Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS
Unicycive Therapeutics, Inc.
Balance Sheets
(in thousands, except
for share and per share amounts)
As of
As of
December 31,
June 30,
2020
2021
(unaudited)
Assets
Current assets:
Cash
$ -
$ 1
Prepaid related party service fee
-
38
Deferred offering costs
200
864
Prepaid expenses and other current assets
4
10
Total current assets
204
913
Total assets
$ 204
$ 913
Liabilities and stockholders’ deficit
Current liabilities:
Accounts payable
$ 184
$ 357
Related party service fee payable
9
-
Accrued liabilities
168
658
Convertible notes
1,528
3,199
Loan from stockholder
967
901
Government loan
19
-
Total current liabilities
2,875
5,115
Total liabilities
2,875
5,115
Commitments and contingencies (Note 7)
Stockholders’ deficit:
Preferred stock: $ 0.001 par value per share— 10,000,000 shares authorized at December 31, 2020 and June 30, 2021 (unaudited); no shares issued and outstanding at December 31, 2020 and June 30, 2021 (unaudited)
$ -
$ -
Common stock, $ 0.001 par value per share – 200,000,000 shares authorized at December 31, 2020 and June 30, 2021 (unaudited); 8,514,070 shares issued and outstanding at December 31, 2020, and 8,771,290 shares issued and outstanding at June 30, 2021 (unaudited)
9
9
Additional paid-in capital
3,242
3,775
Accumulated deficit
( 5,922 )
( 7,986 )
Total stockholders’ deficit
( 2,671 )
( 4,202 )
Total liabilities and stockholders’ deficit
$ 204
$ 913
See accompanying notes to the financial statements
1
Unicycive Therapeutics, Inc.
Statements of Operations
(in thousands, except
for share and per share amounts)
(Unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
2020
2021
2020
2021
Operating expenses:
Research and development
$ 182
$ 493
$ 329
$ 942
General and administrative
154
286
349
568
Total operating expenses
336
779
678
1,510
Loss from operations
( 336 )
( 779 )
( 678 )
( 1,510 )
Other expenses:
Interest expense
( 2 )
( 321 )
( 4 )
( 573 )
Gain on extinguishment of debt
-
-
-
19
Total other expenses
( 2 )
( 321 )
( 4 )
( 554 )
Net loss
$ ( 338 )
$ ( 1,100 )
$ ( 682 )
$ ( 2,064 )
Net loss per share, basic and diluted
$ ( 0.04 )
$ ( 0.13 )
$ ( 0.08 )
$ ( 0.24 )
Weighted-average shares outstanding used in computing net loss per share, basic and diluted
8,483,382
8,771,290
8,472,866
8,677,497
See accompanying notes to the financial statements
2
Unicycive Therapeutics, Inc.
Statements of Stockholders’
Deficit
(in thousands, except
share amounts)
Additional
Total
Common Stock
Preferred stock
Paid-In
Accumulated
Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
Deficit
Balance at December 31, 2019
8,456,179
$ 8
-
$ -
$ 2,766
$ ( 3,658 )
$ ( 884 )
Net loss (unaudited)
-
-
-
-
-
( 344 )
( 344 )
Issuance of common stock for cash (unaudited)
11,862
-
-
-
50
-
50
Issuance of common stock for anti-dilution clause (unaudited)
475
-
-
-
2
-
2
Stock-based compensation expense (unaudited)
-
-
-
-
31
-
31
Balance at March 31, 2020 (unaudited)
8,468,516
8
-
-
2,849
( 4,002 )
( 1,145 )
Net loss (unaudited)
-
-
-
-
-
( 338 )
( 338 )
Issuance of common stock for cash (unaudited)
21,401
1
-
-
91
-
92
Issuance of common stock for anti-dilution clause (unaudited)
6,624
-
-
-
28
-
28
Stock-based compensation expense (unaudited)
-
-
-
-
60
-
60
Balance at June 30, 2020 (unaudited)
8,496,541
$ 9
-
$ -
$ 3,028
$ ( 4,340 )
$ ( 1,303 )
Additional
Total
Common Stock
Preferred stock
Paid-In
Accumulated
Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
Deficit
Balance at December 31, 2020
8,514,070
$ 9
-
$ -
$ 3,242
$ ( 5,922 )
$ ( 2,671 )
Net loss (unaudited)
-
-
-
-
-
( 964 )
( 964 )
Issuance of common stock for exercise of options (unaudited)
233,819
-
-
-
31
-
31
Stock-based compensation expense (unaudited)
-
-
-
-
202
-
202
Balance at March 31, 2021 (unaudited)
8,747,889
9
-
-
3,475
( 6,886 )
( 3,402 )
Net loss (unaudited)
-
-
-
-
-
( 1,100 )
( 1,100 )
Issuance of common stock for exercise of options (unaudited)
23,401
-
-
-
6
-
6
Stock-based compensation expense (unaudited)
-
-
-
-
294
-
294
Balance at June 30, 2021 (unaudited)
8,771,290
$ 9
-
$ -
$ 3,775
$ ( 7,986 )
$ ( 4,202 )
See accompanying notes to the financial statements
3
Unicycive Therapeutics, Inc.
Statements of Cash
Flows
(in thousands)
(Unaudited)
Six Months
Ended
Six Months
Ended
June 30,
June 30,
2020
2021
Cash flows from operating activities
Net loss
$ ( 682 )
$ ( 2,064 )
Adjustments to reconcile net loss to net cash used in operating activities:
R&D Expense for issuance of common stock for anti-dilution clause
30
-
Stock-based compensation expense
91
496
Convertible debt discount amortization
-
447
Convertible debt non-cash interest
-
127
Gain on extinguishment of debt
-
( 19 )
Deferred compensation to CEO
262
157
Changes in assets and liabilities:
Prepaid expense and other current assets
( 23 )
( 7 )
Related party service fee receivable
-
( 38 )
Accounts payable and accrued liabilities
112
20
Related party service fee payable
( 5 )
( 9 )
Net cash used in operating activities
( 215 )
( 890 )
Cash flows from financing activities
Issuance of common stock
142
-
Proceeds from loan from stockholder
40
237
Proceeds from convertible notes
-
1,098
Repayment of loan from stockholder
-
( 460 )
Deferred offering costs
-
( 103 )
Proceeds from exercise of options
-
119
Proceeds from government loan
19
-
Net cash provided by financing activities
201
891
Net (decrease) increase in cash
( 14 )
1
Cash at the beginning of the period
15
-
Cash at the end of the period
$ 1
$ 1
Supplemental cash flow information
Deferred offering costs included in accrued liabilities
$ -
$ 519
Cash paid for income taxes
$ 1
$ -
See accompanying notes to the financial statements
4
Unicycive Therapeutics, Inc.
Notes to the Financial Statements (unaudited)
1. Organization
and Description of Business
Overview
Unicycive Therapeutics, Inc. (“the Company”)
was incorporated in the State of Delaware on August 18, 2016. The Company was dormant until July 2017 when it began evaluating a number
of drug candidates for in-licensing.
The Company in-licensed the drug candidate UNI
494 from Sphaera Pharma Pte. Ltd, a Singapore-based corporation, (“Sphaera”) (Note 3). UNI 494 is a pro-drug of Nicorandill
that is being developed as a treatment for acute kidney injury.
In September 2018, the Company purchased a second
drug candidate, Renazorb RZB 012 (“Renazorb”) and its trademark, RENALAN, and various patents from Spectrum Pharmaceuticals,
Inc. (“Spectrum”) (Note 3). Renazorb is being developed for the treatment of hyperphosphatemia in patients with Chronic Kidney
Disease (“CKD”).
The Company continues to evaluate the licensing
of additional technologies and drugs, targeting orphan diseases and other renal, liver and other metabolic diseases affecting fibrosis
and inflammation.
Liquidity
The Company is subject to risks and uncertainties
common to early-stage companies in the biotechnology industry including, but not limited to, development by competitors of new technological
innovations, protection of proprietary technology, dependence on key personnel, compliance with governmental regulations and the need
to obtain additional financing to fund operations. The Company’s product candidates currently under development will require significant
additional research and development efforts prior to commercialization. The Company has not generated revenue to date.
The Company has incurred operating losses and
negative cash flows from operations since inception and expects to continue to incur negative cash flows from operations for the foreseeable
future. As the Company increases its research and development activities, the operating losses are expected to increase. The Company
has historically relied on private equity offerings, debt financings and loans from a stockholder to fund its operations. As of June
30, 2021 and December 31, 2020, the Company had an accumulated deficit of $ 8.0 million and $ 5.9 million, respectively.
As a result of its initial public offering (“IPO”),
on July 13, 2021 the Company began trading on the Nasdaq Capital Market under the symbol “UNCY”, and on July 15, 2021 received
approximately $ 23,212,000 in net proceeds after deducting the underwriting discounts and commissions and estimated offering expenses.
The Company intends to use the net proceeds from the IPO to complete pre-clinical and clinical studies, submit regulatory filings to
the FDA, and for general and corporate purposes, including hiring additional management and conducting market research and other commercial
planning.
The Company expects to continue incurring losses
for the foreseeable future and will be required to raise additional capital in the future to complete its planned clinical trials, pursue
product development initiatives and penetrate markets for the sale of its products. Management believes that the Company will continue
to have access to capital resources through possible equity offerings, debt financings, corporate collaborations or other means. From
January 2021 through May 2021, the Company received an aggregate of $ 1.1 million upon the issuance of convertible notes. These funds
were used primarily to settle outstanding accounts payable as well as $ 460,000 of the loan outstanding from the chief executive officer
and principal stockholder. There can be no assurance that the Company will be able to obtain additional financing on terms acceptable
to the Company, on a timely basis or at all. If the Company is unable to secure additional capital, it may be required to curtail any
clinical trials and development of new or existing products and take additional measures to reduce expenses in order to conserve its
cash in amounts sufficient to sustain operations and meet its obligations. Based on the Company’s current level of expenditures,
given the Company’s nominal cash balance of $ 1,000 as of June 30, 2021, and after including the net proceeds received on July 15,
2021 as a result of the Company’s IPO, the Company believes that it has sufficient resources to continue operations for at least
one year after the date that these financial statements are available to be issued.
5
2. Summary
of Significant Accounting Policies
Basis of Presentation
The financial statements and accompanying notes
have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”).
All common share amounts and per share amounts
have been adjusted to reflect a 1-for-4.3 reverse stock split of the Company’s common stock that was effected on June 21, 2021.
Use of Estimates
The preparation of financial statements in conformity
with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and
the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during
the periods presented. Management believes that these estimates and assumptions are reasonable; however, actual results may differ and
could have a material effect on future results of operations and financial position. Significant items subject to such estimates and
assumptions include deferred tax asset valuation allowance, unrecognized tax benefits, stock-based compensation and fair value of Company’s
common stock. Actual results may materially differ from those estimates.
Segment Information
The Company operates and manages its business
as one reportable operating segment. The Company’s Chief Executive Officer, who is the chief operating decision maker, reviews
financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance.
Risks and Uncertainties
The Company operates in a dynamic and highly
competitive industry and believes that changes in any of the following areas could have a material adverse effect on the Company’s
future financial position, results of operations, or cash flows: ability to obtain future financing; advances and trends in new technologies
and industry standards; results of clinical trials; regulatory approval and market acceptance of the Company’s products; development
of sales channels; certain strategic relationships; litigation or claims against the Company related to intellectual property, product,
regulatory, or other matters; and the Company’s ability to attract and retain employees necessary to support its growth.
The Company’s general business strategy
may be adversely affected by any such economic downturns (including the current downturn related to the ongoing COVID-19 pandemic),
volatile business environments and continued unstable or unpredictable economic and market conditions.
Any product candidates developed by the Company
will require approvals from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance that
the Company’s current product candidates or any future product candidates will receive the necessary approvals. If the Company
is denied approval, approval is delayed or the Company is unable to maintain approval, it could have a materially adverse impact on the
Company.
The Company has expended and will continue to
expend substantial funds to complete the research, development and clinical testing of its product candidates. The Company also will
be required to expend additional funds to establish commercial-scale manufacturing arrangements and to provide for the marketing and
distribution of products that receive regulatory approval. The Company will require additional funds to commercialize its products. The
Company is unable to entirely fund these efforts with its current financial resources. If adequate funds are unavailable on a timely
basis from operations or additional sources of financing, the Company may have to delay, reduce the scope of or eliminate one or more
of its research or development programs, which would materially and adversely affect its business, financial condition and operations.
The Company is dependent upon the services of
its employees, consultants and other third parties.
6
Deferred Offering Costs
Deferred offering costs, consisting of legal,
accounting and other fees and costs relating to the Company’s Initial Public Offering (“IPO”) are capitalized and recorded
as a current asset on the balance sheets. The deferred offering costs will be offset against the proceeds received upon the closing of
the IPO, which occurred on July 15, 2021. There were $ 0.2 million and $ 0.9 million of deferred offering costs capitalized as of December
31, 2020 and June 30, 2021, respectively.
Fair Value of Financial Instruments
The Company’s financial instruments include
cash, prepaid expenses, accounts payable, convertible notes and a loan from the Chief Executive Officer and stockholder of the Company.
The carrying amounts of these items approximate fair value as of December 31, 2020 and June 30, 2021 due to their short-term nature.
Concentration of Credit Risk
Financial instruments that potentially subject
the Company to concentration of credit risk consist of cash. All of the Company’s cash (which was nominal at December 31, 2020
and at June 30, 2021) was deposited in one account at a financial institution, and the account balance may at times exceed federally
insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial strength of the depository
institution in which the cash is held.
Prepaid Expenses
Prepaid expenses represent costs incurred that
benefit future periods. These costs are amortized over specific time periods based on the agreements.
Research and Development Expenses
Substantially all of the Company’s research
and development expenses consist of expenses incurred in connection with the development of the Company’s product candidates. These
expenses include fees paid to third parties to conduct certain research and development activities on the Company’s behalf, consulting
costs, costs for laboratory supplies, product acquisition and license costs, certain payroll and personnel-related expenses, including
salaries and bonuses, employee benefit costs and stock-based compensation expenses for the Company’s research and product development
employees and allocated overheads, including information technology costs and utilities and expenses for issuance of shares pursuant
to the anti-dilution clause in the purchase of IPR&D technology. The Company expenses both internal and external research and development
expenses as they are incurred.
General and Administrative Expenses
General and administrative expenses represent
personnel costs for employees involved in general corporate functions, including finance, accounting, legal and human resources, among
others. Additional costs included in general and administrative expenses consist of professional fees for legal (including patent costs),
audit and other consulting services, stock-based compensation and other general corporate overhead expenses as well as costs from a service
agreement with a related party (See Note 6).
Patent Costs
The Company expenses all costs as incurred in
connection with patent licenses and applications (including direct application fees, and the legal and consulting expenses related to
making such applications) and such costs are reflected in general and administrative expenses in the statements of operations.
7
Stock-Based Compensation
The Company accounts for stock-based compensation
for all share-based payments made to employees and non-employees by estimating the fair value on the date of grant and recognizing compensation
expense over the requisite service period on a straight-line basis. The Company recognizes forfeitures related to stock-based compensation
as they occur. The Company estimates the fair value of stock options using the Black-Scholes option-pricing model. The Black-Scholes
model requires the input of subjective assumptions, including expected common stock volatility, expected dividend yield, expected term,
risk-free interest rate, and the estimated fair value of the underlying common stock on the date of grant.
Common Stock Valuations
The Company is required to periodically estimate
the fair value of common stock when issuing stock options and computing their estimated stock-based compensation expense. The fair value
of common stock was determined on a periodic basis, with the assistance of an independent third-party valuation expert. The assumptions
underlying these valuations represented Management’s best estimates, which involved inherent uncertainties and the application
of significant levels of Management judgment.
In order to determine the fair value, the Company
considered, among other things, contemporaneous transactions involving the sale of the Company’s common stock to unrelated third
parties; the lack of marketability of the Company’s common stock; and the market performance of comparable publicly traded companies.
Income Taxes
The Company accounts for corporate income taxes
in accordance with GAAP as stipulated in ASC, Topic 740, Income Taxes, (“ASC 740”). This standard entails the use of the
asset and liability method of computing the provision for income tax expense. Current tax expense results from corporate tax payable
at the Federal and California jurisdictions for the Company, which relate to the current accounting period. Deferred tax expense results
primarily from temporary differences between financial statement and tax return reporting, which result in additional tax payable in
future periods. Deferred tax assets and liabilities are determined based on the differences between the financial statement basis and
tax basis of assets and liabilities using enacted tax rates and law. Net future tax benefits are subject to a valuation allowance when
management expects that it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized.
Current and non-current tax assets and liabilities
are based upon an estimate of taxes refundable or payable for each of the jurisdictions in which the Company is subject to tax. In the
ordinary course of business there is inherent uncertainty in quantifying income tax positions. The Company assess income tax positions
and record the largest amount of tax benefit with a greater than 50 % likelihood of being realized upon ultimate settlement with a taxing
authority that has full knowledge of all relevant information. For those income tax positions where it is not more likely than not that
a tax benefit will be sustained, no tax benefit is recognized in the financial statements. The Company’s policy is to recognize
interest or penalties related to income tax matters in income tax expense.
Comprehensive Loss
Comprehensive loss includes all changes in equity
(net assets) during a period from non-owner sources. There were no elements of other comprehensive income (loss) in the periods presented,
as a result comprehensive loss is the same as net loss for each period presented.
Net Loss per Share
Basic net loss per common share is calculated
by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of potentially
dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares
and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, common stock
options are considered to be potentially dilutive securities. Basic and diluted net loss per share is presented in conformity with the two-class method
required for participating securities. The Company has no participating securities and as such, the net loss was attributed entirely
to common stockholders. As the Company has reported a net loss for all periods presented, diluted net loss per common share is the same
as basic net loss per common share for those periods. All common share amounts and per share amounts have been adjusted to reflect a
1-for-4.3 reverse stock split of the Company’s common stock that was effectuated on June 21, 2021.
8
Recent Accounting Pronouncements
From time to time, new accounting pronouncements
are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies and adopted by the Company
as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective are
not expected to have a material impact on the Company’s financial position or results of operations upon adoption.
In August 2020, the FASB issued ASU 2020-06,
Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies the accounting for convertible
instruments. ASU 2020-06 eliminates certain models that require separate accounting for embedded conversion features. Additionally, among
other changes, the guidance eliminates certain of the conditions for equity classification for contracts in an entity’s own equity.
The guidance also requires entities to use the if-converted method for all convertible instruments in the diluted earnings per share
calculation and include the effect of share settlement for instruments that may be settled in cash or shares, except for certain liability-classified
share-based payment awards. This guidance is effective for the Company beginning in the first quarter of 2022 and must be applied using
either a modified or full retrospective approach. Early adoption is permitted, but no earlier than annual periods beginning after December
15, 2020. The Company is currently evaluating the impact this guidance will have on its financial statements.
In February 2016, the FASB issued ASU 2016-02,
Leases (Topic 842). This ASU requires a lessee to recognize in the statement of financial position a liability to make lease payments
(the lease liability) and a right-of-use asset representing its right to use the underlying asset for the leases with a term of greater
than 12 months. This ASU is effective for the Company’s fiscal years beginning after December 15, 2021, with early adoption permitted.
The Company has adopted this standard effective as of January 1, 2019. The Company chose to adopt the package of practical expedients
available from the FASB. As a policy election, the Company chose to expense and amortize, on a straight line, the leases with terms less
than 12 months. The adoption of this standard did not have a material effect on the Company’s financial statements.
3. Significant
Agreements
With regards to manufacturing, testing and potential
commercial supply of Renazorb, the Company has entered into an agreement with Shilpa Medicare Ltd based in India. According to the terms
of the agreement Unicycive will pay the vendor $2 million in the first calendar year when the net revenue reaches $10 million from sales
of Renazorb following its approval by the FDA and commercial supply of the product by the vendor (First Payment). Thereafter, we will
pay $2 million per year for four consecutive years, after the first year’s payment, for the total payments of $10 million, provided
all commercial supplies are continued to be manufactured and supplied by the vendor. Unicycive is not obligated to make any payments
to the vendor until FDA approval of the product is obtained and commercial revenue is generated.
In October 2017, the Company entered into an
exclusive license agreement with Sphaera, a stockholder, for the rights to further develop the drug candidate, UNI 494, for commercialization.
No payments were made upon execution of the agreement but rather payments for $50,000 will be due commencing with the initiation by the
Company of a second clinical trial and $50,000 on completion of such trial. At the time the FDA accepts a NDA application submitted by
the Company for the product, the Company will pay Sphaera $1.65 million. Upon commercialization and sale of the drug product, royalty
payments will also be payable quarterly to Sphaera equal to 2% of net sales on the preceding quarter.
In September 2018, the Company entered into an
Assignment and Asset Purchase Agreement with Spectrum Pharmaceuticals, Inc. (“Spectrum Agreement”) pursuant to which the
Company purchased certain assets from Spectrum, including Spectrum’s right, title, interest in and intellectual property related
to Renazorb RZB 012, also known as RENALAN™ (“Renalan”) and RZB 014, also known as SPI 014 (“SPI” and together
with Renalan, the “Compounds”), to further develop and commercialize Renazorb and related compounds. In partial consideration
for the Spectrum Agreement, the Company issued 313,663 shares of common stock to Spectrum valued at approximately $ 4,000 which represented
four percent of the Company on a fully-diluted basis at the date of the execution of the Spectrum Agreement. The Spectrum Agreement has
an anti-dilution provision, which provides that Spectrum maintain its ownership interest in the Company at 4 % of the Company’s
shares on a fully-diluted basis. Fully-diluted shares of common stock for purposes of the Renazorb Purchase Agreement assumes conversion
of any security convertible into or exchangeable or exercisable for common stock or any combination thereof, including any common stock
reserved for issuance under a stock option plan, restricted stock plan, or other equity incentive plan approved by the Board of Directors
of the Company immediately following the issuance of additional shares of the Company’s common stock (but prior to the issuance
of any additional shares of common stock to Spectrum). Spectrum’s ownership shall not be subject to dilution until the earlier
of thirty-six months from the first date the Company’s stock trades on a public market, or the date upon which the Company attains
a public market capitalization of at least $ 50 million. As part of the anti-dilution clause, the Company issued 149,762 and 105,897 shares
of common stock during the years ended December 31, 2019 and 2020, respectively. The Company recognized $ 145,000 and $ 104,000 for the
years ended December 31, 2019 and 2020, respectively, as research and development expenses as cost to issue those shares. The Company
is also required to pay Spectrum 40% of all of the Company’s sublicense income for any sublicense granted to certain sublicensees
during the first 12 months after the Closing Date (as that term is defined in the Renazorb Purchase Agreement) and 20% of all other sublicense
income. The Company’s payment obligations to Spectrum will expire on the twentieth (20 th ) anniversary of the Closing
Date of the Renazorb Purchase Agreement.
9
On February 8, 2021,
the Company entered into a Master Services Agreement (the “Renazorb Development Agreement”) with Ascent Development Services,
Inc. (“Ascent”) pursuant to which Ascent will provide strategic services related to the development of Renazorb or other
investigational products (the “Compounds”) for clinical use and regulatory approval in Japan and other Asian countries. The
Renazorb Development Agreement anticipates services to be provided by Ascent will include market research, facilitation of informal and
formal meetings with Japan’s Pharmaceutical and Medical Devices Agency (“PMDA”), management of contract research organizations
and clinical trials, and government applications and regulatory filings related to the Asian development of the Compounds. Unicycive
will supply the Compounds or other materials necessary for Ascent to perform the development services. The initial Statement of Work
(“SOW”) under the Renazorb Development Agreement encompasses the development of clinical strategy as well as both informal
and formal meetings with the PMDA. The budget for the initial SOW is approximately 24,000,000 Japanese Yen, and an upfront payment of
approximately $87,000, was paid to Ascent upon the execution of the Renazorb Development Agreement and was recorded to prepaid expenses
and other current assets in accompanying balance sheets. Deliverables for the initial SOW are expected to be completed by December 31,
2021.
4. Balance
Sheet Components
Accounts payable as of December 31, 2020 and
June 30, 2021 consisted of the following (in thousands):
As of
As of
December 31,
June 30,
2020
2021
(unaudited)
Trade accounts payable
$ 183
$ 334
Credit card liability
1
23
Total
$ 184
$ 357
5.
Debt
Convertible Notes
In January through May 2021, the Company issued
convertible notes (the “2021 Notes”) in the aggregate principal amount of approximately $ 1,098,000 . The 2021 Notes bear interest
at a rate of 12 % per annum, payable at maturity, and mature between January and May, 2022. The 2021 Notes shall automatically convert
into shares of the Company’s common stock upon the closing of a financing pursuant to which the Company receives gross proceeds
of at least $ 500,000 (a “Qualified Financing”) or upon a change of control. The 2021 Notes shall convert into such numbers
of shares of the Company’s common stock equal to the conversion amount divided by the Conversion Price. “Conversion Price”
means (i) in the event of a Qualified Financing, 70 % of the price per share (or conversion price, as applicable) of common stock (or
securities convertible into common stock, as applicable) sold in such financing or (ii) in the event of a change of control, the price
per share reflected in such transaction.
10
The Company has accounted for the 2021 Notes
as stock-settled debt and is accreting the carrying amount of the 2021 Notes to the settlement amount through maturity. As of June 30,
2021, unpaid and accrued interest of $ 49,000 as well as debt discount accretion expense of approximately $ 172,000 is included with the
Convertible notes on the balance sheet.
In July through November 2020, the Company issued
convertible notes (the “2020 Notes”) in the aggregate principal amount of $1,290,000. The 2020 Notes bear interest at a rate
of 12% per annum, payable at maturity, and mature between July and November, 2021. The 2020 Notes shall automatically convert into shares
of the Company’s common stock upon the closing of a financing pursuant to which the Company receives gross proceeds of at least
$500,000 (a “Qualified Financing”) or upon a change of control. The 2020 Notes shall convert into such numbers of shares
of the Company’s common stock equal to the conversion amount divided by the Conversion Price. “Conversion Price” means
(i) in the event of a Qualified Financing, 70% of the price per share (or conversion price, as applicable) of common stock (or securities
convertible into common stock, as applicable) sold in such financing or (ii) in the event of a change of control, the price per share
reflected in such transaction.
The Company has accounted for the 2020 Notes as
stock-settled debt and is accreting the carrying amount of the 2020 Notes to the settlement amount through maturity. As of December 31,
2020, unpaid and accrued interest of $ 53,000 as well as debt discount accretion expense of approximately $ 186,000 was included with the
convertible notes on the balance sheet. As of June 30, 2021, unpaid and accrued interest of $ 130,000 as well as debt discount accretion
expense of approximately $ 460,000 is included with the convertible notes on the balance sheet.
In 2017 and 2018, the Company raised $550,000
from the issuance of twelve convertible promissory notes (the “2018 Notes”). The 2018 Notes bear interest at 10% per annum
which was payable at maturity. The 2018 Notes’ principal and interest were due and payable on written demand by the majority of
the 2018 Note holders on the two-year anniversary of the first 2018 Note issued. The first 2018 Note was issued on October 5, 2017 and,
accordingly, all 2018 Notes would have matured on October 5, 2019. In the event the Company consummated an equity financing with an aggregate
sales price of not less than $500,000, then the aggregate outstanding principal and unpaid interest would automatically convert into
shares of the Company’s common stock. The per-share price of the conversion would be equal to 75% of the price per share paid by
the cash purchasers of the common stock sold in the financing.
The Company accounted for the 2018 Notes as stock-settled
debt and accreted the carrying amount of the 2018 Notes to the settlement amount through maturity. On July 31, 2019, all 2018 Notes principal
and accrued interest were converted into 1,159,065 shares of common stock upon the consummation of a 2019 equity financing in excess
of $ 500,000 . The Company recorded, as part of the conversion of the debt, a loss on conversion of $ 63,000 included in other expenses.
Paycheck Protection Program Loan
On April 23, 2020, the Company entered into an
$18,000 loan with Silicon Valley Bank pursuant to the Small Business Administration’s (“SBA”) Paycheck Protection Program
(“PPP”) as well as a $1,000 loan pursuant to the Economic Injury Disaster Assistance Program. The PPP loan proceeds are intended
to be used for payroll over the eight-week period following the date of the loan. The loan terms provide that no principal or interest
payments are due and interest will accrue at 1% per annum commencing on April 23, 2020 through October 23, 2020 (deferral period). Commencing
one month after the deferral period and continuing monthly through the maturity of the loan on April 23, 2022, equal monthly payments
of principal and interest are due. The Company classified the loans as a current liability, has applied for and received loan forgiveness
in February 2021, and recorded a gain on extinguishment of debt in the statement of operations for the six months ended June 30, 2021.
11
6. Related
Party Transactions
Loan from Chief Executive Officer and Stockholder
As of June 30, 2021 and December 31, 2020, the
current liability loan from a stockholder of approximately $ 901,000 and $ 967,000 , respectively, represents primarily the accumulation
of deferred compensation due to the chief executive officer and stockholder. This amount bears no interest and is repayable on demand.
Service agreement with Globavir
On July 1, 2017, as amended on April 6, 2020,
the Company entered into a Service Agreement with Globavir Biosciences, Inc. (“Globavir”), a related party (the “Service
Agreement”). Globavir provides administrative and consulting services and shared office space and other costs in connection with
the Company’s drug development program. The Service Agreement provides Globavir the right to receive $ 50,000 per month for such
services through December 31, 2019 and $ 10,000 per month commencing on January 1, 2020. As of December 31, 2020, $ 9,000 was payable to
Globavir for such service fees. As of June 30, 2021, $ 38,000 was prepaid to Globavir for such service fees. Amounts incurred by the Company
under the Service Agreement were $ 30,000 , $ 30,000 , $ 60,000 and $ 60,000 for the three and six months ended June 30, 2020 and June 30,
2021, respectively, and are included in operating expenses in the statements of operations. The initial amended term of the agreement
ended on December 31, 2020, and unless terminated, the Service Agreement automatically renews for successive one month periods after
the initial termination date.
Common stock purchase agreement and services
agreement
On July 1, 2017, the Company entered into a Common
Stock Purchase Agreement (“Stock Agreement”) with Globavir. The Company’s principal stockholder is also the principal
stockholder in Globavir. The Stock Agreement provided for the distribution of 62,181 shares of the Company’s common stock, valued
at $ 0.013 per share, to Globavir’s stockholders as payment for Globavir’s services and shared costs rendered on behalf of
the Company in 2017, which were issued in 2018.
7. Commitments
and Contingencies
Contingencies
The Company is subject to claims and legal proceedings
that arise in the ordinary course of business. Such matters are inherently uncertain, and there can be no guarantee that the outcome
of any such matter will be decided favorably to the Company or that the resolution of any such matter will not have a material adverse
effect upon the Company’s financial statements. The Company currently has no pending claims or legal proceedings.
In September 2020, the Company signed an engagement
letter (the “Benchmark Agreement”) with The Benchmark Company LLC (“Benchmark”) to act as the lead or managing
underwriter in connection with the Company’s planned initial public offering. In connection with this agreement the Company has
agreed to pay a nonaccountable expense allowance to Benchmark equal to 1.0 % of the gross proceeds received in the Company’s planned
initial public offering. In addition to the non-accountable expense allowance, the Company has also agreed to pay or reimburse the underwriters
for certain of the underwriters’ out-of-pocket expenses relating to the offering, including all reasonable fees and expenses of
the underwriters’ outside legal counsel, and background checks, which shall not exceed in the aggregate $ 132,500 .
In March 2021, the Benchmark Agreement was terminated.
Concurrent with the termination, the Company signed an advisory services agreement pursuant to which the Company will pay Benchmark $ 150,000
upon the closing of the planned initial public offering, and Benchmark will provide advisory services with respect to the planned public
offering. The Company accrued the $ 150,000 advisory fee in June 2021, and the fee is recorded as a deferred offering cost on the accompanying
balance sheet.
Indemnifications
In the normal course of business, the Company
enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications,
including for losses suffered or incurred by the indemnified party, in connection with any trade secret, copyright, patent or other intellectual
property infringement claim by any third party with respect to its technology. The term of these indemnification agreements is generally
perpetual any time after the execution of the agreement. The Company’s exposure under these agreements is unknown because it involves
claims that may be made against the Company in the future, but that have not yet been made. To date, the Company has not paid any claims
or been required to defend any action related to its indemnification obligations.
12
The Company believes that the likelihood of conditions
arising that would trigger these indemnities is remote and, historically, the Company had not made any significant payment under such
indemnification provisions. Accordingly, the Company has not recorded any liabilities relating to these agreements. However, the Company
may record charges in the future as a result of these indemnification obligations.
Additionally, the Company has agreed to indemnify
its directors and officers for certain events or occurrences while the director or officer is, or was serving, at the Company’s
request in such capacity. The indemnification period covers all pertinent events and occurrences during the director’s or officer’s
service. The Company intends to enter into new indemnification agreements with its officers and directors to further expand coverage
of these individuals following the July 15, 2021 completion of the Company’s initial public offering.
8. Stockholders’
Deficit
Authorized Common Stock
The Company is authorized to issue up to 200,000,000
shares of common stock at par value of $ 0.001 per share.
Issuance of Common Stock
During the six months ended June 30, 2021, employees
and consultants exercised a total of 383,721 stock options and the Company received $119,000 in proceeds. A portion of these options were
exercised early (prior to vesting), and as of June 30, 2021, 126,501 of the options remained unvested. Proceeds received related to the
unvested options of $82,000 at June 30, 2021 were recorded in accrued liabilities on the accompanying balance sheets and will be reclassified
to equity as vesting occurs, provided the employees and consultants continue to provide services to the Company. The vested portion of
the exercises was 257,220 shares at June 30, 2021.
During the six months ended June 30, 2020, the
Company issued 33,263 shares to investors in exchange of cash at $ 4.21 per share.
During the year ended December 31, 2020, the
Company issued 33,263 shares to investors in exchange of cash at $ 4.21 per share and 24,627 shares to Spectrum following its anti-dilution
provision (Note 3).
Voting Rights of Common Stock
Each holder of shares of common stock shall be
entitled to one vote for each share thereof held.
Preferred Stock
As of December 31, 2020 and June 30, 2021, the
Company had 10,000,000 shares of preferred stock authorized, par value of $ 0.001 per share and no shares of preferred stock were issued
or outstanding.
9. Stock-based
Compensation
In 2018, the Company adopted the 2018 Equity
Incentive Plan (“2018 Plan”) which allows for the granting of incentive stock options (“ISO”), non-qualified
stock options (“NSO”), stock appreciation rights, restricted stock and restricted stock units to the employees, members of
the board of directors and consultants of the Company. In 2018, the Company granted ISOs and NSOs to consultants and directors from this
plan. As of December 31, 2020 and June 30, 2021, respectively, 465,116 shares are authorized for issuance and 17,442 shares are available
for future grant under the 2018 Plan.
13
In October 2019, the Company adopted the 2019
Stock Option Plan (“2019 Plan”) which allows for the granting of incentive stock options (“ISO”), non-qualified
stock options (“NSO”) to the employees, members of the board of directors and consultants of the Company. In 2019 and during
the first seven months of 2020, the Company granted ISOs and NSOs to consultants and directors from the 2019 Plan. As of December 31,
2019, 232,558 shares were authorized for issuance and 75,581 shares were available for future grant under the 2019 Plan. On April 6,
2020 the Company increased the shares authorized for issuance to 348,837 shares total. On February 17, 2021, the Company increased the
shares authorized for issuance to 1,767,442 shares total. As of June 30, 2021, 1,296,977 shares were available for future grant under
the 2019 Plan.
The following table summarizes activity for stock
options under both plans for the six months ended June 30, 2021:
Weighted-
Number of
Average
Shares
Weighted-
Remaining
Aggregate
Underlying
Average
Contractual
Intrinsic
Outstanding
Exercise
Term
Value
Options
Price
(in Years)
(in thousands)
Outstanding, December 31, 2020
786,047
1.42
8.28
2,201
Options granted
132,093
7.01
Options exercised
( 257,219 )
0.12
Outstanding, June 30, 2021
660,921
3.03
7.61
2,631
Shares vested and exercisable as of June 30, 2021
215,599
$ 2.94
8.19
$ 877
The grant date fair value of options granted
during the six months ended June 30, 2021 was $ 0.7 million.
As of June 30, 2021, the unrecognized compensation
cost related to outstanding stock options was $ 1.2 million, which is expected to be recognized as expense over approximately 2.8 years.
The Company has recorded stock-based compensation
expense, allocated by functional cost as follows for the three and six months ended June 30, 2020 and 2021 (in thousands):
Three Months Ended
Six Months Ended
June 30,
June 30,
2020
2021
2020
2021
Research and development
$ 43
$ 271
$ 60
$ 456
General and administrative
17
23
31
40
Total stock-based compensation
$ 60
$ 294
$ 91
$ 496
Fair Value of Stock Options
The assumptions are based on the following for
each of the periods presented:
Expected Term - The expected
term is calculated using the simplified method which is used when there is insufficient historical data about exercise patterns and post-vesting
employment termination behavior. The simplified method is based on the vesting period and the contractual term for each grant, or for
each vesting-tranche for awards with graded vesting. The mid-point between the vesting date and the maximum contractual expiration
date is used as the expected term under this method.
Common Stock Fair Value - The
fair value of the common stock underlying the Company’s stock options was estimated at each grant date and was determined on a
periodic basis and based either on transactions with third parties in which common stock was sold for cash or with the assistance of
an independent third-party valuation expert. The assumptions underlying these valuations represented management’s best estimates,
which involved inherent uncertainties and the application of significant levels of management judgment.
Volatility - The expected volatility
being used is derived from the historical stock volatilities of a representative industry peer group of comparable publicly listed companies
over a period approximately equal to the expected term of the options.
14
Risk-free Interest Rate - The
risk-free interest rate is based on median U.S. Treasury zero coupon issues with remaining terms similar to the expected term on the
options.
Expected Dividend - The Company
has never declared nor paid any cash dividends and does not plan to pay cash dividends in the foreseeable future, and therefore, used
an expected dividend yield of zero .
The following averaged assumptions were used
to calculate the fair value of awards granted to employees, directors and non-employees for the year ended December 31, 2020 and for
the six months ended June 30, 2020 and 2021:
Six Months Ended
June 30,
2020
2021
Expected volatility
114.00 %
104.00 – 105.00 %
Risk-free interest rate
0.44 - 0.51 %
0.92 %
Dividend yield
- %
- %
Expected term
6.25 years
5.13 – 6.25 years
10. Net
loss per share
The following table sets forth the computation
of basic and diluted net loss per share (in thousands, except share and per share data):
Three
Months Ended
June 30,
Six
Months Ended
June 30,
2020
2021
2020
2021
Numerator:
Net loss
$ ( 338 )
$ ( 1,100 )
$ ( 682 )
$ ( 2,064 )
Denominator:
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted
8,483,382
8,771,290
8,472,866
8,677,497
Net loss per share attributable to common stockholders, basic and diluted
$ ( 0.04 )
$ ( 0.13 )
$ ( 0.08 )
$ ( 0.24 )
The following outstanding shares of potentially
dilutive securities were excluded from the computation of diluted net loss per share for the periods presented because including them
would have been antidilutive:
Three Months Ended
June 30,
Six Months Ended
June 30,
2020
2021
2020
2021
Options to purchase common stock
748,837
660,921
748,837
660,921
Total
748,837
660,921
748,837
660,921
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11. Subsequent
Events
On July 13, 2021, the Company entered into an
underwriting agreement with Roth Capital Partners, pursuant to which the Company issued and sold, in an underwritten initial public offering,
5,000,000 units at a public offering price per unit of $ 5.00 . Each unit consists of one share of common stock and four-fifths of a warrant
to purchase one share of common stock. The warrants have an exercise price of $ 6.00 per share and are exercisable for a period of five
years after the issuance date. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional
750,000 shares of its common stock and/or warrants to purchase up to an additional 600,000 shares of its common stock, at the initial
public offering price, less the underwriting discounts and commissions. On July 15, 2021, the underwriters exercised their option to
purchase warrants for an additional 600,000 shares of common stock, and the Company received gross proceeds of $7,500 for the exercise.
As a result of its initial public offering (“IPO”),
on July 13, 2021 the Company began trading on the Nasdaq Capital Market under the symbol “UNCY”, and on July 15, 2021 received
approximately $ 23,212,000 in net proceeds after deducting the underwriting discounts and commissions and estimated offering expenses.
The Company intends to use the net proceeds from the IPO to complete pre-clinical and clinical studies, submit regulatory filings to
the FDA, and for general and corporate purposes, including hiring additional management and conducting market research and other commercial
planning.
On July 15, 2021, in connection with the
completion of the Company’s IPO, all outstanding convertible notes, including principal and accrued interest, were
automatically converted into shares of common stock. The conversion was calculated based on 70 % of the IPO price per unit and will
result in the issuance of 736,773 shares of common stock and 184,193 warrants to purchase additional shares of common stock.
On July 15, 2021, in connection with the completion
of the Company’s IPO, the Company adopted a new comprehensive equity incentive plan, the 2021 Omnibus Equity Incentive Plan (the
“2021 Plan”). Following the effective date of the 2021 Plan, no further awards may be issued under the 2018 Plan or the 2019
Plan (collectively, the “Prior Plans”). However, all awards under the Prior Plans that are outstanding as of the effective
date of the 2021 Plan will continue to be governed by the terms, conditions and procedures set forth in the Prior Plans and any applicable
award agreements. A total of 1,302,326 shares of common stock are reserved for issuance pursuant to the 2021 Plan. The 2021 Plan provides
for the issuance of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock, restricted stock
units, and other stock-based awards.
On July 2, 2021 we entered into an employment
agreement with Mr. John Townsend, pursuant to which Mr. Townsend serves as our Chief Financial Officer. Mr. Townsend’s employment
agreement provides for an annual base salary of $220,000 and provides that Mr. Townsend will be eligible for an annual discretionary
bonus, with a target amount equal to 30% of his base salary, based on the achievement of certain performance objectives established by
our Board of Directors. In accordance with the terms of Mr. Townsend’s employment agreement, as soon as reasonably practicable
after the date of an initial public offering of the Company, he will receive a one-time equity grant of 18,605 stock options, which shall
vest over a period of three years from the date of grant. In addition, Mr. Townsend’s employment agreement contains standard non-competition
and non-solicitation provisions. Mr. Townsend is also eligible to receive additional equity-based compensation awards as the Company
may grant from time to time. Mr. Townsend’s employment agreement further provides for standard expense reimbursement, vacation
time and other standard executive benefits.
During July 2021, in connection with the completion
of the Company’s IPO, Shalabh Gupta, our Chief Executive Officer, was paid approximately $ 463,000 for previously earned deferred
compensation and approximately $ 219,000 for previously earned bonus amounts. Dr. Gupta was also repaid $ 216,000 for previous loans made
to the Company.
In connection with the completion of the Company’s
IPO, additional shares of common stock will be issued to Spectrum Pharmaceuticals, Inc., in September of 2021. The Company’s agreement
with Spectrum contains an anti-dilution clause such that Spectrum maintains an ownership interest in the Company at 4 % of the Company’s
shares on a fully-diluted basis. The anti-dilution clause automatically expired after July 13, 2021 due to the Company attaining a market
capitalization of more than $ 50 million as a result of the IPO.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.