What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-03-11 compared with 2025-03-03 · 73 added, 125 removed, 144 unchanged (58% of the section changed)

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Certain amounts and percentages herein may not sum or recalculate due to rounding.

The following discussion and analysis does not address certain items regarding the year ended December 31, 2022.

Discussion and analysis of 2022 and year-to-year comparisons between 2023 and 2022 that are not included in this Report can be found in Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations of our 202 3 Annual Report on Form 10-K filed with the U.S.

Securities and Exchange Commission (“SEC" on February 27, 2024).

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject.

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These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.

We are a late-stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis and related diseases.

Our initial focus is on treating fibrosis by inhibiting integrin-mediated activation of TGF-β.

We have applied our deep understanding of fibrosis biology, along with our medicinal chemistry and translational medicine expertise to develop a set of proprietary tools designed to discover and de-risk product candidates quickly and efficiently.

Our wholly owned lead product candidate, bexotegrast, is an oral, small molecule, dual selective inhibitor of αvβ6 and αvβ1 integrins that we are developing for the treatment of idiopathic pulmonary fibrosis, or IPF.

We have recently discontinued BEACON-IPF trial, a global Phase 2b trial in patients with idiopathic pulmonary fibrosis (IPF).

While an imbalance in unadjudicated IPF-related adverse events between the treatment and placebo groups led to the discontinuation of the trial, early evidence of efficacy on the forced vital capacity (FVC) endpoint was also observed.

The Company plans to analyze the complete data from the BEACON-IPF trial and evaluate next steps for bexotegrast’s development.

In January 2023, we received United States Food and Drug Administration, or FDA, clearance of an investigational new drug application, or IND, for PLN-101095, a small molecule, dual selective inhibitor of integrins αvβ8 and αvβ1 for the treatment of solid tumors that are resistant to immune checkpoint inhibitors.

We are currently dosing the fourth of five dose cohorts in a Phase 1 open-label dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors.

Preliminary data from cohorts one through three is expected in the first quarter of 2025.

Our Phase 1-ready program PLN-101325, is in development for treatment of muscular dystrophies, including Duchenne muscular dystrophy.

PLN-101325 is a monoclonal antibody designed to act as an allosteric agonist of integrin α7β1.

PLN-101325 has received a clinical trial approval (CTA) in Australia.

We have also developed PLN-1474, an oral, small molecule selective inhibitor of αvß1 for the treatment of liver fibrosis associated with nonalcoholic steatohepatitis, or MASH.

Global rights to PLN-1474, licensed to Novartis in 2019, were returned to Pliant in 2023 upon termination of our collaboration and license agreement.

Recent Events

Bexotegrast Highlights

• BEACON-IPF discontinued following recommendation from expanded data safety monitoring board (DSMB).

Following a prespecified data review and recommendation by the trial’s independent DSMB, as well as a secondary review and recommendation by an outside expert panel, Pliant has discontinued the BEACON-IPF Phase 2b trial.While an imbalance in unadjudicated IPF-related adverse events between the treatment and placebo groups led to the discontinuation of the trial, early evidence of efficacy on the forced vital capacity (FVC) endpoint was also observed.

The Company plans to analyze the complete data from the BEACON-IPF trial and evaluate next steps for bexotegrast’s development.

BEACON-IPF is a 52-week, multinational, randomized, dose-ranging, double-blind, placebo-controlled trial evaluating bexotegrast at once-daily doses of 160 mg or 320 mg in patients with idiopathic pulmonary fibrosis (IPF).

We are a clinical-stage biopharmaceutical company focused on discovering and developing integrin-based therapeutics.

Our lead program is focused on the development of treatments for solid tumors by inhibiting integrin-mediated activation of transforming growth factor-β (TGF-β).

We have applied our deep understanding of integrin biology, along with our medicinal chemistry and translational medicine expertise to develop a proprietary drug discovery platform that we believe has broad applicability across multiple areas of disease.

Our wholly owned lead product candidate, PLN-101095, is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins in development for the treatment of solid tumors.

In 2025, we announced positive data from a Phase 1 open-label dose-escalation trial of PLN-101095 as monotherapy and in combination with the immunotherapy pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors.

We also continue to explore the full potential of our drug discovery platform consisting of a proprietary library of over 15,000 integrin binding molecules, focusing on integrin-based target-mediated drug delivery.

Fourth Quarter and Recent Developments

Oncology Program

• Phase 1 trial of PLN-101095 in solid tumors continues to enroll, with interim data expected in the first quarter 2025.

This is a Phase 1 open label trial of PLN-101095, an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to block TGF-β activation in the tumor microenvironment.

The trial is currently dosing the fourth of five planned dose cohorts in a Phase 1 open label dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors.

Interim data from the first three cohorts is expected in the first quarter of 2025.

Neuromuscular Program

• PLN-101325 for treatment of muscular dystrophies.

PLN-101325 is a monoclonal antibody that acts as an allosteric agonist of integrin α7β1, currently in development for treatment of muscular dystrophies.

PLN-101325 is Phase 1 ready with clinical trial approval (CTA) open in Australia.

• Data from the Phase 1 trial of PLN-101095 showed deep and durable ongoing responses.

In December, the Company announced positive data showing that, in a heavily pretreated patient population, PLN-101095 demonstrated anti-tumor activity in combination with pembrolizumab , an FDA-approved ICI.

Four responders were observed consisting of one confirmed complete response and three partial responses (two confirmed, one unconfirmed) out of the 10 secondary ICI refractory patients.

These clinical responses were observed in patients with cholangiocarcinoma, melanoma, head and neck squamous cell carcinoma and non-small cell lung cancer (NSCLC).

Notably, all responding patients showed large increases in plasma interferon gamma (IFN-γ) after 14 days of monotherapy with PLN-101095 prior to the addition of pembrolizumab .

No non-responders showed meaningful increases in plasma IFN- γ.

PLN-101095 was generally well tolerated across all doses tested.

IFN-γ is known to play a multifaceted role in modulating anti-tumor immunity, with increased tumor expression levels having previously been linked with better outcomes from immune checkpoint blockade.

• Accelerated development plan of PLN-101095 underway with initiation of Phase 1b indication expansion trial.

Based on the encouraging response data and supportive IFN- γ biomarker data from the Phase 1 trial, the Company is advancing an accelerated clinical development plan of PLN-101095 and has initiated a Phase 1b indication expansion trial.

The Phase 1b open-label, single dose trial will enroll three cohorts of patients including NSCLC, clear cell renal cell carcinoma and tumors with high tumor mutational burden.

Tumor selection was based on data from the Phase 1 trial, as well as strong mechanistic rationale for integrin inhibition.

Patients will be treated for 14 days with PLN-101095 dosed at 1,000 mg twice daily as monotherapy, after which pembrolizumab will be added as combination therapy.

Study start activities for this trial are underway with first patient enrollment anticipated in second quarter.

Interim data is expected in 2027.

• PLN-101095 Phase 1 data accepted for presentation at AACR Annual Meeting 2026.

Data from the Phase 1 trial of PLN-101095 will be the subject of a poster presentation and an oral presentation as part of the Clinical Trials Minisymposium at the upcoming American Association of Cancer Research (AACR) conference to be held April 17-22, 2026, in San Diego, California.

Integrin-Targeted Delivery Platform

• Utilizing cell-specific integrin receptors, Pliant has developed a platform to deliver drug payloads, including siRNAs, to selective tissue types.

Current programs are focused on delivering siRNAs to skeletal muscle cells and other tissues.

The Company believes this integrin-targeting delivery platform has the potential for broad applicability across multiple disease areas utilizing a variety of drug payloads.

Corporate Highlights

• Appointment of Delphine Imbert, Ph.D.

as Chief Technical Officer.

Imbert brings 25 years of product development, process optimization and manufacturing experience across multiple drug modalities.

Most recently, Dr.

Imbert served as Senior Vice President of CMC and Technical Operations at Chinook Therapeutics.

• Appointment of Minnie Kuo as Chief Operating Officer.

Kuo joined Pliant in September 2023 as Chief Development Officer, bringing more than 20 years of multinational clinical development experience across various therapeutic areas.

In this expanded role, Ms.

Kuo bridges Pliant’s science and operations with oversight of clinical operations, early development, program management, regulatory affairs and compliance.

• INTEGRIS-PSC results published in the Journal of Hepatology .

The manuscript, “Phase II INTEGRIS-PSC trial of bexotegrast, an αvβ6 and αvβ1 integrin inhibitor, in primary sclerosing cholangitis”, appears in the January 2026 issue of the Journal of Hepatology .

Since inception, we have had significant operating losses.

Our net loss was $210.3 million, $161.3 million and $123.3 million for the years ended December 31, 2024, 2023 and 2022, respectively.

As of December 31, 2024, we had an

accumulated deficit of $710.1 million and cash, cash equivalents, restricted cash and short-term investments of $357.2 million.

We expect to continue to incur net losses for the foreseeable future, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will increase in connection with our ongoing activities, as we:

Our net loss was $149.3 million, and $210.3 million for the years ended December 31, 2025, and 2024, respectively.

As of December 31, 2025, we had an accumulated deficit of $859.4 million and cash, cash equivalents, restricted cash and short-term investments of $192.4 million.

We expect to continue to incur net losses for the foreseeable future as we:

• perform research and development activities to identify and develop product candidates;

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• seek regulatory approvals for any product candidates that successfully complete clinical trials;

• expand our operational, financial and management systems and increase personnel to support our clinical development, manufacturing and commercialization efforts and our operations as a public company;

• maintain, expand and protect our intellectual property portfolio;

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Financial Operations Overview

We have not generated any revenue from product sales and do not expect to do so in the near future.

Our revenue to date is derived from a Collaboration and License Agreement with Novartis, or the "Novartis Agreement," that was executed in 2019.

The Novartis Agreement was for the development and commercialization of PLN-1474 and up to three additional integrin research targets.

Under the terms of the Novartis Agreement, we received an upfront license fee payment of $50.0 million for the worldwide, exclusive license to PLN-1474 and an additional $29.0 million upon the achievement of specified research and development milestones.

Novartis discontinued clinical development in MASH and, as a result, discontinued development of PLN-1474.

In February 2023, Novartis issued a termination notice for the collaboration and license agreement, and returned global rights to Pliant for PLN-1474.

Following termination of the Novartis Agreement, we were no longer eligible to receive additional milestone or royalty payments under the arrangement, however, we continued to earn research and development services revenues through the effective termination date of April 18, 2023.

Revenues for the years ended December 31, 2024, 2023 and 2022 were nil, $1.6 million and $9.7 million respectively.

Operating Expenses

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Year Ended December 31,

2024 2023 2022

Employee-related expenses $ 41,534 $ 49,597

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Where appropriate, we allocate our third-party research and development expense by product candidate or preclinical program.

These expenses primarily relate to outside consultants, clinical research organizations, contract manufacturing organization.

These expenses primarily relate to outside consultants, clinical research organizations, and contract manufacturing organizations.

When we refer to the research and development expenses associated with a specific product candidate or preclinical program, these refer exclusively to the allocated third-party expenses associated with that product candidate.

Due to the discontinuation of the BEACON-IPF Phase 2b/3 trial in IPF, we expect research and development expenses to decrease in the near term as we curtail spending on the BEACON-IPF trial.

While we plan to analyze data from the BEACON-IPF trial and evaluate next steps for bexotegrast's development, in the near term we will re-prioritize our development of product candidates that are in earlier, less capital intensive stages of development.

Due to the discontinuation of development of bexotegrast in IPF, we expect research and development expenses to decrease on an annual basis in 2026 as we have re-prioritized our development of product candidates that are in earlier, less capital-intensive stages of development, and to grow thereafter commensurate with the stage and status of PLN-101095 and other development efforts.

The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain.

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Our general and administrative expenses consist primarily of salaries, benefits and stock-based compensation for our general and administrative personnel, allocated facilities costs, insurance and other expenses for outside professional services, including legal, marketing, investor relations, human resource and accounting services.

We expect general and administrative expenses to remain relatively consistent for the foreseeable future.

Due to the restructuring activities of 2025, we expect general and administrative expenses to decrease on an annual basis in 2026 and to remain relatively consistent thereafter.

In addition, if we obtain regulatory approval for any of our product candidates and do not enter into a third-party commercialization collaboration, we expect to incur significant expenses related to building a sales and marketing team to support product sales, marketing and distribution activities.

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Interest Expense

Our interest expense is derived from a term loan executed under the Oxford Loan Agreement that we entered into in May 2022 and amended in March 2024 (the "Amended Loan Agreement").

Borrowings under the Amended Loan Agreement bear interest at a rate per annum equal to 1-month term Secured Overnight Financing Rate (SOFR) plus 5.25%, subject to an agreed upon floor of 8.75%.

Interest expense was derived from term loans executed under the Oxford Loan Agreement that we entered into in May 2022 and amended in March 2024 (the "Amended Loan Agreement").

Outstanding term loans pursuant to the Amended Loan Agreement were extinguished in October 2025 and through the date of extinguishment, borrowings incurred an interest rate per annum equal to 1-month term Secured Overnight Financing Rate (SOFR) plus 5.25%.

Loss on Extinguishment of Debt

In October 2025, we completed a voluntary prepayment of the Amended Loan Agreement for $32.4 million, representing all outstanding principal, accrued and unpaid interest, fees, costs and expenses.

The amount by which the pre-payment required to extinguish our obligation exceeded the values recorded to the balance sheet on the extinguishment date is recognized as a loss in the statement of operations.

Results of Operations

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2025 2024 $ Change % Change

Revenue $ — $ 1,580 $ (1,580) (100.0 %)

Operating expenses:

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Interest expense (2,559) (3,024) 465 (15.4 %)

Loss on extinguishment of debt (Note 7) (1,828) — (1,828) 100.0 %

Net loss $ (149,344) $ (210,304) $ 60,960 (29.0) %

Revenue decreased by $1.6 million due to decreased research and development services resulting from the termination of the Novartis Agreement.

Research and Development Expenses

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Facilities expenses 6,409 7,776

Other expenses and other allocations 8,095 6,063

Other expenses and allocations 5,601 8,095

Total unallocated internal expenses 57,817 72,185

Total research and development expenses $ 109,157 $ 169,310

The increase in research and development expenses of $41.5 million was primarily due to:

• $34.9 million increase related to bexotegrast development primarily driven by BEACON-IPF, a Phase 2b/3 study of bexotegrast in patients with IPF, and related manufacturing activities;

• $3.0 million decrease in others pipeline programs as we prioritized BEACON-IPF;

• $2.9 million increase in employee-related costs, including stock-based compensation, driven by an increase in our research and development workforce;

• $5.5 million increase in facilities and other allocated expenses, resulting from the move to our new office and laboratory space.

The decrease in research and development expenses of $60.2 million was primarily due to:

• $44.0 million decrease driven by our decision to discontinue development of bexotegrast in IPF and the related termination of BEACON-IPF, a Phase 2b/3 trial in IPF.

• $1.8 million decrease from other pipeline programs;

• $8.1 million decrease in employee-related costs, including stock-based compensation, due to decreased headcount following our 2025 restructuring plans;

• $3.9 million decrease in facilities and other allocated expenses, driven by our restructuring plans and general cost containment efforts following our strategic realignment of operations initiated in May 2025.

General and Administrative Expenses

General and administrative expenses increased by $1.1 million primarily due to an increase in employee-related costs driven by increased headcount.

General and administrative expenses decreased by $11.8 million primarily due to personnel related expenses, including stock-based compensation, driven by our 2025 restructuring plans implemented during the year.

Interest and Other Income (Expense), Net

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Interest Expense

Interest expense increased $1.8 million due to additional borrowings under the Amended Loan Agreement executed March 11, 2024.

Interest expense decreased $0.5 million due to the extinguishment of term loans in October 2025.

Loss on Extinguishment of Debt

Loss on extinguishment of debt increased $1.8 million resulting from our decision to extinguish all term loans outstanding pursuant to the Amended Loan Agreement executed March 11, 2024.

Liquidity and Capital Resources

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In March 2024, we entered into an Amended Loan Agreement with Oxford Finance LLC (or the “Lender” or “Oxford”) which upsized our existing Term Loan facility to a total size of $150.0 million of non-dilutive capital.

Pursuant to the Amended Loan Agreement, we drew an additional Term Loan of $20.0 million.

The agreement allowed for borrowing up to $70.0 million at our option, $35.0 million being available commencing October 1, 2025 contingent upon the continued operation of the BEACON-IPF study and a further $35.0 million being available upon demonstrating that BEACON-IPF had achieved positive Phase 2b data sufficient to support continued development, in the sole discretion of Oxford.

An additional $50.0 million could be made available to us at the sole discretion of Lender.

Given the discontinuation of the BEACON-IPF trial, we do not expect to have access to additional borrowing under the Oxford Agreement.

Pursuant to the Amended Loan Agreement, we drew term loans of $30.0 million, inclusive of $10.0 million in principal amount previously outstanding under the Oxford Loan Agreement.

The agreement allowed for additional borrowing contingent upon the continued development of bexotegrast in IPF and/or at the sole discretion of Oxford.

Following our decision to discontinue development of bexotegrast in IPF, we decided to complete a voluntary prepayment of our Amended Loan Agreement with Oxford in October, 2025, for $32.4 million, representing all outstanding principal, accrued and unpaid interest, fees, costs and expenses.

Upon prepayment, all obligations, covenants, debts and liabilities under the Amended Loan Agreement were satisfied and discharged in full.

See Note 7 to the Notes to our financial statements of this Report for more information.

In July 2022, we completed an underwritten public offering of 12,432,432 shares of common stock, including the exercise in full of the underwriters' option to purchase 1,621,621 additional shares of common stock.

The shares were offered at a price to the public of $18.50 per share, resulting in aggregate proceeds of approximately $215.4 million, net of underwriting discounts, commissions and offering expenses.

In January 2023, we completed an underwritten public offering of 9,583,334 shares of common stock, including the exercise in full of the underwriters' option to purchase 1,250,000 additional shares of common stock.

The shares were offered at a price to the public of $30.00 per share, resulting in aggregate proceeds of approximately $269.8 million, net of underwriting discounts, commissions and offering expenses.

During the third quarter of 2021, we entered into a Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co., as sales agent, pursuant to which we may issue and sell shares of common stock in an "at-the-market" offering.

In March 2023, we filed a prospectus registering the offer and sale of up to $150.0 million of shares of common stock from time to time pursuant to the Sales Agreement.

We have not issued any shares pursuant to any at-the-market offerings, including pursuant to the Sales Agreement, but may do so at a future date.

We have not issued any shares pursuant to any at-the-market offerings, including pursuant to the Sales Agreement, but may do so at a future date after filing a new prospectus for the Sales Agreement.

We believe that our existing capital resources will be sufficient to fund our anticipated operating expenses and capital expenditure requirements for the next 12 months and beyond.

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If we need to raise additional capital to fund our operations, funding may not be available to us on acceptable terms, or at all.

In addition, the discontinuation of our development of bexotegrast in IPF may intensify the risk that we will be unable to access capital on favorable terms, or at all, as and when needed.

If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or suspend one or more of our preclinical studies, clinical trials, research and development programs or commercialization efforts.

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Year Ended December 31,

2024 2023 2022

Net cash used in operating activities $ (128,336) $ (155,503)

Net cash provided by (used in) investing activities 140,340 (127,012) (150,204)

Net cash provided by financing activities 23,117 274,405 226,854

Net increase (decrease) in cash, cash equivalents and restricted cash

$ 7,954 $ 31,032 $ (17,981)

Net cash provided by investing activities 134,290 140,340

Net cash (used in) provided by financing activities (31,697) 23,117

Net (decrease) increase in cash, cash equivalents and restricted cash $ (25,743) $ 7,954

Cash Used in Operating Activities

Net cash used in operating activities increased due to higher spending related to third-party vendors to support research and development and general and administrative operations:

approximately $27.0 million paid to outside service vendors in support of BEACON-IPF and an increase of $9.5 million in payroll and related employee costs.

Cash Provided (Used in) Investing Activities

Net cash provided by investing activities increased over the same period of prior year as maturities of marketable securities exceeded related purchases during the twelve months ended December 31, 2024, while purchases exceeded maturities during the twelve months ended December 31, 2023 as a result of the public offering of common stock in January 2023.

Cash Provided by Financing Activities

Net cash provided by financing activities decreased by $251.3 million primarily due to net proceeds of $270.3 million from the Company's January 2023 underwritten public offering, which was partially offset by additional Term Loans entered into during the twelve months ended December 31, 2024 associated with the Amended Loan Agreement.

Net cash used in operating activities decreased due to an overall decrease in the volume of operations following our decision to discontinue development of bexotegrast in IPF and the related termination of our phase 2b/3 trial, BEACON-IPF.

Cash Provided by (Used in) Investing Activities

Net cash provided by investing activities decreased over the same period of prior year as maturities of marketable securities exceeded related purchases during the twelve months ended December 31, 2025 to a greater extent than exhibited in the twelve months ended December 31, 2024.

Cash (Used in) Provided by Financing Activities

Net cash used in financing activities increased by $54.8 million primarily due to our voluntary prepayment of the Amended Loan Agreement coupled with the lack of financing inflows from term loans compared to the twelve months ended December 31, 2024 associated with the Amended Loan Agreement.

Off-Balance Sheet Arrangements

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Material Cash Requirements

At December 31, 2024, we have a non-cancelable operating lease for office and laboratory space for a period of seven years through March 31, 2031.

At December 31, 2025, we have a non-cancelable operating lease for office and laboratory space, which expires March 31, 2031.

Refer to Note 14 and Note 15 to our financial statements appearing elsewhere in this Annual Report for a discussion of material obligations and commitments.

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While our significant accounting policies are described in more detail in Note 2 to our financial statements appearing elsewhere in this Annual Report, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.

Revenue Recognition

As of December 31, 2024, all of our revenue to date has been generated from the Novartis Agreement.

We recognize revenue when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services.

To determine the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of Accounting Standards Codification Topic 606, Revenue from Contracts with Customers, ("Topic 606") we perform the following five steps:

(i) identification of the contract(s) with the customer, (ii) identification of the promised goods or services in the contract and determination of whether the promised goods or services are performance obligations, (iii) measurement of the transaction price, (iv) allocation of the transaction price to the performance obligations, and (v) recognition of revenue when (or as) we satisfy each performance obligation.

We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to our customer.

Identification of the Contracts with the Customers

We evaluate every contract to determine whether it in its entirety or in part represent a contract with a customer, or a collaboration agreement and, based on this determination, apply appropriate accounting guidance.

We account for a contract with a customer that is within the scope of Topic 606 when all of the following criteria are met:

(i) the arrangement has been approved by the parties and the parties are committed to perform their respective obligations, (ii) each party’s rights regarding the goods or services to be transferred can be identified, (iii) the payment terms for the goods or services to be transferred can be identified, (iv) the arrangement has commercial substance and (v) collection of substantially all of the consideration to which we will be entitled in exchange for the goods or services that will be transferred to the customer is probable.

Identification of the Performance Obligations

The promised goods or services in our collaboration and option arrangements consist of license and research and development services.

The arrangements also have options for additional items (i.e., license rights).

Options are considered

to be marketing offers and are to be accounted for as separate contracts when the customer elects such options, unless we determine the option provides a material right which would not be provided without entering into the contract.

The determination as to whether such options are material rights requires significant management judgment, and management considers factors such as other similar arrangements, market data and the terms of the contractual arrangement to make such conclusion.

Performance obligations are promised goods or services in a contract to transfer a distinct good or service to the customer.

Promised goods or services are considered distinct when:

(i) the customer can benefit from the good or service on its own or together with other readily available resources and (ii) the promised good or service is separately identifiable from other promises in the contract.

In assessing whether promised goods or services are distinct, we consider factors such as the stage of development of the underlying intellectual property, the capabilities of our customer to develop the intellectual property on their own and whether the required expertise is readily available.

Determination of the Transaction Price

We estimate the transaction price based on the amount of consideration we expect to receive for transferring the promised goods or services in the contract.

The consideration may include both fixed consideration and variable consideration.

At the inception of each arrangement that includes variable consideration, we evaluate the amount of the potential payments and the likelihood that the payments will be received.

We utilize either the most likely amount method or expected value method to estimate the transaction price based on which method better predicts the amount of consideration expected to be received.

If it is probable that a significant revenue reversal would not occur, the variable consideration is included in the transaction price.

All contingent future payments, which include research, development, regulatory, and sales-based royalty payments, were not considered in the initial analysis, as they were contingent upon options being exercised or were subject to significant risk of achievement.

Allocation of Transaction Price

We allocate the transaction price based on the estimated standalone selling price.

We must develop assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract.

We utilize key assumptions to determine the standalone selling price, which may include other comparable transactions, pricing considered in negotiating the transaction, and the estimated costs.

Certain variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated to each performance obligation are consistent with the amounts we would expect to receive for satisfying each performance obligation.

Recognition of Revenue

We recognize revenue at the point in time when distinct, functional licenses are transferred to the licensee and/or over the period of time which we perform research and development services.

We utilize a cost-based input method to measure proportional performance, as such costs have direct relationship between our effort and the progress made towards satisfying its performance obligations to Novartis.

Accrued and Prepaid Research and Development Expenses

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The information set forth under Note 2 to the financial statements under the caption “Recently Issued Accounting Pronouncements” is incorporated herein by reference.

Quantitative and Qualitative Disclosures About Market Risk.

Not applicable.

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.

What changed 10-K

Item 7. Management’s Discussion and Analysis