grepcent / static financial knowledge base

Informational only - not investment advice.

LB PHARMACEUTICALS INC (LBRX)

CIK: 0001691082. SIC: 2834 Pharmaceutical Preparations. Latest 10-K as of: 2026-03-26.

SIC breadcrumb: Manufacturing > Chemicals And Allied Products > SIC 2834 Pharmaceutical Preparations

SEC company page: https://www.sec.gov/edgar/browse/?CIK=1691082. Latest filing source: 0001193125-26-126368.

Selected Fundamentals

MetricValueUnitFYFiled
Net income-25,205,000USD20252026-03-26
Assets312,934,000USD20252026-03-26

Financials

Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-03-26. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001691082.json. Derived margins, ratios, and free cash flow are computed from the extracted annual SEC facts.

Flow metrics use full-year FY periods from 10-K/10-K/A filings; balance-sheet metrics use FY-end instants. Free cash flow = operating cash flow - capital expenditures. Missing metrics are omitted rather than fabricated.

Metric202320242025
Net income-63,102,000-25,205,000
Diluted EPS-176.15-3.13
Operating cash flow-53,052,000-35,208,000
Capital expenditures769,00052,000
Assets33,534,000312,934,000
Liabilities13,829,00011,624,000
Stockholders' equity-34,473,000-94,554,000301,310,000
Cash and cash equivalents22,978,000250,173,000
Free cash flow-53,821,000-35,260,000

Ratios

ROE and ROA use period-end equity/assets. Liabilities / equity uses total liabilities divided by stockholders' equity. Current ratio uses current assets divided by current liabilities when both are reported.

Metric202320242025
Return on equity-8.37%
Return on assets-188.17%-8.05%
Liabilities / equity0.04
Current ratio3.5641.44

Financial Charts

Quarterly

Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-05-12. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001691082.json.

Flow metrics use discrete quarter-length periods from 10-Q/10-Q/A filings. Q4 revenue and net income are derived only when annual FY and nine-month YTD facts exist for the same fiscal year; derived Q4 values are labeled. EPS Q4 is not derived.

QuarterEnd DateRevenueNet IncomeDiluted EPSMethod
2025-Q32025-06-30-4,870,000reported discrete quarter
2025-Q32025-09-30-0.61reported discrete quarter
2025-Q42025-12-31-11,472,000derived Q4 = FY annual - nine-month YTD
2026-Q12026-03-31-19,054,000-0.67reported discrete quarter

Quarterly Charts

Macro Cross-References

Latest quarter (10-Q)

Latest 10-Q source: 0001193125-26-219607.

Extracted structurally from real Item 2 body heading to real Item 3/4 boundary. Confidence: high. Filing date: 2026-05-12. Report date: 2026-03-31.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion should be read in conjunction with our unaudited condensed financial statements and the accompanying notes included elsewhere in this Quarterly Report on Form 10-Q and our audited financial statements and the accompanying notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission, or SEC, on March 26, 2026, or the Annual Report. This discussion and other parts of this Quarterly Report contain forward-looking statements based upon current beliefs, plans, and expectations related to future events and our future financial performance that involve risks, uncertainties and assumptions, such as statements of our plans, objectives, expectations, intentions, forecasts and projections. Our actual results and the timing of selected events could differ materially from those discussed in these forward-looking statements as a result of several factors including, but not limited to, those set forth under the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Our historical results are not necessarily indicative of the results that may be expected for any period in the future, and you should carefully read the section titled “Risk Factors” to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section titled “Special Note Regarding Forward-Looking Statements.” You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Quarterly Report on Form 10-Q.

Overview

We are a late-stage biopharmaceutical company developing novel therapies for the treatment of a wide range of neuropsychiatric disorders including schizophrenia, bipolar depression, adjunctive treatment of major depressive disorder and other diseases. We are building a pipeline that leverages the broad therapeutic potential of our lead product candidate, LB-102, which we believe has the opportunity to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102 is currently in late-stage clinical development for schizophrenia (pivotal Phase 3 NOVA-2 trial) and bipolar depression (Phase 2 ILLUMINATE-1 trial). Concurrently with the Phase 3 NOVA-2 trial, we are running an outpatient, open label trial (NOVA-3) to accrue the requisite safety population required to support NDA submission as well as other clinical trials and non-clinical studies typically required by FDA at the time of approval. We are also planning to conduct a Phase 2 clinical trial evaluating LB-102 as an adjunctive treatment in major depressive disorder, or MDD. LB-102 is a new chemical entity and a methylated derivative of amisulpride, a second-generation antipsychotic drug approved in over 50 countries, not including the United States, because the development and regulatory requirements of the U.S. Food and Drug Administration, or FDA, for amisulpride were incompatible with patent coverage on the drug. Amisulpride is a generic drug that has been extensively used in clinical practice following its initial approval in France in the 1980s, generating at least two million monthly prescriptions in 2023 in a subset of 16 continental European countries. Among these European prescriptions for amisulpride, our data suggest that approximately 60% are for schizophrenia and schizoaffective disorders and approximately 20% are for mood disorders and the remainder are for anxiety and a variety of other indications.

We designed LB-102 to address the limitations of amisulpride with the aim of creating a product candidate with the potential for a differentiated therapeutic profile and strong intellectual property protection. We believe LB-102’s mechanism of action, data from our recently completed Phase 2 trial (NOVA-1) of LB-102 in acute schizophrenia, and the heritage of clinical experience with amisulpride support the continued development of LB-102 in both psychosis and mood disorders. In the future, additional expansion opportunities for LB-102 may include predominantly negative symptoms of schizophrenia, Alzheimer’s disease psychosis and agitation, as well as other neuropsychiatric diseases. We believe that LB-102, if approved, can become a mainstay of psychiatric practice by offering a potentially attractive alternative to branded and generic therapeutics for the treatment of schizophrenia, bipolar depression, adjunctive MDD and other neuropsychiatric diseases, given the compelling balance of clinical activity and tolerability observed to date.

The U.S. market for branded antipsychotic drugs was approximately $12 billion as of 2025. Antipsychotics that have expanded beyond schizophrenia into mood disorder indications have realized substantial increases in revenue. Despite the widespread use of generic antipsychotic drugs, several of these branded drugs each generate U.S. sales greater than $1 billion annually. Additionally, while available therapeutics to treat schizophrenia, bipolar depression, and MDD demonstrate clinical benefit, a significant unmet need remains for a treatment that delivers a more favorable risk–benefit profile by balancing tolerability with rapid onset and sustained, clinically meaningful efficacy with once-daily dosing. This includes addressing persistent residual symptoms—across both psychosis and mood disorders—that continue to impair functioning despite available therapies, underscoring the opportunity for improvement in the management of these conditions.

19

Table of Contents

Our current pipeline is summarized below:

*Subject to positive Phase 3 data.

We anticipate that based on our current plans, our current cash, cash equivalents and marketable securities will support our planned operations into the second quarter of 2029.

Since our inception in 2015, we have devoted substantially all of our resources to the research and development of LB-102 by conducting clinical trials and preclinical studies and recruiting management and technical staff to support these operations. To date, we have funded our operations primarily through the aggregate gross proceeds of approximately $549.5 million from the sales of our redeemable convertible preferred stock, common stock, convertible notes, the proceeds of our initial public offering, or IPO, and proceeds from our private placement. On September 12, 2025, we closed the IPO and issued 21,850,000 shares of common stock at a price to the public of $15.00 per share, including 2,850,000 shares issued upon the exercise in full of the underwriters’ over-allotment option to purchase additional shares. We received gross proceeds of $327.8 million. Net proceeds were $302.3 million, after deducting underwriting commissions and other offering costs totaling $25.4 million. In February 2026, we received gross proceeds of approximately $100.0 million from our private placement. Net proceeds were approximately $93.8 million, after deducting financial advisory and other financing.

We have not generated any revenue from product sales and we have incurred recurring losses since our inception. Our net losses were $19.1 million and $5.3 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $148.6 million. We expect to continue to generate operating losses and negative operating cash flows for the foreseeable future. We anticipate that our operating expenses and capital expenditures will increase substantially with our ongoing activities, particularly as we:

•
continue to progress the clinical development of LB-102 in schizophrenia, bipolar depression, adjunctive MDD and other indications;

•
advance additional product candidates through clinical development;

•
require the manufacture of larger quantities of LB-102 and any additional product candidates to support future clinical trials or potential commercialization;

•
seek marketing authorizations for LB-102 and any of our future product candidates that successfully complete clinical development, if any;

•
scale our organization to support the commercialization of LB-102, if approved;

•
acquire or license other product candidates or technologies;

•
make milestone, royalty, or other payments under our current royalty agreements or any future license agreements;

•
obtain, maintain, protect, and enforce our intellectual property portfolio;

•
seek to attract and retain new and existing skilled personnel; and

•
add operational, legal, financial, and management information systems and personnel to support our product development and clinical execution, as well as to support our transition to a public company.

We will not generate any revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for one or more of our product candidates. If we obtain regulatory approval for any of our product candidates, we expect to incur significant expenses related to developing our internal commercialization capability to support product sales, marketing, and distribution. As a result, we will need substantial additional funding to support our operating

20

Table of Contents

activities as we advance our product candidates through clinical development, seek regulatory approval, and prepare for and, if any of our product candidates are approved, proceed to commercialization. Until such time, if ever, as we can generate substantial revenue from product sales to support our cost structure, we expect to finance our operating activities through a combination of public or private sales of equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. Adequate funding may not be available to us on acceptable terms, or at all.

If we are unable to obtain funding, we will be forced to delay, reduce, or eliminate some or all of our research and development programs, product portfolio expansion, or commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. Although we continue to pursue these plans, there is no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all.

As of March 31, 2026, we had cash, cash equivalents and marketable securities of $365.6 million. Based on our current plans, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to meet our anticipated operating and capital expenditure requirements into the second quarter of 2029. See “—Liquidity and Capital Resources.”

Royalty Agreements

In August 2023, contemporaneously with the closing of the Series C financing, we entered into several Amended and Restated Royalty Agreements with certain of our existing investors, co-founders, former and current directors, and former and current executive officers, including Zachary Prensky, Andrew Vaino, Ph.D., and Marc Panoff, none of whom were new investors of our Series C preferred stock. We received no consideration as part of the Amended and Restated Royalty Agreements. Pursuant to the Amended and Restated Royalty Agreements, we are obligated to pay royalties to all of the holders in an aggregate amount up to 2.75% of net sales arising from LB-102 worldwide through December 31, 2035. Thereafter, we are obligated to pay royalties to such holders in an aggregate amount up to 3.25% in perpetuity. Net sales are defined in these agreements as the gross payments received on total commercial sales of LB-102 less certain standard deductions, whether received by us or any licensee of LB-102. As of M

[Excerpt truncated for page length; source filing is linked above.]

Latest 10-K MD&A

Extracted structurally from real Item 7 body heading to real Item 7A/8 boundary. Confidence: high. Filing date: 2026-03-26. Report date: 2025-12-31.

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our audited financial statements and the related notes included elsewhere in this Annual Report on Form 10-K. This discussion and analysis and other parts of this Annual Report on Form 10-K contain forward-looking statements based upon current beliefs, plans and expectations related to future events and our future financial performance that involve risks, uncertainties and assumptions, such as statements regarding our intentions, plans, objectives and expectations for our business. Our actual results and the timing of selected events could differ materially from those described in or implied by these forward-looking statements as a result of several factors, including those set forth in the section titled “Risk Factors” in Part I, Item 1A of this Annual Report on Form 10-K. See also the section titled “Special Note Regarding Forward-Looking Statements.”

Overview

We are a late-stage biopharmaceutical company developing novel therapies for the treatment of a wide range of neuropsychiatric disorders including schizophrenia, bipolar depression, adjunctive treatment of major depressive disorder and other diseases. We are building a pipeline that leverages the broad therapeutic potential of our lead product candidate, LB-102, which we believe has the potential to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102 is currently in late-stage clinical development for schizophrenia and bipolar depression. We are also planning to conduct a Phase 2 clinical trial evaluating LB-102 as an adjunctive treatment in major depressive disorder, or MDD. LB-102 is a new chemical entity and a methylated derivative of amisulpride, a second-generation antipsychotic drug approved in over 50 countries, not including the United States, because the development and regulatory requirements of the U.S. Food and Drug Administration, or FDA, for amisulpride were incompatible with patent coverage on the drug. Amisulpride is a generic drug that has been extensively used in clinical practice following its initial approval in France in the 1980s, generating at least two million monthly prescriptions in 2023 in a subset of 16 continental European countries. Among these European prescriptions for amisulpride, our data suggest that approximately 60% are for schizophrenia and schizoaffective disorders, approximately 20% are for mood disorders, approximately 14% are for anxiety, and the remainder are for a variety of other indications.

We designed LB-102 to address the limitations of amisulpride with the aim to create a product candidate with the potential for a differentiated therapeutic profile and strong intellectual property protection. We believe LB-102’s mechanism of action, data from our recently completed Phase 2 trial (NOVA-1) of LB-102 in acute schizophrenia, and the heritage of clinical experience with amisulpride support the continued development of LB-102 in both psychosis and mood disorders. In the future, additional expansion opportunities for LB-102 may include predominantly negative symptoms of schizophrenia, Alzheimer’s disease psychosis and agitation, as well as other neuropsychiatric diseases. We believe that LB-102, if approved, can become a mainstay of psychiatric practice by offering a potentially attractive alternative to branded and generic therapeutics for the treatment of schizophrenia, bipolar depression, adjunctive MDD and other neuropsychiatric diseases, given the compelling balance of clinical activity and tolerability observed to date.

The U.S. market for branded antipsychotic drugs was approximately $12 billion as of 2024. Antipsychotics that have expanded beyond schizophrenia and into mood disorder indications have realized substantial increases in revenue. Despite the widespread use of generic antipsychotic drugs, several of these branded drugs each generate U.S. sales in excess of $1 billion annually. Additionally, while available therapeutics to treat schizophrenia, bipolar depression, and MDD demonstrate clinical benefit, a significant unmet need remains for a treatment that delivers a more favorable risk–benefit profile by balancing tolerability with rapid onset and sustained, clinically meaningful efficacy with once-daily dosing. This includes addressing persistent residual symptoms—across both psychosis and mood disorders—that continue to impair functioning despite available therapies, underscoring the opportunity for improvement in the management of these conditions.

For additional information regarding our business, see “Business” in Part I, Item 1 of this Annual Report on Form 10-K.

Pipeline Programs and Operational Updates

Pipeline Programs

We are building a pipeline that leverages the broad therapeutic potential of our lead product candidate, LB-102, which we believe has the potential to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United

125

Table of Contents

States. We have initiated our Phase 3 trial (NOVA-2) of LB-102 in patients with acute schizophrenia and our Phase 2 trial (ILLUMINATE-1) of LB-102 in patients with bipolar depression. We plan to initiate a Phase 2 trial of LB-102 for the adjunctive treatment of MDD in early 2027. Data from the Phase 3 trial in schizophrenia is expected in the second half of 2027, data from the Phase 2 trial in bipolar disorder is expected in the first quarter of 2028 and data from the Phase 2 trial in adjunctive MDD is expected in the first half of 2029.

•
In January 2025, we reported positive results from a robust 359 patient Phase 2 trial of LB-102 in schizophrenia. The trial met the primary endpoint, demonstrating statistically significant reduction from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at 4 weeks at all dose levels compared to placebo. In this trial, LB-102 was observed to be generally well-tolerated.

•
In March 2025, we presented additional positive data from our Phase 2 trial at the 2025 Annual Congress of the Schizophrenia International Research Society (SIRS) demonstrating that treatment with LB-102 resulted in a positive shift in disease severity as measured by mean change from baseline in Clinical Global Impression of Severity (CGI-S) scores.

•
In October 2025, we presented three posters featuring new and previously reported analyses from our Phase 2 clinical trial of LB-102 in acute schizophrenia at the 38th European College of Neuropsychopharmacology (ECNP) Congress.

•
In January 2026, we announced the initiation of the Phase 2 trial (ILLUMINATE-1) evaluating the efficacy and safety of LB-102 in patients with bipolar depression.

Since our inception in 2015, we have devoted substantially all of our resources to the research and development of LB-102 by conducting clinical trials and preclinical studies and recruiting management and technical staff to support these operations. To date, we have funded our operations primarily through the aggregate gross proceeds of approximately $549.5 million from the sales of our redeemable convertible preferred stock, common stock, and convertible notes and the proceeds of our initial public offering, or IPO, and proceeds from our private placement. On September 12, 2025, we closed the IPO and issued 21,850,000 shares of common stock at a price to the public of $15.00 per share, including 2,850,000 shares issued upon the exercise in full of the underwriters’ over-allotment option to purchase additional shares. We received gross proceeds of $327.8 million. Net proceeds were $302.3 million, after deducting underwriting commissions and other offering costs totaling $25.4 million. In February 2026, we received gross proceeds of approximately $100.0 million, before deducting any transaction-related expenses from our private placement.

We have not generated any revenue from product sales and we have incurred recurring losses since our inception. Our net losses were $25.2 million and $63.1 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $129.5 million. We expect to continue to generate operating losses and negative operating cash flows for the foreseeable future. We anticipate that our operating expenses and capital expenditures will increase substantially with our ongoing activities, particularly as we:

•
continue to progress the clinical development of LB-102 in acute schizophrenia, bipolar depression, adjunctive MDD and other indications;

•
advance additional product candidates through clinical development;

•
require the manufacture of larger quantities of LB-102 and any additional product candidates to support future clinical trials or potential commercialization;

•
seek marketing authorizations for LB-102 and any of our future product candidates that successfully complete clinical development, if any;

•
acquire or license other product candidates or technologies;

•
make milestone, royalty, or other payments under our current royalty agreements or any future license agreements;

•
obtain, maintain, protect, and enforce our intellectual property portfolio;

126

Table of Contents

•
seek to attract and retain new and existing skilled personnel; and

•
add operational, legal, financial, and management information systems and personnel to support our product development and clinical execution, as well as to support our transition to a public company.

We will not generate any revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for one or more of our product candidates. If we obtain regulatory approval for any of our product candidates, we expect to incur significant expenses related to developing our internal commercialization capability to support product sales, marketing, and distribution. As a result, we will need substantial additional funding to support our operating activities as we advance our product candidates through clinical development, seek regulatory approval, and prepare for and, if any of our product candidates are approved, proceed to commercialization. Until such time, if ever, as we can generate substantial revenue from product sales to support our cost structure, we expect to finance our operating activities through a combination of public or private sales of equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. Adequate funding may not be available to us on acceptable terms, or at all.

If we are unable to obtain funding, we will be forced to delay, reduce, or eliminate some or all of our research and development programs, product portfolio expansion, or commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. Although we continue to pursue these plans, there is no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all.

As of December 31, 2025, we had cash, cash equivalents and marketable securities of $295.2 million, which does not include net proceeds from our $100 million private placement in February 2026. Based on our current plans, we believe that our existing cash, cash equivalents and marketable securities, including net proceeds from our private placement, will be sufficient to meet our anticipated operating and capital expenditure requirements into the second quarter of 2029. See “—Liquidity and Capital Resources.”

Royalty Agreements

In August 2023, contemporaneously with the closing of the Series C financing, we entered into several Amended and Restated Royalty Agreements with certain of our existing investors, co-founders, former and current directors, and former and current executive officers, including Zachary Prensky, Andrew Vaino, Ph.D., and Marc Panoff, none of whom were new investors of our Series C preferred stock. We received no consideration as part of the Amended and Restated Royalty Agreements. Pursuant to the Amended and Restated Royalty Agreements, we are obligated to pay royalties to all of the holders in an aggregate amount up to 2.75% of net sales arising from LB-102 worldwide through December 31, 2035. Thereafter, we are obligated to pay royalties to such holders in an aggregate amount up to 3.25% in perpetuity. Net sales are defined in these agreements as the gross payments received on total commercial sales of LB-102 less certain standard deductions, whether received by us or any licensee of LB-102. For additional information, see “Item 1. Business—License and Other Agreements—Royalty Agreements.” As of December 31, 2025, certain of our former and current officers and their affiliates held 1.13% of the future royalties.

Components of Results of Operations

Revenue

To date, we have not recognized any revenues, including revenues from product sales. We do not expect to generate any revenue from the sale of products in the foreseeable future. If our development efforts for LB-102 or any future product candidates are successful and result in regulatory approval, or license agreements with third parties, we may generate revenue in the future from product sales. However, there can be no assurance as to when we will generate such revenue, if at all.

Operating Expenses

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for the development of LB-102, which include:

•
personnel expenses, including salaries, benefits, and stock-based compensation expense for our employees engaged in research and development functions;

127

Table of Contents

•
expenses incurred in connection with the preclinical and clinical development of LB-102, including under agreements with clinical sites and CROs;

•
formulation costs and chemistry, manufacturing and controls, or CMC, costs including formulation and active pharmaceutical ingredients, process development, analytical and quality infrastructure build-out, and validation support;

•
expenses incurred under agreements with consultants engaged in research and development functions; and

•
expenses related to regulatory affairs.

We expense research and development costs in the periods in which they are incurred. Costs for certain activities are recognized based on an evaluation of the progress to completion of specific tasks, using information provided to us by our vendors and analyzing the progress of our clinical trials or other services performed. Significant judgment and estimates are made in determining the accrued expense balances at the end of any reporting period.

Research and development activities are central to our business model. We expect our research and development expenses to increase substantially for the foreseeable future as we advance LB-102 and any of our future product candidates into and through later stage clinical trials, pursue regulatory approval of our product candidates, build our operational and commercial capabilities for supplying and marketing our products, if approved, and expand our pipeline of product candidates.

The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming. Furthermore, product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. The actual probability of success for our product candidates may be affected by a variety of factors, including the safety and efficacy of our product candidates, conduct of clinical trials, investment in our clinical programs, competition, manufacturing capability, and commercial viability. We may never succeed in achieving regulatory approval for any of our product candidates. As a result of the uncertainties discussed above, we are unable to determine the duration and completion of costs of our research and development projects or if, when, and to what extent we will generate revenue from the commercialization and sale of LB-102 or any future product candidates, if approved by the FDA and other applicable regulatory authorities.

Our future research and development costs may vary significantly based on factors such as:

•
the timing and progress of our clinical development activities;

•
the number and scope of preclinical and clinical programs we decide to pursue;

•
the amount and timing of any milestone payment due under an existing, or any future, license or collaboration agreement or asset acquisition;

•
the cost and timing of manufacturing our product candidates;

•
the number of patients that participate in our clinical trials, and per participant clinical trial costs;

•
the number and duration of clinical trials required for approval of our product candidates;

•
the number of sites included in our clinical trials, and the locations of those sites;

•
delays or difficulties in adding trial sites and enrolling participants in our clinical trials;

•
patient drop-out or discontinuation rates;

•
potential additional safety monitoring requested by regulatory authorities;

•
the phase of development of our product candidates;

•
the efficacy and safety profile of our product candidates;

•
the timing, receipt, and terms of any approvals from applicable regulatory authorities, including the FDA and non-U.S. regulators;

128

Table of Contents

•
maintaining a continued acceptable safety profile of our product candidates following approval, if any, of our product candidates;

•
hiring and retaining additional personnel such as clinical, quality control, scientific, regulatory, commercial, and administrative;

•
maintain, expand, and protect our intellectual property portfolio;

•
establish sales, marketing, distribution, manufacturing, supply chain, and other commercial infrastructure in the future to commercialize various products for which we may obtain regulatory approval;

•
changes in the competitive outlook;

•
the extent to which we establish additional strategic collaborations or other arrangements; and

•
the impact of any business interruptions to our operations or to those of the third parties with whom we work.

A change in the outcome of any of these variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate.

We also expect to incur significant manufacturing costs as our CDMOs develop scaled commercial manufacturing processes. However, we do not believe that it is possible at this time to accurately project expenses through commercialization. There are numerous factors associated with the successful commercialization of LB-102 or any future product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. Additionally, future commercial and regulatory factors beyond our control will impact our clinical development programs and plans.

General and Administrative Expenses

General and administrative expenses consist primarily of:

•
personnel expenses, including salaries, benefits, and stock-based compensation, for personnel in our executive, finance, corporate and business development, and administrative functions;

•
professional fees for legal, patent, accounting and audit, recruiting, information technology, and tax;

•
consulting services including fees paid to our board of directors; and

•
other expenses including travel expenses, rent expense, and other operating costs.

We expect that our general and administrative expenses will increase in the future as we expand our headcount to support our continued research and development of our product candidates. We also expect to incur increased expenses associated with operating as a public company including:

•
costs related to accounting, audit, legal, compliance, regulatory, and tax-related services;

•
costs related to compliance with the rules and regulations of the SEC and listing standards applicable to companies listed on a national securities exchange;

•
director and officer insurance costs; and

•
investor and public relations costs.

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.

Non-operating Income (Expense)

Non-operating income (expense) consists primarily of interest income on our cash and cash equivalents and marketable securities, and non-cash changes in the fair value of our outstanding preferred stock warrant liability.

129

Table of Contents

Results of Operations

Comparison of the Years Ended December 31, 2025 and 2024

The following table summarizes our results of operations for the years ended December 31, 2025 and 2024 (in thousands):

Year Ended December 31,

2025

2024

Change

Operating expenses

Research and development

$

16,744

$

51,171

$

(34,427

)

General and administrative

13,660

13,659

1

Total operating loss

(30,404

)

(64,830

)

(34,426

)

Non-operating income (expense)

Interest income

3,920

1,721

2,199

Realized gain on sale of marketable securities, net

119

955

(836

)

Gain (loss) on change in fair value of derivative instruments

1,161

(947

)

2,108

Total non-operating income

5,200

1,729

3,471

Loss before income tax

(25,204

)

(63,101

)

(37,897

)

Income tax provision

1

1

—

Net loss

$

(25,205

)

$

(63,102

)

$

(37,897

)

Revenue

We generated no revenue during the year ended December 31, 2025 or 2024.

Research and Development Expenses

The following table summarizes our research and development expenses for the periods presented (in thousands):

Year Ended December 31,

2025

2024

Change

Direct research and development expenses

Clinical trial

$

4,727

$

42,369

$

(37,642

)

Formulation and CMC

3,805

2,270

1,535

Preclinical

129

1,845

(1,716

)

Indirect and unallocated expenses

Personnel-related

5,367

3,689

1,678

Consulting and other

2,716

998

1,718

Total research and development expenses

$

16,744

$

51,171

$

(34,427

)

Research and development expenses were $16.7 million for the year ended December 31, 2025, compared to $51.2 million for the year ended December 31, 2024. The decrease of $34.4 million was primarily due to: (i) a $37.6 million decrease in clinical trial expenses primarily related to our Phase 2 trial of LB-102 in patients with acute schizophrenia, the majority of which took place in 2024 and (ii) a $1.7 million decrease in preclinical expenses primarily related to preclinical studies performed in 2024 required to initiate a Phase 3 clinical trial in patients with acute schizophrenia, partially offset by (iii) a $1.7 million increase in personnel-related expenses due to an increase in headcount; (iv) a $1.7 million increase in consulting and other expenses primarily due to the engagement of industry experts, and (v) a $1.5 million increase in formulation and CMC expenses due to the scale-up and production of LB-102 to be used for clinical development.

General and Administrative Expenses

General and administrative expenses were $13.7 million for the years ended December 31, 2025 and 2024. Changes in general and administrative expenses include: (i) a $3.0 million decrease related to the write off of deferred offering costs in 2024; partially offset by (ii) a $0.7 million increase in stock-based compensation primarily related to the stock option grants and the repricing of stock options upon the closing of the IPO in 2025; (iii) a $0.8 million increase in legal costs primarily related to increased operations and public company compliance; (iv) a $0.8 million increase in public company

130

Table of Contents

costs including directors’ and officers’ insurance and public relations costs; (v) a $0.4 million increase in consulting expenses primarily related to public company readiness; and (vi) a $0.3 million increase in personnel-related costs primarily related to increased headcount.

Non-operating Income (Expense)

Non-operating income was $5.2 million for the year ended December 31, 2025, compared to $1.7 million for the year ended December 31, 2024. The increase of $3.5 million was primarily due to: (i) a $2.1 million increase in the gain (loss) on change in fair value of derivative instruments primarily related to the decrease in the fair value of common stock, resulting from a gain on the change in fair value on warrant liabilities of $1.2 million during 2025 and a $0.9 million loss on the change in fair value of derivative liabilities during 2024; (ii) a $2.2 million increase in interest income related to the increased investment in marketable securities, partially offset by (iii) a $0.8 million decrease in the realized gain on marketable securities primarily due to more sales of investments in marketable securities in 2024 as compared to 2025.

Liquidity and Capital Resources

As of December 31, 2025, we had $295.2 million of cash, cash equivalents and marketable securities. We have incurred net losses and negative cash flows from operations since our inception and anticipate we will continue to incur net losses for the foreseeable future. Prior to our IPO, we funded our operations primarily by gross proceeds of $121.7 million from issuances of our redeemable convertible preferred stock, common stock and convertible notes. In September 2025, we completed our IPO pursuant to which we issued and sold an aggregate of 21,850,000 shares of common stock at a price to the public of $15.00 per share. We received aggregate net proceeds of $302.3 million after deducting underwriting discounts and commissions of $22.9 million and other offering expenses of $2.5 million. In February 2026, we sold shares of our common stock pursuant to a securities purchase agreement in exchange for gross proceeds of approximately $100.0 million, before deducting any transaction-related expenses. Until required for use in our business, we typically invest our cash, in accordance with our investment policy, in money market funds and fixed income securities including U.S. treasury bills and government securities. We attempt to minimize credit risk related to our cash and cash equivalents and marketable securities by maintaining a well-diversified portfolio that limits the amount of exposure as to maturity and investment type.

Our primary use of cash has been to fund operating expenses, which consist of research and development and general and administrative expenditures. As we progress through the phases of development of LB-102 and any of our future product candidates, we anticipate that we will incur increasing losses in future quarters and years compared to historical periods.

Cash Flows

The following table sets forth a summary of the net cash flow activity for the years ended December 31, 2025 and 2024 (in thousands):

Year Ended December 31,

2025

2024

Net cash used in operating activities

$

(35,208

)

$

(53,052

)

Net cash (used in) provided by investing activities

(39,887

)

23,234

Net cash provided by financing activities

302,562

38,315

Net increase in cash, cash equivalents and restricted cash

$

227,467

$

8,497

Operating Activities

Cash used in operating activities for the year ended December 31, 2025 was $35.2 million, consisting of net loss of $25.2 million adjusted for non-cash items, including a $4.2 million charge for stock-based compensation expense, $0.3 million in amortization of premiums on investments, and $0.3 million of depreciation and amortization partially offset by change in the fair value of the warrant liabilities of $1.2 million. Additionally, we had outflows of $13.7 million due to a change in our net operating assets and liabilities from the year ended December 31, 2024, including a $12.3 million increase in prepaid expenses and other current assets primarily related to advance payments to our CRO for the clinical trials initiated in 2025, a $0.9 million decrease in accounts payable and accrued expense primarily related to timing of payments, and a $0.3 million increase in accrued interest on marketable securities primarily due to our holding of no marketable securities investments through September 2025.

131

Table of Contents

Cash used in operating activities for the year ended December 31, 2024 was $53.1 million, consisting of net loss of $63.1 million adjusted for non-cash items, including the realized gain on marketable securities of $1.0 million, partially offset by non-cash items including: (i) stock-based compensation expense of $3.1 million; (ii) write off of deferred offering costs of $3.2 million, (iii) change in fair value of the warrant liabilities of $0.9 million; and (iv) lease expense of $0.3 million related to the lease agreement executed in May 2024. Additionally, we had inflows of $3.3 million due to a change in our net operating assets and liabilities from the year ended December 31, 2023, including a $5.0 million increase in accounts payable and accrued expense related to timing of payments, clinical trial expenses and compensation and termination expenses, partially offset by a $1.7 million increase in prepaid expenses primarily related to advance payments to our CRO for the Phase 2 acute schizophrenia trial.

Investing Activities

Cash used in investing activities for the year ended December 31, 2025 was $39.9 million primarily related to $44.8 million for the purchase of marketable securities to invest our excess cash, partially offset by $5.0 million in proceeds from sale and maturities of marketable securities.

Cash provided by investing activities for the year ended December 31, 2024 was $23.2 million primarily related to proceeds from sale and maturities of marketable securities, partially offset by the purchase of marketable securities to invest our excess cash.

Financing Activities

Cash provided by financing activities for the year ended December 31, 2025 was $302.6 million primarily related to the proceeds from the IPO, net of issuance costs.

Cash provided by financing activities for the year ended December 31, 2024 was $38.3 million primarily related to the proceeds from the issuance of redeemable convertible Series C preferred stock, net of issuance costs.

Future Funding Requirements

We expect our expenses to increase substantially in connection with our ongoing activities, in particular as we continue to advance LB-102 and any of our future product candidates through clinical trials, as well as additional costs associated with operating as a public company.

As of December 31, 2025, we had cash, cash equivalents and marketable securities of $295.2 million, which does not include net proceeds from our $100 million private placement in February 2026. Based on our current plans, we believe that our existing cash, cash equivalents and marketable securities, including net proceeds from our private placement in February 2026, will be sufficient to meet our anticipated operating and capital expenditure requirements into the second quarter of 2029.

We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with research, development, and commercialization of pharmaceutical product candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including:

•
the scope, progress, results, and costs of researching, developing and manufacturing LB-102 for our current and future indications, as well as other product candidates we may develop;

•
the timing of, and the costs involved in, obtaining marketing approvals for LB-102 for our current and future indications, as well as future product candidates we may develop and pursue;

•
the number of future indications and product candidates that we pursue and their development requirements;

•
if approved, the costs of commercialization activities for LB-102 for the treatment of acute schizophrenia, bipolar depression, adjunctive MDD, or any other approved indication, or any other product candidate that receives regulatory approval to the extent such costs are not the responsibility of any future collaborators, including the costs and timing of establishing product sales, marketing, distribution, and manufacturing capabilities;

132

Table of Contents

•
subject to receipt of regulatory approval, revenue, if any, received from commercial sales of LB-102 for any program or revenues received from any future product candidates;

•
the extent to which we in-license or acquire rights to other products, product candidates, or technologies;

•
our headcount growth and associated costs as we expand our organization to achieve our objectives;

•
the costs of preparing, filing, and prosecuting patent applications, and maintaining and protecting our intellectual property rights, including enforcing and defending intellectual property related claims; and

•
the costs of operating as a public company.

A change in the outcome of any of these or other variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Further, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity financings, debt financings, collaborations with other companies or other strategic transactions. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures, or declaring dividends. If we raise additional funds through collaborations, strategic alliances, or marketing, distribution, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce, or terminate our research, product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Further, our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development activities. We currently have no credit facility or committed sources of capital. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated product development programs.

Contractual Obligations and Commitments

Leases

In May 2024, we entered into a new lease agreement for office space in New York, New York totaling approximately 8,900 square feet. The term of this lease commenced on June 21, 2024, which is the date we took control over the leased premises. The lease term continues through March 2032. In November 2025, we entered into an amendment to the lease agreement providing for the lease of approximately 4,600 square feet of additional office space. The lease amendment term continues through March 2032. See Note 7 Leases to our audited financial statements for more information.

Funding Commitments

We enter into contracts in the normal course of business with CROs, CDMOs, and other third parties for clinical trials, preclinical research studies, and testing and manufacturing services. These contracts are cancelable by us upon prior written notice. Payments due upon cancellation consist primarily of payments for services provided or expenses incurred, including noncancelable obligations of our service providers, up to the date of cancellation. The amount and timing of such payments are not known. See Note 13 Commitments and Contingencies to our audited financial statements for more information.

133

Table of Contents

Recently Issued Accounting Pronouncements

A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations, or cash flows is disclosed in Note 2 of our audited financial statements appearing elsewhere in this Annual Report on Form 10-K.

Critical Accounting Estimates

This management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our financial statements. In accordance with GAAP, we evaluate our estimates and judgments on an ongoing basis, including those related to accrued research and development expenses, common stock warrant liabilities, and stock-based compensation. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

We define our critical accounting estimates as those that require us to make subjective estimates and judgments about

matters that are uncertain and are likely to have a material impact on our financial condition and results of operations.

While our significant accounting policies are more fully described in Note 2 to our audited financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe the following are the critical accounting policies used in the preparation of our financial statements that require significant estimates and judgments.

Accrued Research and Development Expenses

As part of the process of preparing our financial statements, we are required to estimate our accrued research and

development expenses as of each balance sheet date. This process involves reviewing open contracts and purchase orders, including our site contracts for sites that are participating in our ongoing clinical trials, communicating with our personnel to identify services that have been performed on our behalf, and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. The majority of our service providers invoice us monthly in arrears for services performed or when contractual milestones are met. We make estimates of our accrued expenses as of each balance sheet date based on facts and circumstances known to us at that time. We periodically confirm the accuracy of our estimates with the service providers and make adjustments if necessary.

We base our expenses related to research and development activities on our estimates of the services received and

efforts expended pursuant to quotes and contracts with vendors that conduct research and development on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the research and development expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepaid balance accordingly. Non-refundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made.

Although we do not expect our estimates to be materially different from amounts incurred, if our estimates of the

status and timing of services performed differ from the actual status and timing of services performed, it could result in us reporting amounts that are too high or too low in any particular period.

Costs incurred in obtaining technology licenses through asset acquisitions or in-licensing arrangements are charged to

research and development expense if the acquired technology has not reached technological feasibility and has no

alternative future use.

Stock-Based Compensation

We account for our stock-based compensation awards in accordance with the Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 718, Compensation—Stock Compensation, or ASC Topic 718.

134

Table of Contents

We have issued stock-based compensation awards including stock options and restricted stock awards and we also account for certain issuances of warrants in accordance with ASC Topic 718.

We measure the cost of employee, nonemployee, and director services received in exchange for an award of equity

instruments based on the fair value of the award on the date of grant and recognize the related expense over the period

during which the employee, nonemployee or director is required to provide service in exchange for the award on a straight line basis.

We estimate the fair value of each award on the date of grant using the Black-Scholes option-pricing model. This model

requires the use of highly subjective assumptions to determine the fair value of each stock-based award, including:

•
Fair value of common stock.

•
Expected term. The expected term represents the period that the stock-based awards are expected to be

outstanding. The expected term for our stock options was calculated based on the weighted-average vesting

term of the awards and the contract period, or simplified method.

•
Expected volatility. Since we do not have sufficient trading history to estimate the volatility of our common stock, the expected volatility was estimated based on the average historical volatilities of common stock of comparable publicly traded entities over a period equal to the expected term of the stock option grants. The comparable companies were chosen based on their size, stage of their life cycle, or area of specialty. We will continue to apply this process until enough historical information regarding the volatility of our stock price becomes available.

•
Risk-free interest rate. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected term of the stock options.

•
Expected dividend yield. We have never paid dividends on our common stock and have no plans to pay dividends on our common stock. Therefore, we used an expected dividend yield of zero.

Changes in the foregoing assumptions can materially affect the fair value and ultimately how much stock-based compensation expense is recognized. These inputs are subjective and generally require significant analysis and judgment to develop.

Warrants

We review the terms of debt instruments, equity instruments, and other financing arrangements to determine whether there are embedded derivative features, including embedded conversion options that are required to be bifurcated and accounted for separately as a derivative financial instrument. Additionally, in connection with the issuance of financing instruments, we may issue freestanding warrants.

We account for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in FASB ASC Topic 480, Distinguishing Liabilities from Equity, or ASC Topic 480, and FASB ASC Topic 815, Derivatives and Hedging, or ASC Topic 815. The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC Topic 480, meet the definition of a liability pursuant to ASC Topic 480, and whether the warrants meet all of the requirements for equity classification under ASC Topic 815, including whether the warrants are indexed to our own stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of our control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.

For warrants that meet all criteria for equity classification, the warrants are recorded as a component of additional paid-in capital, on the statement of stockholders’ deficit at the time of issuance. For warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance, and on each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss in other expense, net, on the statements of operations. The fair value of the warrants was estimated using the Black-Scholes option pricing model, which requires the use of highly subjective and unobservable assumptions to determine the fair value

135

Table of Contents

of the warrants, including the fair value of common stock, expected term, expected volatility, risk free interest rate and expected dividend yield.

Emerging Growth Company and Smaller Reporting Company Status

We are an “emerging growth company” as defined in the JOBS Act, and we may remain an emerging growth company for up to five years following the completion of our IPO. For so long as we remain an emerging growth company, we are permitted and intend to rely on certain exemptions from various public company reporting requirements, including not being required to have our internal control over financial reporting audited by our independent registered public accounting firm pursuant to Section 404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold stock.

In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the benefits of this extended transition period, and therefore, we are not subject to the same requirements to adopt new or revised accounting standards as other public companies that are not emerging growth companies; however, we may adopt certain new or revised accounting standards early. We will remain an “emerging growth company” until the earliest to occur of: (i) the last day of the fiscal year in which we have $1.235 billion or more in annual revenue; (ii) the date on which we first qualify as a large accelerated filer under the rules of the SEC; (iii) the date on which we have, in any prior three-year period issued more than $1.0 billion in non-convertible debt securities; and (iv) the last day of the fiscal year following the fifth anniversary of the consummation of our IPO.

We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

136

Table of Contents