MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
−Removed: should read the following discussion and analysis of our financial condition and plan of operations together with and our accompanying
−Removed: consolidated financial statements and the related notes appearing elsewhere in this Annual Report on Form 10-K.
−Removed: In addition to historical
−Removed: information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions.
−Removed: actual results may differ materially from those discussed below.
−Removed: Factors that could cause or contribute to such differences include,
−Removed: but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included elsewhere
−Removed: in this Annual Report on Form 10-K.
+Added: should read the following discussion and analysis of our financial condition and plan of operations together with our accompanying consolidated
+Added: financial statements and the related notes appearing elsewhere in this Annual Report on Form 10-K.
+Added: In addition to historical information,
+Added: this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions.
+Added: Our actual results
+Added: may differ materially from those discussed below.
+Added: Factors that could cause or contribute to such differences include, but are not limited
+Added: to, those identified below, and those discussed in the section titled “Risk Factors” included elsewhere in this Annual Report
+Added: on Form 10-K.
All amounts in this report are in U.S.
dollars, unless otherwise noted.
−Removed: Immix Biopharma, Inc.
−Removed: is a clinical-stage biopharmaceutical company focused
−Removed: on the application of CAR-T in light chain (AL) Amyloidosis and autoimmune disease.
−Removed: Our lead cell therapy candidate is FDA IND cleared
−Removed: CAR-T NXC-201, currently being evaluated in our ongoing Phase 1b/2a NEXICART-1 (NCT04720313) clinical trial.
−Removed: Based on early clinical data,
−Removed: we believe NXC-201 has the potential to be the world’s first “Single-Day CRS” CAR-T (CRS median onset day 1, median
−Removed: duration 1 day), enabling the potential for a faster return home for patients.
−Removed: NXC-201 has been awarded Orphan Drug Designation (ODD)
−Removed: by the FDA in both AL Amyloidosis and multiple myeloma, and ODD by the European Commission (EMA) in AL Amyloidosis.
+Added: Biopharma, Inc.
+Added: is a clinical-stage biopharmaceutical company focused on the application of chimeric antigen receptor cell therapy in
+Added: light chain (AL) Amyloidosis and select immune-mediated diseases.
+Added: Our lead cell therapy candidate is FDA IND cleared CAR-T NXC-201, currently
+Added: being evaluated in our ongoing United States Phase 1b/2 NEXICART-2 (NCT06097832) clinical trial and our ex-U.S.
+Added: phase 1b/2a NEXICART-1
+Added: (NCT04720313) clinical trial.
inception, we have devoted substantially all of our resources to developing product and technology rights, conducting research and development,
39 unchanged sentences
however, the royalty
−Removed: obligations described herein shall survive the termination of the MSA.
+Added: obligations described therein survived the termination of the MSA.
+Added: of Nexcella Subsidiary
+Added: May 20, 2024, Nexcella, was merged with and into the Company, with the Company as the surviving corporation.
+Added: The Merger was effected
+Added: pursuant to Section 253 of the DGCL when the Company filed a Certificate of Ownership and Merger (“Certificate of Merger”)
+Added: with the Secretary of State of the State of Delaware.
+Added: Immediately prior to the Merger, the Company owned greater than 95% of the outstanding
+Added: common stock on a fully diluted basis of Nexcella, par value $0.0001 per share, and 100% of the outstanding shares of each other class
+Added: of capital stock of Nexcella.
+Added: Under the DGCL, the only approval required was that of the Company’s Board of Directors for the Merger
+Added: to become effective.
+Added: As a result of the Merger, Nexcella ceased to exist and all assets, operations and other property and rights of
+Added: Nexcella have been succeeded to by the Company.
+Added: Pursuant to the terms of the Certificate of Merger, as a result of the Merger, each of
+Added: the outstanding Nexcella Shares (other than Nexcella Shares held by the Company) were converted, into common stock of the Company.
+Added: connection with the Merger, the Company issued 989,876 shares of its common stock to the former stockholders of Nexcella (other than
+Added: shares held by the Company) (including Company common stock issued to third-party cash investors in Nexcella).
+Added: In addition, the Company
+Added: issued to the former participants in the Nexcella 2022 Equity Incentive Plan, 275,759 restricted stock awards to receive common stock
+Added: in the Company and options to purchase up to 595,676 shares of Company common stock at an exercise price of $2.47 per share (the closing
+Added: price on May 17, 2024), under the Company’s Amended and Restated 2021 Omnibus Equity Incentive Plan.
and License Agreement with Hadasit and BIRAD
19 unchanged sentences
Additionally, Licensors may terminate the Agreement if Nexcella becomes insolvent or files for bankruptcy.
−Removed: February 2024, we conducted an underwritten public offering of 5,535,055 shares of common stock at the public offering price is $2.71
−Removed: per shares, for the net proceeds, after underwriter discounts and offering expenses, of approximately $13,529,999.
−Removed: Pursuant to the underwriting
−Removed: agreement, we granted the underwriter a 30-day over-allotment option to purchase up to an additional 783,970 shares of our common stock,
−Removed: which was exercised in full on March 1, 2024 for the net proceeds, after underwiring discounts and offering expenses, of $1,954,594.
+Added: license remains with the Company after the Nexcella Absorption.
+Added: December 16, 2024, Nexcella entered into the First Amendment to the Research and License Agreement (the “First Amendment”)
+Added: with the Licensors.
+Added: The First Amendment includes terms specific to new licensed products and requires an additional upfront license fee
+Added: of $1,500,000, payable no later than April 30, 2025, as well as development milestone payments of up to $4.5 million upon the Company’s
+Added: achievement of certain milestones.
+Added: 2023 ATM Offering
+Added: July 14, 2023, we entered into an ATM Sales Agreement (the “July 2023 Sales Agreement”) with the Sales Agent pursuant to
+Added: which we may offer and sell, from time to time, through the Sales Agent, shares of our common stock, subject to the terms and conditions
+Added: set forth in the July 2023 Sales Agreement.
+Added: Initially, we are eligible to sell up to $4,200,000 worth of shares of our common stock as
+Added: the aggregate market value of our shares of common stock eligible for sale under the July 2023 Sales Agreement is subject to the limitations
+Added: of General Instruction I.B.6 of Form S-3 until such time that our public float equals or exceeds $75.0 million.
+Added: In the event the aggregate
+Added: market value of our outstanding common stock held by non-affiliates equals or exceeds $75.0 million, then the one-third limitation on
+Added: sales set forth in General Instruction I.B.6 of Form S-3 will not apply to additional sales made pursuant to the July 2023 Sales Agreement.
+Added: We agreed to pay the Sales Agent a commission rate of 3.75% of the aggregate gross proceeds from the sale of the shares of our common
+Added: stock pursuant to the July 2023 Sales Agreement and have paid an expense deposit of $15,000 to the Sales Agent, which will be applied
+Added: against the actual out-of-pocket accountable expenses.
+Added: In addition, we have agreed to reimburse the Sales Agent for all expenses related
+Added: to the offering including, without limitation, the fees and expenses of the Sales Agent’s legal counsel up to $50,000, and to reimburse
+Added: the Sales Agent, upon request, for such costs, fees and expenses in an amount not to exceed $7,500 on a quarterly basis for the first
+Added: three fiscal quarters of each year and $10,000 for the fiscal fourth quarter of each year.
+Added: The offering pursuant to the July 2023 Sales
+Added: Agreement will terminate upon the earlier of (i) the sale of all of the shares of common stock subject to the July 2023 Sales Agreement
+Added: and (ii) termination of the July 2023 Sales Agreement as permitted therein.
+Added: We may terminate the July 2023 Sales Agreement in our sole
+Added: discretion at any time by giving ten days’ prior notice to the Sales Agent.
+Added: The Sales Agent may terminate the July 2023 Sales Agreement
+Added: under the circumstances specified in the July 2023 Sales Agreement and in its sole discretion at any time by giving ten days’ prior
+Added: notice to us.
+Added: In addition, the July 2023 Sales Agreement may be terminated upon mutual agreement by us and the Sales Agent.
+Added: July 14, 2023 through February 5, 2024, the Company sold 328,136 common shares pursuant to the July 2023 ATM Facility for net proceeds
+Added: of $1,091,887, after offering expenses.
+Added: On February 5, 2024, the Company suspended, and is not offering any shares of its common stock
+Added: pursuant to, the prospectus supplement dated July 14, 2023, relating to the July 2023 Sales Agreement by and between the Company and
+Added: the Sales Agent.
+Added: The Company will not make any sales of common stock pursuant to the July 2023 Sales Agreement unless and until a new
+Added: prospectus supplement is filed with the SEC;
+Added: however, the Sales Agreement remains in full force and effect.
+Added: February 5, 2024, the Company entered into an Underwriting Agreement with Titan Partners Group LLC, a division of American Capital Partners,
+Added: LLC, relating to an underwritten offering of 5,535,055 shares of common stock of the Company.
+Added: The public offering price was $2.71 per
+Added: share of Common Stock and the Underwriter agreed to purchase the Common Stock pursuant to the Underwriting Agreement at a price of $2.5203
+Added: On February 8, 2024, the Company closed the offering and received net proceeds of $13,565,760, after deducting underwriting
+Added: discounts and commissions and estimated offering expenses.
+Added: Pursuant to the Agreement, the Company granted the Underwriter a 30-day over-allotment
+Added: option to purchase up to an additional 783,970 shares of Common Stock which was exercised in full on March 1, 2024 for net proceeds of
+Added: $1,954,594, after deducting underwriting discounts and offering expenses.
+Added: July 25, 2024, the Company was awarded an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to support
+Added: the clinical development of chimeric antigen receptor T-cell therapy NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.
+Added: The award is payable to the Company upon achievement of milestones that are primarily based on patient enrollment in the Company’s
+Added: clinical trials.
+Added: Additionally, if CIRM determines, in its sole discretion, that the Company has not complied with the terms and conditions
+Added: of the grant, CIRM may suspend or permanently cease disbursements.
+Added: Funds received under this grant may only be used for allowable project
+Added: costs specifically identified with the CIRM-funded project.
+Added: Such costs can include, but are not limited to, salary for personnel, itemized
+Added: supplies, consultants, and itemized clinical study costs.
+Added: Under the terms of the grant, both CIRM and the Company will co-fund the research
+Added: project and the amount of the Company’s co-funding requirement is predetermined as a part of the award.
+Added: The Company signed the
+Added: grant agreement in November 2024 and begin receiving funds from the grant in November of 2024.
+Added: As of March 11, 2025, the Company has
+Added: received $3.6 million in grant reimbursements under the grant agreement.
+Added: February 10, 2025, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to sterically-optimized CAR-T NXC-201 for
+Added: the treatment of relapsed/refractory AL amyloidosis.
+Added: As of June 2024 public information, FDA approved less than half of RMAT applications
+Added: submitted to the agency during the last eight years.
+Added: FDA RMAT designation requires that a drug is an advanced regenerative medicine,
+Added: targets a serious condition, with the potential to treat, modify, reverse, or cure, and preliminary clinical evidence has indicated that
+Added: the drug has the potential to address these unmet medical needs.
of Operations
2 unchanged sentences
and administrative expenses were $11,381,978 for the year ended December 31, 2024 compared to $7,406,082 for the year ended December
−Removed: expenses incurred in both periods were related to salaries, patent maintenance costs and general accounting and other general consulting
−Removed: expenses, which were higher for the year ended December 31, 2023 due to increased professional fees of $516,271, increased investor relations
−Removed: services of $1,041,458, of which $622,423 was non-cash from shares issued for services, increased compensation of $203,274, and increased
−Removed: stock-based compensation of $1,419,217 from additional equity awards issued to the officers, directors and consultants.
+Added: expenses incurred in both periods were related to salaries, patent maintenance costs and general accounting and other general
+Added: consulting expenses, which were higher for the year ended December 31, 2024, due to increased investor relations and professional
+Added: services of $1,839,151 due to service scope expansion and price increases, increased compensation of $1,011,389 due to the hiring of
+Added: additional employees, increased stock-based compensation of $449,913 from additional equity awards issued, and increased other general expenses of $675,443.
and Development Expenses
and development expenses were $11,292,702 for the year ended December 31, 2024, compared to $8,735,031 for the year ended December 31,
−Removed: increased research and development expenses relate to our ongoing Phase 1b/2a clinical trial, including, but not limited to, contract
−Removed: research organization (“CRO”) and related costs for maintaining and treating patients in the clinical trial.
−Removed: to increase spending on research and development in 2023 as a result of our increased fundings from the various equity offerings.
−Removed: income was $572,006 for the year ended December 31, 2023 compared to $0 interest income for the year ended December 31, 2022.
−Removed: income in the current period was related to interest earned on investments in a money market fund.
+Added: increased research and development expenses were related to our ongoing Phase 1b/2a clinical trial and our CAR-T clinical trial, including,
+Added: but not limited to, CRO and related costs for maintaining and treating patients in the clinical trial, as well as site onboarding costs
+Added: and license fees.
+Added: We were able to increase spending on research and development in 2024 as a result of funding from an underwritten public
+Added: offering of 5,535,055 shares of our common stock at the public offering price of $2.71 per share, for net proceeds of $13,565,760, after
+Added: underwriter discounts and offering expenses.
+Added: Additionally, the Company received $1,925,000 in CIRM grant reimbursement which is recorded
+Added: as an offset to research and development expenses.
+Added: income was $1,017,354 for the year ended December 31, 2024, compared to $572,006 of interest income for the year ended December 31, 2023.
+Added: Interest income in the current year was related to interest received on investments in a money market fund and increased from the prior
+Added: year as a result of the Company maintaining higher balances in money market funds during the current year.
for Income Taxes
1 unchanged sentence
taxes relating to our Australian subsidiary.
−Removed: Liquidity and Capital Resources
−Removed: Sources of Liquidity
−Removed: We do not have any approved products for commercial sale and have never generated revenue from product sales and
−Removed: have incurred significant net losses since our inception and expect to continue to incur net operating losses for the foreseeable future.
−Removed: We do not expect to receive any revenue from any product candidates that we develop unless and until we obtain regulatory approval and
−Removed: commercialize our product candidates or enter into collaborative arrangements with third parties.
−Removed: We currently have no credit facility
−Removed: or committed sources of capital.
−Removed: Material Cash Requirements
−Removed: Our primary use of cash and cash equivalents is to fund operating expenses, which consist of clinical research and
−Removed: development expenses, manufacturing expenses, legal and compliance expenses, compensation and related expenses, and general overhead costs.
−Removed: Cash and cash equivalents used to fund operating expenses is impacted by the timing of when we pay or prepay these expenses.
−Removed: our expenses to increase in connection with our ongoing activities, particularly as we expand our clinical programs, continue the research
−Removed: and development of, and seek marketing approval for our product candidates.
−Removed: In addition, if we obtain marketing approval for any of our
−Removed: product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution.
−Removed: of December 31, 2023, we had total assets of approximately $19.9 million and working capital of approximately $16.1 million.
−Removed: of December 31, 2023, our liquidity included approximately $17.5 million of cash and cash equivalents.
−Removed: In February and March 2024,
−Removed: we conducted an underwritten public offering of 6,319,025 shares of our common stock, inclusive of the underwriter’s exercise
−Removed: in full of its over allotment option, at $2.71 per share, for the net proceeds of approximately $15.5 million, after underwriting
+Added: and Capital Resources
+Added: do not have any approved products for commercial sale and have never generated revenue from product sales and have incurred significant
+Added: net losses since our inception and expect to continue to incur net operating losses for the foreseeable future.
+Added: We do not expect to receive
+Added: any revenue from any product candidates that we develop unless and until we obtain regulatory approval and commercialize our product
+Added: candidates or enter into collaborative arrangements with third parties.
+Added: We currently have no credit facility or committed sources of
+Added: February and March 2024, we conducted an underwritten public offering of 6,319,025 shares of our common stock, inclusive of the underwriter’s
+Added: exercise in full of its over allotment option, at $2.71 per share, for the net proceeds of approximately $15.5 million, after underwriting
discounts and offering expenses.
−Removed: We believe that our cash and cash equivalents on hand as of the date of this report will be
−Removed: sufficient to fund our planned operations over the 12-month period following the date of this report;
−Removed: however, there can be no
−Removed: assurance we will not need additional capital sooner.
−Removed: In addition, we believe that we will need additional capital to continue our
−Removed: planned operations beyond the 12-month period following the date of this report.
−Removed: We intend to seek additional funds through various
−Removed: financing sources, including the sale of our equity and debt securities, licensing fees for our product candidates and technology
−Removed: and joint ventures with industry partners.
+Added: July 25, 2024, the Company was awarded an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to support
+Added: the clinical development of chimeric antigen receptor T-cell therapy NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.
+Added: The award is payable to the Company upon achievement of milestones that are primarily based on patient enrollment in the Company’s
+Added: clinical trials.
+Added: Additionally, if CIRM determines, in its sole discretion, that the Company has not complied with the terms and conditions
+Added: of the grant, CIRM may suspend or permanently cease disbursements.
+Added: Funds received under this grant may only be used for allowable project
+Added: costs specifically identified with the CIRM-funded project.
+Added: Such costs can include, but are not limited to, salary for personnel, itemized
+Added: supplies, consultants, and itemized clinical study costs.
+Added: Under the terms of the grant, both CIRM and the Company will co-fund the research
+Added: project and the amount of the Company’s co-funding requirement is predetermined as a part of the award.
+Added: The Company signed the
+Added: grant agreement in November 2024 and begin receiving funds from the grant in November of 2024.
+Added: As of March 11, 2025, the Company has
+Added: received $3.6 million in grant reimbursements under the grant agreement.
+Added: Cash Requirements
+Added: primary use of cash and cash equivalents is to fund operating expenses, which consist of clinical research and development expenses,
+Added: manufacturing expenses, legal and compliance expenses, compensation and related expenses, and general overhead costs.
+Added: Cash and cash equivalents
+Added: used to fund operating expenses are impacted by the timing of when we pay or prepay these expenses.
+Added: We expect our expenses to increase
+Added: in connection with our ongoing activities, particularly as we expand our clinical programs, continue the research and development of,
+Added: and seek marketing approval for our product candidates.
+Added: In addition, if we obtain marketing approval for any of our product candidates,
+Added: we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution.
+Added: of December 31, 2024, we had total assets of approximately $22.9 million and working capital of approximately $11.5 million.
+Added: As of December
+Added: 31, 2024, our liquidity included approximately $17.7 million of cash and cash equivalents.
+Added: We believe that our cash and cash equivalents
+Added: on hand as of the date of this report coupled with expected disbursements under the CIRM grant, will be sufficient to fund our planned
+Added: operations over the 12-month period following the date of this report;
+Added: however, there can be no assurance we will not need additional
+Added: capital sooner.
+Added: In addition, we believe that we will need additional capital to continue our planned operations beyond the 12-month period
+Added: following the date of this report.
+Added: We intend to seek additional funds through various financing sources, including the sale of our equity
+Added: and debt securities, government or other third-party funding, commercialization, marketing and distribution arrangements, other collaborations,
+Added: strategic alliances and licensing arrangements.
In addition, we will consider alternatives to our current business plan that may enable
2 unchanged sentences
no guarantees that such funds will be available on commercially reasonable terms, if at all.
−Removed: If such financing is not available on
−Removed: satisfactory terms, we may be unable to further pursue our business plan and we may be unable to continue operations.
+Added: If such financing is not available on satisfactory
+Added: terms, we may be unable to further pursue our business plan and we may be unable to continue operations.
the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be
10 unchanged sentences
necessary equity financing to continue operations and the attainment of profitable operations.
−Removed: In January 2024,
−Removed: the Company entered into a long-term operating lease agreement for biopharmaceutical manufacturing space in California
+Added: January 2024, the Company entered into a long-term operating lease agreement for biopharmaceutical manufacturing space in California
under a non-cancelable operating lease that expires in December 2033.
−Removed: Under the terms of the lease we expect to make total lease
−Removed: payments of $1.6 million through December 2033.
−Removed: We enter into contracts in the normal course of business with third-party contract organizations
−Removed: for preclinical and clinical studies, manufacture and supply of our preclinical and clinical materials and providing other services and
−Removed: products for operating purposes.
−Removed: Contracts for preclinical and clinical studies and other services generally provide for termination following
−Removed: a certain period after notice, and therefore we believe that our non-cancelable obligations under these agreements are not material.
−Removed: do not have any long-term manufacturing and supply agreements with our third-party contract manufacturers but enter into specific contracts
−Removed: on an as needed basis for individual batch production runs.
+Added: Under the terms of the lease we expect to make total lease payments
+Added: of $1.6 million through December 2033.
+Added: enter into contracts in the normal course of business with third-party contract organizations for preclinical and clinical studies, manufacture
+Added: and supply of our preclinical and clinical materials and providing other services and products for operating purposes.
+Added: Contracts for
+Added: preclinical and clinical studies and other services generally provide for termination following a certain period after notice, and therefore
+Added: we believe that our non-cancelable obligations under these agreements are not material.
+Added: We do not have any long-term manufacturing and
+Added: supply agreements with our third-party contract manufacturers, but we enter into specific contracts on an as needed basis for individual
+Added: batch production runs.
used in operating activities
cash used in operating activities was $14,595,102 for the year ended December 31, 2024 and $11,371,438 for the year ended December 31,
−Removed: Net cash used for the year ended December 31, 2023 was primarily related to our net loss of $15,595,522 offset by non-cash items of stock-based compensation expense of $2,565,708
+Added: Net cash used in operating activities for the year ended December 31, 2024 was primarily related to our net loss of $21,698,363,
+Added: offset by non-cash items of stock-based compensation expense of $3,020,573, depreciation expense of $32,941 and right of use asset amortization
+Added: Operating activities also included an increase in accounts payable and accrued expenses of $4,401,623 and an increase in
+Added: the tax receivable of $971,527, partially offset by a decrease in prepaid expenses of $554,771.
+Added: Net cash used for the year ended December
+Added: 31, 2023 was primarily related to our net loss of $15,595,522 offset by non-cash items of stock-based compensation expense of $2,565,708
and depreciation expense of $5,468.
−Removed: Operating activities also included an increase in accounts payable of $2,434,467, an increase in the
−Removed: tax receivable of $893,401, and a decrease in prepaid expenses of $111,842.
−Removed: Net cash used for the year ended December 31, 2022, was primarily
−Removed: related to our net loss of $8,229,713 offset by non-cash items of stock-based compensation expense of $624,069 and depreciation expense
−Removed: Operating activities also included an increase in accounts payable of $1,131,736 and an increase in the tax receivable of $236,384,
−Removed: offset by an increase in prepaid expenses of $691,047 and decrease in accrued interest of $9,099.
+Added: Operating activities also included an increase in accounts payable and accrued expenses of $2,434,467,
+Added: an increase in the tax receivable of $893,401, and a decrease in prepaid expenses of $111,842.
used in investing activities
−Removed: cash used in investing activities was $52,089 for the year ended December 31, 2023 and $0 for the year ended December 31, 2022.
−Removed: equipment during the year ended December 31, 2023.
+Added: cash used in investing activities was $1,177,680 for the year ended December 31, 2024, consisting solely of purchase of property and
+Added: operating equipment, compared to $52,089 for the year ended December 31, 2023.
provided by financing activities
cash provided by financing activities was $15,948,567 for the year ended December 31, 2024 and $15,463,512 for the year ended December
−Removed: Net cash provided by financing activities in 2023 was primarily related to $9,934,153 in net proceeds from the issuance of
−Removed: shares of our common stock and warrants in our August 2023 private placement and $5,438,970 in net proceeds from the sale of shares of
−Removed: our common stock pursuant to our ATM facilities.
−Removed: Accounting Policies
+Added: Net cash provided by financing activities in 2024 was related to proceeds of $15,946,078 from the sale of common shares through
+Added: a public offering.
+Added: Net cash provided by financing activities in 2023 was primarily related to $9,934,153 in net proceeds from the issuance
+Added: of shares of our common stock and warrants in our August 2023 private placement and $5,438,970 in net proceeds from the sale of shares
+Added: of our common stock pursuant to our ATM facilities.
+Added: Accounting Policies and Estimates
management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial
16 unchanged sentences
estimates used in the preparation of our consolidated financial statements.
−Removed: Compensation - We measure all stock-based awards granted based on their estimated fair value on the date of the grant and recognize
−Removed: the corresponding compensation expense for those awarded to employees and directors over the requisite service period, which is generally
−Removed: the vesting period of the respective award, and for those awarded to nonemployees over the period during which services are rendered
−Removed: by nonemployees until completed.
−Removed: We have typically issued stock options with service-based vesting conditions and we record the expense
−Removed: for these awards using the straight-line method.
+Added: measure all stock-based awards granted based on their estimated fair value on the date of the grant and recognize the corresponding compensation
+Added: expense for those awarded to employees and directors over the requisite service period, which is generally the vesting period of the
+Added: respective award, and for those awarded to nonemployees over the period during which services are rendered by nonemployees until completed.
+Added: We have typically issued stock options with service-based vesting conditions and we record the expense for these awards using the straight-line
estimate the fair value of each stock option grant using the Black-Scholes option-pricing model, which uses as inputs the fair value
11 unchanged sentences
and milestone costs related to in-licensed products and technology.
−Removed: Costs incurred in obtaining technology licenses are charged to research
−Removed: and development expense if the technology licensed has not reached commercial feasibility and has no alternative future use.
−Removed: Such licenses
−Removed: purchased by us require substantial completion of research and development, regulatory and marketing approval efforts in order to reach
+Added: These costs are offset by any reimbursements under grant arrangements.
+Added: Costs incurred in obtaining technology licenses are charged to research and development expense if the technology licensed has not reached
commercial feasibility and has no alternative future use.
+Added: Such licenses purchased by us require substantial completion of research and
+Added: development, regulatory and marketing approval efforts in order to reach commercial feasibility and have no alternative future use.
trial costs are a component of research and development expenses.
14 unchanged sentences
accounting pronouncements applicable to our consolidated financial statements.
−Removed: April 5, 2012, the JOBS Act was enacted.
−Removed: Section 107 of the JOBS Act provides that an “emerging growth company” can take
−Removed: advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting
−Removed: In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those
−Removed: standards would otherwise apply to private companies.
+Added: April 5, 2012, the Jumpstart Our Business Startups Act (the “JOBS Act”) was enacted.
+Added: Section 107 of the JOBS Act provides
+Added: that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of
+Added: the Securities Act for complying with new or revised accounting standards.
+Added: In other words, an “emerging growth company” can
+Added: delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.
have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act for complying
9 unchanged sentences
(ii) the last day of our fiscal year following the fifth anniversary of
−Removed: the date of the completion of our initial public offering;
−Removed: (iii) the date on which we have issued more than $1 billion in nonconvertible
−Removed: debt during the previous three years;
−Removed: or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the
+Added: the date of the completion of our initial public offering (i.e., December 31, 2026);
+Added: (iii) the date on which we have issued more than
+Added: $1 billion in nonconvertible debt during the previous three years;
+Added: or (iv) the date on which we are deemed to be a large accelerated
+Added: filer under the rules of the SEC.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
3 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.