Celcuity (CELC) 10-Q 10 May 21 2020 Q1 Quarterly report Financial data

Cover

Cover - shares	3 Months Ended
	Mar. 31, 2021	May 03, 2021
Cover [Abstract]
Entity Registrant Name	CELCUITY INC.
Entity Central Index Key	0001603454
Document Type	10-Q
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Small Business	true
Entity Shell Company	false
Entity Emerging Growth Company	true
Entity Current Reporting Status	Yes
Document Period End Date	Mar. 31, 2021
Entity Filer Category	Non-accelerated Filer
Document Fiscal Period Focus	Q1
Document Fiscal Year Focus	2020
Entity Ex Transition Period	true
Entity Common Stock Shares Outstanding		12,647,037
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	001-38207
Entity Incorporation State Country Code	DE
Entity Tax Identification Number	82-2863566
Entity Address Address Line 1	16305 36th Avenue North;
Entity Address Address Line 2	Suite 100
Entity Address City Or Town	Minneapolis
Entity Address State Or Province	MN
Entity Address Postal Zip Code	55446
City Area Code	763
Local Phone Number	392-0767
Security 12b Title	Common Stock, $0.001 par value per share
Trading Symbol	CELC
Security Exchange Name	NASDAQ
Entity Interactive Data Current	Yes

Condensed Balance Sheets

Condensed Balance Sheets - USD ($)	Mar. 31, 2021	Dec. 31, 2020
Current Assets:
Cash and cash equivalents	$ 34,936,902	$ 11,637,911
Deposits	22,009	22,009
Deferred transaction costs	13,719	0
Payroll tax receivable	190,000	190,000
Prepaid assets	551,345	317,040
Total current assets	35,713,975	12,166,960
Property and equipment, net	466,484	558,876
Operating lease right-of-use assets	186,602	230,911
Total Assets	36,367,061	12,956,747
Current Liabilities:
Accounts payable	318,213	217,377
Finance lease liabilities	5,819	5,810
Operating lease liabilities	185,656	187,518
Accrued expenses	660,849	774,612
Total current liabilities	1,170,537	1,185,317
Finance lease liabilities	6,841	8,299
Operating lease liabilities	15,139	60,861
Total Liabilities	1,192,517	1,254,477
Stockholders' Equity:
Preferred stock, $0.001 par value: 2,500,000 shares authorized; 0 shares issued and outstanding as of March 31, 2021 and December 31, 2020	0	0
Common stock, $0.001 par value: 25,000,000 shares authorized; 12,287,896 and 10,299,822 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively	12,288	10,300
Additional paid-in capital	64,275,505	38,013,551
Accumulated deficit	(29,113,249)	(26,321,581)
Total Stockholders' Equity	35,174,544	11,702,270
Total Liabilities and Stockholders' Equity	$ 36,367,061	$ 12,956,747

Condensed Balance Sheets (Paren

Condensed Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 2021	Dec. 31, 2020
Condensed Balance Sheets
Preferred stock, par or stated value per share	$ 0.001	$ 0.001
Preferred stock, shares authorized	2,500,000	2,500,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par or stated value per share	$ 0.001	$ 0.001
Common stock, shares authorized	25,000,000	25,000,000
Common stock, shares issued	12,287,896	10,299,822
Common stock, shares outstanding	12,287,896	10,299,822

Condensed Statements of Operati

Condensed Statements of Operations (unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Operating expenses:
Research and development	$ 2,236,342	$ 1,847,414
General and administrative	555,428	463,399
Total operating expenses	2,791,770	2,310,813
Loss from operations	(2,791,770)	(2,310,813)
Other income (expense)
Interest expense	(24)	(33)
Interest income	388	63,851
Loss on sale of fixed assets	(263)	0
Other income, net	101	63,818
Net loss before income taxes	(2,791,668)	(2,246,995)
Income tax benefits	0	0
Net loss	$ (2,791,668)	$ (2,246,995)
Net loss per share, basic and diluted	$ (0.25)	$ (0.22)
Weighted average common shares outstanding, basic and diluted	11,072,097	10,253,988

Condensed Statements of Changes

Condensed Statements of Changes in Stockholders' Equity - USD ($)	Total	Common Stock	Additional Paid-In Capital	Retained Earnings (Accumulated Deficit)
Balance, shares at Dec. 31, 2019		10,253,988
Balance, amount at Dec. 31, 2019	$ 19,297,571	$ 10,254	$ 36,134,723	$ (16,847,406)
Stock-based compensation	464,649	0	464,649	0
Net loss	(2,246,995)	$ 0	0	(2,246,995)
Balance, shares at Mar. 31, 2020		10,253,988
Balance, amount at Mar. 31, 2020	17,515,225	$ 10,254	36,599,372	(19,094,401)
Balance, shares at Dec. 31, 2020		10,299,822
Balance, amount at Dec. 31, 2020	11,702,270	$ 10,300	38,013,551	(26,321,581)
Stock-based compensation	449,098	0	449,098	0
Net loss	(2,791,668)	$ 0	0	(2,791,668)
Exercise of common stock warrants, shares		1,185
Exercise of common stock warrants, amount	11,257	$ 1	11,256	0
Exercise of common stock options, net of shares withheld for exercise price, shares		12,707
Exercise of common stock options, net of shares withheld for exercise price, amount	0	$ 13	(13)	0
Issuance of common stock upon closing of follow-on offering, net of underwriting discounts and offering costs, shares		1,971,100
Issuance of common stock upon closing of follow-on offering, net of underwriting discounts and offering costs, amount	25,768,493	$ 1,971	25,766,522	0
Issuance of common stock in an at-the-market ("ATM") offering, shares		3,082
Issuance of common stock in an at-the-market ("ATM") offering, amount	38,962	$ 3	38,959	0
Issuance costs associated with ATM offering	(3,868)	$ 0	(3,868)	0
Balance, shares at Mar. 31, 2021		12,287,896
Balance, amount at Mar. 31, 2021	$ 35,174,544	$ 12,288	$ 64,275,505	$ (29,113,249)

Condensed Statements of Cash Fl

Condensed Statements of Cash Flows (unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Cash flows from operating activities:
Net loss	$ (2,791,668)	$ (2,246,995)
Adjustments to reconcile net loss to net cash used for operations:
Depreciation	98,222	94,792
Stock-based compensation	449,098	464,649
Loss on sale of fixed assets	263	0
Changes in operating assets and liabilities:
Prepaid assets and deposits	(234,305)	(62,651)
Accounts payable	73,924	(92,197)
Accrued expenses	(113,763)	30,143
Non-cash operating lease, net	(3,276)	(21,342)
Net cash used for operating activities	(2,521,505)	(1,833,601)
Cash flows from investing activities:
Purchases of property and equipment	(30,925)	(45,604)
Proceeds from sale of property and equipment	500	0
Net cash used for investing activities	(30,425)	(45,604)
Cash flows from financing activities:
Proceeds from exercise of common stock warrants	11,257	0
Proceeds from follow-on offering, net of underwriting discounts and offering costs	25,814,167	0
Gross proceeds from an ATM offering	38,962	0
Payments for secondary registration statement costs	(12,016)	0
Payments for finance leases	(1,449)	(1,438)
Net cash provided by (used for) financing activities	25,850,921	(1,438)
Net change in cash and cash equivalents	23,298,991	(1,880,643)
Cash and cash equivalents:
Beginning of period	11,637,911	18,735,002
End of period	34,936,902	16,854,359
Supplemental disclosures of non-cash investing and financing activities:
Property and equipment included in accounts payable	0	14,101
Offering and registration statement costs included in accounts payable	$ 51,245	$ 6,127

Organization

Organization	3 Months Ended
	Mar. 31, 2021
Organization
Note 1. Organization	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.

Summary of Significant Accounti

Summary of Significant Accounting Policies	3 Months Ended
	Mar. 31, 2021
Summary of Significant Accounting Policies
Note 2. Summary of Significant Accounting Policies	2. Summary of Significant Accounting Policies 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 months ended March 31, 2021 are not necessarily indicative of the results to be expected during the remainder of the current year or for any future period. Follow-on Offering 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. 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. 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.

Net Loss Per Common Share

Net Loss Per Common Share	3 Months Ended
	Mar. 31, 2021
Net Loss Per Common Share
Note 3. Net Loss Per Common Share	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 months ended March 31, 2021 and 2020, potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding were options to purchase 855,072 and 630,889 shares of common stock, respectively, warrants to purchase 352,400 and 353,585 shares of common stock, respectively, and 15,686 and 0 shares of restricted common stock, respectively.

Commitments

Commitments	3 Months Ended
	Mar. 31, 2021
Commitments
Note 4. Commitments	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. Supplemental balance sheet information consisted of the following at March 31, 2021: Operating Lease Right-of-use assets $ 186,602 Operating lease liability $ 200,795 Less: short term portion (185,656 ) Long term portion $ 15,139 Finance Lease Furniture and equipment $ 28,932 Less: Accumulated depreciation (16,395 ) Net book value of property and equipment under finance lease $ 12,537 Finance lease liability $ 12,660 Less: short term portion (5,819 ) Long term portion $ 6,841 Maturity analysis under lease agreements consisted of the following as of March 31, 2021: Operating Leases Finance Leases 2021 $ 146,116 $ 5,441 2022 64,940 7,255 2023 - 3,023 Total minimum lease payments 211,056 15,719 Less: Present value discount (10,261 ) (99 ) Less: Amount representing services - (2,960 ) Present value of net minimum lease payments $ 200,795 $ 12,660 Weighted Average Remaining Lease Term Discount Rate Operating lease 1.1 years 4.0 % Finance lease 2.1 years 1.0 % Lease costs for the period ended March 31, 2021: Three-month Period Operating lease cost $ 45,430 Finance lease cost: Amortization 1,447 Interest 24 Variable lease cost 19,869 $ 66,770 Supplemental cash flow information related to leases for the period ended March 31, 2021: Three-month Period Cash paid for amounts included in operating and finance leases: Operating cash outflow from operating leases $ 68,574 Operating cash outflow from finance leases 24 Financing cash outflow from finance leases 1,449 $ 70,047 Clinical Research Studies In May 2017, the Company entered into an agreement with a clinical research organization to conduct a clinical research study. The Company made payments of approximately $275,000 and $100,000 in 2021 and 2020, respectively, and $600,000 prior to 2020. Additional payments will be due as certain milestones are met and clinical sites are added. The maximum amount of these additional payments is estimated to be approximately $2,340,000 over the course of the agreement. In October 2018, the Company entered into an agreement with a biopharmaceutical company and a cancer research center to conduct a clinical research study. The Company made payments of approximately $70,000 prior to 2020. Additional payments of approximately $112,000 will be due as certain milestones are met. In December 2020, the Company entered into an agreement with a biopharmaceutical company and a cancer research center to conduct a clinical research study. The Company made zero payments in 2021 and 2020. Future payments of approximately $740,000 will be due as certain milestones are met. In January 2021, the Company entered into an agreement with a biopharmaceutical company and a cancer research center to conduct a clinical research study. The Company made zero payments in 2021. Future payments of approximately $1,210,600 will be due as certain milestones are met. In March 2021, the Company entered into an agreement with two biopharmaceutical companies and a cancer research center to conduct a clinical research study. The Company made zero payments in 2021. Future payments of approximately $1,548,000 will be due as certain milestones are met.

Stockholders' Equity

Stockholders' Equity	3 Months Ended
	Mar. 31, 2021
Stockholders' Equity
Note 5. Stockholders' Equity	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 three months ended March 31, 2021, the Company sold 3,082 shares of common stock pursuant to the ATM Agreement, at an average selling price of $12.64per share. On February 23, 2021, in conjunction with the Company’s follow-on offering, the ATM Agreement was terminated.

Stock-Based Compensation

Stock-Based Compensation	3 Months Ended
	Mar. 31, 2021
Stock-Based Compensation
Note 6. Stock-Based Compensation	6. Stock-Based Compensation The following table summarizes the activity for all stock options outstanding for the three months ended March 31: 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 38,391 15.20 57,500 10.17 Exercised 29,997 8.00 - - Forfeited (3,271 ) 7.62 (11,826 ) 10.60 Balance at March 31 855,072 $ 9.65 630,889 $ 14.06 Options exercisable at March 31: 406,332 $ 10.37 274,267 $ 9.65 Weighted Average Grant Date Fair Value for options granted during the period: $ 10.07 $ 6.59 The following table summarizes additional information about stock options outstanding and exercisable at March 31, 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 855,072 7.81 $ 9.65 $ 5,179,019 406,332 $ 10.37 $ 2,325,179 The Company recognized stock-based compensation expense for stock options of $418,192 and $450,664 for the three months ended March 31, 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 $13,449 and $0 for the three months ended March 31, 2021 and 2020, respectively. The effect on stock-based compensation over the remaining service period will be approximately $122,000. 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 three months ended March 31: 2021 2020 Risk-free interest rate 0.63% - 1.12 % 1.35% - 1.66 % Expected volatility 76.6 % 73.3 % Expected life (years) 5.0 to 6.07 5.5 to 6.1 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. No restricted stock awards were granted during the three months ended March 31, 2021 and 2020. The Company had 15,686 and 0 shares of restricted stock outstanding as of March 31, 2021 and 2020, respectively, and 0 shares of restricted stock vested during the three months ended March 31, 2021 or 2020. The Company recognized stock-based compensation expense for restricted stock of $20,456 and $0 for the three months ended March 31, 2021 and 2020, respectively. 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. 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 March 31, 2021 was 266,800. Total unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized as follows: 2021 $ 1,032,220 2022 1,147,153 2023 789,853 2024 291,273 2025 11,616 Total estimated compensation cost to be recognized $ 3,272,115 The Company recognized stock-based compensation expense related to its employee stock purchase plan of $10,450 and $13,985 for the three months ended March 31, 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 March 31, 2021 was 163,710. The Company recognized total stock-based compensation expense as follows for the three months ended March 31: Three Months Ended 2021 2020 Stock-based compensation expense in operating expenses: Research and development $ 255,181 $ 293,116 General and administrative 193,917 171,533 Total $ 449,098 $ 464,649

Subsequent Events

Subsequent Events	3 Months Ended
	Mar. 31, 2021
Subsequent Events
Note 7. Subsequent events	7. Subsequent Events On April 8, 2021, the Company entered into a license agreement (the “License Agreement”) with Pfizer, Inc. (“Pfizer”), pursuant to which the Company acquired exclusive (including as to Pfizer) worldwide sublicensable rights 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. Pursuant to the License Agreement, the Company is obligated to use commercially reasonable efforts to develop and seek regulatory approval for at least one product in the United States and if regulatory approval is obtained, to commercialize such product in the United States and at least one international major market. The Company paid Pfizer a $5.0 million upfront fee upon execution of the License Agreement and, pursuant to an Equity Grant Agreement, issued to Pfizer $5.0 million of shares of the Company’s common stock. The number of shares issued was 349,406 and was calculated by dividing $5.0 million by $14.31, the closing price of a share of the Company’s common stock on the Nasdaq Capital Market on April 8, 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 $330.0 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. Also, 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”), as collateral agent and the Lenders listed on Schedule 1.1 thereto, pursuant to which Innovatus, as a Lender, has agreed to make certain term loans to the Company in the aggregate principal amount of up to $25.0 million (the “Term Loans”). Funding of the first $15.0 million tranche occurred on April 8, 2021. The Company will be eligible to draw on a second tranche of $5.0 million upon achievement of certain milestones, including meeting the primary end points of either the FACT-1 or FACT-2 clinical trials and receipt of unrestricted net cash proceeds of at least $50.0 million from the issuance and sale of the Company’s equity securities. The Company will be eligible to draw on a third tranche of $5.0 million upon the achievement of certain additional milestones, including commencement of certain Phase 3 clinical trials and the receipt of unrestricted net cash proceeds of at least $75.0 million from the issuance and sale of the Company’s equity securities. Innovatus 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”). 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%. Additionally, the Company elected to make 2.7% of the interest rate as payable in-kind, which shall accrue as principal monthly. Other fees include a 1.0% facility fee on the funded loan amount, paid at closing and a final fee of 4.5% of the funded loan amount due at the maturity date or earlier if the Company prepays the loan. 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. The Loan Agreement is secured by all assets of the Company. Proceeds will be used for working capital purposes and to fund the Company’s general business requirements. The Loan Agreement contains customary representations and warranties and covenants, subject to customary carve outs, and includes financial covenants related to liquidity and trailing twelve months revenue. In connection with each funding of the Term Loans, the Company is required to issue to Innovatus a warrant (the “Warrants”) to purchase a number of shares of the Company’s common 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) 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 or (ii) the closing price on the last trading day immediately preceding the execution of the Loan Agreement. For the second and third tranches only the exercise price will be based on the lower of (i) the exercise price for the first tranche or (ii) 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 relevant Term Loan funding. The Warrants may be exercised on a cashless basis and are exercisable through the 10 th

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)	3 Months Ended
	Mar. 31, 2021
Summary of Significant Accounting Policies
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 months ended March 31, 2021 are not necessarily indicative of the results to be expected during the remainder of the current year or for any future period.
Follow-on Offering	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.
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.
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.

Commitments (Tables)

Commitments (Tables)	3 Months Ended
	Mar. 31, 2021
Commitments
Schedule of supplemental balance sheet information related to leases	Supplemental balance sheet information consisted of the following at March 31, 2021: Operating Lease Right-of-use assets $ 186,602 Operating lease liability $ 200,795 Less: short term portion (185,656 ) Long term portion $ 15,139 Finance Lease Furniture and equipment $ 28,932 Less: Accumulated depreciation (16,395 ) Net book value of property and equipment under finance lease $ 12,537 Finance lease liability $ 12,660 Less: short term portion (5,819 ) Long term portion $ 6,841
Schedule of maturity analysis under lease agreements	Operating Leases Finance Leases 2021 $ 146,116 $ 5,441 2022 64,940 7,255 2023 - 3,023 Total minimum lease payments 211,056 15,719 Less: Present value discount (10,261 ) (99 ) Less: Amount representing services - (2,960 ) Present value of net minimum lease payments $ 200,795 $ 12,660
Schedule of weighted average discount rate	Weighted Average Remaining Lease Term Discount Rate Operating lease 1.1 years 4.0 % Finance lease 2.1 years 1.0 %
Schedule of lease costs for the period	Three-month Period Operating lease cost $ 45,430 Finance lease cost: Amortization 1,447 Interest 24 Variable lease cost 19,869 $ 66,770
Schedule of supplemental cash flow information related to leases	Supplemental cash flow information related to leases for the period ended March 31, 2021: Three-month Period Cash paid for amounts included in operating and finance leases: Operating cash outflow from operating leases $ 68,574 Operating cash outflow from finance leases 24 Financing cash outflow from finance leases 1,449 $ 70,047

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	3 Months Ended
	Mar. 31, 2021
Stock-Based Compensation
Schedule of activity for all stock options outstanding	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 38,391 15.20 57,500 10.17 Exercised 29,997 8.00 - - Forfeited (3,271 ) 7.62 (11,826 ) 10.60 Balance at March 31 855,072 $ 9.65 630,889 $ 14.06 Options exercisable at March 31: 406,332 $ 10.37 274,267 $ 9.65 Weighted Average Grant Date Fair Value for options granted during the period: $ 10.07 $ 6.59
Schedule of fair value of equity-based awards	2021 2020 Risk-free interest rate 0.63% - 1.12 % 1.35% - 1.66 % Expected volatility 76.6 % 73.3 % Expected life (years) 5.0 to 6.07 5.5 to 6.1 Expected dividend yield 0 % 0 %
Schedule of unrecognized compensation cost	2021 $ 1,032,220 2022 1,147,153 2023 789,853 2024 291,273 2025 11,616 Total estimated compensation cost to be recognized $ 3,272,115
Schedule of stock-based compensation expense	Three Months Ended 2021 2020 Stock-based compensation expense in operating expenses: Research and development $ 255,181 $ 293,116 General and administrative 193,917 171,533 Total $ 449,098 $ 464,649
Schedule of stock options outstanding	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 855,072 7.81 $ 9.65 $ 5,179,019 406,332 $ 10.37 $ 2,325,179

Summary of Significant Accoun_3

Summary of Significant Accounting Policies (Details Narrative) - USD ($) $ / shares in Units, $ in Millions	1 Months Ended	3 Months Ended
	Feb. 26, 2021	Mar. 31, 2021
Summary of Significant Accounting Policies
Issuance of common stock upon closing of follow-on offering, net shares	1,971,100	1,971,100
Issuance of common stock upon closing of follow-on offering, including shares of common stock	257,100	257,100
Public offering price per share		$ 14
Net of underwriting discounts and offering costs		$ 27.6
Deducting underwriting discounts	$ 1.6	1.6
Offering expenses	$ 0.2	$ 0.2

Net Loss Per Common Share (Deta

Net Loss Per Common Share (Details Narative) - shares	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Restricted Stock [Member]
Antidilutive securities excluded from computation of earnings per share	15,686	0
Warrant [Member]
Antidilutive securities excluded from computation of earnings per share	352,400	353,585
Stock Option [Member]
Antidilutive securities excluded from computation of earnings per share	855,072	630,889

Commitments (Details)

Commitments (Details) - USD ($)	Mar. 31, 2021	Dec. 31, 2020
Right-of-use asset	$ 186,602	$ 230,911
Less: short term portion	185,656	187,518
Long term portions	15,139	$ 60,861
Supplemental balance sheet information [Member]
Right-of-use asset	186,602
Operating lease liability	200,795
Less: short term portion	(185,656)
Long term portion	15,139
Furniture and equipment	28,932
Less: Accumulated depreciation	(16,395)
Net book value of property and equipment under finance lease	12,537
Finance lease liability	12,660
Less: short term portions	(5,819)
Long term portions	$ 6,841

Commitments (Details 1)

Commitments (Details 1)	Mar. 31, 2021USD ($)
Operating Leases
2021	$ 146,116
2022	64,940
2023	0
Total minimum lease payments	211,056
Less: present value discount	(10,261)
Less amount representing services	0
Present value of net minimum lease payments	200,795
Finance Leases
Less: present value discount	(99)
2021	5,441
2022	7,255
2023	3,023
Total minimum lease payments	15,719
Less amount representing services	(2,960)
Present value of net minimum lease payments	$ 12,660

Commitments (Details 2)

Commitments (Details 2)	3 Months Ended
	Mar. 31, 2021
Commitments
Operating lease, weighted average remaining lease term	1 year 1 month 6 days
Operating lease, weighted average discount rate, percent	4.00%
Finance lease, weighted average remaining lease term	2 years 1 month 6 days
Finance lease, weighted average discount rate, percent	1.00%

Commitments (Details 3)

Commitments (Details 3)	3 Months Ended
	Mar. 31, 2021USD ($)
Commitments
Operating lease cost	$ 45,430
Finance lease cost:
Amortization	1,447
Interest	24
Variable lease cost	19,869
Total lease cost	$ 66,770

Commitments (Details 4)

Commitments (Details 4)	3 Months Ended
	Mar. 31, 2021USD ($)
Cash paid for amounts included in operating and finance leases:
Operating cash outflow from operating leases	$ 68,574
Operating cash outflow from finance leases	24
Financing cash outflow from finance leases	1,449
Total cash paid for amounts included in operating and finance leases	$ 70,047

Commitments (Details Narrative)

Commitments (Details Narrative) - USD ($)	3 Months Ended	12 Months Ended	32 Months Ended
	Mar. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Increase in operating ROU asset and lease liability	$ 197,211
Payments to acquire in process research and development	275,000	$ 100,000	$ 600,000
Estimated remaining amount of payments	2,340,000
Agreement with biopharmaceutical company 1 [Member]
Contractual obligation			$ 70,000
Future payments required upon certain milestones being met	112,000
Agreement with biopharmaceutical company [Member] | January 2021 [Member]
Future payments required upon certain milestones being met	1,210,600
Agreement with biopharmaceutical company [Member] | March 2021 [Member]
Future payments required upon certain milestones being met	1,548,000
Agreement with biopharmaceutical company 2 [Member]
Future payments required upon certain milestones being met	$ 740,000

Stockholders Equity (Details Na

Stockholders Equity (Details Narrative) - USD ($)	1 Months Ended	3 Months Ended
	Feb. 26, 2021	Mar. 31, 2021	Dec. 31, 2020	Jun. 05, 2020
Public offering price	$ 14
Net proceeds	$ 27,600,000
Net of underwriting commissions	1,600,000	$ 1,600,000
Offering expenses	$ 200,000	$ 200,000
Issuance of common stock upon closing of follow-on offering, including shares of common stock	257,100	257,100
Issuance of common stock upon closing of follow-on offering, net shares	1,971,100	1,971,100
Common stock par value		$ 0.001	$ 0.001
Placement Shares [Member] | ATM Agreement [Member]
Aggregate offering price, common stock shares				$ 10,000,000
Common stock par value				$ 0.001
Sale of stock number of shares issued in transaction		3,082
Average selling price per share		$ 12.64

StockBased Compensation (Detail

StockBased Compensation (Details) - Employee Stock Option - $ / shares	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Shares options outstanding, beginning	849,949	585,215
Shares, granted	38,391	57,500
Shares, exercised	29,997
shares, forfeited	3,271	11,826
Shares options outstanding, ending	855,072	630,889
Shares, options exercisable	406,332	274,267
Weighted average exercise price, beginning	$ 9.33	$ 14.37
Weighted average exercise price, granted	15.20	10.17
Weighted average exercise price, exercised	8
Weighted average exercise price, forfeited	7.62	10.60
Weighted average exercise price, ending	9.65	14.06
Weighted average exercise price, options exercisable	10.37	9.65
Weighted average grant date fair value for options granted during the period:	$ 10.07	$ 6.59

StockBased Compensation (Deta_2

StockBased Compensation (Details 1) - Employee Stock Option	3 Months Ended
	Mar. 31, 2021USD ($)$ / sharesshares
Options Outstanding | shares	855,072
Options outstanding, weighted average remaining contractual life	7 years 9 months 21 days
Options outstanding, weighted average exercise price | $ / shares	$ 9.65
Options outstanding, aggregate intrinsic value | $	$ 5,179,019
Options exercisable | shares	406,332
Options exercisable, weighted average exercise price | $ / shares	$ 10.37
Options exercisable, aggregate intrinsic value | $	$ 2,325,179

StockBased Compensation (Deta_3

StockBased Compensation (Details 2) - Employee Stock Option	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Expected dividend yield	0.00%	0.00%
Expected volatility	76.60%	73.30%
Minimum Member
Risk-free interest rate	0.63%	1.35%
Expected life (years)	5 years	5 years 6 months
Maximum Member
Risk-free interest rate	1.12%	1.66%
Expected life (years)	6 years 25 days	6 years 1 month 6 days

StockBased Compensation (Deta_4

StockBased Compensation (Details 3)	Mar. 31, 2021USD ($)
Stock-Based Compensation
2022	$ 789,853
2023	291,273
2024	11,616
Total estimated compensation cost to be recognized	3,272,115
2020	1,032,220
2021	$ 1,147,153

StockBased Compensation (Deta_5

StockBased Compensation (Details 4) - USD ($)	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Stock-based compensation	$ 449,098	$ 464,649
Research And Development Expense
Stock-based compensation	255,181	293,116
General And Administrative Expense
Stock-based compensation	$ 193,917	$ 171,533

StockBased Compensation (Deta_6

StockBased Compensation (Details Narrative) - USD ($)	May 14, 2020	Mar. 31, 2021	Mar. 31, 2020	Oct. 25, 2017
2017 Stock Incentive Plan
Stock-based compensation		$ 418,192	$ 450,664
Share exercise price	$ 5.10
Common stock shares reserved description		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.
Shares available for grant under the 2017 Plan		266,800
Stock option awards shares modified	203,750
Common stock shares reserved for future issuance				750,000
Restricted Stock Units (RSUs) [Member]
Stock-based compensation		$ 20,456	$ 0
Restricted stock outstanding		15,686	0
Restricted stock vested		0
Employee Stock Option
Stock Based compensation expense related to ESPP		$ 10,450	$ 13,985
Expense Stock Options [Member]
Future expenses			122,000
Stock-based compensation		$ 13,449	$ 0
Employee Stock Purchase Plan [Member]
Common stock shares reserved description		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.
Common stock shares reserved for future issuance				100,000
Remaining shares available for issuance		163,710

Subsequent Events (Details Narr

Subsequent Events (Details Narrative) - USD ($)	1 Months Ended
	Apr. 08, 2021	Mar. 31, 2021	Dec. 31, 2020
Number of shares issued		12,287,896	10,299,822
Common stock shares issued, value		$ 12,288	$ 10,300
Subsequent Event [Member]
Net cash proceeds	$ 50,000,000
Term loans	$ 25,000,000
Description of term Loan	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%. Additionally, the Company elected to make 2.7% of the interest rate as payable in-kind, which shall accrue as principal monthly. Other fees include a 1.0% facility fee on the funded loan amount, paid at closing and a final fee of 4.5% of the funded loan amount due at the maturity date or earlier if the Company prepays the loan. 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
Subsequent Event [Member] | Pfizer, Inc. [Member] | License Agreement [Member]
Closing price per share	$ 14.31
Upfront fee	$ 5,000,000
Number of shares issued	349,406
Description of certain development and commercial milestone events	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 $330.0 million
Subsequent Event [Member] | Pfizer, Inc. [Member] | Equity Grant Agreement [Member]
Common stock shares issued, value	$ 5,000,000
Subsequent Event [Member] | Tranche 3 [Member]
Net cash proceeds	75,000,000
Term loans	5,000,000
Subsequent Event [Member] | Tranche [Member]
Term loans	15,000,000
Subsequent Event [Member] | Tranche 2 [Member]
Term loans	$ 5,000,000