Full Press Release Details
Inc. Reports Second Quarter 2025 Financial Results and Provides Corporate Update
| - | Reported statistically significant and clinically meaningful improvement in both primary endpoints from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial | |
| - | Hazard ratios and improvements in median progression-free survival ("PFS") are unprecedented in HR+/HER2- advanced breast cancer ("ABC") | |
| - | Expect to submit a New Drug Application ("NDA") for gedatolisib, based on data from the PIK3CA wild-type cohort, to the U.S. Food and Drug Administration ("FDA") in the fourth quarter of 2025 | |
| - | Enrollment is ongoing in the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial and topline data readout is anticipated in the fourth quarter of 2025 | |
| - | First patient was dosed in Phase 3 VIKTORIA-2 clinical trial of gedatolisib as a first-line treatment for HR+/HER2- ABC | |
| - | Reported clinical data from two early phase studies of gedatolisib in patients with metastatic castration resistant prostate cancer ("mCRPC") and HER2+ metastatic breast cancer ("mBC") | |
| - | New patent for gedatolisib dosing regimen that extends patent exclusivity into 2042 was issued | |
| - | Completed concurrent offerings of convertible notes, common stock and pre-funded warrants, with net proceeds of $286.5 million; on a proforma basis, the net proceeds of these offerings along with our cash, cash equivalents, and short-term investments of $168.4 million as of June 30, 2025, results in $455 million of cash, cash equivalents, and short-term investments as of the end of Q2 2025 and is expected to fund operations through 2027 | |
| - | Management to host webcast and conference call today, August 14, 2025, at 4:30 p.m. ET |
August 14, 2025 - Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies
for oncology, today announced financial results for the second quarter ended June 30, 2025 and other recent business developments.
have had an eventful past few months at Celcuity. Last month, we announced positive topline data from the PIK3CA wild-type cohort
of the pivotal Phase 3 VIKTORIA-1 clinical trial, which showed unprecedented reduction in risk of disease progression or death and incremental
improvement in progression free survival in patients with HR+/HER2- advanced breast cancer," said Brian Sullivan, CEO and co-founder
of Celcuity. "We believe topline data for both gedatolisib regimens from VIKTORIA-1 are potentially practice-changing. We are on
track to submit the New Drug Application for gedatolisib, based on data from the PIK3CA wild-type cohort, later this year and
to report topline data from the PIK3CA mutant cohort in the fourth quarter of 2025. Additionally, with our recent financing and
our growing body of clinical data, we believe we are in a unique position to advance multiple potential blockbuster indications in breast
and prostate cancer."
Quarter 2025 Business Highlights and Other Recent Developments
| The gedatolisib triplet (gedatolisib, fulvestrant and palbociclib) reduced the risk of disease progression or death by 76% compared to fulvestrant based on a hazard ratio ("HR") of 0.24. The median PFS was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months. | ||
| The gedatolisib doublet (gedatolisib and fulvestrant) reduced the risk of disease progression or death by 67% compared to fulvestrant based on a hazard ratio of 0.33. The median PFS was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months. | ||
| Both gedatolisib regimens showed lower rates of hyperglycemia and stomatitis and the rate of discontinuation of all treatment due to a treatment-related adverse event ("AE"), was lower than was reported in a Phase 1b study in this patient population. | ||
| Full data from the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial will be presented at an upcoming medical conference later this year. | ||
| Celcuity expects to submit an NDA to the FDA in the fourth quarter of 2025 for gedatolisib based on data from the PIK3CA wild-type cohort. | ||
| Enrollment is ongoing in the PIK3CA mutant cohort of the VIKTORIA-1 trial and remains on track to report topline data by the end of 2025. |
| In July 2025, the first patient was dosed in VIKTORIA-2, a Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as a first-line treatment for patients with HR+/HER2- ABC who are endocrine therapy resistant. | |
| In July 2025, the US Patent and Trademark Office issued a new patent for gedatolisib covering the dosing regimen used in the VIKTORIA-1 clinical trial, extending the patent exclusivity in the U.S. into 2042. | |
| In July 2025, the Company conducted a concurrent public offering of 2.750% convertible senior notes due 2031, common stock and pre-funded warrants. The net proceeds from the offerings were $286.5 million, after deducting underwriting discounts and commissions and the Company's estimated offering expenses. | |
| In June 2025, the Phase 1b portion of the CELC-G-201 study reported positive topline data, and additional preliminary results will be presented at a medical conference later this year. |
Quarter 2025 Financial Results
otherwise stated, all comparisons are for the second quarter ended June 30, 2025, compared to the second quarter ended June 30, 2024.
operating expenses were $44.0 million for the second quarter of 2025, compared to $24.3 million for the second quarter of 2024.
and development ("R&D") expenses were $40.2 million for the second quarter of 2025, compared to $22.5 million for the
prior-year period. Of the approximately $17.7 million increase in R&D expenses, $6.6 million was related to increased employee and
consulting expenses, $6.1 million was related to increased research and development costs primarily attributable to
activities supporting our ongoing clinical trials, and $5.0 million is related to an anticipated development milestone payment
under the license agreement with Pfizer.
and administrative ("G&A") expenses were $3.8 million for the second quarter of 2025, compared to $1.8 million for the
prior-year period. Of the approximately $2.0 million increase in general and administrative expenses, $1.6 million was related to increased
employee and consulting expenses. The remaining $0.4 million of the $2.0 million increase resulted from professional fees, expanding
infrastructure and other administrative expenses.
loss for the second quarter of 2025 was $45.3 million, or $1.04 loss per share, compared to a net loss of $23.7 million, or $0.62 loss
per share, for the second quarter of 2024. Non-GAAP adjusted net loss for the second
quarter of 2025 was $40.5 million, or $0.93 loss per share, compared to non-GAAP adjusted net loss of $22.2 million, or $0.58 loss per
share, for the second quarter of 2024. 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 second quarter of 2025 was $36.2 million, compared to $18.1 million for the second quarter
June 30, 2025, Celcuity reported cash, cash equivalents and short-term investments of $168.4 million. However, on a proforma basis, taking
into account the net proceeds of the Celcuity's financing activities in the third quarter, cash, cash equivalents, and short-term
investments as of the end of Q2 2025 was $455 million, which, we believe, when including drawdowns on our debt facility, will fund operations
and Conference Call Information
Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the second quarter 2025 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=1726762&tp_key=047c56f7b8.
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 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- ABC has completed enrollment of and reported topline
data for the PIK3CA wild-type cohort, and is currently enrolling patients for the PIK3CA mutant cohort. A Phase 1/2 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- ABC is currently enrolling patients. More detailed information about Celcuity's active clinical
trials can be found at ClinicalTrials.gov . Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found
press release contains statements that constitute "forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and
timing of our clinical trials; our interpretation of topline clinical trial data; the market opportunity for gedatolisib; the ability
of our data to support the filing of an NDA with the FDA; our expectations regarding the timing of and our ability to obtain and maintain
FDA approval to commercialize gedatolisib; our strategy, marketing and commercialization plans, including the benefits of strategic decisions
regarding studies and trials; other expectations with respect to gedatolisib ; our anticipated use of cash; and the strength of our balance
sheet. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate,"
"estimate," "intend," "confidence," "encouraged," "potential," "plan,"
"targets," "likely," "may," "will," "would," "should" and "could,"
and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are
based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including
that our topline results are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more
comprehensive review of the data related to the clinical trial; unforeseen delays in our clinical trials; unforeseen delays in our planned
NDA for gedatolisib; our ability to obtain and maintain regulatory approvals to commercialize gedatolisib, and the market acceptance
of gedatolisib; the development of therapies and tools competitive with gedatolisib; and our ability to access capital upon favorable
terms. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year
ended December 31, 2024, as such risks may be updated in our subsequent filings with the Securities and Exchange Commission. You are
cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking
statements are qualified in their entirety by these cautionary statements, and we undertake no obligation to revise or update this press
release to reflect events or circumstances after the date hereof.
source version of release on GlobeNewswire.com
Sullivan, bsullivan@celcuity.com
Hahne, vhahne@celcuity.com
| June 30, 2025 | December 31, 2024 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 46,354 | $ | 22,515 | ||||
| Investments | 122,032 | 212,589 | ||||||
| Other current assets | 14,718 | 9,467 | ||||||
| Total current assets | 183,104 | 244,571 | ||||||
| Property and equipment, net | 357 | 336 | ||||||
| Operating lease right-of-use assets | 131 | 216 | ||||||
| Total Assets | $ | 183,592 | $ | 245,123 | ||||
| Liabilities and Stockholders' Equity: | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 11,158 | $ | 9,366 | ||||
| Operating lease liabilities | 139 | 172 | ||||||
| Accrued expenses | 28,644 | 22,185 | ||||||
| Total current liabilities | 39,941 | 31,723 | ||||||
| Operating lease liabilities | - | 54 | ||||||
| Note payable, non-current | 99,276 | 97,727 | ||||||
| Total Liabilities | 139,217 | 129,504 | ||||||
| Total Stockholders' Equity | 44,375 | 115,619 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 183,592 | $ | 245,123 |
Statements of Operations
thousands, except share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 40,222 | $ | 22,498 | $ | 72,449 | $ | 43,145 | ||||||||
| General and administrative | 3,787 | 1,786 | 7,693 | 3,632 | ||||||||||||
| Total operating expenses | 44,009 | 24,284 | 80,142 | 46,777 | ||||||||||||
| Loss from operations | (44,009 | ) | (24,284 | ) | (80,142 | ) | (46,777 | ) | ||||||||
| Other (expense) income | ||||||||||||||||
| Interest expense | (3,204 | ) | (2,260 | ) | (6,387 | ) | (3,661 | ) | ||||||||
| Interest income | 1,945 | 2,822 | 4,264 | 5,104 | ||||||||||||
| Other (expense) income, net | (1,259 | ) | 562 | (2,123 | ) | 1,443 | ||||||||||
| Net loss before income taxes | (45,268 | ) | (23,722 | ) | (82,265 | ) | (45,334 | ) | ||||||||
| Income tax benefits | - | - | - | - | ||||||||||||
| Net loss | $ | (45,268 | ) | $ | (23,722 | ) | $ | (82,265 | ) | $ | (45,334 | ) | ||||
| Net loss per share, basic and diluted | $ | (1.04 | ) | $ | (0.62 | ) | $ | (1.90 | ) | $ | (1.26 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 43,663,364 | 38,444,163 | 43,359,748 | 36,028,109 |
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
thousands, except share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| GAAP net loss | $ | (45,268 | ) | $ | (23,722 | ) | $ | (82,265 | ) | $ | (45,334 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation | ||||||||||||||||
| Research and development (1) | 1,722 | 978 | 3,227 | 1,810 | ||||||||||||
| General and administrative (2) | 982 | 432 | 1,921 | 932 | ||||||||||||
| Non-cash interest expense (3) | 789 | 630 | 1,589 | 1,160 | ||||||||||||
| Non-cash interest income (4) | 1,286 | (485 | ) | 340 | (639 | ) | ||||||||||
| Non-GAAP adjusted net loss | $ | (40,489 | ) | $ | (22,167 | ) | $ | (75,188 | ) | $ | (42,071 | ) | ||||
| GAAP net loss per share - basic and diluted | $ | (1.04 | ) | $ | (0.62 | ) | $ | (1.90 | ) | $ | (1.26 | ) | ||||
| Adjustments to net loss: | ||||||||||||||||
| Stock -based compensation | ||||||||||||||||
| Research and development | 0.04 | 0.02 | 0.08 | 0.05 | ||||||||||||
| General and administrative | 0.02 | 0.01 | 0.04 | 0.03 | ||||||||||||
| Non-cash interest expense | 0.02 | 0.02 | 0.04 | 0.03 | ||||||||||||
| Non-cash interest income | 0.03 | (0.01 | ) | 0.01 | (0.02 | ) | ||||||||||
| Non-GAAP adjusted net loss per share | $ | (0.93 | ) | $ | (0.58 | ) | $ | (1.73 | ) | $ | (1.17 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 43,663,364 | 38,444,163 | 43,359,748 | 36,028,109 |
| (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. |