Full Press Release Details
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 |
March 31, 2025 - 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.
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."
Quarter 2024 Business Highlights and Other Recent Developments
| 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. |
Quarter and Full Year 2024 Financial Results
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.
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.
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.
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.
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.
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.
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.
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.
and Conference Call Information
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.
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 , 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
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.
source version of release on GlobeNewswire.com
Sullivan, bsullivan@celcuity.com
Hahne, vhahne@celcuity.com
| 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 |
| Three Months Ended December 31, | Twelve Months Ended December 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 |
Statement Regarding Non-GAAP Financial Measures
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.
of GAAP Net Loss to Non-GAAP Adjusted Net Loss and
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 |
To reflect a non-cash charge to operating expense for Research and Development stock-based compensation.
To reflect a non-cash charge to operating expense for General and Administrative stock-based compensation.
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.
To reflect a non-cash adjustment to other income for accretion on investments.