UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For
the month of December
Commission
file number:
(Translation of registrant’s name into English)
The Circle 6
8058 Zurich, Switzerland
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
CONTENTS
This Report of Foreign Private Issuer on Form 6-K consists of (i) NLS Pharmaceutics Ltd.’s, or the Registrant’s, Condensed Interim Financial Statements (unaudited) as of June 30, 2023 and December 31, 2022 and for the six month periods ended June 30, 2023 and 2022, which are attached hereto as Exhibit 99.1; and (ii) the Registrant’s Management’s Discussion and Analysis of Financial Condition and Results of Operations for the six months ended June 30, 2023, which is attached hereto as Exhibit 99.2.
This Report of Foreign Private Issuer on Form 6-K is incorporated by reference into the Registrant’s Registration Statements on Form F-3 (File Nos. 333-262489, 333-268690 and 333-269220), filed with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
| 1 |
EXHIBIT INDEX
| Exhibit No. | Document Description | |
| 99.1 | Condensed Financial Statements (unaudited) of NLS Pharmaceutics as of June 30, 2023 and December 31, 2022 and for the six month periods ended June 30, 2023 and 2022. | |
| 99.2 | Management’s Discussion and Analysis of Financial Condition and Results of Operations. | |
| 101.INS | XBRL Instance Document | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document | |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
| 2 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| NLS Pharmaceutics Ltd. | |||
| Date: December 6, 2023 | By: | /s/ Alexander Zwyer | |
| Name: | Alexander Zwyer | ||
| Title: | Chief Executive Officer | ||
| 3 |
Exhibit 99.1
NLS PHARMACEUTICS LTD.
UNAUDITED
INTERIM CONDENSED FINANCIAL STATEMENTS AS OF
JUNE 30, 2023 AND DECEMBER 31, 2022
AND FOR THE SIX MONTH PERIODS ENDED JUNE 30, 2023 AND 2022
NLS PHARMACEUTICS LTD.
UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
i
NLS PHARMACEUTICS LTD.
UNAUDITED INTERIM CONDENSED BALANCE SHEETS
| June 30, 2023 |
December 31, 2022 |
|||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | |
$ | |||||
| Prepaid expenses and other current assets (Note 3) | ||||||||
| Total current assets | ||||||||
| Property and equipment (Note 4) | ||||||||
| Other assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable, including related party of $ |
$ | |
$ | |||||
| Other accrued liabilities, including related party of $ |
||||||||
| Total current liabilities | ||||||||
| Deferred revenues (Note 6) | ||||||||
| Accrued pension liability | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 7) | ||||||||
| Shareholders’ equity (deficit) | ||||||||
| Common shares, CHF |
||||||||
| Treasury shares | ( |
) | ||||||
| Additional paid-in capital | |
|||||||
| Accumulated deficit | ( |
( |
) | |||||
| Accumulated other comprehensive loss | ( |
( |
) | |||||
| Total shareholders’ equity (deficit) | ( |
|||||||
| Total liabilities and shareholders’ equity (deficit) | $ | |
$ | |||||
The accompanying notes are an integral part of these unaudited interim condensed financial statements.
1
NLS PHARMACEUTICS LTD.
UNAUDITED INTERIM CONDENSED STATEMENTS OF OPERATING AND COMPREHENSIVE LOSS
| For the Six Months Ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | $ | ||||||
| General and administrative | | |||||||
| Total operating expenses | | |||||||
| Operating loss | ( | ( | ) | |||||
| Other income (expense), net | ( | ) | ||||||
| Interest expense | ( | ) | ( | ) | ||||
| Net loss | ( | ) | ( | ) | ||||
| Other comprehensive loss: | ||||||||
| Defined pension plan adjustments | ( | ) | ||||||
| Comprehensive loss | $ | ( | $ | ( | ) | |||
| $ | ( | ) | $ | ( | ) | |||
| | ||||||||
The accompanying notes are an integral part of these unaudited interim condensed financial statements.
2
NLS PHARMACEUTICS LTD.
UNAUDITED INTERIM CONDENSED STATEMENTS OF CHANGES IN EQUITY
FOR THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022
| Common Shares | Treasury | Additional Paid in | Accumulated | Accumulated Other Comprehensive | ||||||||||||||||||||||||
| Shares | Amount | Shares | Capital | Deficit | Loss | Total | ||||||||||||||||||||||
| BALANCE, JANUARY 1, 2023 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||
| Issuance of treasury shares | ( | ) | ||||||||||||||||||||||||||
| Stock-based compensation | - | |||||||||||||||||||||||||||
| Defined pension plan adjustments | - | ( | ) | ( | ) | |||||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||||||||||
| BALANCE, JUNE 30, 2023 | $ | $ | ( | ) | $ | $ | ( | ) | ( | ) | ( | ) | ||||||||||||||||
| Common Shares | Treasury | Additional Paid-in | Accumulated | Accumulated Other Comprehensive | ||||||||||||||||||||||||
| Shares | Amount | Shares | Capital | Deficit | Loss | Total | ||||||||||||||||||||||
| BALANCE, JANUARY 1, 2022 | $ | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||
| Issuance of common shares registered direct offering, net | ||||||||||||||||||||||||||||
| Issuance of warrants, net | - | |||||||||||||||||||||||||||
| Issuance of pre-funded warrants, net | - | |||||||||||||||||||||||||||
| Issuance of common shares in At-The-Market (ATM) financing | - | |||||||||||||||||||||||||||
| Issuance of treasury shares | ( | ) | ||||||||||||||||||||||||||
| Defined pension plan adjustments | ||||||||||||||||||||||||||||
| Net loss | ( | ) | ( | ) | ||||||||||||||||||||||||
| BALANCE, JUNE 30, 2022 | $ | $ | ( | ) | $ | $ | ( | ) | ( | ) | $ | ( | ) | |||||||||||||||
The accompanying notes are an integral part of these unaudited interim condensed financial statements.
3
NLS PHARMACEUTICS LTD.
UNAUDITED INTERIM CONDENSED STATEMENTS OF CASH FLOWS
| For the Six Months Ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| Operating Activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in in operating activities: | ||||||||
| Depreciation expense | ||||||||
| Stock-based compensation expense | ||||||||
| Periodic pension costs | ( | ) | ( | ) | ||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other current assets | ( | ) | ||||||
| Accounts payable | ||||||||
| Other accrued liabilities | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Financing Activities: | ||||||||
| Proceeds from the issuance of common shares in ATM financing | ||||||||
| Proceeds from the issuance of common shares in registered direct offering, net | ||||||||
| Proceeds from the issuance of pre-funded warrants, net | ||||||||
| Proceeds from the issuance of warrants, net | ||||||||
| Payments on notes payable | ( | ) | ||||||
| Net cash provided by financing activities | ||||||||
| Effect of exchange rate on cash and cash equivalents | ( | ) | ||||||
| Change in cash and cash equivalents | ( | ) | ( | ) | ||||
| Cash and cash equivalents at the beginning of period | ||||||||
| Cash and cash equivalents at the end of period | $ | $ | ||||||
| Supplemental disclosure of non-cash and financing activities: | ||||||||
| Issuance of note payable for prepaid insurance | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited interim condensed financial statements.
4
NLS PHARMACEUTICS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
Note 1
Background:
NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) (the “Company”) is an emerging biopharmaceutical company engaged in the discovery and development of life-improving drug therapies to treat rare and complex central nervous system disorders, including narcolepsy, idiopathic hypersomnia and other rare sleep disorders, and of neurodevelopmental disorders, such as attention deficit hyperactivity disorder (“ADHD”). The Company’s lead product candidates are Quilience, to treat narcolepsy (type 1 and type 2), and Nolazol, to treat ADHD.
On February
2, 2021, the Company completed the closing of its initial public offering (the “Initial Public Offering”) of
Going Concern
As of June 30, 2023, the Company had an accumulated
deficit of approximately $
As of June 30, 2023, the Company’s cash
and cash equivalents were $
In response to the ever-evolving biotech and pharmaceutical landscape, NLS has initiated exploration of new strategic opportunities. As part of this process, the Company plans to consider a range of options, including strategic partnerships, out-licensing assets of the Company, and other future strategic actions.
Additionally, the Company’s operating plans may change as a result of many factors that may currently be unknown to the Company including:
| ● | the progress and costs of the Company’s pre-clinical studies, clinical trials and other research and development activities; | |
| ● | the scope, prioritization and number of the Company’s clinical trials and other research and development programs; | |
| ● | any cost that the Company may incur under in- and out-licensing arrangements relating to its product candidate that it may enter into in the future; | |
| ● | the costs and timing of obtaining regulatory approval for the Company’s product candidates; | |
| ● | the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; | |
| ● | the costs of, and timing for, strengthening the Company’s manufacturing agreements for production of sufficient clinical and commercial quantities of its product candidates; |
5
NLS PHARMACEUTICS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
| ● | the potential costs of contracting with third parties to provide marketing and distribution services for the Company or for building such capacities internally; and | |
| ● | the costs of acquiring or undertaking the development and commercialization efforts for additional therapeutic applications of the Company’s product candidates and the magnitude of the Company’s general and administrative expenses. | |
As a result, the Company will require additional capital to finance expenditures related to the manufacture of the Company’s product candidates for use in clinical trials, conducting clinical trials and general and administrative expenses. There can be no assurance that funds will be available, or if they are available, that their availability will be on terms acceptable to the Company or in an amount sufficient to enable the Company to fully complete its development activities or sustain operations. If the Company is unable to raise sufficient additional funds, it will have to develop and implement a plan to further extend payables and indebtedness, reduce overhead, or scale back its current business plan until sufficient additional capital is raised to support further operations or force the Company to grant rights to develop and commercialize product candidates that it would otherwise prefer to develop and commercialize on its own.
Accordingly, the accompanying unaudited interim
condensed financial statements have been prepared in conformity with accounting principles generally accepted in the United States of
America (“U.S. GAAP”), which contemplate continuation of the Company as a going concern for a period within
Note 2
Summary of Significant Accounting Policies:
Basis of Preparation
The unaudited interim condensed financial statements have been prepared in accordance with U.S. GAAP for interim financial information and accordingly do not include all information and disclosures as required by U.S. GAAP for complete financial statements. The year-end unaudited interim condensed balance sheet was derived from audited financial statements but does not include all disclosures required by U.S. GAAP. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements included in the Company’s Annual Report on Form 20-F for the year ended December 31, 2022, and any public announcements made by the Company during the interim reporting period.
In the opinion of management, these unaudited interim condensed financial statements reflect all adjustments necessary, which are of a normal recurring nature, to fairly state the balance sheets, statements of operating and comprehensive loss, changes in equity and cash flows for the interim reporting periods presented.
Use of Estimates
The preparation of the unaudited interim condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect amounts reported of assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the interim reporting periods. Actual results could differ from those estimates and be based on events different from those assumptions. As part of these financial statements, the more significant estimates include the valuation allowance related to the Company’s deferred tax assets.
Property and equipment
Property and equipment are recorded at cost, net
of accumulated depreciation and any accumulated impairment losses. Depreciation is computed using the straight-line method over the estimated
useful lives of the assets. The useful lives of property and equipment are
6
NLS PHARMACEUTICS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
Upon retirement or sale, the cost of disposed assets and their related accumulated depreciation are removed from the balance sheet. Any resulting net gains or losses on dispositions of property and equipment are included as a component of operating expenses within the Company’s statements of operating and comprehensive loss. Repair and maintenance costs that do not significantly add value to the property and equipment, or prolong its life, are charged to operating expense as incurred.
Stock-Based Compensation
The Company measures all stock-based awards granted based on the fair value on the date of the grant and recognizes compensation expense with respect to those awards over the requisite service period, which is generally the vesting period of the respective award. Generally, the Company issues awards with only service-based vesting conditions and records the expense for these awards using the straight-line method. The Company recognizes forfeitures related to stock-based compensation awards as they occur and reverses any previously recognized compensation cost associated with forfeited awards in the period the forfeiture occurs.
The Company classifies stock-based compensation expense in the accompanying consolidated statements of operating and comprehensive loss in the same manner in which the award recipients’ payroll costs are classified or in which the award recipients’ service payments are classified.
The fair value of each stock option is estimated on the date of grant using the Black-Scholes option-pricing model (“Black-Scholes”). Black-Scholes requires a number of assumptions, of which the most significant are share price, expected volatility, expected option term (the time from the grant date until the options are exercised or expire), risk-free rate and expected dividend rate. The grant date fair value of a common share is determined by the board of directors (the “Board of Directors”) considering, among other factors, the assistance of a valuation specialist and management. The grant date fair value of a common share is determined using the valuation methodologies, which utilize certain assumptions, including probability weighting of events, volatility, time to liquidation, risk-free interest rate and discount for lack of marketability.
Earnings per Share
Basic loss per common share is computed by dividing
the net loss applicable to common shareholders by the weighted-average number of common shares outstanding during the periods presented.
Diluted loss per common share is computed similar to basic loss per share, except that the denominator is increased to include the number
of additional potential common shares that would have been outstanding if the potential common shares had been issued and if the additional
common shares were dilutive. Potential common shares are excluded from the computation for a period in which a net loss is reported or
if their effect is anti-dilutive. The Company’s potential common shares consist of warrants with their potential dilutive effect
considered using the treasury method. For the six months ended June 30, 2023,
Treasury Shares
Treasury shares are purchased at cost and recognized as a deduction from equity. Income or loss from subsequent sales is presented in equity.
Segment Reporting
The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is on developing therapeutics for the treatment of neurobehavioral and neurocognitive disorders. All of the Company’s tangible assets are held outside the United States of America.
Recently Issued Accounting Standards Not Yet Effective
The Company has implemented all new accounting pronouncements that are in effect and that may impact its consolidated financial statements and does not believe that there are any other new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations.
7
NLS PHARMACEUTICS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
Note 3
Prepaid Expenses and Other Current Assets:
| June 30, 2023 | December 31, 2022 | |||||||
| Vendor prepayments | $ | $ | ||||||
| VAT recoverable and other current assets | ||||||||
| Prepaid insurance | ||||||||
| Prepaid expenses | ||||||||
| Total prepaid expenses and other current assets | $ | $ | ||||||
Note 4
Property and Equipment, net:
| June 30, 2023 | December 31, 2022 | |||||||
| Cost | ||||||||
| Furniture and fixtures | $ | $ | ||||||
| Software | ||||||||
| Total cost | ||||||||
| Accumulated depreciation | ( | ) | ( | ) | ||||
| Total property and equipment, net | $ | $ | ||||||
Deprecation and related amortization expense was
$
Note 5
Other Accrued Liabilities:
| June 30, 2023 | December 31, 2022 | |||||||
| Professional consultants’ expenses | $ | $ | ||||||
| Vendor liabilities | ||||||||
| Expenses | ||||||||
| Accrued board fees | ||||||||
| Accrued bonus | ||||||||
| Other accrued expenses | ||||||||
| Total other accrued liabilities | $ | $ | ||||||
8
NLS PHARMACEUTICS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
Note 6
Deferred Revenues:
In February 2019, the Company entered into a license agreement (the “EF License Agreement”), to develop and commercialize its product candidate, Nolazol, in Latin American countries with Eurofarma Laboratorios S.A. (“Eurofarma”), a Brazilian pharmaceutical company. The EF License Agreement covers the grant of non-transferable licenses, without the right to sublicense, to Eurofarma to develop and commercialize Nolazol in Latin America. The EF License Agreement also specifies the Company’s obligation to advance ongoing development activities with respect to Nolazol in the United States. A joint steering committee will oversee the development and regulatory activities directed towards marketing approval, manufacturing and commercialization phases. The Company believes its participation in the joint steering committee is not of material significance to the licenses in the context of the EF License Agreement on the whole and, as such, management has excluded these activities in the determination of its performance obligation(s) under the EF License Agreement.
The EF License Agreement provides that the parties shall enter into a separate manufacturing and supply agreement during the term of the EF License Agreement.
Under the EF License
Agreement, the Company received a non-refundable, upfront payment, of $
The Company identified the licenses granted to Eurofarma and its obligation to advance development activities with respect to Nolazol in the United States as the material promises under the EF License Agreement. For purposes of identifying the Company’s performance obligations under the EF License Agreement, management believes that while the exclusive licenses were granted to Eurofarma at the outset of the EF License Agreement, the grant of those licenses does not singularly result in the transfer of the Company’s broader obligation to Eurofarma under the EF License Agreement.
The Company is obligated under the EF License Agreement to advance its development activities in the United States and those activities precede Eurofarma’s necessary regulatory approvals for commercialization of Nolazol, in Latin American countries. The Company intends to apply its proprietary know-how to the ongoing development activities in the United States involving its intellectual property relating to Nolazol. These development activities are specific to the Company and the Company believes they are not capable of being distinct in the context of the EF License Agreement on the whole.
The licenses provided to Eurofarma are not transferable and without the right to sublicense therefore Eurofarma is not presently able to monetize its investment in Nolazol as clinical development in the United States or any Latin American countries has yet to be completed and Eurofarma has yet to seek or obtain regulatory approval in any Latin American country. The licenses to Eurofarma represent rights to use the Company’s intellectual property with respect to Nolazol for which revenue is recognized at a point in time which is when Eurofarma is able to use and benefit from the licenses. The licenses are considered of limited value without the Company’s development activities with respect to Nolazol in the United States. As such, the licenses are not capable of being distinct until after successful clinical development and regulatory approval and alone do not have standalone functionality to Eurofarma. Management has determined that the licenses, while capable of being distinct, are not distinct as they do not have stand-alone value to Eurofarma without the Company’s planned development activities in the United States and the approval for sale in Latin America.
Bundled together with the Company’s development activities of Nolazol in the United States, the licenses granted under the EF License Agreement will enable Eurofarma to seek regulatory approvals and ultimately seek to commercialize Nolazol in Latin America. Therefore, management believes the licenses bundled together with the Company’s development activities in the United States constitute a single distinct performance obligation under the EF License Agreement for accounting purposes (the “License Performance Obligation”).
9
NLS PHARMACEUTICS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
The Company has
initially estimated a total transaction price of $
The Company has
allocated the transaction price entirely to the single License Performance Obligation and recorded the $
Amounts expected
to be recognized as revenue within the 12 months following the balance sheet date are classified as a current portion of deferred revenue
in the accompanying condensed balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance
sheet date are classified as deferred revenue, net of current portion. As of June 30, 2023 and December 31, 2022, the Company has long-term
deferred revenues of $
Note 7
Commitments and Contingencies:
Commitments
On March
10, 2021, the Company entered into a License Agreement (the “Agreement”) with Novartis Pharma AG (“Novartis”),
whereby the Company obtained, on an exclusive basis in the U.S., all of the available data referred to and included in the original new
drug application (“NDA”) for Sanorex® (mazindol) submitted to the U.S. Food and Drug Administration (“FDA”)
in February 1972. The Agreement encompasses all preclinical and clinical studies, data used for manufacturing including stability and
other chemistry manufacturing and controls data, formulation data and know-how for all products containing mazindol as an active substance,
and all post-marketing clinical studies and periodic safety reports from 1973 onwards. Under the Agreement, the Company has obtained the
same rights on a non-exclusive basis in all territories outside of the U.S. except for Japan, with the right to cross-reference the Sanorex
NDA with non-U.S. regulatory agencies in the licensed territories. The Agreement includes the right to sublicense or assign the license
to third parties, subject to such third parties meeting certain obligations. As consideration for the license, the Company paid Novartis
$
Litigation
The Company may become involved in miscellaneous litigation and legal actions, including product liability, consumer, commercial, tax and governmental matters, which can arise from time to time in the ordinary course of the Company’s business. Litigation and legal actions are inherently unpredictable, and excessive verdicts can result in such situations. The Company is not currently involved in any such matters.
Note 8
Share Capital and Public Offerings:
Common Shares:
As of June 30, 2023, the Company had
10
NLS PHARMACEUTICS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
On December 13, 2022,
the Company closed a private placement offering with funds affiliated with BVF Partners L.P. (“ BVF”), providing for the issuance
of (i)
The Company engaged Laidlaw
& Company (UK) Ltd. (“Laidlaw”) to serve as the placement agent for the Company in connection with the above-described
offering. The Company agreed to pay Laidlaw a cash placement fee of $
In addition, the Company
and BVF agreed that until the 30th day following receipt of the official written minutes from the end of the Phase 2 meeting
to be held by the Company with the FDA (the “Election Deadline”), among other closing conditions, BVF shall have the right
to purchase at a second closing up to $
On October 7, 2022, the
Company closed on a securities purchase agreement for the issuance in a private placement offering of (i)
The Company engaged Laidlaw
to serve as the placement agent for the Company in connection with the above-described offering. The Company paid Laidlaw a cash placement
fee of $
At the closing of the
October 2022 offering, the Company’s existing convertible short-term notes, with an aggregate principal balance of $
On April 25, 2022, the
Company closed a registered direct offering with healthcare focused institutional investors alongside participation from Mr. Hafner, for
the purchase and sale of (i)
In a concurrent
private placement, the Company issued the investors, who also participated in the registered direct offering, warrants to purchase up
to
11
NLS PHARMACEUTICS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
Under the Sales Agreement, common shares will be offered and sold pursuant to the Company's shelf registration statement on Form F-3 (File No. 333-262489), declared effective by the Securities and Exchange Commission on February 11, 2023. In addition, under the Sales Agreement, sales of common shares may be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended.
On
March 5, 2022, the Company entered into a sales agreement (the “Sales Agreement”) with Virtu Americas LLC (“Virtu”),
as sales agent, initially with $
The Company has no obligation to sell any of the common shares under the Sales Agreement and may at any time suspend the offering of its common shares upon notice and subject to other conditions.
Warrants:
On December 13, 2022,
concurrent with the offering with BVF, the Company issued Laidlaw warrants to purchase up to
On October 7, 2022, in
a concurrent private placement, the Company issued investors who participated in the offering warrants to purchase up to an aggregate
of
On August 19, 2022, concurrent
with the issuance of short-term convertible notes payable, the Company issued the noteholders warrants to purchase up to an aggregate
of
On April 25, 2022, in
a concurrent private placement, the Company issued investors, who also participated in the April 2022 registered direct offering, warrants
to purchase up to
12
NLS PHARMACEUTICS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
| Balance at January 1, 2023 | ||||
| Issuances | ||||
| Exercises | ||||
| Balance at June 30, 2023 |
The intrinsic value of
exercisable but unexercised in-the-money common share warrants at June 30, 2023 was $
Treasury Shares:
In the first half of
2023, through a capital increase of CHF
Option Plan
On December 14, 2021, the Board of Directors adopted
the Share Option Plan Regulation 2021 (the “Option Plan”). The purpose of the Option Plan is to retain, attract and motivate
management, employees, directors and consultants by providing them with options to purchase our common shares. The Board of Directors
allocated fifteen percent (
The exercise prices, vesting and other restrictions
of the awards to be granted under the Option Plan are determined by the Board of Directors, except that no stock option may be issued
with an exercise price less than the fair market value of the common shares at the date of the grant or have a term in excess of
| Number of Options | Weighted Average Exercise Price | |||||||
| Balance at December 31, 2022 | ||||||||
| Granted | ||||||||
| Exercised | ||||||||
| Expired/cancelled | ( | ) | ||||||
| Balance at June 30, 2023 | $ | |||||||
| Options vested and exercisable | ||||||||
| Options expected to vest | ||||||||
The weighted average
remaining contractual life of each of the options outstanding, options vested and exercisable and options expected to vest at June 30,
2023 was
13
NLS PHARMACEUTICS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
| Non-Vested Options | Weighted Average Grant date Fair Value | |||||||
| Balance at December 31, 2021 | ||||||||
| Granted | ||||||||
| Vested | ( | ) | $ | |||||
| Forfeited | ||||||||
| Balance at December 31, 2022 | $ | |||||||
The aggregate intrinsic
value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s
common shares for those stock options that had exercise prices lower than the fair value of the Company’s common shares. The share
price as of June 30, 2023, was $
Stock-based
compensation expense for the six months ended June 30, 2023, was $
Note 9
Related party consulting agreements:
In October 2019, the Company entered into a collaboration agreement
with Adya Consulting, a company founded and managed by the Company’s then Chief Operating Officer, Silvia Panigone. Pursuant to
the collaboration agreement, the Company agreed to pay Adya Consulting a one-time fee of CHF
In January 2017, and as subsequently amended in
October 2020, the Company entered into a consulting agreement with CHG BioVenture SA, an entity controlled by Mr. Hervé Girsault,
the Company’s current Head of Business Development. Pursuant to the consulting agreement, the Company agreed to pay CHG BioVenture
SA a monthly fee of CHF
The Company entered into a new consulting agreement
starting May 1, 2021, for the continuation of Mr. Girsault’s engagement with the Company in his current role. Pursuant to the new
agreement,
14
NLS PHARMACEUTICS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
In March 2021, the Company entered into a consulting
agreement with Mr. Subhasis Roy, the Company’s then Interim Chief Financial Officer, pursuant to which the Company agreed to pay
Mr. Roy a daily rate of CHF
In February 2021, the Company entered into a consulting
agreement with Mr. Eric Konofal, the Company’s current Chief Scientific Officer, pursuant to which the Company agreed to pay Mr.
Konofal a daily rate of CHF
In March 2021, the Company entered into a consulting
agreement with Mr. Carlos Camozzi, the Company’s then Interim Medical Director, pursuant to which the Company agreed to pay Mr.
Camozzi an hourly rate of CHF
In June 2022, the Company entered into a consulting
agreement with Mr. Chad Hellmann, the Company’s then Chief Financial Officer, pursuant to which the Company agreed to pay Mr. Hellmann
an annual salary of $
In December 2022, the Company entered into a consulting
agreement with Ms. Marianne Lambertson, the Company’s current Head of Corporate Communications & Investor Relations, pursuant
to which the Company agreed to pay Ms. Lambertson a monthly retainer of $
In December 2022, the Company entered into a consulting
agreement with Ms. Astrid Sommer, the Company’s Head of Human Resources, pursuant to which the Company agreed to pay Ms. Sommer
a fixed monthly retainer of $
In December 2022, the Company entered into a consulting
agreement with Mr. Thomas Curatolo, the Company’s current Head of U.S. Commercialization, pursuant to which the Company agreed to
pay Mr. Curatolo a monthly retainer of $
15
NLS PHARMACEUTICS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
Note 10
Subsequent Events:
Management has evaluated subsequent events that have occurred through December 6, 2023, the date these financial statements were issued.
On October 25, 2023,
the Company announced that it had received a written notice from Nasdaq Stock Market LLC indicating that the Company was not in compliance
with the minimum bid price requirement for continued listing set forth in Listing Rule 5550(a)(2), which requires listed companies to
maintain a minimum bid price of $
On November 10, 2023, the Company, received a letter (the “Letter”), from its independent auditor, PricewaterhouseCoopers AG (the “Auditor”). The Letter, which was issued pursuant to Art. 725 and Art. 725b par. 1 of the Swiss Code of Obligations, requested that the Company provide a balance sheet at going concern and liquidation values as of October 31, 2023, to assess whether the Company’s equity showed an excess of liabilities over assets, with such balance sheet required to be provided no later than November 20, 2023. The Auditor advised it was issuing the Letter, in part, due to the fact that it has been advised that the Company would not have sufficient cash to fund its operations through December 31, 2023.
On November 15, 2023,
the Company entered into a series of short-term loan agreements with certain existing shareholders of the Company, including Ronald Hafner,
the Company’s Chairman of the Board of Directors, Felix Grisard, Jürgen Bauer and Maria Nayvalt, providing for unsecured loans
to the Company in the aggregate amount of CHF
On November 15, 2023, the Company reported that
had selected a strategic partner and executed a non-binding term sheet for the out-licensing of its intellectual property, including its
key asset Mazindol. The financial terms of the term sheet have not yet been finalized. Additionally, the Company has reported that it
has implemented a workforce reduction of approximately
On December 1, 2023, the Company announced that
it had entered into an exclusive worldwide option agreement with Aexon Labs, Inc., a privately held U.S. company (“Aexon Labs”),
under which it may acquire global development and commercialization rights to Aexon Labs’ Dual Orexin Receptor Agonists platform,
new molecular entities, highly selective dual oral orexin-1 and orexin-2 receptor agonists (OX1R and OX2R) with potential applications
in the treatment of narcolepsy and idiopathic hypersomnia, as well as neuro-degenerative disorders such as Parkinson’s and Alzheimer’s
disease. The transaction will be structured as an exclusive worldwide license for the development and commercialization by the Company
of the Aexon Labs’ compounds and their derivatives. The Company must exercise its option by no later than March 31, 2024. It will
pay Aexon Labs an upfront payment of $
16
Exhibit 99.2
MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis should be read in conjunction with our unaudited interim condensed financial statements and related notes as of and for the six months ended June 30, 2023, included as Exhibit 99.1 to this Report on Form 6-K. This discussion and other parts of the interim report contain forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including but not limited to those set forth under Item 3.D. “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2022, or the Annual Report, on file with the Securities and Exchange Commission, or the SEC.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
Certain information included herein may be deemed to be “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Forward-looking statements are often characterized by the use of forward-looking terminology such as “may,” “will,” “expect,” “anticipate,” “estimate,” “continue,” “believe,” “should,” “intend,” “project” or other similar words, but are not the only way these statements are identified. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. We have based these forward-looking statements on assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.
Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, but are not limited to, statements about:
| ● | the regulatory pathways that we may elect to utilize in seeking European Medicines Agency, or EMA, the U.S. Food and Drug Administration, or FDA, and other regulatory approvals; |
| ● | the use of Quilience (mazindol ER) in a compassionate use program and the results thereof; |
| ● | obtaining EMA and FDA approval of, or other regulatory action in Europe or the United States and elsewhere with respect to, Quilience, Nolazol, NLS-4 or other product candidates that we may seek to develop; |
| ● | the commercial launch and future sales of Quilience, Nolazol, NLS-4 or any other future product candidates; |
| ● | the dosage of Quilience, Nolazol and NLS-4; |
| ● | our expectations regarding the timing of commencing further clinical trials, the process entailed in conducting each such trial, including dosages, and the order of such trials with each of our product candidates or whether such trials will be conducted at all; |
| ● | improved convenience relating to the prescription of and use of Nolazol for prescribers and patients (and their parents); |
| ● | our expectations regarding the supply of mazindol; |
| ● | third-party payor reimbursement for Quilience, Nolazol and NLS-4; |
| ● | our estimates regarding anticipated expenses, capital requirements and our needs for additional financing; |
| ● | changes to the narcolepsy patient market size and market adoption of Quilience by physicians and patients; |
| ● | the timing, cost, regulatory approvals or other aspects of the commercial launch of Quilience, Nolazol and NLS-4; |
| ● | submission of a Marketing Authorisation Application and New Drug Application, with the EMA and FDA for Quilience, Nolazol and NLS-4, respectively; |
| ● | completion and receiving favorable results of clinical trials for Quilience, Nolazol and NLS-4; |
| ● | the issuance of patents to us by the U.S. Patent and Trademark Office, and other governmental patent agencies; |
| ● | new issuances of orphan drug designations; |
| ● | the development and approval of the use of mazindol for additional indications other than narcolepsy and attention deficit hyperactivity disorder, or ADHD; |
| ● | the development and commercialization, if any, of any other product candidates that we may seek to develop; |
| ● | the use of mazindol controlled release for treatment of additional indications other than narcolepsy, idiopathic hypersomnia and ADHD; |
| ● | the ability of our management team to lead the development of our product candidates; |
| ● | our expectations regarding licensing, acquisitions and strategic operations; |
| ● | that our financial position raises substantial doubt about our ability to continue as a going concern. If we are unable to obtain additional capital, we may not be able to continue our operations on the scope or scale as currently conducted, and that could have a material adverse effect on our business, results of operations and financial condition; and |
| ● | our securities maintaining their listing on the Nasdaq Capital Market. |
The foregoing list is intended to identify only certain of the principal factors that could cause actual results to differ. For a more detailed description of the risks and uncertainties affecting our company, reference is made to our Annual Report which was filed with the SEC, on May 5, 2023, and the other risk factors discussed from time to time by our company in reports filed or furnished to the SEC.
Except as otherwise required by law, we undertake no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Unless otherwise indicated, “we,” “us,” “our,” the “Company” and “NLS” refer to NLS Pharmaceutics Ltd. and its wholly owned subsidiary, NLS Pharmaceutics Inc., a Delaware corporation.
Overview
We are a clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system, or CNS, disorders, which have unmet medical needs. Our lead compound mazindol, a triple monoamine reuptake inhibitor and partial orexin receptor 2 agonist, in a proprietary extended-release formulation, is being developed for the treatment of narcolepsy (lead indication) and ADHD (follow-on indication). We believe that this dual mechanism of action will also enable mazindol ER to have the potential therapeutic benefit in other rare and complex CNS disorders. CNS disorders are a diverse group of conditions that include neurological, psychiatric, and substance use disorders.
We have no product candidates approved for commercialization and have never generated any revenue from product sales. Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. It may be several years, if ever, before we complete pivotal clinical studies and have a product candidate approved for commercialization and we begin to generate revenues and royalties from product sales. We have also incurred significant operating losses. For the six months ended June 30, 2023, we have an accumulated deficit of $65.8 million.
2
On February 2, 2021, we completed our initial public offering of 4,819,277 units at a price of $4.15 per unit, raising $17 million in net proceeds. Each unit consisted of one common share and one warrant to purchase one common share, or the Warrants. The common shares and Warrants were immediately separable from the units and were issued separately. The common shares and Warrants began trading on the Nasdaq Capital Market on January 29, 2021 under the symbols “NLSP” and “NLSPW,” respectively.
In March 2021, 277,000 of our outstanding Warrants were exercised raising gross proceeds of approximately $1.15 million.
In September 2021, we entered into the Standby Equity Distribution Agreement, or SEDA, with YA II PN Ltd., or YA. Of the $20 million eligible to be sold pursuant to the SEDA, to date we have sold an aggregate of 1,340,776 common shares for gross proceeds of approximately $1.56 million.
In addition, in October 2021, we sold YA an aggregate of 1,313,232 of our common shares at a price per share of $1.90, for aggregate gross proceeds of $2.5 million.
In March 2022, we entered into an ATM Sales Agreement, or the Sales Agreement, with Virtu Americas LLC, or Virtu, as sales agent, initially with $3.9 million eligible to be sold pursuant to the agreement. On April 13, 2022, we reduced the amount that may be sold pursuant to the Sales Agreement to $230 thousand. To date, we have sold an aggregate of 22,000 common shares for gross proceeds of approximately $32 thousand.
In April 2022, we completed a registered direct offering for 3,015,384 common shares at $1.04 per common share and 1,184,616 pre-funded warrants at $1.04 per common share minus CHF 0.02 per pre-funded warrant, for gross proceeds of approximately $4.3 million. Concurrent with the registered direct offering, in a concurrent private placement, we issued warrants to purchase up to 3,150,000 common shares at $1.04 per common share.
Our financial statements have been presented on the basis that we are a going concern, which contemplates the realization of revenues and the satisfaction of liabilities in the normal course of business. We have incurred losses from the inception of our operations. These factors raise substantial doubt about our ability to continue as a going concern.
3
Components of Operating Results
Licensing Agreement
In February 2019, we entered into a license agreement, or the EF License Agreement, with Eurofarma Laboratorios S.A., or Eurofarma, to develop and commercialize our product candidate, Nolazol, in Latin American countries with Eurofarma. The EF License Agreement covers the grant of non-transferable licenses, without the right to sublicense, to Eurofarma to develop and commercialize Nolazol in Latin America. The EF License Agreement also specifies our obligation to advance development activities with respect to Nolazol in the United States. A joint steering committee will oversee the development and regulatory activities directed towards marketing approval, manufacturing and commercialization phases. We believe that our participation in the joint steering committee is not of material significance to the licenses in the context of the EF License Agreement on the whole and, as such, management has excluded these activities in the determination of its performance obligation(s) under the EF License Agreement. The EF License Agreement also provides that the parties shall enter into a separate manufacturing and supply agreement during the term of the EF License Agreement.
Under the EF License Agreement, we received a non-refundable, upfront payment of $2,500,000 and are further eligible to receive nonrefundable milestone payments of up to $16,000,000, based on the achievement of milestones related to regulatory filings, regulatory approvals and the commercialization of Nolazol. The achievement and timing of the milestones depend on the success of development, approval and sales progress, if any, of Nolazol in the future. In addition, we are also eligible for tiered royalty payments.
Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as a current portion of deferred revenue in the balance sheets in our financial statements included elsewhere in this annual report. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. As of June 30, 2023, and December 31, 2022, we have long-term deferred revenues of $2,500,000, which will be recognized when the development services of Nolazol are completed and the product candidate receives applicable regulatory approval in Latin America that allows Eurofarma to commence commercialization of Nolazol in accordance with the EF License Agreement.
Financing Agreements
On March 4, 2022, we entered into the Sales Agreement with Virtu. Pursuant to the terms of the Sales Agreement, we may issue and sell from time to time our common shares through Virtu, acting as our sales agent, or directly to Virtu, acting as principal. Pursuant to our prospectus supplement filed on March 4, 2022, we could initially issue and sell our common shares having an aggregate offering price of up to $3.9 million. On April 13, 2022, we reduced the amount that may be sold pursuant to the Sales Agreement to $230 thousand. As of June 30, 2023, we have sold an aggregate of 22,000 common shares for gross proceeds of approximately $1.56 million pursuant to the Sales Agreement.
Under the Sales Agreement, common shares will be offered and sold pursuant to our shelf registration statement on Form F-3 (File No. 333-262489), declared effective by the SEC, on February 11, 2022. In addition, under the Sales Agreement, sales of our common shares may be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended.
We will pay Virtu a commission rate of up to 3.0% of the gross proceeds from each sale of common shares and have agreed to provide Virtu with customary indemnification and contribution rights. We will also reimburse Virtu for certain specified expenses in connection with entering into the Sales Agreement. We have no obligation to sell any of the common shares under the Sales Agreement and may at any time suspend the offering of our common shares upon notice and subject to other conditions.
4
Standby Equity Distribution Agreement
On September 27, 2021, we entered into the SEDA with YA. Pursuant to the SEDA, we will be able to sell up to $20,000,000 of our common shares, at our sole option, any time during the three-year period following the execution date of the SEDA. Pursuant to the terms of the SEDA, any common shares sold to YA will be priced at 92% of the market price, which is defined as the lowest daily volume weighted average price of the common shares during the five consecutive trading days commencing on the trading day immediately following our delivery of an advance notice to YA. Any sale of common shares pursuant to the SEDA is subject to certain limitations, including that YA is not permitted to purchase any common shares that would result in it owning more than 9.99% of our common shares.
We are not obligated to utilize any of the $20,000,000 available under the SEDA and there are no minimum commitments or minimum use penalties. The total amount of funds that ultimately can be raised under the SEDA over the three-year term will depend on the market price for the common shares and the number of common shares actually sold. The SEDA does not impose any restrictions on our operating activities. During the term of the SEDA, YA, and its affiliates, are prohibited from engaging in any short selling or hedging transactions related to the common shares.
In addition, we agreed to sell YA an aggregate of 1,313,232 common shares at a price per share of $1.90, or collectively referred to as the Equity Investment. The Equity Investment closed in October 2021, following the execution date of the SEDA.
We have also agreed to pay YA, or its affiliates, a commitment fee, or the Commitment Fee, equal to $400,000, or 2% of the aggregate amount available to be sold under the SEDA. We paid half of the Commitment Fee on the execution date of the SEDA, with the remaining half of the Commitment Fee paid in cash in October 2023.
Pursuant to the SEDA, we are required to register the common shares eligible to be sold pursuant to the SEDA, the common shares comprising the Equity Investment and Commitment Fee Shares, if any, collectively referred to as the Registrable Shares. We filed registration statements with the SEC registering all of the Registrable Shares, which were declared effective on November 3, 2021, and January 6, 2022.
Pursuant to the SEDA, we intend to use the net proceeds from the sale of any common shares sold pursuant to the SEDA, and the Equity Investment, for funding our ongoing clinical and pre-clinical development activities and for general corporate purposes.
On December 14, 2021, we entered into an amendment, or the Amendment, to the SEDA, pursuant to which we amended the maximum advance amount that may be sold pursuant to the SEDA. In that regard, the maximum advance amount of each advance notice was adjusted to the lower of: (i) an amount equal to one hundred percent (100%) of the average of the daily value traded of our common shares during the five consecutive trading days immediately preceding the date of an advance notice, or (ii) $4,000,000 (previously $2,000,000). In addition, the Amendment permits us to include a minimum acceptable price, in lieu of the Advance Price (as defined in the SEDA), provided, however that such minimum acceptable price shall not be more than 85% of the volume weighted average price on the last completed trading day prior to the time of the delivery of an advance notice.
5
| A. | Operating Results |
Operating Expenses
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial statements and the related notes included in our Annual Report, as well as our unaudited interim condensed financial statements and the related notes thereto for the six months ended June 30, 2023, included elsewhere in this Report on Form 6-K. The discussion below contains forward-looking statements that are based upon our current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from these expectations due to inaccurate assumptions and known or unknown risks and uncertainties.
The following financial data in this narrative are expressed in thousands of U.S. dollars, except for share and per share data or as otherwise noted.
Our current operating expenses consist of two components – research and development expenses and general and administrative expenses.
Research and Development Expenses
Our research and development expenses are expensed as incurred and consist primarily of costs of third-party clinical consultants who conduct clinical and pre-clinical trials on our behalf as well as expenses related to lab supplies, materials and facility costs.
Clinical trial costs are a major component of research and development expenses. We accrue and expense clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. We determine the actual costs through monitoring patient enrollment and discussions with internal personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services.
Our research and development expenses have materially increased and will continue to increase in the future as we enter into the Phase 3 clinical development stage of our product candidates and initiate a number of new research initiatives that are complementary to our existing and planned research initiatives and thereby recruit additional research and development employees.
General and Administrative Expenses
General and administrative expenses include personnel costs, expenses for outside professional services, and all other general and administrative expenses. Personnel costs consist of salaries, cash bonuses and benefits. Outside professional services consist of legal fees (including intellectual property and corporate matters), accounting and audit services, IT and other consulting fees.
Finance Expense and Income
Other expenses include exchange rate differences and financial expenses related to credit card fees.
Interest expense relates to interest paid for our financing obligations.
Taxation
NLS Pharmaceutics is subject to corporate Swiss federal, cantonal and communal taxation in Canton of Zurich, Switzerland.
We are entitled under Swiss laws to carry forward any losses incurred for a period of seven years and can offset our losses carried forward against future taxes. As of June 30, 2023, we had tax loss carryforwards totaling $36.9 million. It is not likely that we will make sufficient profits to be able to utilize these tax loss carryforwards in full. As such, we have recorded a 100% valuation on these tax loss carryforwards.
The effective corporate income tax rate (federal, cantonal and communal) where we are domiciled is currently 10.6%.
6
Notwithstanding the corporate income tax, the corporate capital is taxed at a rate of 0.1% (cantonal and communal tax only, as there is no federal tax on capital).
Value Added Tax, or VAT, is charged on all qualifying goods and services by VAT-registered businesses. An amount of 7.7% of the value of the goods or services is added to all sales invoices and is payable to the Swiss tax authorities. Similarly, VAT paid on purchase invoices is reclaimable from the Swiss tax authorities.
Results of Operations
The numbers below have been derived from our unaudited interim condensed financial statements included elsewhere in this Report on Form 6-K. The discussion below should be read along with these financial statements and it is qualified in its entirety by reference to them.
Comparison of the Six Months Ended June 30, 2023 and 2022
| For the Six Months Ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| Research and development expenses | $ | 4,383,625 | $ | 5,544,093 | ||||
| General and administrative expenses | 3,165,858 | 3,143,933 | ||||||
| Operating loss | (7,549,483 | ) | (8,688,026 | ) | ||||
| Other income, net | 63,127 | 56,397 | ||||||
| Interest expense | (129 | ) | (9,180 | ) | ||||
| Net loss | $ | (7,612,739 | ) | $ | (8,640,809 | ) | ||
Research and Development Expenses
Research and development activities are essential to our business and historically represented the majority of our costs incurred. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using information from the clinical sites and our vendors. In addition to these arrangements, we expect that our total future research and development costs will increase over current levels in line with strategy to progress the development of our product candidates, as well as discovery and development of new product candidates.
The following table summarizes our research and development expenses during the six months ended June 30, 2023 and 2022:
| For the Six Months Ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| Pre-clinical development | $ | 251,843 | $ | 364,400 | ||||
| Clinical development | 1,562,710 | 4,256,902 | ||||||
| Clinical manufacturing costs | 1,639,040 | 444,797 | ||||||
| Staff costs | 191,130 | - | ||||||
| Stock compensation expense | 13,400 | - | ||||||
| Subcontractors | 722,366 | 474,707 | ||||||
| Other | 3,136 | 3,287 | ||||||
| Total | $ | 4,383,625 | $ | 5,544,093 | ||||
7
Our research and development expenses totaled $4,383,625 for the six months ended June 30, 2023, representing a decrease of $1,160,468, or 20.9%, compared to $5,544,093 for the six months ended June 30, 2022. In 2022, two phase 2 studies, NLS-1021 and NLS-1022, were ongoing. However, in 2023, no clinical trials were active. In 2023, Chemistry, Manufacturing and Controls, activities led to adequate supply of drug substance as well as drug product to initiate phase 3 of Mazindol ER in narcolepsy.
General and Administrative Expenses
Our general and administrative expenses totaled $3,165,858 for the six months ended June 30, 2023, representing an increase of $21,925, or 0.7%, compared to $3,143,933 for the six months ended June 30, 2022.
Operating Loss
As a result of the foregoing, our operating loss totaled $7,549,483 for the six months ended June 30, 2023, representing a decrease of $1,138,543, or 13.1%, compared to $8,688,026 for the six months ended June 30, 2022.
Other Income /Expense, net
Other income consists of exchange rate differences and financial expenses related to our credit card fees. We recognized other expense of $63,127 for the six months ended June 30, 2023, representing an increase of $119,524, or 211.9%, compared to income of $56,397 for the six months ended June 30, 2022. The increase in expense was primarily attributable to unfavorable exchange rate differences.
Interest Expense
Interest expense consists of interest on notes payable and interest and imputed interest expenses on certain previously outstanding convertible loans. Interest expense was $129 for the six months ended June 30, 2023, representing a decrease of $9,051, or 98.6%, compared to $9,180. The decrease was attributable to reduced costs related to changes in payment terms; there were no notes payable in 2023.
Net Loss
As a result of the foregoing, our net loss totaled $7,612,739 for the six months ended June 30, 2023, representing a decrease of $1,028,070 or 11.9%, compared to $8,640,809 for the six months ended June 30, 2022.
8
| B. | Liquidity and Capital Resources |
Overview
As of June 30, 2023, we had $1,651,452 in cash and cash equivalents.
The table below summarizes our cash flows for the six months ended June 30, 2023 and 2022:
| For the Six Months Ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| Net cash used in operating activities | $ | (7,296,532 | ) | $ | (7,665,420 | ) | ||
| Net cash provided by financing activities | - | 3,588,096 | ||||||
| Effect of exchange rate changes on cash and cash equivalents | (416 | ) | 309 | |||||
| Net decrease in cash and cash equivalents | $ | (7,296,948 | ) | $ | (4,077,015 | ) | ||
Operating Activities
Net cash used in operating activities was $7,296,532 for the six months ended June 30, 2023, compared with net cash used in operating activities of $7,665,420 for the six months ended June 30, 2022. The change in cash used in operating activities for the six months ended June 30, 2023 was due to our reporting a net loss of $7,599,674 for the six months ended June 30, 2023, compared with a net loss of $8,651,912 for the same period in 2022, driven by (i) a $955,928 reduction in research and development costs for the six months ended June 30, 2023 and (ii) a $194,077 reduction in payroll and general and administrative expenses for the six months ended June 30, 2023.
Financing Activities
We had no financing activities during the six months ended June 30, 2023.
Net cash provided by financing activities of $3,588,096 for the six months ended June 30, 2022, consisted of $3,937,920 of net proceeds from the issuance of common shares, pre-funded warrants and warrants, offset in part, by payments on the note payable of $349,824.
September 27, 2021, we entered into the SEDA with YA. Of the $20 million eligible to be sold pursuant to the SEDA, to date we have sold an aggregate of 1,340,776 of our common shares for gross proceeds of approximately $1.56 million. Pursuant to the SEDA, we will be able to sell up to $20.0 million of our common shares, at our sole option, any time during the three-year period following the execution date of the SEDA. Pursuant to the terms of the SEDA, any common shares sold to YA will be priced at 92% of the market price, which is defined as the lowest daily volume weighted average price of the common shares during the five consecutive trading days commencing on the trading day immediately following the delivery of an advance notice to YA. Any sale of common shares pursuant to the SEDA is subject to certain limitations.
We are not obligated to utilize any of the $20.0 million available under the SEDA and there are no minimum commitments or minimum use penalties. The total amount of funds that ultimately can be raised under the SEDA over the three-year term will depend on the market price for the common shares and the number of common shares actually sold. The SEDA does not impose any restrictions on our operating activities. During the term of the SEDA, YA, and its affiliates, are prohibited from engaging in any short selling or hedging transactions related to the common shares.
We also agreed to pay YA, or its affiliates, a commitment fee, or the Commitment Fee, equal to $400,000, or 2% of the aggregate amount available to be sold under the SEDA. We agreed to pay half of the Commitment Fee within 15 business days from the execution date of the SEDA, with the remaining half of the Commitment Fee to be paid within twelve months from the execution date of the SEDA. We elected to issue 26,203 of our common shares as Commitment Shares to YA as partial consideration for its irrevocable commitment to purchase our common Shares under the SEDA and paid the remainder of the initial portion of the commitment fee, of $140,545, in cash.
9
On March 5, 2022, we entered into the Sales Agreement with Virtu, as sales agent. Pursuant to the terms of the Sales Agreement, we may issue and sell from time to time our common shares through Virtu, acting as its sales agent, or directly to Virtu, acting as principal. Pursuant to our prospectus supplement filed on March 5, 2022, we could initially issue and sell our common shares having an aggregate offering price of up to $3.9 million. On April 13, 2022, we reduced the amount that may be sold pursuant to the Sales Agreement to $230 thousand.
On April 25, 2022, we closed a registered direct offering with health-care focused institutional investors alongside participation from our Chairman of the Board of Directors, Ronald Hafner, for the purchase and sale of (i) 3,015,384 common shares, at a purchase price of $1.04 per share, and (ii) pre-funded warrants to purchase up to 1,184,616 common shares, or the Pre-Funded Warrants, at a purchase price of $1.04 minus CHF 0.02 per Pre-Funded Warrant. The Chairman of our Board of Directors, Ronald Hafner, purchased 95,984 of the 3,015,384 common shares in the offering.
In a concurrent private placement, we issued the investors, who also participated in the registered direct offering, warrants to purchase up to 3,150,000 common shares. The warrants have an exercise price of $1.04 per common share, are exercisable six months following the date of issuance and expire 5 years following the initial exercise date. Pursuant to the terms of the securities purchase agreement, dated April 13, 2022, between us and the investors, we agreed to register and create the common shares issuable upon the exercise of the warrants issued as part of the concurrent private placement. The common shares will first need to be created based on Swiss law upon the exercise of the respective warrants by the investors.
We also entered into an agreement, or the Placement Agent Agreement, with A.G.P./Alliance Global Partners, as sole placement agent, or the Placement Agent, dated April 13, 2022, pursuant to which the Placement Agent agreed to serve as our placement agent in connection with the registered direct offering and concurrent private placement. We paid the Placement Agent (except with respect to the securities to be purchased by Mr. Hafner) a cash placement fee equal to 7.0% of the aggregate gross proceeds received for the securities sold in the offerings.
On August 19, 2022, we issued unsecured short-term notes in the amount of $1.53 million with a maturity date of November 19, 2022. The notes bear an annual interest rate of 10%, provide 10% warrant coverage (warrants to purchase 307,844 common shares) with an exercise price of $0.497 and can be converted, at the discretion of the noteholders, into a subsequent equity offering at a 20% discount to the share price of the offering.
On September 30, 2022, we entered into a securities purchase agreement, or the Purchase Agreement, providing for the issuance in a private placement offering of (i) 5,194,802 common shares at a purchase price of $0.77 per share, and (ii) warrants, or Common Warrants, to purchase up to an aggregate of 2,597,401 Common Shares at an exercise of $0.70 per share. The Common Warrants are exercisable immediately and have a term of 5 years. The offering closed on or about October 7, 2022. Our Chairman of the Board of Director, Ronald Hafner, agreed to purchase 324,675 common shares in the offering and our recently appointed Chief Medical Officer, George Apostol, agreed to purchase 1,298,701 common shares in the offering.
The offering resulted in gross proceeds to us of $4 million. We intend to use the net proceeds from the offering to fund the ongoing development of our lead product, Quilience® (Mazindol ER) for the treatment of narcolepsy, to support business development and licensing activities, and for general corporate purposes.
Laidlaw & Company (UK) Ltd. served as sole placement agent, or the Placement Agent, in connection with the above-described offering. We paid the Placement Agent a cash placement fee of $140,000.
At the closing of the offering, our existing short-term notes, with an aggregate principal balance of $1.53 million plus all accrued interest, that were issued in August 2022, were automatically converted into 2,516,429 common shares and the holders received warrants to purchase up to 1,258,215 common shares with an exercise price of $0.70, that are exercisable six months after their issuance and will expire five years following the date that the warrants are initially exercisable, and are otherwise substantially similar to the form of the Common Warrants.
10
On December 6, 2022, we entered into a securities purchase agreement, or the Purchase Agreement, with funds affiliated with BVF Partners L.P., or collectively, BVF, providing for the issuance in a private placement offering of (i) 5,747,126 common shares, and (ii) pre-funded warrants, or the Pre-Funded Warrants, to purchase 5,747,127 common shares at a purchase price of $0.87 per common share and $0.87 per Pre-Funded Warrant, for aggregate gross proceeds of $10 million.
In addition, we and BVF agreed that, until the 30th day following receipt of the official written minutes from the end of the Phase 2 meeting to be held by us with the U.S. Food and Drug Administration, or the Election Deadline, among other closing conditions, BVF shall have the right to purchase at a second closing, or the Second Closing, up to $20 million in units, or the Units, with each Unit consisting of one common share and/or Pre-Funded Warrants to purchase one common share, as well as receive a warrant, or the BVF Warrants, to purchase up to 150% of the number of common shares and/or pre-funded warrant shares purchased in the Second Closing, at a purchase price of $1.50 per Unit, it being understood that we cannot issue fractional shares. The BVF Warrants will have a term of five years, will have an exercise price of $2.03 per share and will be exercisable for pre-funded warrants if, at their expiration, BVF will be unable to purchase common shares due to its beneficial ownership limitation.
Pursuant to the Purchase Agreement, we agreed to grant BVF the right to participate in future offerings of our securities for a period from the closing that took place December 14, 2022, or the First Closing, until the earlier of (i) the 30 month anniversary of the date of the First Closing or (ii) until such time that BVF retains beneficial ownership of less than 9.9% of the issued and outstanding common shares. In addition, the Company agreed to grant BVF the right to nominate one member to our Board of Directors and shall continue to recommend to its shareholders to elect such member for a period from the First Closing until such time that BVF retains beneficial ownership of less than 9.9% of the issued and outstanding common shares.
Pursuant to the Purchase Agreement, we have agreed not to file any registration statement not contemplated by the Purchase Agreement or enter into any agreement to issue or announce the issuance or proposed issuance of any common shares or common share equivalents until the earlier of (A) 60 days following the earlier of (i) the Election Deadline or (ii) the Second Closing or (B) February 28, 2023, subject to certain exceptions. In addition, we agreed to file a resale registration statement with the SEC to register the resale of the securities purchased or to be purchased pursuant to the Purchase Agreement within 30 days of the First Closing.
The First Closing resulted in gross proceeds of $10 million. We intend to use the net proceeds from the offering to fund the ongoing development of our lead product, Quilience® (Mazindol ER) for the treatment of narcolepsy, to support business development and licensing activities, and for general corporate purposes.
We engaged Laidlaw & Company (UK) Ltd. as exclusive introducing broker, or the Broker, in connection with the above-described offering. We agreed to pay the Broker a cash placement fee of $700,000, as well as warrants to purchase the lesser of up to 5.0% of the primary securities sold in the offering, or 1,000,000 shares, with an exercise price of 135% of the offering price and a term of five years.The transaction has now expired.
On September 28, 2023, we entered into a short-term loan agreement with Ronald Hafner, our Chairman of the Board of Directors, providing for an unsecured loan in the aggregate amount of CHF 500,000. The loan bears interest at a rate of 10% per annum and matures on November 30, 2023.
On November 15, 2023, we entered into a series of short-term loan agreements with certain existing shareholders, including Mr. Hafner, our Chairman of the Board of Directors, Felix Grisard, Jürgen Bauer and Maria Nayvalt, providing for unsecured loans in the aggregate amount of CHF 875,000.00 (approximately $1,000,000). The loans bear interest at a rate of 10% per annum and mature on the earlier of June 30, 2024, or a liquidity event with a strategic partner. In addition, the Company and Mr. Hafner agreed to extend the maturity of the previous short-term loan of CHF 500,000 that Mr. Hafner extended to the Company on September 28, 2023, such that it now expires on June 30, 2024.
Current Outlook
During 2023, we have incurred losses and generated negative cash flows from operations since inception in 2015. To date we have not generated revenues, and we do not expect to generate any significant revenue from the sale of our product candidates in the near future.
We expect to generate losses for the foreseeable future, and these losses could increase as we continue product development until we successfully achieve regulatory approvals for our product candidates and begin to commercialize any approved products. We are subject to all the risks pertinent to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. We anticipate that we will need substantial additional funding in connection with our continuing operations. If we need to raise additional capital to fund our operations and complete our ongoing and planned clinical studies, funding may not be available to us on acceptable terms, or at all.
11
As of June 30, 2023, our cash and cash equivalents were $1.7 million. We believe that our existing cash and cash equivalents, including the proceeds of the recently issued short term notes, will not be sufficient to fund our projected operating requirements for a period of one year from the issuance of these financial statements. These conditions raise substantial doubt about our ability to continue as a going concern for one year from the issuance of these financial statements. Additionally, our operating plans may change as a result of many factors that may currently be unknown to us including:
| ● | the progress and costs of our pre-clinical studies, clinical trials and other research and development activities; |
| ● | the scope, prioritization and number of our clinical trials and other research and development programs; |
| ● | any cost that we may incur under in- and out-licensing arrangements relating to our product candidate that we may enter into in the future; |
| ● | the costs and timing of obtaining regulatory approval for our product candidates; |
| ● | the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; |
| ● | the costs of, and timing for, strengthening our manufacturing agreements for production of sufficient clinical and commercial quantities of our product candidates; |
| ● | the potential costs of contracting with third parties to provide marketing and distribution services for us or for building such capacities internally; and |
| ● | the costs of acquiring or undertaking the development and commercialization efforts for additional, future therapeutic applications of our product candidates and the magnitude of our general and administrative expenses. |
As a result, we may require additional capital to finance expenditures related to the manufacture of our product candidates for use in clinical trials, conducting clinical trials and general and administration costs.
In addition, we are in the process of assessing different options to initiate our Phase 3 program as well as our strategic plan. We have significantly reduced our monthly expenditures to extend our cash runway while finalizing its efforts. At this time, we have received several non-binding term sheets for a potential partnership agreement within the pharmaceutical industry. We are still in negotiations, have not executed an agreement with definitive terms, and no party is under any obligation to enter into or continue negotiations regarding an agreement with definitive terms related to any transaction.
We cannot be certain that additional funding will be available to us on acceptable terms, if at all. If funds are not available, we may be required to delay, reduce the scope of, or eliminate research or development plans for, or commercialization efforts with respect to, one or more applications of our product candidates.
Off-Balance Sheet Arrangements
Except for standard operating leases, we have not engaged in any off-balance sheet arrangements, such as the use of unconsolidated subsidiaries, structured finance, special purpose entities or variable interest entities.
We do not believe that our off-balance sheet arrangements and commitments have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.
Quantitative and Qualitative Disclosure About Market Risk
We are exposed to market risks in the ordinary course of our business. Market risk represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates. Our current investment policy is to invest available cash in bank deposits with banks that have a credit rating of at least A-. Accordingly, a substantial majority of our cash and cash equivalents is held in deposits that bear interest. Given the current low rates of interest we receive, we will not be adversely affected if such rates are reduced. Our market risk exposure is primarily a result of foreign currency exchange rates, which is discussed in detail in the following paragraph.
12
Foreign Currency Exchange Risk
Our results of operations and cash flow are subject to fluctuations due to changes in foreign currency exchange rates. The vast majority of our liquid assets is held in U.S. dollars, and a certain portion of our expenses are denominated in CHF or EUR. For instance, during the six months ended June 30, 2023, approximately 31% of our expenses were denominated in CHF and 6% in EUR, respectively. Changes of 5% and 10% in the U.S. dollar/CHF exchange rate would have increased/decreased our operating expenses by 3% and 5%, respectively. However, these historical figures may not be indicative of future exposure, as we expect that the percentage of our CHF denominated expenses will materially decrease in the near future, therefore reducing our exposure to exchange rate fluctuations.
We do not hedge our foreign currency exchange risk. In the future, we may enter into formal currency hedging transactions to decrease the risk of financial exposure from fluctuations in the exchange rates of our principal operating currencies. These measures, however, may not adequately protect us from the material adverse effects of such fluctuations.
JOBS Act Accounting Election
Under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, an emerging growth company, or an EGC, can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have irrevocably elected to avail ourselves of this exemption from new or revised accounting standards, and, therefore, will not be subject to the same new or revised accounting standards as public companies that are not EGCs.
Option Plan
On December 14, 2021, the board of directors, adopted the Share Option Plan Regulation 2021, or the Option Plan. The purpose of the Option Plan is to retain, attract and motivate management, employees, directors and consultants by providing them with options to purchase our common shares. The board of directors allocated fifteen percent (15%) of our fully diluted shares to awards that may be made pursuant to the Option Plan.
C. Research and development, patents and licenses, etc.
For a description of our research and development programs and the amounts that we have incurred over the six months ended June 30, 2023, pursuant to those programs, please see “Operating Results— Operating Expenses— Research and Development Expenses, net” and “Results of Operations— Comparison of the six months ended June 30, 2023, and June 30, 2022, — Research and Development Expenses.”
E. Critical Accounting Estimates
Critical Accounting Policies and Estimates
The preparation of financial statements requires us to make and assumptions that affect the reported amounts of assets, obligations and expenses during the reporting periods.
A comprehensive discussion of our critical accounting policies is included in “Item 5. Operating and Financial Review and Prospects - Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report.
13
Revenue Recognition
The EF License Agreement provides for the development and commercialization of our product candidate, Nolazol, in Latin American countries with Eurofarma. The EF License Agreement is within the scope of Accounting Standards Codification, or ASC, 606, “Revenue from Contract with Customers,” or ASC 606.
Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of ASC 606, we perform the following five steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) we satisfy each performance obligation. We only apply the five-step model to contracts when it is probable that the entity will collect consideration it is entitled to in exchange for the goods or services it transfers to the customer.
As of June 30, 2023, we have not recognized any revenue from the EF License Agreement as the upfront payment we received has been deferred. We have allocated the transaction price entirely to the single license performance obligation and recorded the $2,500,000 as deferred revenue that is expected to be recognized upon Brazilian or other Latin American market approval or, in the event marketing approval in the United States and/or Latin America is not achieved, whether by failure in clinical development or otherwise, when our performance obligations are contractually complete or the EF License Agreement is terminated.
Pension Obligations
We have a single insurance collective pension plan that is fully insured and operated by an insurance company which covers the employee. Both we and the participants provide monthly contributions to the pension plan that are based on the covered salary. A portion of the pension contribution is credited to employees’ savings accounts which earns interest at the rate provided in the plan. The pension plan provides for retirement benefits as well as benefits on long-term disability and death. The pension plan qualifies as a defined benefit plan in accordance with U.S. GAAP. As such, the cost of the defined pension arrangement is determined based on actuarial valuations. An actuarial valuation assumes the estimation of discount rates, estimated returns on assets, future salary increases, mortality figures and future pension increases. Because of the long-term nature of these pension plans, the valuation of these is subject to uncertainties.
Income Taxation
We incur tax loss carryforwards generating deferred tax assets against which a valuation allowance is recorded when it is not more likely than not that the tax benefit can be realized. Significant judgement is required in determining the use of tax loss carryforwards. Management’s current judgment is that it is not more likely than not that the tax benefits can be realized, and a full valuation allowance is therefore recognized.
Risk Factors
In addition to the other information set forth in this Management’s Discussion and Analysis of Financial Condition and Results of Operation, you should carefully consider the risk factors discussed and set forth under Item 3.D. “Risk Factors” in our Annual Report, which could materially affect our business, financial condition, or future results.
We believe our current cash on hand will not be sufficient to fund our projected operating requirements for a period of one year from the issuance of these financial statements. This raises substantial doubt about our ability to continue as a going concern.
We believe that our current cash on hand will not be sufficient to fund our projected operating requirements for a period of one year from the issuance of these financial statements. This raises substantial doubt about our ability to continue as a going concern and could materially limit our ability to raise additional funds through the issuance of equity or debt securities or otherwise. Further reports on our financial statements may include an explanatory paragraph with respect to our ability to continue as a going concern. If we cannot continue as a going concern, our investors may lose their entire investment in our securities. Until we can generate significant revenues, if ever, we expect to satisfy our future cash needs through debt or equity financing. We cannot be certain that additional funding will be available to us on acceptable terms, if at all. If funds are not available, we may be required to delay, reduce the scope of, or eliminate research or development plans for, or commercialization efforts with respect to our products.
14
Failure to meet Nasdaq’s continued listing requirements could result in the delisting of our Common Shares, negatively impact the price of our Common Shares and negatively impact our ability to raise additional capital.
We are currently not in compliance with the quantitative listing standards of Nasdaq, which require, among other things, that listed companies maintain a minimum closing bid price of $1.00 per share. We failed to satisfy this threshold for 30 consecutive trading days and on October 19, 2023, we received a letter from Nasdaq indicating that we have been provided a period of 180 calendar days in which to regain compliance. In the event that we fail to regain compliance by the end of such compliance period or Nasdaq does not grant us an additional compliance period or we fail to regain compliance by the end of such additional compliance period, our board of directors will weigh the available alternatives to regain compliance. However, there can be no assurance that we will be able to successfully resolve such noncompliance.
In addition, as of June 30, 2023, our shareholders’ deficit totaled $4,286,817. The minimum shareholders’ equity requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(1) requires listed companies to maintain shareholders’ equity of at least $2.5 million. As a result, we do not believe we are in compliance with the shareholders’ equity standard and anticipate receiving a deficiency letter from Nasdaq. Upon receipt of such deficiency letter, we will have the opportunity to present a plan to regain compliance.
There can be no assurance that Nasdaq will accept our plan to regain compliance or that we will meet the minimum shareholders’ equity requirement during any compliance period, if one is provided to us. If our Common Shares are de-listed from Nasdaq, it will have material negative impact on the actual and potential liquidity of our securities, as well as material negative impact on our ability to raise future capital.
If, for any reason, Nasdaq should delist our Common Shares from trading on its exchange and we are unable to obtain listing on another national securities exchange or take action to restore our compliance with the Nasdaq continued listing requirements, a reduction in some or all of the following may occur, each of which could have a material adverse effect on our shareholders:
| ● | the liquidity of our Common Shares; |
| ● | the market price of our Common Shares; |
| ● | our ability to obtain financing for the continuation of our operations; |
| ● | the number of institutional and general investors that will consider investing in our Common Shares; |
| ● | the number of investors in general that will consider investing in our Common Shares; |
| ● | the number of market makers in our Common Shares; |
| ● | the availability of information concerning the trading prices and volume of our Common Shares; and |
| ● | the number of broker-dealers willing to execute trades in shares of our Common Shares. |
Further, we would likely become a “penny stock”, which would make trading of our Common Shares much more difficult.
15
Document And Entity Information |
6 Months Ended |
|---|---|
Jun. 30, 2023 | |
| Document Information Line Items | |
| Entity Registrant Name | NLS PHARMACEUTICS LTD. |
| Document Type | 6-K |
| Current Fiscal Year End Date | --12-31 |
| Amendment Flag | false |
| Entity Central Index Key | 0001783036 |
| Document Period End Date | Jun. 30, 2023 |
| Document Fiscal Year Focus | 2023 |
| Document Fiscal Period Focus | Q2 |
| Entity File Number | 001-39957 |
Unaudited Interim Condensed Balance Sheets (Parentheticals) |
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Jun. 30, 2023
SFr / shares
|
Dec. 31, 2022
USD ($)
$ / shares
shares
|
Dec. 31, 2022
SFr / shares
|
|---|---|---|---|---|
| Statement of Financial Position [Abstract] | ||||
| Accounts payable, including related party (in Dollars) | $ | $ 660 | $ 53,365 | ||
| Other accrued liabilities, including related party (in Dollars) | $ | $ 19,325 | $ 4,107 | ||
| Common shares, par value (in Francs per share) | (per share) | $ 0.02 | SFr 0.02 | $ 0.02 | SFr 0.02 |
| Common shares, authorized | 35,671,780 | 35,671,780 | ||
| Common shares, issued | 35,671,780 | 32,428,893 | ||
| Common shares, outstanding | 35,671,780 | 32,428,893 | ||
| Common shares, par value (in Dollars per share) | (per share) | $ 0.02 | SFr 0.02 | $ 0.02 | SFr 0.02 |
Unaudited Interim Condensed Statements of Operating and Comprehensive Loss - USD ($) |
6 Months Ended | |
|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
|
| Operating expenses: | ||
| Research and development | $ 4,383,625 | $ 5,544,093 |
| General and administrative | 3,165,858 | 3,143,933 |
| Total operating expenses | 7,549,483 | 8,688,026 |
| Operating loss | (7,549,483) | (8,688,026) |
| Other income (expense), net | (63,127) | 56,397 |
| Interest expense | (129) | (9,180) |
| Net loss | (7,612,739) | (8,640,809) |
| Other comprehensive loss: | ||
| Defined pension plan adjustments | (15,434) | 119,027 |
| Comprehensive loss | $ (7,628,173) | $ (8,521,782) |
| Basic net loss per common share (in Dollars per share) | $ (0.2) | $ (0.54) |
| Weighted average common shares used for computing basic (in Shares) | 38,176,020 | 15,892,327 |
Unaudited Interim Condensed Statements of Operating and Comprehensive Loss (Parentheticals) - $ / shares |
6 Months Ended | |
|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
|
| Statement of Comprehensive Income [Abstract] | ||
| Diluted net loss per common share | $ (0.20) | $ (0.54) |
| Weighted average common shares used for computing diluted | 38,176,020 | 15,892,327 |
Unaudited Interim Condensed Statements of Changes in Equity - USD ($) |
Common Shares |
Treasury Shares |
Additional Paid in Capital |
Accumulated Deficit |
Accumulated Other Comprehensive Loss |
Total |
|---|---|---|---|---|---|---|
| BALANCE at Dec. 31, 2021 | $ 344,445 | $ (29,497) | $ 42,084,954 | $ (41,705,775) | $ (151,739) | $ 542,388 |
| BALANCE (in Shares) at Dec. 31, 2021 | 16,223,389 | |||||
| Issuance of common shares registered direct offering, net | $ 31,251 | 29,057 | 1,851,205 | 1,911,513 | ||
| Issuance of common shares registered direct offering, net (in Shares) | 1,562,531 | |||||
| Issuance of warrants, net | 900,798 | 900,798 | ||||
| Issuance of pre-funded warrants, net | 1,094,616 | 1,094,616 | ||||
| Issuance of common shares in At-The-Market (ATM) financing | 440 | 30,553 | 30,993 | |||
| Issuance of treasury shares | $ 35,572 | (35,572) | ||||
| Issuance of treasury shares (in Shares) | 1,778,592 | |||||
| Defined pension plan adjustments | 119,027 | 119,027 | ||||
| Net loss | (8,640,809) | (8,640,809) | ||||
| BALANCE at Jun. 30, 2022 | $ 411,268 | (35,572) | 45,962,126 | (50,346,584) | (32,712) | (4,041,474) |
| BALANCE (in Shares) at Jun. 30, 2022 | 19,564,512 | |||||
| BALANCE at Dec. 31, 2022 | $ 668,555 | 60,864,530 | (58,201,455) | (50,791) | $ 3,280,839 | |
| BALANCE (in Shares) at Dec. 31, 2022 | 32,428,893 | 32,428,893 | ||||
| Issuance of treasury shares | $ 64,858 | (64,858) | ||||
| Issuance of treasury shares (in Shares) | 3,242,887 | |||||
| Stock-based compensation | 60,516 | 60,516 | ||||
| Defined pension plan adjustments | (15,434) | (15,434) | ||||
| Net loss | (7,612,739) | (7,612,739) | ||||
| BALANCE at Jun. 30, 2023 | $ 733,413 | $ (64,858) | $ 60,925,046 | $ (65,814,193) | $ (66,225) | $ (4,286,817) |
| BALANCE (in Shares) at Jun. 30, 2023 | 35,671,780 | 35,671,780 |
Background |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||
| Background [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
| Background | Note 1 Background:
NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) (the “Company”) is an emerging biopharmaceutical company engaged in the discovery and development of life-improving drug therapies to treat rare and complex central nervous system disorders, including narcolepsy, idiopathic hypersomnia and other rare sleep disorders, and of neurodevelopmental disorders, such as attention deficit hyperactivity disorder (“ADHD”). The Company’s lead product candidates are Quilience, to treat narcolepsy (type 1 and type 2), and Nolazol, to treat ADHD.
On February 2, 2021, the Company completed the closing of its initial public offering (the “Initial Public Offering”) of 4,819,277 units at a price of $4.15 per unit. Each unit consisted of one common share and one warrant to purchase one common share (the “Warrants”). The common shares and Warrants were immediately separable from the units and were issued separately. The common shares and Warrants began trading on the Nasdaq Capital Market on January 29, 2021, under the symbols “NLSP” and “NLSPW,” respectively. The Company received net proceeds of $17 million, after deducting underwriting discounts and commissions and other estimated offering expenses. The Warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $4.15 per share. In addition, the Company granted the underwriters a 45-day option to purchase up to an additional 722,891 common shares and/or warrants to purchase 722,891 common shares at the public offering price of $0.01 per Warrant, of which the underwriter exercised its option to purchase Warrants to purchase up to 722,891 common shares. These Warrants were issued in the Company’s Initial Public Offering and therefore have the same exercise price of $4.15 per share.
Going Concern
As of June 30, 2023, the Company had an accumulated deficit of approximately $65.8 million and the Company incurred an operating loss for the six months ended June 30, 2023, of approximately $7.5 million. To date, the Company has dedicated most of its financial resources to research and development, clinical studies associated with its ongoing biopharmaceutical business and general and administrative expenses.
As of June 30, 2023, the Company’s cash and cash equivalents were $1.6 million. The Company expects that its existing cash and cash equivalents, including the funds raised as outlined in the subsequent event note, will be sufficient to fund operations until the second quarter of 2024. The Company expects to continue to generate operating losses and negative operating cash flows for the next few years and will need additional funding to support its planned operating activities through profitability. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for one year from the issuance of these financial statements.
In response to the ever-evolving biotech and pharmaceutical landscape, NLS has initiated exploration of new strategic opportunities. As part of this process, the Company plans to consider a range of options, including strategic partnerships, out-licensing assets of the Company, and other future strategic actions.
Additionally, the Company’s operating plans may change as a result of many factors that may currently be unknown to the Company including:
As a result, the Company will require additional capital to finance expenditures related to the manufacture of the Company’s product candidates for use in clinical trials, conducting clinical trials and general and administrative expenses. There can be no assurance that funds will be available, or if they are available, that their availability will be on terms acceptable to the Company or in an amount sufficient to enable the Company to fully complete its development activities or sustain operations. If the Company is unable to raise sufficient additional funds, it will have to develop and implement a plan to further extend payables and indebtedness, reduce overhead, or scale back its current business plan until sufficient additional capital is raised to support further operations or force the Company to grant rights to develop and commercialize product candidates that it would otherwise prefer to develop and commercialize on its own.
Accordingly, the accompanying unaudited interim condensed financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”), which contemplate continuation of the Company as a going concern for a period within one year from the issuance of these unaudited interim condensed financial statements and the realization of assets and satisfaction of liabilities in the normal course of business. The carrying amounts of assets and liabilities presented in these unaudited interim condensed financial statements do not necessarily purport to represent realizable or settlement values. These unaudited interim condensed financial statements do not include any adjustment that might result from the outcome of this uncertainty. |
Summary of Significant Accounting Policies |
6 Months Ended |
|---|---|
Jun. 30, 2023 | |
| Summary of Significant Accounting Policies [Abstract] | |
| Summary of Significant Accounting Policies | Note 2 Summary of Significant Accounting Policies:
Basis of Preparation
The unaudited interim condensed financial statements have been prepared in accordance with U.S. GAAP for interim financial information and accordingly do not include all information and disclosures as required by U.S. GAAP for complete financial statements. The year-end unaudited interim condensed balance sheet was derived from audited financial statements but does not include all disclosures required by U.S. GAAP. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements included in the Company’s Annual Report on Form 20-F for the year ended December 31, 2022, and any public announcements made by the Company during the interim reporting period.
In the opinion of management, these unaudited interim condensed financial statements reflect all adjustments necessary, which are of a normal recurring nature, to fairly state the balance sheets, statements of operating and comprehensive loss, changes in equity and cash flows for the interim reporting periods presented.
Use of Estimates
The preparation of the unaudited interim condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect amounts reported of assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the interim reporting periods. Actual results could differ from those estimates and be based on events different from those assumptions. As part of these financial statements, the more significant estimates include the valuation allowance related to the Company’s deferred tax assets.
Property and equipment
Property and equipment are recorded at cost, net of accumulated depreciation and any accumulated impairment losses. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. The useful lives of property and equipment are five years for furniture and fixtures and three years for software.
Upon retirement or sale, the cost of disposed assets and their related accumulated depreciation are removed from the balance sheet. Any resulting net gains or losses on dispositions of property and equipment are included as a component of operating expenses within the Company’s statements of operating and comprehensive loss. Repair and maintenance costs that do not significantly add value to the property and equipment, or prolong its life, are charged to operating expense as incurred.
Stock-Based Compensation
The Company measures all stock-based awards granted based on the fair value on the date of the grant and recognizes compensation expense with respect to those awards over the requisite service period, which is generally the vesting period of the respective award. Generally, the Company issues awards with only service-based vesting conditions and records the expense for these awards using the straight-line method. The Company recognizes forfeitures related to stock-based compensation awards as they occur and reverses any previously recognized compensation cost associated with forfeited awards in the period the forfeiture occurs.
The Company classifies stock-based compensation expense in the accompanying consolidated statements of operating and comprehensive loss in the same manner in which the award recipients’ payroll costs are classified or in which the award recipients’ service payments are classified.
The fair value of each stock option is estimated on the date of grant using the Black-Scholes option-pricing model (“Black-Scholes”). Black-Scholes requires a number of assumptions, of which the most significant are share price, expected volatility, expected option term (the time from the grant date until the options are exercised or expire), risk-free rate and expected dividend rate. The grant date fair value of a common share is determined by the board of directors (the “Board of Directors”) considering, among other factors, the assistance of a valuation specialist and management. The grant date fair value of a common share is determined using the valuation methodologies, which utilize certain assumptions, including probability weighting of events, volatility, time to liquidation, risk-free interest rate and discount for lack of marketability.
Earnings per Share
Basic loss per common share is computed by dividing the net loss applicable to common shareholders by the weighted-average number of common shares outstanding during the periods presented. Diluted loss per common share is computed similar to basic loss per share, except that the denominator is increased to include the number of additional potential common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. Potential common shares are excluded from the computation for a period in which a net loss is reported or if their effect is anti-dilutive. The Company’s potential common shares consist of warrants with their potential dilutive effect considered using the treasury method. For the six months ended June 30, 2023, 13,297,916 common shares from warrants and 3,242,887 treasury shares were excluded from the computation. For the six months ended June 30, 2022, 9,744,362 shares from warrants and 1,778,592 treasury shares were excluded from the computation.
Treasury Shares
Treasury shares are purchased at cost and recognized as a deduction from equity. Income or loss from subsequent sales is presented in equity.
Segment Reporting
The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is on developing therapeutics for the treatment of neurobehavioral and neurocognitive disorders. All of the Company’s tangible assets are held outside the United States of America.
Recently Issued Accounting Standards Not Yet Effective
The Company has implemented all new accounting pronouncements that are in effect and that may impact its consolidated financial statements and does not believe that there are any other new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations. |
Prepaid Expenses and Other Current Assets |
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Prepaid Expenses and Other Current Assets [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Prepaid Expenses and Other Current Assets | Note 3 Prepaid Expenses and Other Current Assets:
The Company’s prepaid expenses and other current assets consisted of the following as of June 30, 2023, and December 31, 2022:
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Property and Equipment, net: |
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Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Property and Equipment, net [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Property and Equipment, net: | Note 4 Property and Equipment, net:
The following table shows the property and equipment as of June 30, 2023 and December 31, 2022:
Deprecation and related amortization expense was $5,704 for each of the six-month periods ended June 30, 2023 and 2022. |
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Other Accrued Liabilities |
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| Other Accrued Liabilities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Accrued Liabilities | Note 5 Other Accrued Liabilities:
Other accrued liabilities consisted of the following as of June 30, 2023 and December 31, 2022:
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Deferred Revenues |
6 Months Ended |
|---|---|
Jun. 30, 2023 | |
| Deferred Revenues [Abstract] | |
| Deferred Revenues | Note 6 Deferred Revenues:
In February 2019, the Company entered into a license agreement (the “EF License Agreement”), to develop and commercialize its product candidate, Nolazol, in Latin American countries with Eurofarma Laboratorios S.A. (“Eurofarma”), a Brazilian pharmaceutical company. The EF License Agreement covers the grant of non-transferable licenses, without the right to sublicense, to Eurofarma to develop and commercialize Nolazol in Latin America. The EF License Agreement also specifies the Company’s obligation to advance ongoing development activities with respect to Nolazol in the United States. A joint steering committee will oversee the development and regulatory activities directed towards marketing approval, manufacturing and commercialization phases. The Company believes its participation in the joint steering committee is not of material significance to the licenses in the context of the EF License Agreement on the whole and, as such, management has excluded these activities in the determination of its performance obligation(s) under the EF License Agreement.
The EF License Agreement provides that the parties shall enter into a separate manufacturing and supply agreement during the term of the EF License Agreement.
Under the EF License Agreement, the Company received a non-refundable, upfront payment, of $2,500,000 and is further eligible to receive non-refundable milestone payments of up to $16,000,000, based on the achievement of milestones related to regulatory filings, regulatory approvals and the commercialization of Nolazol. The achievement and timing of the milestones depend on the success of development, approval and sales progress, if any, of Nolazol in the future. In addition, the Company is also eligible for tiered royalty payments.
The Company identified the licenses granted to Eurofarma and its obligation to advance development activities with respect to Nolazol in the United States as the material promises under the EF License Agreement. For purposes of identifying the Company’s performance obligations under the EF License Agreement, management believes that while the exclusive licenses were granted to Eurofarma at the outset of the EF License Agreement, the grant of those licenses does not singularly result in the transfer of the Company’s broader obligation to Eurofarma under the EF License Agreement.
The Company is obligated under the EF License Agreement to advance its development activities in the United States and those activities precede Eurofarma’s necessary regulatory approvals for commercialization of Nolazol, in Latin American countries. The Company intends to apply its proprietary know-how to the ongoing development activities in the United States involving its intellectual property relating to Nolazol. These development activities are specific to the Company and the Company believes they are not capable of being distinct in the context of the EF License Agreement on the whole.
The licenses provided to Eurofarma are not transferable and without the right to sublicense therefore Eurofarma is not presently able to monetize its investment in Nolazol as clinical development in the United States or any Latin American countries has yet to be completed and Eurofarma has yet to seek or obtain regulatory approval in any Latin American country. The licenses to Eurofarma represent rights to use the Company’s intellectual property with respect to Nolazol for which revenue is recognized at a point in time which is when Eurofarma is able to use and benefit from the licenses. The licenses are considered of limited value without the Company’s development activities with respect to Nolazol in the United States. As such, the licenses are not capable of being distinct until after successful clinical development and regulatory approval and alone do not have standalone functionality to Eurofarma. Management has determined that the licenses, while capable of being distinct, are not distinct as they do not have stand-alone value to Eurofarma without the Company’s planned development activities in the United States and the approval for sale in Latin America.
Bundled together with the Company’s development activities of Nolazol in the United States, the licenses granted under the EF License Agreement will enable Eurofarma to seek regulatory approvals and ultimately seek to commercialize Nolazol in Latin America. Therefore, management believes the licenses bundled together with the Company’s development activities in the United States constitute a single distinct performance obligation under the EF License Agreement for accounting purposes (the “License Performance Obligation”).
The Company has initially estimated a total transaction price of $2,500,000, consisting of the fixed upfront payment determined to be an advance on the License Performance Obligation. Upon execution of the EF License Agreement and as of June 30, 2023 and December 31, 2022, variable consideration consisting of milestone payments has been constrained and excluded from the transaction price given the significant uncertainty of achievement of the development and regulatory milestones.
The Company has allocated the transaction price entirely to the single License Performance Obligation and recorded the $2,500,000 as deferred revenue that is expected to be recognized upon Brazilian or other Latin American market approval or, in the event marketing approval in the United States and/or Latin America is not achieved, whether by failure in clinical development or otherwise, when the Company’s performance obligations are contractually complete or the EF License Agreement is terminated.
Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as a current portion of deferred revenue in the accompanying condensed balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. As of June 30, 2023 and December 31, 2022, the Company has long-term deferred revenues of $2,500,000, which will be recognized when the development services of Nolazol are completed and the product candidate receives applicable regulatory approval in Latin America that allows Eurofarma to commence commercialization of Nolazol in accordance with the EF License Agreement. |
Commitments and Contingencies |
6 Months Ended |
|---|---|
Jun. 30, 2023 | |
| Commitments and Contingencies [Abstract] | |
| Commitments and Contingencies | Note 7 Commitments and Contingencies:
Commitments On March 10, 2021, the Company entered into a License Agreement (the “Agreement”) with Novartis Pharma AG (“Novartis”), whereby the Company obtained, on an exclusive basis in the U.S., all of the available data referred to and included in the original new drug application (“NDA”) for Sanorex® (mazindol) submitted to the U.S. Food and Drug Administration (“FDA”) in February 1972. The Agreement encompasses all preclinical and clinical studies, data used for manufacturing including stability and other chemistry manufacturing and controls data, formulation data and know-how for all products containing mazindol as an active substance, and all post-marketing clinical studies and periodic safety reports from 1973 onwards. Under the Agreement, the Company has obtained the same rights on a non-exclusive basis in all territories outside of the U.S. except for Japan, with the right to cross-reference the Sanorex NDA with non-U.S. regulatory agencies in the licensed territories. The Agreement includes the right to sublicense or assign the license to third parties, subject to such third parties meeting certain obligations. As consideration for the license, the Company paid Novartis $250,000 upon the signing of the Agreement with milestone payments due as follows: (i) $750,000 payable following the end of a Phase II meeting with the FDA, with the amount to be reduced to $375,000 if toxicology studies must be repeated; (ii) $2 million following the earlier of FDA marketing authorization of Quilience or Nolazol; (iii) 1% of any upfront and milestone payments, if any, from any sublicensees and (iv) $3 million as a one-time payment upon the Company’s product candidate reaching $250 million in cumulative sales.
Litigation
The Company may become involved in miscellaneous litigation and legal actions, including product liability, consumer, commercial, tax and governmental matters, which can arise from time to time in the ordinary course of the Company’s business. Litigation and legal actions are inherently unpredictable, and excessive verdicts can result in such situations. The Company is not currently involved in any such matters. |
Share Capital and Public Offerings |
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| Share Capital and Public Offerings [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share Capital and Public Offerings | Note 8
Common Shares: As of June 30, 2023, the Company had 35,671,780 registered and issued common shares.
On December 13, 2022, the Company closed a private placement offering with funds affiliated with BVF Partners L.P. (“ BVF”), providing for the issuance of (i) 5,747,126 common shares at a purchase price of $0.87 per share and (ii) pre-funded warrants to purchase 5,747,127 common shares at $0.87 minus $0.02 (CHF 0.02) per pre-funded warrant.
The Company engaged Laidlaw & Company (UK) Ltd. (“Laidlaw”) to serve as the placement agent for the Company in connection with the above-described offering. The Company agreed to pay Laidlaw a cash placement fee of $700,000 and warrants to purchase common shares equal to 5% of the common shares sold in the offering.
In addition, the Company and BVF agreed that until the 30th day following receipt of the official written minutes from the end of the Phase 2 meeting to be held by the Company with the FDA (the “Election Deadline”), among other closing conditions, BVF shall have the right to purchase at a second closing up to $20 million in units, with each unit consisting of one common share and/or pre-funded warrants to purchase one common share, as well as receive warrants to purchase up to 150% of the number of common shares and/or pre-funded warrant shares purchased in the second closing, at a purchase price of $1.50 per unit. The warrants will have a term of five years, will have an exercise price of $2.03 per share and will be exercisable for pre-funded warrants if, at their expiration, BVF will be unable to purchase common shares due to its beneficial ownership limitation.
Pursuant to the purchase agreement, the Company agreed to grant BVF the right to participate in future offerings of the Company’s securities for a period from the first closing (the “First Closing”) until the earlier of (i) the 30-month anniversary of the initial closing date or (ii) until such time that BVF retains beneficial ownership of less than 9.9% of the issued and outstanding Common Shares. on the same terms, conditions and price provided for in the subsequent financing or the right to purchase a comparable security with a beneficial ownership limitation. In addition, the Company agreed to grant BVF the right to nominate one member to the Company’s Board of Directors and shall continue to recommend to its shareholders to elect such member for a period from the First Closing until such time that BVF retains beneficial ownership of less than 9.9% of the issued and outstanding common shares.
On October 7, 2022, the Company closed on a securities purchase agreement for the issuance in a private placement offering of (i) 5,194,802 common shares at a purchase price of $0.77 per share, and (ii) warrants to purchase up to an aggregate of 2,597,401 common shares at an exercise of $0.70 per share. The Company’s Chairman of the Board of Directors, Ronald Hafner, purchased 324,675 common shares in the offering and the Company’s Chief Medical Officer, George Apostol, purchased 1,298,701 common shares in the offering.
The Company engaged Laidlaw to serve as the placement agent for the Company in connection with the above-described offering. The Company paid Laidlaw a cash placement fee of $140,000 for the securities sold in the offering.
At the closing of the October 2022 offering, the Company’s existing convertible short-term notes, with an aggregate principal balance of $1,530,000 plus all accrued interest, that were issued in August 2022, were automatically converted into 2,516,429 common shares and the holders received warrants to purchase up to 1,258,215 common shares with an exercise price of $0.70, that are exercisable six months after their issuance and will expire five years following the date that the warrants are initially exercisable, and are otherwise substantially similar to the form of the common warrants.
On April 25, 2022, the Company closed a registered direct offering with healthcare focused institutional investors alongside participation from Mr. Hafner, for the purchase and sale of (i) 3,015,384 common shares, at a purchase price of $1.04 per share, and (ii) pre-funded warrants to purchase up to 1,184,616 common shares at a purchase price of $1.04 minus CHF 0.02 per pre-funded warrant. Mr. Ronald Hafner, purchased 95,984 of the 3,015,384 common shares in the offering.
In a concurrent private placement, the Company issued the investors, who also participated in the registered direct offering, warrants to purchase up to 3,150,000 common shares. The warrants have an exercise price of $1.04 per common share, are exercisable six months following the date of issuance and expire 5 years following the initial exercise date. Pursuant to the terms of the securities purchase agreement, dated April 13, 2022, between the Company and the investors, the Company agreed to register and create the common shares issuable upon the exercise of the warrants issued as part of the concurrent private placement. The common shares will first need to be created based on Swiss law upon the exercise of the respective warrants by the investors.
Under the Sales Agreement, common shares will be offered and sold pursuant to the Company's shelf registration statement on Form F-3 (File No. 333-262489), declared effective by the Securities and Exchange Commission on February 11, 2023. In addition, under the Sales Agreement, sales of common shares may be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended.
On March 5, 2022, the Company entered into a sales agreement (the “Sales Agreement”) with Virtu Americas LLC (“Virtu”), as sales agent, initially with $3.9 million eligible to be sold pursuant to the Sales Agreement. On April 13, 2022, the Company reduced the amount that may be sold pursuant to the Sales Agreement to $230,000. The Company will pay Virtu a commission rate of up to 3.0% of the gross proceeds from each sale of common shares and has agreed to provide Virtu with customary indemnification and contribution rights. The Company will also reimburse Virtu for certain specified expenses in connection with entering into the Sales Agreement.
The Company has no obligation to sell any of the common shares under the Sales Agreement and may at any time suspend the offering of its common shares upon notice and subject to other conditions.
Warrants:
On December 13, 2022, concurrent with the offering with BVF, the Company issued Laidlaw warrants to purchase up to 574,712 common shares. The warrants have an exercise price of $2.03 per common share and expire 5 years following the initial exercise date. The warrants were evaluated under ASC Topic 480, “Distinguishing Liabilities from Equity” and ASC Topic 815, “Derivatives and Hedging”, and the Company determined that equity classification was appropriate. The relative fair value of the warrants issued of $272,892 was allocated from the total net proceeds of the offering.
On October 7, 2022, in a concurrent private placement, the Company issued investors who participated in the offering warrants to purchase up to an aggregate of 2,597,400 common shares at an exercise of $0.70 per share. The warrants will be exercisable six months after their issuance and will expire five years following the date that the warrants are initially exercisable. The warrants were evaluated under ASC Topic 480, “Distinguishing Liabilities from Equity” and ASC Topic 815, “Derivatives and Hedging,” and the Company determined that equity classification was appropriate. The relative fair value of the warrants issued of $806,510 was allocated from the total net proceeds of the offering.
On August 19, 2022, concurrent with the issuance of short-term convertible notes payable, the Company issued the noteholders warrants to purchase up to an aggregate of 307,844 common shares at an exercise price of $0.50 per share. The warrants are exercisable immediately and will have a term of 2 years. The warrants were evaluated under ASC Topic 480, “Distinguishing Liabilities from Equity” and ASC Topic 815, “Derivatives and Hedging”, and the Company determined that equity classification was appropriate. The relative fair value of the warrants issued of $67,008 was accounted for as debt discount. On October 7, 2022, upon conversion of the notes payable, the Company issued the noteholders additional warrants to purchase up to an aggregate of 1,258,214 common shares at an exercise price of $0.70 per share. The warrants are exercisable six months after their issuance and expire five years following the date that the warrants are initially exercisable. The warrants were evaluated under ASC Topic 480, “Distinguishing Liabilities from Equity” and ASC Topic 815, “Derivatives and Hedging”, and the Company determined that equity classification was appropriate. The fair value of the warrants issued of $534,966 was included in the loss on conversion of convertible notes payable.
On April 25, 2022, in a concurrent private placement, the Company issued investors, who also participated in the April 2022 registered direct offering, warrants to purchase up to 3,150,000 common shares. The warrants have an exercise price of $1.04 per common share, are exercisable six months following the date of issuance and expire 5 years following the initial exercise date. The warrants were evaluated under ASC Topic 480, “Distinguishing Liabilities from Equity” and ASC Topic 815, “Derivatives and Hedging”, and the Company determined that equity classification was appropriate. The relative fair value of the warrants issued of $1,477,835 was allocated from the total net proceeds of the common share issuance on a relative basis to the common shares and warrants.
The following table summarizes the common share warrant activity for the six months ended June 30, 2023:
The intrinsic value of exercisable but unexercised in-the-money common share warrants at June 30, 2023 was $8,123,773.
Treasury Shares: In the first half of 2023, through a capital increase of CHF 64,857 divided into 3,242,887 shares, the Company issued treasury shares from its authorized capital for the same amount . On December 31, 2022, the Company held no such treasury shares.
Option Plan On December 14, 2021, the Board of Directors adopted the Share Option Plan Regulation 2021 (the “Option Plan”). The purpose of the Option Plan is to retain, attract and motivate management, employees, directors and consultants by providing them with options to purchase our common shares. The Board of Directors allocated fifteen percent (15%) of the Company’s fully diluted shares to awards that may be made pursuant to the Option Plan.
The exercise prices, vesting and other restrictions of the awards to be granted under the Option Plan are determined by the Board of Directors, except that no stock option may be issued with an exercise price less than the fair market value of the common shares at the date of the grant or have a term in excess of ten years. Options granted under the Option Plan are exercisable in whole or in part at any time subsequent to vesting.
The following table summarizes total stock option activity for the year ended June 30, 2023:
The weighted average remaining contractual life of each of the options outstanding, options vested and exercisable and options expected to vest at June 30, 2023 was 9.5 years.
The following table summarizes unvested stock option activity for the year ended December 31, 2022:
The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common shares for those stock options that had exercise prices lower than the fair value of the Company’s common shares. The share price as of June 30, 2023, was $1.10 and the aggregate intrinsic value for options outstanding and expected to vest each year was $49,113. The intrinsic value of exercisable options was as the exercise price was greater than the share price.
Stock-based compensation expense for the six months ended June 30, 2023, was $60,516. As of June 30, 2023, total unrecognized stock-based compensation expense relating to unvested stock options was $262,574. This amount is expected to be recognized over a weighted-average period of 1.75 years. |
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Related Party Consulting Agreements |
6 Months Ended |
|---|---|
Jun. 30, 2023 | |
| Related Party Transactions [Abstract] | |
| Related party consulting agreements | Note 9 Related party consulting agreements:
In October 2019, the Company entered into a collaboration agreement with Adya Consulting, a company founded and managed by the Company’s then Chief Operating Officer, Silvia Panigone. Pursuant to the collaboration agreement, the Company agreed to pay Adya Consulting a one-time fee of CHF 2,500 ($2,705) for due diligence activities as well as a success fee of 5% for raising funds. For the six months ended June 30, 2023, and 2022, the Company recorded fees to Adya Consulting of $0 and $19,386 included in research and development expenses, respectively, on the statement of operating and comprehensive loss. Effective May 1, 2021, Ms. Panigone entered into an employment agreement with the Company. On September 5, 2022, the Company and Ms. Panigone agreed that she will leave her position as Chief Operating Officer on November 30, 2022.
In January 2017, and as subsequently amended in October 2020, the Company entered into a consulting agreement with CHG BioVenture SA, an entity controlled by Mr. Hervé Girsault, the Company’s current Head of Business Development. Pursuant to the consulting agreement, the Company agreed to pay CHG BioVenture SA a monthly fee of CHF 17,500, as well as an opportunity for a bonus of up to 15% of the annual fee, subject to the Company’s discretion. In addition, the Company has agreed to pay CHG BioVenture SA a 1% fee tied to the net proceeds actually received by the Company in certain transactions, such as, but not limited to, a merger or acquisition transaction. The consulting agreement may be terminated by either party for any reason at the end of each calendar quarter with three months’ prior written notice, or immediately if Mr. Girsault breaches the confidentiality provision. The consulting agreement also provides for a 24-month non-competition clause. The consulting agreement also provides for standard confidentiality provisions as well as reimbursement for certain expenses. For the six months ended June 30, 2023, and 2022, the Company recorded fees to CHG BioVenture SA of $64,378 and $74,989, respectively, included in general and administrative expenses on the statement of operating and comprehensive loss.
The Company entered into a new consulting agreement starting May 1, 2021, for the continuation of Mr. Girsault’s engagement with the Company in his current role. Pursuant to the new agreement, the Company has agreed to pay CHG BioVenture SA a monthly fee CHF 4’375 ($4,733) plus 7.7% VAT for his services. In addition, CHG BioVenture SA is eligible for a 1% success fee payment in the event of closing of a partnering agreement in China.
In March 2021, the Company entered into a consulting agreement with Mr. Subhasis Roy, the Company’s then Interim Chief Financial Officer, pursuant to which the Company agreed to pay Mr. Roy a daily rate of CHF 2,000 for his services. The consulting agreement was terminatable by either party upon 30 days’ written notice or immediately by the Company in the event of a material breach by Mr. Roy that could not be cured. The consulting agreement contained customary confidentiality provisions and provided for an 18-month non-solicitation clause. For the six months ended June 30, 2023 and 2022, the Company recorded fees to Mr. Roy of $0 and $49,728, respectively, included in general and administrative expenses on the statement of operating and comprehensive loss. The Company entered into a new consulting agreement starting July 2021 for the continuation of Mr. Roy’s engagement with the Company. On May 31, 2022, Mr. Roy resigned as the Company’s Interim Chief Financial Officer. Mr. Roy continued to provide transition services to the Company through June 30, 2022.
In February 2021, the Company entered into a consulting agreement with Mr. Eric Konofal, the Company’s current Chief Scientific Officer, pursuant to which the Company agreed to pay Mr. Konofal a daily rate of CHF 2,000 for his services. The consulting agreement may be terminated by either party upon 30 days’ written notice or immediately by the Company in the event of a material breach by Mr. Konofal that cannot be cured. The consulting agreement contains customary confidentiality provisions and provides for an 18-month non-solicitation clause as well as reimbursement for certain expenses. For the six months ended June 30, 2023 and 2022, the Company recorded fees to Mr. Konofal of $121,709 and $103,582, respectively, included in research and development expenses on the statement of operating and comprehensive loss. The Company entered a new consulting agreement starting July 1, 2021 for the continuation of Mr. Konofal’s engagement with the Company in his current role.
In March 2021, the Company entered into a consulting agreement with Mr. Carlos Camozzi, the Company’s then Interim Medical Director, pursuant to which the Company agreed to pay Mr. Camozzi an hourly rate of CHF 230 plus 7.7% VAT for his services. The consulting agreement could be terminated by either party upon 30 days’ written notice or immediately by us in the event of a material breach by Mr. Camozzi that cannot be cured. The consulting agreement contains customary confidentiality provisions and provides for an 18-month non-solicitation clause as well as reimbursement for certain expenses. For the six months ended June 30, 2023 and 2022, the Company recorded fees to Mr. Camozzi of $0 and $75,121, respectively, included in research and development expenses on the statement of operating and comprehensive loss. Mr. Camozzi left his position as Interim Medical Director on September 9, 2023.
In June 2022, the Company entered into a consulting agreement with Mr. Chad Hellmann, the Company’s then Chief Financial Officer, pursuant to which the Company agreed to pay Mr. Hellmann an annual salary of $160,000 for his services. Additionally, Mr. Hellmann was eligible for a bonus of up to $56,000 and he was eligible to receive an option award under the Option Plan. For the six months ended June 30, 2023, and 2022, the Company recorded fees to, the Company recorded fees to Mr. Hellmann of $66,665 and $13,333, included in general and administrative expenses on the statement of operating and comprehensive loss. Mr. Hellmann resigned as of May 31, 2023.
In December 2022, the Company entered into a consulting agreement with Ms. Marianne Lambertson, the Company’s current Head of Corporate Communications & Investor Relations, pursuant to which the Company agreed to pay Ms. Lambertson a monthly retainer of $12,500 for her services. Additionally, Ms. Lambertson will be eligible for a one-time cash bonus based on the share value appreciation on 10,000 phantom shares with share appreciation defined as the difference in the opening share price commencing January 1, 2023, and the closing price ending April 30, 2023. For the year ended December 31, 2022, the Company recorded fees to Ms. Lambertson of $12,500 included in general and administrative expenses on the statement of operating and comprehensive loss. For the six months ended June 30, 2023, the Company recorded fees to Ms. Lambertson of $75,000 included in general and administrative expenses on the statement of operating and comprehensive loss.
In December 2022, the Company entered into a consulting agreement with Ms. Astrid Sommer, the Company’s Head of Human Resources, pursuant to which the Company agreed to pay Ms. Sommer a fixed monthly retainer of $4,756 (CHF 4,400) with an additional per hour rate of $270 (CHF 250) for hours exceeding 20 hours per month. For the year ended December 31, 2022, the Company recorded fees to Ms. Sommer of $4,042 (CHF 3,740) included in general and administrative expenses on the statement of operating and comprehensive loss. For the six months ended June 30, 2023, the Company recorded fees to Ms. Sommer of $39,363 included in general and administrative expenses on the statement of operating and comprehensive loss. Ms. Sommer left her position as Head of Human Resources on May 31, 2023.
In December 2022, the Company entered into a consulting agreement with Mr. Thomas Curatolo, the Company’s current Head of U.S. Commercialization, pursuant to which the Company agreed to pay Mr. Curatolo a monthly retainer of $16,000 per month for his services. Additionally, Mr. Curatolo is eligible to receive a 50,000-option award under the Option Plan. For the year ended December 31, 2022, the Company recorded fees to Mr. Curatolo of $16,000 included in general and administrative expenses on the statement of operating and comprehensive loss. For the six months ended June 30, 2023, the Company recorded fees to Mr. Curatolo of $96,000 included in general and administrative expenses on the statement of operating and comprehensive loss. |
Subsequent Events |
6 Months Ended |
|---|---|
Jun. 30, 2023 | |
| Subsequent Events [Abstract] | |
| Subsequent Events | Note 10 Subsequent Events:
Management has evaluated subsequent events that have occurred through December 6, 2023, the date these financial statements were issued.
On September 28, 2023, the Company entered into a short-term loan agreement with Ronald Hafner, the Company’s Chairman of the Board of Directors, providing for an unsecured loan to the Company in the aggregate amount of CHF 500,000. The loan bears interest at a rate of 10% per annum and matures on November 30, 2023.
On October 25, 2023, the Company announced that it had received a written notice from Nasdaq Stock Market LLC indicating that the Company was not in compliance with the minimum bid price requirement for continued listing set forth in Listing Rule 5550(a)(2), which requires listed companies to maintain a minimum bid price of $1.00 per share. The Company has been granted a period of 180 calendar days to regain compliance with the minimum bid price requirement. The Company has until April 16, 2024, to regain compliance with the minimum bid price requirement.
On November 10, 2023, the Company, received a letter (the “Letter”), from its independent auditor, PricewaterhouseCoopers AG (the “Auditor”). The Letter, which was issued pursuant to Art. 725 and Art. 725b par. 1 of the Swiss Code of Obligations, requested that the Company provide a balance sheet at going concern and liquidation values as of October 31, 2023, to assess whether the Company’s equity showed an excess of liabilities over assets, with such balance sheet required to be provided no later than November 20, 2023. The Auditor advised it was issuing the Letter, in part, due to the fact that it has been advised that the Company would not have sufficient cash to fund its operations through December 31, 2023.
On November 15, 2023, the Company entered into a series of short-term loan agreements with certain existing shareholders of the Company, including Ronald Hafner, the Company’s Chairman of the Board of Directors, Felix Grisard, Jürgen Bauer and Maria Nayvalt, providing for unsecured loans to the Company in the aggregate amount of CHF 875,000.00 (approximately $1,000,000). The loans bear interest at a rate of 10% per annum and mature on the earlier of June 30, 2024, or a liquidity event with a strategic partner. The Company believes that the proceeds from the loas will resolve the issues raised by the Auditor in the Letter. In addition, the Company and Mr. Hafner agreed to extend the maturity of the previous short-term loan of CHF 500,000 that Mr. Hafner extended to the Company on September 28, 2023, such that it now expires on June 30, 2024.
On November 15, 2023, the Company reported that had selected a strategic partner and executed a non-binding term sheet for the out-licensing of its intellectual property, including its key asset Mazindol. The financial terms of the term sheet have not yet been finalized. Additionally, the Company has reported that it has implemented a workforce reduction of approximately 50%. This includes a pause on consulting agreements, reduction in non-clinical staff and reduction in non-essential operating expenses.
On December 1, 2023, the Company announced that it had entered into an exclusive worldwide option agreement with Aexon Labs, Inc., a privately held U.S. company (“Aexon Labs”), under which it may acquire global development and commercialization rights to Aexon Labs’ Dual Orexin Receptor Agonists platform, new molecular entities, highly selective dual oral orexin-1 and orexin-2 receptor agonists (OX1R and OX2R) with potential applications in the treatment of narcolepsy and idiopathic hypersomnia, as well as neuro-degenerative disorders such as Parkinson’s and Alzheimer’s disease. The transaction will be structured as an exclusive worldwide license for the development and commercialization by the Company of the Aexon Labs’ compounds and their derivatives. The Company must exercise its option by no later than March 31, 2024. It will pay Aexon Labs an upfront payment of $30,000 for the option exclusivity, and $170,000 upon execution of the definitive agreement to exercise the option. In addition, Aexon Labs will receive 15% of all proceeds earned by the Company in any future sub-licensing agreements which include upfront payments, regulatory milestones, commercial milestones and royalties earned during the first three years of commercialization in the U.S. and in the EU. The Company will be the sole party responsible for the design and execution of the research and development plan, for the conduct and management of the preclinical as well as clinical studies, and for the interactions with the U.S. Food and Drug Administration and/or any other regulatory agency. The Company will pay all costs associated with executing and completing those studies, as well as those associated with the preparation and submission of a new drug application. The Company will pay for all studies in all indications and regulatory filings in the U.S. as well as outside of the U.S. Eric Konofal, MD, PhD, who works under a part-time consulting agreement for the Company as its Chief Scientific Officer, is the president and founder of Aexon Labs, and owns 59% of Aexon Labs. Alexander Zwyer, Chief Executive Officer of NLS, owns 35% of Aexon Labs. Mr. Zwyer holds no board or executive position at Aexon Labs. |
Accounting Policies, by Policy (Policies) |
6 Months Ended |
|---|---|
Jun. 30, 2023 | |
| Summary of Significant Accounting Policies [Abstract] | |
| Basis of Preparation | Basis of Preparation The unaudited interim condensed financial statements have been prepared in accordance with U.S. GAAP for interim financial information and accordingly do not include all information and disclosures as required by U.S. GAAP for complete financial statements. The year-end unaudited interim condensed balance sheet was derived from audited financial statements but does not include all disclosures required by U.S. GAAP. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements included in the Company’s Annual Report on Form 20-F for the year ended December 31, 2022, and any public announcements made by the Company during the interim reporting period. In the opinion of management, these unaudited interim condensed financial statements reflect all adjustments necessary, which are of a normal recurring nature, to fairly state the balance sheets, statements of operating and comprehensive loss, changes in equity and cash flows for the interim reporting periods presented. |
| Use of Estimates | Use of Estimates The preparation of the unaudited interim condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect amounts reported of assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the interim reporting periods. Actual results could differ from those estimates and be based on events different from those assumptions. As part of these financial statements, the more significant estimates include the valuation allowance related to the Company’s deferred tax assets. |
| Property and equipment | Property and equipment Property and equipment are recorded at cost, net of accumulated depreciation and any accumulated impairment losses. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. The useful lives of property and equipment are five years for furniture and fixtures and three years for software.
Upon retirement or sale, the cost of disposed assets and their related accumulated depreciation are removed from the balance sheet. Any resulting net gains or losses on dispositions of property and equipment are included as a component of operating expenses within the Company’s statements of operating and comprehensive loss. Repair and maintenance costs that do not significantly add value to the property and equipment, or prolong its life, are charged to operating expense as incurred. |
| Stock-Based Compensation | Stock-Based Compensation The Company measures all stock-based awards granted based on the fair value on the date of the grant and recognizes compensation expense with respect to those awards over the requisite service period, which is generally the vesting period of the respective award. Generally, the Company issues awards with only service-based vesting conditions and records the expense for these awards using the straight-line method. The Company recognizes forfeitures related to stock-based compensation awards as they occur and reverses any previously recognized compensation cost associated with forfeited awards in the period the forfeiture occurs. The Company classifies stock-based compensation expense in the accompanying consolidated statements of operating and comprehensive loss in the same manner in which the award recipients’ payroll costs are classified or in which the award recipients’ service payments are classified. The fair value of each stock option is estimated on the date of grant using the Black-Scholes option-pricing model (“Black-Scholes”). Black-Scholes requires a number of assumptions, of which the most significant are share price, expected volatility, expected option term (the time from the grant date until the options are exercised or expire), risk-free rate and expected dividend rate. The grant date fair value of a common share is determined by the board of directors (the “Board of Directors”) considering, among other factors, the assistance of a valuation specialist and management. The grant date fair value of a common share is determined using the valuation methodologies, which utilize certain assumptions, including probability weighting of events, volatility, time to liquidation, risk-free interest rate and discount for lack of marketability. |
| Earnings per Share | Earnings per Share Basic loss per common share is computed by dividing the net loss applicable to common shareholders by the weighted-average number of common shares outstanding during the periods presented. Diluted loss per common share is computed similar to basic loss per share, except that the denominator is increased to include the number of additional potential common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. Potential common shares are excluded from the computation for a period in which a net loss is reported or if their effect is anti-dilutive. The Company’s potential common shares consist of warrants with their potential dilutive effect considered using the treasury method. For the six months ended June 30, 2023, 13,297,916 common shares from warrants and 3,242,887 treasury shares were excluded from the computation. For the six months ended June 30, 2022, 9,744,362 shares from warrants and 1,778,592 treasury shares were excluded from the computation. |
| Treasury Shares | Treasury Shares Treasury shares are purchased at cost and recognized as a deduction from equity. Income or loss from subsequent sales is presented in equity. |
| Segment Reporting | Segment Reporting The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is on developing therapeutics for the treatment of neurobehavioral and neurocognitive disorders. All of the Company’s tangible assets are held outside the United States of America. |
| Recently Issued Accounting Standards Not Yet Effective | Recently Issued Accounting Standards Not Yet Effective The Company has implemented all new accounting pronouncements that are in effect and that may impact its consolidated financial statements and does not believe that there are any other new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations. |
Prepaid Expenses and Other Current Assets (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Prepaid Expenses and Other Current Assets [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Prepaid Expenses and Other Current Assets | The Company’s prepaid expenses and other
current assets consisted of the following as of June 30, 2023, and December 31, 2022:
|
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Property and Equipment, net: (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Property and Equipment, net [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Property and Equipment | The following table shows the property and equipment
as of June 30, 2023 and December 31, 2022:
|
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Other Accrued Liabilities (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Accrued Liabilities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Other Accrued Liabilities | Other accrued liabilities consisted of the following
as of June 30, 2023 and December 31, 2022:
|
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Share Capital and Public Offerings (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share Capital and Public Offerings [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Common Share Warrant Activity | The following table summarizes
the common share warrant activity for the six months ended June 30, 2023:
|
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| Schedule of Stock Option Activity | The following table summarizes total stock option
activity for the year ended June 30, 2023:
|
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| Schedule of Unvested Stock Option | The following table summarizes unvested stock
option activity for the year ended December 31, 2022:
|
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Background (Details) - USD ($) $ / shares in Units, $ in Millions |
6 Months Ended | ||
|---|---|---|---|
Feb. 02, 2021 |
Jun. 30, 2023 |
Oct. 07, 2022 |
|
| Background (Details) [Line Items] | |||
| Initial public offering unit | 4,819,277 | ||
| Price per share unit | $ 4.15 | ||
| Description of warrant | Each unit consisted of one common share and one warrant to purchase one common share (the “Warrants”). | ||
| Net proceeds | $ 17.0 | ||
| Expire term | 5 years | ||
| Exercise price per share | $ 4.15 | $ 0.7 | |
| Additional purchase share | 722,891 | ||
| Additional warrants share | 722,891 | ||
| Warrant offering per share | $ 0.01 | ||
| Warrant purchase common share | 722,891 | ||
| Accumulated deficit | $ 65.8 | ||
| Operating loss | 7.5 | ||
| Cash and cash equivalents | $ 1.6 | ||
| Going concern term | 1 year | ||
| Background [Member] | |||
| Background (Details) [Line Items] | |||
| Exercise price per share | $ 4.15 | ||
| Going Concern [Member] | |||
| Background (Details) [Line Items] | |||
| Going concern term | 1 year |
Summary of Significant Accounting Policies (Details) - shares |
6 Months Ended | |
|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
|
| Summary of Significant Accounting Policies [Line Items] | ||
| Common shares issued | 13,297,916 | 9,744,362 |
| Treasury shares issued | 3,242,887 | 1,778,592 |
| Furniture and Fixtures [Member] | ||
| Summary of Significant Accounting Policies [Line Items] | ||
| Property and equipment use full life | 5 years | |
| Software [Member] | ||
| Summary of Significant Accounting Policies [Line Items] | ||
| Property and equipment use full life | 3 years | |
Prepaid Expenses and Other Current Assets (Details) - Schedule of Prepaid Expenses and Other Current Assets - USD ($) |
Jun. 30, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Schedule of Prepaid Expenses and Other Current Assets [Abstract] | ||
| Vendor prepayments | $ 37,817 | $ 65,739 |
| VAT recoverable and other current assets | 64,282 | 41,243 |
| Prepaid insurance | 448,503 | 36,496 |
| Prepaid expenses | 43,137 | 154,520 |
| Total prepaid expenses and other current assets | $ 593,738 | $ 297,998 |
Property and Equipment, net: (Details) - USD ($) |
6 Months Ended | |
|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
|
| Property and Equipment, net [Line Items] | ||
| Deprecation and related amortization expense | $ 5,704 | $ 5,704 |
Property and Equipment, net: (Details) - Schedule of Property and Equipment - USD ($) |
Jun. 30, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Cost | ||
| Total cost | $ 39,560 | $ 39,560 |
| Accumulated depreciation | (27,162) | (21,458) |
| Total property and equipment, net | 12,398 | 18,102 |
| Furniture and fixtures [Member] | ||
| Cost | ||
| Total cost | 13,341 | 13,341 |
| Software [Member] | ||
| Cost | ||
| Total cost | $ 26,219 | $ 26,219 |
Other Accrued Liabilities (Details) - Schedule of Other Accrued Liabilities - USD ($) |
Jun. 30, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Prepaid Expenses and Other Current Assets [Abstract] | ||
| Professional consultants’ expenses | $ 165,747 | $ 285,398 |
| Vendor liabilities | 13,000 | |
| Expenses | 19,325 | 4,107 |
| Accrued board fees | 72,238 | 149,496 |
| Accrued bonus | 456,040 | 510,678 |
| Other accrued expenses | 65,999 | 23,758 |
| Total other accrued liabilities | $ 779,349 | $ 986,437 |
Deferred Revenues (Details) - USD ($) |
6 Months Ended | |
|---|---|---|
Jun. 30, 2023 |
Dec. 31, 2022 |
|
| Deferred Revenues [Abstract] | ||
| Non-refundable upfront payment | $ 2,500,000 | |
| Non-refundable milestone payments | 16,000,000 | |
| Estimated total transaction price | 2,500,000 | |
| Deferred revenue | 2,500,000 | |
| Long term deferred revenue | $ 2,500,000 | $ 2,500,000 |
Commitments and Contingencies (Details) - USD ($) |
6 Months Ended | |
|---|---|---|
Mar. 10, 2021 |
Jun. 30, 2023 |
|
| Commitments and Contingencies [Abstract] | ||
| License consideration paid | $ 250,000 | |
| Milestone payments due, description | (i) $750,000 payable following the end of a Phase II meeting with the FDA, with the amount to be reduced to $375,000 if toxicology studies must be repeated; (ii) $2 million following the earlier of FDA marketing authorization of Quilience or Nolazol; (iii) 1% of any upfront and milestone payments, if any, from any sublicensees and (iv) $3 million as a one-time payment upon the Company’s product candidate reaching $250 million in cumulative sales. |
Share Capital and Public Offerings (Details) |
1 Months Ended | 6 Months Ended | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dec. 13, 2022
USD ($)
shares
|
Dec. 13, 2022
SFr / shares
shares
|
Oct. 07, 2022
USD ($)
$ / shares
shares
|
Aug. 19, 2022
$ / shares
shares
|
Apr. 25, 2022
USD ($)
$ / shares
shares
|
Apr. 13, 2022
USD ($)
|
Mar. 05, 2022
USD ($)
|
Dec. 14, 2021 |
Aug. 31, 2022
$ / shares
shares
|
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Jun. 30, 2023
CHF (SFr)
shares
|
Dec. 13, 2022
$ / shares
shares
|
Oct. 31, 2022
USD ($)
shares
|
Jun. 30, 2022
shares
|
Apr. 25, 2022
SFr / shares
|
Feb. 02, 2021
$ / shares
|
|
| Share Capital and Public Offerings [Line Items] | ||||||||||||||||
| Issued common shares | 35,671,780 | |||||||||||||||
| Common shares issuance | 5,747,126 | 5,747,126 | ||||||||||||||
| Purchase price per share (in Dollars per share) | $ / shares | $ 1.04 | $ 0.87 | ||||||||||||||
| Warrants to purchase | 5,747,127 | 1,258,215 | ||||||||||||||
| Cash payment fee (in Dollars) | $ | $ 700,000 | |||||||||||||||
| Aggregate gross proceeds | 5.00% | 5.00% | ||||||||||||||
| Purchase unitd (in Dollars) | $ | $ 20,000,000 | |||||||||||||||
| Number of common shares | 150.00% | 150.00% | ||||||||||||||
| Exercise price per share (in Dollars per share) | $ / shares | $ 0.7 | |||||||||||||||
| Share capital and public offerings description | Pursuant to the purchase agreement, the Company agreed to grant BVF the right to participate in future offerings of the Company’s securities for a period from the first closing (the “First Closing”) until the earlier of (i) the 30-month anniversary of the initial closing date or (ii) until such time that BVF retains beneficial ownership of less than 9.9% of the issued and outstanding Common Shares. on the same terms, conditions and price provided for in the subsequent financing or the right to purchase a comparable security with a beneficial ownership limitation. In addition, the Company agreed to grant BVF the right to nominate one member to the Company’s Board of Directors and shall continue to recommend to its shareholders to elect such member for a period from the First Closing until such time that BVF retains beneficial ownership of less than 9.9% of the issued and outstanding common shares. | Pursuant to the purchase agreement, the Company agreed to grant BVF the right to participate in future offerings of the Company’s securities for a period from the first closing (the “First Closing”) until the earlier of (i) the 30-month anniversary of the initial closing date or (ii) until such time that BVF retains beneficial ownership of less than 9.9% of the issued and outstanding Common Shares. on the same terms, conditions and price provided for in the subsequent financing or the right to purchase a comparable security with a beneficial ownership limitation. In addition, the Company agreed to grant BVF the right to nominate one member to the Company’s Board of Directors and shall continue to recommend to its shareholders to elect such member for a period from the First Closing until such time that BVF retains beneficial ownership of less than 9.9% of the issued and outstanding common shares. | ||||||||||||||
| Exercise price per share (in Dollars per share) | $ / shares | $ 0.7 | $ 4.15 | ||||||||||||||
| Cash placement (in Dollars) | $ | $ 140,000 | |||||||||||||||
| Accrued interest (in Dollars) | $ | $ 1,530,000 | |||||||||||||||
| Common shares | 2,516,429 | |||||||||||||||
| Common shares | 3,015,384 | |||||||||||||||
| Purchase of common shares | 574,712 | |||||||||||||||
| Sales agreement amount (in Dollars) | $ | $ 3,900,000 | |||||||||||||||
| Sales agreement amount (in Dollars) | $ | $ 230,000 | |||||||||||||||
| Commission rate percentage | 3.00% | |||||||||||||||
| Expire date | 5 years | 5 years | 2 years | 5 years | ||||||||||||
| Net proceeds received (in Dollars) | $ | $ 272,892 | |||||||||||||||
| Aggregate common shares | 2,597,400 | 307,844 | 3,150,000 | |||||||||||||
| Price per unit (in Dollars per share) | $ / shares | $ 0.7 | $ 0.5 | $ 1.04 | $ 1.1 | ||||||||||||
| Class of warrant outstanding | 806,510 | 67,008 | ||||||||||||||
| Convertible notes payable (in Dollars) | $ | $ 534,966 | $ 1,477,835 | ||||||||||||||
| Common share warrants (in Dollars) | $ | $ 8,123,773 | |||||||||||||||
| Capital increase (in Francs) | SFr | SFr 64,857 | |||||||||||||||
| Issuance of treasury shares | 3,242,887 | 1,778,592 | ||||||||||||||
| Diluted shares percentage | 15.00% | |||||||||||||||
| Grant term | 10 years | 10 years | ||||||||||||||
| Options vested and exercisable | 9 years 6 months | 9 years 6 months | ||||||||||||||
| Aggregate intrinsic value for options outstanding and expected to vest (in Dollars) | $ | $ 49,113 | |||||||||||||||
| Intrinsic value of exercisable options (in Dollars) | $ | ||||||||||||||||
| Stock-based compensation expense (in Dollars) | $ | 60,516 | |||||||||||||||
| Unrecognized stock-based compensation expense (in Dollars) | $ | $ 262,574 | |||||||||||||||
| Weighted-average period | 1 year 9 months | |||||||||||||||
| Pre Funded Warrant [Member] | ||||||||||||||||
| Share Capital and Public Offerings [Line Items] | ||||||||||||||||
| Purchase price per share (in Dollars per share) | $ / shares | $ 1.5 | |||||||||||||||
| Warrant term | 5 years | |||||||||||||||
| Exercise price per share (in Dollars per share) | $ / shares | $ 2.03 | |||||||||||||||
| Private Placement [Member] | ||||||||||||||||
| Share Capital and Public Offerings [Line Items] | ||||||||||||||||
| Exercise price per share (in Dollars per share) | $ / shares | $ 1.04 | |||||||||||||||
| Share issued | 5,194,802 | |||||||||||||||
| Exercise price per share (in Dollars per share) | $ / shares | $ 0.77 | |||||||||||||||
| Purchase of common shares | 3,150,000 | 3,150,000 | ||||||||||||||
| Warrant [Member] | ||||||||||||||||
| Share Capital and Public Offerings [Line Items] | ||||||||||||||||
| Exercise price per share (in Dollars per share) | $ / shares | 2.03 | |||||||||||||||
| Expire date | 5 years | |||||||||||||||
| Aggregate common shares | 1,258,214 | |||||||||||||||
| Price per unit (in Dollars per share) | $ / shares | $ 0.7 | |||||||||||||||
| Common Stock [Member] | ||||||||||||||||
| Share Capital and Public Offerings [Line Items] | ||||||||||||||||
| Share issued | 2,597,401 | |||||||||||||||
| Pre Funded Warrant [Member] | ||||||||||||||||
| Share Capital and Public Offerings [Line Items] | ||||||||||||||||
| Common shares | 1,184,616 | |||||||||||||||
| Maximum [Member] | ||||||||||||||||
| Share Capital and Public Offerings [Line Items] | ||||||||||||||||
| Common per share | $ / shares | $ 1.04 | $ 0.87 | ||||||||||||||
| Minimum [Member] | ||||||||||||||||
| Share Capital and Public Offerings [Line Items] | ||||||||||||||||
| Common per share | SFr / shares | SFr 0.02 | SFr 0.02 | ||||||||||||||
| Mr. Ronald Hafner [Member] | ||||||||||||||||
| Share Capital and Public Offerings [Line Items] | ||||||||||||||||
| Purchase of common shares | 95,984 | |||||||||||||||
| Common shares offering | 3,015,384 | |||||||||||||||
Share Capital and Public Offerings (Details) - Schedule of Common Share Warrant Activity |
6 Months Ended |
|---|---|
|
Jun. 30, 2023
USD ($)
| |
| Schedule of common share warrant activity [Abstract] | |
| Balance at beginning | $ 19,045,043 |
| Issuances | |
| Exercises | |
| Balance at ending | $ 19,045,043 |
Share Capital and Public Offerings (Details) - Schedule of Stock Option Activity - $ / shares |
6 Months Ended | 12 Months Ended |
|---|---|---|
Jun. 30, 2023 |
Dec. 31, 2022 |
|
| Schedule of Stock Option Activity [Abstract] | ||
| Number of Options, Beginning balance | 1,333,123 | |
| Weighted Average Exercise Price, Beginning balance (in Dollars per share) | ||
| Number of Options, Granted | 1,333,123 | |
| Weighted Average Exercise Price, Granted (in Dollars per share) | ||
| Number of Options, Exercised | ||
| Weighted Average Exercise Price, Exercised (in Dollars per share) | ||
| Number of Options, Expired/cancelled | (245,809) | |
| Weighted Average Exercise Price, Expired/cancelled (in Dollars per share) | ||
| Number of Options, Ending balance | 1,087,314 | 1,333,123 |
| Weighted Average Exercise Price, Ending balance (in Dollars per share) | $ 1.29 | |
| Options vested and exercisable | 384,300 | |
| Options expected to vest | 703,014 |
Share Capital and Public Offerings (Details) - Schedule of Unvested Stock Option - $ / shares |
6 Months Ended | 12 Months Ended |
|---|---|---|
Jun. 30, 2023 |
Dec. 31, 2022 |
|
| Schedule of Unvested Stock Option [Abstract] | ||
| Non-Vested Options, Beginning Balance | 1,283,123 | |
| Weighted Average Grant date Fair Value,Beginning Balance (in Dollars per share) | $ 0.25 | |
| Non-Vested Options,Granted | 1,333,123 | |
| Weighted Average Grant date Fair Value,Granted (in Dollars per share) | ||
| Non-Vested Options, Vested | (50,000) | |
| Weighted Average Grant date Fair Value, Vested (in Dollars per share) | $ 0.22 | |
| Non-Vested Options, Forfeited | ||
| Non-Vested Options, Ending Balance | 1,283,123 | |
| Weighted Average Grant date Fair Value, Ending Balance (in Dollars per share) | $ 0.25 |