Item 1. Financial Statements
ITEM 1. Financial Statements
Celcuity Inc.
Condensed Balance Sheets
June 30, 2021
December 31, 2020
(unaudited)
Assets
Current Assets:
Cash and cash equivalents
$ 41,638,623
$ 11,637,911
Deposits
22,009
22,009
Deferred transaction costs
121,307
-
Payroll tax receivable
190,000
190,000
Prepaid assets
279,544
317,040
Total current assets
42,251,483
12,166,960
Property and equipment, net
415,080
558,876
Operating lease right-of-use assets
142,766
230,911
Total Assets
$ 42,809,329
$ 12,956,747
Liabilities and Stockholders' Equity:
Current Liabilities:
Accounts payable
$ 647,172
$ 217,377
Finance lease liabilities
5,830
5,810
Operating lease liabilities
153,684
187,518
Accrued expenses
729,672
774,612
Total current liabilities
1,536,358
1,185,317
Finance lease liabilities
5,379
8,299
Operating lease liabilities
-
60,861
Note payable, non-current
14,233,068
-
Total Liabilities
15,774,805
1,254,477
Stockholders' Equity:
Preferred stock, $ 0.001 par value: 2,500,000 shares authorized; 0 shares issued and outstanding as of June 30, 2021 and December 31, 2020
-
-
Common stock, $ 0.001 par value: 25,000,000 shares authorized; 12,654,898 and 10,299,822 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively
12,655
10,300
Additional paid-in capital
70,167,970
38,013,551
Accumulated deficit
( 43,146,101 )
( 26,321,581 )
Total Stockholders' Equity
27,034,524
11,702,270
Total Liabilities and Stockholders' Equity
$ 42,809,329
$ 12,956,747
See accompanying notes to the financial statements
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Celcuity Inc.
Condensed Statements of Operations
(unaudited)
Three Months Ended June 30,
Six Months Ended June 30,
2021
2020
2021
2020
Operating expenses:
Research and development
$ 13,070,108
$ 1,766,227
$ 15,306,451
$ 3,613,641
General and administrative
573,360
447,714
1,128,787
911,113
Total operating expenses
13,643,468
2,213,941
16,435,238
4,524,754
Loss from operations
( 13,643,468 )
( 2,213,941 )
( 16,435,238 )
( 4,524,754 )
Other income (expense)
Interest expense
( 391,187 )
( 31 )
( 391,210 )
( 64 )
Interest income
1,803
11,983
2,191
75,834
Loss on sale of fixed assets
-
-
( 263 )
-
Other income (expense), net
( 389,384 )
11,952
( 389,282 )
75,770
Net loss before income taxes
( 14,032,852 )
( 2,201,989 )
( 16,824,520 )
( 4,448,984 )
Income tax benefits
-
-
-
-
Net loss
$ ( 14,032,852 )
$ ( 2,201,989 )
$ ( 16,824,520 )
$ ( 4,448,984 )
Net loss per share, basic and diluted
$ ( 1.11 )
$ ( 0.21 )
$ ( 1.42 )
$ ( 0.43 )
Weighted average common shares outstanding, basic and diluted
12,610,917
10,260,234
11,845,758
10,257,111
See accompanying notes to the financial statements
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Condensed Statements of Changes in Stockholders' Equity
Three Months and Six Months Ended June 30, 2021
Common Stock
Additional Paid-In
Accumulated
Shares
Amount
Capital
Deficit
Total
Balance at December 31, 2020
10,299,822
$ 10,300
$ 38,013,551
$ ( 26,321,581 )
$ 11,702,270
Stock-based compensation
-
-
449,098
-
449,098
Exercise of common stock warrants
1,185
1
11,256
-
11,257
Exercise of common stock options, net of shares withheld for exercise price
12,707
13
( 13 )
-
-
Issuance of common stock upon closing of follow-on offering, net of underwriting discounts and offering costs
1,971,100
1,971
25,766,522
-
25,768,493
Issuance of common stock in an at-the-market ("ATM") offering
3,082
3
38,959
-
38,962
Issuance costs associated with ATM offering
-
-
( 3,868 )
-
( 3,868 )
Net loss
-
-
-
( 2,791,668 )
( 2,791,668 )
Balance at March 31, 2021 (unaudited)
12,287,896
$ 12,288
$ 64,275,505
$ ( 29,113,249 )
$ 35,174,544
Stock-based compensation
2,964
3
540,314
-
540,317
Employee stock purchases
5,496
6
25,811
-
25,817
Exercise of common stock options, net of shares withheld for exercise price
9,136
9
36,850
-
36,859
Warrant issued - note payable
-
289,839
-
289,839
Issuance of common stock, licensing agreement
349,406
349
4,999,651
-
5,000,000
Net loss
-
-
-
( 14,032,852 )
( 14,032,852 )
Balance at June 30, 2021 (unaudited)
12,654,898
$ 12,655
$ 70,167,970
$ ( 43,146,101 )
$ 27,034,524
See accompanying notes to the financial statements
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Celcuity Inc.
Condensed Statements of Changes in Stockholders' Equity
Three Months and Six Months Ended June 30, 2020
Common Stock
Additional Paid-In
Accumulated
Shares
Amount
Capital
Deficit
Total
Balance at December 31, 2019
10,253,988
$ 10,254
$ 36,134,723
$ ( 16,847,406 )
$ 19,297,571
Stock-based compensation
-
-
464,649
-
464,649
Net loss
-
-
-
( 2,246,995 )
( 2,246,995 )
Balance at March 31, 2020 (unaudited)
10,253,988
$ 10,254
$ 36,599,372
$ ( 19,094,401 )
$ 17,515,225
Stock-based compensation
15,686
16
423,177
-
423,193
Employee stock purchases
4,678
4
23,893
-
23,897
Issuance of common stock in an at-the-market ("ATM") offering
14,901
15
154,127
-
154,142
Issuance costs associated with ATM offering
-
-
( 52,110 )
-
( 52,110 )
Net loss
-
-
-
( 2,201,989 )
( 2,201,989 )
Balance at June 30, 2020 (unaudited)
10,289,253
$ 10,289
$ 37,148,459
$ ( 21,296,390 )
$ 15,862,358
See accompanying notes to the financial statements
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Celcuity Inc.
Condensed Statements of Cash Flows
(unaudited)
Six Months Ended June 30,
2021
2020
Cash flows from operating activities:
Net loss
$ ( 16,824,520 )
$ ( 4,448,984 )
Adjustments to reconcile net loss to net cash used for operations:
Depreciation
176,597
191,134
Stock-based compensation
989,415
887,842
Issuance of common stock, licensing agreement
5,000,000
-
Amortization of debt issuance costs and discount
81,571
-
PIK interest
93,397
-
Loss on sale of fixed assets
263
-
Changes in operating assets and liabilities:
Prepaid assets and deposits
37,496
41,952
Accounts payable
438,018
( 59,025 )
Accrued expenses
( 124,940 )
26,189
Non-cash operating lease, net
( 6,550 )
( 28,754 )
Net cash used for operating activities
( 10,139,253 )
( 3,389,646 )
Cash flows from investing activities:
Purchases of property and equipment
( 57,897 )
( 66,589 )
Proceeds from sale of property and equipment
500
-
Net cash used for investing activities
( 57,397 )
( 66,589 )
Cash flows from financing activities:
Proceeds from exercise of common stock warrants
11,257
-
Proceeds from exercise of employee stock options
36,859
-
Proceeds from employee stock purchases
25,817
23,897
Proceeds from follow-on offering, net of underwriting discounts and offering costs
25,768,493
-
Proceeds from note payable, net of debt issuance costs and discount of $652,061
14,347,939
-
Gross proceeds from an ATM offering
38,962
154,142
Payments for secondary registration statement costs
( 29,065 )
( 23,367 )
Payments for finance leases
( 2,900 )
( 2,880 )
Net cash provided by financing activities
40,197,362
151,792
Net change in cash and cash equivalents
30,000,712
( 3,304,443 )
Cash and cash equivalents:
Beginning of period
11,637,911
18,735,002
End of period
41,638,623
$ 15,430,559
Supplemental disclosures of non-cash investing and financing activities:
Offering and registration statement costs included in accounts payable and accrued expenses
$ 96,111
$ -
Issuance of common stock warrants and final fee recognized as discount to note payable
$ 964,839
$ -
See accompanying notes to the financial statements
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CELCUITY INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited)
(For the Three and Six Months Ended June 30, 2021 and 2020)
1. Organization
Nature of Business
Celcuity Inc., a Delaware corporation (the “Company”), is a clinical-stage biotechnology company seeking to extend the lives of cancer patients by pursuing an integrated companion diagnostic (CDx) and therapeutic (Rx) strategy. Our CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from targeted therapies. This enables a CELsignia CDx to support advancement of new indications for already approved targeted therapies. Our therapeutic efforts are focused on in-licensing and developing molecularly targeted therapies that address the same cancer driver our companion diagnostics can identify. By pursuing an integrated companion diagnostic and therapeutic strategy, we believe we are uniquely positioned to achieve our goal of helping cancer patients receive the therapeutic best suited to treat their cancer driver. The Company was co-founded in 2012 by Brian F. Sullivan and Dr. Lance G. Laing and is based in Minnesota. The Company has not generated any revenues to date.
Follow-on Offering
On July 1, 2021, the Company completed a follow-on offering whereby it sold 2,250,000 shares of common stock at a public offering price of $ 25.00 per share. The aggregate gross proceeds from the sale of shares in the follow-on offering was approximately $ 56.3 million before deducting underwriting discounts of approximately $ 3.4 million and offering expenses of approximately $ 0.1 million.
2. Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements
Basis of Presentation
The accompanying unaudited financial statements include the accounts of the Company and have been prepared in accordance with Article 10 of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”). Accordingly, as permitted by Article 10, the unaudited financial statements do not include all of the information required by accounting principles generally accepted in the United States (“U.S. GAAP”). The balance sheet at December 31, 2020 was derived from the audited financial statements at that date and does not include all the disclosures required by U.S. GAAP. In the opinion of management, all adjustments which are of a normal recurring nature and necessary for a fair presentation have been reflected in the financial statements. These unaudited condensed financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2020 and the related footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. Operating results for the three and six months ended June 30, 2021 are not necessarily indicative of the results to be expected during the remainder of the current year or for any future period.
Accounting Estimates
Management uses estimates and assumptions in preparing these unaudited condensed financial statements in accordance with U.S. GAAP. Those estimates and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported revenues and expenses. Actual results could differ from those estimates and the difference could be material. Significant items subject to such estimates and assumptions include the valuation of stock-based compensation and prepaid or accrued clinical trial costs.
Risks and Uncertainties
The Company is subject to risks common to companies in the development stage including, but not limited to, dependency on the clinical and commercial success of its diagnostic tests, ability to obtain regulatory approval of its diagnostic tests, the clinical and commercial success of its initial drug product, gedatolisib, the need for substantial additional financing to achieve its goals, uncertainty of broad adoption of its approved products, if any, by physicians and consumers, and significant competition.
Clinical Trial Costs
The Company records prepaid assets or accrued expenses for prepaid or estimated clinical trial costs conducted by third-party service providers, which includes the conduct of preclinical studies and clinical trials. These costs can be a significant component of the Company’s research and development expenses. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with service agreements with its third-party service providers. The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its prepaid assets or accrued expenses. The Company has not experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed, number of patients enrolled, and the rate of patient enrollments may vary from the Company’s estimates, resulting in an adjustment to expense in future periods. Changes in these estimates that result in material changes to the Company’s prepaid assets or accrued expenses could materially affect the Company’s results of operations.
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Application of New or Revised Accounting Standards
Pursuant to the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), a company constituting an “emerging growth company” is, among other things, entitled to rely upon certain reduced reporting requirements. The Company is an emerging growth company but has irrevocably elected not to take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. As a result, the Company will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for public companies that are not emerging growth companies.
Recently Adopted Accounting Pronouncements
In August 2020, the FASB issued ASU No. 2020-06, Debt - Debt with Conversion and other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity ("ASU 2020-06"), which simplifies accounting for convertible instruments by removing major separation models required under current U.S. GAAP. ASU 2020-06 removes certain settlement conditions that are required for equity contracts to qualify for derivative scope exceptions and also simplifies the diluted earnings per share calculation in certain areas. The standard is effective for public business entities, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years and interim periods within those fiscal years beginning after December 15, 2021. For all other entities, the standard will be effective for fiscal years beginning after December 15, 2023. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, and adoption must be as of the beginning of the Company’s annual fiscal year. The Company’s early adoption of this accounting standard on April 8, 2021, in conjunction with the closing of a loan agreement, did not have an impact on the Company’s financial statements and related disclosures.
3. Net Loss Per Common Share
Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average common shares outstanding during the period. For all periods presented, the common shares underlying the options and warrants have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted-average shares outstanding used to calculate both basic and diluted loss per common share are the same.
For the three and six months ended June 30, 2021 and 2020, potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding were options to purchase 1,023,513 and 723,194 shares of common stock, respectively, warrants to purchase 378,442 and 353,585 shares of common stock, respectively, and 2,964 and 15,686 shares of restricted common stock, respectively.
4. Commitments
Operating and Finance Leases
The Company leases its corporate space in Minneapolis, Minnesota. In September 2017, the Company entered into a non-cancelable operating lease agreement for building space. The new lease commenced, and the Company moved to the facility in May 2018, in conjunction with the termination of its then existing lease. Rent expense is recorded on a straight-line basis over the lease term. In July 2020 the Company signed an amendment to extend this lease through April 30, 2022. The lease amendment provides for monthly rent, real estate taxes and operating expenses. As a result of the lease amendment, the Company recorded an incremental $ 197,211 in the operating right-of-use (“ROU”) asset and lease liability.
The lease agreement, as amended, includes the option to extend the term for one additional year. The option to extend is at the Company’s discretion and because the Company has not determined if the option to extend will be exercised, the extended lease term is not included in the ROU assets and lease liabilities. The Company regularly evaluates the renewal options and when it is reasonably certain of exercise, the Company will include the renewal period in its lease term.
In May 2018, the Company entered into a non-cancelable finance lease agreement for office equipment with a five-year term. The underlying assets are included in furniture and equipment. The lease contains a bargain purchase option at the end of the lease.
When an implicit rate is not provided, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of the lease payments.
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Supplemental balance sheet information consisted of the following at June 30, 2021:
Operating Lease
Right-of-use assets
$ 142,766
Operating lease liability
$ 153,684
Less: short term portion
( 153,684 )
Long term portion
$ -
Finance Lease
Furniture and equipment
$ 28,932
Less: Accumulated depreciation
( 17,841 )
Net book value of property and equipment under finance lease
$ 11,091
Finance lease liability
$ 11,209
Less: short term portion
( 5,830 )
Long term portion
$ 5,379
Maturity analysis under lease agreements consisted of the following as of June 30, 2021:
Operating Leases
Finance Leases
2021
$ 97,411
$ 3,627
2022
64,940
7,255
2023
-
3,023
Total minimum lease payments
162,351
13,905
Less: Present value discount
( 8,667 )
( 78 )
Less amount representing services
-
( 2,618 )
Present value of net minimum lease payments
$ 153,684
$ 11,209
Weighted Average
Remaining Lease Term
Discount Rate
Operating lease
0.8 years
4.0 %
Finance lease
1.9 years
1.0 %
Lease costs for the period ended June 30, 2021:
Three-month Period
Six-month Period
Operating lease cost
$ 43,727
$ 89,157
Finance lease cost:
Amortization
1,447
2,893
Interest
21
45
Variable lease cost
19,869
39,738
$ 65,064
$ 131,833
Supplemental cash flow information related to leases for the period ended June 30, 2021:
Three-month Period
Six-month Period
Cash paid for amounts included in operating and finance leases:
Operating cash outflow from operating leases
$ 66,872
$ 135,446
Operating cash outflow from finance leases
21
45
Financing cash outflow from finance leases
1,451
2,900
$ 68,344
$ 138,391
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Clinical Research Studies
The Company enters into contracts in the normal course of business for clinical trials, preclinical studies, manufacturing and other services and products for operating purposes. The Company currently has five Phase II clinical trial agreements in place to evaluate targeted therapies selected with one of our CELsignia tests. The Company also has a license agreement in place with Pfizer to research, develop, manufacture and commercialize gedatolisib. Timing of milestone payments are uncertain and the contracts generally provide for termination following a certain period after notice, therefore the Company believes that non-cancelable obligations under the agreements are not material.
5. Stockholders’ Equity
On February 26, 2021, the Company completed a follow-on offering whereby it sold 1,971,100 shares of common stock (including 257,100 shares of common stock in connection with the full exercise of the underwriters’ option to purchase additional shares) at a public offering price of $ 14.00 per share. The aggregate gross proceeds from the sale of shares in the follow-on offering, including the sale of shares pursuant to the full exercise of the underwriters’ option to purchase additional shares, was approximately $ 27.6 million before deducting underwriting discounts of approximately $ 1.6 million and offering expenses of approximately $ 0.2 million.
On June 5, 2020, the Company entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with B. Riley FBR, Inc. (the “Agent”). Pursuant to the ATM Agreement, the Company was able to offer and sell from time to time, at its option, shares of common stock having an aggregate offering price of up to $ 10,000,000 , par value $0.001 per share (the “Placement Shares”), through the Agent.
The Placement Shares were registered under the Securities Act of 1933, as amended, pursuant to the Registration Statement on Form S-3 (File No. 333-227466), which was originally filed with the SEC on September 21, 2018 and declared effective by the SEC on October 4, 2018, the base prospectus contained within the Registration Statement, and a prospectus supplement that was filed on June 5, 2020. Sales of the Company’s common stock, if any, under this prospectus supplement were able to be made by any method deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.
During the six months ended June 30, 2021, the Company sold 3,082 shares of common stock pursuant to the ATM Agreement, at an average selling price of $ 12.64 per share.
On February 23, 2021, in conjunction with the Company’s follow-on offering, the ATM Agreement was terminated.
6. Stock-Based Compensation
The following table summarizes the activity for all stock options outstanding for the six months ended June 30:
2021
2020
Shares
Weighted Average Exercise Price
Shares
Weighted Average Exercise Price
Options outstanding at beginning of year
849,949
$ 9.33
585,215
$ 14.37
Granted
218,050
24.70
151,231
7.14
Exercised
( 39,620 )
7.32
-
-
Forfeited
( 4,866 )
7.67
( 13,252 )
11.54
Balance at June 30
1,023,513
$ 12.69
723,194
$ 9.71
Options exercisable at June 30:
504,189
$ 9.64
305,778
$ 9.68
Weighted Average Grant Date Fair Value for options granted during the period:
$ 16.39
$ 4.55
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The following table summarizes additional information about stock options outstanding and exercisable at June 30, 2021:
Options Outstanding
Options Exercisable
Options Outstanding
Weighted Average Remaining Contractual Life
Weighted Average Exercise Price
Aggregate Intrinsic Value
Options Exercisable
Weighted Average Exercise Price
Aggregate Intrinsic Value
1,023,513
7.99
$ 12.69
$ 12,101,685
504,189
$ 9.64
$ 7,271,109
The Company recognized stock-based compensation expense for stock options of $ 520,361 and $ 414,272 for the three months ended June 30, 2021 and 2020, respectively and $ 938,553 and $ 864,937 for the six months ended June 30, 2021 and 2020, respectively. In May 2020, the Company modified the exercise price on 203,750 stock option awards to $5.10, the closing market price on the Nasdaq Capital Market on May 14, 2020. No director or officer awards were modified. The effect on stock-based compensation was $ 12,790 and $ 51,000 for the three months ended June 30, 2021 and 2020, respectively and $ 26,239 and $ 51,000 for the six months ended June 30, 2021 and 2020. The effect on stock-based compensation over the remaining service period will be approximately $ 109,000 .
The Black-Scholes option-pricing model was used to estimate the fair value of equity-based awards with the following weighted-average assumptions for the six months ended June 30:
2021
2020
Risk-free interest rate
0.63 % - 1.14 %
0.35 % - 1.66 %
Expected volatility
76.6 % - 76.9 %
73.3 % - 74.4 %
Expected life (years)
5.0 to 6.08
5.5 to 6.12
Expected dividend yield
0 %
0 %
The inputs for the Black-Scholes valuation model require management’s significant assumptions. Prior to the Company’s initial public offering, the price per share of common stock was determined by the Company’s board based on recent prices of common stock sold in private offerings. Subsequent to the initial public offering, the price per share of common stock is determined by using the closing market price on the Nasdaq Capital Market on the grant date. The risk-free interest rates are based on the rate for U.S. Treasury securities at the date of grant with maturity dates approximately equal to the expected life at the grant date. The expected life is based on the simplified method in accordance with the SEC Staff Accounting Bulletin Nos. 107 and 110. The expected volatility is estimated based on historical volatility information of peer companies that are publicly available in combination with the Company’s calculated volatility since being publicly traded.
All assumptions used to calculate the grant date fair value of non-employee options are generally consistent with the assumptions used for options granted to employees. In the event the Company terminates any of its consulting agreements, the unvested options issued in connection with the agreements would also be cancelled.
Restricted stock awards were granted to two members of the Company’s board during the three months ended June 30, 2021 and 2020. The Company had 2,964 and 15,686 shares of restricted stock outstanding as of June 30, 2021 and 2020, respectively, and 15,686 and 0 shares of restricted stock vested during the three months ended June 30, 2021 and 2020. The Company recognized stock-based compensation expense for restricted stock of $ 18,112 and $ 10,912 for the three months ended June 30, 2021 and 2020, respectively and $ 38,567 and $ 10,912 for the six months ended June 30, 2021 and 2020.
The Company initially reserved a maximum of 750,000 shares of common stock for issuance under the 2017 Amended and Restated Stock Incentive Plan (the “2017 Plan”). The number of shares reserved for issuance was automatically increased by 102,540 shares on January 1, 2020 and by 102,998 shares on January 1, 2021 and will increase automatically on January 1 of each of 2022 through 2027 by the number of shares equal to 1.0% of the aggregate number of outstanding shares of Company common stock as of the immediately preceding December 31. At the Annual Meeting held on May 12, 2021, the stockholders approved a one-time, 500,000 increase to the number of shares reserved for issuance under the 2017 Plan. However, the Company’s board may reduce the amount of the increase in any particular year. The total remaining shares available for grant under the Company’s 2017 Plan as of June 30, 2021 was 585,772 .
Total unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized as follows:
2021
$ 1,247,486
2022
2,034,829
2023
1,476,348
2024
979,053
2025
246,916
Total estimated compensation cost to be recognized
$ 5,984,632
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The Company recognized stock-based compensation expense related to its employee stock purchase plan of $ 1,844 and ($ 1,991 ) for the three months ended June 30, 2021 and 2020, respectively and $ 12,295 and $ 11,993 for the six months ended June 30, 2021 and 2020, respectively. The Company initially reserved a total of 100,000 shares for issuance under the employee stock purchase plan.The number of shares reserved for issuance was automatically increased by 51,270 shares on January 1, 2020 and 51,499 shares on January 1, 2021 and will increase automatically on each subsequent January 1 by the number of shares equal to 0.5% of the total outstanding number of shares of Company common stock as of the immediately preceding December 31. However, the Company’s board may reduce the amount of the increase in any particular year. The total remaining shares available for issuance under the employee stock purchase plan as of June 30,2021 was 158,214 .
The Company recognized total stock-based compensation expense as follows for the three and six months ended June 30:
Three Months Ended
Six Months Ended
2021
2020
2021
2020
Stock-based compensation expense in operating expenses:
Research and development
$ 328,077
$ 265,446
$ 583,258
$ 558,562
General and administrative
212,240
157,747
406,157
329,280
Total
$ 540,317
$ 423,193
$ 989,415
$ 887,842
7. Debt
On April 8, 2021, the Company entered into a loan and security agreement (the “Loan Agreement”) with Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership (“Innovatus”) in its capacity as Collateral Agent and sole Lender.The Lender agreed to loan up to $ 25 million in three tranches consisting of (i) a $ 15.0 million non-contingent term A loan that was funded on April 8, 2021, (ii) a $ 5 million term B loan to be funded upon request of the Company no later than March 31, 2022, and (iii) a $ 5 million term C loan to be funded upon request of the Company no later than March 31, 2023 (collectively the “Term Loans”). Funding of the term B and C loan is subject to the Company’s ability to achieve certain milestones. The Innovatus Loan Agreement is secured by a lien covering substantially all assets of the Company.
The loan agreement also contains certain events of default, warranties and covenants of the Company. In connection with each funding of the Term Loans, the Company is required to issue Innovatus a warrant (the “Warrants”) to purchase a number of shares of the Company’s stock equal to 2.5% of the principal amount of the relevant Term Loan funded divided by the exercise price, which will be based on the lower of (i) $ 14.40 per share or (ii) the volume weighted price per share of the Company’s stock for the five-trading day period ending on the last trading day immediately preceding the funding date of the Term B or Term C Loan, as applicable. The warrants may be exercised on a cashless basis and are immediately exercisable through the tenth anniversary of the applicable funding date. In connection with the first tranche of the Term Loans, the Company issued a warrant to Innovatus to purchase 26,042 shares of the Company’s common stock at an exercise price of $14.40 per share. The Company evaluated the warrant under ASC470, debt, and recognized an additional debt discount of approximately $ 0.3 million based on the relative fair value of the base instruments and warrants. The Company calculated the fair value of the warrant using the Black-Scholes model. The Company is also required to maintain a minimum cash balance in agreement with the term loans’ default terms.
The Company is entitled to make interest-only payments for thirty-six months, or up to forty-eight months if certain conditions are met. The Term Loans will mature on the fifth anniversary of the initial funding date and will bear interest at a rate equal to sum of (a) the greater of (i)Prime Rate (as defined in the loan agreement) or (ii) 3.25%, plus (b) 5.70%. The effective interest rate is 11.36% . Additionally, the Company elected to make 2.7% of the interest rate as payable in kind, which shall accrue as principal monthly. The Company is obligated to pay the Lender (i) a non-refundable facility fee in the amount of 1.00% of each term loan that is funded (the “Facility Fee”), and (ii) a final fee equal to 4.50% of the aggregate amount of the term loans funded (the “Final Fee”). In connection with the funding of the first tranche of the Term Loans, a final fee of approximately $ 0.7 million was recorded as additional principal and as a debt discount, and a facility fee of approximately $ 0.1 million was recorded as additional debt discount. The Company has the option to prepay the loan at any time following the first anniversary of the loan closing, with tiered prepayment fees ranging from 0 – 2% based on when the prepayment would occur.
Innovatus also has the right, at its election, after June 1, 2021 and until the third anniversary of the Loan Agreement, to convert up to 20% of the outstanding principal amount of all Terms Loans made under the Loan Agreement into shares of the Company’s common stock at a price per share equal to the volume weighted average closing price of the Company’s stock for the 5-trading day period ending on the last trading day immediately preceding the execution of the Loan Agreement (the “Conversion Right”).
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In connection with the loan agreement and the funding of the first tranche of the Term Loans, the Company incurred debt issuance costs of approximately $ 0.5 million. The debt issuance costs, and the debt discount are amortized to interest expense using the effective interest method over the life of the Term Loans. The carrying value of the debt approximates fair value as of June 30, 2021.
Long-term debt consisted of the following:
June 30, 2021
Note payable
$ 15,000,000
Add: PIK interest (added to principal)
93,397
Add: final fee
675,000
Less: unamortized debt issuance costs
( 466,482 )
Less: unamortized debt discount
( 1,068,847 )
Total long-term debt
$ 14,233,068
Future principal payments, including the final fee, are as follows:
Years Ending
December 31,
2024
$ 5,660,024
2025
7,546,698
2026
2,561,675
Total
$ 15,768,397
8. License Agreement
On April 8 th , the Company entered into a license agreement with Pfizer to research, develop, manufacture and commercialize gedatolisib, a potent, well-tolerated, reversible dual inhibitor that targets PI3K and mTOR, for the treatment, diagnosis and prevention of all diseases. The Company paid Pfizer $ 5.0 million in upfront fees and issued to Pfizer $ 5.0 million of shares of the Company’s common stock pursuant to an Equity Grant Agreement. The upfront payment and the issuance of shares were expensed to research & development in full for the three months ending June 30, 2021.
The Company is also required to make milestone payments to Pfizer upon achievement of certain development and commercial milestone events, up to an aggregate of $ 335.0 million. Additionally, the Company will pay Pfizer tiered royalties on sales of gedatolisib at percentages ranging from the low to mid-teens, which may be subject to deductions for expiration of valid claims, amounts due under third-party licenses and generic competition. Unless earlier terminated, the License Agreement will expire upon the expiration of all royalty obligations. The royalty period will expire on a country-by-country basis upon the later of (a) 12 years following the date of first commercial sale of such product in such country, (b) the expiration of all regulatory or data exclusivity in such country for such product or (c) the date upon which the manufacture, use, sale, offer for sale or importation of such product in such country would no longer infringe, but for the license granted in the License Agreement, a valid claim of a licensed patent right.
The Company has the right to terminate the License Agreement for convenience upon 90 days’ prior written notice. Pfizer may not terminate the agreement for convenience. Either the Company or Pfizer may terminate the License Agreement if the other party is in material breach and such breach is not cured within the specified cure period. In addition, either the Company or Pfizer may terminate the License Agreement in the event of specified insolvency events involving the other party.
9. Subsequent Events
As noted in footnote 2, on July 1, 2021, the Company completed a follow-on offering whereby it sold 2,250,000 shares of common stock at a public offering price of $ 25.00 per share.
On July 19, 2021, the Company signed an amendment to exercise the option to extend the lease for a period of one year. The commencement of the extended period is May 1, 2022 and will terminate on April 30, 2023.
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