SEC Form 424B5 filed by Lisata Therapeutics Inc.
• | our ability to obtain sufficient capital or strategic business arrangements to fund our operations and expansion plans, including collecting amounts owed to us under various licensing and other strategic arrangements, meeting our financial obligations under various licensing and other strategic arrangements, the funding of our clinical trials for product candidates, and the commercialization of the relevant technology; |
• | our ability to build and maintain the management and human resources infrastructure necessary to support the operation and/or growth of our business; |
• | whether a market is established for our products and our ability to capture a meaningful share of this market; |
• | scientific, regulatory and medical developments beyond our control; |
• | our ability to obtain and maintain, as applicable, appropriate governmental licenses, accreditations or certifications or to comply with healthcare laws and regulations or any other adverse effect or limitations caused by government regulation of our business; |
• | whether any of our current or future patent applications result in issued patents, the scope of those patents and our ability to obtain and maintain other rights to technology required or desirable for the conduct of our business, and our ability to commercialize products without infringing upon the claims of third-party patents; |
• | whether any potential strategic or financial benefits of various licensing agreements will be realized; |
• | our ability to diversify our pipeline of development product candidates, which could include an acquisition, merger, business combination, in-license or other strategic transaction, and whether any of such efforts will result in us entering into or completing any transaction or that any such transaction, if completed, will add to shareholder value; |
• | the results of our development activities; |
• | our ability to complete our other planned clinical trials (or initiate other trials) in accordance with our estimated timelines due to delays associated with enrolling patients due to the novelty of the treatment, the size of the patient population, competition with other clinical trials for similar subjects, patient and/or investigator site availability and accessibility due to external macroenvironmental factors and the need of patients to meet the inclusion criteria of the trial or otherwise; |
• | the extent to which any future public health crisis and their long-term effects may impact, directly or indirectly, our business, including our clinical trials and financial condition; and |
• | other factors discussed in “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 29, 2024 (our “2023 Form 10-K”). |
• | Our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 29, 2024, including the information specifically incorporated by reference into the Annual Report on Form 10-K from our definitive proxy statement for the 2024 Annual Meeting of Stockholders; |
• | Our Quarterly Reports on Form 10-Q for the quarterly period ended March 31, 2024, filed with the SEC on May 9, 2024, and for the quarterly period ended June 30, 2024, filed with the SEC on August 12, 2024; |
• | Our Current Reports on Form 8-K filed with the SEC on June 4, 2021 and April 17, 2024; and |
• | The description of our common stock set forth in our Registration Statement on Form 8-A, filed with the SEC on August 2, 2013 (including any amendment or report filed with the SEC for the purpose of updating such description). |
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• | our ability to obtain sufficient capital or strategic business arrangements to fund our operations and expansion plans, including collecting amounts owed to us under various licensing and other strategic arrangements, meeting our financial obligations under various licensing and other strategic arrangements, the funding of our clinical trials for product candidates, and the commercialization of the relevant technology; |
• | our ability to build and maintain the management and human resources infrastructure necessary to support the operation and/or growth of our business; |
• | whether a market is established for our products and our ability to capture a meaningful share of this market; |
• | scientific, regulatory and medical developments beyond our control; |
• | our ability to obtain and maintain, as applicable, appropriate governmental licenses, accreditations or certifications or to comply with healthcare laws and regulations or any other adverse effect or limitations caused by government regulation of our business; |
• | whether any of our current or future patent applications result in issued patents, the scope of those patents and our ability to obtain and maintain other rights to technology required or desirable for the conduct of our business, and our ability to commercialize products without infringing upon the claims of third-party patents; |
• | whether any potential strategic or financial benefits of various licensing agreements will be realized; |
• | our ability to diversify our pipeline of development product candidates, which could include an acquisition, merger, business combination, in-license or other strategic transaction, and whether any of such efforts will result in us entering into or completing any transaction or that any such transaction, if completed, will add to shareholder value; |
• | the results of our development activities; |
• | our ability to complete our other planned clinical trials (or initiate other trials) in accordance with our estimated timelines due to delays associated with enrolling patients due to the novelty of the treatment, the size of the patient population, competition with other clinical trials for similar subjects, patient and/or investigator site availability and accessibility due to external macroenvironmental factors and the need of patients to meet the inclusion criteria of the trial or otherwise; and |
• | the extent to which any future public health crisis and their long-term effects may impact, directly or indirectly, our business, including our clinical trials and financial condition. |
• | common stock; |
• | preferred stock; |
• | debt securities; |
• | warrants to purchase any of the securities listed above; and |
• | units consisting of any combination of the securities listed above. |
• | prior to the date of the transaction, the board of directors of the corporation approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder; |
• | upon completion of the transaction that resulted in the stockholder becoming an interested stockholder, the stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the number of shares outstanding (1) shares owned by persons who are directors and also officers and (2) shares owned by employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; and |
• | on or subsequent to the date of the transaction, the business combination is approved by the board and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock which is not owned by the interested stockholder. |
• | the title of the debt securities; |
• | the limit, if any, upon the aggregate principal amount or issue price of the debt securities of a series; |
• | ranking of the specific series of debt securities relative to other outstanding indebtedness, including any debt of any of our subsidiaries; |
• | the price or prices at which the debt securities will be issued; |
• | the designation, aggregate principal amount and authorized denominations of the series of debt securities; |
• | the issue date or dates of the series and the maturity date of the series; |
• | whether the securities will be issued at par or at a premium over or a discount from their face amount; |
• | the interest rate, if any, and the method for calculating the interest rate and basis upon which interest shall be calculated; |
• | the right, if any, to extend interest payment periods and the duration of the extension; |
• | the interest payment dates and the record dates for the interest payments; |
• | any mandatory or optional redemption terms or prepayment, conversion, sinking fund or exchangeability or convertibility provisions; |
• | the currency of denomination of the securities; |
• | the place where we will pay principal, premium, if any, and interest, if any, and the place where the debt securities may be presented for transfer; |
• | if payments of principal of, premium, if any, or interest, if any, on the debt securities will be made in one or more currencies or currency units other than that or those in which the debt securities are denominated, the manner in which the exchange rate with respect to these payments will be determined; |
• | if other than denominations of $1,000 or multiples of $1,000, the denominations the debt securities will be issued in; |
• | whether the debt securities will be issued in the form of global securities or certificates; |
• | the applicability of and additional provisions, if any, relating to the defeasance of the debt securities; |
• | the portion of principal amount of the debt securities payable upon declaration of acceleration of the maturity date, if other than the entire principal amount; |
• | the currency or currencies, if other than the currency of the United States, in which principal and interest will be paid; |
• | the dates on which premium, if any, will be paid; |
• | any addition to or change in the “Events of Default” described in this prospectus or in the indenture with respect to the debt securities and any change in the acceleration provisions described in this prospectus or in the indenture with respect to the debt securities; |
• | any addition to or change in the covenants described in the prospectus or in the indenture with respect to the debt securities; |
• | our right, if any, to defer payment of interest and the maximum length of this deferral period; and |
• | other specific terms, including any additional events of default or covenants. |
• | the conversion or exchange price; |
• | the conversion or exchange period; |
• | provisions regarding our ability or the ability of the holder to convert or exchange the debt securities; |
• | events requiring adjustment to the conversion or exchange price; and |
• | provisions affecting conversion or exchange in the event of our redemption of the debt securities. |
• | either we are the continuing corporation or the successor corporation or the person which acquires by sale, lease or conveyance substantially all our or our subsidiaries’ assets is a corporation organized under the laws of the United States, any state thereof, or the District of Columbia, and expressly assumes the due and punctual payment of the principal of, and premium, if any, and interest, if any, on all the debt securities and the due performance of every covenant of the indenture to be performed or observed by us, by supplemental indenture satisfactory to the trustee, executed and delivered to the trustee by such corporation; |
• | immediately after giving effect to such transactions, no Event of Default described under the caption “Events of Default and Remedies” below or event which, after notice or lapse of time or both would become an Event of Default, has happened and is continuing; and |
• | we have delivered to the trustee an officers’ certificate and an opinion of counsel each stating that such transaction and such supplemental indenture comply with the indenture provisions relating to merger, consolidation and sale of assets. |
i. | default in paying interest on the debt securities when it becomes due and the default continues for a period of 30 days or more; |
ii. | default in paying principal, or premium, if any, on the debt securities when due; |
iii. | default is made in the payment of any sinking or purchase fund or analogous obligation when the same becomes due, and such default continues for 30 days or more; |
iv. | default in the performance, or breach, of any covenant or warranty in the indenture (other than defaults specified in clause (1), (2) or (3) above) and the default or breach continues for a period of 60 days or more after we receive written notice of such default from the trustee or we and the trustee receive notice from the holders of at least 25% in aggregate principal amount of the outstanding debt securities of the series; |
v. | certain events of bankruptcy, insolvency, reorganization, administration or similar proceedings with respect to us have occurred; and |
vi. | any other Event of Default provided with respect to debt securities of that series that is set forth in the applicable prospectus supplement accompanying this prospectus. |
• | evidence a successor to the trustee; |
• | cure ambiguities, defects or inconsistencies; |
• | provide for the assumption of our obligations in the case of a merger or consolidation or transfer of all or substantially all of our assets that complies with the covenant described under “- Merger, Consolidation or Sale of Assets”; |
• | make any change that would provide any additional rights or benefits to the holders of the debt securities of a series; |
• | add guarantors or co-obligors with respect to the debt securities of any series; |
• | secure the debt securities of a series; |
• | establish the form or forms of debt securities of any series; |
• | add additional Events of Default with respect to the debt securities of any series; |
• | add additional provisions as may be expressly permitted by the Trust Indenture Act; |
• | maintain the qualification of the indenture under the Trust Indenture Act; or |
• | make any change that does not adversely affect in any material respect the interests of any holder. |
• | change the maturity date or the stated payment date of any payment of premium or interest payable on the debt securities; |
• | reduce the principal amount, or extend the fixed maturity, of the debt securities; |
• | change the method of computing the amount of principal or any interest of any debt security; |
• | change or waive the redemption or repayment provisions of the debt securities; |
• | change the currency in which principal, any premium or interest is paid or the place of payment; |
• | reduce the percentage in principal amount outstanding of debt securities of any series which must consent to an amendment, supplement or waiver or consent to take any action; |
• | impair the right to institute suit for the enforcement of any payment on the debt securities; |
• | waive a payment default with respect to the debt securities; |
• | reduce the interest rate or extend the time for payment of interest on the debt securities; |
• | adversely affect the ranking or priority of the debt securities of any series; or |
• | release any guarantor or co-obligor from any of its obligations under its guarantee or the indenture, except in compliance with the terms of the indenture. |
• | either: |
• | all debt securities of any series issued that have been authenticated and delivered have been delivered to the trustee for cancellation; or |
• | all the debt securities of any series issued that have not been delivered to the trustee for cancellation have become due and payable, will become due and payable within one year, or are to be called for redemption within one year and we have made arrangements satisfactory to the trustee for the giving of notice of redemption by such trustee in our name and at our expense, and in each case, we have irrevocably deposited or caused to be deposited with the trustee sufficient funds to pay and discharge the entire indebtedness on the series of debt securities; and |
• | we have paid or caused to be paid all other sums then due and payable under the indenture; and |
• | we have delivered to the trustee an officers’ certificate and an opinion of counsel, each stating that all conditions precedent under the indenture relating to the satisfaction and discharge of the indenture have been complied with. |
• | the rights of holders of the debt securities to receive principal, interest and any premium when due; |
• | our obligations with respect to the debt securities concerning issuing temporary debt securities, registration of transfer of debt securities, mutilated, destroyed, lost or stolen debt securities and the maintenance of an office or agency for payment for security payments held in trust; |
• | the rights, powers, trusts, duties and immunities of the trustee; and |
• | the defeasance provisions of the indenture. |
• | we must irrevocably have deposited or caused to be deposited with the trustee as trust funds for the purpose of making the following payments, specifically pledged as security for, and dedicated solely to the benefits of the holders of the debt securities of a series: |
• | money in an amount; or |
• | U.S. government obligations (or equivalent government obligations in the case of debt securities denominated in other than U.S. dollars or a specified currency) that will provide, not later than one day before the due date of any payment, money in an amount; or |
• | a combination of money and U.S. government obligations (or equivalent government obligations, as applicable), |
• | in the case of legal defeasance, we have delivered to the trustee an opinion of counsel stating that, under then applicable federal income tax law, the holders of the debt securities of that series will not recognize income, gain or loss for federal income tax purposes as a result of the deposit, defeasance and discharge to be effected and will be subject to the same federal income tax as would be the case if the deposit, defeasance and discharge did not occur; |
• | in the case of covenant defeasance, we have delivered to the trustee an opinion of counsel to the effect that the holders of the debt securities of that series will not recognize income, gain or loss for federal income tax purposes as a result of the deposit and covenant defeasance to be effected and will be subject to the same federal income tax as would be the case if the deposit and covenant defeasance did not occur; |
• | no event of default or default with respect to the outstanding debt securities of that series has occurred and is continuing at the time of such deposit after giving effect to the deposit or, in the case of legal defeasance, no default relating to bankruptcy or insolvency has occurred and is continuing at any time on or before the 91st day after the date of such deposit, it being understood that this condition is not deemed satisfied until after the 91st day; |
• | the legal defeasance or covenant defeasance will not cause the trustee to have a conflicting interest within the meaning of the Trust Indenture Act, assuming all debt securities of a series were in default within the meaning of such Act; |
• | the legal defeasance or covenant defeasance will not result in a breach or violation of, or constitute a default under, any other agreement or instrument to which we are a party; |
• | if prior to the stated maturity date, notice shall have been given in accordance with the provisions of the indenture; |
• | the legal defeasance or covenant defeasance will not result in the trust arising from such deposit constituting an investment company within the meaning of the Investment Company Act of 1940, as amended, unless the trust is registered under such Act or exempt from registration; and |
• | we have delivered to the trustee an officers’ certificate and an opinion of counsel stating that all conditions precedent with respect to the legal defeasance or covenant defeasance have been complied with. |
• | in the case of warrants to purchase debt securities, the right to receive payments of principal of, or premium, if any, or interest on, the debt securities purchasable upon exercise or to enforce covenants in the applicable indenture; or |
• | in the case of warrants to purchase common stock or preferred stock, the right to receive dividends, if any, or, payments upon our liquidation, dissolution or winding up or to exercise voting rights, if any. |
• | the offering price and aggregate number of warrants offered; |
• | the currency for which the warrants may be purchased; |
• | if applicable, the designation and terms of the securities with which the warrants are issued and the number of warrants issued with each such security or each principal amount of such security; |
• | if applicable, the date on and after which the warrants and the related securities will be separately transferable; |
• | in the case of warrants to purchase debt securities, the principal amount of debt securities purchasable upon exercise of one warrant and the price at, and currency in which, this principal amount of debt securities may be purchased upon such exercise; |
• | in the case of warrants to purchase common stock or preferred stock, the number of shares of common stock or preferred stock, as the case may be, purchasable upon the exercise of one warrant and the price at which these shares may be purchased upon such exercise; |
• | the effect of any merger, consolidation, sale or other disposition of our business on the warrant agreement and the warrants; |
• | the terms of any rights to redeem or call the warrants; |
• | any provisions for changes to or adjustments in the exercise price or number of securities issuable upon exercise of the warrants; |
• | the dates on which the right to exercise the warrants will commence and expire; |
• | the manner in which the warrant agreement and warrants may be modified; |
• | a discussion on any material or special United States federal income tax consequences of holding or exercising the warrants; |
• | the terms of the securities issuable upon exercise of the warrants; and |
• | any other specific terms, preferences, rights or limitations of or restrictions on the warrants. |
• | the designation and terms of the units and of the securities comprising the units, including whether and under what circumstances those securities may be held or transferred separately; |
• | any provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units; |
• | the terms of the unit agreement governing the units; |
• | United States federal income tax considerations relevant to the units; and |
• | whether the units will be issued in fully registered global form. |
• | directly to one or more purchasers; |
• | through agents; |
• | in “at the market offerings” to or through a market maker or into an existing trading market, or a securities exchange or otherwise; |
• | to or through underwriters, brokers or dealers; or |
• | through a combination of any of these methods. |
• | a block trade in which a broker-dealer will attempt to sell as agent, but may position or resell a portion of the block, as principal, in order to facilitate the transaction; |
• | purchases by a broker-dealer, as principal, and resale by the broker-dealer for its account; |
• | ordinary brokerage transactions and transactions in which a broker solicits purchasers; or |
• | privately negotiated transactions. |
• | enter into transactions with a broker-dealer or affiliate thereof in connection with which such broker-dealer or affiliate will engage in short sales of the Common Stock pursuant to this prospectus, in which case such broker-dealer or affiliate may use shares of Common Stock received from us to close out its short positions; |
• | sell securities short and redeliver such shares to close out our short positions; |
• | enter into option or other types of transactions that require us to deliver Common Stock to a broker-dealer or an affiliate thereof, who will then resell or transfer the Common Stock under this prospectus; or |
• | loan or pledge the Common Stock to a broker-dealer or an affiliate thereof, who may sell the loaned shares or, in an event of default in the case of a pledge, sell the pledged shares pursuant to this prospectus. |
• | the terms of the offering; |
• | the name or names of any underwriters or agents and the amounts of securities underwritten or purchased by each of them, if any; |
• | the public offering price or purchase price of the securities and the net proceeds to be received by us from the sale; |
• | any delayed delivery arrangements; |
• | any underwriting discounts or agency fees and other items constituting underwriters’ or agents’ compensation; |
• | any discounts or concessions allowed or reallowed or paid to dealers; and |
• | any securities exchange or markets on which the securities may be listed. |
• | at a fixed price or prices, which may be changed; |
• | at market prices prevailing at the time of sale, including in “at the market offerings”; |
• | at prices related to the prevailing market prices; or |
• | at negotiated prices. |
• | Our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 29, 2024; and |
• | Our Current Report on Form 8-K filed with the SEC on April 17, 2024; and |
• | The description of our common stock set forth in our Registration Statement on Form 8-A, filed with the SEC on August 2, 2013 (including any amendment or report filed with the SEC for the purpose of updating such description). |