NEW YORK, Nov. 06, 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
Mtattory@lifescicomms.com
Investor Relations:
Joyce Allaire
LifeSci Advisors
JAllaire@LifeSciAdvisors.com
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 Nine Months Ended September
September 30, 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
(END) Dow Jones Newswires
November 06, 2025 08:00 ET (13:00 GMT)