Celcuity Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update
- Celcuity dosed the first patient in a Phase 1b/2 trial for metastatic castration resistant prostate cancer
- The company raised $65 million and expects funds to last until the first half of 2026
- Nonclinical data presented demonstrated the superior effects of gedatolisib compared to other inhibitors
- Operating expenses increased, leading to a net loss for the fourth quarter and full year 2023
- Significant funding was secured through equity sales for future development
- Operating expenses increased significantly, leading to a net loss for the company
- Net loss for the fourth quarter and full year 2023 increased compared to the previous year
- The company reported a non-GAAP adjusted net loss for the fourth quarter and full year 2023
- Cash used in operating activities increased for the fourth quarter and full year 2023 compared to the previous year
Insights
The initiation of a Phase 1b/2 trial for gedatolisib in combination with darolutamide represents a significant step forward in Celcuity's clinical pipeline, specifically targeting metastatic castration-resistant prostate cancer (mCRPC). From a medical research perspective, the potential of gedatolisib, a PI3K/AKT/mTOR (PAM) inhibitor, has been underscored by nonclinical data suggesting superior cytotoxicity compared to other inhibitors in this class. The implications for patients with mCRPC, a population with limited treatment options, could be profound if the trial results are positive.
Furthermore, the financial commitment to the project, as evidenced by the recent equity sale raising $65 million, indicates a robust backing for the development of gedatolisib. The projected funding into the first half of 2026 suggests confidence in the drug's pipeline and its potential market impact. For stakeholders, the long-term benefits hinge on successful trial outcomes, which could lead to a new therapeutic option in a high-need oncology segment.
Analyzing the financial results presented by Celcuity Inc., the increase in operating expenses, primarily driven by research and development (R&D) for their VIKTORIA-1 Phase 3 trial and the CELC-G-201 Phase 1b/2 clinical trial, reflects a strategic investment in their drug development programs. The reported net losses for the fourth quarter and full year of 2023, while substantial, are not uncommon for clinical-stage biotech companies focused on R&D.
The capital raised through equity sales is a important indicator of market confidence in Celcuity's pipeline. This capital infusion, coupled with a prudent cash burn rate, positions the company to operate without the immediate need for additional financing, which is a positive sign for investors. However, the dependency on the success of clinical trials for future revenue generation remains a risk factor that must be monitored closely.
The prostate cancer treatment market is highly competitive, with several established therapies and numerous drugs in development. Celcuity's strategic focus on a combination therapy approach with gedatolisib and darolutamide could differentiate it from monotherapies currently available. This approach aligns with the trend towards personalized medicine, where the efficacy of treatment is enhanced by targeting specific pathways involved in cancer progression.
Given that the Phase 1b/2 trial results will not be available until the first half of 2025, the impact on Celcuity's market position will be long-term. Yet, early positive indicators from nonclinical studies may position Celcuity favorably among investors and industry partners. In the interim, Celcuity's financial health and operational execution will be critical to maintaining stakeholder confidence.
- Dosed the first patient in a Phase 1b/2 trial evaluating gedatolisib in combination with darolutamide for the treatment of metastatic castration resistant prostate cancer
- Presented nonclinical data demonstrating the superior therapeutic effects of gedatolisib compared to other PI3K/AKT/mTOR inhibitors at the 2023 SABCS
- Raised
$65 million from the sale of equity; expect cash, cash equivalents, investments and available funds under our debt facility, to fund current operational activities into first half of 2026 - Management to host webcast and conference call today, March 27, 2024, at 4:30 p.m. ET
MINNEAPOLIS, March 27, 2024 (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 and full year ended December 31, 2023 and other recent business developments.
“In 2023, we made significant progress advancing development of gedatolisib while strengthening our balance sheet and adding to our leadership team,” said Brian Sullivan, CEO and Co-Founder of Celcuity. “Our Phase 3 VIKTORIA-1 trial remains on track to report topline data from the PI3KCA wild type patient sub-group in the second half of this year. We were also excited to begin development of gedatolisib for patients with metastatic castration resistant prostate cancer this past year. Enrollment has begun in our Phase 1b/2 trial evaluating gedatolisib in combination with darolutamide, and we look forward to sharing preliminary data from this trial in the first half of 2025.”
Fourth Quarter 2023 Business Highlights and Other Recent Developments
- The VIKTORIA-1 Phase 3 trial remains on track to provide topline data for the PIK3CA wild type patient sub-group in the second half of 2024 and for the PIK3CA mutant patient sub-group in the first half of 2025.
- 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 Phase 3 VIKTORIA-1 clinical trial is enrolling patients at approximately 220 sites in 23 countries in North and South America, Europe, and Asia.
- The Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide for the treatment of metastatic castration resistant prostate cancer (mCRPC) was initiated in the fourth quarter of 2023. In February 2024, the first patient was dosed.
- The trial is expected to enroll up to 54 patients with mCRPC whose disease progressed after treatment with an androgen receptor signaling inhibitor.
- In December 2023, Celcuity presented data from nonclinical studies evaluating gedatolisib and other PI3K/AKT/mTOR (PAM) inhibitors in breast cancer cell lines during a poster session at the 2023 San Antonio Breast Cancer Symposium (SABCS). In a panel of breast cancer cell lines, gedatolisib was found to be more cytotoxic and at least 300-fold more potent, on average, compared to the single node PAM inhibitors.
- In February 2024, Eldon Mayer was appointed Chief Commercial Officer. His 30 years of biopharmaceutical commercial experience includes senior leadership roles at several companies where he led the launch of their first drug.
Fourth Quarter and Full Year 2023 Financial Results
Unless otherwise stated, all comparisons are for the fourth quarter and full year ended December 31, 2023, compared to the fourth quarter and full year ended December 31, 2022.
Total operating expenses were
Research and development (R&D) expenses were
R&D expenses for the full year 2023 were
General and administrative (G&A) expenses were
G&A expenses for the full year 2023 were
Net loss for the fourth quarter of 2023 was
Net cash used in operating activities for the fourth quarter of 2023 was
In October of 2023, Celcuity closed a private placement of equity that resulted in gross proceeds of approximately
At December 31, 2023, Celcuity reported cash, cash equivalents and short-term investments of
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 2023 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-888-886-7786 or 1-416-764-8658. A live webcast presentation can also be accessed using this weblink: https://viavid.webcasts.com/starthere.jsp?ei=1655995&tp_key=04c7a07803. 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 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. The company's CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies. 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; our strategy, marketing and commercialization plans; 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, 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 to be 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.
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 Westwicke
Maria Yonkoski, maria.yonkoski@westwicke.com
(203) 682-7167
| Celcuity Inc. | |||||||
| Balance Sheets | |||||||
| December 31, 2023 | December 31, 2022 | ||||||
| Assets | |||||||
| Current Assets: | |||||||
| Cash and cash equivalents | $ | 30,662,774 | $ | 24,571,557 | |||
| Investments | 149,919,974 | 144,015,954 | |||||
| Other current assets | 10,007,849 | 6,603,026 | |||||
| Total current assets | 190,590,597 | 175,190,537 | |||||
| Property and equipment, net | 228,782 | 260,294 | |||||
| Operating lease right-of-use assets | 400,019 | 246,266 | |||||
| Total Assets | $ | 191,219,398 | $ | 175,697,097 | |||
| Liabilities and Stockholders' Equity: | |||||||
| Current Liabilities: | |||||||
| Accounts payable | $ | 5,076,699 | $ | 2,627,076 | |||
| Finance lease liabilities | - | 2,449 | |||||
| Operating lease liabilities | 184,950 | 191,749 | |||||
| Accrued expenses | 8,927,094 | 4,060,280 | |||||
| Total current liabilities | 14,188,743 | 6,881,554 | |||||
| Operating lease liabilities | 225,922 | 61,002 | |||||
| Note payable, non-current | 37,035,411 | 34,983,074 | |||||
| Total Liabilities | 51,450,076 | 41,925,630 | |||||
| Total Stockholders' Equity | 139,769,322 | 133,771,467 | |||||
| Total Liabilities and Stockholders' Equity | $ | 191,219,398 | $ | 175,697,097 | |||
| Celcuity Inc. | |||||||||||||||
| Statements of Operations | |||||||||||||||
| Three Months Ended December 31, | Years Ended December 31, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 18,081,194 | $ | 10,604,043 | $ | 60,594,005 | $ | 35,289,548 | |||||||
| General and administrative | 1,648,079 | 1,035,161 | 5,636,326 | 4,101,543 | |||||||||||
| Total operating expenses | 19,729,273 | 11,639,204 | 66,230,331 | 39,391,091 | |||||||||||
| Loss from operations | (19,729,273 | ) | (11,639,204 | ) | (66,230,331 | ) | (39,391,091 | ) | |||||||
| Other income (expense) | |||||||||||||||
| Interest expense | (1,397,247 | ) | (678,003 | ) | (5,326,387 | ) | (2,106,111 | ) | |||||||
| Interest income | 2,278,048 | 735,863 | 7,777,602 | 1,127,162 | |||||||||||
| Other income (expense), net | 880,801 | 57,860 | 2,451,215 | (978,949 | ) | ||||||||||
| Net loss before income taxes | (18,848,472 | ) | (11,581,344 | ) | (63,779,116 | ) | (40,370,040 | ) | |||||||
| Income tax benefits | - | - | - | - | |||||||||||
| Net loss | $ | (18,848,472 | ) | $ | (11,581,344 | ) | $ | (63,779,116 | ) | $ | (40,370,040 | ) | |||
| Net loss per share, basic and diluted | $ | (0.65 | ) | $ | (0.69 | ) | $ | (2.69 | ) | $ | (2.64 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 28,900,075 | 16,872,018 | 23,679,472 | 15,418,543 | |||||||||||
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 December 31, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| GAAP net loss | $ | (18,848,472 | ) | $ | (11,581,344 | ) | $ | (63,779,116 | ) | $ | (40,370,040 | ) | |||
| Adjustments: | |||||||||||||||
| Stock-based compensation | |||||||||||||||
| Research and development (1) | 745,629 | 625,583 | 2,700,318 | 2,563,291 | |||||||||||
| General and administrative (2) | 496,904 | 513,838 | 2,201,116 | 2,074,914 | |||||||||||
| Non-cash interest expense (3) | 528,637 | 254,884 | 2,052,336 | 850,831 | |||||||||||
| Non-cash interest income (4) | (554,126 | ) | (142,928 | ) | (993,457 | ) | (142,928 | ) | |||||||
| Non-GAAP adjusted net loss | $ | (17,631,428 | ) | $ | (10,329,967 | ) | $ | (57,818,803 | ) | $ | (35,023,932 | ) | |||
| GAAP net loss per share - basic and diluted | $ | (0.65 | ) | $ | (0.69 | ) | $ | (2.69 | ) | $ | (2.64 | ) | |||
| Adjustment to net loss (as detailed above) | 0.04 | 0.08 | 0.25 | 0.35 | |||||||||||
| Warrant modification adjustment (5) | - | - | - | 0.02 | |||||||||||
| Non-GAAP adjusted net loss per share | $ | (0.61 | ) | $ | (0.61 | ) | $ | (2.44 | ) | $ | (2.27 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 28,900,075 | 16,872,018 | 23,679,472 | 15,418,543 | |||||||||||
| (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. |
| (5) | To reflect an adjustment to basic and diluted net loss per share related to a warrant modification. |
FAQ
When was the first patient dosed in the Phase 1b/2 trial for metastatic castration resistant prostate cancer?
How much funding did Celcuity raise?
Until when do they expect the funds raised to last?
What was presented at the recent symposium regarding gedatolisib?
What were the financial results for the fourth quarter and full year 2023?
