Exhibit
99.1

Celcuity
Inc. Reports Release of Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
| |
– |
The
U.S. Food and Drug Administration (“FDA”) accepted Celcuity’s New Drug Application (“NDA”) and granted
Priority Review with a Prescription Drug User Fee Act (“PDUFA”) goal date of July 17, 2026, for gedatolisib in HR+/HER2-/PIK3CA
wild-type (“WT”) advanced breast cancer (“ABC”) |
| |
– |
Results
from PIK3CA WT cohort of Phase 3 VIKTORIA-1 study of gedatolisib regimens in HR+/HER2- ABC published in Journal of Clinical Oncology |
| |
– |
Topline
results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study are expected to be released in the second quarter of 2026 |
| |
– |
Management
to host webcast and conference call today, March 25, 2026, at 4:30 p.m. EDT |
MINNEAPOLIS,
March 25, 2026 — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies
for oncology, today announced financial results for the fourth quarter and full year ended December 31, 2025, and other recent business
developments.
“We
expect this year to be a transformative one for Celcuity. We plan to release topline results from the PIK3CA mutant cohort of
our Phase 3 VIKTORIA-1 study in the second quarter of 2026, which, if positive, could potentially advance the standard-of-care second
line therapy for a significant number of patients with HR+/HER2- advanced breast cancer,” said Brian Sullivan, CEO and co-founder
of Celcuity. “Additionally, our efforts remain on track to launch gedatolisib commercially in anticipation of its potential FDA
approval in the third quarter of 2026.”
Fourth
Quarter 2025 Business Highlights and Other Recent Developments
| |
● |
In
December 2025, updated efficacy and safety results from the Phase 3 VIKTORIA-1 PIK3CA WT cohort were presented at the 2025
San Antonio Breast Cancer Symposium including patient sub-group analyses, safety analyses and patient reported outcomes for well-being
measures. |
| |
○ |
For
patients enrolled in the U.S., Canada, Western Europe, and Asia Pacific, median progression free survival (“PFS”) was
16.6 months with the gedatolisib triplet (gedatolisib + fulvestrant + palbociclib) versus 1.9 months for fulvestrant (HR=0.14; 95%
CI: 0.08-0.28; p<0.0001). |
| |
○ |
The
gedatolisib triplet delayed time to definitive
deterioration versus fulvestrant according to patient reported outcomes for well-being measures that included mobility, self-care,
usual activities, pain/discomfort, and anxiety/depression (the EQ-5D-5L score). The median time to definitive deterioration was 23.7
months (HR=0.39; 95% CI: 0.25-0.67; p = 0.0003) for patients treated with the gedatolisib triplet versus 4.0 months for fulvestrant.
Additionally, for the first 8 cycles of treatment, the patients’ assessment of their well-being remained stable relative
to their assessment prior to starting treatment with gedatolisib. |
| |
○ |
As
reported earlier, the gedatolisib triplet was generally well tolerated in the trial with mostly low-grade treatment-related adverse
events (“TRAEs”). The most common Grade 3+ TRAEs for the gedatolisib triplet and fulvestrant included neutropenia (62.3%
and 0.8% of patients, respectively); stomatitis (19.2% and 0%); rash (4.6% and 0%); and hyperglycemia (2.3% and 0%). No patients
experienced Grade 4 hyperglycemia. TRAEs led to the discontinuation of study treatment in 2.3% of patients in the gedatolisib triplet
group and 0% in the fulvestrant group. |
| |
● |
In
January 2026, the FDA accepted for filing Celcuity’s NDA for gedatolisib in HR+/HER2- PIK3CA WT ABC. The FDA granted
Priority Review and assigned a PDUFA goal date of July 17, 2026. |
| |
|
|
| |
● |
In
March 2026, efficacy and safety results from the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib
were published in the Journal of Clinical Oncology. The cohort consisted of patients with HR+/HER2-/PIK3CA WT ABC whose
disease progressed while on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor. |
| |
|
|
| |
● |
As
reported previously, the results from the VIKTORIA-1 Phase 3 PIK3CA WT cohort, established several new milestones in the history
of drug development for HR+/HER2- ABC: |
| |
○ |
The
hazard ratio for the gedatolisib triplet is more favorable than has ever been reported by any Phase 3 trial for patients with HR+/HER2-
ABC. |
| |
○ |
The
7.3-months incremental improvements in median PFS for the gedatolisib triplet over fulvestrant is higher than has ever
been reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving at least their second line of endocrine therapy-based
regimen. |
| |
○ |
Gedatolisib
is the first inhibitor targeting the PI3K/AKT/mTOR (“PAM”) pathway to demonstrate positive Phase 3 results in patients
with HR+/HER2-/PIK3CA WT ABC whose disease progressed on or after treatment with a CDK4/6 inhibitor. |
| |
○ |
Median
duration of response (“DOR”) of 17.5 months and incremental objective response rate (“ORR”)
improvement of 31% relative to control for the gedatolisib triplet is the highest reported for an endocrine therapy-based
regimen in second line HR+/HER2- ABC. |
Fourth
Quarter and Full Year 2025 Financial Results
Unless
otherwise stated, all comparisons are for the fourth quarter and full year ended December 31, 2025, compared to the fourth quarter and
full year ended December 31, 2024.
Total
operating expenses were $49.2 million for the fourth quarter of 2025, compared to $36.4 million for the fourth quarter of 2024. Operating
expenses for the full year 2025 were $172.2 million, compared to $113.3 million for the full year 2024.
Research
and development (“R&D”) expenses were $37.6 million for the fourth quarter of 2025, compared to $33.5 million for the
prior-year period. Of the $4.1 million increase in R&D expenses, $8.6 million was related to increased employee and consulting expenses,
of which $5.3 million related to commercial headcount additions and other launch-related activities. These amounts were partially offset
by a $4.5 million decrease primarily related to costs supporting ongoing activities for the VIKTORIA-1 Phase 3 trial.
R&D
expenses for the full year 2025 were $145.0 million, compared to $104.2 million for the prior year. Of the $40.8 million increase in
R&D expenses, $26.7 million was related to increased employee and consulting expenses, of which $13.1 million related to commercial
headcount additions and other launch-related activities. The remaining $14.1 million increase was primarily related to activities supporting
our ongoing clinical trials, a development milestone payment under the license agreement with Pfizer, and other commercial launch-related
activities.
General
and administrative (“G&A”) expenses were $11.6 million for the fourth quarter of 2025, compared to $3.0 million for the
prior year period. Of the $8.6 million increase, $6.9 million was related to increased employee-related and consulting expenses, of which
$5.4 million related to non-cash stock-based compensation. The remaining $1.7 million increase was primarily related to professional
fees, expanding infrastructure costs, and other administrative expenses.
G&A
expenses for the full year 2025 were $27.2 million, compared to $9.1 million for the prior year. Of the $18.1 million increase in G&A
expenses, $14.9 million was related to increased employee-related and consulting expenses, of which $10.4 million related to non-cash
stock-based compensation. The remaining $3.2 million increase was primarily related to professional fees, expanding infrastructure costs,
and other administrative expenses.
Net
loss for the fourth quarter of 2025 was $51.0 million, or $0.97 per share, compared to a net loss of $36.7 million, or $0.85 per share,
for the fourth quarter of 2024. Net loss for the full year 2025 was $177.0 million, or $3.79 per share, compared to a net loss of $111.8
million, or $2.83 per share, in 2024. Non-GAAP adjusted net loss for the fourth quarter of 2025 was $38.4 million, or $0.73 per share,
compared to non-GAAP adjusted net loss of $32.3 million, or $0.75 per share, for the fourth quarter of 2024. Non-GAAP adjusted net loss
for the full year 2025 was $150.8 million, or $3.22 per share, compared to non-GAAP adjusted net loss of $101.9 million, or $2.58 per
share, for 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.
Net
cash used in operating activities for the fourth quarter of 2025 was $36.4 million, compared to $27.8 million for the fourth quarter
of 2024. Net cash used in operating activities for the full year 2025 was $153.3 million, compared to $83.5 million for the full year
2024. Cash, cash equivalents and short-term investments were $441.5 million at the end of fiscal year 2025 and are expected to finance
our operations through 2027.
Webcast
and Conference Call Information
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 the weblink below. A replay of the webcast will be available on the Celcuity website
following the live event. https://viavid.webcasts.com/starthere.jsp?ei=1751140&tp_key=9ff20687c4.
About
Celcuity
Celcuity
is a clinical-stage biotechnology company pursuing the development of targeted therapies for the 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 PI3Kα, 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
(“ABC”), has completed enrollment, and the company has reported detailed results for the PIK3CA wild-type cohort.
A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients
with endocrine treatment resistant HR+/HER2- ABC, is ongoing. 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. 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 at www.celcuity.com. Follow us on LinkedIn and X.
Forward
Looking Statements
This
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 clinical trial data; the status and timing of the FDA’s review of our New
Drug Application for gedatolisib, including the PDUFA goal date assigned by the FDA; the market opportunity for gedatolisib; our expectations
regarding the timing of and our ability to obtain 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 clinical results are based on an ongoing 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 or the FDA’s review of our 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, 2025, 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.
Contacts:
Celcuity
Inc.
Brian
Sullivan, bsullivan@celcuity.com
Vicky
Hahne, vhahne@celcuity.com
(763)
392-0123
Jodi
Sievers, jsievers@celcuity.com
(415)
494-9924
Celcuity
Inc.
Balance
Sheets
(in
thousands)
| | |
December 31, 2025 | | |
December 31, 2024 | |
| Assets | |
| | | |
| | |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 165,703 | | |
$ | 22,515 | |
| Investments | |
| 275,794 | | |
| 212,589 | |
| Other current assets | |
| 24,162 | | |
| 9,467 | |
| Total current assets | |
| 465,659 | | |
| 244,571 | |
| Property and equipment, net | |
| 499 | | |
| 336 | |
| Operating lease right-of-use assets | |
| 51 | | |
| 216 | |
| Other non-current assets | |
| 349 | | |
| — | |
| Total assets | |
$ | 466,558 | | |
$ | 245,123 | |
| Liabilities and stockholders’ equity | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 6,407 | | |
$ | 9,366 | |
| Accrued expenses | |
| 37,691 | | |
| 22,185 | |
| Operating lease liabilities, current | |
| 54 | | |
| 172 | |
| Total current liabilities | |
| 44,152 | | |
| 31,723 | |
| Operating lease liabilities, non-current | |
| — | | |
| 54 | |
| Convertible debt | |
| 195,324 | | |
| — | |
| Note payable, non-current | |
| 126,527 | | |
| 97,727 | |
| Total liabilities | |
| 366,003 | | |
| 129,504 | |
| Total stockholders’ equity | |
| 100,555 | | |
| 115,619 | |
| Total liabilities and stockholders’ equity | |
$ | 466,558 | | |
$ | 245,123 | |
Celcuity
Inc.
Statements
of Operations
(in
thousands, except share and per share amounts)
| | |
Three Months Ended December 31, | | |
Year Ended December 31, | |
| | |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| | |
(unaudited) | | |
| | |
| |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
$ | 37,631 | | |
$ | 33,471 | | |
$ | 144,995 | | |
$ | 104,203 | |
| General and administrative | |
| 11,570 | | |
| 2,959 | | |
| 27,197 | | |
| 9,064 | |
| Total operating expenses | |
| 49,201 | | |
| 36,430 | | |
| 172,192 | | |
| 113,267 | |
| Loss from operations | |
| (49,201 | ) | |
| (36,430 | ) | |
| (172,192 | ) | |
| (113,267 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Other (expense) income: | |
| | | |
| | | |
| | | |
| | |
| Interest expense | |
| (6,166 | ) | |
| (3,275 | ) | |
| (17,148 | ) | |
| (10,280 | ) |
| Interest income | |
| 4,394 | | |
| 3,052 | | |
| 12,298 | | |
| 11,768 | |
| Other (expense) income, net | |
| (1,772 | ) | |
| (223 | ) | |
| (4,850 | ) | |
| 1,488 | |
| Net loss before income taxes | |
| (50,973 | ) | |
| (36,653 | ) | |
| (177,042 | ) | |
| (111,779 | ) |
| Income taxes | |
| — | | |
| — | | |
| — | | |
| — | |
| Net loss | |
$ | (50,973 | ) | |
$ | (36,653 | ) | |
$ | (177,042 | ) | |
$ | (111,779 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Net loss per share, basic and diluted | |
$ | (0.97 | ) | |
$ | (0.85 | ) | |
$ | (3.79 | ) | |
$ | (2.83 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Weighted average common shares outstanding, basic and diluted | |
| 52,539,744 | | |
| 42,873,934 | | |
| 46,757,691 | | |
| 39,449,393 | |
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
(in
thousands, except share and per share amounts)
| | |
Three Months Ended December 31, | | |
Year Ended December 31, | |
| | |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| GAAP net loss | |
$ | (50,973 | ) | |
$ | (36,653 | ) | |
$ | (177,042 | ) | |
$ | (111,779 | ) |
| Adjustments to net loss: | |
| | | |
| | | |
| | | |
| | |
| Stock-based compensation | |
| | | |
| | | |
| | | |
| | |
| Research and development (1) | |
| 3,124 | | |
| 1,404 | | |
| 8,409 | | |
| 4,405 | |
| General and administrative (2) | |
| 6,332 | | |
| 911 | | |
| 12,974 | | |
| 2,583 | |
| Non-cash interest expense (3) | |
| 1,602 | | |
| 803 | | |
| 4,241 | | |
| 2,695 | |
| Non-cash interest income (4) | |
| 1,470 | | |
| 1,263 | | |
| 630 | | |
| 150 | |
| Non-GAAP adjusted net loss | |
$ | (38,445 | ) | |
$ | (32,272 | ) | |
$ | (150,788 | ) | |
$ | (101,946 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| GAAP net loss per share - basic and diluted | |
$ | (0.97 | ) | |
$ | (0.85 | ) | |
$ | (3.79 | ) | |
$ | (2.83 | ) |
| Adjustments to net loss: | |
| | | |
| | | |
| | | |
| | |
| Stock-based compensation | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
| 0.06 | | |
| 0.03 | | |
| 0.18 | | |
| 0.11 | |
| General and administrative | |
| 0.12 | | |
| 0.02 | | |
| 0.29 | | |
| 0.07 | |
| Non-cash interest expense | |
| 0.03 | | |
| 0.02 | | |
| 0.09 | | |
| 0.07 | |
| Non-cash interest income | |
| 0.03 | | |
| 0.03 | | |
| 0.01 | | |
| — | |
| Non-GAAP adjusted net loss per share - basic and diluted | |
$ | (0.73 | ) | |
$ | (0.75 | ) | |
$ | (3.22 | ) | |
$ | (2.58 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Weighted average common shares outstanding, basic and diluted | |
| 52,539,744 | | |
| 42,873,934 | | |
| 46,757,691 | | |
| 39,449,393 | |
(1)
To reflect a non-cash charge to operating expenses for research and development stock-based compensation.
(2)
To reflect a non-cash charge to operating expenses for general and administrative stock-based compensation.
(3)
To reflect a non-cash charge to other expense for amortization of debt issuance costs and discount and payment-in-kind interest related
to the issuance of a note payable.
(4)
To reflect a non-cash adjustment to other income for accretion on investments and change in accrued interest income.