Full Press Release Details
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.
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
New Team Appointments
Financial Results for the Three Months ended September 30, 2025
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 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 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, 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 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
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 was $13.7 million for the nine months ended September 30, 2025, as compared to $58.0 million for the nine months ended
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.
LifeSci Communications
LB Pharmaceuticals Inc
Condensed Balance Sheets
(In thousands, except share and per share data)
| 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)
| 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 |