美國

證券交易委員會

華盛頓，特區。20549

表格10-Q

(馬克 一)

截至季度結束九月三十日， 2024

在從_______________到_______________的過渡期間

委員會檔案編號 001-41952

特隆製藥公司

（公司章程中指定的準確公司名稱）

註冊人電話號碼（包括區號）：

(813) 864-2558

不適用

(公司更名、更改地址和更改財年情況的以往名稱、以前地址和以前財年，如與上次報告有所改變)

根據法案第12(b)節註冊的證券:

請勾選標記以指示註冊者是否（1）在過去12個月內（或註冊者需要提交這些報告的更短時間內）已提交證券交易所法案第13或15（d）節要求提交的所有報告，及　（2）是否已被提交要求過去90天的提交要求所制約。是 ☒ No ☐

通過勾選圓圈表明註冊者是否在過去12個月內(或註冊者需要提交這些文件的較短期限內)已經遞交規章S-T(本章第232.405條)規定的每個交互式數據文件。是 ☒ No ☐

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請勾選適用的圓圈，表示註冊登記者是否是空殼公司(根據交易所法案第12b-2條的定義)。是 ☐ 否☒

截至2024年11月12日，共有 29,609,814 股公司普通股已發行並流通。

TELOMIR 製藥公司。

每季度 表格 10-Q 報告

目錄

TELOMIR 製藥公司。

簡化資產負債表

截至2024年9月30日和2023年12月31日

See notes to condensed financial statements.

TELOMIR PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF OPERATIONS

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023

(Unaudited)

See notes to condensed financial statements.

TELOMIR PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2024 AND SEPTEMBER 30, 2023

(Unaudited)

See notes to condensed financial statements.

TELOMIR PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF CASH FLOWS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023

(Unaudited)

See notes to condensed financial statements.

TELOMIR PHARMACEUTICALS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023

(Unaudited)

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis should be read in conjunction with the Condensed Financial Statements and Notes thereto included elsewhere in this Quarterly Report. This discussion contains certain forward-looking statements that involve risks and uncertainties. The Company’s actual results and the timing of certain events could differ materially from those discussed in these forward-looking statements as a result of certain factors, including, but not limited to, those set forth herein and elsewhere in this Quarterly Report and in the Company’s other filings with the SEC. See “Cautionary Note Regarding Forward Looking Statements” below.

As used in this Management’s Discussion and Analysis of Financial Condition and Results of Operations, unless otherwise indicated, the terms “the Company”, “we”, “us”, “our” and similar terminology refer to Telomir Pharmaceuticals, Inc.

Background of the Company

We are a pre-clinical-stage pharmaceutical company focused on the development and commercialization of TELOMIR-1, a novel small molecule being developed to lengthen the DNA’s protective telomere caps, potentially promoting longevity in humans and canine animals by treating age-related conditions. Telomeres, the protective end caps of chromosomes composed of DNA sequences and proteins, naturally shorten as humans age. This shortening is accelerated by metal reactivity, which increases the risk of degenerative and age-related diseases.

Our goal is to advance the clinical development of TELOMIR-1 in the United States for the treatment of age-related inflammatory conditions and commercialize Telomir-1, proposed to be dosed orally, with the broader aim of promoting longevity and enhancing overall quality of life.

To date, we have not generated any revenue nor do we expect to generate revenue unless and until we successfully complete preclinical and clinical development of, receive regulatory approval for, and commercialize a program and we do not know when, or if at all, that will occur. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and studies and initiate clinical trials. In addition, if we obtain regulatory approval for any programs, we expect to incur significant expenses related to production of sales, marketing, and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential collaborators. We expect to incur additional costs associated with operating as a public company.

Our operating expenses have historically been the costs associated with our initial investment in pre-clinical research and development activities. We expect research and development expenses will increase in the future as we advance TELOMIR-1 into and through clinical trials and pursue regulatory approvals, which will require a significant investment in costs of clinical trials, regulatory support, and contract manufacturing. In addition, we will evaluate opportunities to acquire or in-license additional product candidates and technologies, which may result in higher research and development expenses due to license fee and/or milestone payments, as well as added clinical development costs.

We had net losses of $13.6 million and $3.7 million for the nine months ended September 30, 2024 and 2023, respectively.

Components of Our Results of Operations

Research and development expenses represent costs incurred to conduct research and development of our product candidate. We recognize all research and development costs as they are incurred. Research and development expenses consist primarily of the following:

Our operating expenses have historically been the costs associated with our initial investment in pre-clinical research and development activities. We expect research and development expenses will increase in the future as we advance TELOMIR-1 into and through clinical trials and pursue regulatory approvals, which will require a significant investment in costs of clinical trials, regulatory support, and contract manufacturing. In addition, we will evaluate opportunities to acquire or in-license additional product candidates and technologies, which may result in higher research and development expenses due to license fee and/or milestone payments, as well as added clinical development costs.

The process of conducting clinical trials necessary to obtain regulatory approval is costly and time-consuming. We may never succeed in timely development and achieving regulatory approval for our product candidates. The probability of success of our product candidates may be affected by numerous factors, including clinical data, competition, manufacturing capability and commercial viability. As a result, we are unable to determine the duration and completion costs of our development projects or when and to what extent we will generate revenue from the commercialization and sale of our product candidates.

Critical Accounting Policies

See Note 1 of the Notes to Condensed Financial Statements included in Item 1 of this Quarterly Report for a summary of significant accounting policies and information on recently issued accounting pronouncements.

Results of Operations

For the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023

Research and Development Expenses. During the nine months ended September 30, 2024, we incurred $1.9 million in research and development expenses, which were primarily related to toxicology studies, pre-clinical research projects and related manufacturing for pre-clinical research projects. We incurred $1.4 million in research and development expenses during the nine months ended September 30, 2023, relating to initial payments for toxicology studies and consulting arrangements. Research and development expenses represent costs incurred to conduct research and development of our product candidate and consist primarily of contracted pre-clinical research and manufacturing, toxicology, consulting arrangements and other expenses incurred to advance the Company’s research and development activities.

General and Administrative Expenses. We incurred $7.0 million and $0.2 million in general and administrative expenses during the nine months ended September 30, 2024 and September 30, 2023, respectively. The increase is primarily due to payroll costs for management and consultants that began after the IPO and were not incurred during the nine months ended September 30, 2023. Additionally, the Company granted stock options in August 2024 to employees totaling approximately $4.8 million. General and administrative expenses consist of expenses paid in connection with administrative functions, as well as fees paid for legal, consulting fees and facilities costs not otherwise included in research and development expenses. Legal costs include general corporate legal fees and license costs.

Related Party Travel Costs. We incurred $0.4 million and $1.3 million in related party travel costs during the nine months ended September 30, 2024 and September 30, 2023, respectively. Related party travel costs consisted of a lease and use of an airplane with MIRALOGX, an entity under common control with us. We will not participate in the use of the MIRALOGX airplane after March of 2024 and, pursuant to the terms of our agreement with MIRALOGX related to this matter, will not have any further obligation under the agreement.

Interest expense, net. We incurred $4.3 and $0.9 million in interest expense, net during the nine months ended September 30, 2024 and September 30, 2023, respectively. The 2024 interest expense consists of the amortization of the deferred financing costs on warrants issued in connection with the related party line of credit as disclosed in Note 5 to the accompanying condensed financial statements.

For the three months ended September 30, 2024 compared to the three months ended September 30, 2023

Research and Development Expenses. During the three months ended September 30, 2024, we incurred $0.6 million in research and development expenses, which were primarily related to toxicology studies, pre-clinical research projects and related manufacturing for pre-clinical research projects. We incurred $0.3 million in research and development expenses during the three months ended September 30, 2023, relating to initial payments for toxicology studies and consulting arrangements. Research and development expenses represent costs incurred to conduct research and development of our product candidate and consist primarily of contracted pre-clinical research and manufacturing, toxicology, consulting arrangements and other expenses incurred to advance the Company’s research and development activities.

General and Administrative Expenses. We incurred $5.3 million and $0.1 million in general and administrative expenses during the three months ended September 30, 2024 and September 30, 2023, respectively. The increase is primarily due to payroll costs for management and consultants that began upon the IPO and were not incurred during the three months ended September 30, 2023. Additionally, the Company granted stock options in August 2024 to employees totaling approximately $4.8 million. General and administrative expenses consist of administrative functions, as well as fees paid for legal and consulting fees and facilities costs not otherwise included in research and development expenses. Legal costs include general corporate legal fees and license costs. We expect to incur additional expenses as a result of becoming a public company, including expenses related to compliance with the rules and regulations of the SEC and Nasdaq, additional insurance, investor relations and other administrative expenses and professional services.

Related Party Travel Costs. We incurred $0.6 million in related party travel costs during the three months ended September 30, 2023. There was no such expense incurred during the same period ended September 30, 2024. Related party travel costs consisted of a lease and use of an airplane with MIRALOGX, an entity under common control with us. We will not participate in the use of the MIRALOGX airplane after March of 2024 and, pursuant to the terms of our agreement with MIRALOGX related to this matter, will not have any further obligation under the agreement.

Interest income (expense). We earned $0.02 million in interest income during the three months ended September 30, 2024 and incurred $0.8 million in interest expense during the three months ended September 30, 2023. The interest income in the three months ended September 30, 2024 is primarily related to interest earned from money market account.

Liquidity and Capital Resources

As of September 30, 2024, we had cash of approximately $0.8 million. We used approximately $4.5 million of cash in operations during the nine months ended September 30, 2024.

Historically, we have been primarily engaged in developing TELOMIR-1. During these activities, we have sustained substantial losses. We have incurred net losses of $13.6 million for the nine months ended September 30, 2024, of which $7 million was attributable to general and administrative expenses, Since inception, we have financed its operations through an initial public offering, related party financings and a private financing. During the nine months ended September 30, 2024, we secured $5 million in additional funding pursuant to the Starwood Note (see Note 4 to the accompanying financial statements). Based on current projections, we do not have sufficient cash and cash equivalents as of the date of this report to support our operations for at least the 12 months following the date that the financial statements are issued. Accordingly, substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that the financial statements are issued.

Our ability to fund ongoing operations and future clinical trials required for FDA approval is dependent on our ability to obtain significant additional external funding in the near term. Although, additional sources of financing may be sought by us, there can be no assurance that any fundraising will be achieved on commercially reasonable terms, if at all. The failure to obtain sufficient capital on acceptable terms when needed would have a material adverse effect on our business, results of operations and financial condition. Accordingly, we have concluded that substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that the financial statements are issued.

Sources of Liquidity

Since our inception in August 2021, we have financed our operations primarily through proceeds from our initial public offering that occurred in February of 2024, an unsecured line of credit with the Bay Shore Trust, our majority shareholder, and through a $1.0 million private placement of shares of our Common Stock that occurred during the first quarter 2023 at $3.73 per share (after giving effect to our 1-for-2.05 reverse stock split that occurred on December 11, 2023). We intend to finance our clinical development programs and working capital needs from existing cash and potential new sources of debt and equity financing. Further, we plan to conduct a raise of capital in the near future to assist in financing working capital needs.

On September 24, 2024 we entered into an unsecured Promissory Note and Loan Agreement with the Starwood Trust, a separate trust which was established by our founder for the benefit of his family. Under this Promissory Note and Loan Agreement (the “Starwood Note”), we have the right to borrow up to an aggregate of $5 million from the Starwood Trust at any time up until the second anniversary of the note. Our right to borrow funds under the Starwood Note is subject to the absence of a material adverse change in its assets, operations, or prospects. The Starwood Note, together with accrued interest, is to become due and payable on the second anniversary of the issuance of the note, and provides for prepayment at any time without penalty. The Starwood Note accrues interest at a rate equal of 7% per annum, simple interest.

We have incurred significant losses and negative cash flows from operations since inception and expect to incur additional losses until such time that we can generate significant revenue and profit, which we do not expect to occur in the near future. We had negative cash flow from operations of approximately $4.5 million for the nine months ended September 30, 2024. As of September 30, 2024, we had cash and cash equivalents of approximately $0.8 million and an accumulated deficit of approximately $27.7 million.

We currently expect that our cash and cash equivalents, when taking into account the net proceeds of $5.8 million from our initial public offering and potential advances from the Starwood Note, will not be sufficient to fund our operations, development plans, and capital expenditures through the third quarter of 2025 without additional financing. As such, there is substantial doubt about the Company’s ability to continue as a going concern.

Cash Flows

The following table provides information regarding our cash flows for the periods presented:

Net Cash Flows from Operating Activities

The cash used in operating activities resulted primarily from our net losses, amortization of debt issuance costs, stock compensation expense and changes in components of accounts payable and prepaid expenses.

For the nine months ended September 30, 2024, operating activities used $4.5 million of cash, primarily due to a net loss of $13.6 million, offset by amortization of debt issuance costs of $4.3 million, stock compensation expense of $4.8 million and a $0.01 million change in accounts payable, accrued and prepaid expenses. Accounts payable, accrued and prepaid expenses was primarily composed of research and development payables, consultant costs, insurance costs, legal and accounting expenses.

For the nine months ended September 30, 2023, operating activities used $2.7 million of cash, primarily due to a net loss of $3.7 million, offset by amortization of debt issuance costs of $0.9 million and $0.1 million increase in accounts payable and accrued expenses. Accounts payable and accrued expenses was primarily composed of research and development expenses and consultant costs.

Net Cash Flows from Financing Activities

For the nine months ended September 30, 2024, financing activities provided $5.3 million of cash, resulting primarily from $5.8 million in proceeds from sale of Common Stock, net of offering costs, offset by $0.4 million payments to related parties, and $0.1 million of repayments under the related party line of credit.

For the nine months ended September 30, 2023, financing activities provided $2.8 million of cash, resulting primarily from $1 million in proceeds from sale of Common Stock, $1.3 million in borrowing from related party line of credit, and $0.7 million in borrowings from related parties, offset by $0.2 million net in related party borrowings and payments.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act, and therefore are not required to provide the information under this item per Item 305(e) of Regulation S-K.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Our management, our Chief Executive Officer (our principal executive officer) and our Chief Financial Officer (our principal financial officer) (the “Certifying Officers”), has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Exchange Act) as of September 30, 2024. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by the company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal accounting officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. The Certifying Officers have concluded, based on their evaluation as of the end of the period covered by this Report, that our disclosure controls and procedures were not effective to provide reasonable assurance that the objectives of our disclosure control system were met. Management is in the process of implementing plans to remediate the ineffectiveness of its disclosure controls and procedures through enhancements to its internal control environment as more fully described below.

Changes in Internal Control over Financial Reporting

During 2024, we designed and implemented new and enhanced controls to strengthen our internal controls over financial reporting, including hiring additional experienced accounting personnel, among other enhancements. Management believes these enhancements will be sufficient to remediate previously identified material weaknesses. However, the new and enhanced controls have not operated for a sufficient amount of time to conclude that the Company’s disclosure controls and procedures were effective.

Other than as described above, there were no additional changes in our internal control over financial reporting (as defined in Rule 13(a)-15(f) of the Exchange Act) that occurred during the period covered by this quarterly report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential”, or “continue” or the negative of these terms or other similar expressions. In particular, statements about the markets in which we operate, including growth of our various markets, and our expectations, beliefs, plans, strategies, objectives, prospects, assumptions, or future events or performance contained in this quarterly report under the headings “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business” are forward-looking statements. We have based these forward-looking statements on our current expectations, assumptions, estimates and projections. While we believe these expectations, assumptions, estimates, and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond our control. These and other important factors, including those discussed in this quarterly report under the headings “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business,” may cause our actual results, performance, or achievements to differ materially from any future results, performance or achievements expressed or implied by these forward-looking statements, or could affect our share price. Important factors that could cause actual results or events to differ materially from those expressed in forward-looking statements include, but are not limited to, the following:

● our use of the net proceeds from our initial public offering and other financings;

● our ability to obtain and maintain regulatory approval of our product candidates;

● our ability to successfully commercialize and market our product candidates, if approved;

● our ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately under such contract;

● the potential market size, opportunity, and growth potential for our product candidates, if approved;

● our ability to obtain additional funding for our operations and development activities;

● the accuracy of our estimates regarding expenses, capital requirements and needs for additional financing;

● the initiation, timing, progress and results of our pre-clinical studies and clinical trials, and our research and development programs;

● the timing of anticipated regulatory filings;

● the timing of availability of data from our clinical trials;

● our future expenses, capital requirements, need for additional financing, and the period over which we believe that the net proceeds from our initial public offering, together with our existing cash and cash equivalents, will be sufficient to fund our operating expenses and capital expenditure requirements;

● our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;

●our ability to advance product candidates into, and successfully complete, clinical trials;

● our ability to recruit and enroll suitable patients in our clinical trials;

● the timing or likelihood of the accomplishment of various scientific, clinical, regulatory, and other product development objectives;

● the pricing and reimbursement of our product candidates, if approved;

● the rate and degree of market acceptance of our product candidates, if approved;

● the implementation of our business model and strategic plans for our business, product candidates, and technology;

● the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;

● developments relating to our competitors and our industry; and

● other risks and factors listed under “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2023.

Given the risks and uncertainties set forth in this quarterly report, you are cautioned not to place undue reliance on such forward-looking statements. The forward-looking statements contained in this quarterly report are not guarantees of future performance and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this quarterly report. In addition, even if our results of operations, financial condition and liquidity, and events in the industry in which we operate, are consistent with the forward-looking statements contained in this quarterly report, they may not be predictive of results or developments in future periods.

Any forward-looking statement that we make in this quarterly report speaks only as of the date of such statement. Except as required by federal securities laws, we do not undertake any obligation to update or revise, or to publicly announce any update or revision to, any of the forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this quarterly report.

PART II. OTHER INFORMATION

Item 1. Legal Proceedings

From time to time, we may be named in claims arising in the ordinary course of business. Currently, no legal proceedings, government actions, administrative actions, investigations, or claims are pending against us or involve us that, in the opinion of our management, could reasonably be expected to have a material adverse effect on our business and financial condition.

Item 1A. Risk Factors.

Our business, financial condition, results of operations and cash flows are subject to, and could be materially adversely affected by, various risks and uncertainties. These risks are more fully disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, any one of which could cause our actual results to vary materially from recent results or our anticipated future results, and also include the following risks.

We expect to rely on third parties to conduct our pre-clinical trials and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials or failing to comply with regulatory requirements or our pre-clinical protocols.

We currently rely on third-party contract research organizations (“CROs”) to conduct our pre-clinical trials, as we currently do not plan to independently conduct pre-clinical trials of any of our product candidates. Our agreements with these CROs, and other third parties might terminate for a variety of reasons, including a failure to perform by the third parties to such agreements. If we were ever to need to enter into alternative arrangements or if we were to need to change a CRO for an ongoing pre-clinical trial, we might experience delays in our pre-clinical development activities.

Geopolitical events and global economic conditions, such as the Israel-Hamas war may impact the third parties that we engage to supply materials or manufacture any products for our preclinical tests and clinical trials, which increases the risk of potential delay of development efforts, as applicable.

If the third parties that we engage to supply any materials or manufacture any products for our preclinical tests and clinical trials should cease to continue to do so for any reason, including due to the effects of global economic conditions, including the Hamas-Israel war, we likely would experience delays in advancing these tests and trials while we identify and qualify replacement suppliers or manufacturers, as applicable, and we may be unable to obtain replacement supplies on terms that are favorable to us. In addition, if we are not able to obtain adequate supplies of our product, or the substances used to manufacture them, it will be more difficult for us to develop our product, and compete effectively.

Our current and anticipated dependence upon third-party suppliers may adversely affect our ability to develop our product and product candidates, and could delay our clinical trials and development programs as well as affect our marketing and commercialization efforts. In addition, such dependence may increase our costs and expenses, and may otherwise harm our operations and financial condition.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

On February 13, 2024, the Company closed its IPO consisting of 1,000,000 shares at a price of $7.00 per share for approximately $7.0 million in gross proceeds. After deducting the underwriting commission and other offering expenses totaling $1.2 million, the net proceeds to the Company was $5.8 million. None of the underwriting discounts and commissions or other offering expenses were incurred or paid, directly or indirectly, to any of our directors or officers or their associates or to persons owning 10% or more of our Common Stock or to any of our affiliates.

The shares were offered and sold pursuant to the Company’s Registration Statement on Form S-1, as amended (File No. 333-275534), originally filed with the SEC on November 14, 2023 (the “Registration Statement”) and the final quarterly report filed with the Commission pursuant to Rule 424(b)(4) of the Securities Act of 1933, as amended. The Registration Statement was declared effective by the Commission on February 8, 2024. The Common Stock began trading on The Nasdaq Capital Market on February 9, 2024 under the symbol “TELO”. The closing of the IPO occurred on February 13, 2024.

Item 3. Defaults upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

None.

Item 6. Exhibits.

SIGNATURES

Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.