Category: Archives

Event exploring the escalating threat of emerging infectious diseases

Discussion covering going-private transaction with Aditxt, strategic growth partner

 

HALIFAX, Nova Scotia, April 2, 2025 – Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced that its President and CEO, Don Cilla, Pharm.D., M.B.A., will join Aditxt, Inc. (NASDAQ: ADTX) (“Aditxt”) Co-founder and CEO, Amro Albanna, for the Aditxt Weekly Update on April 4, 2025 at 11:30AM ET. The discussion will cover the Company’s recent operational highlights, including $117 million in new federal funding applications, and the status of the going-private transaction with Aditxt.

Dr. Cilla will join Aditxt to explore the escalating threat of emerging infectious diseases and highlight the vital role of strategic partnerships in developing innovative treatments and improving global public health. The Aditxt Weekly Update will also provide insights into Appili’s diverse near-to-market portfolio, designed to address critical unmet patient needs.

Additionally, the discussion will highlight Appili’s proven track record in securing non-dilutive funding, showcasing $33.2 million in prior government awards and the recent submission of $117 million in new federal funding applications. By leveraging financial support, Appili can strengthen its ability to accelerate the development of new and existing infectious disease treatments aligned with public health priorities.

Participants are encouraged to register in advance by clicking here. The event will also include a Q&A session, with questions welcomed at [email protected].

Appili will join additional Aditxt Weekly Updates throughout the year.

 

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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 an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. 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 the potential for partnered projects to be developed, the potential that Appili will receive government awards and / or contracts related to its proposal submissions, the availability of future funding under the USAFA cooperative agreement, the Company’s development plan with respect to ATI-1701 and the expected timing and process to complete the Transaction. 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. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in (i) the annual information form of the Company dated June 25, 2024, (ii) the Circular, and (iii) and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). 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.

 

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Media Contact:

Jenna McNeil, Corporate Affairs and Communications Manager

Appili Therapeutics

E: [email protected]

 

Investor Relations Contact:

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

Appili Therapeutics

E: [email protected]

Four new funding proposals, totalling US$117.5 million, have been submitted for review

Modifications received to U.S. Air Force Academy Cooperative Agreement

Outside date for going-private transaction extended to March 31, 2025

 

HALIFAX, Nova Scotia, March 18, 2025 – Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced that, the Company along with its partners, have submitted applications for four new federal funding opportunities. The funding, if awarded, would total up to US$117.5 million and support the company’s efforts to advance urgent infectious disease treatments aligned with critical public health priorities.

 

Funding Opportunities

By leveraging Appili’s proven government contracting expertise, the Company and its partner have applied for two solicitations announced by the National Institute of Allergy and Infectious Diseases (“NIAID”).  The first proposal seeks US$46.3 million in funding to develop a vaccine aimed at protecting against invasive fungal infections.  The second proposal requests US$36.4 million to develop an antifungal monoclonal antibody targeting a rare fungal infection.  If awarded, the NIAID funds are expected to support development of both products through to Investigational New Drug (“IND”) applications and Phase 1 clinical studies.

Appili also submitted two proposals to the US Medical CBRN Defense Consortium (“MCDC”) seeking a total of US$34.8 million. The first proposal seeks US$20.1 million to develop a potential broad-spectrum host-directed treatment for viral infections. This project, developed in collaboration with partners, aims to address the critical medical needs for warfighters at high risk of exposure to dangerous viral infections. The second proposal submitted to MCDC, seeks US$14.7 million to develop a broad-spectrum direct-acting antiviral, potentially useful for treating patients infected with RNA viruses such as influenza, coronavirus, West Nile, Zika, and other severely pathogenic viruses. If awarded, the funding is expected to support the advancement of both projects through manufacturing, non-clinical development and regulatory activities necessary to support an IND application.

 

Medical CBRN Defense Consortium Membership

The Company was recently selected to join the MCDC, further demonstrating Appili’s commitment to U.S. preparedness and biodefense. With the consortium having awarded over US $7 billion in project funding to date, Appili is solidifying its position as a key player in developing cutting-edge medical countermeasures.

Through the consortium, Appili plans to engage government stakeholders, collaborate with industry partners, and pursue funding opportunities that align with the priorities of the U.S. Department of Defense.

 

US$33.2 million received in non-dilutive funding awards to date

Appili has successfully raised approximately US$33.2 million in prior government funding awards, showcasing its ability to develop compelling research proposals for groundbreaking technologies and form strategic partnerships to compete for government funding. The funds from prior awards helped advance development activities, for pipeline programs including, ATI-1701, a vaccine candidate to eliminate a serious biological weapon threat, and LIKMEZ™ (ATI-1501), an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections.

 

Update to USAFA Awards

Appili has received an update to its arrangement with the United States Air Force Academy (“USAFA”) for ATI-1701, a biodefense vaccine candidate. Previously, ATI-1701 was awarded a total of approximately US$14 million from USAFA, of which US$11.6 million was allotted to pay for services under the agreement.

In the recent modification to the USAFA Cooperative Agreement, Appili received an increased General & Administrative (G&A) overhead recovery rate.  This rate was applied retroactively to the start of the Cooperative Agreement, resulting in an increase to the reimbursement for all past and future invoices.  The increase in the allowable G&A overhead recovery rate is a significant benefit to Appili.  While the total awarded amount is approximately US$14 million, due to ongoing U.S. Defense Department budget constraints and other factors, the Company does not anticipate additional funds to be allotted beyond the US$11.6 million that has been funded to date for ATI-1701. Without additional funding, Appili does not expect to be in a position to submit an Investigational New Drug Application for ATI-1701 to the U.S. Food and Drug Administration by the end of this year, as originally expected.

Appili has received US$9.7 million in USAFA reimbursements to date, covering labor expenses, subcontractor and vendor costs, as well as other direct and indirect costs for budgeted program activities. The company remains committed to advancing ATI-1701 and will continue to invoice USAFA for program expenses, utilizing the existing funding.

 

Update on Going-Private Transaction with Aditxt

The Company also wishes to provide an update on its proposed going-private transaction pursuant to which Aditxt Inc. (NASDAQ:ADTX) (“Aditxt”), through its wholly-owned subsidiary, Adivir, Inc.  (“Adivir”) will acquire all of the issued and outstanding Class A common shares of the Company by way of a court-approved plan of arrangement under the Business Corporations Act (Ontario) (the “Transaction”).

As previously announced, shareholders of the Company overwhelmingly voted in favour of a special resolution approving the Transaction. The Company has also secured all necessary court approvals to affect the Transaction.

Among other customary closing conditions, the Transaction remains subject to Aditxt securing sufficient financing to complete the Transaction. In this regard, on February 28, 2025, Appili granted a waiver to Aditxt to extend the outside for the Transaction to March 31, 2025 in exchange for a payment by Aditxt of US$250,000 (the “Waiver Payment”).  The parties have also agreed that, if a termination fee becomes payable to the Company by Aditxt or Adivir at any time, the Waiver Payment would be credited towards any such termination payment.

Subject to satisfaction or waiver of the remaining closing conditions, Appili expects the Transaction to close in the first quarter of calendar 2025.

For further details regarding the Transaction, please see Appili’s press release dated April 2, 2024 and Appili’s management information circular (the “Circular”) dated October 4, 2024, a copy of which is available under Appili’s profile on SEDAR+ (sedarplus.ca).

 

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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 an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. 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 the potential for partnered projects to be developed, the potential that Appili will receive government awards and / or contracts related to its proposal submissions, the availability of future funding under the USAFA cooperative agreement, the Company’s development plan with respect to ATI-1701 and the expected timing and process to complete the Transaction. 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. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in (i) the annual information form of the Company dated June 25, 2024, (ii) the Circular, and (iii) and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). 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.

 

Dislcaimer

The views expressed are those of the author and do not necessarily reflect the official policy or position of the United States Air Force Academy, the United States Air Force, the Department of Defense, or the U.S. Government. Approved for public release: distribution unlimited. PA#: USAFA-DF-2025-348

 

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Media Contact:

Jenna McNeil, Corporate Affairs and Communications Manager
Appili Therapeutics
E: [email protected]

 

Investor Relations Contact:

Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: [email protected]

Received overwhelming shareholder support in favour of take-private transaction with Aditxt

Advanced key pipeline programs, engaged regulatory authorities on ATI-1801 and preparing ATI-1701 for an Investigational New Drug submission

Further strengthened government partnerships, reinforcing Appili’s position as a key player in biodefense and infectious disease solutions.

 

HALIFAX, Nova Scotia, February 14, 2025 – Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced its financial and operational results for the third quarter of its fiscal year 2025, which ended on December 31, 2024. All figures are in Canadian dollars unless otherwise stated.

“As we move into 2025, I want to extend my deepest gratitude to our supporters and partners who have stood by us through both challenges and progress,” said Dr. Don Cilla, President and CEO of Appili. “The past year highlighted global concerns surrounding public health and biosecurity, reaffirming the urgent need for infectious disease solutions. With strong government partnerships, promising near-clinical stage programs, and a dedicated team, we are well-positioned to accelerate the development of critical infectious disease treatments.”

“Building on our expanded government partnerships, and the commercial launch of LIKMEZ™, Appili continues to make significant strides in our pipeline programs targeting critical infectious diseases for which effective treatments are currently unavailable,” Dr. Cilla added. “This year, we will continue to outline the vital role these programs play in protecting patients and the value they bring to our stakeholders.”

 

ATI-1701, our Biodefense Vaccine Candidate with Strong Government Support

Appili’s ATI-1701 development program, focused on the prevention of Francisella tularensis infection, has secured awards totaling US$14 million from the U.S. Air Force Academy (“USAFA”). Under this cooperative agreement, Appili is leading a comprehensive development initiative that includes nonclinical studies, manufacturing, clinical preparatory work, and regulatory activities, all supporting an Investigational New Drug (“IND”) submission planned for 2025. To date, Appili has been reimbursed for subcontractor and vendor costs, as well as labor costs for budgeted program activities, totaling US$8.9 million.

In October 2024, Appili presented positive findings at the Military Health System Research Symposium and IDWeek 2024™ demonstrating that a single dose of ATI-1701 provided full protection against lethal tularemia one year after vaccination. These results, combined with research highlighting the elevated risk of tularemia outbreaks in conflict zones, underscore ATI-1701’s potential as a critical tool in protecting military personnel and addressing global biodefense needs.

 

ATI-1801, our topical antiparasitic product

ATI-1801 is a novel topical formulation of paromomycin (15% w/w) under advanced clinical development for the treatment of cutaneous leishmaniasis, a disfiguring infection of the skin that affects hundreds of thousands of people around the world annually.

In October 2024, Appili announced alignment with the U.S. Food and Drug Administration (“FDA”) on ATI-1801 development requirements, providing a clear path towards an NDA submission. In response to Appili’s recent Type B meeting request, the agency agreed with our proposed strategy to establish a scientific bridge between previous clinical trial material and new drug product batches, enabling Appili to leverage key results from the clinical dossier for ATI-1801, including successful Phase 3 study outcomes.

ATI-1801 has received Orphan Drug Designation from the FDA for certain forms of cutaneous leishmaniasis. We are evaluating its eligibility for a priority review voucher (“PRV”), which, if confirmed, would make it the second potentially PRV-eligible program at Appili, alongside ATI-1701.

 

LIKMEZ™ ATI-1501: FDA Approved Product,

Through Appili’s commercialization partner Saptalis Pharmaceuticals LLC (“Saptalis”), LIKMEZ launched in the U.S., and the product is available to patients. LIKMEZ is the first and only FDA-approved liquid formulation of metronidazole providing a novel prescribing option for patients with difficulty swallowing or experiencing taste-related hurdles.

The current tablet form of metronidazole is the only other approved oral form on the U.S. market, but its bitter taste and lack of appropriate dosage forms for patients with difficulty swallowing often presents treatment compliance challenges. LIKMEZ was developed to address these issues.

The FDA approval of LIKMEZ, shortly after securing patent coverage through 2039, is an important milestone that demonstrates Appili’s ability to identify promising opportunities and develop and monetize them for the benefit of both patients and shareholders. Collaborating with Saptalis, Appili is eligible to receive sales-based milestone payments and royalties based on sale of the product. Saptalis is currently in the process of identifying an alternative commercialization partner.

 

Shareholder Support and Strategic Transactions

On November 6, 2024, shareholders of the Company overwhelmingly voted in favour of a special resolution approving a plan of arrangement pursuant to which Aditxt Inc. (NASDAQ:ADTX) (“Aditxt”), through its wholly-owned subsidiary, Adivir, Inc. will acquire all of the issued and outstanding Class A common shares of the Company by way of a court-approved plan of arrangement under the Business Corporations Act (Ontario) (the “Transaction”).

For further details regarding the Transaction, please see Appili’s press release dated April 2, 2024 and Appili’s management information circular (the “Circular”) dated October 4, 2024, a copy of which is available under Appili’s profile on SEDAR+ (sedarplus.ca).

Among other customary closing conditions, the Transaction remains subject to Aditxt securing sufficient financing to complete the Transaction.   In this regard, on January 31, Appili granted a waiver to Aditxt to extend the outside for the Transaction to February 28, 2025 in exchange for a payment by Aditxt of US$250,000 (payable in the month of February 2025).

Subject to satisfaction or waiver of the remaining closing conditions, Appili expects the Transaction to close in the first quarter of calendar 2025.

 

Looking Ahead

Dr. Cilla added: “It is a tremendous privilege to lead the company towards new stages of growth, and I’m excited to steer Appili towards new milestones. This year holds significant importance, marked by advancing funded ATI-1701 activities to IND submission and engaging regulatory authorities to align on ATI-1801 development plans”.

 

Financial Results

The Company prepares its financial statements in accordance with IFRS Accounting Standards as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook–Accounting. All figures are in Canadian dollars unless otherwise stated.

The net loss and comprehensive loss for the three months ended December 31, 2024, totaled $0.5 million ($0.00 loss per share), reflecting a $0.4 million increase compared to the $0.1 million net loss ($0.00 loss per share) reported for the same period in 2023. This increase was primarily due to a $0.08 million rise in financing costs, a $0.6 million increase in foreign exchange losses, and a $0.4 million decrease in revenue. However, these factors were partially offset by a $0.1 million reduction in general and administrative expenses, a $0.5 million increase in government assistance, and a $0.05 million decrease in both business development and research and development expenses. As of December 31, 2024, the Company had cash of $0.2 million, compared to $0.09 million on March 31, 2024.

As of February 14, 2025, the Company had 121,266,120 issued and outstanding Common Shares, 10,910,281 stock options, and 37,139,874 warrants outstanding.

This press release should be read in conjunction with the Company’s unaudited interim condensed consolidated financial statements for the third quarter of the 2025 fiscal year and the related MD&A, copies of which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca.

 

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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 an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. 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 the funding commitment from USAFA and expected timing of invoice payment, advancing program towards IND, further anticipated milestones and the timing thereof, the Company’s development plans and timelines with respect to ATI-1501, ATI-1701 and ATI-1801, the timing of any milestone and/or royalty payments in respect of ATI-1501, the expected timing and process to complete the Transaction, and the Company’s expectations with respect to its ability to operate as a going concern and satisfy its ongoing working capital requirements. 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. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in (i) the annual information form of the Company dated June 25, 2024, (ii) the Circular, and (iii) the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). 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.

 

All statements included in this press release relating to the Transaction are qualified by reference to the “Forward Looking Statements” section included in Appili’s press release issued on April 2, 2024 announcing the Transaction.

 

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Media Contact:

Jenna McNeil, Communications Manager

Appili Therapeutics

E: [email protected]

 

Investor Relations Contact:

Don Cilla, President and CEO

Appili Therapeutics

E: [email protected]

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

Court’s approval allows transaction with Aditxt to proceed, subject to other closing conditions

 

HALIFAX, Nova Scotia – November 19, 2024 – Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, is pleased to announce receipt of the final order of the Ontario Superior Court of Justice (Commercial List) for the plan of arrangement (the “Arrangement”) pursuant to which Aditxt, Inc. (“NASDAQ:ADTX”) (“Aditxt”), through its wholly-owned subsidiary, Adivir, Inc., will acquire all of the issued and outstanding Class A common shares of the Company (the “Transaction”). As previously announced, the Transaction was overwhelmingly approved by the Company’s shareholders at a special meeting held on November 6, 2024.

“The successful shareholder vote and court approval represent critical milestones for Appili, bringing the transaction with Aditxt one step closer to completion,” said Don Cilla, President and CEO of Appili “through Aditxt’s social innovation platform, we look forward to activating promising opportunities to improve and protect public health across the infectious disease and medical countermeasures landscape.”

Closing of the Transaction remains subject to the satisfaction of certain closing conditions. Subject to the satisfaction of all requisite closing conditions, the Transaction is expected to close in Q4 2024.

Following completion of the Transaction, the Company’s shares will be delisted from the Toronto Stock Exchange and the Company will apply to cease to be a reporting issuer in each of the applicable jurisdictions in Canada.

For more information on the Transaction, please refer to the Company’s management information circular (the “Circular”) dated October 4, 2024 and the appended Arrangement Agreement, which are available on the Company’s SEDAR+ profile at www.sedarplus.ca.

 

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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 an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This news release contains “forward-looking information” within the meaning of applicable securities laws. Forward-looking information contained in this press release may be identified by the use of words such as, “may”, “would”, “could”, “will”, “likely”, “expect”, “anticipate”, “believe, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook” and other similar expressions. Forward-looking information is not a guarantee of future performance and is 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 relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment, and the availability of licenses, approvals and permits.

Forward-looking statements in this news release include, but are not limited to closing of the Transaction and the timing thereof. Actual results and developments may differ materially from those contemplated by these statements. Such forward-looking statements are based on certain assumptions regarding Aditxt and Appili, including the successful completion of the conditions precedent of the Transaction. While Appili considers these assumptions to be reasonable, based on information currently available, they may prove to be incorrect. Among other things, there can be no assurance that the Transaction will be completed. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information, including those identified in the Circular. Consequently, readers are cautioned not to place undue reliance on the forward-looking statements and information contained in this press release.

The statements in this press release are made as of the date of this release. Appili disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Neither CIRO nor any stock exchange or other securities regulatory authority accepts responsibility for the adequacy or accuracy of this release.

 

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Media Contact:

Jenna McNeil, Corporate Affairs and Communications Manager
Appili Therapeutics
E: [email protected]

 

Investor Relations Contact:
Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: [email protected]

Overwhelming shareholder support in favour of take-private transaction with Aditxt

Studies presented at IDWeek 2024™ demonstrate ATI-1701 provides full protection against lethal tularemia in animal models after one year

Alignment with U.S. Food and Drug Administration on development requirements for ATI-1801 NDA Submission

 

HALIFAX, Nova Scotia, November 14, 2024 – Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced its financial and operational results for the second quarter of its fiscal year 2025, which ended on September 30, 2024. All figures are stated in Canadian dollars unless otherwise stated.

“During fiscal year 2025, Appili shareholders voted overwhelmingly in favor of the transaction with Aditxt, facilitating our access to capital and activating promising opportunities for Appili,” said Dr. Don Cilla, President and CEO of Appili. “The shareholder vote is an important milestone for Appili and brings us one step closer to ‘Making Promising Innovations Possible Together’ through Aditxt’s social incubator platform.”

ATI-1701, Biodefense Vaccine Candidate with Strong U.S. Air Force Academy Funding Commitments

ATI-1701, a novel live-attenuated vaccine for preventing F. tularensis, has previously secured US$14 million in awards from the United States Air Force Academy (“USAFA”). Under the cooperative agreement with USAFA, Appili manages a comprehensive development program, including nonclinical studies, CMC/manufacturing, clinical preparatory, and regulatory activities supporting an IND submission in 2025.

Recent data presented by Appili’s scientific team at the Military Health System Research Symposium and IDWeek 2024™ demonstrated strong efficacy results. Studies showed that a single dose of ATI-1701 provided full protection against lethal tularemia in animal models, with protection for one year after vaccination. Additional research highlighted the heightened risk of tularemia outbreaks in conflict zones and positioned ATI-1701 as a potentially valuable tool in protecting warfighters.

Appili has recently had positive interactions with the United States Food and Drug Administration (“FDA”) in the form of a pre-IND meeting, confirming the development pathway for the majority of Appili’s proposed development plan. Appili is currently in the process of implementing suggested changes in its development effort.

ATI-1801, Demonstrated safety and efficacy across multiple Phase 2 and Phase 3 studies

ATI-1801, a novel topical formulation of paromomycin (15% w/w), is under advanced clinical development for treating cutaneous leishmaniasis, a disfiguring skin infection affecting hundreds of thousands globally.

In a recent response to Appili’s Type B meeting request, the FDA agreed with the Company’s proposed strategy to establish a scientific bridge between previous clinical trial material and new drug product batches. The approach enables Appili to leverage key results from the clinical dossier for ATI-1801 licensed from U.S. Army Medical Materiel Development Activity, including the successful results of a Phase 3 study, and allows the completion of a New Drug Application much sooner than if additional clinical data were required.

ATI-1801 has received Orphan Drug Designation from the FDA for certain forms of cutaneous leishmaniasis. The company is evaluating ATI-1801’s eligibility for a priority review voucher (“PRV”), which, if confirmed, would make it the second PRV-eligible program at Appili, alongside ATI-1701, which is potentially eligible for a PRV pending renewal of certain U.S. legislation.

LIKMEZ™ (ATI-1501), FDA Approved Liquid Oral Reformulation of the Antibiotic Metronidazole

In September 2023, Appili, together with its U.S. partner, Saptalis Pharmaceuticals LLC., announced the approval by the FDA of LIKMEZ™ (ATI-1501), LIKMEZ® is the first and only FDA-approved liquid formulation of metronidazole providing a novel prescribing option for patients with difficulty swallowing or experiencing taste-related hurdles.

LIKMEZ, with patent coverage through 2039, addresses the unmet need in patients with dysphagia to avoid risks associated with drug compounding, and discontinuation related anti-microbial resistance. In November 2023, Saptalis, through a commercialization partner, launched LIKMEZ in the U.S. and the product is now available to patients and doctors. Appili earned milestone payments from Saptalis and is entitled to receive additional sales-based milestone payments and royalties from Saptalis based on sale of the product. Saptalis is currently in the process of identifying an alternative commercialization partner.

 

Aditxt Arrangement

On November 6, 2024, shareholders of the Company overwhelmingly voted in favour of a special resolution approving a plan of arrangement pursuant to which Aditxt Inc. (NASDAQ:ADTX) (“Aditxt”), through its wholly-owned subsidiary, Adivir, Inc. will acquire all of the issued and outstanding Class A common shares of the Company by way of a court-approved plan of arrangement under the Business Corporations Act (Ontario) (the “Transaction”).

Approximately 29.50% of the outstanding Appili Shares were voted by shareholders and the Transaction was approved by 99.79% of the votes cast.

For further details regarding the Transaction, please see Appili’s press release dated April 2, 2024 and Appili’s management information circular (the “Circular”) dated October 4, 2024, a copy of which is available under Appili’s profile on SEDAR+ (sedarplus.ca).

Appili and Aditxt are in the process of satisfying the remaining closing conditions, which include: (1) the Company obtaining final court approval for the Transaction, and (2) Aditxt securing sufficient financing to complete the Transaction.

Subject to satisfaction or waiver of the remaining closing conditions, Appili expects the Transaction to close in December 2024.

 

Financial Results

The Company prepares its financial statements in accordance with IFRS Accounting Standards as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook–Accounting. All figures are stated in Canadian dollars unless otherwise stated.

The net loss and comprehensive loss of $0.8 million or $0.01 loss per share for the three months ended September 30, 2024, was $0.2 million lower than the net loss and comprehensive loss of $1 million or $0.01 loss per share during the three months ended September 30, 2023. This relates mainly to an increase in research and development expenses of $1 million, an increase in financing costs of $0.1 million and a decrease in revenue of $0.3 million. This increase was offset by a decrease in general and administrative expenses by $0.1 million, an increase in government assistance of $1.3 million, and an increase of $0.2 million in foreign exchange gain.

As of September 30, 2024, the Company had cash of $0.7 million, compared to $0.1 million on March 31, 2024.

As of November 13, 2024, the Company had 121,266,120 issued and outstanding Common Shares, 11,520,281 stock options, and 41,356,874 warrants outstanding.

This press release should be read in conjunction with the Company’s unaudited interim condensed consolidated financial statements for the second quarter of the 2025 fiscal year and the related MD&A, copies of which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca.

 

+++

 

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-infective s, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. 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 the funding commitment from USAFA and expected timing of invoice payment, advancing program towards IND, further anticipated milestones and the timing thereof, the Company’s development plans and timelines with respect to ATI-1501, ATI-1701 and ATI-1801, the timing of any milestone and/or royalty payments in respect of ATI-1501,  consideration to be received by shareholders in connection with the proposed Transaction, the expected timing and process to complete the Transaction, and the Company’s expectations with respect to its ability to operate as a going concern and satisfy its ongoing working capital requirements. 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. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in (i) the annual information form of the Company dated June 25, 2024, (ii) the Cicular, and (iii) the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). 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.

All statements included in this press release relating to the Arrangement are qualified by reference to the “Forward Looking Statements” section included in the Arrangement Press Release.

 

###

 

Media Contact:

Jenna McNeil, Communications Manager

Appili Therapeutics

E: [email protected]

 

Investor Relations Contact:

Don Cilla, President and CEO

Appili Therapeutics

E: [email protected]

 

 

 

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

 

HALIFAX, Nova Scotia – November 6, 2024 – Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced the results from its special meeting of shareholders held earlier today (the “Meeting”). Shareholders of the Company (the “Shareholders”), overwhelmingly voted in favour of a special resolution approving a plan of arrangement pursuant to which Aditxt Inc. (NASDAQ:ADTX) (“Aditxt”), through its wholly-owned subsidiary, Adivir, Inc. will acquire all of the issued and outstanding Class A common shares of the Company (the “Appili Shares”) by way of a court-approved plan of arrangement under the Business Corporations Act (Ontario) (the “Transaction”).

A total of 35,770,287 Appili Shares were voted at the Meeting, representing approximately 29.50% of the outstanding Appili Shares. The Transaction was approved by (i) 99.79% of the votes cast by Shareholders at the Meeting and (ii) 99.65% of the votes cast by Shareholders at the Meeting (excluding the votes cast by persons whose votes may not be included in determining minority approval of a “business combination” in accordance with Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions). The successful close of this transaction is an important milestone for Appili as it focuses on advancing its pipeline of anti-infective therapies and delivering on its mission to protect patients from severe infectious diseases.

“The alignment with Aditxt will facilitate our access to capital and activates promising opportunities for Appili across multiple fronts. Through Aditxt’s social incubator platform, we can amplify our impact and reach in the infectious diseases and medical countermeasure landscape.” said Dr. Don Cilla, President and CEO of Appili. “By leveraging Aditxt’s mission to “Make Promising Innovations Possible Together“, we aim to prepare ATI-1701 for IND submission, implement FDA’s agreed upon strategy for ATI-1801, and enhance commercialization for LIKMEZ™ and capitalize on the strategic value of two potential PRV eligible programs.”

The Transaction is conditional upon certain customary closing conditions and Aditxt raising at least US$20 million in financing. The Transaction is expected to close in Q4 2024.

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

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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 an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

About Aditxt

Aditxt, Inc.® is an innovation platform dedicated to accelerating promising health innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to “Make Promising Innovations Possible Together.” The innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address significant societal challenges. Aditxt operates a unique model that democratizes innovation, ensures every stakeholder’s voice is heard and valued and empowers collective progress.

Aditxt currently operates two programs focused on immune health and precision health. The Company plans to introduce two additional programs dedicated to public health and women’s health. For these, Aditxt has entered into an Arrangement Agreement with Appili Therapeutics, Inc. (“Appili”) (TSX: APLI; OTCPink: APLIF), which focuses on infectious diseases, and a Merger Agreement with Evofem Biosciences, Inc. (OTCQB: EVFM). Each program will be designed to function autonomously while collectively advancing Aditxt’s mission of discovering, developing, and deploying innovative health solutions to tackle some of the most urgent health challenges. The closing of each of the transactions with Appili and Evofem is subject to several conditions, including but not limited to approval of the transactions by the respective target shareholders and Aditxt raising sufficient capital to fund its obligations at closing. No assurance can be provided that all of the conditions to closing will be obtained or satisfied or that either of the transactions will ultimately close.

For more information, www.aditxt.com .

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This news release contains “forward-looking information” within the meaning of applicable securities laws. Forward-looking information contained in this press release may be identified by the use of words such as, “may”, “would”, “could”, “will”, “likely”, “expect”, “anticipate”, “believe, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook” and other similar expressions. Forward-looking information is not a guarantee of future performance and is 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 relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment, and the availability of licenses, approvals and permits.

Forward-looking statements in this news release include, but are not limited to closing of the Transaction and the timing thereof. Actual results and developments may differ materially from those contemplated by these statements.

Such forward-looking statements are based on certain assumptions regarding Aditxt and Appili, including the successful completion of the conditions precedent of the Transaction. While Appili considers these assumptions to be reasonable, based on information currently available, they may prove to be incorrect. Among other things, there can be no assurance that the Transaction will be completed.

Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Consequently, readers are cautioned not to place undue reliance on the forward-looking statements and information contained in this press release.

The statements in this press release are made as of the date of this release. Appili disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Neither CIRO nor any stock exchange or other securities regulatory authority accepts responsibility for the adequacy or accuracy of this release.

 

###

 

Media Contact:

Jenna McNeil, Corporate Affairs and Communications Manager
Appili Therapeutics
E: [email protected]

Investor Relations Contact:
Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: [email protected]

 

Demonstrated safety and efficacy across multiple Phase 2 and Phase 3 studies

Appili provides update on Aditxt transaction and encourages shareholders to vote their shares as soon as possible for the November 6, 2024 shareholders meeting

 

HALIFAX, Nova Scotia, October 31, 2024– Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced that the U.S. Food and Drug Administration (“FDA”) has provided positive feedback regarding the development strategy for ATI-1801, and agreed on the necessary registration package to support a New Drug Application (“NDA”). ATI-1801, a novel topical formulation of paromomycin (15% w/w), is under advanced clinical development for treating cutaneous leishmaniasis, a disfiguring skin infection affecting hundreds of thousands globally.

“This positive response from the FDA simplifies and de-risks our development program for ATI-1801,” said Don Cilla, President and CEO of Appili Therapeutics. “The agency’s agreement with our proposed strategy enables Appili to leverage key results from the clinical dossier for ATI-1801 licensed from U.S. Army Medical Materiel Development Activity (“USAMMDA”), including the successful results of a Phase 3 study, and provides a clear path towards an NDA submission.”

In a recent response to Appili’s Type B meeting request, the FDA agreed with the Company’s proposed strategy to establish a scientific bridge between previous clinical trial material and new drug product batches. This approach includes developing an appropriately validated in-vitro release test (“IVRT”) method and manufacturing a new reference standard to use in IVRT studies to support the scientific bridge to products used in prior studies. This will allow completion and submission of an NDA much sooner than if additional clinical data were required.

Subject to securing the requisite funding Appili expects to implement the agreed-upon strategy and continue to advance ATI-1801 topical paromomycin cream (15% w/w) program to NDA submission.

ATI-1801 has received Orphan Drug Designation from the FDA for certain forms of cutaneous leishmaniasis. The company is evaluating ATI-1801’s eligibility for a priority review voucher (“PRV”), which, if confirmed, would make it the second PRV-eligible program at Appili, alongside ATI-1701, which is potentially eligible for a PRV pending renewal of certain U.S. legislation.

 

Aditxt Arrangement

On April 2, 2024, the Company announced that it had entered into a definitive arrangement agreement (the “Arrangement Agreement”) pursuant to which Aditxt Inc. (NASDAQ: ADTX) (“Aditxt”), through its wholly-owned subsidiary, Adivir, Inc., agreed to acquire all of the issued and outstanding Class A common shares of the Company. Under the terms of the Arrangement Agreement, shareholders of the Company will receive (i) US$ 0.0467 in cash and (ii) 0.0000686251 of a share of Adixt common stock (the “Transaction”).

This Transaction represents a premium to Appili’s recent trading price, and assuming the completion of the transaction, provides shareholders with immediate value.

On October 1, 2024, the Company obtained an interim order from the Ontario Superior Court of Justice in connection with the Transaction. The order permits the mailing of all requisite meeting materials in connection with the special meeting of Appili shareholders (the “Meeting”) scheduled to be held virtually on November 6, 2024 at 11:00 am ET.

Shareholders are encouraged to vote their shares as soon as possible.

The notice of the special meeting of shareholders and management information circular containing all relevant details with respect to the Meeting (including voting instructions) and the Transaction are available on the Company’s website at: www.appilitherapeutics.com/proxy-info/ as well as under Appili’s profile on SEDAR+ www.sedarplus.ca.

 

+++

 

About ATI-1801

Licensed from the U.S. Department of Defense through the U.S. Army Medical Materiel Development Activity, Appili’s ATI-1801 is a novel topical product with demonstrated safety and efficacy across multiple Phase 2 and Phase 3 studies. As current treatments are often invasive and require hospitalization, ATI-1801 has the potential to significantly reduce suffering from cutaneous leishmaniasis by providing patients in need with a safe and effective topical therapy that can be used in the outpatient setting.

 

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 an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. 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 (i) the potential for ATI-1801 as a treatment for leishmaniasis and the proposed development plan for ATI-1801(including the NDA submission and the expected timing thereof) and (ii) the potential that certain of Appili’s programs may be PRV-eligible. 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. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in the annual information form of the Company dated June 25, 2024, and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). 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.

 

###

 

Media Contact:

Jenna McNeil, Corporate Affairs and Communications Manager
Appili Therapeutics
E: [email protected]

 

Investor Relations Contact:

Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: [email protected]

ATI-1701 provides full protection against lethal tularemia in animal models after one year

Company to provide update on tularemia vaccine candidate ATI-1701 and present new data on efficacy

Presentation scheduled for 3:15 pm ET on October 17, 2024

 

HALIFAX, Nova Scotia, October 17, 2024– Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced that Gary Nabors, Ph.D., Chief Development Officer, and key members of Appili’s scientific team, will participate at IDWeek 2024™, and present an update on the Appili biodefense program ATI-1701. The conference is being held from October 16-19 2024, at the Los Angeles Convention Center.

The poster presentation will provide an update on ATI-1701, Appili’s potential first-in-class vaccine candidate for the prevention of tularemia caused by F. tularensis and will summarize the latest findings from preclinical studies. These studies have demonstrated that a single dose of ATI-1701 provides full protection in animal models against lethal tularemia one year after vaccination.

Appili secured a US$14M funding commitment for ATI-1701 from the United States Air Force Academy, who is working in partnership with the Defense Threat Reduction Agency. These funds along with other potential funding sources, are anticipated to advance the ATI-1701 program to IND submission to the United States Food and Drug Administration (“FDA”) in 2025.

“Appili and our government partners are greatly encouraged by our manufacturing progress, and the results from the 365-day vaccination and challenge study” said Dr. Gary Nabors, Chief Development Officer. “These findings, along with government funding commitments strengthen ATI-1701’s advanced development and are expected to position the program for an IND submission in 2025.”

Presentation details for Appili are as follows:

Poster Title: Toward the clinical development of ATI-1701, a genetically defined live attenuated tularemia vaccine
Date: October 17^th, 2024
Time: 12:15 PM PT / 3:15 PM ET
Location: Los Angeles Convention Center, Los Angeles, CA, Hall J & K

Appili management is also in attendance at the meeting and is available for in-person meetings throughout the conference. To request a meeting with Appili, please contact [email protected].

 

+++

 

About ATI-1701

ATI-1701 is a novel, live-attenuated vaccine for F. tularensis, which causes tularemia, a Category A pathogen which can be aerosolized and is over 1,000 times more infectious than anthrax. Since it is a highly infectious pathogen capable of causing severe illness, medical countermeasures for F. tularensis are a top biodefense priority for the United States and governments around the world. There is currently no approved vaccine for the prevention of tularemia in the United States or other major global markets.

 

About IDWeek 2024

IDWeek 2024™ is an annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS) and the Society of Infectious Diseases Pharmacists (SIDP). With the theme “Advancing Science, Improving Care,” IDWeek features the latest science and bench-to-bedside approaches in prevention, diagnosis, treatment and epidemiology of infectious diseases, including HIV, across the lifespan. IDWeek 2024™ takes place Oct. 16-19 at the Los Angeles Convention Center (1201 S Figueroa St) in Los Angeles, CA. For more information, visit www.idweek.org.

 

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 an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. 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 the potential for ATI-1701 as a treatment for tularemia and the proposed development plan for ATI-1701 (including the timing of filing an IND). 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. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in the annual information form of the Company dated June 25, 2024, and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). 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.

 

###

 

Media Contact:

Jenna McNeil, Corporate Affairs and Communications Manager
Appili Therapeutics
E: [email protected]

 

Investor Relations Contact:

Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: [email protected]

Your vote is important no matter how many votes you hold.

Shareholders who have questions or need assistance with voting their shares should contact [email protected]

                                                

HALIFAX, Nova Scotia – October 10, 2024 – Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, announces its special meeting of shareholder date. The notice of the special meeting of shareholders (the “Meeting“) and management information circular (the “Circular”) will be available on the Company’s website at: appilitherapeutics.com/proxy-info/  as well as under Appili’s profile on SEDAR+ www.sedarplus.ca.

Appili’s board of directors recommend that shareholders vote in favour of the resolution pursuant to which Aditxt Inc. (“Aditxt”), through its wholly-owned subsidiary, Adivir, Inc., agreed to acquire all of the issued and outstanding Class A common shares of the Company (“Appili Shares”) by way of a court-approved plan of arrangement (the “Arrangement”).

Under the terms of the Arrangement, for each Appili Share, shareholders will receive (i) US$ 0.0467 in cash and (ii) 0.0000686251 of a share of Adixt common stock (the “Aditxt Shares”) (representing a value of approximately US$0.00013 per Appili Share based on the closing price of the Aditxt Shares on October 3, 2024 (the date immediately preceding the date of the Circular)). This Amalgamation represents a significant premium to Appili’s recent trading price, and assuming the completion of the transaction, provides shareholders with immediate value. In addition to the diversifying Appili’s shareholders’ investments, the combined enterprise should enhance access to capital and accelerate the development of Appili’s programs.

“Aditxt’s expertise in development operations and commercialization will significantly accelerate the advancement of Appili’s programs, including facilitating access to new U.S. non-dilutive funding sources, preparing ATI-1701 IND submission, and supporting manufacturing activities for ATI-1801. By leveraging Aditxt’s robust capabilities, we aim to work with partners to enhance the commercialization of LIKMEZ™ and capitalize on the strategic value of two potentially PRV eligible programs.”  said Don Cilla, President and CEO of Appili. “Together, we are committed to delivering critical solutions to health challenges and accelerate innovation across early detection and healthcare delivery.”

 

YOUR VOTE IS IMPORTANT. VOTE YOUR SHARES FOR THE ARRANGEMENT AS SOON AS POSSIBLE.

 

The Company is in the process of mailing the Circular and related materials for the Meeting to Appili’s shareholders. Copies of the notice of the meeting, proxy form and Circular will be available on Appili’s investor relations website at appilitherapeutics.com/proxy-info/.

 

Shareholder Meeting Details

The Company’s Meeting will be held virtually via a live teleconference hosted through the facilities of Chorus Call at 11:00 a.m. (Toronto time), on November 6, 2024 (as more particularly described in the Circular). Shareholders are encouraged to read the Circular and vote their shares as soon as possible. The deadline for voting your shares is 11:00 a.m. (Eastern time) on November 4, 2024.

Appili’s board of directors recommends that shareholders vote FOR the resolution approving the Arrangement (the “Arrangement Resolution”).

Shareholders representing approximately 11.9% of the outstanding Appili Shares have entered into support and voting agreements to vote in favour of the Arrangement Resolution. It has also been communicated to the Company that shareholders holding an additional approximately 17.1% of the outstanding Appili Shares intend to vote in favour of the Arrangement Resolution.

 

Recommendation of Appili’s Special Committee and Appili’s Board

The special committee of the board of directors of Appili and the board of directors of Appili have recommended that shareholder vote in favour of the Arrangement Resolution.

 

Aditxt Arrangement

Aditxt’s strategy is anchored in accelerating promising health innovations. With two subsidiaries in immune health and precision diagnostics already established, the proposed acquisitions of Evofem Biosciences, Inc., and Appili seek to further extend Aditxt’s presence into women’s health and public health, supporting its continued expansion.

Support from Aditxt may enable Appili to accelerate clinical and commercial stage innovations and activate the strategic value of potentially PRV eligible products.

 

LIKMEZ™ (ATI-1501), Expansion of FDA Approved Liquid Oral Reformulation of the Antibiotic Metronidazole

In September 2023, Appili, together with its U.S. partner, Saptalis Pharmaceuticals LLC., announced the FDA approval of LIKMEZ™ (ATI-1501), a proprietary taste-masked liquid suspension formulation of metronidazole. LIKMEZ addresses the unmet need in both pediatric patients and elderly patients with dysphagia and mitigating risks associated with drug compounding and antimicrobial resistance.

LIKMEZ, the first FDA-approved ready-made suspension of metronidazole with patent coverage through 2039, is expected to expand accessibility to patients in need.

 

ATI-1701, Accelerate Development to IND Submission

Collaboration within the Aditxt ecosystem has the potential to facilitate access to new U.S. non dilutive funding sources and accelerate the development of the program.

Existing funding including the Company’s USAFA $14M awards, along with new non-dilutive funding sources facilitated by Aditxt are expected to advance Appili’s ATI-1701 biodefense program toward an Investigational New Drug submission to the U.S. FDA in 2025.

 

ATI-1801, Advance Clinical Development of Paromomycin

Aditxt’s presence, established in public health and women’s health areas, is expected to accelerate the advanced clinical development for treating cutaneous leishmaniasis, a disfiguring skin infection affecting hundreds of thousands globally.

Appili also expects to capitalize on the strategic value of potentially PRV eligible ATI-1801, which, if confirmed, would make it the second PRV-eligible products at Appili, alongside ATI-1701, pending renewal of certain U.S. legislation.

 

Additional Infectious Disease Development Opportunities

Appili has partnered with other companies to explore additional infectious disease development opportunities in the fungal disease and viral disease space.   By collaborating with these partners, the development programs benefit from prior work on the asset by the partner and leverage Appili’s government contracting expertise to solicit non-dilutive funding to fund the programs infectious disease development.  This allows Appili the opportunity to lead in the development of new infectious disease assets.  Through these partnerships, Appili can potentially access additional government funding, and potentially gain substantial benefit on commercialization.

 

+++

 

About Appili

Appili 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. Appili is currently advancing a diverse range of anti-infectives, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information about Appili Therapeutics Inc., visit www.AppiliTherapeutics.com.

 

About Aditxt

Aditxt, Inc.® is an innovation platform dedicated to accelerating promising health innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to “Make Promising Innovations Possible Together.” The innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address significant societal challenges. Aditxt operates a unique model that democratizes innovation, ensures every stakeholder’s voice is heard and valued and empowers collective progress.

 

Shareholder Questions

Shareholders who have any questions or require assistance with voting may contact Appili Therapeutics [email protected].

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This news release contains “forward-looking information” within the meaning of applicable securities laws. Forward-looking information contained in this press release may be identified by the use of words such as, “may”, “would”, “could”, “will”, “likely”, “expect”, “anticipate”, “believe, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook” and other similar expressions. Forward-looking information is not a guarantee of future performance and is 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 relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment, and the availability of licenses, approvals and permits.

Forward-looking statements in this news release include, but are not limited to: statements with respect to the anticipated completion of the Arrangement, shareholders voting in favour or the Arrangement Resolution, anticipated effects of the Arrangement on Aditxt, the Company and the combined company’s strategy going forward and statements with respect to the anticipated benefits associated with the acquisition of Appili. Actual results and developments may differ materially from those contemplated by these statements.

Such forward-looking statements are based on certain assumptions regarding Aditxt and Appili, including the successful completion of the Arrangement, anticipated benefits from the Arrangement, and expected growth, results of operations, performance, industry trends and growth opportunities. While Appili considers these assumptions to be reasonable, based on information currently available, they may prove to be incorrect.

Among other things, there can be no assurance that the Arrangement will be completed or that the anticipated benefits from the Arrangement will be achieved.

Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information, including those set out in the Circular. Consequently, readers are cautioned not to place undue reliance on the forward-looking statements and information contained in this press release.

The statements in this press release are made as of the date of this release. Appili disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Neither IIROC nor any stock exchange or other securities regulatory authority accepts responsibility for the adequacy or accuracy of this release.

 

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Media Contact:

Jenna McNeil, Corporate Affairs and Communications Manager
Appili Therapeutics
E: [email protected]

 

Investor Relations Contact:

Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: [email protected]

 

 

HALIFAX, Nova Scotia – September 17, 2024 – Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced the results from its annual and special meeting of shareholders held earlier today.

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 Prakash Gowd.

Voting results for each director are summarized below:

Name of Nominee	Percentage of Votes For	Percentage of Votes Against
Don Cilla	27,929,188 (94.54%)	1,612,685 (5.46%)
Brian Bloom	28,409,188 (96.17%)	1,132,685 (3.83%)
Theresa Matkovits	29,377,973 (99.45%)	163,900 (0.55%)
Juergen Froehlich	29,377,973 (99.45%)	163,900 (0.55%)
Armand Balboni	28,409,188 (96.17%)	1,132,685 (3.83%)
Prakash Gowd	29,377,973 (99.45%)	163,900 (0.55%)

 

All other matters considered at the Meeting were approved by shareholders, including 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,a special resolution approving the Company’s continuation (the “Continuance”) from a corporation governed under the Canada Business Corporations Act to a corporation governed under the Business Corporations Act (Ontario) (“OBCA”) and special resolution to authorize the board of directors of the Company, following the Continuance, to set the number of directors from time to time within the minimum and maximum number of directors set forth in the articles of the Company, in accordance with Section 125(3) of the OBCA.

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.

 

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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 an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

 

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Media Contact:

Jenna McNeil, Corporate Affairs and Communications Manager
Appili Therapeutics
E: [email protected]

 

Investor Relations Contact:
Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: [email protected]