Appili Therapeutics Announces Results of Annual Meeting of Shareholders and Provides Corporate Update

Rhea-AI Summary

Appili Therapeutics announces positive results from annual meeting of shareholders and recent progress in drug development programs.

Positive

• All tabled resolutions were approved by shareholders.
• ATI-1501 program received FDA approval, entitling Appili to royalties and milestone payments.
• ATI-1701 program received $7.3 million award from USAFA for development and regulatory activities.
• Temporary waivers of cash balance requirement available for Appili.
• ATI-1801 program progressing with selection of new CDMO and plans to meet FDA requirements.

Negative

• None.

HALIFAX, Nova Scotia--(BUSINESS WIRE)-- Appili Therapeutics Inc. (TSX: APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced the results from its annual meeting of shareholders held earlier today.

Results of Annual Meeting

Based on the proxies received and the vote conducted at the meeting, all tabled resolutions were approved by the shareholders of the Company, including the election of the following directors for the ensuing year: Don Cilla, Brian Bloom, Theresa Matkovits, Juergen Froehlich, Armand Balboni and Rochelle Stenzler.

Voting results for each director are summarized below:

Name of Nominee	Percentage of Votes For	Percentage of Votes Against
Don Cilla	15,441,269 (86.24%)	2,463,125 (13.76%)
Brian Bloom	15,444,109 (86.26%)	2,460,285 (13.74%)
Theresa Matkovits	17,601,894 (98.31%)	302,500 (1.69%)
Juergen Froehlich	17,602,394 (98.31%)	302,000 (1.69%)
Armand Balboni	15,431,769 (86.19%)	2,472,625 (13.81%)
Rochelle Stenzler	17,599,053 (98.29%)	305,340 (1.71%)

Shareholders also approved the re-appointment of PricewaterhouseCoopers, LLP, Chartered Accountants, as the independent auditor of the Company for the ensuing year and authorized the directors of the Company to fix their remuneration.

The Company has filed a report of the voting results on all resolutions voted on the Meeting on the Company’s SEDAR+ profile at www.sedarplus.ca.

Corporate Update

Since Appili’s last annual meeting, the Company has made significant progress. Most recently, the Company’s ATI-1501 program for the treatment of anaerobic bacterial infections, received U.S. Food and Drug Administration (“FDA”) approval on September 22, 2023. The approval of this product, with the brand name of LIKMEZ^TM, entitles Appili to receive royalties and milestone payments from its partner Saptalis Pharmaceuticals LLC.

Appili’s developmental program ATI-1701 for the prevention of F. Tularensis, has received an award of approximately US$7.3 million from the U.S. Air Force Academy (“USAFA”). The initial funding commitment of US$7.3 million was used to kick-off ATI-1701 early-stage development and regulatory activities, which are currently ongoing. Under the terms of the agreement with USAFA, Appili will be reimbursed for the subcontractor and vendor costs necessary to carry out the technical tasks. These committed funds, and other tranches of planned funding, are expected to advance the ATI-1701 program to an IND submission to the FDA. Additionally, Appili will be reimbursed for direct labour costs associated with budgeted program activities, including a portion of its overhead costs. Appili has also entered into an agreement with its lender whereby, if needed, Appili may obtain temporary waivers of a minimum cash balance requirement. Such waivers may from time to time be necessary depending on the timing of reimbursements for expenses submitted to USAFA.

With respect to Appili’s ATI-1801 program, for the treatment of cutaneous leishmaniasis, the Company has selected a new CDMO and is planning to meet with the FDA to align on the requirements to bridge to the prior Phase 3 efficacy data to support a New Drug Application.

About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including a vaccine candidate to eliminate a serious biological weapon threat, a topical antiparasitic for the treatment of a disfiguring disease, and a novel easy to use, liquid oral formulation targeting parasitic and anaerobic infections. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

Forward-Looking Statements

This news release contains “forward-looking statements”, including with respect to commercialization plans and timeline with respect to its programs. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for,” and similar expressions have been used to identify these forward-looking statements. Forward looking statements contained in this press release are provided in reliance on certain assumptions, including with respect to the satisfaction of all conditions precedent to the advancement of the funding commitment from USAFA (including receipt by USAFA of any requisite U.S. federal budget approvals, general development plans with respect to ATI-1701, general access to data required to support regulatory submissions, the nature and scope of the services to be provided by Appili to USAFA with respect to advancing the ATI-1701 program and the timing, scope and budget of additional contracts with USAFA and the ability of the Company to receive timely expense reimbursements from USAFA (including expense reimbursement for costs incurred prior to USAFA’s initial commitment of funds) and the commercialization plans for LIKMEZ. . Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, the Company cannot give assurance that these expectations will prove to have been correct. Forward looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, the risk that the final conditions governing the funding and the relationship between Appili and USAFA may not be satisfactory to the Company, the final funding amount may be different than that communicated herein (including as a result of the failure to secure the requisite U.S. government budget approvals, the inability of the Company to access committed funding under the terms and conditions of the existing contractual arrangements with USAFA in a timely manner or at all or any changes in funding arrangements between USAFA and the US Defense Threat Reduction Agency, as the ultimate funding agency), receipt of funding may be delayed as a result of any U.S. government shutdown or if any remaining conditions are not satisfied in a timely manner, other standard risks associated with government grants and contracting of this nature and the other risk factors listed in the annual information form of the Company dated June 22, 2023 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.com). In particular, any delays in the reimbursement by USAFA of previously submitted expenses in the near term may, in the absence of the Company securing satisfactory alternative funding arrangements or a waiver, result in the Company not being able to satisfy its covenants to maintain a minimum cash balance pursuant to the loan agreement with Long Zone Holdings Inc. (“LZH”). Absent a waiver, such default may result in the acceleration of all obligations owing to LZH under such agreement. Delays in future expense reimbursements by USAFA in the near term may also materially and adversely impact the Company’s working capital requirements in the absence of securing satisfactory alternative funding arrangements. For further details, please refer to the Company’s going concern note in the Company’s management’s discussion and analysis for the fiscal year ended March 31, 2023. Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230927413073/en/

Media Contact:

Jenna McNeil, Corporate Affairs and Communications Manager

Appili Therapeutics

E: JMcNeil@AppiliTherapeutics.com

Investor Relations Contact:

Don Cilla, Pharm.D. M.B.A.

Appili Therapeutics

E: Info@AppiliTherapeutics.com

Source: Appili Therapeutics