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Zenas BioPharma Reports Third Quarter 2024 Financial Results and Provides Corporate Updates -Completed initial public offering, raising $258.7 million in gross proceeds, to fund the expanded clinical development of lead

Key Takeaway: Reports Third Quarter 2024 Financial Results and Provides Corporate Updates public offering, raising $258.7 million in gross proceeds, to fund the expanded clinical development of lead product candidate, obexelimab, and support company growth strategy- enrollment of Phase 3 IN

Full Press Release Details

Reports Third Quarter 2024 Financial Results and Provides Corporate Updates
public offering, raising $258.7 million in gross proceeds, to fund the expanded clinical development of lead product candidate, obexelimab,
and support company growth strategy-
enrollment of Phase 3 INDIGO trial evaluating obexelimab for the treatment of Immunoglobulin G4-Related Disease (IgG4-RD)-
obexelimab Phase 2 and Phase 3 clinical trials with results expected throughout 2025-
November 12, 2024 (GLOBE NEWSWIRE) - Zenas BioPharma, Inc. ("Zenas" or the "Company") (Nasdaq:
ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative
immunology-based therapies, today reported financial results for the third quarter ended September 30, 2024, and provided recent
quarter, we successfully completed our initial public offering, providing capital to fund our growth strategy for the Company and expand
the clinical development of our lead product candidate, obexelimab, for the treatment of autoimmune diseases," said Lonnie Moulder,
Founder and Chief Executive Officer of Zenas. "With the achievement of targeted enrollment for INDIGO, the largest IgG4-RD clinical
trial ever conducted, we expect to report topline results for this registration-directed study by the end of 2025."
bifunctional monoclonal antibody designed to bind both CD19 and Fc RIIb, which are broadly present across B cell lineage, to inhibit
the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique mechanism of action and chronic
dosing regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease.
with obexelimab, during the third quarter and more recently, the Company:
Third quarter 2024 financial results
for the quarter ended September 30, 2024
is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative
immunology-based therapies for patients in need. Our core business strategy combines our experienced leadership team with a disciplined
product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior
clinical benefits to patients living with autoimmune diseases. Zenas' lead product candidate, obexelimab, is a bifunctional monoclonal
antibody designed to bind both CD19 and Fc RIIb, which are broadly present across B cell lineage, to inhibit the activity of cells
that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab's mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. For more information
contains "forward-looking statements" which involve risks, uncertainties and contingencies, many of which are beyond the
control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance,
or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as "may," "will," "should,"
"expect," "plan," "anticipate," "could," "intend," "target,"
"project," "contemplate," "believe," "estimate," "predict," "potential"
or "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain
these words. Forward-looking statements include, but are not limited to, statements concerning Zenas's plans, objectives, expectations
and intentions; the timing and results of ongoing and future clinical trials, including expectations on the timing of reporting INDIGO
trial topline results, the 12-week primary endpoint data for the MoonStone trial, completing 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.
CONSOLIDATED STATEMENTS OF OPERATIONS
thousands except share and per share amounts)
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
CONSOLIDATED BALANCE SHEET DATA
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
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Last updated: Nov 12, 2024