The following discussion and analysis should be read in conjunction with the financial statements and related notes included in "Item 8 - Financial Statements and Supplementary Data" in this Annual Report on Form 10-K. The following discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those expressed or implied in any forward-looking statements as a result of various factors, including those set forth under the caption "Item 1A. Risk Factors."
Overview
InMarch 2023 , we announced our decision to discontinue our ongoing Phase 1/2 clinical trials evaluating the safety and preliminary efficacy of our GoCAR-T cell product candidates (including BPX-601 and BPX-603) in combination with rimiducid in heavily pre-treated cancer patients following our assessment of the risk/benefit profile of BPX-601 in combination with rimiducid. We are communicating with clinical trial sites and regulatory agencies regarding our decision to discontinue these trials. We are evaluating and exploring a variety of strategic and financing alternatives focused on maximizing shareholder value, including, but not limited to, a merger, sale, or other business combination, a strategic partnership with one or more parties, or the licensing, sale or divestiture of our programs. Despite undertaking this process, we may not be successful in completing a transaction, and, even if a strategic transaction is completed, it ultimately may not deliver the anticipated benefits or enhance stockholder value. If we do not successfully consummate a strategic alternative, our board of directors may decide to pursue a dissolution and liquidation of the Company.
Results of Operations
The following table sets forth our results of operations for the periods indicated: Year Ended (in thousands) December 31, 2022 December 31, 2021 Change Revenues Supply agreement $ - $ 700$ (700) License revenue 1,500 5,500 (4,000) Total revenues $ 1,500 $ 6,200$ (4,700) Operating expenses: Research and development 22,764 23,578 (814) General and administrative 5,717 7,010 (1,293) Total operating expenses 28,481 30,588 (2,107) Other operating expense Loss on dispositions, net - (478) 478 Total other operating expense - (478) 478 Loss from operations (26,981) (24,866) (2,115) Other income: Interest income, net of interest expense 46 28 18 Change in fair value of warrant and private placement option liabilities 1,964 15,126 (13,162) Other income - 7 (7) Total other income 2,010 15,161 (13,151) Loss before tax (24,971) (9,705) (15,266) Income tax expense (2) - (2) Net loss $ (24,973) $ (9,705)$ (15,268) Revenues The decrease in revenues for the year endedDecember 31, 2022 , compared to the year endedDecember 31, 2021 , was mainly due to new supply and license agreements executed with external parties during 2021. In the first quarter of 2021, we entered into a multi- 46
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year supply agreement withTakeda Development Center Americas, Inc. , or Takeda, for the supply of rimiducid for potential use in clinical trials of TAK-007 (CD19 CAR-NK cell therapy). The supply was fulfilled in the second quarter of 2021 generating revenue of$0.7 million , although we may generate additional revenue under the agreement based on future sales. In the third quarter of 2021, we entered into an option and license agreement withThe University of Texas M.D. Anderson Cancer Center , orM.D. Anderson for certain option and license rights to CaspaCIDe and related technologies. An upfront fee under the agreement of$5.0 million was recognized as revenue, together with$0.5 million of annual license fee under a previous license agreement withM.D. Anderson . For the year endedDecember 31, 2022 , revenue recognized consisted of the annual license fees of$0.5 million and$1.0 million from the 2019 and 2021 M.D. Anderson Option and License Agreement, respectively.
Research and Development Expenses (R&D)
The decrease in R&D expenses of$0.8 million for the year endedDecember 31, 2022 , compared to the year endedDecember 31, 2021 , was primarily due to continued reduction of expenses related to rivo-cel activities. We discontinued active efforts to identify a partner for rivo-cel in late 2021. As a result, we have further decreased the budget on rivo-cel by limiting activities to maintaining regulatory compliance and long-term follow-up and monitoring patients previously enrolled in rivo-cel clinical trials, leading to a reduction in clinical trial and consulting expenses of$1.8 million for the twelve months endedDecember 31, 2022 , compared to the prior year. Additionally, there were delays in enrolling new patients for our clinical trials, which resulted in a reduction in clinical research costs of$0.7 million for the twelve months endedDecember 31, 2022 , compared to the prior year. These decreases were partially offset by an increase in salaries, benefits, travel, and share-based compensation related charges from R&D departments of$1.7 million for the twelve months endedDecember 31, 2022 , as a result of increased R&D personnel hired during 2022. At the end of 2022, we had 11 full time equivalent employees in our R&D departments, compared to five at the end of 2021. As discussed above, we have discontinued our BPX-601 and BPX-603 Phase 1/2 clinical trials, which we expect will contribute to decreases in R&D expenses in future periods.
General and Administrative Expenses (G&A)
The decrease in G&A expenses of$1.3 million for the year endedDecember 31, 2022 , compared to the year endedDecember 31, 2021 , was primarily due to a reduction in share-based compensation expenses, and IT and communication expenses from G&A departments by$1.1 million . Additionally, insurance and other public company costs decreased by$0.2 million for the twelve months endedDecember 31, 2022 as a result of a reduced company size and administrative activities, compared to the same period in 2021.
Loss on dispositions, net
We did not incur any gain or loss on dispositions for the year endedDecember 31, 2022 . The loss of$0.5 million recognized for the year endedDecember 31, 2021 was a result of the lease termination of the South San Francisco office space in the first quarter of 2021. Upon the termination and exit of the office space, we disposed of substantially all of the assets and liabilities associated with the lease including a right-of-use asset of$0.6 million , leased equipment with a net book value less than$0.1 million , and the related lease liability of$1.0 million . Other Income (Expense) Other income or expense primarily consists of interest income, interest expense, and changes in fair values of our warrant liability and the private placement option, which are remeasured at each reporting period. Due to the nature of the inputs in the model used to assess the fair value of the warrant liability and private placement option, we may experience significant fluctuations at each reporting period. These fluctuations may be due to a variety of factors, including changes in our stock price and changes in stock price volatility over the remaining term of the warrants and options. The private placement option was terminated inDecember 2021 , and we recognized$2.6 million of gain from the change in fair value of the private placement option liabilities during the year endedDecember 31, 2021 . We did not record any change in fair value of the private placement option liabilities during 2022. The decrease in other income for the year endedDecember 31, 2022 , was primarily due to a decrease in the gain recognized for the change in fair value of our warrant liability compared to the prior year. In 2022, we recognized$2.0 million of gain, compared to a gain of$15.2 million recognized for 2021. The primary reason of a larger amount of gain in 2021 was a significant decrease of the fair value of our warrant liability of$12.6 million during the year as a result of continued decrease in our stock price with a high volatility rate, compared to the change in fair value during 2022.
Liquidity and Capital Resources
Sources of Liquidity
As of
47 -------------------------------------------------------------------------------- Table of Contents The accompanying financial statements have been prepared on a basis that assumes that we will continue as a going concern, and do not include any adjustments that may result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of our assets and the satisfaction of our liabilities and commitments in the normal course of business and does not include any adjustments to reflect the possible future effects of the recoverability and classification of recorded asset amounts or amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern. We have experienced net losses since our inception and as ofDecember 31, 2022 , we have an accumulated deficit of$575.4 million . We believe that there is substantial doubt that our current capital resources, which consist of cash and cash equivalents, are sufficient to fund operations through at least the next twelve months from the date the accompanying financial statements are issued. InMarch 2023 , we announced our decision to discontinue our ongoing Phase 1/2 clinical trials evaluating the safety and preliminary efficacy of our GoCAR-T cell product candidates in combination with rimiducid in heavily pre-treated cancer patients. The trials for BPX-601 and BPX-603 are being discontinued following our assessment of the risk/benefit profile of BPX-601 in combination with rimiducid. We are communicating with clinical trial sites and regulatory agencies regarding its decision to discontinue its trials, and an evaluation of our strategic alternatives is underway. Based on our current status, we are evaluating strategic alternatives, including, but not limited to, a merger, sale, or other business combination, a strategic partnership with one or more parties, or the licensing, sale, or divestiture of our programs. Despite undertaking this process, we may not be successful in completing a transaction, and, even if a strategic transaction is completed, it ultimately may not deliver the anticipated benefits. If we do not successfully consummate a strategic alternative, our board of directors may decide to pursue a dissolution and liquidation of the Company.
Cash Flows
Operating Activities
Net cash used in operating activities during the year endedDecember 31, 2022 was$25.8 million compared to$23.1 million for the year endedDecember 31, 2021 . The primary operating activities during 2022 were (1)$25.0 million of net losses, (2) a$2.0 million non-cash gain from change in fair market value of warrant derivative liability, and (3) a$1.4 million net decrease from operating assets and liabilities. These activities were partially offset by share-based compensation charges of$2.6 million and other smaller non-cash items.
Investing Activities
Net cash used in investing activities during the year endedDecember 31, 2022 was less than$0.1 million compared to net cash provided by investing activities of$0.9 million for the year endedDecember 31, 2021 . The cash used in investing activities for the year endedDecember 31, 2022 was primarily for the purchase of computer equipment. The$0.9 million of net cash provided by investing activities during 2021 was related to proceeds from the sale of property and equipment. Financing Activities There was no cash used in or provided by financing activities during the year endedDecember 31, 2022 , compared to net cash provided by financing activities of$32.9 million during the year endedDecember 31, 2021 . The net cash provided by financing activities for the year endedDecember 31, 2021 was generated from the issuance of pre-funded warrants during the private placement that closed inDecember 2021 , net of offering expenses.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements (as defined by applicable regulations of theSEC ) that are reasonably likely to have a current or future material effect on our financial condition, results of operations, liquidity, capital expenditures or capital resources. We do not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or for any other contractually narrow or limited purpose.
Critical Accounting Estimates
Our consolidated financial statements are prepared in accordance withU.S. generally accepted accounting principles, or GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, costs and expenses and related disclosures. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. In many instances, we could have reasonably used different accounting estimates, and in other instances changes in the accounting estimates are reasonably likely to occur from period to period. Accordingly, actual results could differ significantly from management's estimates under different assumptions or conditions. To the 48
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extent that there are material differences between these estimates and actual results, our future financial statement presentation, financial condition, results of operations and cash flows will be affected. While our significant accounting policies are described in the notes to our financial statements, we believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies related to the more significant areas involving management's judgments and estimates. Our management has discussed the development and selection of these critical accounting estimates with the audit committee of our board of directors and the audit committee has reviewed our disclosure relating to it in this MD&A.
Warrant Derivatives
Freestanding public warrants exercisable for multiple underlying instruments are classified as liabilities. The Company accounts for these warrants in accordance with ASC Topic 480, Distinguishing Liabilities From Equity ("ASC 480") and ASC Topic 815, Accounting for Derivative Instruments and Hedging Activities ("ASC 815"). The Company estimates the fair value of these liabilities using the Black-Scholes model. The option pricing model of our warrant derivative liabilities are estimates and are sensitive to changes to certain inputs used in the pricing model. See Note 1 - Organization, Basis of Presentation, and Summary of Significant Accounting Policies for a discussion of how the Company accounts for its warrant derivatives. Freestanding pre-funded warrants and accompanying warrants exercisable for multiple underlying instruments are classified as equity. The Company accounts for these warrants in accordance with ASC Topic 480, Distinguishing Liabilities From Equity ("ASC 480") and ASC Topic 815, Accounting for Derivative Instruments and Hedging Activities ("ASC 815"). Upon the issuance of pre-funded warrants or the exercise of its accompanying common warrants, the Company receives proceeds from its investors which are recognized as equity. Furthermore, because pre-funded warrants and accompanying warrants do not participate in dividends with common stockholders, they are not considered a participating security in its current form. The pre-funded warrants will be considered in the Company's basic and diluted EPS calculations, and the common warrants would be included in diluted EPS calculation (if the Company was in a net income position). See Note 1 - Organization, Basis of Presentation, and Summary of Significant Accounting Policies for a discussion of how the Company accounts for its pre-funded warrants.
Private Placement Option
The Company previously entered into a 2019 securities purchase agreement that contained a call option on preferred shares that are puttable outside the control of the Company. The Company accounted for the option in accordance with ASC Topic 480, Distinguishing Liabilities From Equity ("ASC 480") and ASC Topic 815, Accounting for Derivative Instruments and Hedging Activities ("ASC 815"). The Company estimated the fair value of the liability using a binomial lattice model, which is sensitive to changes to certain inputs. See Note 1 - Organization, Basis of Presentation, and Summary of Significant Accounting Policies for a discussion of how the Company accounted for its private placement option derivative. The private placement option was terminated onDecember 4, 2021 , in connection with the 2021 securities purchase agreement.
Research and Development
Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for research and development employees and consultants, facilities expenses, overhead expenses, cost of laboratory supplies, manufacturing expenses, fees paid to third parties and other outside expenses. We accrue for costs incurred as the services are being provided by monitoring the status of the clinical trial or project and the invoices received from our external service providers. We adjust our accrual as actual costs become known. See Note 1 - Organization, Basis of Presentation, and Summary of Significant Accounting Policies for a discussion of how the Company accounts for research and development expenses.
Share-Based Compensation
The Company's share-based awards include stock option grants and restricted stock awards. The estimated fair value for stock options, which determines the Company's calculation of compensation expense, is based on the Black-Scholes pricing model, which requires a number of estimates, including the expected lives of awards, interest rates, stock volatility and other assumptions. Additionally, we apply a forfeiture rate to estimate the number of grants that will ultimately vest, as applicable, and adjust the expense as these awards vest. See Note 1 - Organization, Basis of Presentation, and Summary of Significant Accounting Policies for a discussion of how the Company accounts for share-based compensation.
Recently Issued Accounting Pronouncements
See Note 1 - Organization, Basis of Presentation, and Summary of Significant Accounting Policies for discussion regarding recent accounting pronouncements.
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