Celcuity (CELC) secures REVTORPYK FDA approval while Q2 net loss hits $78.9M
Rhea-AI Filing Summary
Celcuity Inc. reported second quarter 2026 results alongside major clinical, regulatory and financing milestones. The U.S. FDA approved REVTORPYK (gedatolisib) on July 14, 2026 for HR+/HER2-, PIK3CA wild-type locally advanced or metastatic breast cancer after endocrine therapy, with commercial launch activities underway and shipments expected late in the third quarter of 2026. REVTORPYK in combination with fulvestrant, with or without palbociclib, was added to NCCN Guidelines as a preferred Category 1 second-line option.
In the PIK3CA-mutant cohort of the Phase 3 VIKTORIA-1 trial, gedatolisib regimens roughly doubled progression-free survival versus alpelisib plus fulvestrant, with hazard ratios of 0.50 and 0.51 and median PFS of 11.1 and 11.3 months versus 5.6 months. Objective response rates reached 49% for the triplet and 36% for the doublet, with lower discontinuation rates due to adverse events than alpelisib.
Net loss for the quarter widened to $78.9 million or $1.44 per share from $45.3 million or $1.04. Total operating expenses rose to $66.1 million, driven by a jump in SG&A to support commercialization, while R&D declined as VIKTORIA-1 costs eased. Celcuity completed a $575.0 million 0.250% convertible note offering, using $137.0 million to prepay term debt, and ended the quarter with $754.0 million in cash, cash equivalents and investments, which it expects will fund operations at least into 2029.
Positive
- FDA approval of REVTORPYK for HR+/HER2-, PIK3CA wild-type advanced breast cancer establishes Celcuity’s first commercial product and a new second-line treatment option.
- Phase 3 VIKTORIA-1 PIK3CA-mutant data showed 11.1–11.3 months PFS vs 5.6 months with alpelisib plus fulvestrant, with hazard ratios of 0.50 and 0.51 and favorable discontinuation rates.
- A $575.0 million 0.250% convertible senior note offering, net proceeds $557.2 million, plus $137.0 million term loan prepayment leaves $754.0 million in liquidity and runway at least into 2029.
Negative
- Quarterly net loss increased to $78.9 million from $45.3 million, and non-GAAP adjusted net loss rose to $58.7 million from $40.5 million year over year.
- Total operating expenses climbed to $66.1 million from $44.0 million, with SG&A expanding to $35.0 million from $7.6 million largely due to commercialization build-out.
- Total liabilities grew to $841.0 million and stockholders’ equity shifted to a $12.8 million deficit, reflecting higher convertible debt and recognition of a $50.0 million accrued license milestone.
Filing Explained
The completed financing is recorded as convertible-note liabilities, not a reported common-share issuance; conversion terms and dilution remain unspecified.
The completed convertible-note issuance is reflected on Celcuity’s June 30 balance sheet as a financing obligation, with stockholders’ equity reported as a deficit.
The balance sheet shows convertible notes of
The filing does not report common-stock issuance, conversion terms, or a resulting share-count change for the notes, so it does not establish dilution for existing common holders.
Separately, the company expanded the Phase 3 VIKTORIA-2 trial to add Study 2, evaluating gedatolisib with palbociclib and letrozole in treatment-naive, endocrine-sensitive patients.
The filing identifies a planned supplemental New Drug Application submission in the third quarter of 2026 for the PIK3CA-mutant VIKTORIA-1 results; it does not report that submission or any resulting approval.
8-K Event Classification
Key Figures
Key Terms
progression-free survival medical
convertible senior notes financial
objective response rate medical
Expanded Access Program medical
non-GAAP adjusted net loss financial
loss on debt extinguishment financial
Earnings Snapshot
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 13, 2026, Celcuity Inc. (the “Company”) issued a press release regarding the Company’s financial results for the quarter ended June 30, 2026. A copy of the Company’s press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.
The information in this Item 2.02, including the accompanying exhibit, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in this Item 2.02 shall not be incorporated into any filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1 |
Press release dated August 13, 2026 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: August 13, 2026
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CELCUITY INC. |
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/s/ Brian F. Sullivan |
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Brian F. Sullivan |
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Chief Executive Officer |
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Exhibit 99.1
Celcuity Inc. Reports Release of Second Quarter 2026 Financial Results and Provides Corporate Update
MINNEAPOLIS, August 13, 2026 — Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced financial results for the second quarter ended June 30, 2026 and other recent business developments.
“Celcuity made monumental progress these past few months, achieving critical clinical and regulatory milestones related to gedatolisib. With the FDA approval of REVTORPYK, positive results from the PIK3CA MT cohort of the pivotal VIKTORIA-1 study, and a preferred Category 1 recommendation in the NCCN Guidelines®, we are well positioned to address a significant unmet need for the tens of thousands of patients affected each year by HR+/HER2-, PIK3CAwild-type locally advanced or metastatic breast cancer whose disease has progressed after endocrine therapy,” said Brian Sullivan, CEO and co-founder of Celcuity. “We are on track to begin shipping REVTORPYK late in the third quarter of 2026, and we look forward to making this important therapy available to patients with locally advanced or metastatic breast cancer.”
Mr. Sullivan added, “Based on the positive data from the PIK3CAmutant cohort of the Phase 3 VIKTORIA-1 study, we plan to submit an sNDA to FDA in the third quarter of 2026. Additionally, our VIKTORIA-2 study was expanded to enable evaluation of treatment-naïve patients who have endocrine-sensitive breast cancer, positioning gedatolisib regimens to potentially be available for nearly all patients in the first- and second-line setting, irrespective of their endocrine sensitivity or PIK3CA mutation status.”
Clinical Highlights
HR+/HER2- Advanced Breast Cancer
2nd Line Setting – PIK3CA Wild-Type
Following the unprecedented results from the PIK3CA WT cohort of the VIKTORIA-1 Phase 3 clinical trial, on July 14, 2026 Celcuity announced that the U.S. Food and Drug Administration (“FDA”) had approved REVTORPYK, the company’s pan-PI3K, mTORC1/2 inhibitor, for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth factor 2 receptor negative (”HER2-“), locally advanced or metastatic breast cancer (“ABC”) without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
Celcuity subsequently announced that REVTORPYK in combination with fulvestrant, with or without palbociclib, was recommended by the National Comprehensive Cancer Network® (“NCCN®”) as a preferred Category 1 second-line and/or subsequent-line therapy for the treatment of patients with HR+/HER2- breast cancer without a PIK3CA mutation following progression on or after treatment with at least one line of endocrine therapy.
The build-out of the commercialization infrastructure needed to support a successful launch of REVTORPYK is complete and commercial launch activities for REVTORPYK commenced immediately after approval. Shipments of REVTORPYK are expected to begin late in the third quarter of 2026.
To make gedatolisib available to patients prior to commercial availability of REVTORPYK, last week Celcuity opened an Expanded Access Program (EAP) to participating physicians on behalf of eligible patients, and we have begun to distribute gedatolisib to those physicians.
2nd Line Setting – PIK3CA Mutant-Type
Gedatolisib continued to demonstrate a differentiated clinical profile across different patient populations when combined with fulvestrant, with or without palbociclib. At the 2026 American Society of Clinical Oncology (“ASCO”) Annual Meeting, detailed results from the PIK3CA MT cohort of the global VIKTORIA-1 Phase 3 study were presented at a late-breaking abstract Oral Session. The study demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of progression-free survival (“PFS”) compared with alpelisib plus fulvestrant, with a manageable safety profile.
Gedatolisib plus fulvestrant and palbociclib (the “gedatolisib-triplet”) reduced the risk of disease progression or death by 50% vs. alpelisib plus fulvestrant (HR=0.50; 95% CI: 0.37–0.68; p<0.0001). Median PFS was 11.1 months with the gedatolisib triplet versus 5.6 months with alpelisib plus fulvestrant. Gedatolisib plus fulvestrant (the “gedatolisib-doublet”) reduced the risk of disease progression or death by 49% vs. alpelisib plus fulvestrant (HR=0.51; 95% CI: 0.33–0.79; descriptive p=0.0013). Median PFS was 11.3 months with the gedatolisib-doublet versus 5.6 months with alpelisib plus fulvestrant. Gedatolisib regimens demonstrated robust and durable responses: 49% objective response rate (“ORR”) and median duration of response (“DoR”) of 15.7 months for the gedatolisib-triplet and 36% ORR and median DoR of 24.2 months for the gedatolisib-doublet.
The safety data for the gedatolisib-triplet and -doublet were consistent with previously reported data from the PIK3CA wild-type cohort of VIKTORIA-1. Analyses of the treatment discontinuation rate due to an adverse event for gedatolisib and alpelisib in the PIK3CA MT cohort were updated using the same methodology that determined the discontinuation rate due to an adverse event for the PIK3CA WT cohort presented in the REVTORPYK label. For patients who received the gedatolisib triplet and gedatolisib doublet, 5.2% and 3.8% of patients discontinued gedatolisib due to an adverse event, respectively. For patients who received alpelisib, 19.1% discontinued treatment with alpelisib due to an adverse event.
Celcuity intends to submit these data to the FDA in the third quarter as an sNDA and to submit VIKTORIA-1 data to other regulatory authorities outside the U.S. following the sNDA submission.
Analyses of the mean number of gedatolisib treatment cycles patients received in the PIK3CAWT and MT cohorts of the VIKTORIA-1 Phase 3 trial were also updated as of August 2, 2026, with a median follow-up period of approximately 21 months and 17 months for the PIK3CA WT and MT cohorts, respectively. For patients who received the gedatolisib-triplet, the mean number of treatment cycles on gedatolisib was 9.0 and 10.0 cycles in the PIK3CA WT and MT cohorts, respectively, with 12% (16) and 22% (34) of patients still receiving gedatolisib therapy in each cohort, respectively. For patients who received the gedatolisib-doublet, the mean number of treatment cycles on gedatolisib was 9.7 and 11.3 cycles in the PIK3CA WT and MT cohorts, respectively, with 12% (15) and 19% (10) of patients still receiving gedatolisib therapy in each cohort, respectively.
Celcuity expects to provide further updates to results from both the PIK3CA MT and WT cohorts of VIKTORIA-1 at medical conferences in the fourth quarter.
1st Line Setting
Celcuity continues to advance gedatolisib combined with palbociclib and endocrine therapy in the first-line setting for patients with HR+/HER2- ABC through its ongoing Phase 3 VIKTORIA-2 clinical trial. The VIKTORIA-2 trial was expanded in the second quarter 2026 to include a second study (Study 2) evaluating the efficacy and safety of gedatolisib in combination with palbociclib and letrozole in patients with treatment-naive endocrine-sensitive HR+/HER2- ABC. Study 1 of the VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and fulvestrant in patients with treatment-naïve endocrine-resistant HR+/HER2- ABC.
Metastatic Castration-Resistant Prostate Cancer (“mCRPC”)
Development of gedatolisib in combination with darolutamide continues to advance. In the dose finding portion of Celcuity’s Phase 1b study, evaluation of a 240 mg dose of gedatolisib was completed. No adverse events led to treatment discontinuation of gedatolisib and dose limiting toxicity criteria for dose reduction were not met. Evaluation of a 300 mg dose is ongoing. Once the Phase 1/1b portion of the study is completed, Celcuity expects to select the recommended phase 2 dose level(s) and control arm options for the randomized Phase 2 portion of the study. The company expects to provide updated clinical data and additional visibility into its mCRPC development strategy during the fourth quarter of 2026.
Other Recent Developments
In June 2026, the Company conducted a public offering of 0.250% convertible senior notes due 2032. The net proceeds from the offering were $557.2 million, after deducting underwriting discounts and commissions and the Company’s estimated offering expenses. The Company utilized $137.0 million of the net proceeds to prepay term loan debt.
Celcuity’s advancement of a subcutaneous gedatolisib formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. The subcutaneous formulation is aimed to support potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years.
Second Quarter 2026 Financial Results
Unless otherwise stated, all comparisons are for the second quarter ended June 30, 2026, compared to the second quarter ended June 30, 2025.
Net loss for the second quarter of 2026 was $78.9 million, or $1.44 per share, compared to a net loss of $45.3 million, or $1.04 per share, for the prior year period. Non-GAAP adjusted net loss for the second quarter of 2026 was $58.7 million, or $1.07 per share, compared to non-GAAP adjusted net loss of $40.5 million, or $0.93 per share, for the prior year period. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, non-cash investment (income) expense and loss on debt extinguishment. 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.
Total operating expenses were $66.1 million for the second quarter of 2026, compared to $44.0 million for the prior year period.
Research and development (“R&D”) expenses were $31.1 million for the second quarter of 2026, compared to $36.4 million for the prior year period. The $5.3 million decrease in R&D expenses was primarily due to a $7.0 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VIKTORIA-1 Phase 3 clinical trial, and a $5.0 million decrease in license milestone costs. These decreases were partially offset by a $3.8 million increase in employee-related and consulting expenses, of which $0.9 million related to stock-based compensation, and a $2.9 million increase in manufacturing and other costs.
Selling, general and administrative (“SG&A”) expenses were $35.0 million for the second quarter of 2026, compared to $7.6 million for the prior year period. The $27.4 million increase in SG&A expenses was primarily due to a $14.5 million increase in employee-related expenses, of which $3.3 million related to stock-based compensation. The increase in employee-related expenses was primarily driven by the hiring of additional personnel within our commercial function to support the anticipated launch of REVTORPYK. The remaining $12.9 million increase was primarily due to a $10.8 million increase in costs to support pre-commercial launch activities, including consulting expenses, professional fees and expanding infrastructure costs, and a $2.1 million increase in other administrative expenses. In the aggregate, $23.4 million of the $27.4 million SG&A increase related to commercial headcount additions and other launch-related activities.
Net cash used in operating activities for the second quarter of 2026 was $55.4 million, compared to $36.2 million for the prior year period. Cash, cash equivalents and short-term investments were $754.0 million at the end of the second quarter of 2026. We expect that our current cash, cash equivalents and short-term investments will finance our operations at least into 2029.
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 this weblink: https://viavid.webcasts.com/starthere.jsp?ei=1767665&tp_key=7e57f2ab18. A replay of the webcast will be available on the Celcuity website following the live event.
About REVTORPYK (gedatolisib)
REVTORPYK (gedatolisib) is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
Please click here for Important Safety Information and Full Prescribing Information for REVTORPYK.
About Celcuity
We are a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. Our first FDA-approved product is REVTORPYKTM (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 PI3Kα, AKT or mTORC1 alone or together. Our Phase 3 clinical trial, VIKTORIA-1, evaluated gedatolisib in combination with fulvestrant, with or without palbociclib, for the treatment of patients with HR+/HER2- ABC. Data from this trial is the basis for FDA approval of REVTORPYK for use in adult patients with HR+/HER2- ABC without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of the VIKTORIA-1 study have been released. Our Phase 3 clinical trial, VIKTORIA-2, is an ongoing trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib in combination with palbociclib and fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib in combination with palbociclib and letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1b/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 and its products, including important safety information and full prescribing information 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 REVTORPYK and the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; the status and timing of the submission, and the FDA’s review, of the Company’s sNDA for gedatolisib, and for making comparable filings with other regulatory authorities outside the U.S.; the market opportunity for gedatolisib; the Company’s expectations regarding the timing of and its ability to commercialize REVTORPYK; the Company’s strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to gedatolisib, including subcutaneous formulations to support potential future indications for gedatolisib regimens; the Company’s anticipated use of cash; and the strength of its 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 the Company’s topline clinical results are based on an ongoing analysis of 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 the Company’s clinical trials or the submission, and FDA’s review of, its sNDA for gedatolisib; the Company’s ability to obtain regulatory approval of its sNDA and maintain regulatory approvals to commercialize REVTORPYK in the U.S. and obtain regulatory approval of gedatolisib outside the U.S., and the market acceptance of REVTORPYK; the development of therapies and tools competitive with gedatolisib; and the Company’s ability to access capital upon favorable terms. In addition, all forward-looking statements are subject to other risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in its 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 the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
References:
1. Internal estimates using data from National Cancer Institute, SEER, 2024; Pan, H, NEJM, 2017;377:1836-46; Dowsett, M 2009; Salvo, E. M. et al. 2021
© 2026 Celcuity Inc. All rights reserved. REVTORPYK and the Celcuity logo are trademarks of Celcuity Inc.
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.
Condensed Balance Sheets
(in thousands)
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June 30, |
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December 31, |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
182,049 |
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$ |
165,703 |
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Investments |
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571,995 |
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275,794 |
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Prepaid clinical trial costs |
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12,996 |
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18,896 |
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Other current assets |
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8,801 |
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5,266 |
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Total current assets |
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775,841 |
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465,659 |
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Property and equipment, net |
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611 |
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499 |
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Intangible assets, net |
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50,000 |
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— |
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Operating lease right-of-use assets |
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1,107 |
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51 |
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Other non-current assets |
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661 |
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349 |
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Total assets |
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$ |
828,220 |
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$ |
466,558 |
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Liabilities and stockholders' equity (deficit) |
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Current liabilities: |
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Accounts payable |
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$ |
8,093 |
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$ |
6,407 |
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Accrued clinical trial costs |
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7,942 |
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16,826 |
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Accrued license milestone |
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50,000 |
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5,000 |
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Other accrued expenses |
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20,581 |
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15,865 |
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Operating lease liabilities, current |
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257 |
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54 |
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Total current liabilities |
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86,873 |
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44,152 |
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Operating lease liabilities, non-current |
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893 |
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— |
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Convertible notes |
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753,235 |
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195,324 |
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Note payable |
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— |
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126,527 |
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Total liabilities |
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841,001 |
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366,003 |
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Total stockholders' equity (deficit) |
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(12,781 |
) |
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100,555 |
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Total liabilities and stockholders' equity (deficit) |
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$ |
828,220 |
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$ |
466,558 |
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Celcuity Inc.
Condensed Statements of Operations
(unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Operating expenses: |
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||||
Research and development (1) |
$ |
31,077 |
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$ |
36,415 |
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|
$ |
64,140 |
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$ |
66,174 |
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Selling, general and administrative (1) |
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35,041 |
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7,594 |
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52,485 |
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13,968 |
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Total operating expenses |
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66,118 |
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44,009 |
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|
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116,625 |
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80,142 |
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Loss from operations |
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(66,118 |
) |
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(44,009 |
) |
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(116,625 |
) |
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(80,142 |
) |
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Other (expense) income: |
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Interest expense |
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(5,423 |
) |
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|
(3,204 |
) |
|
|
(11,508 |
) |
|
|
(6,387 |
) |
Interest income |
|
4,154 |
|
|
|
1,945 |
|
|
|
7,905 |
|
|
|
4,264 |
|
Loss on debt extinguishment |
|
(11,477 |
) |
|
|
— |
|
|
|
(11,477 |
) |
|
|
— |
|
Other expense, net |
|
(12,746 |
) |
|
|
(1,259 |
) |
|
|
(15,080 |
) |
|
|
(2,123 |
) |
Net loss before income taxes |
|
(78,864 |
) |
|
|
(45,268 |
) |
|
|
(131,705 |
) |
|
|
(82,265 |
) |
Income taxes |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
$ |
(78,864 |
) |
|
$ |
(45,268 |
) |
|
$ |
(131,705 |
) |
|
$ |
(82,265 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share, basic and diluted |
$ |
(1.44 |
) |
|
$ |
(1.04 |
) |
|
$ |
(2.41 |
) |
|
$ |
(1.90 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average common shares outstanding, basic and diluted |
|
54,816,437 |
|
|
|
43,663,364 |
|
|
|
54,640,608 |
|
|
|
43,359,748 |
|
(1) |
Certain prior period amounts have been reclassified from research and development expenses to selling, general and administrative expenses to conform to the current period presentation. |
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, non-cash investment (income) expense and loss on debt extinguishment 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
(unaudited)
(in thousands, except share and per share amounts)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
GAAP net loss |
|
$ |
(78,864 |
) |
|
$ |
(45,268 |
) |
|
$ |
(131,705 |
) |
|
$ |
(82,265 |
) |
Adjustments to net loss: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development (1), (2) |
|
|
2,240 |
|
|
|
1,261 |
|
|
|
4,352 |
|
|
|
2,425 |
|
Selling, general and administrative (1), (3) |
|
|
4,664 |
|
|
|
1,443 |
|
|
|
7,877 |
|
|
|
2,723 |
|
Non-cash interest expense (4) |
|
|
1,471 |
|
|
|
789 |
|
|
|
3,048 |
|
|
|
1,589 |
|
Non-cash investment (income) expense (5) |
|
|
332 |
|
|
|
1,286 |
|
|
|
(551 |
) |
|
|
340 |
|
Loss on debt extinguishment (6) |
|
|
11,477 |
|
|
|
— |
|
|
|
11,477 |
|
|
|
— |
|
Non-GAAP adjusted net loss |
|
$ |
(58,680 |
) |
|
$ |
(40,489 |
) |
|
$ |
(105,502 |
) |
|
$ |
(75,188 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
GAAP net loss per share - basic and diluted |
|
$ |
(1.44 |
) |
|
$ |
(1.04 |
) |
|
$ |
(2.41 |
) |
|
$ |
(1.90 |
) |
Adjustments to net loss: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development (1), (2) |
|
|
0.04 |
|
|
|
0.03 |
|
|
|
0.08 |
|
|
|
0.06 |
|
Selling, general and administrative (1), (3) |
|
|
0.08 |
|
|
|
0.03 |
|
|
|
0.14 |
|
|
|
0.06 |
|
Non-cash interest expense (4) |
|
|
0.03 |
|
|
|
0.02 |
|
|
|
0.06 |
|
|
|
0.04 |
|
Non-cash investment (income) expense (5) |
|
|
0.01 |
|
|
|
0.03 |
|
|
|
(0.01 |
) |
|
|
0.01 |
|
Loss on debt extinguishment (6) |
|
|
0.21 |
|
|
|
— |
|
|
|
0.21 |
|
|
|
— |
|
Non-GAAP adjusted net loss per share - basic and diluted |
|
$ |
(1.07 |
) |
|
$ |
(0.93 |
) |
|
$ |
(1.93 |
) |
|
$ |
(1.73 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average common shares outstanding, basic and diluted |
|
|
54,816,437 |
|
|
|
43,663,364 |
|
|
|
54,640,608 |
|
|
|
43,359,748 |
|
(1) |
Certain prior period amounts have been reclassified from research and development expenses to selling, general and administrative expenses to conform to the current period presentation. |
(2) |
To reflect a non-cash adjustment to operating expenses for research and development stock-based compensation. |
(3) |
To reflect a non-cash adjustment to operating expenses for selling, general and administrative stock-based compensation. |
(4) |
To reflect a non-cash adjustment to other (expense) income for amortization of debt issuance costs and discount and payment-in-kind interest related to the issuance of the convertible notes and note payable. |
(5) |
To reflect a non-cash adjustment to other (expense) income for accretion on investments and change in accrued interest income. |
(6)
|
To reflect a non-cash adjustment to other (expense) income for loss on extinguishment related to the repayment of the note payable. |