumab in patients with melanoma and non-melanoma
+Added: skin cancers.
+Added: As reported, RP1 in combination with nivolumab has continued to be well tolerated, and we believe demonstrates continued
+Added: promising efficacy signals of anti-tumor activity in patients with skin cancers, including in patients with anti-PD-1 failed and
+Added: other difficult-to-treat melanomas, and in patients with CSCC.
+Added: We continue to enroll
+Added: patients in other Phase 2 cohorts under our collaboration with BMS in which we are testing RP1 in combination with nivolumab,
+Added: including a non-melanoma skin cancers cohort, a microsatellite instability high, or MSI-H/dMMR tumor cohort, and we have recently
+Added: opened for enrollment a cohort of 30 patients with anti-PD-1 failed non-small cell lung cancer, or NSCLC.
+Added: We and BMS recently agreed
+Added: to increase the number of patients in our non-melanoma skin cancer cohort from 30 to 45 patients to include anti-PD-1 failed patients.
+Added: Due in part to COVID-19 related disruptions, we expect the original 30 patient non-melanoma skin cancer cohort to be fully accrued
+Added: in early 2021.
+Added: Before we determine the next stages of development in this indication, we intend to enroll a total of 15 patients
+Added: into our MSI-H/dMMR cohort.
+Added: We continue to accumulate data in the MSI-H/dMMR cohort and expect to decide whether to pursue MSI-H/dMMR
+Added: tumors into registration-directed development later in 2021.
+Added: We are also developing
+Added: additional product candidates, RP2 and RP3, that have been further engineered to enhance anti-tumor immune responses and are intended
+Added: to address additional tumor types.
+Added: In addition to the expression of GALV-GP R(-) and human GM-CSF, RP2 has been engineered to express
+Added: an antibody-like molecule intended to block the activity of CTLA-4, a protein that inhibits the full activation of an immune response,
+Added: including to tumors.
+Added: RP3, which does not include the expression of GM-CSF, has been engineered with the intent to further stimulate
+Added: an anti-tumor immune response through activation of the immune co-stimulatory pathways through expression of the ligands for CD40L
+Added: and 4-1BBL, in addition to anti-CTLA-4 and GALV-GP R(-).
+Added: We initiated a Phase 1
+Added: clinical trial of RP2 alone and in combination with nivolumab in October 2019.
+Added: This clinical trial is also being conducted
+Added: as part of our collaboration with BMS, under which BMS has granted us a non-exclusive, royalty-free license to, and will supply
+Added: at no cost, nivolumab, for use in combination with RP2.
+Added: We and BMS recently agreed to increase the number of patients in the combination
+Added: part of the clinical trial from 12 to 30 patients.
+Added: In October 2020, we presented positive data from the single agent RP2 portion
+Added: of the clinical trial that showed deep and durable responses, including demonstration of uninjected tumor response in patients
+Added: with difficult to treat advanced cancers.
+Added: This data supports the hypothesis that anti-CTLA-4 delivered intra-tumorally through
+Added: oncolytic virus replication, with accompanying antigen release and presentation, can provide potent anti-tumor effects.
+Added: the monotherapy phase of this clinical trial with RP2, enrollment of patients treated with RP2 used in combination with nivolumab
+Added: is currently underway and we expect to present initial combination data in mid-2021.
+Added: We have obtained clearance
+Added: from the Medicines and Healthcare Products Regulatory Agency in the United Kingdom to begin clinical development with RP3 and in
+Added: December 2020 we initiated dosing in this clinical trial.
+Added: This Phase 1 clinical trial is designed to evaluate RP3 alone and
+Added: combined with anti-PD-1 therapy in advanced solid tumor patients.
+Added: Initial data from this clinical trial is expected to be presented
+Added: in the second half of 2021.
+Added: RP1, RP2 and RP3 are
+Added: administered by direct injection into solid tumors, guided either visually or by ultrasound, computerized tomography, or CT, or
+Added: other imaging methods.
+Added: We believe that direct injection maximizes virus-mediated tumor cell death, provides the most efficient
+Added: delivery of virus-encoded immune activating proteins into the tumor with the goal of activating systemic immunity, and limits the
+Added: systemic toxicities that could be associated with intravenous administration.
+Added: Activation of systemic immunity through local administration
+Added: is intended to lead to the induction of anti-tumor immune responses leading to clinical response of tumors that have not themselves
+Added: been injected.
+Added: Since our inception,
+Added: we have devoted substantially all of our resources to developing our Immulytic platform, building our intellectual property portfolio,
+Added: conducting research and development of our product candidates, business planning, raising capital and providing general and administrative
+Added: support for our operations.
+Added: To date, we have financed our operations primarily with proceeds from the sale of equity securities
+Added: and to a lesser extent the proceeds from the issuance of debt securities.
+Added: We do not have any products approved for sale and have
+Added: not generated any revenue from product sales.
+Added: Since our initial public
+Added: offering, or IPO, on July 24 2018, we have raised an aggregate of approximately $569.2 million in net proceeds to fund our
+Added: operations, of which $101.2 million was from our IPO, $463.6 million was from three separate follow-on offerings, or the Public
+Added: Offerings, that we closed in November 2019, June 2020 and October 2020, respectively, and $4.4 million was from
+Added: at-the-market offerings.
+Added: We sold 7,407,936 shares of common stock in our IPO, an aggregate of 13,619,822 shares of our common stock
+Added: and pre-funded warrants to purchase 5,284,238 shares of our common stock in the Public Offerings, and 287,559 shares of common
+Added: stock through our at-the-market facility.
+Added: Funds affiliated with
+Added: two separate institutional investors hold all of our outstanding pre-funded warrants.
+Added: Other than as set forth in Note 8 of our
+Added: condensed consolidated financial statements appearing elsewhere in this Quarterly Report, the shares of our common stock into which
+Added: our outstanding pre-funded warrants are exercisable are not included in the number of issued and outstanding shares of our common
+Added: stock set forth in this Quarterly Report.
+Added: In addition, on August 8,
+Added: 2019, we entered into a Loan and Security Agreement with Hercules Capital, Inc., or Hercules, which we refer to as the Hercules
+Added: Loan Agreement, pursuant to which we borrowed $10.0 million under a secured term loan facility in the amount of $30.0 million.
+Added: The Hercules Loan Agreement was subsequently amended on June 1, 2020, in order to, among other things, increase the secured
+Added: term loan facility from $30.0 million to $40.0 million.
+Added: On December 15, 2020, we paid a total of $10.8 million, representing
+Added: the outstanding principal, accrued and unpaid interest, fees, costs and expenses due and owing under the Hercules Loan Agreement
+Added: and related loan documents, in repayment of all of our outstanding obligations thereunder, and thereby terminated the Hercules
+Added: Loan Agreement and the related loan documents.
+Added: Since our inception,
+Added: we have incurred significant operating losses.
+Added: Our ability to generate product revenue sufficient to achieve profitability will
+Added: depend on the successful development and eventual commercialization of one or more of our product candidates.
+Added: Our net losses were
+Added: $21.8 million and $16.2 million for the three months ended December 31, 2020 and 2019, respectively and net losses of $59.4
+Added: million and $36.8 million for the nine months ended December 31, 2020 and 2019, respectively.
+Added: As of December 31, 2020,
+Added: we had an accumulated deficit of $171.7 million.
+Added: These losses have resulted primarily from costs incurred in connection with research
+Added: and development activities and general and administrative costs associated with our operations.
+Added: We expect to continue to incur
+Added: significant expenses and increasing operating losses for at least the next several years.
+Added: We anticipate that
+Added: our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly as we
+Added: advance the preclinical activities and clinical trials of our product candidates, and if and as we:
+Added: ● conduct our current and future clinical trials with RP1, RP2 and RP3;
+Added: ● further preclinical development of our platform;
+Added: ● operate our own in-house manufacturing facility;
+Added: ● seek to identify and develop additional product candidates;
+Added: ● seek marketing approvals for any of our product candidates that successfully complete clinical
+Added: trials, if any;
+Added: ● establish a sales, marketing and distribution infrastructure to commercialize any products for
+Added: which we may obtain marketing approval;
+Added: ● until our manufacturing facility is fully validated, continued limited manufacturing by third parties
+Added: for clinical development;
+Added: ● maintain, expand and protect our intellectual property portfolio;
+Added: ● hire and retain additional clinical, quality control, scientific and general and administration
+Added: ● acquire or in-license other drugs and technologies;
+Added: ● add operational, financial and management information systems and personnel, including personnel
+Added: to support our research and development programs, any future commercialization efforts and operating as a public company.
+Added: We will not generate
+Added: revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for RP1
+Added: or our other product candidates.
+Added: If we obtain regulatory approval for any of our product candidates and do not enter into a commercialization
+Added: partnership in any jurisdiction, we expect to incur significant expenses related to developing our internal commercialization capability
+Added: to support product sales, marketing, and distribution.
+Added: As a result, we will
+Added: need additional funding to support our continuing operations and pursue our growth strategy.
+Added: Until such time as we can generate
+Added: significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings,
+Added: debt financings, collaborations, strategic alliances, and marketing, distribution, or licensing arrangements.
+Added: We may be unable
+Added: to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all.
+Added: fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back, or discontinue
+Added: the development and commercialization of one or more of our product candidates.
+Added: Because of the numerous
+Added: risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount
+Added: of increased expenses or when, or if, we will be able to achieve or maintain profitability.
+Added: Even if we are able to generate product
+Added: sales, we may not become profitable.
+Added: If we fail to become profitable or are unable to sustain profitability on a continuing basis,
+Added: then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
+Added: As of December 31,
+Added: 2020, we had cash and cash equivalents and short-term investments of $493.3 million.
+Added: We believe that our existing cash and cash
+Added: equivalents and short-term investments will enable us to fund our operating expenses and capital expenditure requirements through
+Added: at least 12 months from the issuance of the consolidated financial statements included in this Quarterly Report.
+Added: See “—Liquidity
+Added: and capital resources”
+Added: and “Risk factors—Risks related to our financial position and need for additional capital.”
+Added: In December 2019,
+Added: a novel strain of coronavirus, which causes the disease known as COVID-19, was reported to have surfaced in Wuhan, China.
+Added: In March 2020,
+Added: the World Health Organization declared the COVID-19 outbreak a pandemic, which continues to spread throughout the U.S.
+Added: and worldwide.
+Added: We could be materially and adversely affected by the risks, or the public perception of the risks, related to an epidemic, pandemic,
+Added: outbreak, or other public health crisis, such as the recent outbreak of COVID-19.
+Added: We are continuing to monitor the global outbreak
+Added: and spread of COVID-19 and have taken steps to identify and mitigate the adverse impacts on, and risks to, our business posed by
+Added: its spread and actions taken by governmental and health authorities to address the COVID-19 pandemic.
+Added: The spread of COVID-19 has
+Added: caused us to modify our business practices, including implementing a global work from home policy for certain employees who are
+Added: able to perform their duties remotely and reducing travel.
+Added: For those employees working from our facilities, including certain essential
+Added: employees in our laboratory and who perform manufacturing functions, and certain other employees as deemed essential from time
+Added: to time, we have implemented stringent safety measures designed to comply with applicable federal, state and local guidelines instituted
+Added: in response to the COVID-19 pandemic.
+Added: Fluctuation in infection rates in the regions in which we operate has resulted in periodic
+Added: changes in restrictions that vary from region to region and require vigilant attention and rapid response to new or reinstated
+Added: We expect to continue to take actions as may be required or recommended by government authorities or as we determine are
+Added: in the best interests of our employees, the patients we serve and other business partners in light of COVID-19.
+Added: The COVID-19 pandemic
+Added: has delayed, and we expect it may continue to delay, the timing of patient enrollment and treatment in certain of our ongoing clinical
+Added: For example, the enrollment of our clinical trial of RP1 in liver and kidney transplant patients with CSCC, representing
+Added: highly immunocompromised patient populations, has been slower than expected for reasons we attribute to the COVID-19 pandemic.
+Added: However, the extent of these delays is currently unknown and has and will likely continue to vary by clinical study site and may
+Added: be amplified as a result of the impacts of a “second wave”
+Added: of the virus outbreak.
+Added: In addition, we may incur unforeseen
+Added: costs as a result of disruptions in clinical supply or preclinical study or clinical trial delays.
+Added: While vaccines for COVID-19
+Added: are being, and have been developed, there is no guarantee that any such vaccine will be effective, work as expected or be made
+Added: available or will be accepted on a significant scale and in a timely manner.
+Added: The impact of COVID-19 on our business future results
+Added: will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate
+Added: geographic spread of the disease, the duration of the pandemic, travel restrictions and social distancing in the United States
+Added: and other countries, business closures or business disruptions, the ultimate impact on financial markets and the global economy,
+Added: and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.
+Added: See “Risk
+Added: Factors—Our financial condition and results of operations could be adversely affected by the recent novel coronavirus disease-2019,
+Added: or COVID-19, outbreak.”
+Added: in Part II, Item 1A of this Quarterly Report.
+Added: Components of our results of operations
+Added: To date, we have not
+Added: generated any revenue from product sales as we do not have any approved products and do not expect to generate any revenue from
+Added: the sale of products in the near future.
+Added: If our development efforts for RP1 or any other product candidates that we may develop
+Added: in the future are successful and result in regulatory approval, or if we enter into collaboration or license agreements with third
+Added: parties, we may generate revenue in the future from a combination of product sales or payments from those collaborations or license
+Added: Operating expenses
+Added: Our expenses since
+Added: inception have consisted solely of research and development costs and general and administrative costs.
+Added: Research and development expenses
+Added: Research and development
+Added: expenses consist primarily of costs incurred for our research activities, including our discovery efforts and the development of
+Added: our product candidates, and include:
+Added: ● expenses incurred under agreements with third parties, including clinical research organizations,
+Added: or CROs, that conduct research, preclinical activities and clinical trials on our behalf as well as contract manufacturing organizations,
+Added: or CMOs, that manufacture our product candidates for use in our preclinical and clinical trials;
+Added: ● salaries, benefits and other related costs, including stock-based compensation expense, for personnel
+Added: engaged in research and development functions;
+Added: ● costs of outside consultants, including their fees, stock-based compensation and related travel
+Added: ● costs of laboratory supplies and acquiring, developing and manufacturing preclinical study and
+Added: clinical trial materials;
+Added: ● costs related to compliance with regulatory requirements in connection with the development of
+Added: our product candidates;
+Added: ● facility-related expenses, which include direct depreciation costs and allocated expenses for rent
+Added: and maintenance of facilities and other operating costs.
+Added: costs will be partially offset by our agreement with Regeneron related to our
+Added: Phase 2 clinical trial of RP1 in approximately 240 patients with clinical trial CSCC .
+Added: We expense research
+Added: and development costs as incurred.
+Added: We recognize external development costs based on an evaluation of the progress to completion
+Added: of specific tasks using information provided to us by our service providers.
+Added: Payments for these activities are based on the terms
+Added: of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our consolidated financial
+Added: statements as prepaid or accrued research and development expenses.
+Added: Our direct external
+Added: research and development expenses are tracked on a program-by-program basis and consist of costs, such as fees paid to consultants,
+Added: contractors, CMOs, and CROs in connection with our preclinical and clinical development activities.
+Added: We do not allocate personnel
+Added: costs, costs associated with our discovery efforts, laboratory supplies, and facilities, including depreciation or other indirect
+Added: costs, to specific product development programs because these costs are deployed across multiple product development programs and,
+Added: as such, are not separately classified.
+Added: All non-employee costs associated with our manufacturing facility have been fully burdened
+Added: to our RP1 program.
+Added: The table below summarizes
+Added: our research and development expenses by product candidate or development program for each of the periods presented:
+Added: Three Months Ended
+Added: Nine Months Ended
+Added: (Amounts in thousands)
+Added: Direct research and development expenses by program:
+Added: Unallocated research and development expenses:
+Added: Personnel related (including stock-based compensation)
+Added: Total research and development expenses
+Added: Research and development
+Added: activities are central to our business model.
+Added: Product candidates in later stages of clinical development generally have higher
+Added: development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage
+Added: clinical trials.
+Added: We expect that our research and development expenses will continue to increase for the foreseeable future as we
+Added: continue enrollment and initiate additional clinical trials and continue to discover and develop additional product candidates.
+Added: The successful development and commercialization of our product candidates is highly uncertain.
+Added: This is due to the numerous risks
+Added: and uncertainties associated with product development and commercialization, including the following:
+Added: ● the scope, rate of progress, expense and results of our ongoing clinical trials, as well future
+Added: clinical trials or other product candidates and other research and development activities that we may conduct;
+Added: ● the number and scope of preclinical and clinical programs we decide to pursue;
+Added: ● our ability to maintain our current research and development programs and to establish new ones;
+Added: ● uncertainties in clinical trial design;
+Added: ● the rate of enrollment in clinical trials;
+Added: ● the successful completion of clinical trials with safety, tolerability, and efficacy profiles that
+Added: are satisfactory to the FDA or any comparable foreign regulatory authority;
+Added: ● the receipt of regulatory approvals from applicable regulatory authorities;
+Added: ● our success in operating a manufacturing facility, or securing manufacturing supply through relationships
+Added: with third parties;
+Added: ● our ability to obtain and maintain patents, trade secret protection, and regulatory exclusivity,
+Added: both in the United States and internationally;
+Added: ● our ability to protect our rights in our intellectual property portfolio;
+Added: ● the commercialization of our product candidates, if and when approved;
+Added: ● the acceptance of our product candidates, if approved, by patients, the medical community, and
+Added: third-party payors;
+Added: ● our ability to successfully develop our product candidates for use in combination with third-party
+Added: products or product candidates;
+Added: ● negative developments in the field of immuno-oncology;
+Added: ● competition with other products;
+Added: ● significant and changing government regulation and regulatory guidance.
+Added: A change in the outcome
+Added: of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and
+Added: timing associated with the development of that product candidate.
+Added: For example, if the FDA or another regulatory authority were
+Added: to require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development
+Added: of a product candidate, or if we experience significant trial delays due to patient enrollment or other reasons, we would be required
+Added: to expend significant additional financial resources and time on the completion of clinical development.
+Added: We may never succeed in
+Added: obtaining regulatory approval for any of our product candidates.
+Added: General and administrative expenses
+Added: General and administrative
+Added: expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in our executive,
+Added: finance, corporate and business development and administrative functions.
+Added: General and administrative expenses also include professional
+Added: fees for legal, patent, accounting, auditing, tax and consulting services;
+Added: travel expenses;
+Added: and facility-related expenses, which
+Added: include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.
+Added: We expect that our
+Added: general and administrative expenses will increase in the future as we increase our general and administrative headcount to support
+Added: our continued research and development and potential commercialization of our product candidates.
+Added: We also expect to continue to
+Added: incur increased expenses, including accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance
+Added: with exchange listing and SEC requirements;
+Added: director and officer insurance costs;
+Added: and investor and public relations costs.
+Added: Other income (expense), net
+Added: Research and development incentives
+Added: Research and development
+Added: incentives consists of reimbursements of research and development expenditures.
+Added: We participate, through our subsidiary in the United
+Added: Kingdom, in the research and development program provided by the United Kingdom tax relief program, such that a percentage of up
+Added: to 14.5% of our qualifying research and development expenditures are reimbursed by the United Kingdom government, and such incentives
+Added: are reflected as other income.
+Added: Investment income
+Added: Investment income consists
+Added: of income earned on our cash and cash equivalents and short-term investments.
+Added: Interest expense on finance lease liability
+Added: Interest expense on
+Added: finance lease liability consists of amortization of finance charges under our financing lease.
+Added: Interest expense on debt obligations
+Added: Interest expense on
+Added: debt obligations consists of the amortization of debt discount and cash paid for interest under the term loan facility with Hercules.
+Added: Other income (expense), net
+Added: Other income (expense),
+Added: net consists primarily of realized and unrealized foreign currency transaction gains and losses.
+Added: Since our inception
+Added: and through December 31, 2020, we have not recorded any income tax benefits for the net losses we incurred in each jurisdiction
+Added: in which we operate, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our
+Added: net operating loss carryforwards will not be realized.
+Added: Results of operations
+Added: Comparison of the three months ended
+Added: December 31, 2020 and 2019
+Added: The following table
+Added: summarizes our results of operations for the three months ended December 31, 2020 and 2019:
+Added: Three Months Ended
+Added: (Amounts in thousands)
+Added: Operating expenses:
+Added: Research and development
+Added: General and administrative
+Added: Total operating expenses
+Added: Loss from operations
+Added: Other income (expense):
+Added: Research and development incentives
+Added: Investment income
+Added: Interest expense on finance lease liability
+Added: Loss on extinguishment of debt
+Added: Interest expense on debt obligations
+Added: Other income (expense)
+Added: Total other income (expense), net
+Added: Research and development expenses
+Added: Three Months Ended
+Added: (Amounts in thousands)
+Added: Direct research and development expenses by program:
+Added: Unallocated research and development expenses:
+Added: Personnel related (including stock-based compensation)
+Added: Total research and development expenses
+Added: Research and development
+Added: expenses for the three months ended December 31, 2020 were $14.3 million, compared to $11.9 million for the three months ended
+Added: December 31, 2019.
+Added: The increase of $2.4 million was due primarily to an increase of approximately $3.5 million in direct research
+Added: costs, off set by an approximately $1.2 million decrease in our unallocated research and development costs.
+Added: The increase in RP1
+Added: costs was due primarily to an increase in clinical trial costs in the three months ended December 31, 2020 associated with
+Added: our ongoing clinical trials as well as costs associated with operations of our new manufacturing facility for RP1 clinical trial
+Added: The increase in costs associated with RP2 and RP3 are primarily associated with the continued clinical trial development
+Added: of these product candidates.
+Added: The decrease in unallocated
+Added: research and development expenses reflected an increase of $1.3 million in personnel-related costs.
+Added: The increase in personnel-related
+Added: costs largely reflected the hiring of additional personnel in our research and development functions as we expanded the development
+Added: plan in multiple indications.
+Added: Personnel related costs for the three months ended December 31, 2020 and 2019 included stock-based
+Added: compensation expense of $1.5 million and $1.3 million, respectively.
+Added: Other costs decreased primarily due to our manufacturing operations
+Added: focused on the potential registrational studies associated with our RP1 development plan with multiple cohorts.
+Added: General and administrative expenses
+Added: General and administrative
+Added: expenses were $6.0 million for the three months ended December 31, 2020, compared to $4.7 million for the three months ended
+Added: December 31, 2019.
+Added: The increase of $1.2 million primarily reflected increases of $0.9 million in personnel related costs,
+Added: including stock-based compensation of $0.6 million, and increases of $0.2 million in facility and other variable costs.
+Added: in personnel related costs was due to the hiring of additional personnel in our general and administrative functions as we expanded
+Added: our operations in the United States.
+Added: The increase in facility and other variable costs was due primarily to an increase in costs
+Added: associated with our directors and officers insurance.
+Added: Total other income (expense), net
+Added: Other income (expense)
+Added: was $(1.5) million for the three months ended December 31, 2020, compared to $0.5 million for the three months ended December 31,
+Added: The decrease of $2.0 million was primarily attributable to a $0.9 million increase associated with the loss from extinguishment
+Added: of debt under our term loan facility with Hercules, a $0.2 million increase in interest expense on debt obligations related to
+Added: our term loan facility with Hercules, a $0.3 decrease in other income due primarily to the changes in foreign exchange rates of
+Added: the Great British Pounds to United States Dollar, a $0.4 million decrease in investment income due to fluctuations in the rate
+Added: of return on investments, and a $0.4 million decrease in research and development incentives.
+Added: Comparison of the nine months ended
+Added: December 31, 2020 and 2019
+Added: The following table summarizes our results
+Added: of operations for the nine months ended December 31, 2020 and 2019:
+Added: Research and development expenses
+Added: Nine Months Ended
+Added: (Amounts in thousands)
+Added: Operating expenses:
+Added: Research and development
+Added: General and administrative
+Added: Total operating expenses
+Added: Loss from operations
+Added: Other income (expense):
+Added: Research and development incentives
+Added: Investment income
+Added: Interest expense on finance lease liability
+Added: Interest expense on debt obligations
+Added: Loss on extinguishment of debt
+Added: Other income (expense)
+Added: Total other income (expense), net
+Added: Nine Months Ended
+Added: (Amounts in thousands)
+Added: Direct research and development expenses by program:
+Added: Unallocated research and development expenses:
+Added: Personnel related (including stock-based compensation)
+Added: Total research and development expenses
+Added: Research and development
+Added: expenses for the nine months ended December 31, 2020 were $40.5 million, compared to $27.6 million for the nine months ended
+Added: December 31, 2019.
+Added: The increase of $13.0 million was due primarily to an increase of approximately $9.5 million in direct
+Added: research costs associated with RP1, $1.5 million in direct research costs associated with RP2 and RP3, and approximately $1.9 million
+Added: increase in our unallocated research and development costs.
+Added: The increase in RP1 costs was due primarily to an increase in clinical
+Added: trial costs in the nine months ended December 30, 2020 associated with our ongoing clinical trials as well as costs associated
+Added: with operations of our new manufacturing facility for RP1 clinical trial supplies.
+Added: The increase in costs associated with RP2 and
+Added: RP3 is primarily associated with the continued clinical trial development of these product candidates.
+Added: The increase in unallocated
+Added: research and development expenses reflected an increase of $5.1 million in personnel-related costs, including stock-based compensation
+Added: of $0.8 million, partially offset by a decrease of $3.2 million in other costs.
+Added: The increase in personnel-related costs largely
+Added: reflected the hiring of additional personnel in our research and development functions as we expanded the development plan in multiple
+Added: Personnel related costs for the nine months ended December 31, 2020 and 2019 included stock-based compensation
+Added: expense of $3.8 million and $3.0 million, respectively.
+Added: Other costs decreased primarily due to our manufacturing operations focused
+Added: on the potential registrational studies associated with our RP1 development plan with multiple cohorts.
+Added: General and administrative expenses
+Added: General and administrative
+Added: expenses were $17.2 million for the nine months ended December 31, 2020, compared to $12.2 million for the nine months ended
+Added: December 31, 2019.
+Added: The increase of $5.0 million primarily reflected increases of $2.8 million in personnel related costs,
+Added: including stock-based compensation of $1.6 million, increases of $1.3 million in facility and other variable costs and increases
+Added: of $0.8 million in professional fees.
+Added: The increase in personnel related costs was due to the hiring of additional personnel in
+Added: our general and administrative functions as we expanded our operations in the United States.
+Added: The increase in professional fees
+Added: was due to costs associated with increased spending to build out our information technology capabilities as well legal and accounting
+Added: fees related to ongoing business operations and enhancements to the internal control environment.
+Added: The increase in facility and
+Added: other variable costs was due primarily to an increase in costs associated with our directors and officers insurance of approximately
+Added: $0.4 million and depreciation expense of $0.4 million associated with our corporate headquarters.
+Added: Total other income (expense), net
+Added: Other income (expense)
+Added: was $(1.6) million for the nine months ended December 31, 2020, compared to $3.0 million for the nine months ended December 31,
+Added: The decrease of $4.6 million was primarily attributable to a $0.7 million increase in interest expense related to our finance
+Added: lease liability, a $0.8 million increase in interest expense on debt obligations related to our term loan facility with Hercules,
+Added: a $0.9 million increase associated with the loss from extinguishment of debt under our term loan facility with Hercules a $1.0
+Added: million increase in other expense due primarily to the changes in foreign exchange rates of the Great British Pounds to United
+Added: States Dollar, a $1.0 million decrease in investment income due to fluctuations in the rate of return on investments, and a $0.2
+Added: million decrease in research and development incentives.
+Added: Liquidity and capital resources
+Added: Since our inception,
+Added: we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from
+Added: our operations.
+Added: We have not yet commercialized any of our product candidates, which are in various phases of preclinical and clinical
+Added: development, and we do not expect to generate revenue from sales of any products for the foreseeable future, if at all.
+Added: Sources of liquidity
+Added: To date, we have financed
+Added: our operations primarily with proceeds from the sale of equity securities and, to a lesser extent, proceeds from the issuance of
+Added: debt securities.
+Added: Through December 31, 2020, we had received gross proceeds of approximately $706.5 million from our sales
+Added: of equity instruments and $10.0 million from our incurrence debt under the term loan facility with Hercules, which was repaid in
+Added: full in December 2020.
+Added: As of December 31, 2020, we had cash and cash equivalents and short-term investments of $493.3
+Added: In July 2018,
+Added: we completed our IPO and issued and sold 7,407,936 shares of our common stock at a public offering price of $15.00 per share, resulting
+Added: in net proceeds of $103.4 million after deducting underwriting discounts and commissions but before deducting offering costs.
+Added: the fourth calendar quarter of 2019, we closed a registered public offering for the issuance and sale of 4,516,561 shares of our
+Added: common stock at a public offering price of $13.61 per share and pre-funded warrants to purchase 2,200,000 shares of our common
+Added: stock at a purchase price of $13.6099 per pre-funded warrant, the public offering price per share of the common stock less the
+Added: $0.0001 per share exercise price of each pre-funded warrant.
+Added: We received aggregate net proceeds of approximately $85.6 million
+Added: after deducting underwriting discounts, commissions and other offering expenses of approximately $5.8 million.
+Added: In June 2020,
+Added: we closed a second public offering for the issuance and sale of 3,478,261 shares of our common stock at a public offering price
+Added: of $23.00 per share and pre-funded warrants to purchase 1,521,738 shares of our common stock at a purchase price of $22.9999 per
+Added: pre-funded warrant, the public offering price per share of common stock less the $0.0001 per share exercise price of each pre-funded
+Added: We received aggregate net proceeds of approximately $107.8 million after deducting underwriting discounts, commissions
+Added: and other offering expenses of approximately $7.2 million.
+Added: On October 26, 2020, we closed a third public offering for the
+Added: issuance and sale of 5,625,000 shares of our common stock at a public offering price of $40.00 per share and pre-funded warrants
+Added: to purchase 1,562,500 shares of our common stock at a purchase price of $39.99 per pre-funded warrant, the public offering price
+Added: per share of common stock less the $0.0001 per share exercise price of each pre-funded warrant.
+Added: We received aggregate net proceeds
+Added: of approximately $270.0 million after deducting underwriting discounts, commissions and other offering expenses of approximately
+Added: $17.5 million.
+Added: In addition to registered
+Added: public equity offerings, we also established an at-the-market offering program pursuant to a sales agreement that we entered into
+Added: with SVB Leerink LLC, or the Agent, on August 8, 2019, or the 2019 Sales Agreement.
+Added: Under the 2019 Sales Agreement, and prior
+Added: to its amendment in June 2020, we could sell from time to time, at our option, up to an aggregate of $75.0 million of shares
+Added: of our common stock.
+Added: In June 2020, we amended the 2019 Sales Agreement to reduce the aggregate offering amount thereunder
+Added: from $75.0 million to $30.0 million We sold 287,559 shares of our common stock under the 2019 Sales Agreement for net proceeds
+Added: of approximately $4.4 million.
+Added: On August 11, 2020, in connection with our entry into separate sales agreement with the Agent,
+Added: or the 2020 Sales Agreement, we and the Agent mutually agreed to terminate the 2019 Sales Agreement.
+Added: Under the 2020 Sales Agreement,
+Added: and prior to its amendment in October 2020, we could sell from time to time, at our option, up to an aggregate of $75.0 million
+Added: of shares of our common stock.
+Added: In October 2020, we amended the 2020 Sales Agreement to reduce the aggregate offering amount
+Added: thereunder from $75.0 million to $62.5 million.
+Added: We have not sold any shares of our common stock under the 2020 Sales Agreement.
+Added: Our incurrence of debt
+Added: was conducted entirely under the Hercules Loan Agreement, as amended, pursuant to which we borrowed $10.0 million of a maximum
+Added: of $40.0 million.
+Added: On December 15, 2020, we entered into a Payoff Letter with Hercules and paid a total of $10.8 million to
+Added: Hercules representing the outstanding principal, accrued and unpaid interest, fees, costs and expense due and owed to Hercules,
+Added: thereby terminating the Hercules Loan Agreement and the related loan documents.
+Added: The following table
+Added: summarizes our cash flows for each of the periods presented:
+Added: Nine Months Ended
+Added: (Amounts in thousands)
+Added: Net cash used in operating activities
+Added: Net cash provided by (used in) investing activities
+Added: Net cash provided by financing activities
+Added: Effect of exchange rate changes on cash and cash equivalents
+Added: Net increase (decrease) in cash and cash equivalents
+Added: Operating activities
+Added: During the nine months
+Added: ended December 31, 2020, net cash used in operating activities was $45.3 million, primarily resulting from our net loss of
+Added: $ 59.4 million, partially offset by the net cash provided by changes in our operating assets and liabilities of $2.6 million
+Added: and non-cash charges of $11.4 million.
+Added: Net cash used by our changes in our operating assets and liabilities for the nine months
+Added: ended December 31, 2020 consisted primarily of a $1.1 million decrease in research and development incentive receivables,
+Added: partially from the United Kingdom government due to the timing and amount of our qualifying expenditures, $1.2 million increase
+Added: in prepaid expenses and other current assets and $1.0 million decrease in accounts payable, partially offset by $1.9 million increase
+Added: in accrued expenses and other current liabilities and $1.9 million net decrease related to ASC 842 (including changes in operating
+Added: lease liabilities, operating lease, right-of-use asset and financing lease, right-of-use asset).
+Added: The changes in accounts payable
+Added: were primarily due to the timing of vendor invoicing and payments.
+Added: During the nine months
+Added: ended December 31, 2019, net cash used in operating activities was $49.3 million, primarily resulting from our net loss of
+Added: $36.8 million and net cash used by changes in our operating assets and liabilities of $17.8 million, partially offset by net non-
+Added: cash charges of $5.3 million.
+Added: Net cash used by changes in our operating assets and liabilities for the nine months ended December 31,
+Added: 2019 consisted primarily of a $14.1 million increase in long-term prepaid rent, a $2.6 million decrease in accounts payable, a
+Added: $2.2 million increase in research and development incentives receivable, partially from the United Kingdom government due to the
+Added: timing and amount of our qualifying expenditures, a $1.5 million increase in prepaid expenses and other current assets and a $0.3
+Added: million decrease in operating lease liabilities offset by a $1.8 million increase in accrued expenses and other current liabilities,
+Added: $0.7 million decrease in operating lease, right-of-use asset and $0.4 million decrease in financing lease, right-of-use-asset.
+Added: Investing activities
+Added: During the nine months
+Added: ended December 31, 2020, net cash used in investing activities was $62.5 million, consisting of $225.0 million in purchases
+Added: of available for sale securities and $1.6 million in purchases of property, plant and equipment, partially offset by $164.1 million
+Added: in proceeds from sales and maturities of short-term investments.
+Added: During the nine months
+Added: ended December 31, 2019, net cash used in investing activities was $13.1 million, consisting of $119.6 million in purchases
+Added: of available for sale securities and $5.2 million in purchases of property, plant and equipment, partially offset by $111.7 million
+Added: in proceeds from sales and maturities of short-term investments.
+Added: Financing Activities
+Added: During the nine months
+Added: ended December 31, 2020, net cash provided by financing activities was $371.7 million, consisting of $286.1 million from the
+Added: issuance of common stock, $91.7 million from the issuance of pre-funded warrants to purchase common stock, $4.9 million in proceeds
+Added: from the exercise of stock options, partially offset by $10.0 million in debt payments under the Hercules Loan Agreement and $0.8
+Added: million of fees associated with the extinguishment of the obligations under the Hercules Loan Agreement.
+Added: During the nine months
+Added: ended December 31, 2019, net cash provided by financing activities was $100.1 million, consisting of $57.5 million in proceeds
+Added: from the issuance of common stock, $28.1 million in proceeds from issuance of pre-funded warrants to purchase common stock, $10.0
+Added: million in proceeds from the long-term debt, $4.4 million in proceeds from the issuance of common stock through sales under the
+Added: 2019 Sales Agreement and $0.5 million in proceeds from the exercise of stock options, partially offset by $0.4 million in payments
+Added: of issuance costs and $22,000 in principal payments of finance lease obligations.
+Added: Hercules Loan Agreement
+Added: On August 8, 2019
+Added: and as amended on June 1, 2020, we and certain of our affiliates entered into the Hercules Loan Agreement with Hercules, which
+Added: provided for aggregate borrowings of up to $40.0 million in the form of term loans.
+Added: We borrowed $10.0 million at closing under
+Added: the Hercules Loan Agreement and, subject to the achievement of certain milestones, had the ability to borrow the unused $30.0 million
+Added: available thereunder in three separate $10.0 million advances between October 1, 2020 and December 15, 2020, July 1,
+Added: 2020 and June 30, 2021, and July 1, 2021 and December 15, 2021, respectively.
+Added: On December 15,
+Added: 2020, we entered into a Payoff Letter with respect to the Hercules Loan Agreement.
+Added: Pursuant to the Payoff Letter, we paid a total
+Added: of $10.8 million to Hercules, representing the outstanding principal, accrued and unpaid interest, fees, costs and expenses due
+Added: and owed to Hercules under the Hercules Loan Agreement.
+Added: Upon the execution of the Payoff Letter, in repayment of all of our outstanding
+Added: obligations thereunder, the Hercules Loan Agreement and the related loan documents were terminated.
+Added: Borrowings under the
+Added: Hercules Loan Agreement bore interest at a rate per annum equal to 8.75%.
+Added: Under the Hercules Loan Agreement, we were required to
+Added: make monthly interest-only payments through September 1, 2022.
+Added: As of December 31, 2020, there was no amount of outstanding
+Added: principal under the Hercules Loan Agreement due and owing.
+Added: The term loan facility
+Added: with Hercules was secured by substantially all of our assets, excluding our intellectual property, and subject to certain exceptions
+Added: and exclusions.
+Added: All liens on our assets held by Hercules were released in connection with the our execution of the Payoff Letter.
+Added: Funding requirements
+Added: Our plan of operation
+Added: is to continue implementing our business strategy, continue research and development of RP1 and our other product candidates and
+Added: continue to expand our research pipeline and our internal research and development capabilities.
+Added: We expect our expenses to increase
+Added: substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials
+Added: of our product candidates and if and as we:
+Added: ● conduct our current and future clinical trials with RP1, RP2 and RP3;
+Added: ● further preclinical development of our platform;
+Added: ● operate our own in-house manufacturing facility;
+Added: ● seek to identify and develop additional product candidates;
+Added: ● seek marketing approvals for any of our product candidates that successfully complete clinical
+Added: trials, if any;
+Added: ● establish a sales, marketing and distribution infrastructure to commercialize any products for
+Added: which we may obtain marketing approval;
+Added: ● until our planned manufacturing facility is fully validated, continued limited manufacturing by
+Added: third parties for clinical development.
+Added: ● maintain, expand and protect our intellectual property portfolio;
+Added: ● acquire or in-license other drugs and technologies;
+Added: ● add operational, financial and management information systems and personnel, including personnel
+Added: to support our research and development programs, any future commercialization efforts and operations as a public company.
+Added: As of December 31,
+Added: 2020, we had cash and cash equivalents and short-term investments of $493.3 million.
+Added: We believe that our existing cash, cash equivalents
+Added: and short-term investments as of December 31, 2020, will enable us to fund our overall operations into the second half of
+Added: We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources
+Added: sooner than we expect.
+Added: Because of the numerous
+Added: risks and uncertainties associated with the development of RP1 and other product candidates and programs, and because the extent
+Added: to which we may enter into collaborations with third parties for development of our product candidates is unknown, we are unable
+Added: to estimate the timing and amounts of increased capital outlays and operating expenses associated with completing the research
+Added: and development of our product candidates.
+Added: Our future capital requirements will depend on many factors, including those described
+Added: in this section and above under “—Operating expenses—Research and development expenses.”
+Added: Developing novel biopharmaceutical
+Added: products, including conducting preclinical studies and clinical trials, is a time-consuming, expensive and uncertain process that
+Added: takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval for any
+Added: product candidates or generate revenue from the sale of any products for which we may obtain marketing approval.
+Added: In addition, our
+Added: product candidates, if approved, may not achieve commercial success.
+Added: Our commercial revenues, if any, will be derived from sales
+Added: of therapies that we do not expect to be commercially available for many years, if ever.
+Added: Accordingly, we will need to obtain substantial
+Added: additional funds to achieve our business objectives.
+Added: Adequate additional
+Added: funds may not be available to us on acceptable terms, or at all.
+Added: We do not currently have any committed external source of funds.
+Added: To the extent that we raise additional capital through the sale of our equity or convertible debt securities, our shareholders’
+Added: interest may be diluted, and the terms of these securities may include liquidation or other preferences and anti-dilution protections
+Added: that could adversely affect the rights of our common stockholder.
+Added: Additional debt or preferred equity financing, if available,
+Added: may involve agreements that include restrictive covenants that may limit our ability to take specific actions, such as incurring
+Added: debt adversely impact our ability to conduct our business, and may require the issuance of warrants, which could potentially dilute
+Added: your ownership interest.
+Added: If we raise additional
+Added: funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable
+Added: rights to our technology, future revenue streams, research programs, or product candidates or grant licenses on terms that may
+Added: not be favorable to us.
+Added: If we are unable to raise additional funds through equity or debt financings or collaborations, strategic
+Added: alliances or licensing arrangements with third parties when needed, we may be required to delay, limit, reduce and/or terminate
+Added: our product development programs or any future commercialization efforts or grant rights to develop and market product candidates
+Added: that we would otherwise prefer to develop and market ourselves.
+Added: Contractual obligations and commitments
+Added: During the nine months
+Added: ended December 31, 2020, there were no material changes to our contractual obligations and commitments from those described
+Added: under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Contractual
+Added: Obligations and Commitments”
+Added: in our Annual Report on Form 10-K for the year ended March 31, 2020, which was filed
+Added: with the SEC on June 3, 2020.
+Added: Collaborations
+Added: On February 26,
+Added: 2018, we entered into a Clinical Trial Collaboration and Supply Agreement with Bristol-Myers Squibb Company, or BMS.
+Added: the agreement, BMS is providing to us, at no cost, nivolumab, its anti-PD-1 therapy, for use in combination with RP1 in our ongoing
+Added: Phase 1/2 clinical trial.
+Added: Under the agreement, we will sponsor, fund and conduct the clinical trial in accordance with an agreed-upon
+Added: BMS granted us a non-exclusive, non-transferrable, royalty-free license (with a right to sublicense) under its intellectual
+Added: property to use nivolumab in the clinical trial and has agreed to supply nivolumab, at no cost to us, for use in the clinical trial.
+Added: Both parties will own the study data produced in the clinical trial, other than study data related solely to nivolumab, which will
+Added: belong solely to BMS, or study data related solely to RP1, which will belong solely to us.
+Added: In January 2020, this agreement
+Added: was expanded to cover an additional cohort of 125 patients with anti-PD-1 failed melanoma.
+Added: Unless earlier terminated,
+Added: the agreement will remain in effect until (i) the completion of the clinical trial, (ii) all related clinical trial data
+Added: have been delivered to both parties and (iii) the completion of any statistical analyses and bioanalyses contemplated by the
+Added: clinical trial protocol or any analysis otherwise agreed upon by the parties.
+Added: The agreement may be terminated by either party (i) in
+Added: the event of an uncured material breach by the other party, (ii) in the event the other party is insolvent or in bankruptcy
+Added: proceedings or (iii) for safety reasons.
+Added: Upon termination, the licenses granted to us to use nivolumab in the clinical trial
+Added: will terminate.
+Added: The agreement contains representations, warranties, undertakings and indemnities customary for a transaction of
+Added: On April 12, 2019,
+Added: we entered into a separate agreement with BMS on terms similar to the terms set forth in the agreement described above, pursuant
+Added: to which BMS will provide, at no cost to us, nivolumab for use in our Phase 1 clinical trial of RP2 in combination with nivolumab.
+Added: On May 29, 2018,
+Added: we entered into a Master Clinical Trial Collaboration and Supply Agreement with Regeneron Pharmaceuticals, Inc., or Regeneron.
+Added: Pursuant to the agreement we agreed to undertake one or more clinical trials with Regeneron for the administration of our product
+Added: candidates in combination with cemiplimab, an anti-PD-1 therapy developed by Regeneron, across multiple solid tumor types, the
+Added: first of which is our ongoing Phase 2 clinical trial testing RP1 in combination with cemiplimab versus cemiplimab alone in
+Added: patients with CSCC.
+Added: Each clinical trial will be conducted pursuant to an agreed study plan which, among other things, will identify
+Added: the name of the sponsor and which party will manage the particular study, and include the protocol, the budget and a schedule of
+Added: clinical obligations.
+Added: The first study plan related to the Phase 2 clinical trial in CSCC has been agreed.
+Added: Pursuant to the terms
+Added: of the agreement, each party granted the other party a non-exclusive license of their respective intellectual property and agreed
+Added: to contribute the necessary resources needed to fulfill their respective obligations, in each case, under the terms of agreed
+Added: Development costs of a particular clinical trial will be split equally.
+Added: The agreement contains representations, warranties,
+Added: undertakings and indemnities customary for a transaction of this nature.
+Added: The agreement also contains certain covenants that restrict
+Added: us from entering into a third-party arrangement with respect to the use of our product candidates in combination with an anti-PD-1
+Added: therapy and that restrict Regeneron from entering into a third-party arrangement with respect to the use of cemiplimab in combination
+Added: with an HSV-1 virus, in each case, for the treatment of a tumor type that is the subject of a clinical trial to which the covenants
+Added: Unless otherwise mutually agreed in a future study plan, these covenants are only applicable to our ongoing Phase 2
+Added: clinical trial in CSCC, and expire upon the one-year anniversary of the commencement of the applicable study plan.
+Added: The agreement may be
+Added: terminated by either party if (i) there is no active study plan for which a final study report has not been completed, (ii) the
+Added: parties have not entered into a study plan for an additional clinical trial within a period of time after the delivery of the most
+Added: recent final study report or (iii) in the event of a material breach.
+Added: Critical accounting policies and significant
+Added: judgments and estimates
+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 generally accepted accounting principles in the United States.
+Added: The preparation of our consolidated
+Added: financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of
+Added: assets and liabilities, costs and expenses and the disclosure of contingent assets and liabilities in our consolidated financial
+Added: We base our estimates on historical experience, known trends and events and various other factors that we believe are
+Added: reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets
+Added: and liabilities that are not readily apparent from other sources.
+Added: We evaluate our estimates and assumptions on an ongoing basis.
+Added: Our actual results may differ from these estimates under different assumptions or conditions.
+Added: While our significant
+Added: accounting policies are described in greater detail in Note 2 to our consolidated financial statements appearing elsewhere
+Added: in this Quarterly Report, we believe that the following accounting policies are those most critical to the judgments and estimates
+Added: used in the preparation of our consolidated financial statements.
+Added: research and development expenses
+Added: As part of the process
+Added: of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses.
+Added: This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that
+Added: have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service
+Added: when we have not yet been invoiced or otherwise notified of actual costs.
+Added: The majority of our service providers invoice us in arrears
+Added: for services performed, on a pre-determined schedule or when contractual milestones are met;
+Added: however, some require advanced payments.
+Added: We make estimates of our accrued expenses as of each balance sheet date in the consolidated financial statements based on facts
+Added: and circumstances known to us at that time.
+Added: Examples of estimated accrued research and development expenses include fees paid to:
+Added: ● CROs in connection with performing research activities and conducting preclinical studies and clinical
+Added: trials on our behalf;
+Added: ● CMOs in connection with the production of preclinical and clinical trial materials;
+Added: ● investigative sites or other service providers in connection with clinical trials;
+Added: ● vendors in connection with preclinical and clinical development activities;
+Added: ● vendors related to product manufacturing and development and distribution of preclinical and clinical
+Added: We base our expenses
+Added: related to preclinical studies and clinical trials on our estimates of the services received and efforts expended pursuant to
+Added: quotes and contracts with multiple CMOs and CROs that supply, conduct and manage preclinical studies and clinical trials on our
+Added: The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven
+Added: payment flows.
+Added: There may be instances in which payments made to our vendors will exceed the level of services provided and result
+Added: in a prepayment of the expense.
+Added: Payments under some of these contracts depend on factors such as the successful enrollment of
+Added: patients and the completion of clinical trial milestones.
+Added: In accruing service fees, we estimate the time period over which services
+Added: will be performed and the level of effort to be expended in each period.
+Added: If the actual timing of the performance of services or
+Added: the level of effort varies from the estimate, we adjust the accrual or the amount of prepaid expenses accordingly.
+Added: do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing
+Added: of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts
+Added: that are too high or too low in any particular period.
+Added: To date, there have not been any material adjustments to our prior estimates
+Added: of accrued research and development expenses.
+Added: Stock-based compensation
+Added: We measure stock-based
+Added: awards granted to employees and directors based on their fair value on the date of the grant and recognize compensation expense
+Added: for those awards over the requisite service period, which is generally the vesting period of the respective award.
+Added: We have to date
+Added: only issued stock-based awards with service-based vesting conditions and record the expense for these awards using the straight-line
+Added: The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model,
+Added: which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term
+Added: of the option, the risk-free interest rate for a period that approximates the expected term of the option, and our expected dividend
+Added: See Note 9 to our consolidated financial statements appearing elsewhere in this Quarterly Report
+Added: for more information.
+Added: Forfeitures are accounted for as they occur.
+Added: The fair value of each stock-based award is estimated on the
+Added: date of grant based on the fair value of our common stock on that same date.
+Added: Prior to the adoption
+Added: of ASC 2018-07 on April 1, 2019, for stock-based awards granted to consultants and non-employees, we recognize compensation
+Added: expense over the period during which services are rendered by such non-employees and consultants until completed.
+Added: At the end of
+Added: each financial reporting period prior to completion of the service, the fair value of these awards is remeasured using the then-current
+Added: fair value of our common stock and updated assumption inputs in the Black-Scholes option pricing model.
+Added: After the adoption
+Added: of ASC 2018-07, for stock-based awards granted to consultants and non-employees, we measure stock-based these awards based on their
+Added: fair value on the date of the grant and recognizes compensation expense for those awards over the requisite service period, which
+Added: is generally the vesting period of the respective award.
+Added: We have to date only issued stock-based awards with service-based vesting
+Added: conditions and record the expense for these awards using the straight-line method.
+Added: The fair value of each stock option grant is
+Added: estimated on the date of grant using the Black-Scholes option-pricing model, which requires inputs based on certain subjective
+Added: assumptions, including the expected stock price volatility, the expected term of the option, the risk-free interest rate for a
+Added: period that approximates the expected term of the option, and our expected dividend yield.
+Added: We classify stock-based
+Added: compensation expense in our consolidated statements of operations in the same manner in which the award recipient’s payroll
+Added: costs are classified or in which the award recipient’s service payments are classified.
+Added: Off-balance sheet arrangements
+Added: We did not have any
+Added: off-balance sheet arrangements during the periods presented, and we do not currently have any off-balance sheet arrangements,
+Added: as defined in the rules and regulations of the SEC.
+Added: Recently issued accounting pronouncements
+Added: A description of recently
+Added: issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2
+Added: to our consolidated financial statements appearing elsewhere in this Quarterly Report.
+Added: Emerging growth company status
+Added: As an “emerging
+Added: growth company,”
+Added: the Jumpstart Our Business Startups Act of 2012 permits us to take advantage of an extended transition period
+Added: to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to
+Added: private companies.
+Added: We have irrevocably elected to “opt out”
+Added: of this provision and, as a result, we will comply with
+Added: new or revised accounting standards when they are required to be adopted by public companies that are not emerging growth companies.
+Added: Quantitative and Qualitative
+Added: Disclosures about Market Risks.
+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.