Defence Therapeutics Awarded Broad U.S. Patent Covering Its Pioneering Cancer-Killing AccuTOX(R) Technology

On behalf of Defence Therapeutics Inc.

Vancouver, British Columbia–(March 4, 2024) – Defence Therapeutics Inc. (CSE:DTC) (OTCQB:DTCFF) (FSE:DTC) (“Defence” or the “Company“), a Canadian biopharmaceutical company developing novel immune-oncology therapeutics and drug delivery technologies, is pleased to announce the granting of US patent no. 11,890,350 (‘350) by the United States Patent and Trademark Office (USPTO), broadly covering its breakthrough AccuTOX^® technology. The ‘350 patent, which includes valuable composition-of-matter claims covering a portfolio of therapeutically-active molecules making up the AccuTOX^® platform, provides Defence with potential market exclusivity until late 2042.

The AccuTOX^® platform is based on the discovery that certain bile acid-peptide conjugates, in their free forms, induce cancer cell death by triggering heightened metabolic stress and the production of reactive oxygen species. The ‘350 patent demonstrates that the bile acid-peptide conjugates, when used past cytotoxic threshold concentrations, can potently induce cell death in multiple tumor cells in vitro, including lung, breast, colon, melanoma, and lymphoma cancer cells, and can dramatically reduce lymphoma tumor volumes and enhance survival in vivo in treated mice compared to controls.

Defence’s ‘350 patent was issued with broad claims encompassing a plurality of AccuTOX^® molecules having cytotoxic or cytostatic activity, either as a monotherapy or in combination with other therapeutics. The granted claims also cover AccuTOX^® molecules releasably conjugated to a variety of carrier molecules, such as cancer-specific antibodies, where AccuTOX^® effectively plays the role of a cytotoxic drug, thereby pioneering a potentially new class of next-generation antibody-drug conjugates (ADCs).

Stemming from the data published in the ‘350 patent, pre-clinical and GLP studies for AccuTOX^®, either alone or in combination with immune checkpoint inhibitors such as anti-PD-1 and anti-LAG3, were undergone, and have shown that the compound is safe and well tolerated using both rodents and canine animal models, and have also demonstrated significant solid tumor growth reductions. Subsequently, Defence has now received FDA approval to commence its Phase I clinical trial to evaluate the effect of intratumoral administration of AccuTOX^® as a monotherapy, as well as in combination with Opdualag (fixed IV doses), in patients with unresectable stage IIIB to IV melanoma refractory to or relapse from standard therapy.

“The rapid granting of the broad ‘350 patent by the USPTO affirms the innovative and groundbreaking potential of AccuTOX^® as a leading cancer therapeutic, and also importantly provides a long patent runway and period of market exclusivity for Defence to fully explore the commercial potential of the AccuTOX^® platform and maximize the benefit to our partners and investors,” says Mr. Plouffe, CEO and president of Defence.

This patent marks the fourth granted US patent in Defence’s ever-growing patent portfolio, which currently includes seven published patent families.

About Defence:

Defence Therapeutics is a publicly-traded biotechnology company working on engineering the next generation vaccines and ADC products using its proprietary platform. The core of Defence Therapeutics platform is the ACCUM^® technology, which enables precision delivery of vaccine antigens or ADCs in their intact form to target cells. As a result, increased efficacy and potency can be reached against catastrophic illness such as cancer and infectious diseases.

For further information:
Sebastien Plouffe, President, CEO and Director
P: (514) 947-2272
[email protected]
www.defencetherapeutics.com

Cautionary Statement Regarding “Forward-Looking” Information

This release includes certain statements that may be deemed “forward-looking statements”. All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company’s management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management’s beliefs, estimates or opinions, or other factors, should change.

Neither the CSE nor its market regulator, as that term is defined in the policies of the CSE, accepts responsibility for the adequacy or accuracy of this release.

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6) This document contains forward-looking information and forward-looking statements, within the meaning of applicable Canadian securities legislation, (collectively, “forward-looking statements”), which reflect management's expectations regarding Defence Therapeutics Inc.’s future growth, future business plans and opportunities, expected activities, and other statements about future events, results or performance. Wherever possible, words such as “predicts”, “projects”, “targets”, “plans”, “expects”, “does not expect”, “budget”, “scheduled”, “estimates”, “forecasts”, “anticipate” or “does not anticipate”, “believe”, “intend” and similar expressions or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved, or the negative or grammatical variation thereof or other variations thereof, or comparable terminology have been used to identify forward-looking statements. These forward-looking statements include, among other things, statements relating to: (a) revenue generating potential with respect to Defence Therapeutics Inc.’s industry; (b) market opportunity; (c) Defence Therapeutics Inc.’s business plans and strategies; (d) services that Defence Therapeutics Inc. intends to offer; (e) Defence Therapeutics Inc.’s milestone projections and targets; (f) Defence Therapeutics Inc.’s expectations regarding receipt of approval for regulatory applications; (g) Defence Therapeutics Inc.’s intentions to expand into other jurisdictions including the timeline expectations relating to those expansion plans; and (h) Defence Therapeutics Inc.’s expectations with regarding its ability to deliver shareholder value. Forward-looking statements are not a guarantee of future performance and are based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors that management believes to be relevant and reasonable in the circumstances, as of the date of this document including, without limitation, assumptions about: (a) the ability to raise any necessary additional capital on reasonable terms to execute Defence Therapeutics Inc.’s business plan; (b) that general business and economic conditions will not change in a material adverse manner; (c) Defence Therapeutics Inc.’s ability to procure equipment and operating supplies in sufficient quantities and on a timely basis; (d) the accuracy of budgeted costs and expenditures; (e) Defence Therapeutics Inc.’s ability to attract and retain skilled personnel; (f) political and regulatory stability; (g) the receipt of governmental, regulatory and third-party approvals, licenses and permits on favorable terms; (h) changes in applicable legislation; (i) stability in financial and capital markets; and (j) expectations regarding the level of disruption to as a result of CV-19. Such forward-looking information involves a variety of known and unknown risks, uncertainties and other factors which may cause the actual plans, intentions, activities, results, performance or achievements of Defence Therapeutics Inc. to be materially different from any future plans, intentions, activities, results, performance or achievements expressed or implied by such forward-looking statements. Such risks include, without limitation: (a) Defence Therapeutics Inc.’s operations could be adversely affected by possible future government legislation, policies and controls or by changes in applicable laws and regulations; (b) public health crises such as CV-19 may adversely impact Defence Therapeutics Inc.’s business; (c) the volatility of global capital markets; (d) political instability and changes to the regulations governing Defence Therapeutics Inc.’s business operations (e) Defence Therapeutics Inc. may be unable to implement its growth strategy; and (f) increased competition.

Except as required by law, Defence Therapeutics Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future event or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. Neither does Defence Therapeutics Inc. nor any of its representatives make any representation or warranty, express or implied, as to the accuracy, sufficiency or completeness of the information in this document. Neither Defence Therapeutics Inc. nor any of its representatives shall have any liability whatsoever, under contract, tort, trust or otherwise, to you or any person resulting from the use of the information in this document by you or any of your representatives or for omissions from the information in this document.

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