MINNEAPOLIS, MN / ACCESSWIRE / May 16, 2022 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and companion diagnostic strategy for treating patients with cancer, today announced financial results for the first quarter ended March 31, 2022 and other recent business progress.
“Earlier today, we entered into a definitive securities purchase agreement with a premier group of biopharmaceutical investors in a private placement that is expected to result in aggregate gross proceeds to Celcuity of $100 million,” said Brian Sullivan, CEO and Co-Founder of Celcuity. “The expected proceeds will further support the clinical development of gedatolisib, including our planned Phase 3 clinical study, VIKTORIA-1. We are very pleased to have attracted such a well-regarded group of investors in this very difficult equity capital market.
“There is an urgent unmet need for better therapeutic options for patients with HR+/HER2- metastatic breast cancer given the limited benefit currently available targeted therapies provide. This financing transaction is a testament to gedatolisib’s potential to address this unmet need,” Sullivan added.
First Quarter 2022 Business Highlights and Other Recent Developments
First Quarter 2022 Financial Results
Unless otherwise stated, all comparisons are for the first quarter ended March 31, 2022, compared to the first quarter ended March 31, 2021.
Total operating expenses were $7.5 million for the first quarter of 2022, compared to $2.8 million for the first quarter of 2021. Net cash used in operating activities for the first quarter of 2022 was $5.9 million, compared to $2.5 million for the first quarter of 2021. Research and development (R&D) expenses were $6.7 million for the first quarter of 2022, compared to $2.2 million for the first quarter of 2021. The approximately $4.5 million increase during the first quarter of 2022, compared to the first quarter of 2021, resulted primarily from the development of gedatolisib. Employee related expenses, including consulting fees, accounted for $1.6 million of the $4.5 million increase, including $0.2 million in non-cash stock-based compensation. The remaining increase of $2.9 million of the $4.5 million is related to costs for existing clinical trials and for activities supporting the initiation of the VIKTORIA-1 pivotal trial.
General and administrative (G&A) expenses were $0.8 million for the first quarter of 2022, compared to $0.6 million for the first quarter of 2021. The approximately $0.2 million increase in G&A during the first quarter of 2022, compared to the first quarter of 2021, arose primarily from employee related expenses, including approximately $0.1 million in non-cash stock-based compensation.
Net loss for the first quarter of 2022 was $7.9 million, or $0.53 per share, compared to a net loss of $2.8 million, or $0.25 per share for 2021. Non-GAAP adjusted net loss for the first quarter of 2022 was $7.0 million, or $0.47 per share, compared to non-GAAP adjusted net loss of $2.3 million, or $0.21 per share, for the first quarter of 2021. Non-GAAP adjusted net loss excludes stock-based compensation expense and non-cash interest. 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 (GAAP) in the United States to non-GAAP financial measures, please see the financial tables at the end of this news release.
At March 31, 2022, Celcuity had cash and cash equivalents of $78.3 million, compared to cash and cash equivalents of $84.3 million at December 31, 2021.
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 first quarter 2022 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial (844) 825-9789 and international callers should dial (412) 317-5180 and reference conference code 10166506. A live webcast presentation can also be accessed using this weblink: https://viavid.webcasts.com/starthere.jsp?ei=1545538&tp_key=5a345444e1. 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 seeking to extend the lives of cancer patients by pursuing an integrated therapeutic and companion diagnostic strategy. The company’s lead therapeutic candidate is gedatolisib, a potent, reversible dual inhibitor that selectively targets all Class I isoforms of PI3K and mTOR. 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. The company expects to initiate a Phase 3 study evaluating gedatolisib in patients with HR+/HER2- advanced breast cancer in 2022. Its 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. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com.
Forward-Looking Statements
This press release contains statements that constitute “forward-looking statements” that involve risks and uncertainties including, but not limited to, the timing of initiating and enrolling patients in clinical trials and receiving results from such trials, including without limitation, Celcuity’s planned Phase 3 clinical trial (VIKTORIA-1), the costs and expected results from any ongoing or planned clinical trials, expectations with respect to planned clinical collaborations, and the expected timing of funding for the private placement. 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 conditions, many of which are beyond the control of Celcuity, which include, but are not limited to, the unknown impact of the COVID-19 pandemic on Celcuity’s business and those other risks set forth in the Risk Factors section in Celcuity’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission on March 23, 2022. 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.
Contacts:
Celcuity Inc.
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
763-392-0123
ICR Westwicke
Robert Uhl, robert.uhl@westwicke.com
619-228-5886
Celcuity Inc.
Condensed Balance Sheets
|
March 31, 2022 | December 31, 2021 | ||||||
|
(unaudited) | |||||||
Assets
|
||||||||
Current Assets:
|
||||||||
Cash and cash equivalents
|
$ | 78,295,426 | $ | 84,286,381 | ||||
Deposits
|
22,009 | 22,009 | ||||||
Deferred transaction costs
|
170,503 | 22,144 | ||||||
Payroll tax receivable
|
193,034 | 298,764 | ||||||
Prepaid assets
|
762,882 | 722,677 | ||||||
Total current assets
|
79,443,854 | 85,351,975 | ||||||
Property and equipment, net
|
291,076 | 312,444 | ||||||
Operating lease right-of-use assets
|
194,925 | 241,901 | ||||||
Total Assets
|
$ | 79,929,855 | $ | 85,906,320 | ||||
Liabilities and Stockholders’ Equity:
|
||||||||
Current Liabilities:
|
||||||||
Accounts payable
|
$ | 2,139,291 | $ | 1,507,099 | ||||
Finance lease liabilities
|
5,860 | 5,850 | ||||||
Operating lease liabilities
|
189,267 | 189,858 | ||||||
Accrued expenses
|
1,216,392 | 802,893 | ||||||
Total current liabilities
|
3,550,810 | 2,505,700 | ||||||
Finance lease liabilities
|
981 | 2,449 | ||||||
Operating lease liabilities
|
15,328 | 61,771 | ||||||
Note payable, non-current
|
14,823,021 | 14,625,923 | ||||||
Total Liabilities
|
18,390,140 | 17,195,843 | ||||||
Stockholders’ Equity:
|
||||||||
Members’ equity contributions
|
– | – | ||||||
Common stock
|
14,920 | 14,919 | ||||||
Additional paid-in capital
|
125,386,089 | 124,622,405 | ||||||
Accumulated deficit
|
(63,861,294 | ) | (55,926,847 | ) | ||||
Total Stockholders’ Equity
|
61,539,715 | 68,710,477 | ||||||
Total Liabilities and Stockholders’ Equity
|
$ | 79,929,855 | $ | 85,906,320 | ||||
Celcuity Inc.
Condensed Statements of Operations
(unaudited)
Three Months Ended March 31, | ||||||||
2022 | 2021 | |||||||
Operating expenses:
|
||||||||
Research and development
|
$ | 6,696,313 | $ | 2,236,342 | ||||
General and administrative
|
811,292 | 555,428 | ||||||
Total operating expenses
|
7,507,605 | 2,791,770 | ||||||
Loss from operations
|
(7,507,605 | ) | (2,791,770 | ) | ||||
Other income (expense)
|
||||||||
Interest expense
|
(435,001 | ) | (24 | ) | ||||
Interest income
|
8,159 | 389 | ||||||
Loss on sale of fixed assets
|
– | (263 | ) | |||||
Other income (expense), net
|
(426,842 | ) | 102 | |||||
Net loss before income taxes
|
(7,934,447 | ) | (2,791,668 | ) | ||||
Income tax benefits
|
– | – | ||||||
Net loss
|
$ | (7,934,447 | ) | $ | (2,791,668 | ) | ||
Net loss per share, basic and diluted
|
$ | (0.53 | ) | $ | (0.25 | ) | ||
Weighted average common shares outstanding, basic and diluted
|
14,917,187 | 11,072,097 | ||||||
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, issuance of common stock and non-cash interest 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 March 31, | ||||||||
2022 | 2021 | |||||||
GAAP net loss
|
$ | (7,934,447 | ) | $ | (2,791,668 | ) | ||
Adjustments:
|
||||||||
Stock-based compensation
|
||||||||
Research and development (1)
|
450,520 | 255,181 | ||||||
General and administrative (2)
|
305,751 | 193,917 | ||||||
Non-cash interest expense (3)
|
197,098 | – | ||||||
Non-GAAP adjusted net loss
|
$ | (6,981,078 | ) | $ | (2,342,570 | ) | ||
GAAP net loss per share – basic and diluted
|
$ | (0.53 | ) | $ | (0.25 | ) | ||
Adjustment to net loss (as detailed above)
|
0.06 | 0.04 | ||||||
Non-GAAP adjusted net loss per share
|
$ | (0.47 | ) | $ | (0.21 | ) | ||
Weighted average common shares outstanding, basic and diluted
|
14,917,187 | 11,072,097 |
(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.
SOURCE: Celcuity Inc.
View source version on accesswire.com:
https://www.accesswire.com/701563/Celcuity-Inc-Reports-First-Quarter-2022-Financial-Results-and-Business-Updates
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