LBRX 8-K
Lb Pharmaceuticals Inc (LBRX)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| (state or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
| |
||
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code:
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 | ||
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 6, 2025, LB Pharmaceuticals Inc (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2025. 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 (the “Securities Act”), 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 |
Description | |
| 99.1 | Press Release dated November 6, 2025. | |
| 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 6, 2025
Exhibit 99.1
LB Pharmaceuticals Reports 3Q 2025 Financial Results and Recent Corporate Updates
NEW YORK, November 6, 2025 (GLOBE NEWSWIRE) – LB Pharmaceuticals Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX) today announced financial results for the third quarter ended on September 30, 2025 and provided recent corporate updates.
“Following our recent initial public offering, we are well-positioned to continue executing on our strategy to advance LB-102 into a Phase 3 trial in acute schizophrenia, as well as a Phase 2 trial in bipolar depression,” said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. “The robust and statistically significant results recently reported from our potentially registrational Phase 2 trial in acute schizophrenia confirm the meaningful clinical impact and differentiated tolerability of LB-102, which we believe has the potential to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. Our team is focused on advancing LB-102 towards FDA approval to expand treatment options for underserved patients.”
Recent Corporate Updates
| • | In September 2025, the Company announced the pricing of its upsized initial public offering of 21,850,000 shares of its common stock at a price of $15.00 per share. The aggregate gross proceeds to LB Pharmaceuticals from the offering were $327.8 million. |
| • | In October 2025, the Company presented three posters featuring new and previously reported analyses from its Phase 2 NOVA1 clinical trial of LB-102 in acute schizophrenia at the 38th European College of Neuropsychopharmacology (“ECNP”) Congress, which took place in Amsterdam, The Netherlands, from October 11-14, 2025. Using a validated battery of cognitive tests in its Phase 2 acute schizophrenia trial, a post-hoc analysis demonstrated that after four weeks of treatment with LB-102, a robust, dose-dependent, and significant treatment effect size was identified in a completer population for all doses of LB-102 compared with placebo. The treatment effect size versus placebo was 0.26 (p=0.0476) at the 50 mg dose, 0.41 (p=0.0027) at the 75 mg dose and reached 0.66 (p=0.0018) at the 100 mg dose. Significant effect sizes of the magnitude reported in this trial provide early evidence that LB-102 may positively impact cognitive deficits—an area of significant unmet need that spans across schizophrenia and mood disorders. |
| • | The Company presented two additional posters at ECNP, which included an encore presentation of the primary efficacy and safety results from the NOVA1 trial, and a post-hoc analysis focused on the effects of LB-102 on negative symptoms in a subset of patients with prominent negative symptoms at baseline. |
| • | Collectively, these analyses further reinforce LB-102’s balanced clinical profile, which is characterized by clinically meaningful reduction in Positive and Negative Syndrome Scale (“PANSS”) scores, a generally favorable and potentially class-leading tolerability profile and differentiated clinical activity across multiple symptom domains. |
| • | To increase the statistical power of its planned Phase 3 clinical trial in acute schizophrenia, the Company plans to increase the sample size of this trial from approximately 400 patients to approximately 460 patients. The Company is planning to initiate this trial in the first quarter of 2026 and continues to expect to report topline data for this trial in the second half of 2027. |
| • | The Company also plans to initiate a potentially registrational Phase 2 trial in bipolar depression in the first quarter of 2026 and expects to report topline data for this trial in the first quarter of 2028. |
New Team Appointments
| • | In September 2025, the Company announced the appointments of William Kane and Rekha Hemrajani to its Board of Directors. These new Board members add valuable expertise in finance, business development, CNS product commercialization, and corporate strategy. |
| • | In October 2025, LB Pharmaceuticals announced the appointment of James Rawls, Pharm.D., as Senior Vice President of Regulatory Affairs. Throughout his career, Dr. Rawls has led or contributed to more than a dozen successful regulatory filings and product approvals in the United States, Europe, and Japan, with specific experience in neuropsychiatric diseases. |
Financial Results for the Three Months ended September 30, 2025
| • | Research & Development Expenses: |
Research and development expenses were $2.4 million for the third quarter of 2025, as compared to $10.7 million in the third quarter of 2024. The decrease was primarily due to a decrease in clinical trial expenses related to the conduct of our Phase 2 clinical trial of LB-102 in acute schizophrenia in 2024.
| • | General & Administrative Expenses: |
General and administrative expenses were $2.8 million for the third quarter of 2025, as compared to $5.4 million for the third quarter of 2024. The decrease was primarily due to the write-off of deferred financing costs in 2024.
| • | Net Loss: |
Net loss was $3.6 million for the third quarter of 2025, as compared to a net loss of $14.2 million for the third quarter of 2024.
| • | Cash Position: |
Cash, cash equivalents and marketable securities as of September 30, 2025 were approximately $314.5 million following the Company’s initial public offering in September. Based on current operating assumptions, the Company anticipates its current cash, cash equivalents and marketable securities will support its planned operations into the second quarter of 2028.
Financial Results for the Nine Months ended September 30, 2025
| • | Research & Development Expenses: |
Research and development expenses were $8.3 million for the nine months ended September 30, 2025, as compared to $50.8 million for the nine months ended September 30, 2024. The decrease was primarily due to a decrease in clinical trial expenses related to the conduct of our Phase 2 clinical trial of LB-102 in acute schizophrenia in 2024.
| • | General & Administrative Expenses: |
General and administrative expenses were $8.3 million for the nine months ended September 30, 2025, as compared to $8.5 million for the nine months ended September 30, 2024.
| • | Net Loss: |
Net loss was $13.7 million for the nine months ended September 30, 2025, as compared to $58.0 million for the nine months ended September 30, 2024.
About LB-102
LB-102 is a Phase 3-ready oral, small molecule and a methylated derivative of amisulpride. In early 2025, LB Pharmaceuticals announced positive data from a four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia. The Phase 2 trial demonstrated statistically significant benefit versus placebo at all doses studied, a potentially class leading safety profile among D2 antagonists and partial agonists, and positive effects on negative symptoms and cognition. LB-102 is advancing into a Phase 3 clinical trial for acute schizophrenia and a Phase 2 clinical trial for bipolar depression. Additional expansion opportunities for LB-102 could include major depressive disorder (MDD), predominantly negative symptoms of schizophrenia, Alzheimer’s disease psychosis and agitation, as well as bipolar mania and cognitive impairment associated with schizophrenia.
About LB Pharmaceuticals
LB Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapies for the treatment of schizophrenia, bipolar depression, and other neuropsychiatric diseases. 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 potential 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 a potentially attractive alternative to branded and generic therapeutics for the treatment of schizophrenia, bipolar depression, and 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 design, objectives and timing of the Phase 3 trial in acute schizophrenia and the Phase 2 trial in bipolar depression; the expected regulatory pathway and therapeutic benefits of LB-102 and continuing advancement of LB-102 and the Company’s portfolio; and anticipated cash runway into the second quarter of 2028. 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 Company’s filings with the Securities and Exchange Commission (the “SEC”) and its other documents to be subsequently filed with or furnished to the SEC. 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.
Contacts
Media:
Michael Tattory
LifeSci Communications
Investor Relations:
Joyce Allaire
LifeSci Advisors
LB Pharmaceuticals Inc
Condensed Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
| As of | ||||||||
| September 30, 2025 |
December 31, 2024 |
|||||||
| Assets |
||||||||
| Current assets |
||||||||
| Cash and cash equivalents |
$ | 269,744 | $ | 22,978 | ||||
| Marketable securities |
44,735 | 5,021 | ||||||
| Prepaid expenses and other current assets |
1,922 | 880 | ||||||
|
|
|
|
|
|||||
| Total current assets |
316,401 | 28,879 | ||||||
| Operating lease right-of-use assets, net |
2,198 | 2,298 | ||||||
| Property and equipment, net |
1,635 | 1,859 | ||||||
| Restricted cash |
512 | 498 | ||||||
|
|
|
|
|
|||||
| Total assets |
$ | 320,746 | $ | 33,534 | ||||
|
|
|
|
|
|||||
| Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) |
||||||||
| Current liabilities |
||||||||
| Accounts payable |
$ | 2,590 | $ | 2,320 | ||||
| Accrued expenses |
3,327 | 5,302 | ||||||
| Operating lease liability, current |
730 | 487 | ||||||
|
|
|
|
|
|||||
| Total current liabilities |
6,647 | 8,109 | ||||||
| Derivative liability - warrants |
942 | 2,504 | ||||||
| Operating lease liability, noncurrent |
2,936 | 3,216 | ||||||
|
|
|
|
|
|||||
| Total liabilities |
10,525 | 13,829 | ||||||
|
|
|
|
|
|||||
| Commitments and contingencies |
||||||||
| Redeemable convertible preferred stock |
||||||||
| Series Seed preferred stock, $0.0001 par value, zero and 295,467 shares authorized, zero and 295,467 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively. Liquidation preference of zero and $443 as of September 30, 2025 and December 31, 2024, respectively. |
— | 435 | ||||||
| Series A preferred stock, $0.0001 par value, zero and 3,655,374 shares authorized, zero and 3,655,374 outstanding as of September 30, 2025 and December 31, 2024, respectively. Liquidation preference of zero and $8,407 as of September 30, 2025 and December 31, 2024, respectively. |
— | 6,179 | ||||||
| Series B preferred stock, $0.0001 par value, zero and 301,119 shares authorized, zero and 301,119 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively. Liquidation preference of zero and $903 as of September 30, 2025 and December 31, 2024, respectively. |
— | 580 | ||||||
| Series C preferred stock, $0.0001 par value, zero and 75,000,000 shares authorized, zero and 73,820,346 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively. Liquidation preference of zero and $110,731 as of September 30, 2025 and December 31, 2024, respectively. |
— | 107,065 | ||||||
| Stockholders’ equity (deficit) |
||||||||
| Common stock, $0.0001 par value, 500,000,000 and 105,000,000 shares authorized, 25,299,102 and 251,655 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively. |
3 | 1 | ||||||
| Additional paid-in capital |
428,327 | 9,657 | ||||||
| Accumulated deficit |
(118,056 | ) | (104,323 | ) | ||||
| Accumulated other comprehensive (loss) income |
(53 | ) | 111 | |||||
|
|
|
|
|
|||||
| Total stockholders’ equity (deficit) |
310,221 | (94,554 | ) | |||||
|
|
|
|
|
|||||
| Total liabilities, redeemable convertible preferred stock and stockholders’ deficit |
$ | 320,746 | $ | 33,534 | ||||
|
|
|
|
|
|||||
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, |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses |
||||||||||||||||
| Research and development |
$ | 2,419 | $ | 10,664 | $ | 8,261 | $ | 50,795 | ||||||||
| General and administrative |
2,827 | 5,419 | 8,273 | 8,496 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total operating loss |
(5,246 | ) | (16,083 | ) | (16,534 | ) | (59,291 | ) | ||||||||
| Non-operating income (expense) |
||||||||||||||||
| Interest income |
707 | 384 | 1,120 | 1,423 | ||||||||||||
| Realized gain on sale of marketable securities, net |
— | 503 | 119 | 593 | ||||||||||||
| Gain (loss) on change in fair value of derivative instruments |
983 | 1,015 | 1,562 | (756 | ) | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total non-operating income |
1,690 | 1,902 | 2,801 | 1,260 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Loss before income tax |
(3,556 | ) | (14,181 | ) | (13,733 | ) | (58,031 | ) | ||||||||
| Income tax provision |
— | — | — | — | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss |
$ | (3,556 | ) | $ | (14,181 | ) | $ | (13,733 | ) | $ | (58,031 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss per share, basic and diluted |
$ | (0.61 | ) | $ | (39.49 | ) | $ | (6.26 | ) | $ | (162.15 | ) | ||||
| Weighted average shares outstanding used in calculating net loss per share, basic and diluted |
5,806,862 | 359,079 | 2,195,199 | 357,891 | ||||||||||||