Category: Archives

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.

 

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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.

 

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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

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 info@appilitherapeutics.com.

 

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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.

 

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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

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

Shareholders who have questions or need assistance with voting their shares should contact info@appilitherapeutics.com

                                                

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.

 

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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 info@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: 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: JMcNeil@AppiliTherapeutics.com

 

Investor Relations Contact:

Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: Info@AppiliTherapeutics.com

 

 

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: JMcNeil@AppiliTherapeutics.com

 

Investor Relations Contact:
Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: Info@AppiliTherapeutics.com

 

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

 

HALIFAX, Nova Scotia – August 21, 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 that it has entered into a third amending agreement (the “Amending Agreement”) among the Company, Aditxt, Inc. (“Aditxt”) and Adivir, Inc. (“Adivir” and together with the Company and Aditxt, the “Parties”) to amend the previously announced arrangement agreement dated April 1, 2024 among the Parties (as amended on July 1, 2024 and July 17, 2024, the “Arrangement Agreement”), pursuant to which Aditxt, through its wholly-owned subsidiary, Adivir, will acquire all of the issued and outstanding Class A common shares of the Company (the “Transaction”). For further information on the Transaction please see the Company’s news releases dated April 2, 2024, July 2, 2024 and July 18, 2024, which are available on the Company’s profile on SEDAR+ at www.sedarplus.ca.

Under the Amending Agreement, the Arrangement Agreement was amended to, inter alia: (i) change the Outside Date (as defined in the Arrangement Agreement) from September 30, 2024 to November 19, 2024; (ii) require the Company to convene an annual and special shareholder’s meeting of the Company to consider, among other things, the Continuance (as defined below) as promptly as practicable; (iii) change the deadline to convene a special shareholders’ meeting to consider the Transaction from September 30, 2024 to November 6, 2024; (iv) change the deadline for Aditxt to complete the Financing (as defined in the Arrangement Agreement) from September 15, 2024 to October 18, 2024; and (v) have the completion of the Continuance as a condition to the completion of the Arrangement.

A copy of the Amending Agreement will be available on the Company’s profile on SEDAR+ at www.sedarplus.ca.

To address certain regulatory matters relating to the Transaction, as a preliminary matter to consummating the Transaction, the Company will continue from a corporation incorporated under the Canada Business Corporations Act to a corporation incorporated under the Business Corporations Act (Ontario) (the “Continuance”). This will allow the Company to consummate the transaction by way of a court-approved plan of arrangement under the Business Corporations Act (Ontario). For further information on the Continuance please see the Company’s management information circular sent to shareholders in connection with the upcoming annual and special shareholder’s meeting to be held on September 17, 2024 which will be made available on the Company’s profile on SEDAR+ at www.sedarplus.ca.

 

Lender Approval

The Company’s senior secured lender, Long Zone Holdings Inc. (“LZH”), has provided certain waivers required pursuant to the terms of the loan agreement between the Company and LZH. In connection with such waivers, Appili has agreed to pay LZH a cash payment equal to $18,000. Additionally, Appili and LZH agreed that Appili could fulfill its prior obligation to issue LZH an aggregate of $18,000 worth of Class A common shares of Appili prior to the closing of the Transaction by way of a cash payment equal to $18,000.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the securities described herein. The securities offered have not been registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as both such terms are defined in Regulation S promulgated under the U.S. Securities Act) absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities offered in any jurisdiction in which such offer, solicitation, or sale would be unlawful.

 

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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 information”, including with respect to the proposed use of proceeds. 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, the timing for shareholder meetings, the closing of the Transaction and those risks 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.

 

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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

 

Definitive agreement with Aditxt, if approved by Appili shareholders, provides significant premium to shareholders and resources to advance key programs

ATI-1701 funding commitments from U.S. Air Force Academy and interactions with the U.S. Food and Drug Administration, confirming the development pathway through IND submission

U.S. Food and Drug Administration meeting request submitted to discuss ATI-1801 registration strategy

 

HALIFAX, Nova Scotia, August 13, 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 first quarter of its fiscal year 2025, which ended on June 30, 2024. All figures are stated in Canadian dollars unless otherwise stated.

“In recent months, we’ve achieved significant milestones by engaging regulatory authorities for ATI-1701 and ATI-1801, and together with our partner, Saptalis Pharmaceuticals, we launched our leading asset, LIKMEZ™ (ATI-1501).” said Don Cilla, President and CEO of Appili. “These achievements, together with ATI-1701 U.S. Air Force Academy (“USAFA”) funding commitments, are expected to enable us to execute on our infectious disease programs and advance their development with the aim of bringing them to market for the benefit of both patients and shareholders.”

 

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 secured US$14 million in awards from the USAFA. Under the USAFA Cooperative Agreement, Appili will manage a comprehensive development program, including nonclinical studies, CMC/manufacturing, clinical preparatory, and regulatory activities supporting an IND submission in 2025.

Appili has engaged with the U.S. Food and Drug Administration (“FDA”) via a pre-IND meeting, confirming the development pathway for ATI-1701, and is incorporating suggested changes into the development plan.

 

ATI-1801, Topical Antiparasitic Product in Advanced Clinical Development

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.

Appili is currently engaging with the FDA, having submitted a type-B meeting request in 2024 to discuss linking previously generated Phase 3 data and agreeing on the necessary registration package for a New Drug Application submission. Appili aims to pursue non-dilutive funding and partnerships with NGOs and government agencies focused on tropical diseases to complete remaining development work.

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 United States Food and Drug Administration (“FDA”) of LIKMEZ™ (ATI-1501), a proprietary taste-masked liquid suspension formulation of metronidazole. LIKMEZ is the first FDA-approved ready-made suspension of metronidazole, addressing the unmet need in both pediatric patients and patients with dysphagia and mitigating risks associated with drug compounding and antimicrobial resistance.

LIKMEZ, with patent coverage through 2039, is the first and only FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections that addresses the unmet need in patients with dysphagia to avoid risks associated with drug compounding, and discontinuation related anti-microbial resistance. Saptalis launched LIKMEZ in November 2023 and the product is now available to patients and doctors in the United States. Appili has the right to receive sales-based milestone payments and royalties from Saptalis based on sale of the product.

 

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. (“Aditxt”), through its wholly-owned subsidiary, Adivir, Inc., agreed to acquire all of the issued and outstanding Class A common shares of the Company (“Common Shares”) by way of a court-approved plan of arrangement (the “Arrangement”) under the Canada Business Corporations Act. Under the terms of the Arrangement Agreement, shareholders of the Company will receive (i) 0.002745004 of a share of common stock of Aditxt and (ii) US$0.0467 in cash, for each Common Share held at the time of the closing of the proposed Arrangement. For further details regarding the Arrangement, please see Appili’s press release dated April 2, 2024 (the “Arrangement Press Release”).

Additional details of the Transaction will be described in the management information circular that will be mailed to the Appili Shareholders (the “Appili Circular”) in connection with a special meeting of the Appili Shareholders (the “Appili Meeting”) currently expected to be held in the fall of 2024 to approve the Transaction. Additional information regarding the terms of the Arrangement Agreement, the background to the Transaction, the rationale for the recommendations made by the Appili board of directors (on the basis of the recommendation of its independent special committee) and how shareholders can participate in and vote at the Appili Meeting will be provided in the Appili Circular.

 

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 $1.6 million or $0.01 loss per share for the three months ended June 30, 2024, was $0.1 million higher than the net loss and comprehensive loss of $1.5 million or $0.01 loss per share during the three months ended June 30, 2023. This relates mainly to an increase in research and development expenses of $0.8 million, an increase in financing costs of $0.8 million and an increase of $0.2 million in foreign exchange loss. These increases were offset by an increase in government assistance of $1.6 million, and a decrease in general and administrative expenses by $0.1 million.

As of June 30, 2024, the Company had cash of $0.3 million, compared to $.1 million on March 31, 2024.

As of August 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 first 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-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 Arrangement, the expected timing and process to complete the Arrangement, 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 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.

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.

 

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Media Contact:

Jenna McNeil, Communications Manager

Appili Therapeutics

E: JMcNeil@AppiliTherapeutics.com

 

Investor Relations Contact:

Don Cilla, President and CEO

Appili Therapeutics

E: Info@AppiliTherapeutics.com

 

 

 

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

HALIFAX, Nova Scotia – July 18, 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 that it has entered into a second amending agreement (the “Amending Agreement”) among the Company, Aditxt, Inc. (“Aditxt”) and Adivir, Inc. (“Adivir” and together with the Company and Aditxt, the “Parties”) to amend the previously announced arrangement agreement dated April 1, 2024 among the Parties (as amended on July 1, 2024, the “Arrangement Agreement”), pursuant to which Aditxt, through its wholly-owned subsidiary, 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 Canada Business Corporations Act (the “Transaction”). For further information on the Transaction please see the Company’s news releases dated April 2, 2024 and July 2, 2024, which are available on the Company’s profile on SEDAR+ at www.sedarplus.ca.

Under the Amending Agreement, (a) the Outside Date (as defined in the Arrangement Agreement) was changed from August 30, 2024 to September 30, 2024, (b) the deadline to convene the Company’s special shareholders’ meeting was changed from August 30, 2024 to September 30, 2024, and (c) the deadline for Aditxt to complete the Financing (as defined in the Arrangement Agreement) was changed from August 30, 2024 to September 15, 2024 or such later date as the Parties may agree in writing.

A copy of the Amending Agreement will be available on the Company’s profile on SEDAR+ at www.sedarplus.ca.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the securities described herein. The securities offered have not been registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as both such terms are defined in Regulation S promulgated under the U.S. Securities Act) absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities offered in any jurisdiction in which such offer, solicitation, or sale would be unlawful.

 

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 Information

This news release contains “forward-looking information”, including with respect to the proposed use of proceeds. 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, the closing of the Transaction and those risks 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: JMcNeil@AppiliTherapeutics.com

Investor Relations Contact:
Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: Info@AppiliTherapeutics.com

 

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

HALIFAX, Nova Scotia – July 2, 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 that it has entered into an amending agreement (the “Amending Agreement”) among the Company, Aditxt, Inc. (“Aditxt”) and Adivir, Inc. (“Adivir” and together with the Company and Aditxt, the “Parties”) to amend the previously announced arrangement agreement dated April 1, 2024 among the Parties (the “Arrangement Agreement”), pursuant to which Aditxt, through its wholly-owned subsidiary, 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 Canada Business Corporations Act (the “Transaction”). For further information on the Transaction please see the Company’s news release dated April 2, 2024, which is available on the Company’s profile on SEDAR+ at www.sedarplus.ca.

Under the Amending Agreement, (a) the Outside Date (as defined in the Arrangement Agreement) was changed from July 31, 2024 to August 30, 2024; (b) the deadline to convene the Company’s special shareholders’ meeting was changed from June 30, 2024 to August 30, 2024; and (c) the deadline for Aditxt to complete the Financing (as defined in the Arrangement Agreement) was changed from June 30, 2024 to August 30, 2024 or such later date as the Parties may agree in writing.

A copy of the Amending Agreement will be available on the Company’s profile on SEDAR+ at www.sedarplus.ca.

 

Increase to Bridge Loan

The Company further announces that it has increased the principal amount of its previously announced unsecured bridge financing (the “Bridge Loan”) from Bloom Burton & Co. Inc. (the “Lender”) from C$300,000 to C$400,000 (the “Principal Increase”). The Bridge Loan is evidenced by a grid promissory note dated April 26 2024 in favor of the Lender (the “Note”) and other than the Principal Increase, the terms of the Note remain unchanged. For further information on the Bridge Loan, please see the Company’s news release dated April 26, 2024, which is available on the Company’s profile on SEDAR+ at www.sedarplus.ca.

The Lender is considered to be a “related party” of the Company, and the Bridge Loan is considered to be a “related party transaction” for purposes of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”). The Company is relying on exemptions from the formal valuation and minority shareholder approval requirements available under MI 61-101. The Company is exempt from the formal valuation requirement in section 5.4 of MI 61-101 in reliance on sections 5.5(a) of MI 61-101 as the fair market value of the transaction, insofar as it involves interested parties, is not more than the 25% of the Company’s market capitalization. Additionally, the Company is exempt from the minority shareholder approval requirement in section 5.6 of MI 61-101 in reliance on section 5.7(a) of MI 61-101 as the fair market value of the transaction, insofar as it involves interested parties, is not more than the 25% of the Company’s market capitalization.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the securities described herein. The securities offered have not been registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as both such terms are defined in Regulation S promulgated under the U.S. Securities Act) absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities offered in any jurisdiction in which such offer, solicitation, or sale would be unlawful.

 

+++

 

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 Information

This news release contains “forward-looking information”, including with respect to the proposed use of proceeds. 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, the Company’s ability to repay the amount under the Bridge Loan, the closing of the Transaction and those risks 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: JMcNeil@AppiliTherapeutics.com

Investor Relations Contact:

Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: Info@AppiliTherapeutics.com

LIKMEZ™ (ATI-1501) for Metronidazole Oral Suspension 500mg/5mL launched and commercial sales ongoing

Funding commitments from U.S. Air Force Academy intended to advance ATI-1701 toward an IND submission to the FDA

Engaging regulatory authorities to align on ATI-1801 development plans 

 

HALIFAX, Nova Scotia, June 25, 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 fiscal year ended March 31, 2024 (“FYE 2024”), and provided an update on the Company’s strategy for fiscal 2025. All figures are stated in Canadian dollars unless otherwise stated.

“Notably, during this past fiscal year, the Company’s most advanced asset LIKMEZ (ATI-1501), received U.S. Food and Drug Administration (“FDA”) approval, and together with our partner, Saptalis launched the product and commercial sales which remain ongoing. The launch of LIKMEZ, shortly after securing patent coverage through 2039, is an important milestone that demonstrates Appili’s ability to identify promising opportunities, accelerate their development, and unlock value for the benefit of both patients and shareholders” said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili. “The U.S. Air Force Academy (“USAFA”) also awarded funding commitments for the advancement of ATI-1701, bringing the total program funding awarded to approximately US$14 million. These funding commitments strengthen Appili’s foundation in biodefense and should enable us to continue to advance this program towards an Investigational New Drug (“IND”) application.”

 

LIKMEZ™ ATI-1501, is FDA Approved for the Treatment of Anaerobic bacterial Infections,

During FYE 2024, Appili announced the FDA approval of LIKMEZ™ (ATI-1501), our proprietary taste-masked liquid suspension formulation of metronidazole, through our U.S. partner, Saptalis Pharmaceuticals LLC (“Saptalis”).

LIKMEZ is the first and only FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections that addresses the unmet need in patients with dysphagia to avoid risks associated with drug compounding, and discontinuation related anti-microbial resistance. Saptalis launched LIKMEZ in November 2023 and commercial sales in the United States are ongoing.

In May 2023, United States Patent and Trademark Office published patent claims for ATI-1501 under the US Application No. 18/072,154, which covers the composition and preparation methods for the drug through 2039. Collaborating with Saptalis, Appili earned US$600,000 in milestone payments during FYE 2024. Appili expects to receive additional sales-based milestone payments and royalties from Saptalis based on sale of the product.

 

ATI-1701, Biodefense Vaccine Candidate with Funding Awarded from the U.S. Air Force Academy

ATI-1701, a novel, live-attenuated vaccine for the prevention of F. Tularensis, has received awards totaling US$14 million from the U.S. Air Force Academy (“USAFA”). Under the terms of the USAFA Cooperative Agreement, Appili will oversee a comprehensive development program for ATI-1701, which includes nonclinical studies, CMC/manufacturing, clinical preparatory, and regulatory activities to support an IND submission in 2025.

Appili has had interactions with the FDA in the form of a pre-IND meeting, confirming the development pathway for the Company’s efforts through IND submission and is incorporating suggested changes in the development plan.

 

ATI-1801, our Licensed Topical Antiparasitic Product demonstrated safe and effective across Phase 3 studies.

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.

Appili is currently engaging with the FDA and submitted a type-B meeting request with the FDA in 2024, to discuss linking to the previously generated Phase 3 data and agreeing on the necessary registration package to support a New Drug Application submission, which the Company expects will include available nonclinical, manufacturing, and clinical data generated to date. Appili expects to pursue non-dilutive funding and partnership opportunities with NGOs and government agencies which share the Company’s focus on tropical diseases to help complete remaining development work.

ATI-1801 has received an Orphan Drug Designation from the FDA for the treatment of certain forms of cutaneous leishmaniasis. The Company is actively evaluating the eligibility of ATI-1801 for a priority review voucher (“PRV”) which, if confirmed, would make ATI-1801 the second PRV eligible program at Appili, joining ATI-1701, subject to renewal of certain legislation in the United States.

 

Aditxt Arrangement

Subsequent to FYE 2024, on April 2, 2024, the Company announced that it had entered into a definitive arrangement agreement (the “Arrangement Agreement“) 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 (“Common Shares”) by way of a court-approved plan of arrangement (the “Arrangement”) under the Canada Business Corporations Act .Under the terms of the Arrangement Agreement, shareholders of the Company will receive (i) 0.002745004 of a share of common stock of Aditxt and (ii) US$0.0467 in cash, for each Common Share held at the time of the closing of the proposed Arrangement.

The Arrangement is subject to certain customary conditions, including court and shareholder approval. The Arrangement is also subject to Aditxt raising a minimum of US$20 million in additional funding.  Since the date of the Arrangement Agreement, Aditxt has raised approximately US $5.5 million. However, these funds have not been specifically reserved for the Arrangement.  Aditxt is continuing its efforts to raise additional capital as required to complete the Arrangement.

A special meeting of the shareholders of Appili is expected to be held in calendar Q3 2024 and, subject to satisfaction or waiver of the applicable closing conditions, the Arrangement is expected to be completed before the end of calendar Q3 2024.  For further details regarding the Arrangement, please see Appili’s press release dated April 2, 2024 (the “Arrangement Press Release”).  Additional information regarding the Arrangement will be included in the management information circular of Appili to be mailed to the Appili shareholders prior to the Appili shareholders meeting.

 

Annual Financial Results

The Company prepares its financial statements in accordance with IFRS as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook – Accounting.

The net loss and comprehensive loss of $3.8 million or $0.03 loss per share for FYE 2024, was $5.4 million lower than the net loss and comprehensive loss of $9.2 million or $0.08 loss per share during the year ended March 31, 2023. This relates mainly to a $5.7 million increase in government assistance, relating to the USAFA Cooperative Agreement, a $0.5 million increase in revenue, $1.4 million decrease in general and administrative expenses, and $0.3 million decrease in exchange loss, offset by a $2 million increase in research and development expenses, and $0.5 million increase in financing costs.

On March 31, 2024, the Company had cash of $0.1 million compared to $2.5 million on March 31, 2023.  The Company has included a going concern note in its financial statements for the FYE 2024. In particular, the Company is dependent in large part on successfully closing the proposed transaction with Aditxt or raising additional financing through equity and/or non-dilutive funding and receiving all USAFA funding in a timely manner. Delays in reimbursement for previously submitted expenses in the near term may, in the absence of alternative funding arrangements, result in the Company not being able to meet various covenant obligations as required pursuant to its long-term debt arrangements with Long Zone Holdings Inc. For further details, please refer to the Company’s going concern note in the Company’s management’s discussion and analysis (the “MD&A”) for the FYE 2024.

As of June 25, 2024, the Company had 121,266,120 issued and outstanding Common Shares, 11,520,281 stock options and 44,856,874 warrants outstanding.

This press release should be read in conjunction with the Company’s audited annual consolidated financial statements for the FYE 2024, 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 Arrangement 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 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.

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: JMcNeil@AppiliTherapeutics.com

 

Investor Relations Contact:

Don Cilla, President and CEO

Appili Therapeutics

E: Info@AppiliTherapeutics.com

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

HALIFAX, Nova Scotia – April 26, 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 it has secured additional bridge financing in the amount of C$300,000 (the “Bridge Loan”) from  Bloom Burton & Co. Inc. (the “Lender”). The Bridge Loan evidenced by a grid promissory note in favor of the Lender pursuant to which further advances may be made from time to time as agreed to by the Company and the Lender, subject to any requisite regulatory and third party consents.

The Bridge Loan will be used primarily for working capital and general administrative purposes and bears interest at 10% per annum (to be accrued on a quarterly basis and capitalized against the principal loan amount).  The principal amount of the Bridge Loan, together with all accrued and capitalized interest, will be due and repayable in full upon the earlier of: (a) April 26, 2025; and (b) the occurrence of a Change of Control (as defined in the Bridge Loan) of the Company.

The Company may require additional financing prior to the closing of the Company’s proposed acquisition by Aditxt, Inc. (as announced on April 2, 2024) or as may otherwise be required to satisfy the Company’s obligations as they become due.

The Lender is considered to be a “related party” of the Company, and the Bridge Loan is considered to be a “related party transaction” for purposes of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”). Pursuant to MI 61-101, the Company will file a material change report providing disclosure in relation to the Bridge Loan under the Company’s profile on SEDAR+ at www.sedarplus.com. The Company did not file the material change report more than 21 days before the expected closing date of the Bridge Loan as the details of the Bridge Loan were not settled until shortly prior to the closing, and the Company wished to complete the Bridge Loan on an expedited basis for business reasons. The Company is relying on exemptions from the formal valuation and minority shareholder approval requirements available under MI 61-101. The Company is exempt from the formal valuation requirement in section 5.4 of MI 61-101 in reliance on sections 5.5(a) of MI 61-101 as the fair market value of the transaction, insofar as it involves interested parties, is not more than the 25% of the Company’s market capitalization. Additionally, the Company is exempt from the minority shareholder approval requirement in section 5.6 of MI 61-101 in reliance on section 5.7(a) of MI 61-101 as the fair market value of the transaction, insofar as it involves interested parties, is not more than the 25% of the Company’s market capitalization.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the securities described herein. The securities offered have not been registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as both such terms are defined in Regulation S promulgated under the U.S. Securities Act) absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities offered in any jurisdiction in which such offer, solicitation, or sale would be unlawful.

 

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 Information

This news release contains “forward-looking information”, including with respect to the proposed use of proceeds. 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, the Company’s ability to repay the amount under the Bridge Loan, the closing of the proposed transaction with Aditxt, Inc. and those risks listed in the annual information form of the Company dated June 23, 2023 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: JMcNeil@AppiliTherapeutics.com

Investor Relations Contact:
Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: Info@AppiliTherapeutics.com