ACCESS Newswire
12 Aug 2022, 01:31 GMT+10
MINNEAPOLIS, MN / ACCESSWIRE / August 11, 2022 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for a number of different cancers, today announced financial results for the second quarter ended June 30, 2022 and other recent business developments.
'We made progress on a variety of fronts in the second quarter of 2022. The Breakthrough Therapy Designation recently granted to gedatolisib by the FDA will facilitate close collaboration with the agency as we seek to advance this therapy to the clinic as quickly as possible. Our early phase study evaluating gedatolisib in combination with palbociclib and fulvestrant in patients with advanced breast cancer whose disease progressed on a CDK4/6 inhibitor, reported promising efficacy, with high response rates, and tolerability, with low discontinuation rates due to adverse events. We are now excited to take the next step in the development of this potential first-in-class PI3K/mTOR inhibitor. Our Phase 3 clinical trial, VIKTORIA-1, remains on track to dose the first patient in the next few months,' said Brian Sullivan, CEO and Co-Founder of Celcuity.
'We also made great progress strengthening our balance sheet over the past few months to support the clinical development of gedatolisib. The $100 million private placement we signed in May and the amendment we signed just this week increasing our debt financing facility to $75 million is expected to provide the capital we need to fund operations through 2025.'
Second Quarter 2022 Business Highlights and Other Recent Developments
Second Quarter 2022 Financial Results
Unless otherwise stated, all comparisons are for the second quarter ended June 30, 2022, compared to the second quarter ended June 30, 2021.
The following discussion should be read in conjunction with our unaudited condensed consolidated financial statements and related notes on Form 10-Q for the second quarter ended June 30, 2022. Total operating expenses were $9.6 million for the second quarter of 2022, compared to $13.6 million for the second quarter of 2021.
Research and development (R&D) expenses were $8.4 million for the second quarter of 2022, compared to $13.1 million for the second quarter of 2021. The approximately $4.7 million decrease during the second quarter of 2022, compared to the second quarter of 2021, reflected a $10 million reduction in gedatolisib licensing related expenses, partially offset by increases of $5.3 million in other research and development expenses. Of the $5.3 million increase in research and development expenses, $1.5 million was related to increased employee and consulting expenses, of which $0.5 million was in the form of non-cash stock-based compensation. The remaining $3.8 million increase in research and development expenses is primarily 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 $1.2 million for the second quarter of 2022, compared to $0.6 million for the second quarter of 2021. The approximately $0.6 million increase in G&A expenses during the second quarter of 2022, compared to the second quarter of 2021, arose primarily from approximately $0.5 million in non-cash stock-based compensation.
Net loss for the second quarter of 2022 was $10.0 million, or $0.67 loss per share, compared to a net loss of $14.0 million, or $1.11 loss per share, for the second quarter of 2021. Non-GAAP adjusted net loss for the second quarter of 2022 was $8.3 million, or $0.55 loss per share, compared to non-GAAP adjusted net loss of $8.3 million, or $0.66 loss per share, for the second quarter of 2021. Non-GAAP adjusted net loss excludes stock-based compensation expense, issuance of common stock 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 in the United States (GAAP) to non-GAAP financial measures, please see the financial tables at the end of this press release.
Net cash used in operating activities for the second quarter of 2022 was $11.3 million, compared to $7.6 million for the second quarter of 2021. At June 30, 2022, Celcuity had cash and cash equivalents of $66.9 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 second quarter 2022 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-877-407-0784 and international callers should dial 1-201-689-8560 and reference conference ID: 13731012. A live webcast presentation can also be accessed using this weblink: https://viavid.webcasts.com/starthere.jsp?ei=1557419&tp_key=2043138d9a. 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 a number of different cancers. The company's lead therapeutic candidate is gedatolisib, a potent, reversible dual inhibitor that selectively targets all Class 1 PI3K isoforms 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 and expects to dose the first patient in the next few months. 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.
About Innovatus Capital Partners, LLC
Innovatus Capital Partners, LLC, is an independent adviser and asset management firm with approximately $1.7B in assets under management. Innovatus adheres to an investment strategy that identifies disruptive and growth opportunities across multiple asset categories with a unifying theme of capital preservation, income generation, and upside optionality. The firm has a dedicated team of life sciences investment professionals with deep experience in healthcare, including life sciences. Innovatus and its principals have significant experience providing debt financing to medical device, diagnostics, and biotechnology companies that address unmet medical needs, improve patient outcomes, and reduce overall healthcare expenditures. To date Innovatus Life Sciences Strategy has made over $1.2B in capital commitments for debt and equity support. Further information can be found at www.innovatuscp.com.
Forward-Looking Statements
This press release contains statements that constitute 'forward-looking statements' 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, the expected timing of funding for our private placement and additional tranches under our debt financing agreement, and expectations with respect to available cash to fund operations. 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, 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 Quarterly Report for the period ended March 31, 2022 filed with the Securities and Exchange Commission on May 16, 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, [email protected]
Vicky Hahne, [email protected]
763-392-0123
ICR Westwicke
Robert Uhl, [email protected]
(619) 228-5886
Celcuity Inc.
Condensed Balance Sheets
Celcuity Inc.
Condensed Statements of Operations
(unaudited)
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
(unaudited)
(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 operating expense for the issuance of common stock related to a licensing agreement.
(4) 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.
Get a daily dose of Boston Star news through our daily email, its complimentary and keeps you fully up to date with world and business news as well.
Publish news of your business, community or sports group, personnel appointments, major event and more by submitting a news release to Boston Star.
More InformationHONG KONG: China has fired back at the European Union in an escalating trade dispute by imposing new restrictions on medical device...
NEW YORK, New York - Monday's trading session saw mixed performances across U.S. and global markets, with several major indices posting...
WASHINGTON, D.C.: The U.S. government has granted GE Aerospace permission to resume jet engine shipments to China's COMAC, a person...
DUBAI, U.A.E.: Saudi Aramco is exploring asset sales as part of a broader push to unlock capital, with gas-fired power plants among...
MILAN, Italy: Italian regulators have flagged four non-EU countries—including Russia—as carrying systemic financial risk for domestic...
NEW YORK CITY, New York: With just weeks to spare before a potential government default, U.S. lawmakers passed a sweeping tax and spending...
FRANKLIN, Tennessee: Hundreds of thousands of Nissan and Infiniti vehicles are being recalled across the United States due to a potential...
(Photo credit: Paul Rutherford-Imagn Images) The Boston Red Sox are facing a light portion of their schedule and taking advantage...
(Photo credit: Thomas Shea-Imagn Images) Brayan Rocchio lined a go-ahead, two-run double into the left field corner with two outs...
(Photo credit: Paul Rutherford-Imagn Images) Roman Anthony hit his first career home run at Fenway Park en route to his sixth multi-hit...
(Photo credit: Kim Klement-Imagn Images) Tyler Johnson, who played 13 seasons in the NHL and won back-to-back Stanley Cups with the...
(Photo credit: David Reginek-Imagn Images) The struggling Washington Nationals flew into St. Louis with new leadership in both the...