Celcuity Inc. Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
-- The PIK3CA wild-type cohort of the VIKTORIA-1 Phase 3 trial is on track
to report topline data in Q2 2025
-- VIKTORIA-2 Phase 3 remains on track to enroll its first patient in Q2
2025
-- Presented encouraging preliminary overall survival data from the Phase 1b
study evaluating gedatolisib in combination with palbociclib and
endocrine therapy at the 2024 SABCS
-- Approximately $235.1 million in cash, cash equivalents and short-term
investments at end of Q4 2024 expected to fund current clinical
development program activities through 2026
-- Management to host webcast and conference call today, March 31, 2025, at
4:30 p.m. ET
MINNEAPOLIS, March 31, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial results for the fourth quarter ended December 31, 2024 and other recent business developments.
"We expect 2025 to be a transformational year for Celcuity as we anticipate reporting several clinical data readouts, including primary analysis for the PIK3CA wild-type cohort of the VIKTORIA-1 trial. We expect to share topline data in Q2 2025," said Brian Sullivan, CEO and co-founder of Celcuity. "In addition, we anticipate reporting topline data for the Phase 1b/2 trial in metastatic castration resistant prostate cancer in late Q2 2025, and topline data for the PIK3CA mutant-type cohort of the VIKTORIA-1 trial in Q4 2025. We also remain on track to enroll the first patient for our VIKTORIA-2 Phase 3 trial in Q2 2025."
Fourth Quarter 2024 Business Highlights and Other Recent Developments
-- The VIKTORIA-1 Phase 3 clinical trial evaluating gedatolisib in
combination with fulvestrant with and without palbociclib in adults with
HR+, HER2- advanced breast cancer who have received prior treatment with
a CDK4/6 inhibitor is 100% enrolled for the PIK3CA wild-type cohort. We
expect to provide topline data in Q2 2025.
-- Enrollment for the PIK3CA mutant cohort remains on track and
topline data is expected in Q4 of 2025.
-- The VIKTORIA-2 Phase 3 open-label randomized study evaluating the
efficacy and safety of gedatolisib in combination with fulvestrant plus a
CDK4/6 inhibitor, either ribociclib or palbociclib, in comparison to
fulvestrant plus a CDK4/6 inhibitor as a first-line treatment for
patients with HR+/HER2- advanced breast cancer who are endocrine therapy
resistant remains on track to enroll its first patient in Q2 2025.
-- A safety run-in study preceding the initiation of the Phase 3
portion of the study will be conducted in 12-36 participants to
assess the safety profile of gedatolisib in combination with
ribociclib and fulvestrant.
-- Site selection activities are completed. We expect to activate
approximately 200 sites across North America, Europe, Latin
America, and Asia-Pacific.
-- The Phase 3 portion of the study is expected to enroll
approximately 638 patients.
-- The Phase 1b/2 clinical trial, evaluating gedatolisib in combination with
darolutamide for the treatment of patients with metastatic castration
resistant prostate cancer ("mCRPC"), is ongoing and remains on track to
report preliminary data in late Q2 2025.
-- The study is expected to enroll up to 54 patients with mCRPC whose
disease progressed while on or after treatment with an androgen
receptor signaling inhibitor.
-- In December 2024, Celcuity presented overall survival data from a Phase
1b trial, which evaluated gedatolisib in combination with palbociclib and
either letrozole or fulvestrant, in patients with HR+, HER2- advanced or
metastatic breast cancer during a poster session at the 2024 San Antonio
Breast Cancer Symposium (SABCS). Median overall survival was 77.3 months
among patients with HR+, HER2- advanced breast cancer who were
treatment-naïve in the advanced setting and 33.9 months among
patients previously treated with a CDK4/6 inhibitor.
-- Results compare favorably to published data for currently
available first- or second-line standard-of-care treatment
regimens for patients with HR+, HER2- advanced breast cancer and
highlight the promising clinical development strategy of
simultaneously inhibiting the ER, CDK4/6, and PAM (PI3K/AKT/mTOR)
signaling pathways.
Fourth Quarter and Full Year 2024 Financial Results
Unless otherwise stated, all comparisons are for the fourth quarter and full year ended December 31, 2024, compared to the fourth quarter and full year ended December 31, 2023.
Total operating expenses were $36.4 million for the fourth quarter of 2024, compared to $19.7 million for the fourth quarter of 2023. Operating expenses for the full year 2024 were $113.3 million, compared to $66.2 million for the full year 2023.
Research and development ("R&D") expenses were $33.5 million for the fourth quarter of 2024, compared to $18.1 million for the prior-year period. Of the approximately $15.4 million increase in R&D expenses, $9.9 million primarily related to costs supporting ongoing activities for the VIKTORIA-1 Phase 3 trial and the CELC-G-201 Phase 1b/2 trial, along with the commencement of the VIKTORIA-2 Phase 3 trial. The remaining $5.5 million primarily relates to increased employee and consulting expenses.
R&D expenses for the full year 2024 were $104.2 million, compared to $60.6 million for the prior year. Of the approximately $43.6 million increase in R&D expenses, $30.7 million was related to costs supporting ongoing activities for the VIKTORIA-1 Phase 3 trial and the CELC-G-201 Phase 1b/2 clinical trial, along with the commencement of the VIKTORIA-2 Phase 3 trial. The remaining $12.9 million increase in R&D expenses was primarily related to increased employee and consulting expenses.
General and administrative ("G&A") expenses were $3.0 million for the fourth quarter of 2024, compared to $1.6 million for the prior year period. Of the approximately $1.4 million increase, $1.1 million was related to increased employee-related expenses, and $0.3 million was related to professional fees, expanding infrastructure costs and other administrative expenses.
G&A expenses for the full year 2024 were $9.1 million, compared to $5.6 million for the prior year. Of the approximately $3.4 million increase in G&A expenses, $2.6 million was related to increased employee-related expenses, and $0.8 million was related to professional fees, expanding infrastructure costs, and other administrative expenses.
Net loss for the fourth quarter of 2024 was $36.7 million, or $0.85 loss per share, compared to a net loss of $18.8 million, or $0.65 loss per share, for the fourth quarter of 2023. Net loss for the full year 2024 was $111.8 million, or $2.83 loss per share, compared to a net loss of $63.8 million, or $2.69 loss per share, in 2023. Non-GAAP adjusted net loss for the fourth quarter of 2024 was $32.3 million, or $0.75 loss per share, compared to non-GAAP adjusted net loss of $17.6 million, or $0.61 loss per share, for the fourth quarter of 2023. Non-GAAP adjusted net loss for the full year 2024 was $101.9 million, or $2.58 loss per share, compared to non-GAAP adjusted net loss of $57.8 million, or $2.44 loss per share, for 2023. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity's cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States ("GAAP") to non-GAAP financial measures, please see the financial tables at the end of this press release.
Net cash used in operating activities for the fourth quarter of 2024 was $27.8 million, compared to $18.5 million for the fourth quarter of 2023. Net cash used in operating activities for the full year 2024 was $83.5 million, compared to $53.8 million for the full year 2023. Cash, cash equivalents and short-term investments were approximately $235.1 million at the end of fiscal year 2024 and are expected to fund current clinical development program activities through 2026.
Webcast and Conference Call Information
The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the fourth quarter and full year 2024 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this weblink: https://viavid.webcasts.com/starthere.jsp?ei=1704367&tp_key=f99d4186f3. A replay of the webcast will be available on the Celcuity website following the live event.
About Celcuity
Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PI3K/AKT/mTOR ("PAM") pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3K<ALPHA>, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+, HER2- advanced breast cancer is currently enrolling patients. More detailed information about the VIKTORIA-1 study can be found at ClinicalTrials.gov . A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer is currently recruiting patients. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com . Follow us on LinkedIn and Twitter .
Forward-Looking Statements
This press release contains statements that constitute "forward-looking statements" including, but not limited to, the design of our clinical trials; the timing of initiating and enrolling patients in, and receiving results and data from, our clinical trials; the costs and expected results from any ongoing or planned clinical trials; the market opportunity for gedatolisib; revenue expectations; our strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to Celcuity's lead product candidate, gedatolisib, and its CELsignia platform; our anticipated use of cash; and the strength of our balance sheet. In some cases, you can identify forward-looking statements by terminology such as "may," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "intends" or "continue," and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. Forward-looking statements are subject to numerous risks, uncertainties, and conditions, many of which are beyond the control of Celcuity. These include, but are not limited to, unforeseen delays in our clinical trials, our ability to obtain and maintain regulatory approvals to commercialize our products, and the market acceptance of such products, the development of therapies and tools competitive with our products, our ability to access capital upon favorable terms or at all, and those risks set forth in the Risk Factors section in Celcuity's Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission on March 31, 2025. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Celcuity undertakes no obligation to update these statements for revisions or changes after the date of this press release, except as required by law.
View source version of release on GlobeNewswire.com
Contacts:
Celcuity Inc.
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
(763) 392-0123
ICR Healthcare
Patti Bank, patti.bank@icrhealthcare.com
(415) 513-1284
Celcuity Inc.
Balance Sheets
December 31, 2024 December 31, 2023
------------------- -------------------
Assets
Current Assets:
Cash and cash equivalents $ 22,514,823 $ 30,662,774
Investments 212,588,960 149,919,974
Other current assets 9,467,247 10,007,849
Total current assets 244,571,030 190,590,597
Property and equipment, net 336,515 228,782
Operating lease right-of-use
assets 215,502 400,019
Total Assets $ 245,123,047 $ 191,219,398
=============== ===============
Liabilities and Stockholders'
Equity:
Current Liabilities:
Accounts payable $ 9,366,007 $ 5,076,699
Operating lease liabilities 171,952 184,950
Accrued expenses 22,184,948 8,927,094
Total current liabilities 31,722,907 14,188,743
Operating lease liabilities 53,969 225,922
Note payable, non-current 97,727,136 37,035,411
Total Liabilities 129,504,012 51,450,076
--------------- ---------------
Total Stockholders' Equity 115,619,035 139,769,322
--------------- ---------------
Total Liabilities and
Stockholders' Equity $ 245,123,047 $ 191,219,398
=============== ===============
Celcuity Inc.
Statements of Operations
Three Months Ended December Twelve Months Ended December
31, 31,
2024 2023 2024 2023
------------ ------------ ------------- ------------
Operating
expenses:
Research and
development $ 33,471,213 $ 18,081,194 $ 104,203,230 $ 60,594,005
General and
administrative 2,958,918 1,648,079 9,063,721 5,636,326
Total operating
expenses 36,430,131 19,729,273 113,266,951 66,230,331
------------ ------------ ------------- ------------
Loss from
operations (36,430,131) (19,729,273) (113,266,951) (66,230,331)
------------ ------------ ------------- ------------
Other (expense)
income
Interest
expense (3,275,161) (1,397,247) (10,280,445) (5,326,387)
Interest income 3,052,251 2,278,048 11,768,291 7,777,602
Other (expense)
income, net (222,910) 880,801 1,487,846 2,451,215
------------ ------------ ------------- ------------
Net loss before
income taxes (36,653,041) (18,848,472) (111,779,105) (63,779,116)
------------ ------------ ------------- ------------
Income tax
benefits - - - -
Net loss $(36,653,041) $(18,848,472) $(111,779,105) $(63,779,116)
============ ============ ============= ============
Net loss per
share, basic and
diluted $ (0.85) $ (0.65) $ (2.83) $ (2.69)
Weighted average
common shares
outstanding,
basic and
diluted 42,873,934 28,900,075 39,449,393 23,679,472
Cautionary Statement Regarding Non-GAAP Financial Measures
This press release contains references to non-GAAP adjusted net loss and non-GAAP adjusted net loss per share. Management believes these non-GAAP financial measures are useful supplemental measures for planning, monitoring, and evaluating operational performance as they exclude stock-based compensation expense, non-cash interest expense, and non-cash interest income from net loss and net loss per share. Management excludes these items because they do not impact Celcuity's cash position, which management believes better enables Celcuity to focus on cash used in operations. However, non-GAAP adjusted net loss and non-GAAP adjusted net loss per share are not recognized measures under GAAP and do not have a standardized meaning prescribed by GAAP. As a result, management's method of calculating non-GAAP adjusted net loss and non-GAAP adjusted net loss per share may differ materially from the method used by other companies. Therefore, non-GAAP adjusted net loss and non-GAAP adjusted net loss per share may not be comparable to similarly titled measures presented by other companies. Investors are cautioned that non-GAAP adjusted net loss and non-GAAP adjusted net loss per share should not be construed as alternatives to net loss, net loss per share or other statements of operations data (which are determined in accordance with GAAP) as an indicator of Celcuity's performance or as a measure of liquidity and cash flows.
Celcuity Inc.
Reconciliation of GAAP Net Loss to Non-GAAP Adjusted
Net Loss and
GAAP Net Loss Per Share to Non-GAAP Adjusted Net Loss
Per Share
Three Months Ended December
31, Years Ended
2024 2023 2024 2023
------------ ------------ ------------- ------------
GAAP net loss $(36,653,041) $(18,848,472) $(111,779,105) $(63,779,116)
------------ ------------ ------------- ------------
Adjustments:
Stock-based
compensation
Research and
development
(1) 1,403,877 745,629 4,404,518 2,700,318
General and
administrative
(2) 911,404 496,904 2,583,823 2,201,116
Non-cash interest
expense (3) 803,222 528,637 2,694,361 2,052,336
Non-cash interest
income (4) 1,262,841 (554,126) 150,421 (993,457)
Non-GAAP adjusted
net loss $(32,271,697) $(17,631,428) $(101,945,982) $(57,818,803)
============ ============ ============= ============
GAAP net loss per
share - basic and
diluted $ (0.85) $ (0.65) $ (2.83) $ (2.69)
Adjustment to net
loss (as detailed
above) 0.10 0.04 0.25 0.25
------------ ------------ ------------- ------------
Non-GAAP adjusted
net loss per share $ (0.75) $ (0.61) $ (2.58) $ (2.44)
============ ============ ============= ============
Weighted average
common shares
outstanding, basic
and diluted 42,873,934 28,900,075 39,449,393 23,679,472
(1) To reflect a non-cash charge to operating expense
for Research and Development stock-based compensation.
(2) To reflect a non-cash charge to operating expense
for General and Administrative stock-based compensation.
(3) To reflect a non-cash charge to other expense
for amortization of debt issuance and discount costs
and PIK interest related to the issuance of a note
payable.
(4) To reflect a non-cash adjustment to other income
for accretion on investments.
(END) Dow Jones Newswires
March 31, 2025 16:01 ET (20:01 GMT)
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