Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2022 | May 12, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | HCW Biologics Inc. | |
Entity Central Index Key | 0001828673 | |
Current Fiscal Year End Date | --12-31 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 82-5024477 | |
Entity Address, Address Line One | 2929 N | |
Entity Address, Address Line Two | Commerce Parkway | |
Entity Address, City or Town | Miramar | |
Entity Address, State or Province | FL | |
Entity Address, Postal Zip Code | 33025 | |
City Area Code | 954 | |
Local Phone Number | 842–2024 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | HCWB | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 35,796,457 | |
Entity File Number | 001-40591 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 18,117,074 | $ 11,730,677 |
Short-term investments | 16,969,298 | 24,983,520 |
Accounts receivable, net | 553,007 | 133,000 |
Prepaid expenses | 2,020,545 | 2,196,557 |
Other current assets | 245,617 | 1,436,616 |
Total current assets | 37,905,541 | 40,480,370 |
Investments | 11,351,310 | 11,522,050 |
Property and equipment, net | 1,012,402 | 1,119,091 |
Other assets | 686,414 | 393,318 |
Total assets | 50,955,667 | 53,514,829 |
Current liabilities: | ||
Accounts payable | 743,120 | 223,664 |
Accrued liabilities and other current liabilities | 674,296 | 2,097,925 |
Total current liabilities | 1,417,416 | 2,321,589 |
Other Liabilities | 139,597 | 0 |
Total Liabilities | 1,557,013 | 2,321,589 |
Commitments and contingencies (Note 7) | ||
Stockholders' equity: | ||
Common Stock, Value, Issued | 3,578 | 3,577 |
Additional paid-in capital | 82,089,626 | 81,827,006 |
Accumulated deficit | (32,694,550) | (30,637,343) |
Total stockholders' equity | 49,398,654 | 51,193,240 |
Total liabilities and stockholders' equity | $ 50,955,667 | $ 53,514,829 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
Condensed Balance Sheets [Line Items] | ||
Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 |
Common Stock, Shares Authorized | 250,000,000 | 250,000,000 |
Common Stock, Shares, Issued | 35,779,489 | 35,768,264 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Revenues: | ||
Revenues | $ 3,117,545 | $ 0 |
Cost of Revenues | (1,328,076) | 0 |
Net Revenues | 1,789,469 | 0 |
Operating expenses: | ||
Research and development | 1,789,678 | 2,329,812 |
General and administrative | 1,880,601 | 1,082,360 |
Total operating expenses | 3,670,279 | 3,412,172 |
Loss from operations | (1,880,810) | (3,412,172) |
Interest and other income, net | (176,397) | 568,176 |
Net loss | (2,057,207) | (2,843,996) |
Less: cumulative preferred dividends earned in the period | 0 | (477,358) |
Net loss available for distribution to common stockholders | $ (2,057,207) | $ (3,321,354) |
Net loss per share, basic and diluted | $ (0.06) | $ (0.69) |
Weighted average shares outstanding, basic and diluted | 35,778,032 | 4,839,871 |
Condensed Statements of Changes
Condensed Statements of Changes In Redeemable Preferred Stock And Stockholders' Deficit - USD ($) | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit | Series A Redeemable preferred stock [Member] | Series A Redeemable preferred stock [Member]Preferred Stock | Series B Redeemable preferred stock [Member] | Series B Redeemable preferred stock [Member]Preferred Stock | Series C Redeemable preferred stock [Member] | Series C Redeemable preferred stock [Member]Preferred Stock |
Beginning balance (in shares) at Dec. 31, 2020 | 4,793,393 | 6,316,691 | 12,012,617 | 5,439,112 | ||||||
Beginning balance , Value at Dec. 31, 2020 | $ (16,718,397) | $ 480 | $ (16,718,877) | $ 6,140,792 | $ 13,680,306 | $ 11,294,301 | ||||
Issuance of Class A Common Stock upon exercise of stock options , Shares | 88,702 | |||||||||
Issuance of Class A Common Stock upon exercise of stock options , Value | 13,385 | $ 8 | 13,377 | |||||||
Stock-based compensation , Value | 641 | 641 | ||||||||
6% cumulative dividends on redeemable preferred stock , Value | (477,358) | (14,018) | (463,340) | |||||||
Cumulative dividends on redeemable preferred stock , Value | $ 95,992 | $ 213,971 | $ 167,395 | |||||||
Redeemable Preferred Stock , Accretion of issuance costs , Value | $ 3,929 | $ 10,200 | ||||||||
Net loss | (2,843,996) | (2,843,996) | ||||||||
Ending balance (in shares) at Mar. 31, 2021 | 4,882,095 | 6,316,691 | 12,012,617 | 5,439,112 | ||||||
Ending balance , Value at Mar. 31, 2021 | (20,025,725) | $ 488 | (20,026,213) | $ 6,236,784 | $ 13,898,206 | $ 11,471,896 | ||||
Beginning balance (in shares) at Dec. 31, 2021 | 35,768,264 | |||||||||
Beginning balance , Value at Dec. 31, 2021 | 51,193,240 | $ 3,577 | 81,827,006 | (30,637,343) | ||||||
Issuance of Class A Common Stock upon exercise of stock options , Shares | 11,225 | |||||||||
Issuance of Class A Common Stock upon exercise of stock options , Value | 2,273 | $ 1 | 2,272 | |||||||
Stock-based compensation , Value | 260,348 | 260,348 | ||||||||
Net loss | (2,057,207) | (2,057,207) | ||||||||
Ending balance (in shares) at Mar. 31, 2022 | 35,779,489 | |||||||||
Ending balance , Value at Mar. 31, 2022 | $ 49,398,654 | $ 3,578 | $ 82,089,626 | $ (32,694,550) |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (2,057,207) | $ (2,843,996) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 142,785 | 158,806 |
Stock-based compensation | 260,348 | |
Gain on extinguishment of debt | 0 | 567,311 |
Unrealized loss on investments, net | 185,122 | 0 |
Reduction in the carrying amount of right of use asset | 209 | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (420,007) | 1,200,000 |
Prepaid expenses and other assets | 1,380,215 | 150,356 |
Accounts payable and other liabilities | (1,071,084) | 713,055 |
Operating lease liability | (12,543) | |
Net cash used in operating activities | (1,592,162) | (1,489,802) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (23,554) | (23,279) |
Proceeds for sale or maturities of short-term investments | (7,999,840) | 0 |
Net cash (used in) provided by investing activities | 7,976,286 | (23,279) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | 2,273 | 13,385 |
Offering Cost | 100,000 | |
Net cash (used in) provided by financing activities | 2,273 | (86,615) |
Net changes in cash and cash equivalents | 6,386,397 | (1,599,696) |
Cash and cash equivalents at the beginning of the period | 11,730,677 | 8,455,834 |
Cash and cash equivalents at the end of the period | 18,117,074 | 6,856,138 |
Non-cash operating, investing and financing activities: | ||
Cumulative dividends earned, accrued and forfeited in the reporting period | 477,358 | |
PPP loan forgiveness | 567,311 | |
Offering costs | 200,000 | |
Operating lease liabilities arising from obtaining right-of-use assets | $ 306,509 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Summary of Significant Accounting Policies | 1. Organization and Summary of Significant Accounting Policies Organization HCW Biologics Inc. (the “Company”) is a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases. The Company believes age-related low-grade chronic inflammation, or “inflammaging,” is a significant contributing factor to several chronic diseases and conditions, such as cancer, cardiovascular disease, diabetes, neurodegenerative diseases, and autoimmune diseases. The Company is located in Miramar, Florida and was incorporated in the state of Delaware in April 2018. Reverse Stock Split In June 2021, the Company’s board of directors and stockholders approved an amendment to the Company’s certificate of incorporation to effect a 3-for-7 reverse stock split for all issued and outstanding common stock , redeemable preferred stock, and stock options, that was effective on June 25, 2021 (the “Reverse Stock Split”). The number of authorized shares and the par values of the common stock and redeemable preferred stock were not adjusted as a result of the Reverse Stock Split. The accompanying condensed interim financial statements and notes to the condensed interim financial statements give retroactive effect to the Reverse Stock Split for all periods presented. Liquidity As of March 31, 2022, the Company had not generated any revenue from commercial product sales of its internally-developed immunotherapeutic products for the treatment of cancer and other age-related diseases. In the course of its development activities, the Company has sustained operating losses and expects to continue to incur operating losses for the foreseeable future. Since inception, substantially all the Company’s activities have consisted of research, development, establishing large-scale cGMP production for clinical trials, and raising capital. The Company's total revenues to date have been generated principally from the Wugen License and manufacturing and supply arrangement with Wugen. In the three months ended March 31, 2022, the Company recognized revenues of $ 3.1 million from manufacturing and supply of materials for Wugen. On July 19, 2021, the Company’s registration statement on Form S-1 for its initial public offering (“IPO”) was declared effective by the Securities and Exchange Commission (the “SEC”). On July 22, 2021, the Company closed its IPO with the sale of 7,000,000 shares of common stock, at a public offering price of $ 8.00 per share, resulting in net proceeds of approximately $ 49.2 million, after deducting underwriting discounts and commissions and estimated offering expenses paid by the Company. The IPO met the provisions for mandatory conversion of all shares of redeemable preferred stock according to the designations for these securities. As a result of the conversion, the Company issued 23,768,416 shares of common stock to the former holders of redeemable preferred stock. In addition, as a result of conditions for mandatory conversion, the Company was relieved of its obligation to pay $ 2.8 million in cumulative dividends that were accrued and unpaid on the conversion date. As of March 31, 2022 , the Company had cash and cash equivalents of $ 18.1 million, short-term investments of $ 17.0 million held in U.S. government-backed securities, and long-term investments of $ 9.8 million held in U.S. government-backed securities. Since inception to March 31, 2022, the Company incurred cumulative net losses of $ 30.0 million. Management expects to incur additional losses in the future to conduct product research and development and recognizes the need to raise addition al capital to fully implement its business plan. The Company intends to raise capital through the issuance of additional equity financing and/or third-party collaboration funding. However, if such financing is not available at adequate levels, the Company will need to reevaluate its operating plan and may be required to delay the development of some of its products. Summary of Significant Accounting Policies Basis of Presentation Unaudited Interim Financial Information The accompanying unaudited condensed interim financial statements as of March 31, 2022 and for the three months ended March 31, 2021 and 2022 have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to Article 10 of Regulation S-X of the Securities Act of 1933, as amended (the “Securities Act”). Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. These unaudited condensed interim financial statements include only normal and recurring adjustments that the Company believes are necessary to fairly state the Company’s financial position and the results of its operations and cash flows. The results for the three months ended March 31, 2022 are not necessarily indicative of the results expected for the full fiscal year or any subsequent interim period. The condensed balance sheet at December 31, 2021 has been derived from the audited financial statements at that date but does not include all disclosures required by U.S. GAAP for complete financial statements. Because all of the disclosures required by U.S. GAAP for complete financial statements are not included herein, these unaudited condensed interim financial statements and the notes accompanying them should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2021 which appear in the Company’s Annual Report on Form 10-K (No. 333-256510) filed for the year ended December 31, 2021 with the Securities and Exchange Commission (the "SEC") on March 29, 2022 and in other filings with the SEC. Revenue Recognition The Company accounts for revenues in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“Topic 606”). To determine revenue recognition for arrangements that fall within the scope of Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods or services transferred to the customer. At contract inception, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. To date, the Company's revenues have been generated solely from the Wugen License. The Wugen License includes licenses of intellectual property, cost reimbursements, upfront signing fees, milestone payments and royalties on future licensee’s product sales. In addition, the Company and Wugen have an agreement for supply of materials. License Grants: For out-licensing arrangements that include a grant of a license to the Company’s intellectual property, the Company considers whether the license grant is distinct from the other performance obligations included in the arrangement. For licenses that are distinct, the Company recognizes revenues from nonrefundable, upfront payments and other consideration allocated to the license when the license term has begun and the Company has provided all necessary information regarding the underlying intellectual property to the customer, which generally occurs at or near the inception of the arrangement. Milestone and Contingent Payments: At the inception of the arrangement and at each reporting date thereafter, the Company assesses whether it should include any milestone and contingent payments or other forms of variable consideration in the transaction price using the most likely amount method. If it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty, the associated milestone value is included in the transaction price. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of each such milestone and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Since milestone and contingent payments may become payable to the Company upon the initiation of a clinical study or filing for or receipt of regulatory approval, the Company reviews the relevant facts and circumstances to determine when the Company should update the transaction price, which may occur before the triggering event. When the Company updates the transaction price for milestone and contingent payments, the Company allocates the changes in the total transaction price to each performance obligation in the agreement on the same basis as the initial allocation. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment, which may result in recognizing revenue for previously satisfied performance obligations in such period. The Company’s licensees will generally pay milestones payments subsequent to achievement of the triggering event. Materials Supply: The Company provides clinical and research grade materials so that licensees may develop products based on the licensed molecules. The Company plans to enter into commercialization supply agreements when licensees enter the commercial stage of their company. The amounts billed are recognized as revenue as the performance obligations are satisfied by the Company, once the Company determines that a contract exists. On June 18, 2021, the Company entered into a master services agreement ("MSA") for the supply of materials for clinical development of licensed products. On March 14, 2022, the Company entered into statements-of-work ("SOWs") contemplated under the MSA for all current and historical purchases of clinical and research grade materials. The Company determined that upon entering into the SOWs all requirements were met to qualify as a contract under Topic 606. No contract existed in prior reporting periods and all amounts received for the supply of materials were recorded as deferred revenue. The manufacturing of the clinical and research materials supplied by the Company each represents a single performance obligation that is satisfied over time. The Company recognizes revenue using an input method based on the costs incurred relative to the total expected cost, which determines the extent of the Company's progress toward completion. As part of the accounting for these arrangements, the Company must develop estimates and assumptions that require judgement to determine the progress towards completion. The Company reviews its estimate of the progress toward completion based on the best information available to recognize the cumulative progress toward completion as of the end of each reporting period, and makes revisions to such estimates, if facts and circumstances change during each reporting period. For the three months ended March 31, 2022, the Company recognized $ 3.1 m illion in revenue related to sale of development supply materials. Deferred Revenue Deferred revenue represents amounts billed, or in certain cases, yet to be billed to the Company’s customer for which the related revenues have not been recognized because one or more of the revenue recognition criteria has not been met. The Company had deferred revenue of $ 239,000 and nil as of March 31, 2021 and 2022, respectively. All deferred revenue balances are current liabilities and reported within Accrued liabilities and other current liabilities. Investments The Company holds a minority interest in Wugen which is accounted for using the measurement alternative whereby the investment is recorded at cost less impairment, adjusted for observable price changes in orderly transactions for an identical or similar investment of the same investee. No impairment has been recognized. As of March 31, 2021 and 2022, the Company included $ 1.6 million for the investment in Wugen in Investments in the accompanying condensed balance sheet. The Company invests net proceeds of its IPO in bills and notes issued by the U.S. Treasury which are classified as trading securities. As of March 31, 2022, the Company held $ 17.0 million in U.S. Treasury bills included in Short-term investments and $ 9.8 million in U.S. Treasury notes included in Investments in the accompanying condensed balance sheet. Operating Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in Other assets, Accrued Liabilities and other current liabilities, and Other liabilities on its balance sheets. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The Company has a lease agreement with lease and non-lease components, which are accounted for separately. Net Loss Per Share Basic loss per share of common stock is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during each period. Diluted loss per share of common stock includes the effect, if any, from the potential exercise of stock options and unvested shares of restricted stock, which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive. Recently Issued Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (“Topic 842”), which requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases. The Company adopted Topic 842 as of January 1, 2022. Effective March 1, 2022, the Company entered into noncancelable operating leases for its current location with a two-year term. These are the only leases in scope of Topic 842 or above the Company's capitalization threshold. |
Accrued Liabilities and Other C
Accrued Liabilities and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities and Other Current Liabilities | 2. Accrued Liabilities and Other Current Liabilities As of December 31, 2021 , the Company had a balance of $ 2.1 million in Accrued liabilities and other current liabilities, consisting of $ 1.8 million related to deferred revenue, $ 48,750 related to manufacturing materials, $ 51,000 related to legal fees, and $ 50,000 for other expenses. On January 8, 2021, the Company received full loan forgiveness of $ 567,311 for obligations related to the PPP loan. The Company accounted for the PPP loan as debt, and the loan forgiveness was accounted for as a debt extinguishment. As of March 31, 2022, the Company had a balance of $ 674,000 in Accrued liabilities and other current liabilities, consisting of $ 229,000 related to salary and benefits, $ 167,000 related to short term lease liability, and $ 278,000 related to other current liabilities which were primarily accrued legal fees and clinical fees. |
Redeemable Preferred Stock
Redeemable Preferred Stock | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Redeemable Preferred Stock | 3. Redeemable Preferred Stock On July 22, 2021, the Company closed on its IPO, and the requirements for mandatory conversion were met. All outstanding shares of Series A, Series B, and Series C Preferred Stock converted into an equal number of shares of common stock. As a result, the rights, preferences, and terms ascribed to these shares are no longer applicable. Cumulative dividends of $ 2.8 million accrued as of the conversion date were forfeited and such forfeiture was recognized through Additional paid-in capital. At December 31, 2021 and March 31, 2022 , the Company has 10,000,000 shares of preferred stock authorized and no shares issued. |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 4. Net Loss Per Share The following table summarizes the computation of the basic and diluted net loss per share: Three Months Ended March 31, 2021 2022 Numerator: Net loss $ ( 2,843,996 ) $ ( 2,057,207 ) Less: cumulative preferred dividends earned in the period ( 477,358 ) — Net loss available for distribution to common stock holders $ ( 3,321,354 ) $ ( 2,057,207 ) Denominator: Weighted-average common shares outstanding 4,839,871 35,778,032 Net loss per share, basic and diluted $ ( 0.69 ) $ ( 0.06 ) The following table summarizes the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their inclusion would be anti-dilutive: At March 31, 2021 2022 Redeemable Preferred Stock 23,768,416 — Common stock options 653,345 1,745,630 Potentially diluted securities 24,421,761 1,745,630 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 5. Fair Value of Financial Instruments The carrying amount of the Company’s financial instruments, including cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, U.S. government-backed securities with maturity dates up to one year, accounts payable and accrued liabilities, approximate fair value due to their short-term maturities. Money market funds included in cash and cash equivalents and U.S. government-backed securities are measured at fair value based on quoted prices in active markets, which are considered Level 1 inputs. No transfers between levels occurred during the periods presented. The following table presents the Company’s assets which were measured at fair value at December 31, 2021 and March 31, 2022: At December 31, 2021: Level 1 Level 2 Level 3 Total Assets: Money market funds $ 9,506,499 $ — $ — $ 9,506,499 Treasury bills 24,983,520 — — 24,983,520 Treasury notes 9,922,300 — — 9,922,300 Total $ 44,412,319 $ — $ — $ 44,412,319 At March 31, 2022: Level 1 Level 2 Level 3 Total Assets: Money market funds $ 16,294,805 $ — $ — $ 16,294,805 Treasury bills 16,969,298 — — 16,969,298 Treasury notes 9,751,560 — — 9,751,560 Total $ 43,015,663 $ — $ — $ 43,015,663 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 6. Income Taxes The Company computes its quarterly income tax expense/(benefit) by using a forecasted annual effective tax rate and adjusts for any discrete items arising during the quarter. The Company did no t have a provision for income taxes (current or deferred tax expense) as of December 31, 2021 and March 31, 2022. The Company will continue to maintain a 100 % valuation allowance on total deferred tax assets. The Company believes it is more likely than not that the related deferred tax asset will not be realized. As a result, the Company’s effective tax rate will remain at 0.00 % because no items either estimated or discrete items would impact the tax provision. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies Operating Leases The Company has operating leases for approximately 12,250 square feet of space located in Miramar, Florida. The leases have a two-year term which commenced on March 1, 2022 and will terminate on February 29, 2024 . Upon the commencement of the leases, the Company used its incremental borrowing rate of 6.0 % to determine the amounts to recognize for a ROU asset and a lease liability. There are no obligations under finance leases. The components of the lease expense for the three months ended March 31, 2022 were as follows: Three Months Ended 2022 Operating lease cost $ 13,929 Supplemental cash flow information related to lease was as follows: Three Months Ended Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 13,929 Right-of-use assets obtained in exchange for lease obligations: Operating lease $ 12,543 As of March 31, 2022, the supplemental balance sheet information related to leases were as follows: March 31, 2022 Operating lease right-of-use assets $ 306,300 Other current liabilities $ 166,912 Operating lease liabilities, net of current portion 139,597 Total operating lease liabilities $ 306,509 As of March 31, 2022, the remaining lease payments were as follows: 2022 (remaining 9 months) $ 125,358 2023 171,322 2024 28,693 Total future minimum lease payments $ 325,373 For the three months ended March 31, 2021 and 2022, rent expense recognized by the Company was $ 31,516 and $ 38,883 , respectively, of which $ 14,431 and $ 19,207 , respectively, is included in research and development in the accompanying condensed statements of operations . Contractual Commitments The Company operates under the provisions of agreements with a third-party global contract development and manufacturer of biologics for the manufacture of the Company’s proprietary molecules for use in clinical trials. At December 31, 2021, future payment obligations under such agreements were $ 2.5 million of which approximately $ 181,600 was paid in January 2022. A t March 31, 2022, future payment obligations under such agreements were $ 2.1 million. Legal Management has no knowledge of any pending or unasserted claims against the Company. Other In March 2020, the World Health Organization declared the outbreak of a novel coronavirus (COVID-19) as a pandemic, which continues to spread throughout the United States and the world. The spread of COVID-19 has caused significant volatility in the U.S. and international markets. There is significant uncertainty around the breadth and duration of business disruptions related to COVID-19, as well as its impact on the U.S. and international economies and, as such, the Company is unable to determine if it will have a material impact to its operations. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 8. Subsequent Events Subsequent events have been evaluated through the date the financial statements were available to be issued. As of such date, there were no material subsequent events identified that required recognition or disclosure other than as disclosed below or in the footnotes herein. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation Unaudited Interim Financial Information The accompanying unaudited condensed interim financial statements as of March 31, 2022 and for the three months ended March 31, 2021 and 2022 have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to Article 10 of Regulation S-X of the Securities Act of 1933, as amended (the “Securities Act”). Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. These unaudited condensed interim financial statements include only normal and recurring adjustments that the Company believes are necessary to fairly state the Company’s financial position and the results of its operations and cash flows. The results for the three months ended March 31, 2022 are not necessarily indicative of the results expected for the full fiscal year or any subsequent interim period. The condensed balance sheet at December 31, 2021 has been derived from the audited financial statements at that date but does not include all disclosures required by U.S. GAAP for complete financial statements. Because all of the disclosures required by U.S. GAAP for complete financial statements are not included herein, these unaudited condensed interim financial statements and the notes accompanying them should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2021 which appear in the Company’s Annual Report on Form 10-K (No. 333-256510) filed for the year ended December 31, 2021 with the Securities and Exchange Commission (the "SEC") on March 29, 2022 and in other filings with the SEC. |
Revenue Recognition | Revenue Recognition The Company accounts for revenues in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“Topic 606”). To determine revenue recognition for arrangements that fall within the scope of Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods or services transferred to the customer. At contract inception, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. To date, the Company's revenues have been generated solely from the Wugen License. The Wugen License includes licenses of intellectual property, cost reimbursements, upfront signing fees, milestone payments and royalties on future licensee’s product sales. In addition, the Company and Wugen have an agreement for supply of materials. License Grants: For out-licensing arrangements that include a grant of a license to the Company’s intellectual property, the Company considers whether the license grant is distinct from the other performance obligations included in the arrangement. For licenses that are distinct, the Company recognizes revenues from nonrefundable, upfront payments and other consideration allocated to the license when the license term has begun and the Company has provided all necessary information regarding the underlying intellectual property to the customer, which generally occurs at or near the inception of the arrangement. Milestone and Contingent Payments: At the inception of the arrangement and at each reporting date thereafter, the Company assesses whether it should include any milestone and contingent payments or other forms of variable consideration in the transaction price using the most likely amount method. If it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty, the associated milestone value is included in the transaction price. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of each such milestone and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Since milestone and contingent payments may become payable to the Company upon the initiation of a clinical study or filing for or receipt of regulatory approval, the Company reviews the relevant facts and circumstances to determine when the Company should update the transaction price, which may occur before the triggering event. When the Company updates the transaction price for milestone and contingent payments, the Company allocates the changes in the total transaction price to each performance obligation in the agreement on the same basis as the initial allocation. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment, which may result in recognizing revenue for previously satisfied performance obligations in such period. The Company’s licensees will generally pay milestones payments subsequent to achievement of the triggering event. Materials Supply: The Company provides clinical and research grade materials so that licensees may develop products based on the licensed molecules. The Company plans to enter into commercialization supply agreements when licensees enter the commercial stage of their company. The amounts billed are recognized as revenue as the performance obligations are satisfied by the Company, once the Company determines that a contract exists. On June 18, 2021, the Company entered into a master services agreement ("MSA") for the supply of materials for clinical development of licensed products. On March 14, 2022, the Company entered into statements-of-work ("SOWs") contemplated under the MSA for all current and historical purchases of clinical and research grade materials. The Company determined that upon entering into the SOWs all requirements were met to qualify as a contract under Topic 606. No contract existed in prior reporting periods and all amounts received for the supply of materials were recorded as deferred revenue. The manufacturing of the clinical and research materials supplied by the Company each represents a single performance obligation that is satisfied over time. The Company recognizes revenue using an input method based on the costs incurred relative to the total expected cost, which determines the extent of the Company's progress toward completion. As part of the accounting for these arrangements, the Company must develop estimates and assumptions that require judgement to determine the progress towards completion. The Company reviews its estimate of the progress toward completion based on the best information available to recognize the cumulative progress toward completion as of the end of each reporting period, and makes revisions to such estimates, if facts and circumstances change during each reporting period. For the three months ended March 31, 2022, the Company recognized $ 3.1 m illion in revenue related to sale of development supply materials. |
Deferred Revenue | Deferred Revenue Deferred revenue represents amounts billed, or in certain cases, yet to be billed to the Company’s customer for which the related revenues have not been recognized because one or more of the revenue recognition criteria has not been met. The Company had deferred revenue of $ 239,000 and nil as of March 31, 2021 and 2022, respectively. All deferred revenue balances are current liabilities and reported within Accrued liabilities and other current liabilities. |
Investment | Investments The Company holds a minority interest in Wugen which is accounted for using the measurement alternative whereby the investment is recorded at cost less impairment, adjusted for observable price changes in orderly transactions for an identical or similar investment of the same investee. No impairment has been recognized. As of March 31, 2021 and 2022, the Company included $ 1.6 million for the investment in Wugen in Investments in the accompanying condensed balance sheet. The Company invests net proceeds of its IPO in bills and notes issued by the U.S. Treasury which are classified as trading securities. As of March 31, 2022, the Company held $ 17.0 million in U.S. Treasury bills included in Short-term investments and $ 9.8 million in U.S. Treasury notes included in Investments in the accompanying condensed balance sheet. |
Operating Leases | Operating Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in Other assets, Accrued Liabilities and other current liabilities, and Other liabilities on its balance sheets. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The Company has a lease agreement with lease and non-lease components, which are accounted for separately. |
Net Loss Per Share | Net Loss Per Share Basic loss per share of common stock is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during each period. Diluted loss per share of common stock includes the effect, if any, from the potential exercise of stock options and unvested shares of restricted stock, which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (“Topic 842”), which requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases. The Company adopted Topic 842 as of January 1, 2022. Effective March 1, 2022, the Company entered into noncancelable operating leases for its current location with a two-year term. These are the only leases in scope of Topic 842 or above the Company's capitalization threshold. |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Summary of Basic and Diluted Net Income (Loss) Per Common Share | The following table summarizes the computation of the basic and diluted net loss per share: Three Months Ended March 31, 2021 2022 Numerator: Net loss $ ( 2,843,996 ) $ ( 2,057,207 ) Less: cumulative preferred dividends earned in the period ( 477,358 ) — Net loss available for distribution to common stock holders $ ( 3,321,354 ) $ ( 2,057,207 ) Denominator: Weighted-average common shares outstanding 4,839,871 35,778,032 Net loss per share, basic and diluted $ ( 0.69 ) $ ( 0.06 ) |
Summary of Outstanding Potentially Dilutive Securities | The following table summarizes the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their inclusion would be anti-dilutive: At March 31, 2021 2022 Redeemable Preferred Stock 23,768,416 — Common stock options 653,345 1,745,630 Potentially diluted securities 24,421,761 1,745,630 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of assets and liabilities that are measured at fair value on a recurring basis | The following table presents the Company’s assets which were measured at fair value at December 31, 2021 and March 31, 2022: At December 31, 2021: Level 1 Level 2 Level 3 Total Assets: Money market funds $ 9,506,499 $ — $ — $ 9,506,499 Treasury bills 24,983,520 — — 24,983,520 Treasury notes 9,922,300 — — 9,922,300 Total $ 44,412,319 $ — $ — $ 44,412,319 At March 31, 2022: Level 1 Level 2 Level 3 Total Assets: Money market funds $ 16,294,805 $ — $ — $ 16,294,805 Treasury bills 16,969,298 — — 16,969,298 Treasury notes 9,751,560 — — 9,751,560 Total $ 43,015,663 $ — $ — $ 43,015,663 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | |
Summary of components of the lease expense | The components of the lease expense for the three months ended March 31, 2022 were as follows: Three Months Ended 2022 Operating lease cost $ 13,929 |
Summary of supplemental cash flow information related to lease | Supplemental cash flow information related to lease was as follows: Three Months Ended Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 13,929 Right-of-use assets obtained in exchange for lease obligations: Operating lease $ 12,543 |
Supplemental balance sheet information related to lease | As of March 31, 2022, the supplemental balance sheet information related to leases were as follows: March 31, 2022 Operating lease right-of-use assets $ 306,300 Other current liabilities $ 166,912 Operating lease liabilities, net of current portion 139,597 Total operating lease liabilities $ 306,509 |
Schedule of remaining lease payments | As of March 31, 2022, the remaining lease payments were as follows: 2022 (remaining 9 months) $ 125,358 2023 171,322 2024 28,693 Total future minimum lease payments $ 325,373 |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | Jul. 22, 2021 | Jun. 25, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 |
Revenue recognized | $ 3,117,545 | $ 0 | |||
Investments | 11,351,310 | $ 11,522,050 | |||
Short-term investments | 16,969,298 | 24,983,520 | |||
Accounts receivable, net | 553,007 | 133,000 | |||
Common stock issued to holder of redeemable preferred stock | 23,768,416 | ||||
Cumulative Dividends | $ 2,800,000 | ||||
Stockholders' Equity, Reverse Stock Split | a 3-for-7 reverse stock split for all issued and outstanding common stock | ||||
Cash and cash equivalents | 18,117,074 | 11,730,677 | |||
Research and development | 30,000,000 | ||||
U.S. Government Backed Securities [Member] | |||||
Investments | 9,800,000 | ||||
Short-term investments | 17,000,000 | ||||
IPO [Member] | U.S. Treasury bills [Member] | |||||
Proceeds from initial public offering | 17,000,000 | ||||
IPO [Member] | US Treasury Notes [Member] | |||||
Proceeds from initial public offering | 9,800,000 | ||||
Common Stock [Member] | IPO [Member] | |||||
Stock Issued During Period Shares | 7,000,000 | ||||
Share Price | $ 8 | ||||
Proceeds from initial public offering | $ 49.2 | ||||
Wugen License [Member] | |||||
Revenue recognized | 3.1 | ||||
Investments | 1,600,000 | 1,600,000 | |||
Accounts Payable and Accrued Liabilities [Member] | |||||
Deferred Revenue | $ 0 | $ 239,000,000,000 | |||
Deferred Revenue, Current | $ 1,800,000 |
Accrued Liabilities and Other_2
Accrued Liabilities and Other Current Liabilities - Additional Information (Detail) - USD ($) | Jan. 08, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 |
Payables And Accruals [Line Items] | ||||
Accrued liabilities and other current liabilities | $ 674,296 | $ 2,097,925 | ||
Debt Instrument, Decrease, Forgiveness | $ 567,311 | |||
Accounts Payable and Accrued Liabilities, Current | 674,000 | 2,100,000 | ||
Other expense | 50,000 | |||
short term lease liability | 166,912 | |||
Accrued Expenses Current [Member] | ||||
Payables And Accruals [Line Items] | ||||
Debt Instrument, Decrease, Forgiveness | $ 567,311 | |||
Accounts Payable and Accrued Liabilities [Member] | ||||
Payables And Accruals [Line Items] | ||||
Deferred Revenue, Current | 1,800,000 | |||
Manufacturing materials | 48,750 | |||
Salaries and Employee Benefits | 229,000 | |||
Legal Fees | $ 51,000 | |||
short term lease liability | 167,000 | |||
OtherLiabilitiesCurrent | $ 278,000 |
Redeemable Preferred Stock - Ad
Redeemable Preferred Stock - Additional Information (Detail) - USD ($) $ in Millions | Mar. 31, 2022 | Dec. 31, 2021 | Jul. 22, 2021 |
Class of Stock [Line Items] | |||
Cumulative Dividends | $ 2.8 | ||
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 | |
Preferred Stock, Shares Issued | 0 | 0 |
Net Loss Per Share - Summary of
Net Loss Per Share - Summary of Basic and Diluted Net Income (Loss) Per Common Share (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Numerator: | ||
Net loss | $ (2,057,207) | $ (2,843,996) |
Less: cumulative preferred dividends earned in the period | 0 | (477,358) |
Net loss available for distribution to common stockholders | $ (2,057,207) | $ (3,321,354) |
Denominator: | ||
Weighted average shares outstanding, basic and diluted | 35,778,032 | 4,839,871 |
Net loss per share, basic and diluted | $ (0.06) | $ (0.69) |
Net Loss Per Share - Summary _2
Net Loss Per Share - Summary of Outstanding Potentially Dilutive Securities (Detail) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially diluted securities | 1,745,630 | 24,421,761 |
Redeemable Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially diluted securities | 23,768,416 | |
Common Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially diluted securities | 1,745,630 | 653,345 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Summary of Assets and Liabilities Measured at Fair Value on a Recurring Basis (Detail) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Assets: | ||
Assets | $ 43,015,663 | $ 44,412,319 |
Money Market Funds [Member] | ||
Assets: | ||
Assets | 16,294,805 | 9,506,499 |
Treasury bills [Member] | ||
Assets: | ||
Assets | 16,969,298 | 24,983,520 |
Treasury Notes [Member] | ||
Assets: | ||
Assets | 9,751,560 | 9,922,300 |
Level 1 [Member] | ||
Assets: | ||
Assets | 43,015,663 | 44,412,319 |
Level 1 [Member] | Money Market Funds [Member] | ||
Assets: | ||
Assets | 16,294,805 | 9,506,499 |
Level 1 [Member] | Treasury bills [Member] | ||
Assets: | ||
Assets | 16,969,298 | 24,983,520 |
Level 1 [Member] | Treasury Notes [Member] | ||
Assets: | ||
Assets | 9,751,560 | 9,922,300 |
Level 2 [Member] | ||
Assets: | ||
Assets | 0 | 0 |
Level 2 [Member] | Money Market Funds [Member] | ||
Assets: | ||
Assets | 0 | 0 |
Level 2 [Member] | Treasury bills [Member] | ||
Assets: | ||
Assets | 0 | 0 |
Level 2 [Member] | Treasury Notes [Member] | ||
Assets: | ||
Assets | 0 | 0 |
Level 3 [Member] | ||
Assets: | ||
Assets | 0 | 0 |
Level 3 [Member] | Money Market Funds [Member] | ||
Assets: | ||
Assets | 0 | 0 |
Level 3 [Member] | Treasury bills [Member] | ||
Assets: | ||
Assets | 0 | 0 |
Level 3 [Member] | Treasury Notes [Member] | ||
Assets: | ||
Assets | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Provision for income taxes | $ 0 | $ 0 |
Deferred Tax Assets Valuation Allowance, Percent | 100.00% | |
Effective Income Tax Rate Reconciliation, Percent | 0.00% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 3 Months Ended | ||||
Mar. 31, 2022USD ($)ft² | Mar. 31, 2021USD ($) | Mar. 01, 2022 | Jan. 31, 2022USD ($) | Dec. 31, 2021USD ($) | |
Operating Leased Assets [Line Items] | |||||
Area of land | ft² | 12,250 | ||||
Lease term | 2 years | ||||
Lease termination date | Feb. 29, 2024 | ||||
Operating Lease, Weighted Average Discount Rate, Percent | 6.00% | ||||
Operating Leases, Rent Expense | $ 38,883 | $ 31,516 | |||
Future payment obligations | 2.1 | $ 181,600 | $ 2.5 | ||
Research and Development Expense [Member] | |||||
Operating Leased Assets [Line Items] | |||||
Operating Leases, Rent Expense | $ 19,207 | $ 14,431 |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of components of the lease expense (Detail) | 3 Months Ended |
Mar. 31, 2022USD ($) | |
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | |
Operating lease cost | $ 13,929 |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of supplemental cash flow information related to lease (Detail) | 3 Months Ended |
Mar. 31, 2022USD ($) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
Operating cash flows | $ 13,929 |
Right-of-use assets obtained in exchange for lease obligations: | |
Operating lease | $ 12,543 |
Commitments and Contingencies_4
Commitments and Contingencies - Supplemental balance sheet information related to lease (Detail) - USD ($) | Mar. 31, 2022 | Mar. 31, 2021 |
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | ||
Operating lease right-of-use assets | $ 306,300 | |
Other current liabilities | 166,912 | |
Operating lease liabilities, net of current portion | 139,597 | |
Total operating lease liabilities | $ 306,509 |
Commitments and Contingencies_5
Commitments and Contingencies - Summary of the Future Minimum Payments for the Lease and Sublease Agreements (Detail) | Mar. 31, 2022USD ($) |
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | |
2022 (remaining 9 months) | $ 125,358 |
2023 | 171,322 |
2024 | 28,693 |
Total future minimum lease payments | $ 325,373 |