enrollment and reporting topline results for the SunStone trial and reporting initial SApHiAre trial data; its growth strategy; and cash balance guidance. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company's actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company's limited operating history, incurrence of substantial losses since the Company's inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company's need for substantial additional financing to achieve the Company's goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company's current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company's product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies in the Company's current indications; the Company's ability to realize the benefits of the Company's current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company's ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company's dependence on the services of the Company's senior management and other clinical and scientific personnel, and the Company's ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company's ability to grow the Company's organization, and manage the Company's growth and expansion of the Company's operations; risks related to the manufacturing of the Company's product candidates, which is complex, and the risk that the Company's third-party manufacturers may encounter difficulties in production; the Company's ability to obtain and maintain sufficient intellectual property protection for the Company's product candidates or any future product candidates the Company may develop; the Company's reliance on third parties to conduct the Company's preclinical studies and clinical trials; the Company's compliance with the Company's obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company's product candidates; risks related to the operations of the Company's suppliers, many of which are located outside of the United States, including the Company's current sole contract manufacturing organization for drug substance and drug product, WuXi Biologics (Hong Kong) Limited, which is located in China; and other risks and uncertainties described in the section "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as well as other information we file with the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain and are not guarantees of future events. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company's control, you should not unduly rely on these forward-looking statements. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
The Zenas BioPharma word mark and logos are trademarks of Zenas BioPharma, Inc. or its affiliated companies.
Zenas BioPharma, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except share and per share amounts)
Unaudited
Three Months Ended
September 30,
--------------------------
2024 2023
----------- -------------
Revenue:
Collaboration revenue $ -- $ 50,000
Total revenue -- 50,000
Operating expenses:
Research and development 33,530 9,352
General and administrative 7,454 5,024
Total operating expenses 40,984 14,376
--------- ---------
(Loss) income from operations (40,984) 35,624
--------- ---------
Other income (expense), net:
Other income (expense), net 2,378 (16)
--------- ---------
Total other income (expense), net 2,378 (16)
--------- ---------
Net (loss) income $ (38,606) $ 35,608
========= =========
Net (loss) income per share
attributable to common stockholders
- basic $ (5.02) $ 2.42
=========
Net (loss) income per share
attributable to common stockholders
- diluted $ (5.02) $ 1.96
========= =========
Weighted-average common stock
outstanding - basic 7,697,695 1,537,918
========= =========
Weighted-average common stock
outstanding - diluted 7,697,695 1,898,391
========= =========
Zenas BioPharma, Inc.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
Unaudited
September 30,
-----------------
2024
-----------------
Cash, cash equivalents and short-term investments $ 386,799
Working capital 349,781
Total assets 403,432
Accumulated deficit (334,786)
Total stockholders' equity 359,435
Investor Contact:
Matthew Osborne
Investor Relations and Corporate Communications
Matt.osborne@zenasbio.com
Media Contact:
Argot Partners
Zenas@argotpartners.com
(END) Dow Jones Newswires
November 12, 2024 07:10 ET (12:10 GMT)
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