STOCK TITAN

LB Pharmaceuticals Q3 loss widens to $59.1M

Susan G. Kozauer, M.D., was appointed chief medical officer, and Joseph Miller was appointed chief financial officer.

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Form Type
8-K

Rhea-AI Filing Summary

LB Pharmaceuticals reported a third-quarter net loss of $59.066 million, compared with $3.556 million a year earlier, as research and development expense was $51.516 million versus $2.419 million. Net loss for the first nine months of 2026 was $129.723 million, compared with $13.733 million in the same 2025 period.

Cash, cash equivalents and short-term investments totaled $403.760 million as of September 30, 2026, compared with $295.213 million as of December 31, 2025. The company expects these funds to support operations beyond Q2 2029 and through multiple clinical milestones. It completed a $150 million private placement in July 2026 to fund expansion of LB-102 into new indications.

The company said it remains on track to report topline results from the pivotal Phase 3 NOVA-2 schizophrenia trial in the first half of 2027; the Phase 2 ILLUMINATE-1 trial in bipolar 1 depression is ongoing.

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Positive

  • None.

Negative

  • Moderate pointQuarterly net loss rose to $59.066 million from $3.556 million in 2025.
Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Net loss $59.066 million Three months ended September 30, 2026; compared with $3.556 million in the same 2025 period
Research and development expense $51.516 million Three months ended September 30, 2026; compared with $2.419 million in the same 2025 period
Net loss $129.723 million Nine months ended September 30, 2026; compared with $13.733 million in the same 2025 period
Cash, cash equivalents and short-term investments $403.760 million As of September 30, 2026
Private placement $150 million Completed in July 2026 to fund expansion of LB-102 into new indications
Expected cash runway Beyond Q2 2029 Company expects funds to support operations through multiple clinical milestones
Expected NOVA-2 topline readout First half of 2027 Pivotal Phase 3 trial in schizophrenia; company said it remains on track
topline data readout technical
"on track for topline data readout from the pivotal Phase 3 NOVA-2 trial"
A topline data readout is the initial summary of a clinical trial’s most important results, showing whether the study met its main goals. Like a headline score after a sports game, it gives investors a quick sense of success or failure that can shift a company’s outlook, affect future funding, and move the stock while more detailed analyses and regulatory reviews follow.
pivotal Phase 3 trial medical
"pivotal Phase 3 NOVA-2 trial of LB-102 in schizophrenia"
A pivotal phase 3 trial is the late-stage clinical study designed to provide the decisive evidence regulators need to approve a new drug or medical treatment. Think of it as the final exam where the treatment must prove it works and is safe in a large group of people; investors watch the results closely because a positive outcome can unlock regulatory approval, sales, milestone payments and big changes in a company’s valuation.
bimodal mechanism of action technical
"preclinical data supporting LB-102’s bimodal mechanism of action"
cash runway financial
"cash runway expected to extend beyond the second quarter of 2029"
Cash runway is the amount of time a company can continue operating using its available cash before needing additional funding or generating enough revenue. It’s like a countdown showing how long a business can keep running with its current funds. Knowing the cash runway helps investors assess the company's financial health and whether it has enough resources to reach its goals or needs to find more support soon.
benzamide antipsychotic medical
"first benzamide antipsychotic drug approved for neuropsychiatric disorders"
Net loss, three months $59.066 million Compared with $3.556 million in the same 2025 period
Research and development expense, three months $51.516 million Compared with $2.419 million in the same 2025 period
Net loss, nine months $129.723 million Compared with $13.733 million in the same 2025 period
Cash, cash equivalents and short-term investments $403.760 million Compared with $295.213 million as of December 31, 2025

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What cash runway did LBRX report in its third-quarter update?

LB Pharmaceuticals reported $403.760 million in cash, cash equivalents and short-term investments as of September 30, 2026, and said it expected those funds to support operations beyond Q2 2029, through multiple clinical milestones.

When does LBRX expect NOVA-2 results?

LB Pharmaceuticals said it remains on track to report topline results from its pivotal Phase 3 NOVA-2 trial in schizophrenia in the first half of 2027.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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false 0001691082 0001691082 2026-11-05 2026-11-05
 
 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 5, 2026

 

 

LB Pharmaceuticals Inc

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-42831   81-1854347

(state or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

1 Pennsylvania Plaza, Suite 1025

New York, NY

  10119
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (212) 605-0300

Not applicable

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol

 

Name of each exchange

on which registered

Common Stock, $0.0001 par value per share   LBRX   The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 
 


Item 2.02

Results of Operations and Financial Condition.

On November 5, 2026, LB Pharmaceuticals Inc (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2026. A copy of the press release is furnished hereto as Exhibit 99.1.

The information in this Item 2.02, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section. The information contained in this Item 2.02 and in the accompanying exhibit is not incorporated by reference in any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
No.
  

Description

99.1    Press Release dated November 5, 2026.
104    Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document)


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

LB PHARMACEUTICALS INC
By:  

/s/ Heather Turner

  Heather Turner
  Chief Executive Officer

Dated: November 5, 2026

Exhibit 99.1

 

LOGO

LB Pharmaceuticals Reports Third Quarter 2026 Financial Results and Provides Corporate Update

Strengthened leadership with the appointment of Susan G. Kozauer, M.D., as Chief Medical Officer and Joseph Miller as Chief Financial Officer

On track for topline data readout from the pivotal Phase 3 NOVA-2 trial of LB-102 in schizophrenia in 1H 2027

Presented new preclinical data supporting LB-102’s bimodal mechanism of action at the 39th ECNP Congress

Completed a private placement of $150 million to fund expansion of LB-102 into new indications

Cash, cash equivalents, and short-term investments of $403.8 million as of September 30, 2026, expected to fund operations beyond Q2 2029, through multiple clinical milestones

NEW YORK, November 5, 2026 (GLOBE NEWSWIRE) – LB Pharmaceuticals Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX), a neuromedicines company dedicated to developing and commercializing high-impact therapies that address the multiple dimensions of underserved brain disorders, today announced financial results for the third quarter ended September 30, 2026, and provided a corporate update.

“We recently strengthened our leadership team with the appointments of Dr. Susan Kozauer as Chief Medical Officer and Joe Miller as Chief Financial Officer, adding two highly accomplished executives whose expertise is directly aligned with our next phase of growth as we advance LB-102 across multiple neuropsychiatric indications and prepare for potential commercialization in schizophrenia,” said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. “Our recent R&D Day highlighted why we believe LB-102 has the potential to become the branded antipsychotic of choice, based on a differentiated profile with the potential to balance efficacy, tolerability, and simplicity of use. We remain on track to report topline results from our Phase 3 NOVA-2 trial of LB-102 in schizophrenia in the first half of 2027. With a strong balance sheet and cash runway expected to extend beyond the second quarter of 2029, we believe we are exceptionally well positioned to maximize the broader potential of LB-102.”

Third Quarter 2026 and Recent Highlights

The Company’s lead asset, LB-102, is a novel investigational medicine designed to address the substantial unmet treatment needs of patients living with schizophrenia, bipolar depression, major depressive disorder (“MDD”), and other brain disorders. LB-102 is in late-stage development and has the opportunity to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States.

LB-102 in Schizophrenia

 

  •  

Enrollment in the pivotal Phase 3 NOVA-2 trial evaluating the efficacy and safety of LB-102 in patients with acute schizophrenia continues to progress strongly with topline data expected in the first half of 2027. The Company expects to schedule a pre-New Drug Application meeting with the U.S. Food and Drug Administration (“FDA”) thereafter in the second half of 2027.


  •  

The 52-week open-label safety and tolerability trial (NOVA-3), evaluating the long-term safety and tolerability of LB-102 in patients with stable schizophrenia, continues to enroll eligible patients who have completed NOVA-2, as well as de novo patients.

 

  •  

Presented four posters at the 39th European College of Neuropsychopharmacology (ECNP) Congress in October 2026 highlighting new preclinical data supporting LB-102’s bimodal mechanism of action and the late-stage clinical development program in schizophrenia.

 

  •  

Based on ongoing engagement with FDA about a trial in predominantly negative symptoms of schizophrenia, the Company expects to provide an update about a potential trial design in the first quarter of 2027.

LB-102 in Mood Disorders: Bipolar Depression and Adjunctive Treatment of MDD

 

  •  

The Phase 2 ILLUMINATE-1 trial evaluating the efficacy and safety of LB-102 in patients with bipolar 1 depression continues to enroll patients, with topline data expected in the first quarter of 2028.

 

  •  

Initiation of the Phase 2 trial in the adjunctive treatment of MDD is expected in early 2027, with topline data expected in the first half of 2029.

Corporate Updates

 

  •  

In July 2026, the Company completed a private placement of $150.0 million with participation from new and existing institutional investors. The proceeds are intended to fund expansion of LB-102 into new indications, potentially including negative symptoms of schizophrenia and Alzheimer’s disease psychosis/agitation, and for general corporate purposes. Net proceeds were approximately $140.9 million, after deducting financial advisory fees and other financing expenses.

 

  •  

In September 2026, the Company announced the appointments of:

 

  •  

Susan G. Kozauer, M.D., as Chief Medical Officer. Dr. Kozauer is a leader in neuropsychiatric drug development with more than two decades of development expertise spanning early-stage clinical studies through regulatory approval.

 

  •  

Joseph Miller as Chief Financial Officer. Mr. Miller is a biopharmaceutical finance executive with more than two decades of experience leading financial strategy and operations and enterprise transformation for publicly traded companies.

 

  •  

In October 2026, the Company’s management hosted an R&D Day, featuring Roger McIntyre, M.D., FRCPC. The event highlighted new scientific insights on LB-102’s unique mechanism of action that underlies the emerging clinical profile and potential opportunity across a wide variety of brain disorders, and featured discussion of the ongoing Phase 3 trial in schizophrenia, its upcoming topline data readout, and pre-commercial planning activities.

Financial Results for the Three and Nine Months Ended September 30, 2026

 

  •  

Research & Development Expenses: 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. For the nine months ended September 30, 2026, research and development expenses were $110.3 million, compared to $8.3 million for the nine months ended September 30, 2025. The increases are primarily attributable to the advancement of our Phase 3 trial of LB-102 in the treatment of patients with acute schizophrenia, and our Phase 2 trial of LB-102 in the treatment of patients with bipolar depression.


  •  

General & Administrative Expenses: 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. For the nine months ended September 30, 2026, general and administrative expenses were $28.2 million, compared to $8.3 million for the nine months ended September 30, 2025. The increases are primarily attributable to cash and non-cash compensation due to an increase in employee headcount, as well as increased consulting expenses and costs associated with being a public company.

 

  •  

Net Loss: Net loss was $59.1 million for the three months ended September 30, 2026, as compared to $3.6 million for the three months ended September 30, 2025. For the nine months ended September 30, 2026, net loss was $129.7 million, as compared to $13.7 million for the nine months ended September 30, 2025.

 

  •  

Cash Position: Cash, cash equivalents, and short-term investments as of September 30, 2026, were $403.8 million. Based on current operating assumptions, the Company anticipates its current cash, cash equivalents, and short-term investments will support its planned operations beyond the second quarter of 2029.

About LB Pharmaceuticals

LB Pharmaceuticals is a neuromedicines company dedicated to developing and commercializing high-impact therapies that address the multiple dimensions of underserved brain disorders. The Company is building a pipeline that leverages the broad therapeutic potential of its lead product candidate, LB-102, which the Company believes has the opportunity to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102, if approved, has the potential to become a mainstay of psychiatric practice by offering balanced clinical activity and tolerability along with simplicity of use that provides a potentially attractive alternative to branded and generic therapeutics for the treatment of a broad range of neuropsychiatric diseases.

About LB-102

LB-102 is a novel, once-daily, orally administered investigational small molecule being developed for multiple neuropsychiatric disorders. It is a new chemical entity that has been structurally engineered with a modification to amisulpride, a widely used antipsychotic outside the United States, and has the potential to be the first benzamide antipsychotic in the United States for the treatment of neuropsychiatric disorders. LB-102 was developed with the aim of retaining amisulpride’s benefits while addressing its limitations. LB-102 is a potent and selective antagonist of D2, D3, and 5-HT7 receptors with few off-target effects and which may have broad therapeutic potential across psychosis and mood disorders. In early 2025, LB Pharmaceuticals announced positive data from a four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia. In this trial, LB-102 demonstrated statistically significant benefit versus placebo at all doses studied, including rapid onset of effect at week 1 and sustained benefit through the endpoint of the trial, a potentially class-leading safety profile with low rates of EPS (including akathisia), minimal sedation and few GI side effects, alongside effects on negative symptoms and cognitive performance. These data underscore LB-102’s potential to address multiple dimensions of neuropsychiatric illness. The pivotal Phase 3 NOVA-2 trial of LB-102 for acute schizophrenia and the Phase 2 ILLUMINATE-1 trial of LB-102 for bipolar 1 depression are ongoing, and a Phase 2 trial of LB-102 in adjunctive treatment of MDD is planned. The Company is also pursuing additional expansion opportunities for LB-102 including predominantly negative symptoms of schizophrenia, Alzheimer’s disease psychosis and agitation, as well as other neuropsychiatric diseases.


Cautionary Note Regarding Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected clinical development and regulatory pathway and therapeutic benefits of LB-102; the design, objectives, initiation, timing, progress and results of clinical trials of LB-102, including the pivotal Phase 3 NOVA-2 trial in acute schizophrenia and the expected pre-NDA meeting with the FDA, our open label trial (NOVA-3), the Phase 2 ILLUMINATE-1 trial in bipolar 1 depression and the Phase 2 trial for the adjunctive treatment of MDD; the Company’s plan to pursue any additional indications including negative symptoms of schizophrenia and Alzheimer’s disease psychosis/agitation; the intended use of proceeds from the Company’s July 2026 private placement; the Company’s pre-commercial planning activities; and anticipated cash runway beyond the second quarter of 2029; continued advancement of LB-102 and the Company’s portfolio. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: the Company’s limited operating history and historical losses; the Company’s ability to raise additional funding to complete the development and any commercialization of LB-102; the Company’s dependence on the success of its lead product candidate, LB-102; the Company’s ability to obtain regulatory approval of and successfully commercialize its product candidate; the early stages of clinical development of the Company’s lead product candidate, LB-102; any undesirable side effects or other properties of the Company’s product candidate; that the Company may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; the Company’s ability to obtain, maintain and protect its intellectual property; and the Company’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies.

These and other risks are described more fully in the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, and its other documents to be subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Media and Investor Contact:

Ellen Rose

erose@lbpharma.us


LB Pharmaceuticals Inc

Condensed Statements of Operations

(in thousands, except share and per share data)

(Unaudited)

 

 

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2026     2025     2026     2025  

Operating expenses

        

Research and development

   $ 51,516     $ 2,419     $ 110,307     $ 8,261  

General and administrative

     10,982       2,827       28,211       8,273  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating loss

     (62,498 )      (5,246 )      (138,518 )      (16,534 ) 

Non-operating income

        

Interest income

     3,771       707       9,596       1,120  

Realized gain on sale of short-term investments, net

     3       —        3       119  

(Loss) gain on change in fair value of derivative instruments

     (342 )      983       (804 )      1,562  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total non-operating income

     3,432       1,690       8,795       2,801  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income tax

     (59,066 )      (3,556 )      (129,723 )      (13,733 ) 

Income tax provision

     —        —        —        —   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (59,066 )    $ (3,556 )    $ (129,723 )    $ (13,733 ) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share, basic and diluted

   $ (1.79 )    $ (0.61 )    $ (4.25 )    $ (6.26 ) 

Weighted average shares outstanding used in calculating net loss per share, basic and diluted

     33,080,348       5,806,862       30,504,318       2,195,199  


LB Pharmaceuticals Inc

Unaudited Condensed Balance Sheets

(In thousands)

 

 

 

     As of  
     September 30, 2026      December 31, 2025  

Cash, cash equivalents and short-term investments

   $ 403,760      $ 295,213  

Total assets

   $ 453,370      $ 312,934  

Total liabilities

   $ 35,730      $ 11,624  

Total stockholders’ equity

   $ 417,640      $ 301,310  

Filing Exhibits & Attachments

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