LB PHARMACEUTICALS INC
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 5, 2026
LBRX$42.01+10.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-11.
0001193125-26-343490
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-05.
0001193125-26-449994
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 143 previous paragraphs and 114 current paragraphs.
68 unchanged; 34 reworded; 8 added; 34 removed; 7 previous and 4 current paragraphs rearranged.
Tables are not compared: 5 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (8)
Current report
Pursuant to Amended and Restated Royalty Participation Agreements entered into in August 2023, for which no consideration was received, we are obligated to pay certain investors, co-founders, and current and former directors and executive officers royalties on worldwide net sales of LB-102 in perpetuity, whether such sales are made by us or a licensee. As of September 30, 2026 and December 31, 2025, current and former directors and executive officers and their affiliates held 1.13% of these royalty interests.
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
30, 2026 and resulted in aggregate gross proceeds of $150.0 million, consisting of approximately $125.0 million from the sale of common stock and approximately $25.0 million from the sale of pre-funded warrants. Net proceeds were approximately $140.9 million, after deducting financial advisory fees and other financing costs of approximately $9.1 million. The pre-funded warrants are exercisable at any time for $0.0001 per share, have no expiration date, and are classified in permanent equity. In connection with the July private placement, we filed a registration statement on Form S-3ASR (File No. 333-299235) on October 1, 2026 (the “S-3 Registration Statement”), which became automatically effective upon filing. The S-3 Registration Statement also registered any and all unsold or unissued shares of common stock by the selling stockholders under the S-1 Registration Statement. Upon the effectiveness of the S-3 Registration Statement, we filed a post-effective amendment and terminated any and all offerings of our securities pursuant to the S-1 Registration Statement.
Current report
On October 1, 2026, we entered into a Sales Agreement (the “Sales Agreement”) with TD Securities (USA) LLC (“TD Cowen”) with respect to an “at-the-market” offering program, pursuant to which we may issue and sell, from time to time, shares of our common stock, par value $0.0001 per share. The issuance and sale, if any, of shares of our common stock under the Sales Agreement will be effected pursuant to the S-3 Registration Statement, which automatically became effective upon filing with the SEC on October 1, 2026. In accordance with the terms of the Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to $200.0 million from time to time through TD Cowen.
Current report
Cash provided by financing activities for the nine months ended September 30, 2025 was $303.7 million primarily related to the proceeds from the IPO, net of issuance costs.
Removed paragraphs (34)
Previous report
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 June 30, 2026, certain of our former and current officers and their affiliates held 1.13% of the future royalties.
Previous report
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.
Previous report
Our future research and development costs may vary significantly based on factors such as:
Previous report
the timing and progress of our clinical development activities;
Previous report
the number and scope of preclinical and clinical programs we decide to pursue;
Previous report
the amount and timing of any milestone payment due under an existing, or any future, license or collaboration agreement or asset acquisition;
Previous report
the number of patients that participate in our clinical trials, and per participant clinical trial costs;
Previous report
the number and duration of clinical trials required for approval of our product candidates;
Previous report
the number of sites included in our clinical trials, and the locations of those sites;
Previous report
delays or difficulties in adding trial sites and enrolling participants in our clinical trials;
Previous report
patient drop-out or discontinuation rates;
Previous report
potential additional safety monitoring requested by regulatory authorities;
Previous report
the phase of development of our product candidates;
Previous report
the efficacy and safety profile of our product candidates;
Previous report
the cost and timing of the development and manufacturing of our product candidates;
Previous report
the timing, receipt, and terms of any approvals from applicable regulatory authorities, including the FDA and non-U.S. regulators;
Previous report
maintaining a continued acceptable safety profile of our product candidates following approval, if any, of our product candidates;
Previous report
hiring and retaining additional personnel such as clinical, quality control, scientific, commercial, and administrative;
Previous report
maintain, expand, and protect our intellectual property portfolio;
Previous report
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;
Previous report
changes in the competitive outlook;
Previous report
the extent to which we establish additional strategic collaborations or other arrangements; and
Previous report
the impact of any business interruptions to our operations or to those of the third parties with whom we work.
Previous report
costs related to accounting, audit, legal, compliance, regulatory, and tax-related services;
Previous report
costs related to compliance with the rules and regulations of the SEC and listing standards applicable to companies listed on a national securities exchange;
Previous report
investor and public relations costs.
Previous report
Results of Operations
Previous report
Comparison of the six months ended June 30, 2026 and 2025
Previous report
Revenue
Previous report
Non-operating Income
Previous report
In July 2026, we issued and sold shares of our common stock and pre-funded warrants to purchase shares of our common stock pursuant to a securities purchase agreement in exchange for gross proceeds of approximately $150.0 million, before deducting any transaction-related expenses.
Previous report
clinical trial expenses, partially offset by a $0.3 million decrease in prepaid expenses primarily related to decreased
Previous report
payments to our CRO due to the completion of the Phase 2 acute schizophrenia trial.
Previous report
There were no financing activities for the six months ended June 30, 2025.
Reworded paragraphs (34)
Previous wording
We are a neuromedicines company dedicated to developing and commercializing high-impact therapies that address the multiple dimensions of underserved brain diseases. Our growing pipeline 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 enrolling 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 for an NDA approval.
Current wording
We are a neuromedicines company dedicated to developing and commercializing high-impact therapies that address the multiple dimensions of underserved brain diseases. Our growing pipeline 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 enrolling an outpatient, open label trial (NOVA-3) to accrue, along with other trials of LB-102, the requisite safety population required to support NDA submission as well as other clinical trials and non-clinical studies typically required by FDA for an NDA approval.
Previous wording
We are also planning to conduct a Phase 2 clinical trial evaluating LB-102 as an adjunctive treatment in major depressive disorder (“aMDD”). Additional pipeline expansion is planned for LB-102 in new indications with strong mechanistic rationale and validating clinical and real-world experience from amisulpride, potentially including negative symptoms of schizophrenia (with potential for trial initiation in the second half of 2027, subject to regulatory feedback and other factors) and Alzheimer’s disease agitation/psychosis. We are also developing a long-acting injectable (“LAI”) formulation of LB-102, which may improve adherence, a common issue in patients with schizophrenia and bipolar disorder. LB-102 is a new chemical entity and a methylated derivative of amisulpride, a second-generation antipsychotic drug approved in over 50 countries. Amisulpride is not available in the United States because the development and regulatory requirements of the U.S. Food and Drug Administration (“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.
Current wording
We are also planning to conduct a Phase 2 clinical trial evaluating LB-102 as an adjunctive treatment in major depressive disorder (“aMDD”). Additional pipeline expansion is planned for LB-102 in new indications with strong mechanistic rationale and validating clinical and real-world experience from amisulpride, potentially including negative symptoms of schizophrenia (with potential for trial initiation in the second half of 2027, subject to regulatory feedback and other factors) and Alzheimer’s disease agitation/psychosis. Based on ongoing engagement with FDA about a trial in predominantly negative symptoms of schizophrenia, we expect to provide an update about a potential trial design in the first quarter of 2027. We are also developing a long-acting injectable (“LAI”) formulation of LB-102, which may improve adherence, a common issue in patients with schizophrenia and bipolar disorder. LB-102 is a new chemical entity and a structural modification of amisulpride, a second-generation antipsychotic drug approved in over 50 countries. Amisulpride is not available in the United States because the development and regulatory requirements of the U.S. Food and Drug Administration (“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.
Previous wording
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 and real-world experience with amisulpride support the continued development of LB-102 in both psychosis and mood disorders. 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.
Current wording
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 Phase 2 trial (NOVA-1) of LB-102 in acute schizophrenia, and the heritage of clinical and real-world experience with amisulpride support the continued development of LB-102 in both psychosis and mood disorders.
Previous wording
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, with some approaching between $2 billion to $4 billion in annual U.S. sales. Additionally, while available therapeutics to treat schizophrenia, bipolar depression, MDD, and other neuropsychiatric diseases 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 – across both psychosis and mood disorders – persistent residual symptoms such as anhedonia and cognitive impairment that continue to impact functioning despite available therapies, underscoring the opportunity for improvement in the management of these conditions.
Current wording
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, with some approaching between $2 billion to $4 billion in annual U.S. sales. Additionally, while available therapeutics to treat schizophrenia, bipolar depression, MDD, and other neuropsychiatric diseases 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 simple to use, with once-daily dosing. This includes addressing – across both psychosis and mood disorders – persistent residual symptoms such as anhedonia and cognitive impairment that continue to impact functioning despite available therapies, underscoring the opportunity for improvement in the management of these conditions.
Previous wording
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 (“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 $93.7 million, after deducting financial advisory and other financing costs. In July 2026, we completed a private placement financing resulting in total gross proceeds of $150.0 million before deducting any transaction-related expenses.
Current wording
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 from the sales of our redeemable convertible preferred stock, common stock, convertible notes, the proceeds of our initial public offering (“IPO”) and proceeds from our private placements. 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 a private placement. Net proceeds were approximately $93.7 million, after deducting financial advisory and other financing costs. In July 2026, we received gross proceeds of approximately $150.0 million from an additional private placement. Net proceeds were approximately $140.9 million, after deducting financial advisory and other financing costs.
Previous wording
We have not generated any revenue from product sales and we have incurred recurring losses since our inception. Our net losses were $70.7 million and $10.2 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $200.2 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:
Current wording
We have not generated any revenue from product sales and we have incurred recurring losses since our inception. Our net losses were $129.7 million and $13.7 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $259.3 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:
Previous wording
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.
Current wording
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 if 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.
Previous wording
As of June 30, 2026, we had cash, cash equivalents and marketable securities of $327.8 million, which does not include net proceeds from our $150.0 million private placement in July 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 beyond the second quarter of 2029. See “Liquidity and Capital Resources” for further information.
Current wording
As of September 30, 2026, we had cash, cash equivalents and short-term investments of $403.8 million. Based on our current plans, we believe that our existing cash, cash equivalents and short-term investments will be sufficient to meet our anticipated operating and capital expenditure requirements beyond the second quarter of 2029. See “Liquidity and Capital Resources” for further information.
Previous wording
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.
Current wording
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 capabilities, and expand our pipeline of product candidates.
Previous wording
professional fees for legal, patent, accounting and audit, information technology, and tax;
Current wording
professional fees for legal, patent, compliance, regulatory, accounting and audit, information technology, and tax related services;
Previous wording
consulting services including fees paid to our board of directors; and
Current wording
consulting services including fees paid to our board of directors;
Previous wording
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:
Current wording
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.
Previous wording
Non-operating income 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 warrant liabilities.
Current wording
Non-operating income consists primarily of interest income on our cash and cash equivalents and short-term investments, and non-cash changes in the fair value of our outstanding warrant liabilities.
Previous wording
Comparison of the Three Months Ended June 30, 2026 and 2025
Current wording
Comparison of the three and nine months ended September 30, 2026 and 2025
Previous wording
The following table summarizes our results of operations for the three months ended June 30, 2026 and 2025 (in thousands):
Current wording
The following table summarizes our results of operations for the three and nine months ended September 30, 2026 and 2025 (in thousands):
Previous wording
We generated no revenue during the three months ended June 30, 2026 and 2025.
Current wording
We generated no revenue during the three and nine months ended September 30, 2026 and 2025.
Previous wording
The following table summarizes our research and development expenses for the three months ended June 30, 2026 and 2025 (in thousands):
Current wording
The following table summarizes our research and development expenses for the three and nine months ended September 30, 2026 and 2025 (in thousands):
Previous wording
Research and development expenses were $44.1 million for the three months ended June 30, 2026, compared to $2.4 million for the three months ended June 30, 2025. The increase of $41.7 million was primarily due to: (i) a $32.1 million increase in clinical trial expenses primarily related to our Phase 3 trial of LB-102 in the treatment of patients with acute schizophrenia; (ii) a $2.7 million increase related to the conduct of our Phase 2 trial of LB-102 in the treatment of patients with bipolar depression; (iii) a $2.0 million increase in expenses related to the formulation and production of LB-102 for use in our active and planned clinical trials; (iv) a $4.0 million increase in personnel-related expenses primarily due to an increase in headcount, an increase in termination benefits, and an increase in stock compensation expense related to an option modification; and (v) a $1.3 million increase in preclinical and other direct expenses related to LB-102.
Current wording
Research and development expenses were $51.5 million for the three months ended September 30, 2026, compared to $2.4 million for the three months ended September 30, 2025. The increase of $49.1 million was primarily due to: (i) a $36.4 million increase in clinical trial expenses primarily related to our Phase 3 trial of LB-102 in the treatment of patients with acute schizophrenia; (ii) a $2.7 million increase related to the conduct of our Phase 2 trial of LB-102 in the treatment of patients with bipolar depression; (iii) a $2.0 million increase in expenses related to the formulation and production of LB-102 for use in our active and planned clinical trials; (iv) a $4.0 million increase in preclinical and other direct expenses primarily related to start-up costs for our Phase 2 trial in the adjunctive treatment of MDD and other costs related to LB-102; and (v) a $3.9 million increase in personnel-related expenses primarily due to an increase in headcount.
Previous wording
Research and development expenses were $58.8 million for the six months ended June 30, 2026, compared to $5.8 million for the six months ended June 30, 2025. The increase of $52.9 million was primarily due to: (i) a $36.8 million increase in clinical trial expenses related to our Phase 3 trial of LB-102 in the treatment of patients with acute schizophrenia; (ii) a $5.7 million increase related to the conduct of our Phase 2 trial of LB-102 in the treatment of patients with bipolar depression; (iii) a $3.6 million increase in expenses related to the formulation and production of LB-102 for use in our active and planned clinical trials; (iv) a $1.9 million increase in preclinical and other direct expenses primarily related to LB-102; and (v) a $5.0 million increase in personnel-related expenses primarily due to an increase in headcount, an increase in termination benefits, and an increase in stock compensation expense related to an option modification.
Current wording
Research and development expenses were $110.3 million for the nine months ended September 30, 2026, compared to $8.3 million for the nine months ended September 30, 2025. The increase of $102.0 million was primarily due to: (i) a $73.1 million increase in clinical trial expenses primarily related to our Phase 3 trial of LB-102 in the treatment of patients with acute schizophrenia; (ii) an $8.4 million increase related to the conduct of our Phase 2 trial of LB-102 in the treatment of patients with bipolar depression; (iii) a $5.6 million increase in expenses related to the formulation and production of LB-102 for use in our active and planned clinical trials; (iv) a $5.9 million increase in preclinical and other direct expenses primarily related to start-up costs for our Phase 2 trial in the adjunctive treatment of MDD and other costs related to LB-102; and (v) a $8.9 million increase in personnel-related expenses primarily due to an increase in headcount, an increase in termination benefits, and an increase in stock compensation expense related to an option modification.
Previous wording
General and administrative expenses were $9.8 million for the three months ended June 30, 2026, compared to $2.4 million for the three months ended June 30, 2025. The increase of $7.3 million was primarily due to: (i) a $2.8 million increase in stock-based compensation expense primarily related to stock options granted and repriced in connection with the IPO, new hire grants and an option modification; (ii) a $2.1 million increase in personnel-related expenses primarily due to an increase in headcount; (iii) a $0.9 million increase in professional fees, including accounting and legal fees partially related to costs associated with being a public company; (iv) a $1.0 million increase in consulting fees primarily related to strategy consulting; and (v) a $0.4 million increase in public company expenses including D&O insurance.
Current wording
General and administrative expenses were $11.0 million for the three months ended September 30, 2026, compared to $2.8 million for the three months ended September 30, 2025. The increase of $8.2 million was primarily due to: (i) a $2.1 million increase in stock-based compensation expense primarily related to stock options granted and repriced in connection with the IPO and new hire grants; (ii) a $2.9 million increase in personnel-related expenses primarily due to an increase in headcount; (iii) a $0.9 million increase in professional fees, including accounting and legal fees partially related to costs associated with being a public company; (iv) a $1.4 million increase in consulting fees primarily related to brand and strategy consulting; and (v) a $0.3 million increase in public company expenses including D&O insurance.
Previous wording
General and administrative expenses were $17.2 million for the six months ended June 30, 2026, compared to $5.4 million for the six months ended June 30, 2025. The increase of $11.8 million was primarily due to: (i) a $4.4 million increase in stock-based compensation expense primarily related to stock options granted and repriced in connection with the IPO, new hire grants and an option modification; (ii) a $3.6 million increase in personnel-related expenses primarily due to an increase in headcount; (iii) a $1.9 million increase in professional fees, including accounting and legal fees partially related to costs associated with being a public company; (iv) a $1.4 million increase in consulting fees primarily related to strategy consulting; and (v) a $0.7 million increase in public company expenses including D&O insurance.
Current wording
General and administrative expenses were $28.2 million for the nine months ended September 30, 2026, compared to $8.3 million for the nine months ended September 30, 2025. The increase of $19.7 million was primarily due to: (i) a $6.5 million increase in stock-based compensation expense primarily related to stock options granted and repriced in connection with our IPO, new hire grants and an option modification; (ii) a $6.5 million increase in personnel-related expenses primarily due to an increase in headcount; (iii) a $2.8 million increase in professional fees, including accounting and legal fees partially related to costs associated with being a public company; (iv) a $2.7 million increase in consulting fees primarily related to brand and strategy consulting; and (v) a $1.1 million increase in public company expenses including D&O insurance.
Previous wording
Non-operating income was $2.3 million for the three months ended June 30, 2026, compared to a non-operating loss of less than $0.1 million for the three months ended June 30, 2025. The increase of $2.3 million was primarily due to a $2.8 million increase in interest income as a result of higher cash balances in interest-bearing accounts in 2026, partially offset by a $0.5 million increase in loss on the change in fair value of derivative instruments when compared to the prior year comparable period.
Current wording
Non-operating income was $3.4 million for the three months ended September 30, 2026, compared to non-operating income of $1.7 million for the three months ended September 30, 2025. The increase of $1.7 million was primarily due to a $3.1 million increase in interest income as a result of higher cash balances in interest-bearing accounts in 2026, partially offset by a $1.3 million increase in loss on the change in fair value of derivative instruments when compared to the prior year comparable period.
Previous wording
Non-operating income was $5.4 million for the six months ended June 30, 2026, compared to $1.1 million for the six months ended June 30, 2025. The increase of $4.3 million was primarily due to a $5.4 million increase in interest income as a result of higher cash balances in interest-bearing accounts in 2026, partially offset by a $1.0 million decrease in gain on change in fair value of derivative instruments when compared to the prior year comparable period.
Current wording
Non-operating income was $8.8 million for the nine months ended September 30, 2026, compared to $2.8 million for the nine months ended September 30, 2025. The increase of $6.0 million was primarily due to an $8.5 million increase in interest income as a result of higher cash balances in interest-bearing accounts in 2026, partially offset by a $2.4 million decrease in gain on change in fair value of derivative instruments when compared to the prior year comparable period.
Previous wording
As of June 30, 2026, we had $327.8 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. 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.
Current wording
As of September 30, 2026, we had $403.8 million of cash, cash equivalents and short-term investments. 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. 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 short-term investments by maintaining a well-diversified portfolio that limits the amount of exposure as to maturity and investment type.
Previous wording
In February 2026, we completed a private placement pursuant to which we issued and sold to certain investors an aggregate of (i) 3,306,571 shares of our common stock at a purchase price of $21.17 per share and (ii) pre-funded warrants to purchase 1,417,107 shares of our common stock at a purchase price of $21.1699 per pre-funded warrant, which represents the per share purchase price less the $0.0001 per share exercise price of each pre-funded warrant. The transaction closed on February 6, 2026 and resulted in aggregate gross proceeds of approximately $100.0 million, consisting of approximately $70.0 million from the sale of common stock and approximately $30.0 million from the sale of pre-funded warrants. Net proceeds were approximately $93.7 million, after deducting financial advisory fees and other financing costs of approximately $6.3 million. The pre-funded warrants are exercisable at any time for $0.0001 per share, have no expiration date, and are classified in permanent equity. In connection with the private placement, we entered into a registration rights agreement with the investors pursuant to which we filed a registration statement on Form S-1 (File No. 333-294900) on April 6, 2026, which was declared effective by the SEC on April 14, 2026.
Current wording
In February 2026, we completed a private placement pursuant to which we issued and sold to certain investors an aggregate of (i) 3,306,571 shares of our common stock at a purchase price of $21.17 per share and (ii) pre-funded warrants to purchase 1,417,107 shares of our common stock at a purchase price of $21.1699 per pre-funded warrant, which represents the per share purchase price less the $0.0001 per share exercise price of each pre-funded warrant. The transaction closed on February 6, 2026 and resulted in aggregate gross proceeds of approximately $100.0 million, consisting of approximately $70.0 million from the sale of common stock and approximately $30.0 million from the sale of pre-funded warrants. Net proceeds were approximately $93.7 million, after deducting financial advisory fees and other financing costs of approximately $6.3 million. The pre-funded warrants are exercisable at any time for $0.0001 per share, have no expiration date, and are classified in permanent equity. In connection with the private placement, we entered into a registration rights agreement with the investors pursuant to which we filed a registration statement on Form S-1 (File No. 333-294900) on April 6, 2026 (the “S-1 Registration Statement”), which was declared effective by the SEC on April 14, 2026.
Previous wording
The following table sets forth a summary of the net cash flow activity for the six months ended June 30, 2026 and 2025 (in thousands):
Current wording
The following table sets forth a summary of the net cash flow activity for the nine months ended September 30, 2026 and 2025 (in thousands):
Previous wording
Cash used in operating activities for the six months ended June 30, 2026 was $60.9 million, consisting of net loss of $70.7 million adjusted for non-cash items, including a $7.5 million charge for stock-based compensation expense, $0.5 million change in the fair value of the warrant liabilities, and $0.2 million in depreciation expense. Additionally, we had inflows of $1.5 million due to a change in our net operating assets and liabilities for the six months ended June 30, 2026, including a $16.0 million increase in accounts payable and accrued expense primarily related to timing of payments and clinical trial expenses, partially offset by a $14.3 million increase in prepaid expenses and other current assets primarily related to deposits made to our CRO for clinical trial expenses.
Current wording
Cash used in operating activities for the nine months ended September 30, 2026 was $125.2 million, consisting of net loss of $129.7 million adjusted for non-cash items, including a $11.1 million charge for stock-based compensation expense, $0.8 million change in the fair value of the warrant liabilities, and $0.3 million in depreciation expense, partially offset by $0.4 million accretion of discounts on investments, net. Additionally, we had outflows of $7.5 million due to a change in our net operating assets and liabilities for the nine months ended September 30, 2026, including a $29.6 million increase in prepaid expenses and other current assets primarily related to deposits made to our CRO for clinical trial expenses, partially offset by a $22.0 million increase in accounts payable and accrued expenses primarily related to timing of payments and clinical trial expenses.
Previous wording
Cash provided by investing activities for the six months ended June 30, 2026 was $0.1 million primarily related to $10.2 million in proceeds from the sales and maturities of marketable securities, partially offset by $9.7 million for purchases of marketable securities and $0.4 million for purchases of property and equipment primarily related to our office expansion,.
Current wording
Cash used in investing activities for the nine months ended September 30, 2026 was $144.6 million primarily related to $166.1 million for the purchase of short-term investments to invest our excess cash and $0.5 million for purchases of property and equipment primarily related to our office expansion, partially offset by $22.0 million in proceeds from the sales and maturities of short-term investments.
Previous wording
Cash provided by investing activities for the six months ended June 30, 2025 was $5.0 million primarily related to proceeds from the sale and maturities of marketable securities.
Current wording
Cash used in investing activities for the nine months ended September 30, 2025 was $39.8 million primarily related to $44.8 million for the purchase of short-term investments to invest our excess cash, partially offset by $5.0 million in proceeds from the sale and maturities of short-term investments.
Previous wording
Cash provided by financing activities for the six months ended June 30, 2026 was approximately $93.8 million primarily related to the net proceeds from the private placement in February 2026.
Current wording
Cash provided by financing activities for the nine months ended September 30, 2026 was approximately $234.7 million primarily related to the net proceeds from the private placements in February 2026 and July 2026.
Previous wording
We expect our expenses to increase substantially in connection with our ongoing activities, as we continue to advance LB-102 and any of our future product candidates through clinical trials, scale the organization in preparation for a commercial launch of LB-102, if approved, as well as additional costs associated with operating as a public company.
Current wording
We expect our expenses to increase substantially in connection with our ongoing activities, as we continue to advance LB-102 through clinical trials, scale the organization in preparation for a commercial launch of LB-102, if approved, as well as additional costs associated with operating as a public company.
Previous wording
As of June 30, 2026, we had cash, cash equivalents and marketable securities of $327.8 million, which does not include net proceeds from our $150.0 million private placement in July 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 July 2026, will be sufficient to meet our anticipated operating and capital expenditure requirements beyond the second quarter of 2029.
Current wording
As of September 30, 2026, we had cash, cash equivalents and short-term investments of $403.8 million. Based on our current plans, we believe that our existing cash, cash equivalents and short-term investments will be sufficient to meet our anticipated operating and capital expenditure requirements beyond the second quarter of 2029.
Previous wording
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. We determined the amendment for additional space should be treated as a separate lease and recorded a right-of-use asset of $1.4 million and corresponding lease liability of $1.8 million during the three months ended June 30, 2026. See Note 7 Leases to our unaudited condensed financial statements for more information regarding such leases.
Current wording
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. We determined the amendment for additional space should be treated as a separate lease. See Note 11 Commitments and Contingencies to our unaudited condensed financial statements for more information regarding such leases.
Previous wording
We contract 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. These payments are not included in the preceding table as the amount and timing of such payments are not known.
Current wording
We contract 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 generally 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, and may also include termination penalties.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Current report — wording carried from elsewhere
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, tolerability and simplicity of use observed to date.
Current report — wording carried from elsewhere
In July 2026, we completed a private placement pursuant to which we issued and sold to certain investors an aggregate of (i) 3,577,560 shares of our common stock, par value $0.0001 per share, at a purchase price of $34.94 per share and (ii) pre-funded warrants to purchase up to 715,513 shares of our common stock at a purchase price of $34.9399 per pre-funded warrant, which represents the share price less the $0.0001 per share exercise price of each pre-funded warrant. The transaction closed on July
Current report — wording carried from elsewhere
Cash used in operating activities for the nine months ended September 30, 2025 was $17.1 million, consisting of net loss of $13.7 million adjusted for non-cash items, including a $1.9 million charge for stock-based compensation expense and $0.1 million in noncash lease expense partially offset by change in the fair value of the warrant liabilities of $1.6 million. Additionally, we had outflows of $4.1 million due to a change in our net operating assets and liabilities from the year ended December 31, 2024, including a $2.9 million decrease in accounts payable and accrued expense primarily related to timing of payments and clinical trial expenses, and a $1.0 million increase in prepaid expenses primarily related to payments for public company director and officers insurance.
Rearranged previous paragraphs (7)
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025 (in thousands):
Previous report — wording carried elsewhere
We generated no revenue during the six months ended June 30, 2026 and 2025.
Previous report — wording carried elsewhere
The following table summarizes our research and development expenses for the six months ended June 30, 2026 and 2025 (in thousands):
Previous report — wording carried elsewhere
Cash used in operating activities for the six months ended June 30, 2025 was $13.7 million, consisting of net loss of $10.2 million adjusted for non-cash items, including a gain on the change in fair value of the warrant liabilities of $0.6 million offset by a $1.0 million charge for stock-based compensation expense. Additionally, we had
Previous report — wording carried elsewhere
outflows of $4.0 million due to a change in our net operating assets and liabilities from the year ended December 31, 2024,
Previous report — wording carried elsewhere
including a $4.4 million decrease in accounts payable and accrued expense primarily related to timing of payments and