Evofem Biosciences Inc
For the period ended Mar 31, 2025. Filed May 15, 2025.
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Mar 31, 2025 · Filed May 15, 2025
Contents
(Note 4)
- Debt
Convertible Notes
Baker Notes (temporarily owned by Aditxt from December 11, 2023 through February 26, 2024 and owned by Future Pak, LLC since July 23, 2024)
On April 23, 2020, the Company entered into a Securities Purchase and Security Agreement (the Baker Bros. Purchase Agreement) with certain affiliates of Baker Bros. Advisors LP, as purchasers (the Baker Purchasers), and Baker Bros. Advisors LP, as designated agent, pursuant to which the Company agreed to issue and sell to the Baker Purchasers (i) convertible senior secured promissory notes (the Baker Notes) in an aggregate principal amount of up to $25.0 million and (ii) warrants to purchase shares of common stock (the Baker Warrants) in a private placement, which closed in two closings (April 24, 2020, the Baker Initial Closing, and June 9, 2020, the Baker Second Closing). As a result of the two closings, the Company issued and sold Baker Notes with an aggregate principal amount of $25.0 million and Baker Warrants exercisable for 2,731 shares of common stock. Upon the completion of the underwritten public offering in June 2020, the exercise price of the Baker Warrants was $4,575 per share. The Baker Warrants have a five-year term with a cashless exercise provision and are immediately exercisable at any time from their respective issuance date. The April 2020 Baker Warrants expired on April 24, 2025. The June 2020 Baker Warrants will expire on June 9, 2025 unless earlier exercised.
The Baker Notes have a five-year term, with no pre-payment ability during the first three years. Interest on the unpaid principal balance of the Baker Notes (the Baker Outstanding Balance) accrues at 10.0% per annum, with interest accrued during the first year from the two respective closing dates recognized as payment-in-kind. The effective interest rate for the periods was 10.0%. Accrued interest beyond the first year of the respective closing dates is to be paid in arrears on a quarterly basis in cash or recognized as payment-in-kind, at the direction of the Baker Purchasers. As discussed below, with the amendment to the Baker Bros. Purchase Agreement, interest payments were paid in-kind. Interest pertaining to the Baker Notes for the three months ended March 31, 2025 and 2024 was approximately $2.7 million and $2.5 million, respectively, which was added to the outstanding principal balance. The Company accounts for the Baker Notes under the fair value method as described below and, therefore, the interest associated with the Baker Notes is included in the fair value determination.
The Baker Notes were callable by the Company on 10 days’ written notice beginning on the third anniversary of the initial closing date of April 24, 2020 at a call price equal to 100% of the Baker Outstanding Balance plus accrued and unpaid interest if the Company’s common stock as measured using a 30-day volume weighted average price (VWAP) was greater than the benchmark price of $9,356.25 as stated in the Baker Bros. Purchase Agreement, or 110% of the Baker Outstanding Balance plus accrued and unpaid interest if the VWAP was less than such benchmark price. The Baker Purchasers also had the option to require the Company to repurchase all or any portion of the Baker Notes in cash upon the occurrence of certain events. In a repurchase event, as defined in the Baker Bros. Purchase Agreement, the repurchase price will equal 110% of the Baker Outstanding Balance plus accrued and unpaid interest. In the event of default or the Company’s change of control, the repurchase price would equal to the sum of (x) three times of the Baker Outstanding Balance plus (y) the aggregate value of future interest that would have accrued. The Baker Notes were convertible at any time at the option of the Baker Purchasers at the conversion price of $4,575 per share prior to the First and Second Baker Amendments (as defined below).
On November 20, 2021, the Company entered into the first amendment to the Baker Bros. Purchase Agreement (the First Baker Amendment), in which each Baker Purchaser had the right to convert all or any portion of the Baker Notes into common stock at a conversion price equal to the lesser of (a) $4,575 and (b)115% of the lowest price per share of common stock (or, as applicable with respect to any equity securities convertible into common stock,115% of the applicable conversion price) sold in one or more equity financings until the Company has met a qualified financing threshold defined as one or more equity financings resulting in aggregate gross proceeds to the Company of at least $50 million (the Financing Threshold).
The First Baker Amendment extended, effective upon the Company’s achievement of the Financing Threshold, the affirmative covenant to achieve $100.0 million in cumulative net sales of PHEXXI by June 30, 2022 to June 30, 2023. Additionally per the First Baker Amendment, if the Company were to issue warrants to purchase capital stock of the Company (or other similar consideration) in any equity financing that closed on or prior to the date on which the Company met the Financing Threshold, the Company was required to issue to the Baker Purchasers an equivalent coverage of warrants (or other similar consideration) on the same terms as if the Baker Purchasers had participated in the financing in an amount equal to the then outstanding principal of Baker Notes held by the Baker Purchasers. In satisfaction of this requirement and in connection with the closing of the May 2022 Public Offering, the Company issued warrants to purchase 582,886 shares of the Company’s common stock at an exercise price of $93.75 per share to the Baker Purchasers (the June 2022 Baker Warrants). As required by the terms of the First Baker Amendment, the June 2022 Baker Warrants have substantially the same terms as the warrants issued in the May 2022 Public Offering. Refer to Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit for further information. The exercise price of the initial Baker Warrants and the June 2022 Baker Warrants was reset multiple times as a result of various Notes issuances in accordance with the agreement. The exercise price was $0.0154 per share as of March 31, 2025.
On March 21, 2022, the Company entered into the second amendment to the Baker Bros. Purchase Agreement (the Second Baker Amendment), which granted each Baker Purchaser the right to convert all or any portion of the Baker Notes into common stock at a conversion price equal to the lesser of (a) $725.81 or (b)100% of the lowest price per share of common stock (or as applicable with respect to any equity securities convertible into common stock,100% of the applicable conversion price) sold in any equity financing until the Company (i) met the qualified financing threshold by June 30, 2022, defined as a single underwritten financing resulting in aggregate gross proceeds to the Company of at least $20 million (Qualified Financing Threshold) and (ii) disclosed top-line results from theEVOGUARDclinical trial (the Clinical Trial Milestone) on or before October 31, 2022. The Second Baker Amendment also provided that the exercise price of the Baker Warrants will equal the conversion price of the Baker Notes. The Company met the Qualified Financing Threshold upon the closing of the May 2022 Public Offering, and as of September 30, 2022, the conversion price and exercise price of the Baker Warrants was reset to $93.75. The Company achieved the Clinical Trial Milestone in October 2022. Also, with the achievement of the Qualified Financing Threshold and the Clinical Trial Milestone, the affirmative covenant to achieve $100.0 million in cumulative net sales of PHEXXI was extended to June 30, 2023, which was subsequently waived via the Baker Fourth Amendment as discussed below.
On September 15, 2022, the Company entered into the third amendment to the Baker Bros. Purchase Agreement (the Third Baker Amendment), pursuant to which the conversion price was amended to $26.25, subject to adjustment for certain dilutive Company equity issuance adjustments for a two-year period; an interest make-whole payment due in certain circumstances was removed; and certain change of control and liquidation payment amounts were reduced from three times the outstanding amounts of the Baker Notes to two times the outstanding amounts. In addition, the Third Baker Amendment provided that the Company may make future interest payments to the Baker Purchasers in kind or in cash, at the Company’s option. On the same day, the Company also entered into a Secured Creditor Forbearance Agreement with the Baker Purchasers (Forbearance Agreement), according to which the Baker Purchasers agreed to forebear the defaults that existed at that time.
On December 19, 2022, the Company entered into the First Amendment to the Forbearance Agreement (the Amendment) effective as of December 15, 2022 to amend certain provisions of the Forbearance Agreement dated September 15, 2022. The Amendment revised the Forbearance Agreement to (i) amend the Fifth Recital Clause to clarify that the Purchasers consent to any additional indebtednesspari passu, but not senior to that of the Purchasers, in an amount not to exceed $5.0 million, and (ii) strike and entirely replace Section 4 to clarify the terms of the Purchasers’ consent to Interim Financing (as defined therein). No other revisions were made to the Forbearance Agreement.
On March 7, 2023, Baker Bros. Advisors, LP (the Designated Agent) provided a Notice of Event of Default and Reservation of Rights (the Notice of Default) relating to the Baker Bros. Purchase Agreement. The Notice of Default claimed that the Company failed to maintain the “Required Reserve Amount” as required by the Third Baker Amendment. The Designated Agent, at the direction of the Baker Purchasers, accelerated repayment of the outstanding balance payable. As a result, approximately $92.7 million, representing two times the sum of the outstanding balance and all accrued and unpaid interest thereon and all other amounts due under the Baker Bros. Purchase Agreement and other documents, was due and payable within three business days of receipt of the Notice of Default. In addition, the Company did not meet the $100.0 million cumulative net sales threshold by June 30, 2023 and as such was in default as of that date. As discussed below, all existing defaults were cured upon the signing of the Fourth Baker Amendment.
On September 8, 2023, the Company entered into the Fourth Amendment to the Baker Bros. Purchase Agreement (the Fourth Baker Amendment) with the Baker Purchasers. The Fourth Amendment amends certain provisions within the Baker Bros. Purchase Agreement including:
| (i) | the rescission of the Notice of Default delivered to the Company on March 7, 2023 and waiver of the Events of Default named therein; |
| (ii) | the waiver of any and all other Events of Default existing as of the Fourth Amendment date; |
| (iii) | the removal of the conversion feature into shares of Company common stock, including the removal of any requirement to reserve shares of common stock for conversion of the Baker Notes as well as any registration rights related thereto; |
| (iv) | the clarification that for the sole purpose of enabling ex-U.S. license agreements for such assets, any Patents, Trademarks or Copyrights acquired after the Effective Date shall be excluded from the definition of Collateral; and, |
| (v) | the removal of the requirement for the Company to achieve $100 million in cumulative net PHEXXI sales in the specified timeframe. |
The outstanding balance of the Baker Notes will continue to accrue interest at 10% per annum and, in the event of a default in the agreement or a failure to pay the Repurchase Price (as defined below) on or before September 8, 2028 (the Maturity Date), the Baker Purchasers may collect on the full principal amount then outstanding.
The Company paid the required $1.0 million upfront payment in September 2023 and is required to make quarterly cash payments based upon a percentage of the Company’s global net product revenue. The cash payments will be determined based upon the quarterly global net revenue of PHEXXI according to the table below.
| Quarterly global net revenue | Quarterly cash payment |
|---|---|
| ≤ $5.0 million | 3% of such global net revenues |
| >$5.0 million and ≤ $7.0 million | 3% on net revenue ≤ $5.0 million; 4% on the net revenue over $5.0 million |
| Greater than $7.0 million | 3% on the net revenue ≤ $5.0 million; 4% on the net revenue over $5.0 million and up to $7.0 million; 5% on net revenue over $7.0 million |
The quarterly cash payments were payable beginning in the fourth quarter of 2023 and have been timely paid.
Regardless of the percentage paid, the quarterly cash payment amounts, along with the $1.0 million upfront payment, will be deducted from the Repurchase Price as Applicable Reductions. Quarterly cash payments that will be treated as Applicable Reductions paid to date as of March 31, 2025, amount to $0.7 million.
The Fourth Amendment also granted the Company the ability to repurchase the principal amount and accrued and unpaid interest of the Baker Notes for up to a five-year period for the one-time Repurchase Price designated below:
| Date of Notes’ Repurchase | Repurchase Price |
|---|---|
| On or prior to September 8, 2024 | $14,000,000 (less Applicable Reductions) |
| September 9, 2024-September 8, 2025 | $16,750,000 (less Applicable Reductions) |
| September 9, 2025-September 8, 2026 | $19,500,000 (less Applicable Reductions) |
| September 9, 2026-September 8, 2027 | $22,250,000 (less Applicable Reductions) |
| September 9, 2027-September 8, 2028 | $25,000,000 (less Applicable Reductions) |
The Company evaluated whether any of the Embedded Features required bifurcation as a separate component. The Company elected the fair value option (FVO) under ASC 825,Financial Instruments (ASC 825), as the Baker Notes are qualified financial instruments and are, in whole, classified as liabilities. Under the FVO, the Company recognized the debt instrument at fair value, inclusive of the Embedded Features, with changes in fair value related to changes in the Company’s credit risk being recognized as a component of accumulated other comprehensive loss in the condensed consolidated balance sheets. All other changes in fair value were recognized in the condensed consolidated statements of operations.
As part of the consideration for the Merger, on December 11, 2023, the Baker Purchasers signed an agreement to assign the Baker Notes to Aditxt (the December Assignment Agreement). Upon execution of the December Assignment Agreement, Aditxt assumed all terms under the Baker Notes, with Aditxt becoming the new senior secured debtholder of the Company, governed by the requirements under the Fourth Baker Amendment. The Baker Notes were re-assigned back to the Baker Purchasers on February 26, 2024 (the February Assignment Agreement).
Due to the execution of the February Assignment Agreement, the Company reviewed the Baker Notes in accordance with ASC 470. The Baker Notes, having been effectively terminated, were extinguished on February 26, 2024, resulting in removing the fair value of the old Baker Notes of $13.5 million. The newly re-assigned Baker Notes were subsequently recorded at fair value using the valuation methods discussed in Note 6 – Fair Value of Financial Instruments.
On July 23, 2024, the Company consented to the transfer of ownership of the Baker Notes from Baker Brothers Life Sciences, 667, L.P., and Baker Bros. Advisors, LP, each a Delaware limited partnership (collectively, Baker) to Future Pak, LLC (the Assignee) (the July 2024 Assignment). The terms of the Baker Notes were not changed in connection with the assignment from Baker to the Assignee. Due to the July 2024 Assignment, the Company reviewed the Baker Notes in accordance with ASC 470. The Baker Notes, having been effectively terminated, were extinguished on July 23, 2024, resulting in removing the fair value of the old Baker Notes of $12.3 million and the related accumulated other comprehensive income of $0.1 million as of the date of the extinguishment. The newly re-assigned Baker Notes were subsequently recorded at fair value using the valuation methods discussed in Note 6 – Fair Value of Financial Instruments.
The Company did not repurchase the Baker Notes prior to September 8, 2024. As of March 31, 2025, the Baker Notes are recorded at fair value in the condensed consolidated balance sheet as short-term Notes – carried at fair value with a total fair value of $13.8 million, and the total outstanding balance including principal and accrued interest is $112.2 million. As of December 31, 2024, the Baker Notes were recorded at fair value in the condensed consolidated balance sheet as short-term convertible notes payable with a total balance of $13.8 million, and the total outstanding balance including principal and accrued interest was $109.5 million.
On September 27, 2024, the Assignee, as agent for the Purchasers (in such capacity, the Designated Agent), provided a Notice of Event of Default and Reservation of Rights (the September 2024 Notice of Default) relating to the Securities Purchase and Security Agreement dated April 23, 2020, as amended, by and among the Company, Designated Agent, as certain guarantors and the purchasers (each a Purchaser and collectively Purchasers). The September 2024 Notice of Default claims that by entering into arrangements to pay certain existing obligations, including obligations owed to the U.S. Department of Health and Human Services, an Event of Default has occurred under Section 9.1(e) of the SPA.
According to the Notice of Default, the Designated Agent has accelerated repayment of the outstanding principal balance owed by the Company under the Securities Purchase Agreement. If all Purchasers exercise the Section 5.7 Option (as defined below), the repurchase price would be equal to the total outstanding balance, including principal and accrued interest. Pursuant to Section 5.7(b) of the SPA, upon the occurrence of an Event of Default, each Purchaser may elect, at its option, to require the Company to repurchase the Note held by such Purchaser (or any portion thereof) at a repurchase price equal to two times the sum of the outstanding principal balance and all accrued and unpaid interest thereon, due within three business days after such Purchaser delivers a notice of such election (the Section 5.7 Option).
On October 27, 2024, the Designated Agent sent an amended and supplemental notice to the Initial Notice of Default (the Amended Notice of Default) which adds new claims of default based on the Company’s current payment agreements of existing obligations, including obligations owed to the U.S. Department of Health and Human Services, an Event of Default has occurred under Section 9.1(e) of the Baker Bros. Purchase Agreement, as amended. Furthermore, the Amended Notice stated that, because the events of default described in the Amended Notice of Default are not the certain prior events of default listed in the Forbearance Agreement (Specified Defaults), the Designated Agent and the holders of the senior secured promissory notes described in the SPA thereby provided notice to the Company that the Forbearance Agreement is terminated as of October 27, 2024.
On November 8, 2024, the Designated Agent sent an amended and supplemental notice tothe Notices (the Third Amended Notice of Default) which adds new claims of default based on (i) the Company’s failure to maintain a cash position of $1.0 million or greater, as required under Section 5(b) of the Forbearance Agreement (ii) the Company’s failure to deliver financial and operating reports in accordance with the timeline required under the Section 8.1(n) of the Baker Stock Purchase Agreement, and (iii) to clarify the outstanding balance under the notes of the Baker Stock Purchase Agreement plus all accrued and unpaid interest thereon, in the sum of approximately is $107.0 million as opposed to the Repurchase Price as defined in the Fourth Amendment.
The Company strongly disagrees with the Designated Agent’s claim that an Event of Default has occurred. The Company intends to vigorously contest any attempt by the Designated Agent and the Purchasers to exercise their default rights and remedies under the SPA.
Adjuvant Notes
On October 14, 2020, the Company entered into a Securities Purchase Agreement (the Adjuvant Purchase Agreement) with Adjuvant Global Health Technology Fund, L.P., and Adjuvant Global Health Technology Fund DE, L.P. (together, the Adjuvant Purchasers), pursuant to which the Company sold unsecured convertible promissory notes (the Adjuvant Notes) in aggregate principal amount of $25.0 million.
The Adjuvant Notes have a five-year term, and in connection with certain Company change of control transactions, the Adjuvant Notes may be prepaid at the option of the Company or will become payable on the date of the consummation of a change of control transaction at the option of the Adjuvant Purchasers. The Adjuvant Notes have interest accruing at 7.5% per annum on a quarterly basis in arrears to the outstanding balance of the Adjuvant Notes and are recognized as payment-in-kind. The effective interest rate for the three months ended March 31, 2025 was 7.5%.
Interest expense for the Adjuvant Notes consists of the following, and is included in short-term convertible notes – Adjuvant on the condensed consolidated balance sheets as of March 31, 2025 and in other expense, net on the condensed consolidated statements of operations for the three months ended March 31, 2025 and 2024 (in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Coupon interest | $577 | $536 |
| Amortization of issuance costs | - | 28 |
| Total | $577 | $564 |
The Adjuvant Notes are convertible, subject to customary 4.99% and 19.99% beneficial ownership limitations, into shares of the Company’s common stock, par value $0.0001 per share, at any time at the option of the Adjuvant Purchasers at a conversion price of $6,843.75 per share. In connection with certain Company change of control transactions, the Adjuvant Notes may be prepaid at the option of the Company or will become payable at the option of the Adjuvant Purchasers. To the extent not previously prepaid or converted, the Adjuvant Notes were originally automatically convertible into shares of the Company’s common stock at a conversion price of $6,843.75 per share immediately following the earliest of the time at which the (i) 30-day value-weighted average price of the Company’s common stock was $18,750 per share, or (ii) the Company achieved cumulative net sales of $100.0 million, provided such net sales were achieved prior to July 1, 2022.
On April 4, 2022, the Company entered into the first amendment to the Adjuvant Purchase Agreement (the Adjuvant Amendment). The Adjuvant Amendment extended the affirmative covenant to achieve $100.0 million in cumulative net sales of PHEXXI by June 30, 2022 to June 30, 2023. The Adjuvant Amendment also provided for an adjustment to the conversion price of the Adjuvant Notes such that the conversion price (the Conversion Price) for these Notes, effective as of the May 2023 reverse stock split, will now be the lesser of (i) $678.49 and (ii)100% of the lowest price per share of common stock (or with respect to securities convertible into common stock,100% of the applicable conversion price) sold in any equity financing until the Company met the Qualified Financing Threshold. Effective as of the Company’s achievement of the Qualified Financing Threshold, the automatic conversion provisions in the Agreement were further amended to provide that the Adjuvant Notes will automatically convert into shares of the Company’s common stock at the Conversion Price immediately following the earliest of the time at which the (i)30-day value-weighted average price of the Company’s common stock is $18,750 per share, or (ii) the Company achieves cumulative net sales of PHEXXI of $100.0 million, provided such net sales were achieved prior to July 1, 2023.
The Adjuvant Notes contain various customary affirmative and negative covenants agreed to by the Company. On September 12, 2022, the Company was in default of the Adjuvant Notes due to the default with the Baker Notes under the cross-default provision. On September 15, 2022, the Company entered into a Forbearance Agreement (the Adjuvant Forbearance Agreement) with the Adjuvant Purchasers, pursuant to which the Adjuvant Purchasers agreed to forbear from exercising any of their rights and remedies during the Forbearance Period as defined in therein, but solely with respect to the specified events of default provided under the Adjuvant Forbearance Agreement.
On September 15, 2022, the Company also entered into the second amendment to the Adjuvant Purchase Agreement (the Second Adjuvant Amendment), pursuant to which the conversion price per share was reduced to $26.25, subject to adjustment for certain dilutive Company equity issuance adjustments for a two-year period. In addition, the Company entered into an exchange agreement, pursuant to which the Adjuvant Purchasers agreed to exchange 10% of the outstanding amount of the Adjuvant Notes as of September 15, 2022 (or $2.9 million) for rights to receive 109,842 shares of common stock (the Adjuvant Purchase Rights). The number of shares for each Adjuvant Purchase Right was initially fixed, but is subject to certain customary adjustments, and, until the second anniversary of issuance (i.e., October 14, 2022), adjustments for certain dilutive Company equity issuances. Refer to Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit for discussion regarding additional issuances of purchase rights under this provision. The Adjuvant Purchase Rights expire on June 28, 2027 and do not have an exercise price per share and, therefore, will not result in cash proceeds to the Company. As of March 31, 2025, all Adjuvant Purchase Rights remain outstanding. The conversion price of the Adjuvant Notes was $0.0154 as of March 31, 2025. Assuming this conversion price per share, the Adjuvant Notes could be converted into 2,035,422,831 shares of common stock.
The Adjuvant Notes are accounted for in accordance with authoritative guidance for convertible debt instruments and are classified as current liabilities in the condensed consolidated balance sheets. The aggregate proceeds of $25.0 million were initially classified as restricted cash for financial reporting purposes due to contractual stipulations that specify the types of expenses the money can be spent on and how it must be allocated. The conversion feature was evaluated and is classified as part of stockholders’ deficit in accordance with ASC 815,Derivatives and Hedging (ASC 815) as of March 31, 2025. See Note 6 - Fair Value of Financial Instruments for a description of the accounting treatment for the Adjuvant Purchase Rights.
The Company was in default of the Adjuvant Notes as of September 30, 2023, due to the failure to meet the cumulative net sales requirement. However, Adjuvant forbore such default in October 2023 and therefore the Company is no longer in default.
As of March 31, 2025, the Adjuvant Notes are recorded in the condensed consolidated balance sheet as short-term convertible notes – Adjuvant with a total balance of $31.3 million. The balance is comprised of $22.5 million in principal, net of unamortized debt issuance costs, and $8.8 million in accrued interest. As of December 31, 2024, the Adjuvant Notes were recorded in the condensed consolidated balance sheet as short-term convertible notes – Adjuvant with a total balance of $30.8 million. The balance was comprised of $22.5 million in principal, net of unamortized debt issuance costs, and $8.3 million in accrued interest.
Term Notes
December 2022 and February, March, April, July, August, and September 2023 Notes (SSNs)
The Company entered into eight Securities Purchase Agreements (SPAs) between December 2022 and September 2023 with certain investors. Each of the agreements was materially similar. The variable details of each SPA, such as the principal amount of each note offering, net proceeds, and maturity date, are outlined in the table below. Pursuant to each SPA, the Company agreed to sell in a registered direct offering (i) unsecured 8.0% senior subordinated notes with the maturity dates and aggregate issue prices (ii) warrants to purchase the listed number of shares of the Company’s common stock, $0.0001 par value per share (including prefunded common stock Warrants as a part of the September 2023 SPA) and (iii) Series D Preferred Stock (the Preferred Shares; December 2022 SPA only) (collectively, the Senior Subordinated Notes, or SSNs). The SSNs had net proceeds to the Company, and are convertible at, the amounts listed below. Assuming the applicable conversion price per share, the SSNs could be converted into 638,093,561 shares of common stock as of March 31, 2025.
The SSNs’ interest rates are subject to increase to 12% upon an event of default and the SSNs have no Company right to prepayment prior to maturity; however, the Company has the option to redeem the respective SSNs at a redemption premium of 32.5%. The Purchasers can also require the Company to redeem their respective SSNs a) at the respective premium rate tied to the occurrence of certain subsequent transactions, and b) in the event of subsequent placements (as defined). Also, pursuant to the terms of the SPAs, Purchasers have certain rights to participate in subsequent issuances of the Company’s securities, subject to certain exceptions. Additionally, the conversion rate and warrant strike price are subject to adjustment upon the issuance of other securities (as defined) below the stated conversion rate and strike price at issuance. The strike prices adjusted as discussed in the table below.
The Company evaluated the SSNs in accordance with ASC 480 and determined that the SSNs were all liability instruments at issuance. The applicable SSNs were then evaluated in accordance with the requirements of ASC 825 and the Company concluded that they were not precluded from electing the fair value option for the applicable SSNs.
The Company also evaluated the Warrants in accordance with ASC 480 and as of both March 31, 2025 and December 31, 2024, the warrants are recorded in equity.
On December 21, 2023, warrants to purchase up to 9,972,074 shares of the Company’s common stock were exchanged for 613 shares of the Company’s series F-1 convertible and redeemable preferred stock (Series F-1 Shares, as defined below). The Series F-1 Shares, some of which were also issued based on the partial value of certain purchase rights, as described above, were immediately exchanged for Aditxt series A-1 preferred stock;26,280 Series F-1 Shares were outstanding as of both March 31, 2025 and December 31, 2024, and held by Aditxt.
Summary of SSNs and Warrants at Issuance (December 2022 to September 2023):
| Conversion Price | ||||||||
|---|---|---|---|---|---|---|---|---|
| Notes | Principal At Issuance (in Thousands) | Net Proceeds Before Issuance costs (in Thousands) | Common Warrants | Preferred Shares | Maturity Date | At Issuance | At 12/31/2024 | At 3/31/2025 |
| December 2022 Notes | $2,308 | $1,500 | 369,230 | 70 - Series D | 12/21/2025 | $6.25 | $0.0154 | $0.0154 |
| February 2023 Notes(1) | 1,385 | 900 | 653,538 | - | 2/17/2026 | $2.50 | $0.0154 | $0.0154 |
| March 2023 Notes | 600 | 390 | 240,000 | - | 3/17/2026 | $2.50 | $0.0154 | $0.0154 |
| March 2023 Notes(2) | 538 | 350 | 258,584 | - | 3/20/2026 | $2.50 | $0.0154 | $0.0154 |
| April 2023 Notes | 769 | 500 | 615,384 | - | 3/6/2026 | $1.25 | $0.0154 | $0.0154 |
| July 2023 Notes | 1,500 | 975 | 1,200,000 | - | 3/6/2026 | $1.25 | $0.0154 | $0.0154 |
| August 2023 Notes | 1,000 | 650 | 799,999 | - | 8/4/2026 | $1.25 | $0.0154 | $0.0154 |
| September 2023 Notes(3) | 2,885 | 1,875 | 26,997,041 | - | 9/26/2026 | $0.13 | $0.0154 | $0.0154 |
| Total Offerings | $10,985 | $7,140 | 31,133,776 | |||||
| (1) | Warrants include 99,692 issued to the placement agent. |
| (2) | Warrants include 43,200 issued to the placement agent. |
| (3) | Warrants include 22,189,349 common warrants at $0.13 per share at issuance and 4,807,692 pre-funded warrants exercisable at $0.001 per share. |
5. Balance Sheet Details
Inventories
Inventories consist of the following (in thousands):
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Raw materials | $374 | $350 |
| Work in process | 873 | 982 |
| Finished goods | 1,016 | 245 |
| Total | $2,263 | $1,577 |
Prepaid and Other Current Assets
Prepaid and other current assets consist of the following (in thousands):
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Insurance | $162 | $391 |
| Prescription Drug User Fee Act (PDUFA) fees | 404 | 606 |
| Outside service retainers | 100 | 160 |
| Short-term deposits | 125 | 127 |
| Other | 561 | 175 |
| Total | $1,352 | $1,459 |
Property and Equipment, Net
Property and equipment, net, consists of the following (in thousands):
| Useful Life | March 31, 2025 | December 31, 2024 | |
|---|---|---|---|
| Research equipment | 5 years | $39 | $585 |
| Computer equipment and software | 3 years | 32 | 145 |
| Construction in-process | - | 405 | 429 |
| Property and equipment, gross | 476 | 1,159 | |
| Less: accumulated depreciation | (47) | (701) | |
| Total, net | $429 | $458 |
Depreciation expense for property and equipment was immaterial in each of the three months ended March 31, 2025 and 2024, respectively.
Intangible Asset, Net
Intangible asset, net, acquired in July 2024, consists of the following (in thousands):
| Useful Life | March 31, 2025 | December 31, 2024 | |
|---|---|---|---|
| Intellectual property | 16 years | $7,330 | $10,216 |
| Less: accumulated amortization | (843) | (619) | |
| Total, net | $6,487 | $9,597 |
The intangible asset relates entirely to the asset acquired with the SOLOSEC asset acquisition and as described further in Note 7 – Commitments and Contingencies, the useful life is based on the SOLOSEC IP patent expiration. Amortization expense was $0.2 million in the three months ended March 31, 2025. Amortization expense is expected to be approximately $0.3 million for the remainder of 2025 and $0.4 million in each subsequent year until the intangible asset is fully amortized, which will be in approximately 15.4 years. As described in Note 2 – Summary of Significant Accounting Policies, the intangible asset value is adjusted at each reporting date in conjunction with the mark-to-market adjustment of the contingent liabilities, which could impact the expected amortization. The initial intangible asset fair value was $16.1 million at acquisition; this was reduced by $5.9 million for the year ended December 31, 2024. The adjustment for the three months ended March 31, 2025 was a reduction to the intangible balance of $2.9 million.
Accrued Expenses
Accrued expenses consist of the following (in thousands):
| March 31, 2025 · December 31, 2024 | |||
|---|---|---|---|
| Clinical trial related costs | $ | - | $2,498 |
| Accrued royalty | 1,990 | 1,976 | |
| Accrued compensation for non-employee directors | 558 | 505 | |
| Other | 695 | 530 | |
| Total | $3,243 | $5,509 | |
6. Fair Value of Financial Instruments
Fair Value of Financial Liabilities
The following tables summarize the Company’s convertible debt instruments as of March 31, 2025 and December 31, 2024, respectively (in thousands):
| Fair Value | ||||||
|---|---|---|---|---|---|---|
| As of March 31, 2025 · Principal Amount · Accrued Interest · Net Carrying Amount · Amount · Leveling | ||||||
| Baker Notes(1)(2) | $112,225 | $ | - | $112,225 | $13,833 | Level 3 |
| Adjuvant Notes(3) | 22,500 | 8,846 | 31,346 | N/A | N/A | |
| December 2022 Notes(1) | 992 | - | 992 | 50 | Level 3 | |
| February 2023 Notes (1) | 1,000 | - | 1,000 | 50 | Level 3 | |
| March 2023 Notes (1) | 1,233 | - | 1,233 | 63 | Level 3 | |
| April 2023 Notes (1) | 901 | - | 901 | 45 | Level 3 | |
| July 2023 Notes (1) | 1,349 | - | 1,349 | 68 | Level 3 | |
| August 2023 Notes (1) | 1,141 | - | 1,141 | 57 | Level 3 | |
| September 2023 Notes (1) | 3,210 | - | 3,210 | 161 | Level 3 | |
| Totals | $144,551 | $8,846 | $153,397 | $14,327 | N/A | |
| Fair Value | ||||||
|---|---|---|---|---|---|---|
| As of December 31, 2024 · Principal Amount · Accrued Interest · Net Carrying Amount · Amount · Leveling | ||||||
| Baker Notes(1)(2) | $109,488 | $ | - | $109,488 | $13,801 | Level 3 |
| Adjuvant Notes(3) | 22,500 | 8,269 | 30,769 | N/A | N/A | |
| December 2022 Notes(1) | 973 | - | 973 | 118 | Level 3 | |
| February 2023 Notes (1) | 980 | - | 980 | 120 | Level 3 | |
| March 2023 Notes (1) | 1,209 | - | 1,209 | 147 | Level 3 | |
| April 2023 Notes (1) | 883 | - | 883 | 108 | Level 3 | |
| July 2023 Notes (1) | 1,322 | - | 1,322 | 161 | Level 3 | |
| August 2023 Notes (1) | 1,119 | - | 1,119 | 136 | Level 3 | |
| September 2023 Notes (1) | 3,147 | - | 3,147 | 383 | Level 3 | |
| Totals | $141,621 | $8,269 | $149,890 | $14,974 | N/A | |
| (1) | These liabilities are/were carried at fair value in the condensed consolidated balance sheets. As such, the principal and accrued interest was included in the determination of fair value. The related debt issuance costs were expensed. |
| (2) | The Baker Notes principal amount includes $27.7 million and $24.9 million of interest paid in-kind as of March 31, 2025, and December 31, 2024, respectively. |
| (3) | The Adjuvant Notes are recorded in the condensed consolidated balance sheets at their net carrying amount which includes principal and accrued interest, net of unamortized issuance costs. |
The following tables summarize the Company’s derivative liabilities as of March 31, 2025 and December 31, 2024 as discussed in Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit (in thousands):
| Fair Value | |||
|---|---|---|---|
| March 31, 2025 | December 31, 2024 | Leveling | |
| Purchase rights | $138 | $1,359 | Level 3 |
| Total derivative liabilities | $138 | $1,359 | |
Change in Fair Value of Level 3 Financial Liabilities
The following table summarizes the changes in Level 3 financial liabilities related to Baker Notes and SSNs measured at fair value on a recurring basis for the three months ended March 31, 2025 (in thousands):
| Baker Notes (Assigned to Future Pak; Note 4) | Total SSNs (Note 4) | Total | |
|---|---|---|---|
| Balance at December 31, 2024 | $13,801 | $1,173 | $14,974 |
| Change in fair value presented in the Condensed Consolidated Statements of Comprehensive Operations | 32 | (679) | (647) |
| Balance at March 31, 2025 | $13,833 | $494 | $14,327 |
The following table summarizes the changes in Level 3 financial liabilities related to Baker Notes and SSNs measured at fair value on a recurring basis for the three months ended March 31, 2024 (in thousands):
| Baker Notes (Assigned to Future Pak; Note 4) | Total SSNs (Note 4) | Total | |
|---|---|---|---|
| Balance at December 31, 2023 | $13,510 | $1,221 | $14,731 |
| Extinguishment/conversion | (13,510) | (35) | (13,545) |
| Balance at issuance | 12,390 | - | 12,390 |
| Change in fair value presented in the Condensed Consolidated Statements of Comprehensive Operations | (130) | (194) | (324) |
| Balance at March 31, 2024 | $12,260 | $992 | $13,252 |
The following table summarizes the changes in Level 3 financial liabilities related to derivative liabilities measured at fair value on a recurring basis for the three months ended March 31, 2025 (in thousands):
| Purchase Rights | Derivative Liabilities Total | |
|---|---|---|
| Balance at December 31, 2024 | $1,359 | $1,359 |
| Change in fair value presented in the Condensed Consolidated Statements of Operations | (1,221) | (1,221) |
| Balance at March 31, 2025 | $138 | $138 |
The following table summarizes the changes in Level 3 financial liabilities related to derivative liabilities measured at fair value on a recurring basis for the three months ended March 31, 2024 (in thousands):
| Purchase Rights | Derivative Liabilities Total | |
|---|---|---|
| Balance at December 31, 2023 | $1,926 | $1,926 |
| Balance at issuance | 3,275 | 3,275 |
| Exercises | (89) | (89) |
| Change in fair value presented in the Condensed Consolidated Statements of Operations | (802) | (802) |
| Balance at March 31, 2024 | $4,310 | $4,310 |
Valuation Methodology
Baker Notes
The fair value of the Baker Notes is determined using a Monte Carlo simulation-based model. The Monte Carlo simulation was used to take into account several embedded features and factors, including the exercise of the repurchase rights, the Company’s future revenues, meeting certain debt covenants, the maturity term of the note and dissolution. For the dissolution scenario, the cost approach, an adjusted net asset value method was used to determine the net recoverable value of the Company, including an estimate of the fair value of the Company’s intellectual property. The estimated fair value of the Company’s intellectual property was valued using a relief from royalty method which required management to make significant estimates and assumptions related to forecasts of future revenue, and the selection of the royalty (5.0%) and discount (15.0%) rates.
The fair value of the Baker Notes is subject to uncertainty due to the assumptions that are used in the Monte Carlo simulation-based model. These factors include but are not limited to the Company’s future revenue, the probability and timing of the exercise of the repurchase right, and expectations regarding potential dissolution. The fair value of the Baker Notes is sensitive to these estimated inputs made by management that are used in the calculation.
SSNs
The fair value of the SSNs issued as described in Note 4 – Debt, were determined by estimating the fair value of the MVIC of the Company on a going-concern basis. This was estimated using forms of the cost and market approaches. In the cost approach, an adjusted net asset value method was used to determine the net recoverable value of the Company, including an estimate of the fair value of the Company’s intellectual property. The estimated fair value of the Company’s intellectual property was valued using a relief from royalty method which required management to make significant estimates and assumptions related to forecasts of future revenue, and the selection of the royalty and discount rates. The guideline public company method served as another valuation indicator. In this form of the market approach, comparable market revenue multiples were selected and applied to the Company’s forward revenue forecast to ultimately derive a MVIC indication. An option-pricing model (OPM) was then applied to value the SSNs by allocating the estimated MVIC through the Company’s capital structure including the more senior notes payoff in a hypothetical exit event. Under the OPM, each debt or equity class is modeled as a call option with a distinct claim on the total value of the Company. The option’s exercise price is based on the Company’s total value available for each participating security holder. By constructing a series of options in which the exercise price is set at incremental levels of value, which correspond to the value necessary for each level of equity to participate, we determined the incremental option value of each series. When multiplied by the percentage of ownership of each equity class participating under that series, the result is the incremental value allocated to each class under that series.
Purchase Rights
The Adjuvant Purchase Rights and the May Note Purchase Rights (collectively Purchase Rights) are recorded as derivative liabilities in the condensed consolidated balance sheets. The Purchase Rights are valued using an OPM, like a Black-Scholes Methodology, with changes in the fair value being recorded in the condensed consolidated statements of operations. The assumptions used in the OPM are considered level 3 assumptions and include, but are not limited to, the market value of invested capital, the cumulative equity value of the Company as a proxy for the exercise price and the expected term the Purchase Rights will be held prior to exercise and a risk-free interest rate.
Warrants
Warrants are classified as equity and the Company re-evaluates the classification of its warrants at the close of each reporting period to determine their proper balance sheet classification. The warrants are valued using an OPM based on the applicable assumptions, which include the exercise price of the warrants, time to expiration, expected volatility of our peer group, risk-free interest rate, and expected dividends. The assumptions used in the OPM are considered level 3 assumptions and include, but are not limited to, the market value of invested capital, the cumulative equity value of the Company as a proxy for the exercise price, the expected term the warrants will be held prior to exercise, a risk-free interest rate, and probability of change of control event. Additionally, because the warrants are re-priced under certain provisions in the agreements, at each re-pricing event the Company must value the warrants using a Black-Scholes model immediately prior to and immediately following the re-pricing event. The incremental fair value is recorded as an increase to accumulated deficit and additional paid-in-capital, in accordance with ASC 470.
SOLOSEC Asset Acquisition Intangible Asset and Contingent Liabilities
The total consideration for the SOLOSEC asset acquisition included an up-front payment (paid at closing), sales-based payments to be paid over the next 15 years (the Earnout Term) in each year in which SOLOSEC adjusted net revenue is over a specified threshold, a $10.0 million one-time payment once the cumulative SOLOSEC adjusted net revenues reach $100 million, and assumption of quarterly royalty payments based on SOLOSEC net revenue. As discussed in Note 7 – Commitments and Contingencies, the fair value of the consideration is attributed to the SOLOSEC product line and was therefore recorded as an intangible asset.
The fair value of the total consideration, including cash paid and future sales-based payments, is determined using a Monte Carlo simulation model, which assumes the Company’s revenue follows a geometric Brownian motion. Using specific revenue factors, including expected growth, risk adjustments, and revenue volatility, future revenues were simulated through the Earnout Term to assess whether sales-based payments would be triggered in each relevant period, as stipulated by the SOLOSEC Asset Purchase Agreement. The average output of the Monte Carlo simulations for each period provides the expected payment value, which is then discounted to its present value to derive the fair value of future sales-based payments and recorded as contingent liabilities. The discount rate is based on (i) the risk-free rate, plus (ii) a credit spread reflecting the Company’s interest-bearing debt, (iii) an additional spread to account for credit migration as of the valuation date, and (iv) a further incremental spread to reflect that the contingent liabilities is subordinated obligations relative to the Company’s other debt obligations.
The fair value of the SOLOSEC contingent liabilities is subject to uncertainty due to the assumptions made by management that are used in the Monte Carlo simulation-based model. These factors include the estimated future SOLOSEC net revenue, the risk-neutral revenue calculation and simulation assumptions, payment timing, and the discount rate.
The fair value of the SOLOSEC contingent liabilities will be updated at each reporting period using the methodology described above. Any changes to the fair value will be recorded as an adjustment to the carrying value of both the contingent liabilities and the SOLOSEC IP intangible asset as per ASC 323,Investments – Equity Method and Joint Ventures (ASC 323). Periodic intangible amortization will also be prospectively updated based on the new fair value of the SOLOSEC IP.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.