Full Press Release Details
Inc. Reports Third Quarter Financial Results and Provides Corporate Update
| - | The PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial is 100% enrolled; expect to report topline data for this cohort in late Q1 2025 or Q2 2025 | |
| - | Approximately $264 million in cash, cash equivalents and investments at end of Q3 2024 expected to fund current clinical development program activities through 2026 | |
| - | Management to host webcast and conference call today, November 14, 2024, at 4:30 p.m. ET |
November 14, 2024 - Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies
for oncology, today announced financial results for the third quarter ended September 30, 2024 and other recent business developments.
in our VIKTORIA-1 study remains robust and on-track. The PIK3CA wild-type cohort is 100% enrolled, and enrollment in the PIK3CA
mutant cohort is on plan," said Brian Sullivan, CEO and co-founder of Celcuity. "Based on our current forecast of reaching
the event thresholds that will trigger primary analysis in both the PIK3CA wild-type and mutant cohorts, we expect to report topline
data for the PIK3CA wild-type cohort sometime in late Q1 2025 or during Q2 2025 and to report topline data for the PIK3CA
mutant cohort in the second half of 2025."
Quarter 2024 Business Highlights and Other Recent Developments
| VIKTORIA-1 is 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. | ||
| The PIK3CA wild-type cohort is 100% enrolled and enrollment of the PIK3CA mutant cohort is on-track relative to plan. |
| The VIKTORIA-2 study is a global Phase 3 open-label randomized clinical trial 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. | ||
| Prior to the initiation of the Phase 3 portion of the trial, a safety run-in study will be conducted in 12-36 participants to assess the safety profile of gedatolisib in combination with ribociclib and fulvestrant. | ||
| Site qualification activities to support activation of up to 200 sites across North America, Europe, Latin America, and Asia are on track. |
| Abstract Title: Overall survival in patients with HR+/HER2- advanced breast cancer treated in a phase 1b trial evaluating gedatolisib in combination with palbociclib and endocrine therapy (SESS-1510) | ||
| Presentation Number: P4-08-25 | ||
| Date/Time: Thursday, December 12, 5:30 PM CST |
| Abstract Title: Mechanism of action of gedatolisib in combination with fulvestrant and/or palbociclib in estrogen receptor positive breast cancer models (SESS-989) | ||
| Abstract Title: Different effects of gedatolisib versus single-node PI3K/AKT/mTOR pathway inhibitors on breast cancer cell metabolic functions (SESS-997) |
Quarter 2024 Financial Results
otherwise stated, all comparisons are for the third quarter ended September 30, 2024, compared to the third quarter ended September 30,
operating expenses were $30.1 million for the third quarter of 2024, compared to $18.9 million for the third quarter of 2023.
and development (R&D) expenses were $27.6 million for the third quarter of 2024, compared to $17.5 million for the prior-year period.
Of the approximately $10.1 million increase in R&D expenses, $6.3 million primarily related to activities supporting the VIKTORIA-1
Phase 3 trial, the Phase 1b/2 trial and the initiation of the VIKTORIA-2 Phase 3 trial, and $3.8 million was related to increased employee
and consulting expenses.
and administrative (G&A) expenses were $2.5 million for the third quarter of 2024, compared to $1.4 million for the prior-year period.
Employee and consulting related expenses accounted for $0.9 million of the increase. Professional fees and other administrative expenses
accounted for the remaining increase of approximately $0.2 million.
loss for the third quarter of 2024 was $29.8 million, or $0.70 loss per share, compared to a net loss of $18.4 million, or $0.83 loss
per share, for the third quarter of 2023. Non-GAAP adjusted net loss for the third quarter of 2024 was $27.6 million, or $0.65 loss per
share, compared to non-GAAP adjusted net loss of $17.3 million, or $0.78 loss per share, for the third quarter of 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 third quarter of 2024 was $20.6 million, compared to $12.7 million for the third quarter of
September 30, 2024, Celcuity reported cash, cash equivalents and short-term investments of $264.1 million.
and Conference Call Information
Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the third quarter 2024 financial results
and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-800-717-1738 or 1-646-307-1865.
A live webcast presentation can also be accessed using this weblink: https://viavid.webcasts.com/starthere.jsp?ei=1688854&tp_key=0b14db1255.
A replay of the webcast will be available on the Celcuity website following the live event.
is a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications.
The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic
properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR 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 enrolling patients. 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 expected to begin
enrolling patients in the second quarter of 2025. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be
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, 2023 filed with the Securities and Exchange Commission on March 27, 2024. 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
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
| September 30, 2024 | December 31, 2023 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 12,603,289 | $ | 30,662,774 | ||||
| Investments | 251,455,468 | 149,919,974 | ||||||
| Other current assets | 8,379,682 | 10,007,849 | ||||||
| Total current assets | 272,438,439 | 190,590,597 | ||||||
| Property and equipment, net | 338,787 | 228,782 | ||||||
| Operating lease right-of-use assets | 259,744 | 400,019 | ||||||
| Total Assets | $ | 273,036,970 | $ | 191,219,398 | ||||
| Liabilities and Stockholders' Equity: | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 9,158,778 | $ | 5,076,699 | ||||
| Operating lease liabilities | 175,226 | 184,950 | ||||||
| Accrued expenses | 16,974,725 | 8,927,094 | ||||||
| Total current liabilities | 26,308,729 | 14,188,743 | ||||||
| Operating lease liabilities | 95,699 | 225,922 | ||||||
| Note payable, non-current | 96,923,914 | 37,035,411 | ||||||
| Total Liabilities | 123,328,342 | 51,450,076 | ||||||
| Total Stockholders' Equity | 149,708,628 | 139,769,322 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 273,036,970 | $ | 191,219,398 |
Condensed Statements of Operations
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 27,587,483 | $ | 17,488,236 | $ | 70,732,017 | $ | 42,512,811 | ||||||||
| General and administrative | 2,472,416 | 1,409,801 | 6,104,803 | 3,988,248 | ||||||||||||
| Total operating expenses | 30,059,899 | 18,898,037 | 76,836,820 | 46,501,059 | ||||||||||||
| Loss from operations | (30,059,899 | ) | (18,898,037 | ) | (76,836,820 | ) | (46,501,059 | ) | ||||||||
| Other (expense) income | ||||||||||||||||
| Interest expense | (3,343,989 | ) | (1,372,132 | ) | (7,005,284 | ) | (3,929,140 | ) | ||||||||
| Interest income | 3,612,099 | 1,865,629 | 8,716,040 | 5,499,555 | ||||||||||||
| Other income, net | 268,110 | 493,497 | 1,710,756 | 1,570,415 | ||||||||||||
| Net loss before income taxes | (29,791,789 | ) | (18,404,540 | ) | (75,126,064 | ) | (44,930,644 | ) | ||||||||
| Income tax benefits | - | - | - | - | ||||||||||||
| Net loss | $ | (29,791,789 | ) | $ | (18,404,540 | ) | $ | (75,126,064 | ) | $ | (44,930,644 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.70 | ) | $ | (0.83 | ) | $ | (1.96 | ) | $ | (2.05 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 42,793,047 | 22,117,626 | 38,299,548 | 21,920,147 |
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.
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 September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| GAAP net loss | $ | (29,791,789 | ) | $ | (18,404,540 | ) | $ | (75,126,064 | ) | $ | (44,930,644 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation | ||||||||||||||||
| Research and development (1) | 1,190,424 | 660,706 | 3,000,641 | 1,954,689 | ||||||||||||
| General and administrative (2) | 740,777 | 447,931 | 1,672,418 | 1,704,213 | ||||||||||||
| Non-cash interest expense (3) | 730,741 | 520,794 | 1,891,139 | 1,523,699 | ||||||||||||
| Non-cash interest income (4) | (473,584 | ) | (480,520 | ) | (1,112,420 | ) | (439,331 | ) | ||||||||
| Non-GAAP adjusted net loss | $ | (27,603,431 | ) | $ | (17,255,629 | ) | $ | (69,674,286 | ) | $ | (40,187,374 | ) | ||||
| GAAP net loss per share - basic and diluted | $ | (0.70 | ) | $ | (0.83 | ) | $ | (1.96 | ) | $ | (2.05 | ) | ||||
| Adjustment to net loss (as detailed above) | 0.05 | 0.05 | 0.14 | 0.22 | ||||||||||||
| Non-GAAP adjusted net loss per share | $ | (0.65 | ) | $ | (0.78 | ) | $ | (1.82 | ) | $ | (1.83 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 42,793,047 | 22,117,626 | 38,299,548 | 21,920,147 |
| (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. |