10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2022

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from __________ to ___________

Commission File Number: 001-40192

 

Longboard Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

84-5009619

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

4275 Executive Square, Suite 950

La Jolla, CA

92037

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (619) 592-9775

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common stock, par value $0.0001 per share

 

LBPH

 

The Nasdaq Global Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

 

Accelerated filer

 

 

 

 

 

Non-accelerated filer

 

 

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

 

Emerging growth company

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No ☒

As of August 2, 2022, the registrant had 17,215,350 shares of common stock, $0.0001 par value per share, outstanding, comprised of 13,585,950 shares of voting common stock, $0.0001 par value per share, and 3,629,400 shares of non-voting common stock, $0.0001 par value per share.

 

 


 

Table of Contents

 

 

 

Page

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

1

 

SUMMARY OF RISKS ASSOCIATED WITH OUR BUSINESS

2

 

 

 

PART I.

FINANCIAL INFORMATION

4

Item 1.

Financial Statements (Unaudited)

4

 

Condensed Balance Sheets

4

 

Condensed Statements of Operations and Comprehensive Loss

5

 

Condensed Statements of Cash Flows

6

 

Notes to Unaudited Condensed Financial Statements

7

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

19

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

29

Item 4.

Controls and Procedures

29

 

 

 

PART II.

OTHER INFORMATION

30

Item 1.

Legal Proceedings

30

Item 1A.

Risk Factors

30

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

74

Item 3.

Defaults Upon Senior Securities

74

Item 4.

Mine Safety Disclosures

74

Item 5.

Other Information

74

Item 6.

Exhibits

75

Signatures

76

 

i


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (this “Quarterly Report”) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that involve substantial risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements, which speak only as of the date they are made and are not guarantees of future performance. In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “consider,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would” or the negative or plural of these words or other comparable terminology. These forward-looking statements generally relate to future events or our future financial or operating results and may include, but are not limited to, statements about:

our plans to research, develop and commercialize our product candidates;
the initiation, progress, success, cost and timing of our clinical trials and product development activities;
the therapeutic potential of our product candidates, and the disease indications for which we intend to develop our product candidates;
our ability and timing to advance our product candidates into, and to successfully initiate, conduct, enroll and complete, clinical trials;
our ability to manufacture our product candidates for clinical development and, if approved, for commercialization, and the timing and costs of such manufacture;
the performance of third parties in connection with the development and manufacture of our product candidates, including third parties conducting our clinical trials as well as third-party suppliers and manufacturers;
our ability to obtain funding for our operations, including funding necessary to initiate and complete clinical trials of our product candidates;
the size and growth of the potential markets for our product candidates and our ability to serve those markets;
the potential scope, duration and value of our intellectual property rights;
our ability, and the ability of our licensors, to obtain, maintain, defend and enforce intellectual property rights protecting our product candidates, and our ability to develop and commercialize our product candidates without infringing the proprietary rights of third parties;
our ability to recruit and retain key personnel;
the effects on our operations of general political and economic conditions, including the COVID-19 pandemic, the invasion of Ukraine by Russia, economic slowdowns, recessions or market corrections, inflation, rising interest rates and tightening of credit markets resulting from the pandemic, the conflict in Ukraine or another cause; and
other risks and uncertainties, including those described under Part II, Item 1A, “Risk Factors” of this Quarterly Report.

Any forward-looking statements in this Quarterly Report reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under Part II, Item 1A, “Risk Factors” of this Quarterly Report. Given these uncertainties, you should not place undue reliance on these forward-looking statements or rely on forward-looking statements as predictions of future events. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

Unless the context otherwise indicates, references in this Quarterly Report to the terms, “Longboard,” “the Company,” “we,” “our” and “us” refer to Longboard Pharmaceuticals, Inc. and references to our “common stock” refer to our voting common stock.

 

1


 

SUMMARY OF RISKS ASSOCIATED WITH OUR BUSINESS

An investment in shares of our common stock involves a high degree of risk. Below is a list of the more significant risks associated with our business. This summary does not address all of the risks that we face. Additional discussion of the risks listed in this summary, as well as other risks that we face, are set forth under Part II, Item 1A, “Risk Factors” in this Quarterly Report. Some of the material risks associated with our business include the following:

Arena was acquired by Pfizer, Inc. on March 11, 2022, and Arena’s acquisition may negatively impact our development programs and stock price.
We have a very limited operating history, and we have incurred losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future. We may never generate any revenue or become profitable or, if we achieve profitability, we may not be able to sustain it.
We will need substantial additional capital to finance our operations, which may not be available on acceptable terms, or at all. A recession or other unfavorable market conditions, including economic slowdowns, recessions, inflation, rising interest rates and tightening of credit markets caused by the ongoing COVID-19 pandemic, the conflict in Ukraine or otherwise, may limit our access to capital. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate certain of our product development efforts or other operations.
We are early in our development efforts and have only one product candidate, LP352, in early clinical development. All of our other product candidates are in the preclinical or research stage. If we are unable to advance our product candidates in clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.
Clinical and preclinical drug development involves a lengthy and expensive process with an uncertain outcome. The results of prior clinical trials and early preclinical studies and clinical trials of our product candidates are not necessarily predictive of future results.
The regulatory approval processes of the U.S. Food and Drug Administration (“FDA”) and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
Because we have multiple product candidates in our clinical pipeline and are considering a variety of target indications, we may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
If the market opportunities for our product candidates are smaller than we estimate, even assuming approval of a product candidate, our business may suffer. Because the patient populations in the market for our product candidates may be small, we must be able to successfully identify patients and acquire a significant market share to achieve profitability and growth.
We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may have to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate product revenue.
COVID-19 has impacted and could continue to adversely impact our business.
We intend to rely on third parties to conduct, supervise and monitor our preclinical studies and clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.
Our principal stockholders and management own a significant percentage of our stock and are able to exert significant control over matters subject to stockholder approval. Our stock market price may be negatively affected if our principal stockholders and management sell some or all of their stock.
We depend on intellectual property licensed from third parties, including Arena, and the failure of our licensors to protect the licensed intellectual property or the termination of our license which could result in the loss of significant rights, which would harm our business.

2


 

If we are unable to obtain and maintain patent protection for our current or any future product candidates, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.

 

3


 

PART I—FINANCIAL INFORMATION

 

Item 1. Financial Statements.

Longboard Pharmaceuticals, Inc.

Condensed Balance Sheets

(unaudited)

 

 

 

June 30,

 

 

December 31,

 

(in thousands, except share and per share data)

 

2022

 

 

2021

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

27,716

 

 

$

66,346

 

Short-term investments

 

 

59,702

 

 

 

40,379

 

Prepaid expenses and other current assets

 

 

2,728

 

 

 

1,659

 

Total current assets

 

 

90,146

 

 

 

108,384

 

Right-of-use assets

 

 

355

 

 

 

521

 

Property and equipment

 

 

12

 

 

 

14

 

Other long-term assets

 

 

 

 

 

33

 

Total assets

 

$

90,513

 

 

$

108,952

 

LIABILITIES AND EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

602

 

 

$

1,028

 

Accrued research and development expenses

 

 

4,215

 

 

 

2,245

 

Accrued compensation and related expenses

 

 

1,019

 

 

 

1,480

 

Accrued other expenses

 

 

1,345

 

 

 

352

 

Right-of-use liabilities, current portion

 

 

363

 

 

 

339

 

Total current liabilities

 

 

7,544

 

 

 

5,444

 

Right-of-use liabilities, net of current portion

 

 

 

 

 

185

 

Commitments and contingencies (see Note 9)

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; authorized shares - 10,000,000 at June 30, 2022 and December 31, 2021; issued and outstanding shares - none at June 30, 2022 and December 31, 2021

 

 

 

 

 

 

Voting common stock, $0.0001 par value; authorized shares - 300,000,000 at June 30, 2022 and December 31, 2021; issued and outstanding shares - 13,527,869 and 13,440,761 at June 30, 2022 and December 31, 2021, respectively, excluding 58,081 and 145,189, respectively, subject to repurchase

 

 

1

 

 

 

1

 

Non-voting common stock, $0.0001 par value; authorized shares - 10,000,000 at June 30, 2022 and December 31, 2021; issued and outstanding shares - 3,629,400 at June 30, 2022 and December 31, 2021

 

 

 

 

 

 

Additional paid-in capital

 

 

146,953

 

 

 

145,683

 

Accumulated other comprehensive loss

 

 

(784

)

 

 

(164

)

Accumulated deficit

 

 

(63,201

)

 

 

(42,197

)

Total stockholders' equity

 

 

82,969

 

 

 

103,323

 

Total liabilities and stockholders' equity

 

$

90,513

 

 

$

108,952

 

 

The accompanying notes are an integral part of these financial statements.

4


 

Longboard Pharmaceuticals, Inc.

Condensed Statements of Operations and Comprehensive Loss

(unaudited)

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

(in thousands, except share and per share data)

2022

 

 

2021

 

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

$

8,921

 

 

$

4,915

 

 

$

16,042

 

 

$

9,313

 

General and administrative

 

2,646

 

 

 

2,072

 

 

 

5,145

 

 

 

3,377

 

Total operating expenses

 

11,567

 

 

 

6,987

 

 

 

21,187

 

 

 

12,690

 

Loss from operations

 

(11,567

)

 

 

(6,987

)

 

 

(21,187

)

 

 

(12,690

)

Interest income, net

 

127

 

 

 

13

 

 

 

159

 

 

 

17

 

    Other income (expense)

 

33

 

 

 

(6

)

 

 

24

 

 

 

(6

)

Net loss

$

(11,407

)

 

$

(6,980

)

 

$

(21,004

)

 

$

(12,679

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

$

(0.67

)

 

$

(0.41

)

 

$

(1.23

)

 

$

(1.07

)

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average shares outstanding, basic and diluted

 

17,130,307

 

 

 

16,827,556

 

 

 

17,108,582

 

 

 

11,846,653

 

 

 

 

 

 

 

 

 

 

 

 

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(11,407

)

 

$

(6,980

)

 

$

(21,004

)

 

$

(12,679

)

Unrealized loss on short-term investments

 

(188

)

 

 

(34

)

 

 

(620

)

 

 

(34

)

Comprehensive loss

$

(11,595

)

 

$

(7,014

)

 

$

(21,624

)

 

$

(12,713

)

 

The accompanying notes are an integral part of these financial statements.

5


 

Longboard Pharmaceuticals, Inc.

Condensed Statements of Cash Flows

(unaudited)

 

 

 

Six Months Ended June 30,

 

(in thousands)

 

2022

 

 

2021

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(21,004

)

 

$

(12,679

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Stock-based compensation expense

 

 

1,270

 

 

 

845

 

Depreciation

 

 

3

 

 

 

 

Amortization of premiums (accretion of discounts) on investments

 

 

149

 

 

 

(2

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

(1,037

)

 

 

(1,835

)

Accounts payable

 

 

(426

)

 

 

(298

)

Accrued research and development expenses

 

 

1,970

 

 

 

668

 

Accrued compensation and related expenses

 

 

(461

)

 

 

451

 

Accrued other expenses

 

 

993

 

 

 

(46

)

Operating right-of-use assets and lease liabilities, net

 

 

4

 

 

 

 

Net cash used in operating activities

 

 

(18,539

)

 

 

(12,896

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of short-term investments

 

 

(34,291

)

 

 

(28,012

)

Maturities of short-term investments

 

 

14,200

 

 

 

 

Net cash used in investing activities

 

 

(20,091

)

 

 

(28,012

)

Cash flows from financing activities:

 

 

 

 

 

 

Series A convertible preferred stock financing costs

 

 

 

 

 

(1

)

Proceeds from initial public offering

 

 

 

 

 

84,774

 

Initial public offering costs

 

 

 

 

 

(8,320

)

Net cash provided by financing activities

 

 

 

 

 

76,453

 

Net (decrease) increase in cash and cash equivalents

 

 

(38,630

)

 

 

35,545

 

Cash and cash equivalents at the beginning of the period

 

 

66,346

 

 

 

55,316

 

Cash and cash equivalents at the end of the period

 

$

27,716

 

 

$

90,861

 

 

 

 

 

 

 

 

Non-cash investing and financing activities:

 

 

 

 

 

 

Initial public offering costs in accrued other expenses

 

$

 

 

$

1

 

 

The accompanying notes are an integral part of these financial statements.

6


 

Longboard Pharmaceuticals, Inc.

Notes to Unaudited Financial Statements

Note 1. Organization and Basis of Presentation

Description of Business

Longboard Pharmaceuticals, Inc. (the “Company”), formerly Arena Neuroscience, Inc., was incorporated in the state of Delaware on January 3, 2020, and is based in San Diego, California. The Company was organized and initially wholly-owned by Arena Pharmaceuticals, Inc. (“Arena”), until the closing of its Series A convertible preferred stock (“Series A Preferred Stock”) financing in October 2020. The Company is a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases. The Company’s most advanced product candidate, LP352, is being developed for the treatment of seizures associated with developmental and epileptic encephalopathies and is currently in a Phase 1b/2a clinical trial (“the PACIFIC Study”). The Company’s preclinical product candidates include LP659 and LP143, which are potential therapies for multiple neurological diseases.

Initial Public Offering

On March 16, 2021, the Company completed the initial public offering (“IPO”) of its common stock. In connection with the IPO, the Company issued and sold 5,298,360 shares of voting common stock, which included 298,360 shares of its voting common stock issued pursuant to the option granted to the underwriters to purchase additional shares in April 2021, at a public offering price of $16.00 per share. The Company raised $76.2 million in net proceeds from the IPO after deducting underwriters’ discounts and commissions of $5.9 million and issuance costs of $2.6 million. Unless otherwise noted, all references in the financial statements and related footnotes to the Company's “common stock” refers to the Company's voting common stock.

Immediately prior to the closing of the IPO, 2,630,000 shares of Series A Preferred Stock were exchanged for 3,629,400 shares of non-voting common stock and 2,970,000 shares were automatically converted into 4,098,600 shares of voting common stock. Following the IPO, there were no shares of Series A Preferred Stock outstanding.

Forward Stock Splits

On October 27, 2020, the Company filed an amendment to the Company’s certificate of incorporation to effect a forward stock split of shares of the Company’s common stock on a 2,783-for-1 basis (the “October 2020 Forward Stock Split”). The par value of the common stock was not adjusted as a result of the October 2020 Forward Stock Split. The accompanying financial statements and notes to the financial statements give retroactive effect to the October 2020 Forward Stock Split for the periods presented.

On March 5, 2021, the Company filed an amendment to the Company’s amended and restated certificate of incorporation to effect a forward stock split of shares of the Company’s common stock on a 1.38-for-1 basis (the “March 2021 Forward Stock Split”). Adjustments corresponding to the March 2021 Forward Stock Split were made to the ratio at which the Company’s Series A Preferred Stock were converted into common stock immediately prior to the closing of the IPO. The par value of the common stock and number of shares authorized were not adjusted as a result of the March 2021 Forward Stock Split. All references to common stock, options to purchase common stock, share data, per share data, and related information contained in the financial statements and related footnotes have been retrospectively adjusted to reflect the effect of the March 2021 Forward Stock Split for all periods presented.

Basis of Presentation

The Company’s unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and applicable regulations of the U.S. Securities and Exchange Commission (“SEC”). Accordingly, the accompanying unaudited condensed financial statements do not include all of the information and notes required by GAAP for complete financial statements. The unaudited condensed financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair statement of the results for the periods presented. All such adjustments are of a normal and recurring nature. The balance sheet as of December 31, 2021 has been derived from the audited financial statements at that date but does not include all information and notes required by GAAP for complete financial statements. The operating results presented in these unaudited condensed financial statements are not necessarily indicative of the results that may be expected for any future periods. The Company’s unaudited condensed financial statements should be read in conjunction with the audited financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed on March 3, 2022.

Liquidity and Capital Resources

Since its inception, the Company has devoted substantially all of its resources to research and development (“R&D”) activities, organizing and staffing, business planning, raising capital, in-licensing intellectual property rights and establishing its intellectual

7


 

property portfolio, and providing general and administrative (“G&A”) support for these operations and has funded its operations primarily with the net proceeds from the issuance of Series A Preferred Stock and common stock. The Company has incurred losses and negative cash flows from operations since commencement of its operations. The Company had an accumulated deficit of $63.2 million and $42.2 million as of June 30, 2022, and December 31, 2021, respectively.

Management expects the Company will incur substantial operating losses for the foreseeable future in order to complete preclinical studies and clinical trials, seek regulatory approval, and launch and commercialize any product candidates for which it receives regulatory approval. The Company will need to raise additional capital through public or private equity or debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements.

The COVID-19 pandemic and the conflict in Ukraine continue to evolve and have resulted in a significant disruption of global financial markets. The Company’s ability to raise additional capital may be adversely impacted by potential worsening of global economic conditions and the disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the pandemic and conflict. If the disruption persists or deepens, the Company could experience an inability to access additional capital.

 

As of June 30, 2022, the Company had available cash, cash equivalents and short-term investments of $87.4 million and working capital of $82.6 million to fund future operations. Management believes that its capital resources as of June 30, 2022, will be sufficient to fund the Company’s operations for at least 12 months after the date these unaudited condensed financial statements are issued.

Note 2. Summary of Significant Accounting Policies

Use of Estimates

The Company’s financial statements are prepared in accordance with GAAP. The preparation of the Company’s financial statements requires the Company to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the financial statements and accompanying notes. Such estimates include the accrual of R&D expenses and stock-based compensation. Management evaluates its estimates on an ongoing basis. Estimates are based on the Company’s historical experience, knowledge of current events and actions it may undertake in the future, and actual results may materially differ from these estimates and assumptions.

 

Concentration of Credit Risk

 

Financial instruments which potentially subject the Company to significant concentration of credit risk consist of cash, cash equivalents and short-term investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits and invests in short-term investments with the primary objectives of seeking to preserve principal, achieve liquidity requirements and safeguard funds. Management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held and the nature, including the credit-ratings, of its short-term investments.

 

Comprehensive Loss

 

Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on short-term investments.

 

Cash and Cash Equivalents

The Company considers all highly liquid investments with original maturities of three months or less when purchased to be cash equivalents. Cash and cash equivalents include cash in readily available checking accounts, money market funds, corporate debt securities, and obligations of U.S. government-sponsored enterprises. The carrying amounts reported in the unaudited condensed balance sheets for cash and cash equivalents are valued at cost, which approximates fair value.

Short-Term Investments

Short-term investments primarily consist of commercial paper, corporate debt securities, and government and agency bonds. The Company has classified these investments as available-for-sale securities, as the sale of such investments may be required prior to maturity to implement management strategies, and therefore has classified all investments with maturity dates beyond three months at the date of purchase as current assets in the accompanying unaudited balance sheets. Any premium or discount arising at purchase is amortized and/or accreted to interest income as an adjustment to yield using the straight-line method over the life of the instrument.

8


 

Investments are reported at their estimated fair value. Unrealized gains and losses are included in accumulated other comprehensive loss as a component of stockholders' equity until realized.

R&D Expenses

 

R&D expenses are expensed in the periods in which they are incurred. External expenses consist primarily of payments to contract research organizations, outside consultants and other third parties in connection with the Company’s discovery, preclinical and clinical activities, process development, manufacturing activities, regulatory and other services. Certain R&D external expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to the Company by its service providers or the estimate of the level of service that has been performed at each reporting date. R&D expenses amounted to $8.9 million, $16.0 million, $4.9 million and $9.3 million for the three and six months ended June 30, 2022 and 2021, respectively.

Stock-Based Compensation

 

Stock-based awards are measured at fair value and compensation expense is recognized over the requisite service period. Forfeitures are accounted for in the period they occur. The Company estimates the fair value of each stock-based award on the date of grant using the Black-Scholes option pricing model which requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest rate, dividend yield, and expected term of the option.

 

Leases

 

The Company determines if an arrangement is a lease or contains lease components at inception. Lease terms are determined at the commencement date by considering whether renewal options and termination options, if any, are reasonably assured of exercise. For long-term operating leases, the Company recognizes a lease liability and a right-of-use (“ROU”) asset on its balance sheets and recognizes lease expense on a straight-line basis over the lease term. The lease liability is determined as the present value of future lease payments using the discount rate implicit in the lease or, if the implicit rate is not readily determinable, an estimate of the Company’s incremental borrowing rate. The ROU asset is based on the lease liability, adjusted for any prepaid or deferred rent. The Company does not have any financing leases.

 

Net Loss Per Share

 

Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock and potentially dilutive securities outstanding for the period. Since the Company had a net loss in each of the periods presented, basic and diluted net loss per share of common stock are the same.

 

The table below provides potentially dilutive securities not included in the calculation of the diluted net loss per share as it would be anti-dilutive:

 

 

Three and Six Months Ended June 30,

 

 

2022

 

 

2021

 

Options to purchase common stock

 

2,496,166

 

 

 

1,285,656

 

Restricted stock awards, issued but unvested

 

58,081

 

 

 

348,450

 

Total

 

2,554,247

 

 

 

1,634,106

 

 

Recent Accounting Pronouncements

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (ASU 2016-13), to improve financial reporting by requiring timely recording of credit losses on loans and other financial instruments held by financial institutions and other organizations. ASU 2016-13 requires the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. This guidance will become effective for the Company beginning January 1, 2023, with early adoption permitted. The Company does not expect the adoption of this standard to have a material impact on its financial statements.

Risks and Uncertainties

 

In December 2019, COVID-19, a novel strain of coronavirus, was first identified in Wuhan, China. In March 2020, the World Health Organization categorized COVID-19 as a pandemic, and the virus has spread to over 100 countries, including the United

9


 

States. The impact of this pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world.

 

Potential impacts to the Company’s business include, but are not limited to, temporary closures of facilities of its vendors, disruptions or restrictions on its employees’ ability to travel, disruptions to or delays in ongoing laboratory experiments, preclinical studies, clinical trials, third-party manufacturing supply and other operations, the potential diversion of healthcare resources away from the conduct of clinical trials to focus on pandemic concerns, interruptions or delays in the operations of the U.S. Food and Drug Administration or other regulatory authorities, and the Company’s ability to raise capital and conduct business development activities.

 

In February 2022, Russia commenced a military invasion of Ukraine. The ongoing geopolitical turmoil, including continuing military action in the region and sanctions imposed on Russia, have contributed to further disruption, instability and volatility of the financial markets, which may have an adverse impact on the Company’s business or ability to access the capital markets in the future.

 

Note 3. Fair Value Measurements

 

The accounting guidance defines fair value, establishes a consistent framework for measuring fair value, and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

 

Level 1 — Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.

 

Level 2 — Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability.

 

Level 3 — Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).

 

10


 

The following table summarizes the Company's financial instruments measured at fair value on a recurring basis as of June 30, 2022 and December 31, 2021.

 

 

 

 

 

 

Fair Value Measurements at
Reporting Date Using

 

(in thousands)

 

Total

 

 

Quoted Prices in Active Markets for Identical Assets
(Level 1)

 

 

Significant Other Observable Inputs
(Level 2)

 

 

Significant Unobservable Inputs
(Level 3)

 

As of June 30, 2022

 

 

 

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

  Money market funds

 

$

25,718

 

 

$

25,718

 

 

$

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  Commercial paper

 

$

9,860

 

 

$

 

 

$

9,860

 

 

$

 

  Corporate debt securities

 

 

20,743

 

 

 

 

 

 

20,743

 

 

 

 

  Government and agency securities

 

 

30,097

 

 

 

24,795

 

 

 

5,302

 

 

 

 

Total assets measured at fair value

 

$

86,418

 

 

$

50,513

 

 

$

35,905

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As of December 31, 2021

 

 

 

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

  Money market funds

 

$

36,014

 

 

$

36,014

 

 

$

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  Commercial paper

 

$

13,987

 

 

$

 

 

$

13,987

 

 

$

 

  Corporate debt securities

 

 

14,017

 

 

 

 

 

 

14,017

 

 

 

 

  Government and agency securities

 

 

12,375

 

 

 

9,559

 

 

 

2,816

 

 

 

 

Total short-term investments

 

 

40,379

 

 

 

9,559

 

 

 

30,820

 

 

 

 

Total assets measured at fair value

 

$

76,393

 

 

$

45,573

 

 

$

30,820

 

 

$

 

 

Note 4. Short-Term Investments

 

The following table summarizes short-term investments:

 

 

 

As of June 30, 2022

 

 

 

 

 

 

Unrealized

 

 

 

 

(in thousands)

 

Amortized Cost

 

 

Gains

 

 

Losses

 

 

Estimated Fair Value

 

Commercial paper

 

$

8,863

 

 

$

 

 

$

(1

)

 

$

8,862

 

Corporate debt securities

 

 

21,158

 

 

 

 

 

 

(415

)

 

 

20,743

 

Government and agency securities

 

 

30,465

 

 

 

 

 

 

(368

)

 

 

30,097

 

  Total short-term investments

 

$

60,486

 

 

$

 

 

$

(784

)

 

$

59,702

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As of December 31, 2021

 

 

 

 

 

 

Unrealized

 

 

 

 

(in thousands)

 

Amortized Cost

 

 

Gains

 

 

Losses

 

 

Estimated Fair Value

 

Commercial paper

 

$

13,987

 

 

$

 

 

$

 

 

$

13,987

 

Corporate debt securities

 

 

14,117

 

 

 

 

 

 

(100

)

 

 

14,017

 

Government and agency securities

 

 

12,439

 

 

 

 

 

 

(64

)

 

 

12,375

 

  Total short-term investments

 

$

40,543

 

 

$

 

 

$

(164

)

 

$

40,379

 

 

The Company reviews its investments to identify and evaluate investments that have an indication of possible other-than-temporary impairment. Factors considered in determining whether a loss is other-than-temporary include the length of time and extent to which fair value has been less than the cost basis, any changes to the underlying credit risk of the investment, and the Company’s intent and ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in market value. As of June 30, 2022, the Company held 34 securities, with an aggregate fair value of $51.8 million, in an unrealized loss position. These

11


 

securities have not been in a continuous loss position for more than 12 months and there were no individual securities that were in a significant unrealized loss position as of June 30, 2022. The Company does not generally intend to sell these investments and it is not more likely than not that the Company will be required to sell these investments before recovery of their amortized cost basis which may be at maturity. As such, the Company has classified these losses as temporary in nature.

 

The following table summarizes the maturities of the Company's short-term investments at June 30, 2022:

 

 

 

 

 

 

 

Amortized Cost

 

 

Estimated Fair Value

 

Due in one year or less

 

 

 

 

 

$

49,040

 

 

$

48,668

 

Due after one year through three years

 

 

 

 

 

 

11,446

 

 

 

11,034

 

  Total short-term investments

 

 

 

 

 

$

60,486

 

 

$

59,702

 

 

Note 5. Accrued Other Expenses

 

Accrued other expenses consisted of the following:

 

 

 

As of

 

(in thousands)

 

June 30, 2022

 

 

December 31, 2021

 

Insurance premium finance liability

 

$

794

 

 

$

 

Accrued consulting fees

 

 

278

 

 

 

97

 

Accrued legal and accounting fees

 

 

171

 

 

 

7

 

Accrued computer related expenses

 

 

10

 

 

 

27

 

Accrued taxes

 

 

31

 

 

 

168

 

Accrued recruiting fees

 

 

 

 

 

30

 

Accrued other

 

 

61

 

 

 

23

 

Total

 

$

1,345

 

 

$

352

 

The Company entered into a premium finance agreement in March 2022 in connection with the renewal of its annual directors and officers insurance. The total amount financed was $1.2 million and is paid over nine months beginning in April 2022. The total finance charge for the premium finance agreement is $15,000 which is recorded to interest expense monthly on a straight-line basis.

Note 6. Stockholders’ Equity

Amended and Restated Certificate of Incorporation

In March 2021, the Company amended and restated the Company’s certificate of incorporation to, among other things, increase the authorized shares of voting common stock, non-voting common stock and preferred stock to 300,000,000 shares, 10,000,000 shares and 10,000,000 shares, respectively.

Voting Common Stock and Non-Voting Common Stock

As of June 30, 2022, the Company had 13,527,869 shares of voting common stock outstanding, excluding 58,081 shares subject to repurchase, and 3,629,400 shares of non-voting common stock outstanding. As of December 31, 2021, the Company had 13,440,761 shares of voting common stock outstanding, excluding 145,189 shares subject to repurchase, and 3,629,400 shares of non-voting common stock outstanding.

Series A Preferred Stock

In October 2020, the Company issued and sold 5,600,000 shares of Series A Preferred Stock at a price of $10.00 per share, resulting in gross proceeds of $56.0 million, including 100,000 shares purchased by Arena. The Company incurred $0.2 million in issuance costs related to the Series A Preferred Stock financing. On March 16, 2021, immediately prior to the closing of the IPO, 2,630,000 shares of the Series A Preferred Stock were exchanged for 3,629,400 shares of non-voting common stock. Upon the closing of the IPO, 2,970,000 shares of the Series A Preferred Stock were automatically converted into 4,098,600 shares of voting common stock. Following the IPO, there were no shares of Series A Preferred Stock outstanding.

 

12


 

Reconciliation of Changes in Stockholders’ Equity

The following tables document the changes in stockholders' equity for the three and six months ended June 30, 2022 and 2021 (unaudited):

 

 

 

Convertible Preferred Stock

 

 

 

Voting Common Stock

 

 

Non-Voting