Celcuity Inc. Reports Second Quarter Financial Results and Provides Corporate Update
Celcuity Inc. (Nasdaq: CELC) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Plan to initiate Phase 3 VIKTORIA-2 trial for gedatolisib in HR+, HER2- advanced breast cancer, with first patient enrollment expected in Q2 2025.
2. VIKTORIA-1 PIK3CA WT cohort enrollment target expected in Q4 2024, with topline data anticipated in late Q4 2024 or Q1 2025.
3. Raised $129 million in gross proceeds from equity and debt financings, extending operational runway through 2026.
4. Q2 2024 financial results: Total operating expenses of $24.3 million, net loss of $23.7 million ($0.62 per share), and cash position of $283.1 million as of June 30, 2024.
Celcuity Inc. (Nasdaq: CELC) ha riportato i risultati finanziari del secondo trimestre del 2024 e ha fornito un aggiornamento aziendale. I punti salienti includono:
1. Piano per avviare la fase 3 dello studio VIKTORIA-2 per gedatolisib nel carcinoma mammario avanzato HR+, HER2-, con un primo paziente previsto per il secondo trimestre del 2025.
2. Obiettivo di arruolamento della coorte PIK3CA WT di VIKTORIA-1 previsto per il quarto trimestre del 2024, con i dati preliminari attesi entro la fine del quarto trimestre 2024 o nel primo trimestre del 2025.
3. Raccolti 129 milioni di dollari in ricavi lordi da finanziamenti azionari e debitorii, estendendo la durata operativa fino al 2026.
4. Risultati finanziari del secondo trimestre 2024: spese operative totali di 24,3 milioni di dollari, perdita netta di 23,7 milioni di dollari (0,62 dollari per azione) e posizione di cassa di 283,1 milioni di dollari al 30 giugno 2024.
Celcuity Inc. (Nasdaq: CELC) reportó sus resultados financieros del segundo trimestre de 2024 y proporcionó una actualización corporativa. Los aspectos destacados incluyen:
1. Plan para iniciar el ensayo de fase 3 VIKTORIA-2 para gedatolisib en cáncer de mama avanzado HR+, HER2-, con la primera inscripción de pacientes esperada en el segundo trimestre de 2025.
2. Se espera que el objetivo de inscripción de la cohorte PIK3CA WT de VIKTORIA-1 se cumpla en el cuarto trimestre de 2024, con datos preliminares anticipados para finales del cuarto trimestre de 2024 o el primer trimestre de 2025.
3. Se recaudaron 129 millones de dólares en ingresos brutos de financiamientos de acciones y deudas, extendiendo la duración operativa hasta 2026.
4. Resultados financieros del segundo trimestre de 2024: gastos operativos totales de 24,3 millones de dólares, pérdida neta de 23,7 millones de dólares (0,62 dólares por acción) y una posición de efectivo de 283,1 millones de dólares al 30 de junio de 2024.
Celcuity Inc. (Nasdaq: CELC)는 2024년 2분기 재무 결과를 발표하고 기업 업데이트를 제공했습니다. 주요 요점은 다음과 같습니다:
1. HR+, HER2- 진행성 유방암에 대한 gedatolisib의 3상 VIKTORIA-2 시험을 시작할 계획이며, 첫 환자 등록은 2025년 2분기에 예상됩니다.
2. VIKTORIA-1 PIK3CA WT 코호트 등록 목표는 2024년 4분기로 예상되며, 탑라인 데이터는 2024년 4분기 말 또는 2025년 1분기에 기대됩니다.
3. 주식과 채무 자금을 통해 1억 2,900만 달러의 총 수익을 올리며 2026년까지 운영 기간을 연장했습니다.
4. 2024년 2분기 재무 결과: 총 운영비용 2,430만 달러, 순손실 2,370만 달러(주당 0.62 달러), 2024년 6월 30일 기준 현금 잔액 2억 8,310만 달러입니다.
Celcuity Inc. (Nasdaq: CELC) a publié ses résultats financiers pour le deuxième trimestre 2024 et a fourni une mise à jour de l'entreprise. Les points clés incluent :
1. Un plan pour initier l'essai VIKTORIA-2 de phase 3 pour gedatolisib dans le cancer du sein avancé HR+, HER2-, avec le premier patient prévu pour le deuxième trimestre 2025.
2. L'objectif de recrutement de la cohorte PIK3CA WT de VIKTORIA-1 est prévu pour le quatrième trimestre 2024, avec des données préliminaires attendues fin du quatrième trimestre 2024 ou au premier trimestre 2025.
3. 129 millions de dollars de produits bruts levés par le biais de financements par actions et par dettes, prolongeant l'échéance opérationnelle jusqu'en 2026.
4. Résultats financiers du deuxième trimestre 2024 : dépenses d'exploitation totales de 24,3 millions de dollars, perte nette de 23,7 millions de dollars (0,62 dollar par action) et une position de trésorerie de 283,1 millions de dollars au 30 juin 2024.
Celcuity Inc. (Nasdaq: CELC) hat seine Finanzzahlen für das zweite Quartal 2024 veröffentlicht und ein Unternehmensupdate bereitgestellt. Die wichtigsten Punkte sind:
1. Geplante Einleitung der Phase-3-Studie VIKTORIA-2 für gedatolisib bei HR+, HER2- fortgeschrittenem Brustkrebs, mit erwartetem ersten Patientenrekruitment im zweiten Quartal 2025.
2. Ziel für die Rekrutierung der PIK3CA WT Kohorte von VIKTORIA-1 wird im vierten Quartal 2024 erwartet, mit ersten Ergebnissen, die Ende des vierten Quartals 2024 oder im ersten Quartal 2025 erwartet werden.
3. 129 Millionen Dollar brutto aus Eigenkapital- und Schuldenfinanzierungen gesammelt, was die operative Laufzeit bis 2026 verlängert.
4. Finanzielle Ergebnisse für das zweite Quartal 2024: Gesamte Betriebsausgaben von 24,3 Millionen Dollar, Nettoverlust von 23,7 Millionen Dollar (0,62 Dollar pro Aktie) und eine Liquiditätsposition von 283,1 Millionen Dollar zum 30. Juni 2024.
- Raised $129 million in gross proceeds, extending operational runway through 2026
- Strong cash position of $283.1 million as of June 30, 2024
- VIKTORIA-1 Phase 3 trial enrollment remains robust and on-track
- Initiated efforts to launch VIKTORIA-2 Phase 3 study for first-line treatment
- Net loss increased to $23.7 million in Q2 2024 from $14.6 million in Q2 2023
- Total operating expenses increased to $24.3 million in Q2 2024 from $15.1 million in Q2 2023
- Delayed enrollment target for PIK3CA wild-type cohort from Q3 to Q4 2024
- Shift in topline data release for PIK3CA WT cohort to late Q4 2024 or Q1 2025
Insights
Celcuity's Q2 results reflect significant R&D investment in their lead candidate, gedatolisib. The
The delay in VIKTORIA-1's PIK3CA wild-type cohort enrollment to Q4 2024 may slightly impact near-term catalysts. However, the initiation of VIKTORIA-2 expands gedatolisib's potential market. Investors should monitor cash burn rate and clinical progress, as positive trial results could significantly impact Celcuity's valuation.
The clinical development of gedatolisib in HR+, HER2- advanced breast cancer is promising. The VIKTORIA-1 trial's robust enrollment and the planned VIKTORIA-2 study targeting first-line treatment are significant steps. The combination of gedatolisib with fulvestrant and CDK4/6 inhibitors could potentially offer a new treatment paradigm.
The recent publications in The Lancet Oncology and npj Breast Cancer support gedatolisib's potential superiority over single-node PI3K/AKT/mTOR inhibitors. The expansion into prostate cancer with the Phase 1b/2 trial is also noteworthy. These developments suggest gedatolisib could become a versatile oncology asset, potentially improving outcomes across multiple cancer types.
Celcuity's pipeline progress is encouraging, particularly the advancement of gedatolisib. The shift in PIK3CA wild-type patient proportion in VIKTORIA-1 is intriguing and may provide valuable insights into the drug's efficacy across different genetic profiles. The planned VIKTORIA-2 study, involving 638 patients across 200 sites, demonstrates a robust approach to validating gedatolisib's potential in first-line treatment.
The multiple recent publications in prestigious journals like The Lancet Oncology strengthen gedatolisib's scientific foundation. The expansion into prostate cancer further diversifies the potential applications. Investors should closely monitor upcoming data readouts, as positive results could significantly enhance Celcuity's position in the competitive oncology market.
- Announced plan to initiate Phase 3 VIKTORIA-2 trial evaluating gedatolisib combined with fulvestrant plus a CDK4/6 inhibitor as first-line treatment for patients with HR+, HER2- advanced breast cancer; expect to enroll first patient in Q2 2025
- Expect to reach enrollment target for VIKTORIA-1 PIK3CA WT cohort in Q4 2024 and report topline data for this cohort in late Q4 2024 or Q1 2025
- Raised
$129 million in gross proceeds from equity and debt financings; extending runway of current operational activities through 2026 - Management to host webcast and conference call today, August 14, 2024, at 4:30 p.m. ET
MINNEAPOLIS, Aug. 14, 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 second quarter ended June 30, 2024 and other recent business developments.
“We made significant strides advancing the clinical development of gedatolisib this quarter. Overall enrollment in VIKTORIA-1 remains robust and on-track relative to our previous projections,” said Brian Sullivan, CEO and co-founder of Celcuity. “We also initiated efforts to launch VIKTORIA-2, a Phase 3 study to evaluate gedatolisib as a first-line treatment option for patients with HR+, HER2- advanced breast cancer.”
“In our VIKTORIA-1 study, while overall enrollment is on track, the proportion of patients who have PIK3CA wild-type tumors, versus those with PIK3CA mutations, has recently shifted lower than our original estimates. As a result, we expect to reach the enrollment target for the PIK3CA wild-type cohort in the fourth quarter, rather than the third quarter, as we originally forecasted. In light of this, we expect topline data for the PIK3CA WT cohort to shift to sometime between late Q4 2024 and Q1 2025.”
Second Quarter 2024 Business Highlights and Other Recent Developments
- The VIKTORIA-1 Phase 3 trial expects to provide topline data for the PIK3CA wild-type cohort in late Q4 2024 or Q1 2025 and for the PIK3CA mutant cohort 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.
- Enrollment of the PIK3CA wild-type cohort is more than
80% complete and expected to reach the enrollment target during Q4 2024. The PIK3CA wild-type cohort represents approximately60% of the total patients enrolled to date in VIKTORIA-1.
- In May, the Company announced its plan to initiate VIKTORIA-2, a Phase 3 study to evaluate 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.
- A safety run-in study to evaluate the safety of gedatolisib combined with ribociclib and fulvestrant will precede initiation of the Phase 3 portion of the study.
- The Phase 3 portion of the study is expected to enroll approximately 638 patients at up to 200 sites across North America, Europe, Latin America, and Asia.
- First patient enrollment is expected in the second quarter of 2025.
- During the quarter, the Company secured a combined total of
$129 million in gross proceeds from equity and debt financings, which extended the cash runway for current clinical development program activities through 2026. - The Phase 1b/2 trial, evaluating gedatolisib in combination with darolutamide for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC), remains on track to report preliminary data in the first half of 2025.
- Enrollment is ongoing and the trial is expected to enroll up to 54 patients with mCRPC whose disease progressed after treatment with an androgen receptor signaling inhibitor.
- Three manuscripts reporting clinical and nonclinical results for gedatolisib were published recently.
- In April, The Lancet Oncology published results from the dose expansion groups of its Phase 1b study evaluating gedatolisib in combination with palbociclib and endocrine therapy in HR+/HER2- advanced breast cancer. The published manuscript is available online and on the publications section of Celcuity’s website.
- In June, npj Breast Cancer published results of nonclinical studies showing gedatolisib’s superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors in breast cancer models. The article is available online and on the publications section of Celcuity’s website.
- In August, Molecular Oncology published results of nonclinical studies in prostate cancer models showing gedatolisib’s superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors. The article is available online and will soon be available on the publications section of Celcuity’s website.
Second Quarter 2024 Financial Results
Unless otherwise stated, all comparisons are for the second quarter ended June 30, 2024, compared to the second quarter ended June 30, 2023.
Total operating expenses were
Research and development (R&D) expenses were
General and administrative (G&A) expenses were
Net loss for the second quarter of 2024 was
Net cash used in operating activities for the second quarter of 2024 was
At June 30, 2024, 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 second 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=1678191&tp_key=c55c86e8c3. 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. 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 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; 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 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. | |||||||
| Condensed Balance Sheets | |||||||
| June 30, 2024 | December 31, 2023 | ||||||
| (unaudited) | |||||||
| Assets | |||||||
| Current Assets: | |||||||
| Cash and cash equivalents | $ | 30,458,800 | $ | 30,662,774 | |||
| Investments | 252,609,622 | 149,919,974 | |||||
| Other current assets | 8,862,940 | 10,007,849 | |||||
| Total current assets | 291,931,362 | 190,590,597 | |||||
| Property and equipment, net | 308,444 | 228,782 | |||||
| Operating lease right-of-use assets | 305,179 | 400,019 | |||||
| Total Assets | $ | 292,544,985 | $ | 191,219,398 | |||
| Liabilities and Stockholders' Equity: | |||||||
| Current Liabilities: | |||||||
| Accounts payable | $ | 6,203,132 | $ | 5,076,699 | |||
| Operating lease liabilities | 178,587 | 184,950 | |||||
| Accrued expenses | 13,146,769 | 8,927,094 | |||||
| Total current liabilities | 19,528,488 | 14,188,743 | |||||
| Operating lease liabilities | 138,533 | 225,922 | |||||
| Note payable, non-current | 96,193,172 | 37,035,411 | |||||
| Total Liabilities | 115,860,193 | 51,450,076 | |||||
| Total Stockholders' Equity | 176,684,792 | 139,769,322 | |||||
| Total Liabilities and Stockholders' Equity | $ | 292,544,985 | $ | 191,219,398 | |||
| Celcuity Inc. | |||||||||||||||
| Condensed Statements of Operations | |||||||||||||||
| (unaudited) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 22,496,975 | $ | 13,746,082 | $ | 43,144,534 | $ | 25,024,575 | |||||||
| General and administrative | 1,786,111 | 1,309,403 | 3,632,387 | 2,578,447 | |||||||||||
| Total operating expenses | 24,283,086 | 15,055,485 | 46,776,921 | 27,603,022 | |||||||||||
| Loss from operations | (24,283,086 | ) | (15,055,485 | ) | (46,776,921 | ) | (27,603,022 | ) | |||||||
| Other income (expense) | |||||||||||||||
| Interest expense | (2,260,583 | ) | (1,314,996 | ) | (3,661,295 | ) | (2,557,008 | ) | |||||||
| Interest income | 2,821,849 | 1,782,794 | 5,103,941 | 3,633,926 | |||||||||||
| Other income (expense), net | 561,266 | 467,798 | 1,442,646 | 1,076,918 | |||||||||||
| Net loss before income taxes | (23,721,820 | ) | (14,587,687 | ) | (45,334,275 | ) | (26,526,104 | ) | |||||||
| Income tax benefits | - | - | - | - | |||||||||||
| Net loss | $ | (23,721,820 | ) | $ | (14,587,687 | ) | $ | (45,334,275 | ) | $ | (26,526,104 | ) | |||
| Net loss per share, basic and diluted | $ | (0.62 | ) | $ | (0.66 | ) | $ | (1.26 | ) | $ | (1.22 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 38,444,163 | 21,957,140 | 36,028,109 | 21,819,772 | |||||||||||
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 June 30, | Six Months Ended June 30, | ||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||
| GAAP net loss | $ | (23,721,820 | ) | $ | (14,587,687 | ) | $ | (45,334,275 | ) | $ | (26,526,104 | ) | |||||
| Adjustments: | |||||||||||||||||
| Stock-based compensation | |||||||||||||||||
| Research and development(1) | 978,037 | 639,511 | 1,810,216 | 1,293,982 | |||||||||||||
| General and administrative(2) | 432,475 | 637,471 | 931,642 | 1,256,282 | |||||||||||||
| Non-cash interest expense(3) | 629,579 | 507,717 | 1,160,398 | 1,002,905 | |||||||||||||
| Non-cash interest income(4) | (484,991 | ) | 1,656,623 | (638,836 | ) | (41,188 | ) | ||||||||||
| Non-GAAP adjusted net loss | $ | (22,166,720 | ) | $ | (11,146,365 | ) | $ | (42,070,855 | ) | $ | (23,014,123 | ) | |||||
| GAAP net loss per share - basic and diluted | $ | (0.62 | ) | $ | (0.66 | ) | $ | (1.26 | ) | $ | (1.22 | ) | |||||
| Adjustment to net loss (as detailed above) | 0.04 | 0.15 | 0.09 | 0.17 | |||||||||||||
| Non-GAAP adjusted net loss per share | $ | (0.58 | ) | $ | (0.51 | ) | $ | (1.17 | ) | $ | (1.05 | ) | |||||
| Weighted average common shares outstanding, basic and diluted | 38,444,163 | 21,957,140 | 36,028,109 | 21,819,772 | |||||||||||||
| (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 and interest receivable on investments. | |||||||||||||||||
FAQ
What were Celcuity's (CELC) Q2 2024 financial results?
When is Celcuity (CELC) expecting to report topline data for the VIKTORIA-1 PIK3CA WT cohort?
How much funding did Celcuity (CELC) raise in Q2 2024?
When does Celcuity (CELC) plan to enroll the first patient in the VIKTORIA-2 trial?
