1 unchanged sentence
INMUNE BIO, INC.
−Removed: CONDENSED CONSOLIDATED BALANCE
+Added: CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
+Added: September 30,
CURRENT ASSETS
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INMUNE BIO, INC.
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF
−Removed: OPERATIONS AND COMPREHENSIVE LOSS
+Added: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
+Added: AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
For the Three
+Added: September 30,
+Added: September 30,
OPERATING EXPENSES
7 unchanged sentences
COMPREHENSIVE LOSS
−Removed: Other comprehensive income (loss) - foreign currency translation
+Added: Other comprehensive loss - foreign currency translation
Total comprehensive loss
2 unchanged sentences
INMUNE BIO, INC.
−Removed: CONDENSED CONSOLIDATED STATEMENT OF
−Removed: CHANGES IN STOCKHOLDERS’ EQUITY
−Removed: FOR THE SIX MONTHS ENDED JUNE 30, 2021
+Added: CONDENSED CONSOLIDATED STATEMENT OF CHANGES
+Added: IN STOCKHOLDERS’ EQUITY
+Added: FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2021
(In thousands, except share amounts)
1 unchanged sentence
Stockholders’
+Added: Income (Loss)
Balance as of December 31, 2020
9 unchanged sentences
Balance as of June 30, 2021
+Added: Issuance of common stock for cash
+Added: Cashless exercise of warrants
+Added: Exercise of stock options
+Added: Stock-based compensation
+Added: Loss on foreign currency translation
+Added: Balance as of September 30, 2021
The accompanying
notes are an integral part of these unaudited condensed consolidated financial statements.
−Removed: CONDENSED CONSOLIDATED STATEMENT OF
−Removed: CHANGES IN STOCKHOLDERS’ EQUITY
−Removed: FOR THE SIX MONTHS ENDED JUNE 30, 2020
+Added: CONDENSED CONSOLIDATED STATEMENT OF CHANGES
+Added: IN STOCKHOLDERS’ EQUITY
+Added: FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2020
(In thousands, except share amounts)
1 unchanged sentence
Stockholders’
+Added: Income (Loss)
Balance as of December 31, 2019
9 unchanged sentences
Balance at June 30, 2020
+Added: Issuance of common stock for cash, net
+Added: Cashless exercise of warrants
+Added: Stock-based compensation
+Added: Loss on foreign currency translation
+Added: Balance as of September 30, 2020
The accompanying notes are an integral part of
1 unchanged sentence
INMUNE BIO, INC.
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF CASH
+Added: CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
+Added: September 30,
CASH FLOWS FROM OPERATING ACTIVITIES:
14 unchanged sentences
CASH FLOWS FROM INVESTING ACTIVITIES:
−Removed: paid to Xencor to settle warrant for acquired research and development intangible assets
+Added: Cash paid to Xencor to settle warrant for acquired research and development intangible assets
Net cash used in investing activities
2 unchanged sentences
Net proceeds from sale of common stock
+Added: Net proceeds from exercise of stock options
Net proceeds from the exercise of warrants
2 unchanged sentences
Impact on cash from foreign currency translation
−Removed: NET INCREASE (DECREASE) IN CASH
+Added: NET INCREASE IN CASH
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
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INMUNE BIO, INC.
−Removed: NOTES TO THE UNAUDITED CONDENSED
−Removed: CONSOLIDATED FINANCIAL STATEMENTS
+Added: NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED
+Added: FINANCIAL STATEMENTS
NOTE 1 – ORGANIZATION AND
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many diseases.
−Removed: DN-TNF is currently being developed for COVID-19 complications (Quellor), cancer (INB03), Alzheimer’s and treatment
−Removed: resistant depression (XPro595), and NASH (LIVNate).
−Removed: The Natural Killer Cell Priming Platform includes INKmune aimed at priming the patient’s
−Removed: NK cells to eliminate minimal residual disease in patients with cancer.
−Removed: INmune Bio’s product platforms utilize a precision medicine
−Removed: approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation.
+Added: DN-TNF is currently being developed for Alzheimer’s and treatment resistant depression (XPro595) and cancer (INB03).
+Added: The Natural Killer Cell Priming Platform includes INKmune aimed at priming the patient’s NK cells to eliminate minimal residual
+Added: disease in patients with cancer.
+Added: INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide
+Added: variety of hematologic malignancies, solid tumors and chronic inflammation.
NOTE 2 – LIQUIDITY
−Removed: As of June 30, 2021, the Company had an accumulated
+Added: As of September 30, 2021, the Company had an accumulated
deficit of approximately $ 54.0 million and experienced losses since its inception.
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Company has taken the following steps to capitalize the business and achieve its business plan:
−Removed: ● During July 2021, the Company completed a
−Removed: registered direct public offering in which it sold 1,818,182 shares of common stock to investors for estimated net proceeds of $ 36.9
+Added: ● During July 2021, the Company completed a registered direct public offering in which it sold 1,818,182 shares of common stock to investors for estimated net proceeds of $ 36.9 million.
● During June 2021, the Company entered into a loan and security agreement and drew down a $ 15.0 million term loan.
1 unchanged sentence
The Company is required to pay BTIG a commission of 3 % of the gross proceeds from the sale of shares.
−Removed: During July 2021, the Company sold 713,192 shares of its common stock at an average price of $ 21.73 through the 2021 ATM for net proceeds of $ 15.0 million.
−Removed: ● During July 2020, the Company completed an underwritten public offering in which it sold 2,500,000 shares of common stock at a public offering price of $ 10.00 per share.
−Removed: Aggregate net proceeds from the underwritten public offering were approximately $ 23.1 million, net of $ 1.9 million in underwriting discounts and commissions and offering expenses.
+Added: The Company has sold 713,192 shares of its common stock at an average price of $ 21.73 through the 2021 ATM for net proceeds of $ 14.9 million.
● During April 2020, the Company entered into a sales agreement with BTIG, as sales agent, to establish an ATM offering program to sell up to $ 10.0 million of the Company’s common stock (the “2020 ATM”).
1 unchanged sentence
From April 2020 through December 2020, the Company sold 178,600 shares of common stock at an average price of $ 5.45 per share for net proceeds of approximately $ 0.8 million.
−Removed: During the six months ended June 30, 2021, the Company sold in aggregate 1,439,480 shares on common stock at an average price of $ 20.17 per share for net proceeds of $ 28.4 million.
−Removed: As of June 30, 2021, sales of our common stock pursuant to the 2020 ATM have been completed.
+Added: During the nine months ended September 30, 2021, the Company sold in aggregate 1,439,480 shares on common stock at an average price of $ 20.17 per share for net proceeds of $ 28.4 million.
+Added: As of September 30, 2021, sales of our common stock pursuant to the 2020 ATM have been completed.
Although it is difficult to predict the Company’s
−Removed: liquidity requirements, as of June 30, 2021, and based upon the Company’s current operating plan, the Company believes that it will
−Removed: have sufficient cash to meet its projected operating requirements for at least the next 12 months following the filing date of this Quarterly
−Removed: Report on Form 10-Q based on the balance of cash available as of June 30, 2021.
−Removed: The Company anticipates that it will continue to incur
−Removed: net losses for the foreseeable future as it continues the development of its clinical drug candidates and preclinical programs and incurs
−Removed: additional costs associated with being a public company.
+Added: liquidity requirements, as of September 30, 2021, and based upon the Company’s current operating plan, the Company believes that
+Added: it will have sufficient cash to meet its projected operating requirements for at least the next 12 months following the filing date of
+Added: this Quarterly Report on Form 10-Q based on the balance of cash available as of September 30, 2021.
+Added: The Company anticipates that it will
+Added: continue to incur net losses for the foreseeable future as it continues the development of its clinical drug candidates and preclinical
+Added: programs and incurs additional costs associated with being a public company.
NOTE 3 – SUMMARY OF SIGNIFICANT
87 unchanged sentences
basic and diluted shares outstanding due to the Company’s net loss position.
−Removed: At June 30, 2021 and 2020, the Company had potentially
−Removed: issuable shares as follows:
+Added: At September 30, 2021 and 2020, the Company had
+Added: potentially issuable shares as follows:
+Added: September 30,
Stock options
56 unchanged sentences
Subsequent Events
−Removed: evaluates events that have occurred after the balance sheet date of June 30, 2021, through the date which the financial statements are
+Added: evaluates events that have occurred after the balance sheet date of September 30, 2021, through the date which the financial statements
NOTE 4 – RESEARCH AND DEVELOPMENT
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$ 833,000 , respectively.
−Removed: During the six months ended June 30, 2021 and 2020, the Company received $ 0 of R&D tax credit reimbursements
−Removed: The Company expects to receive R&D tax credit reimbursements during the second half of 2021.
+Added: During the nine months ended September 30, 2021 and 2020, the Company received $ 0 of R&D tax credit reimbursements
+Added: The UK subsidiary expects to receive R&D tax credit reimbursements during the fourth quarter of 2021.
According to AUS tax law, the Company is allowed
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The Company’s Australian subsidiary submits R&D tax credit requests annually for research and development expenses incurred.
−Removed: At June 30, 2021 and December 31, 2020, the Company recorded a research and development tax credit receivable of $ 1,281,000 and $ 853,000 ,
+Added: At September 30, 2021 and December 31, 2020, the Company recorded a research and development tax credit receivable of $ 2,016,000 and $ 853,000 ,
respectively, for R&D expenses incurred in Australia.
−Removed: During the six months ended June 30, 2021 and 2020, the Company received $ 0
−Removed: R&D tax credit reimbursements from Australia.
−Removed: The Company expects to receive R&D tax credit reimbursements during the second half of 2021.
+Added: During the nine months ended September 30, 2021 and 2020, the Company received
+Added: $ 0 and $ 0.2 million, respectively, of R&D tax credit reimbursements from Australia.
+Added: The Australian subsidiary received an R&D
+Added: tax reimbursement of approximately $ 1.3 million during October 2021.
License Agreement
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on the market price of the common stock as of June 10, 2021, which the Company issued in June 2021.
−Removed: The Company agreed to file a registration
−Removed: statement covering the resale of these shares on or before the earlier to occur of September 8, 2021, or the date on which the Company
−Removed: next files a registration statement (other than a registration statement on Form S-8 or any statement on Form S-3 previously filed) and
−Removed: to keep the registration statement continuously effective until all such shares cease to be outstanding or otherwise cease to be registrable
−Removed: securities as defined in the Option Cancellation Agreement.
−Removed: The Company charged the cash consideration paid to Xencor to enter into the
−Removed: Option Cancellation Agreement to equity as the fair value of the warrant immediately prior to the Option Cancellation Agreement was greater
−Removed: than the consideration paid to Xencor.
+Added: The Company filed a registration statement
+Added: covering the resale of these shares during September 2021 and agreed to keep the registration statement continuously effective until all
+Added: such shares cease to be outstanding or otherwise cease to be registrable securities as defined in the Option Cancellation Agreement.
+Added: Company charged the cash consideration paid to Xencor to enter into the Option Cancellation Agreement to equity as the fair value of the
+Added: warrant immediately prior to the Option Cancellation Agreement was greater than the consideration paid to Xencor.
INKmune License Agreement
4 unchanged sentences
In consideration for the patent rights, the Company
−Removed: agreed to the following milestone payments (of which none were met as of June 30, 2021):
+Added: agreed to the following milestone payments:
(in thousands)
4 unchanged sentences
Each NDA/EMA awarded
+Added: During July 2021, the Company initiated a Phase
+Added: I clinical trial using INKmune and the Company paid Immune Ventures a $ 25,000 milestone payment.
In addition, the Company agreed to pay Immune
3 unchanged sentences
are the owners of Immune Ventures.
−Removed: As of June 30, 2021, no sales had occurred under this license.
+Added: As of September 30, 2021, no sales had occurred under this license.
The term of the agreement began on October 29,
10 unchanged sentences
to achieve the following milestones:
−Removed: Initiation of Phase 1 clinical or equivalent trials
−Removed: by October 29, 2021
Initiation of Phase II clinical trials or equivalent
9 unchanged sentences
of written notice by Immune Ventures, then Immune Ventures may provide notice to terminate the license or convert it to a non-exclusive
−Removed: During July 2021, the Company initiated a Phase
−Removed: I clinical trial using INKmune and the Company paid Immune Ventures a $ 25,000 milestone payment.
University of Pittsburg License Agreement
21 unchanged sentences
The Company had no amounts owed pursuant to the
−Removed: PITT Agreement as of June 30, 2021.
+Added: PITT Agreement as of September 30, 2021.
The PITT Agreement expires upon the earlier of:
15 unchanged sentences
methodology of GMP grade human umbilical cord mesenchymal stem/stromal cells (“MSC”).
−Removed: In exchange for the license agreement, the Company
−Removed: paid UCLB an initial license fee of $10,000 and shall pay annual licensing fees of approximately $13,000 per year for the remaining term
−Removed: of the agreement.
−Removed: The Company will pay UCLB a royalty of 3-3.5% of the net sales value (as defined in the agreement) of all licensed
−Removed: products sold or used by the Company.
−Removed: In the event the Company sub-licenses the technology and know-how, the Company will pay UCLB a royalty
−Removed: of twelve (12) percent of consideration (cash or non-cash) received by the Company in relation to the development or sub-licensing of
−Removed: any of the technology and know-how.
−Removed: On July 15, 2021, the Company notified UCLB of its intent to terminate
−Removed: the license agreement.
+Added: During July 2021, the Company terminated
+Added: its license agreement with UCLB.
NOTE 5 – LEASE
9 unchanged sentences
Variable lease costs for the Company’s lease consists of operating expenses for the spaces.
−Removed: Below is a summary
−Removed: of the Company’s right-of-use assets and liabilities as of June 30, 2021:
+Added: In September 2021, the Company signed a lease
+Added: for office space in Boca Raton, Florida.
+Added: Below is a summary of the Company’s right-of-use
+Added: assets and liabilities as of September 30, 2021:
(in thousands, except years and rate)
6 unchanged sentences
NOTE 6 – RELATED PARTY TRANSACTIONS
−Removed: At June 30, 2021 and December 31, 2020, the Company
−Removed: owed UCL Consultants Limited (“UCL”) $ 9,000 and $ 34,000 , respectively, in connection with medical research performed on behalf
−Removed: of the Company.
−Removed: At June 30, 2021 and December 31, 2020, the Company recorded prepaid expenses of $ 15,000 and $ 0 , respectively, for medical
−Removed: research to be performed on behalf of the Company by UCL.
−Removed: During the six months ended June 30, 2021 and 2020, the Company paid UCL $ 132,000
−Removed: and $ 0 , respectively, for medical research performed on behalf of the Company.
−Removed: UCL is a wholly owned subsidiary of the University of London.
+Added: At September 30, 2021 and December 31, 2020, the
+Added: Company owed UCL Consultants Limited (“UCL”) $ 10,000 and $ 34,000 , respectively, in connection with medical research performed
+Added: on behalf of the Company.
+Added: At September 30, 2021 and December 31, 2020, the Company recorded prepaid expenses of $ 14,000 and $ 0 , respectively,
+Added: for medical research to be performed on behalf of the Company by UCL.
+Added: During the nine months ended September 30, 2021 and 2020, the Company
+Added: paid UCL $ 176,000 and $ 335,000 , respectively, for medical research performed on behalf of the Company.
+Added: UCL is a wholly owned subsidiary
+Added: of the University of London.
The Company’s Chief Scientific and Manufacturing Officer is a professor at the University of London.
−Removed: During the six months ended June 30, 2021 and
−Removed: 2020, the Company paid CTI $ 0 and $ 127,000 , respectively, for medical research performed on behalf of the Company.
−Removed: During the six months
−Removed: ended June 30, 2020, the Company recorded a capital contribution of $ 216,000 for the forgiveness of certain accounts payable due to CTI.
−Removed: The Company had no amounts payable to CTI as of June 30, 2021 and December 31, 2020.
+Added: During the nine months ended September 30, 2021
+Added: and 2020, the Company paid CTI $ 0 and $ 127,000 , respectively, for medical research performed on behalf of the Company.
+Added: During the nine
+Added: months ended September 30, 2020, the Company recorded a capital contribution of $ 216,000 for the forgiveness of certain accounts payable
+Added: The Company had no amounts payable to CTI as of September 30, 2021 and December 31, 2020.
NOTE 7 – DEBT
−Removed: On June 10, 2021, the Company entered into a
−Removed: Loan and Security Agreement (the “Term Loan”) with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P., together
−Removed: (the “Lenders”).
−Removed: The Term Loan provides for a $ 15.0 million term loan, of which the Company borrowed the entire
−Removed: amount on June 10, 2021, and is secured by the Company’s assets.
−Removed: The Term Loan also provides for the Company to request an
−Removed: additional $ 5.0 million term loan from the Lenders, which may be granted or denied at the sole discretion of the Lenders.
+Added: On June 10, 2021, the Company entered into a Loan
+Added: and Security Agreement (the “Term Loan”) with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P., together (the
+Added: The Term Loan provides for a $ 15.0 million term loan, of which the Company borrowed the entire amount
+Added: on June 10, 2021, and is secured by the Company’s assets.
+Added: The Term Loan also provides for the Company to request an additional
+Added: $ 5.0 million term loan from the Lenders, which may be granted or denied at the sole discretion of the Lenders.
The Company paid the Lenders $ 47,000 to access
−Removed: the term loan, which has been included as a component of the debt discount and is amortized to interest expense over the term of the
−Removed: The term loan and debt discount are as follows as of June 30, 2021:
+Added: the term loan, which has been included as a component of the debt discount and is amortized to interest expense over the term of the loan.
+Added: The term loan and debt discount are as follows as of September 30, 2021:
(in thousands)
2 unchanged sentences
Long-term debt
−Removed: three and six months ended June 30, 2021 the Company recognized interest expense of $ 0.1 million related to the Term Loan.
−Removed: The term loan repayment schedule provides for
−Removed: interest only payments beginning on July 1, 2021, and continuing for 12 months, followed by 30 consecutive equal monthly installments
−Removed: of principal, plus monthly payments of accrued interest, starting on July 1, 2022 and continuing through the maturity date of January
−Removed: The interest-only period may be extended for one year upon the achievement of an equity
−Removed: milestone as fully defined in the Term Loan .
−Removed: All outstanding principal and accrued and unpaid interest will be due and payable
−Removed: on the maturity date.
−Removed: The Term Loan provides for an annual interest rate equal to the greater of (i) the prime rate then in effect
−Removed: as reported in The Wall Street Journal plus 4.50 % and (ii) 7.75 %.
−Removed: At June 30, 2021, the interest rate was 7.75 %.
+Added: three and nine months ended September 30, 2021 the Company recognized interest expense of $ 0.4 million and $ 0.5 million, respectively,
+Added: related to the Term Loan.
+Added: The term loan repayment schedule provided for
+Added: interest only payments beginning on July 1, 2021, and continuing for 12 months, followed by monthly principal and interest payments,
+Added: starting on July 1, 2022 and continuing through the maturity date of January 1, 2025.
+Added: During August, the Lenders extended the interest-only
+Added: period for one year due to the Company achieving an equity milestone as fully defined in the Term Loan .
+Added: As a result of achieving
+Added: the equity milestone, monthly principal and interest payments begin on July 1, 2023.
+Added: All outstanding principal and accrued and unpaid
+Added: interest will be due and payable on the maturity date.
+Added: The Term Loan provides for an annual interest rate equal to the greater of
+Added: (i) the prime rate then in effect as reported in The Wall Street Journal plus 4.50 % and (ii) 7.75 %.
+Added: At September 30, 2021, the
+Added: interest rate was 7.75 %.
The Term Loan includes a final payment fee equal
4 unchanged sentences
of the original principal amount borrowed for any prepayment after the second anniversary of the loan but before the maturity date.
−Removed: expected repayment of the $ 15.0 million Term loan principal is as follows as of June 30, 2021:
+Added: repayment of the $ 15.0 million Term loan principal is as follows as of September 30, 2021:
(in thousands, except years)
−Removed: occurrence of certain events, including but not limited to the Company’s failure to satisfy its payment obligations under the Term
+Added: Upon the occurrence of certain events, including but not limited to the Company’s failure to satisfy its payment obligations under the Term
Loan, the breach of certain of its other covenants under the Term Loan, or the occurrence of a material adverse change, the Lenders will
1 unchanged sentence
the final payment fee and, if the payment of principal and interest is due prior to maturity, the applicable prepayment fee.
−Removed: Term Loan, the Company agreed to issue the Lenders warrants to purchase shares of its common stock.
−Removed: On June 10, 2021, upon the draw of
−Removed: the term loan, the Company issued to the Lenders warrants to purchase in aggregate 45,386 shares of common stock at a per share exercise
−Removed: price of $ 14.05 .
−Removed: The warrants were immediately exercisable upon issuance, and other than in connection with certain mergers or acquisitions,
−Removed: will expire on the ten-year anniversary of the date of issuance.
−Removed: The fair value of the warrants was estimated at $ 0.6 million
−Removed: using a Black-Scholes model and assuming:
−Removed: (i) expected volatility of 103 % based on the trading history of similar companies ,
−Removed: (ii) discount rate of 1.45 % based on the applicable US Treasury bill rate , (iii) an expected
−Removed: life of 10 years and (iv) zero expected dividends.
−Removed: The fair value of the warrants was included as a discount to
−Removed: the term loan and also as a component of additional paid-in capital at June 30, 2021.
−Removed: NOTE 8 – STOCKHOLDERS’
+Added: NOTE 8 – STOCKHOLDERS’ EQUITY
On May 15, 2019, the Company entered into both
3 unchanged sentences
the 24-month period that commenced on May 15, 2019.
−Removed: During the six months ended June 30, 2020, the Company issued 196,000 shares of its
−Removed: common stock to Lincoln Park for approximately $ 1.0 million of cash.
+Added: During the nine months ended September 30, 2020, the Company issued 196,000 shares
+Added: of its common stock to Lincoln Park for approximately $ 1.0 million of cash.
During April 2021, the Company terminated the
3 unchanged sentences
cancelled 220,000 shares of its common stock from a shareholder in exchange for approximately $ 1.0 million of cash.
+Added: Underwritten Stock Offering
+Added: During July 2020, the Company completed an underwritten
+Added: public offering in which it sold 2,500,000 shares of common stock at a public offering price of $ 10.00 per share.
+Added: The 2,500,000 shares
+Added: sold included the full exercise of the underwriters’ option to purchase 326,086 shares at a price of $ 10.00 per share.
+Added: net proceeds from the underwritten public offering were $ 23.1 million, net of $ 1.9 million in underwriting discounts and commissions and
+Added: offering expenses.
Common Stock – At the Market Offering
−Removed: During the six months ended June 30, 2020, we
−Removed: issued and sold 150,682 shares of common stock at an average price of $ 5.44 per share under the 2020 ATM program.
−Removed: The aggregate net proceeds
−Removed: were approximately $ 0.7 million after BTIG’s commission and other offering expenses.
−Removed: During the six months ended June 30, 2021, the
−Removed: Company sold 1,439,480 shares of its common stock at an average price of $ 20.17 per share under the 2020 ATM program.
+Added: During the nine months ended September 30, 2020,
+Added: we issued and sold 178,600 shares of common stock at an average price of $ 5.45 per share under the 2020 ATM program.
The aggregate net
proceeds were approximately $ 0.8 million after BTIG’s commission and other offering expenses.
+Added: During the nine months ended September 30, 2021,
+Added: the Company sold 1,439,480 shares of its common stock at an average price of $ 20.17 per share under the 2020 ATM program.
+Added: The aggregate
+Added: net proceeds were approximately $ 28.4 million after BTIG’s commission and other offering expenses.
+Added: During the nine months ended September 30, 2021,
+Added: the Company sold 713,192 shares of its common stock at an average price of $ 21.73 per share under the 2021 ATM program.
+Added: The aggregate
+Added: net proceeds were approximately $ 14.9 million after BTIG’s commission and other offering expenses.
+Added: Registered Direct Offering
+Added: During July 2021, the Company completed a registered
+Added: direct offering whereby the Company sold 1,818,182 shares of its common stock to investors for net proceeds of $ 36.9 million.
+Added: Common Stock Issued for Services
+Added: During July 2020, the Company granted a consultant
+Added: 50,000 fully vested warrants with a 5 -year term, of which 25,000 warrants had an exercise price of $ 5.50 per share and 25,000 warrants
+Added: had an exercise price of $ 10.00 per share.
+Added: The fair value of these warrants was $ 356,874 based on the Black-Scholes Option Pricing Model
+Added: and was recorded within general and administrative expense.
+Added: The assumptions used for these warrants consist of the exercise prices, expected
+Added: dividends of 0 %, expected volatility of 111.67 % based on the trading history of similar companies, risk-free rate of 0.30 % based on the
+Added: applicable US Treasury bill rate and an expected life of 5.0 years.
+Added: During July 2020, the Company issued the consultant 20,000 shares
+Added: of common stock and cancelled the 50,000 warrants.
+Added: The 20,000 shares were issued from the Company’s 2019 Incentive Stock Plan and
+Added: had a fair value of approximately $ 230,000 based on the market value of the Company’s common stock on the grant date.
+Added: accounted for the exchange of the warrants for shares of common stock as a modification and recorded no additional expense in connection
+Added: with the exchange as the fair value of warrants exceeded the fair value of the shares issued.
Issuance of shares to Xencor
18 unchanged sentences
expected dividends.
+Added: During July, August and September 2021,
+Added: the Company granted certain employees and consultants options to purchase in aggregate 373,000 shares of its common stock pursuant to
+Added: the 2021 Incentive Stock Plan.
+Added: The stock options have a fair value of approximately $ 6.3 million that was calculated using the Black-Scholes
+Added: option-pricing model.
+Added: Variables used in the Black-Scholes option-pricing model include:
+Added: (1) discount rate of 0.96 % - 1.31 % based on the
+Added: applicable US Treasury bill rate (2) expected life of 6.0 – 10.0 years, (3) expected volatility of approximately 105 % - 109 % based
+Added: on the trading history of similar companies, and (4) zero expected dividends.
The following
−Removed: table summarizes stock option activity during the six months ended June 30, 2021:
+Added: table summarizes stock option activity during the nine months ended September 30, 2021:
(in thousands, except share and per share amounts)
3 unchanged sentences
Options cancelled
−Removed: Outstanding at June 30, 2021
−Removed: Exercisable at June 30, 2021
−Removed: During the six months ended June 30, 2021 and
−Removed: 2020, the Company recognized stock-based compensation expense of approximately $ 1.7 million and $ 1.4 million, respectively, related to
−Removed: the vesting of stock options.
−Removed: As of June 30, 2021, there was approximately $ 9.9 million of total unrecognized compensation cost related
−Removed: to non-vested stock options which is expected to be recognized over a weighted-average period of 2.87 years.
−Removed: The Company issued 45,386 warrants to the Company’s lenders upon
−Removed: obtaining its loan in June 2021.
+Added: Outstanding at September 30, 2021
+Added: Exercisable at September 30, 2021
+Added: During the nine months ended September 30, 2021
+Added: and 2020, the Company recognized stock-based compensation expense of approximately $ 3.3 million and $ 2.1 million, respectively, related
+Added: to the vesting of stock options.
+Added: As of September 30, 2021, there was approximately $ 14.6 million of total unrecognized compensation cost
+Added: related to non-vested stock options which is expected to be recognized over a weighted-average period of 2.73 years.
+Added: The Company issued 45,386 warrants
+Added: to the Company’s lenders upon obtaining its loan in June 2021.
The warrants have a 10-year term and an exercise price of $ 14.05 .
−Removed: The warrants have a fair value of approximately
−Removed: $ 0.6 million that was calculated using the Black-Scholes option-pricing model.
−Removed: Variables used in the Black-Scholes option-pricing model
−Removed: (1) discount rate of 1.45 % based on the applicable US Treasury bill rate (2) expected life of 10.0 years, (3) expected volatility
−Removed: of approximately 103 % based on the trading history of similar companies, and (4) zero expected dividends.
−Removed: At June 30, 2021, the intrinsic
−Removed: value of these warrants is $ 160,000 .
+Added: The warrants have a fair value of approximately $ 0.6 million that was calculated using the Black-Scholes option-pricing model.
+Added: used in the Black-Scholes option-pricing model include:
+Added: (1) discount rate of 1.45 % based on the applicable US Treasury bill rate (2)
+Added: expected life of 10.0 years, (3) expected volatility of approximately 103 % based on the trading history of similar companies, and (4)
+Added: zero expected dividends.
+Added: At September 30, 2021, the intrinsic value of these warrants is $ 244,000 .
In connection with the Company’s initial
1 unchanged sentence
an exercise price of $ 9.60 per common share, which warrants are exercisable until December 19, 2023.
−Removed: At June 30, 2021, 34,835 of these
−Removed: warrants are outstanding and the intrinsic value is $ 278,000 .
+Added: During the nine months ended September
+Added: 30, 2021, 6,147 of these warrants were exercised on a cashless basis in exchange for 3,758 shares of common stock.
+Added: At September 30, 2021,
+Added: 28,688 of these warrants are outstanding and the intrinsic value is $ 282,000 .
On June 30, 2017, the Company issued fully vested
1 unchanged sentence
The warrants have a $ 1.50 exercise price and expire on June 30, 2022 .
−Removed: During the six months ended June 30, 2021, 11,875 of these
−Removed: warrants were exercised for cash proceeds of $ 18,000 .
−Removed: At June 30, 2021, 19,792 of these warrants are outstanding, with an intrinsic value
−Removed: of $ 318,000 .
+Added: During the nine months ended September 30, 2021, 11,875 of
+Added: these warrants were exercised for cash proceeds of $ 18,000 .
+Added: At September 30, 2021, 19,792 of these warrants are outstanding, with an intrinsic
+Added: value of $ 355,000 .
Stock-based Compensation by Class of Expense
The following summarizes the components of stock-based
−Removed: compensation expense in the consolidated statements of operations for the three and six months ended June 30, 2021 and 2020 respectively:
+Added: compensation expense in the consolidated statements of operations for the three and nine months ended September 30, 2021 and 2020
+Added: respectively:
(in thousands)
−Removed: Three Months Ended
−Removed: Three Months Ended
+Added: September 30,
+Added: September 30,
+Added: September 30,
+Added: September 30,
Research and development
16 unchanged sentences
in vitro and to fund a study of the efficacy of XPro1595 to protect against ALS model phenotypes in vivo.
−Removed: During the six months ended
−Removed: June 30, 2021 and 2020, the Company received $ 0.1 million and $ 0.3 million, respectively, of cash proceeds pursuant to this grant which
−Removed: the Company recorded as deferred liabilities.
+Added: During the nine months ended
+Added: September 30, 2021 and 2020, the Company received $ 0.1 million and $ 0.3 million, respectively, of cash proceeds pursuant to this grant
+Added: which the Company recorded as deferred liabilities.
The Company offsets costs incurred related to this research against the grants.
−Removed: 30, 2021 and December 31, 2020, the Company recorded approximately $ 0.2 million and $ 0.1 million, respectively, as deferred liabilities
−Removed: in the consolidated balance sheet related to the ALS grant.
+Added: of September 30, 2021 and December 31, 2020, the Company recorded approximately $ 0.2 million and $ 0.1 million, respectively, as deferred
+Added: liabilities in the consolidated balance sheet related to the ALS grant.
During September 2020, the Company was awarded
2 unchanged sentences
in patients with treatment resistant depression.
−Removed: As of June 30, 2021, the Company has not received any proceeds pursuant to this grant.
+Added: As of September 30, 2021, the Company has not received any proceeds pursuant to this
NOTE 10 – COMMITMENTS AND CONTINGENCIES
4 unchanged sentences
The lessor is CTI.
+Added: During September 2021,
+Added: the Company signed a lease agreement with a third party for office space in Boca Raton, Florida.
+Added: The lease agreement has a 64 -month term
+Added: and will commence during the fourth quarter of 2021.
Future minimum payments pursuant
−Removed: to the lease are as follows:
+Added: to the leases are as follows:
(in thousands, except years)
−Removed: During the three and six months ended June 30,
+Added: During the three and nine months ended September
30, 2021, the Company recognized $ 19,000 and $ 45,000 , respectively, in operating lease expense, which is included in general and administrative
expenses in the Company’s consolidated statement of operations.
−Removed: The Company is subject to claims and suits that arise from time to
−Removed: time in the ordinary course of our business.
−Removed: Although management currently believes that resolving claims against the Company, individually
−Removed: or in aggregate, will not have a material adverse impact in the Company’s consolidated financial statements, these matters are subject
−Removed: to inherent uncertainties and management’s view of these matters may change in the future.
−Removed: NOTE 11 – SUBSEQUENT EVENTS
−Removed: During July 2021, the Company sold 713,192 shares
−Removed: of its common stock through 2021 ATM program for net proceeds of $ 15.0 million.
−Removed: During July 2021, the Company sold 1,818,182 shares
−Removed: of its common stock to investors through a registered direct offering for estimated net proceeds of $ 36.9 million.
−Removed: During July 2021, the Company awarded 333,000
−Removed: stock options to employees with a 3 -year vesting term and an estimated fair value of $ 5.6 million.
−Removed: Variables used in the Black-Scholes
−Removed: option-pricing model include:
−Removed: (1) discount rate of 1.04 -1.19% based on the applicable US Treasury bill rate (2) expected life of 6.0 years,
−Removed: (3) expected volatility of approximately 108 % based on the trading history of similar companies, and (4) zero expected dividends.
−Removed: During July 2021, certain employees of the Company
−Removed: exercised 45,000 stock options in exchange for approximately $ 176,000 of cash proceeds.
+Added: The Company is subject to claims and suits that
+Added: arise from time to time in the ordinary course of our business.
+Added: Although management currently believes that resolving claims against the
+Added: Company, individually or in aggregate, will not have a material adverse impact in the Company’s consolidated financial statements,
+Added: these matters are subject to inherent uncertainties and management’s view of these matters may change in the future.
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.