UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1933 |
For the transition period from to
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(Registrant’s telephone number, including area code)
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(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
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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.
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 (Section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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 | ☐ |
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☒ | Smaller Reporting Company | ||
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| 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
On December 31, 2023, there were
TABLE OF CONTENTS
PAGE | ||
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PART I Financial Information | 3 | |
3 | ||
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 23 | |
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | 33 | |
33 | ||
PART II Other Information | 35 | |
35 | ||
35 | ||
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS | 37 | |
40 |
2
PART I. Financial Information
Item 1. Consolidated Financial Statements
CytoDyn Inc.
Consolidated Balance Sheets
(Unaudited, in thousands, except par value)
November 30, 2023 |
| May 31, 2023 | ||||
Assets |
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Current assets: |
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Cash | $ | | $ | | ||
Restricted cash |
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Prepaid expenses |
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Prepaid service fees |
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Total current assets |
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Other non-current assets |
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Total assets | $ | | $ | | ||
Liabilities and Stockholders’ Deficit |
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Current liabilities: |
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Accounts payable | $ | | $ | | ||
Accrued liabilities and compensation |
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Accrued interest on convertible notes |
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Accrued dividends on convertible preferred stock |
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Convertible notes payable, net |
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Derivative liability - equity instruments | | | ||||
Total current liabilities |
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Notes payable, net | — | | ||||
Operating leases |
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Total liabilities |
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Commitments and Contingencies (Note 8) |
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Stockholders’ deficit: |
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Preferred stock, $ |
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Series B convertible preferred stock, $ |
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Series C convertible preferred stock, $ |
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Series D convertible preferred stock, $ |
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Common stock, $ |
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Treasury stock, $ | ||||||
Additional paid-in capital |
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Accumulated deficit |
| ( |
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Total stockholders’ deficit |
| ( |
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Total liabilities and stockholders' deficit | $ | | $ | |
See accompanying notes to consolidated financial statements.
3
CytoDyn Inc.
Consolidated Statements of Operations
(Unaudited, in thousands, except per share data)
Three months ended November 30, | Six months ended November 30, | ||||||||||||
| 2023 |
| 2022 |
| 2023 |
| 2022 | ||||||
Operating expenses: |
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General and administrative | $ | | $ | | $ | | $ | | |||||
Research and development |
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Amortization and depreciation |
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Inventory charge | — | | — | | |||||||||
Total operating expenses |
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Operating loss |
| ( |
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Interest and other expenses: | |||||||||||||
Interest on convertible notes |
| ( |
| ( |
| ( |
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Amortization of discount on convertible notes | ( | ( | ( | ( | |||||||||
Amortization of debt issuance costs |
| ( |
| ( |
| ( |
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Issuance costs for private placement of shares and warrants through placement agent (Note 5) | ( | — | ( | — | |||||||||
Loss on induced conversion |
| ( | ( | ( | ( | ||||||||
Finance charges |
| ( |
| ( |
| ( |
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Loss on note extinguishment |
| ( |
| — |
| ( |
| — | |||||
Gain (loss) on derivatives | ( | — | ( | ( | |||||||||
Total interest and other expenses |
| ( |
| ( |
| ( |
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Loss before income taxes |
| ( |
| ( |
| ( |
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Income tax benefit |
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Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Basic and diluted: | |||||||||||||
Weighted average common shares outstanding | | | | | |||||||||
Loss per share | $ | ( | $ | ( | $ | ( | $ | ( |
See accompanying notes to consolidated financial statements.
4
CytoDyn Inc.
Consolidated Statement of Changes in Stockholders’ Deficit
(Unaudited, in thousands)
Preferred stock | Common stock | Treasury stock |
| Additional |
| Accumulated |
| Total stockholders' | ||||||||||||||||
| Shares |
| Amount |
| Shares |
| Amount |
| Shares |
| Amount | paid-in capital | deficit | deficit | ||||||||||
Balance at May 31, 2023 | | $ | — | | $ | | | $ | — | $ | | $ | ( | $ | ( | |||||||||
Issuance of stock for convertible note repayment | — | — | | | — | — |
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| — |
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Loss on induced conversion | — | — | — | — | — | — |
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| — |
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Warrants issued in note offering | — | — | — | — | — | — |
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| — |
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Stock issued for compensation | — | — | | | — | — |
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Warrant exercises | — | — | | | — | — |
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Dividends accrued on Series C and D convertible preferred stock | — | — | — | — | — | — |
| ( |
| — |
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Reclassification of warrants from liability to equity classified | — | — | — | — | — | — | | — | | |||||||||||||||
Stock-based compensation | — | — | — | — | — | — |
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| — |
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Net loss | — | — | — | — | — | — |
| — |
| ( |
| ( | ||||||||||||
Balance at August 31, 2023 | | — | | | | — | | ( | ( | |||||||||||||||
Issuance of stock for convertible note repayment | — | — | | | — | — | | — |
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Loss on induced conversion | — | — | — | — | — | — | | — | | |||||||||||||||
Warrants issued in note offering | — | — | — | — | — | — | | — | | |||||||||||||||
Note conversion | — | — | | | — | — | | — | | |||||||||||||||
Stock issued for compensation | — | — | | | — | — | | — | | |||||||||||||||
Stock issued for private offering | — | — | | | — | — | | — |
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Dividends accrued on Series C and D convertible preferred stock | — | — | — | — | — | — | ( | — |
| ( | ||||||||||||||
Stock-based compensation | — | — | — | — | — | — | | — |
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Net loss | — | — | — | — | — | — | — | ( |
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Balance at November 30, 2023 | | $ | — | | $ | | | $ | — | $ | | $ | ( | $ | ( |
Preferred stock | Common stock | Treasury stock |
| Additional |
| Accumulated |
| Total stockholders' | ||||||||||||||||
| Shares |
| Amount |
| Shares |
| Amount |
| Shares |
| Amount | paid-in capital | deficit | deficit | ||||||||||
Balance at May 31, 2022 | | $ | — | | $ | | | $ | — | $ | | $ | ( | $ | ( | |||||||||
Stock issued for compensation | — | — | | | — | — |
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Stock issued for private offerings | — | — | | | — | — |
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Issuance costs related to stock issued for private offerings | — | — | — | — | — | — |
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Conversion of Series C convertible preferred stock to common stock | ( | — | | | — | — |
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Warrant exercises | — | — | | | — | — |
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Deemed dividend paid in common stock due to down round provision, recorded in additional paid-in capital | — | — | | | — | — |
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Accrued preferred stock dividends | — | — | — | — | — | — |
| ( |
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Reclassification of warrants from liability to equity classified | — | — | — | — | — | — | | — | | |||||||||||||||
Stock-based compensation | — | — | — | — | — | — |
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Reclassification of prior period preferred stock dividends | — | — | — | — | — | — | ( | | — | |||||||||||||||
Net loss | — | — | — | — | — | — |
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Balance at August 31, 2022 | | — | | | | — | | ( | ( | |||||||||||||||
Issuance of stock for convertible note repayment | — |
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Loss on induced conversion | — | — | — | — | — | — | | — | | |||||||||||||||
Stock issued for compensation | — |
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Exercise of warrants, net of issuance costs | — |
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Make-whole shares related to private warrant exchange | — |
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Dividend paid in common stock upon conversion of Series C convertible preferred stock ($0.50 per share) | — | — | | — | — | — | | — | | |||||||||||||||
Dividends accrued on Series C and D convertible preferred stock | — |
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Stock-based compensation | — |
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Net loss | — |
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Balance at November 30, 2022 | | $ | — | | $ | | | $ | — | $ | | $ | ( | $ | ( |
See accompanying notes to consolidated financial statements.
5
CytoDyn Inc.
Consolidated Statements of Cash Flows
(Unaudited, in thousands)
Six months ended November 30, | ||||||
| 2023 |
| 2022 | |||
Cash flows from operating activities: |
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Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Amortization and depreciation |
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Amortization of debt issuance costs |
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Issuance costs for private placement of shares and warrants through placement agent | | — | ||||
Amortization of discount on convertible notes |
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Loss on derivatives | | | ||||
Loss on induced conversion | | | ||||
Loss on note extinguishment |
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Inventory charge | — | | ||||
Stock-based compensation |
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Changes in operating assets and liabilities: |
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(Increase) decrease in prepaid expenses and other assets | ( | ( | ||||
(Decrease) increase in accounts payable and accrued expenses |
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Net cash used in operating activities |
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Cash flows from investing activities: |
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Net cash Provided by/used in investing activities |
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Cash flows from financing activities: |
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Proceeds from warrant transactions, net of offering costs | — | | ||||
Proceeds from sale of common stock and warrants, net of issuance costs |
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Proceeds from warrant exercises |
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Proceeds held in trust |
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Proceeds from convertible note and warrant issuances, net of issuance costs | | — | ||||
Net cash provided by financing activities |
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Net change in cash and restricted cash |
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Cash and restricted cash at beginning of period |
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Cash and restricted cash at end of period | $ | | $ | | ||
Cash and restricted cash consisted of the following: | ||||||
Cash | $ | | $ | | ||
Restricted cash | | | ||||
Total cash and restricted cash | $ | | $ | | ||
Supplemental disclosure: | ||||||
Cash paid for interest | $ | | $ | — | ||
Non-cash investing and financing transactions: |
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Derivative liability associated with warrants | $ | | $ | | ||
Issuance of common stock for principal of convertible notes | $ | | $ | | ||
Accrued dividends on Series C and D convertible preferred stock | $ | | $ | | ||
Warrants issued to placement agent | $ | | $ | | ||
Deemed dividend on common stock issued due to down round provision, recorded in additional paid-in capital | $ | — | $ | | ||
Note conversion to common stock and warrants | $ | | $ | — |
See accompanying notes to consolidated financial statements.
6
CYTODYN INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
AS OF NOVEMBER 30, 2023
(Unaudited)
Note 1. Organization
CytoDyn Inc. (together with its wholly owned subsidiaries, the “Company”) was originally incorporated under the laws of Colorado on May 2, 2002, under the name RexRay Corporation and, effective August 27, 2015, reincorporated under the laws of Delaware. The Company is a clinical-stage biotechnology company focused on the clinical development of innovative treatments for multiple therapeutic indications based on its product candidate, leronlimab, a novel humanized monoclonal antibody targeting the C-C chemokine receptor type 5 (“CCR5”).
The Company has been investigating leronlimab as a viral entry inhibitor for treatment of human immunodeficiency virus (“HIV”), believed to competitively bind to the N-terminus and second extracellular loop of the CCR5 receptor. For immunology, the CCR5 receptor is believed to be implicated in immune-mediated illnesses such as Metabolic dysfunction-associated steatohepatitis (“MASH”), replacement for the term nonalcoholic steatohepatitis (“NASH”). Leronlimab is being or has been studied in MASH, MASH-HIV, solid tumors in oncology, and other HIV indications where CCR5 is believed to play an integral role.
Note 2. Summary of Significant Accounting Policies
Basis of presentation
The unaudited interim consolidated financial statements include the accounts of CytoDyn Inc. and its wholly owned subsidiary, CytoDyn Operations Inc. All intercompany transactions and balances are eliminated in consolidation. The consolidated financial statements reflect all normal recurring adjustments which are, in the opinion of management, necessary for a fair statement of the results of operations for the interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP” or “GAAP”) have been omitted in accordance with the rules and regulations of the United States Securities and Exchange Commission (“SEC”). The interim financial information and notes thereto should be read in conjunction with the Company's latest Annual Report on Form 10-K for the fiscal year ended May 31, 2023 (the “2023 Form 10-K”). The results of operations for the periods presented are not necessarily indicative of results to be expected for the entire fiscal year or for any other future annual or interim period.
Reclassifications
Certain prior year and prior quarter amounts shown in the accompanying consolidated financial statements have been reclassified to conform to the current period presentation. Such reclassifications did not have a material effect on the Company’s previously reported financial position, results of operations, stockholders’ deficit, or net cash provided by operating activities.
Going concern
The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. As presented in the accompanying consolidated financial statements, the Company had losses for all periods presented. The Company incurred a net loss of approximately $
7
The Company’s continuance as a going concern is dependent upon its ability to obtain additional operating capital, complete the development of its product candidate, leronlimab, obtain approval to commercialize leronlimab from regulatory agencies, continue to outsource manufacturing of leronlimab, and ultimately achieve revenues and attain profitability. The Company plans to continue to engage in research and development activities related to leronlimab and a new or modified longer-acting therapeutic for multiple indications and expects to incur significant research and development expenses in the future, primarily related to its regulatory compliance, including seeking the lifting of the U.S Food and Drug Administration’s (the “FDA”) clinical hold with regard to the Company’s HIV program, performing additional pre-clinical and clinical studies in various indications, and seeking regulatory approval for its product candidate for commercialization. These research and development activities are subject to significant risks and uncertainties. The Company intends to finance its future development activities and its working capital needs primarily from the sale of equity and debt securities, combined with additional funding from other sources. However, there can be no assurance that the Company will be successful in these endeavors.
Use of estimates
The preparation of the consolidated financial statements in accordance with accounting principles GAAP requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities at the date of consolidated financial statements, and the reported amounts of revenue and expenses during the reporting period. Estimates are assessed each period and updated to reflect current information, such as the status of our analysis of the results of our clinical trials and/or discussions with the FDA which could have an impact on the Company’s significant accounting estimates and assumptions. The Company’s estimates are based on historical experience and on various market and other relevant, appropriate assumptions. Significant estimates include, but are not limited to, those relating to capitalization and write-off of pre-launch inventories, charges for excess and obsolete inventories, research and development expenses, commitments and contingencies, stock-based compensation, and the assumptions used to value warrants and warrant modifications. Actual results could differ from these estimates.
Restricted cash
As of November 30, 2023, the Company had recorded approximately $
Recent Accounting Pronouncements
In July 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2023-03, “Presentation of Financial Statements (Topic 205), Income Statement - Reporting Comprehensive Income (Topic 220), Distinguishing Liabilities from Equity (Topic 480), Equity (Topic 505), and Compensation - Stock Compensation (Topic 718): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 120, SEC Staff Announcement at the March 24, 2022 EITF Meeting, and Staff Accounting Bulletin Topic 6.B, Accounting Series Release 280 - General Revision of Regulation S-X: Income or Loss Applicable to Common Stock” (“ASU 2023-03”). This ASU amends various paragraphs in the accounting codification pursuant to the issuance of Commission Staff Bulletin ("SAB") number 120. ASU 2023-03 does not provide any new guidance and is immediately effective. ASU 2023-03 did not have a material impact on the consolidated financial statements.
In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements – Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. The amendments clarify or improve disclosure and presentation requirements on various disclosure areas, including the statement of cash flows, earnings per share, debt, equity, and derivatives. The amendments will align the requirements in the FASB ASC with the SEC’s regulations. The amendments in this ASU will be effective on the date the related disclosures are removed from Regulation S-X or Regulation S-K by the SEC, and will not be effective if the SEC has not removed the applicable disclosure requirement by June 30, 2027. Early adoption is prohibited. The Company is currently evaluating the impact of the amendments on its financial statement disclosures.
8
On December 14, 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures, which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. The ASU is effective for annual periods beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option. The Company is currently evaluating the effect of this update on its consolidated financial statements and related disclosures.
Note 3. Accounts Payable and Accrued Liabilities and Compensation
As of November 30, 2023 and May 31, 2023, the accounts payable balance was approximately $
The components of accrued liabilities and compensation are as follows (in thousands):
November 30, 2023 | May 31, 2023 | |||||
Compensation and related expense | $ | | $ | | ||
Legal fees and settlement | | | ||||
Clinical expense | | | ||||
Accrued inventory charges and expenses |
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License fees | | | ||||
Lease payable | | | ||||
Total accrued liabilities | $ | | $ | |
Note 4. Convertible Instruments and Accrued Interest
Convertible preferred stock
The following table presents the number of potentially issuable shares of common stock should shares of preferred stock and amounts of undeclared and accrued preferred dividends be converted to common stock.
November 30, 2023 | May 31, 2023 | |||||||||||||||||
(in thousands except conversion rate) |
| Series B |
| Series C |
| Series D |
| Series B |
| Series C |
| Series D | ||||||
Shares of preferred stock outstanding | | | | | | | ||||||||||||
Common stock conversion rate | ||||||||||||||||||
Total shares of common stock if converted | | | | | | | ||||||||||||
Undeclared dividends | $ | | $ | - | $ | - | $ | | $ | - | $ | - | ||||||
Accrued dividends | $ | - | $ | | $ | | $ | - | $ | | $ | | ||||||
Total shares of common stock if dividends converted | | | | | | |
Under the Company’s Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), dividends on its outstanding shares of Series B Convertible Preferred Stock (the “Series B preferred stock”) may be paid in cash or shares of the Company’s common stock at the option of the Company. Dividends on outstanding shares of Series C Convertible Preferred Stock (the “Series C preferred stock”) and Series D Convertible Preferred Stock (the “Series D preferred stock”) are payable in cash or shares of common stock at the election of the holder. The preferred stockholders have the right to dividends only when and if declared by the Company’s Board of Directors. Under Section 170 of the Delaware General Corporation Law, the Company is permitted to pay dividends only out of capital surplus or, if none, out of net profits for the fiscal year in which the dividend is declared or net profits from the preceding fiscal year.
Series B preferred stock provides for a liquidation preference over the common shares of $
9
Convertible notes and accrued interest
November 30, 2023 | May 31, 2023 | |||||||||||||||||||||||
(in thousands) |
| April 2, 2021 Note |
| April 23, 2021 Note |
| Short-term Notes | Total |
| April 2, 2021 Note |
| April 23, 2021 Note | Placement Agent Notes | Total | |||||||||||
Convertible notes payable outstanding principal | $ | | $ | | $ | | $ | | $ | | $ | | $ | | $ | | ||||||||
Less: Unamortized debt discount and issuance costs | ( | ( | ( | ( | ( | ( | ( | ( | ||||||||||||||||
Convertible notes payable, net | | | | | | | | | ||||||||||||||||
Accrued interest on convertible notes | | | - | | | | | | ||||||||||||||||
Outstanding convertible notes payable, net and accrued interest | $ | | $ | | $ | | $ | | $ | | $ | | $ | | $ | |
Reconciliation of changes to the outstanding balance of convertible notes, including accrued interest, were as follows:
(in thousands) | April 2, 2021 Note | April 23, 2021 Note | Placement Agent Notes | Short-Term Notes | Total | ||||||||||
Outstanding balance at May 31, 2023 | $ | | $ | | $ | | $ | - | $ | | |||||
Consideration received | - | - | | | | ||||||||||
Amortization of issuance discount and costs | | | | | | ||||||||||
Interest expense | |