Author: rajarshi

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.

 

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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 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: [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 – 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: [email protected]

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

 

Transaction consideration provides a significant premium to the Appili shareholders

Combined enterprise expected to provide enhanced synergies and resources to advance key programs

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

 

HALIFAX, Nova Scotia, April 2, 2024 – Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (“Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced that it has entered into a definitive arrangement agreement (the “Arrangement Agreement“) pursuant to which Aditxt Inc. (NASDAQ: ADTX) (“Aditxt”), a Richmond, Virginia- based company dedicated to discovering, developing, and deploying promising health innovation, through its wholly-owned subsidiary, Adivir, Inc. (“Adivir” or the “Buyer”), agreed to acquire all of the issued and outstanding Class A common shares (the “Appili Shares“) of Appili by way of a court-approved plan of arrangement under the Canada Business Corporations Act (the “Transaction“).

 

Overview and Rationale for the Transaction

Under the terms of the Arrangement Agreement, shareholders of Appili (the “Appili Shareholders“) will receive (i) 0.002745004 of a share of common stock (each whole share, an “Aditxt Share”) of Aditxt (the “Share Consideration”) and (ii) US$0.0467 (or approximately CAD$0.0633 with reference to the Bank of Canada closing exchange rate on March 29, 2024) for each Appili Share held (the “Cash Consideration” and together with the Share Consideration collectively, the “Transaction Consideration”) representing implied total consideration per Appili Share of approximately US$0.0561(or approximately CAD$0.07598 with reference to the Bank of Canada closing exchange rate on March 29, 2024) based on the closing price of the Aditxt shares on March 28, 2024. The Transaction Consideration represents an approximately 117% premium to the trading price of the Appili Shares based on the closing price of the shares of Appili on April 1, 2024 (the last trading prior to the execution of the Arrangement Agreement) and an approximately 141% premium to the 30-day volume weighted average price of the Appili Shares prior to the date of the Arrangement Agreement.

The Transaction is expected to provide much needed resources and access to capital which will allow the combined enterprise to execute its development plans more efficiently. Aditxt and its subsidiaries have complementary medical and scientific knowledge in immunology and immune profiling and expertise in diagnostics and other tools, which can be used to expedite development programs and be used in clinical practice.

“This transaction with Aditxt aligns with our goals on multiple levels. Through the Aditxt platform, we can amplify our impact and reach in the fight against life-threatening infectious diseases. We see this as an opportunity for growth, innovation, and collaboration. Our shared vision and combined expertise will undoubtedly accelerate our mission to develop innovative treatments and solutions for some of the most challenging health threats facing the world today. Appili’s programs can now leverage Aditxt’s proven research and development, operations, and commercialization expertise to accelerate the development of our three programs. Secondly, as a NASDAQ-listed company, Aditxt will facilitate access to capital for Appili’s programs in this challenging economic environment. We welcome this new chapter, confident that together, we will achieve even greater heights in deploying innovative healthcare solutions.” said Dr. Don Cilla, President and CEO of Appili Therapeutics.

The Transaction is expected to enhance the combined entity’s portfolio of products and potentially create substantive synergies among existing programs, particularly precision diagnostics. Integrating Appili’s expertise and product lines with Aditxt could pave the way for a comprehensive approach to population health, from early detection and prevention to treatment. Collaboration within the Aditxt ecosystem has the potential to streamline patient care, from early detection through precision diagnostics to the development of tailored treatment strategies. This synergy provides an opportunity to accelerate innovation and enhances the effectiveness and personalization of healthcare delivery.

Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt, elaborated on the significance of this acquisition, stating, “The acquisition of Appili would represent another step in Aditxt’s journey towards advancing promising innovations in health. Our mission is to accelerate some of the most promising health innovations, like those developed by Appili, to reach their full potential and to have a lasting impact. The urgency for innovative and effective public health solutions is unprecedented. The need to discover and bring new treatments to the market or to enhance existing ones to combat public health challenges has never been more critical. By integrating Appili’s proven expertise and diverse portfolio in the infectious disease and biodefence domain, Aditxt can substantially contribute to advancing public health solutions.”

 

Additional Transaction Details

The Transaction will be effected by way of a court-approved plan of arrangement pursuant to the Canada Business Corporations Act. Under the terms of the Arrangement Agreement, Adivir will acquire all of the issued and outstanding Appili Shares, with each Appili Shareholder receiving the Transaction Consideration. In connection with the Transaction, each outstanding option and warrant of Appili will be cashed-out based on the implied in-the-money value of the Transaction Consideration.

In connection with the Transaction Aditxt will: (i) agree to repay no less than 50% in outstanding senior secured debt at the closing of the Transaction (the “Closing”) and to repay the remaining outstanding senior secured debt by no later than December 31, 2024; (ii) assume all of Appili’s remaining outstanding liabilities and indebtedness, and (iii) agree to satisfy certain payables of Appili at Closing as further detailed in the Arrangement Agreement.

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 prior to end of calendar Q2 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 Special Committees (as defined below) and how shareholders can participate in and vote at the Appili Meeting will be provided in the Appili Circular.

The Transaction is subject to the approval of at least two-thirds of the votes cast by the Appili Shareholders at the Appili Meeting.

All of Appili’s directors and officers, and certain shareholders holding approximately 11.9% of the total voting power of the issued and outstanding Appili Shares have entered into voting support agreements with the Buyer to vote in favor of the Transaction.

The Transaction is conditional upon Aditxt raising at least US$20 million in financing (the “Aditxt Financing”) prior to Closing. In addition, completion of the Transaction is subject to other customary conditions, including the receipt of all necessary court, regulatory and stock exchange approvals. Subject to the receipt of all required approvals, Closing is currently expected to occur not later than early calendar Q3 2024.

The Arrangement Agreement contains customary terms and conditions, including non-solicitation provisions which are subject to Appili’s right to consider and accept a superior proposal subject to a matching right in favour of Aditxt. The Arrangement Agreement also provides for the payment of a termination fee of CDN$1.25 million in certain circumstances.

A copy of the Arrangement Agreement will be available through Appili’s filings with the securities regulatory authorities in Canada on SEDAR+ at www.sedarplus.ca.

None of the securities to be issued pursuant to the Arrangement Agreement have been or will be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act“), or any state securities laws, and any securities issued in the Transaction are anticipated to be issued in reliance upon available exemptions from such registration requirements pursuant to Section 3(a)(10) of the U.S. Securities Act and applicable exemptions under state securities laws. This news release does not constitute an offer to sell or the solicitation of an offer to buy any securities.

If the Transaction is completed, the Appili Shares will be delisted from the TSX and the OTCQX and Appili will apply to cease to be a reporting issuer.

 

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

The special committee (the “Appili Special Committee“) of the board of directors of Appili (the “Appili Board“), comprised of Theresa Matkovits, Jurgen Froehlich and Prakash Gowd, after receiving legal and financial advice, including the fairness opinion from its independent financial advisor discussed below, has unanimously recommended the Transaction having determined that the consideration to be received by the Appili Shareholders pursuant to the Transaction is fair, from a financial point of view, to the Appili Shareholders.

The Appili Special Committee has obtained a fairness opinion from BDO Canada LLP to the effect that, as of the date of the Arrangement Agreement, and subject to the assumptions, limitations and qualifications on which such opinions are based, the consideration to be received by the Appili Shareholders pursuant to the Transaction is fair, from a financial point of view, to the Appili Shareholders.

After receiving the recommendations of the Appili Special Committee, and the fairness opinion from its financial advisor discussed above, the Appili Board has unanimously determined that: (i) the consideration to be received by the Appili Shareholders pursuant to the Transaction is fair, from a financial point of view, to the Appili Shareholders; (ii) the Transaction is in the best interests of Appili; and (iii) it approve and authorize the Transaction and the entering into of the Arrangement Agreement and all ancillary agreements; and (iv) in accordance with and subject to the terms of the Arrangement Agreement, it recommend to the Appili Shareholders that they vote in favour of the resolution to approve the Transaction at the Appili Meeting.

Additional details concerning the rationale for the recommendations made by the Appili Special Committee and the Appili Board, including copies of the fairness opinion prepared by the independent financial advisor to the Appili Special Committee and the Appili Board, will be set out in the Appili Circular to be filed and mailed to the Appili Shareholders in the coming weeks, which, together with the Arrangement Agreement, will be available under Appili’s profile on SEDAR+ at www.sedarplus.ca.

 

Lender Approval

Appili’s senior secured lender, Long Zone Holdings (“LZH”), has provided the requisite consent to the Transaction along with certain waivers required pursuant to the terms of the loan agreement between Appili and LZH.  In connection with such consent and waivers, Appili has agreed to issue to LZH an aggregate of $18,000 worth of Appili Shares prior to the Closing, subject to TSX approval.

 

Advisors

Dentons Canada LLP acted as legal counsel to Appili.  Bloom Burton Securities Inc. acted as financial advisor to the Appili Board and BDO Canada LLP acted as independent financial advisor to the Appili Special Committee.

Aird & Berlis LLP acted as Canadian legal counsel to Aditxt. Sheppard, Mullin, Richter & Hampton LLP acted as US securities counsel to Aditxt and Nelson Mullins Riley & Scarborough LLP acted as US M&A counsel to Aditxt.

 

About Aditxt

Aditxt is an innovation platform dedicated to discovering, developing, and deploying promising 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 has a diverse innovation portfolio, including Adimune™, Inc., which is leading the charge in developing a novel class of therapeutics for retraining the immune system to combat organ rejection, autoimmunity, and allergies. Adivir™, Inc. focuses on enhancing national and population health and impacting public health globally. Pearsanta™, Inc., delivers rapid, personalized, and high-quality lab testing accessible anytime, anywhere, led by its CLIA-certified and CAP-accredited clinical laboratory based in Richmond, VA.

For more information about Aditxt, Inc., visit www.aditxt.com.

 

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.

 

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 Transaction, the timing for its completion, and the delisting of the Appili Shares from the TSX; the timing for the holding of the Appili Meeting; the satisfaction of closing conditions which include, without limitation (i) required Appili shareholder approval, (ii) the Aditxt Financing, (iii) certain termination rights available to the parties under the Arrangement Agreement, and (iv) other approvals and closing conditions contained in the Arrangement Agreement; statements with respect to the anticipated effects of the Transaction on Aditxt and its 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 Transaction, anticipated benefits from the Transaction, 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 Transaction will be completed or that the anticipated benefits from the Transaction 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. Such risks and uncertainties include, but are not limited to, risks relating to: (i) current and future market conditions; (ii) federal, state, provincial, territorial, local and foreign government laws, rules and regulations; (iii) the ability of the parties to satisfy the closing conditions of the Arrangement Agreement, including the Aditxt Financing; (iv) the ability of the Appili Board to consider and approve a superior proposal for Appili prior to the completion of the Transaction; (v) failure to receive the necessary shareholder, court or regulatory approvals where applicable, or failure of the parties to obtain such approvals or satisfy such conditions in a timely manner; (vi) unforeseen challenges in integrating the businesses of Aditxt and Appili; (vii) failure to realize the anticipated benefits of the Transaction; (viii) the business, operational and/or financial performance or achievements of Aditxt and Appili may be materially different from that currently anticipated; (ix) other unforeseen events, developments, or factors causing any of the aforesaid expectations, assumptions; and (x) the risk factors set out in Appili’s most recently filed annual information form, as well as discussions of potential risks, uncertainties, and other important factors in the Appili’s other filings with the Canadian securities regulators on SEDAR+. In particular, the benefits anticipated in respect of the Transaction are based on the current business, operational and financial position of each of Aditxt and Appili, which are subject to a number of risks and uncertainties. Readers are cautioned that the foregoing list of risks, uncertainties and assumptions are not exhaustive. In addition, if the Transaction is not completed, and Appili continues as an independent entity, there are risks that the announcement of the Arrangement Agreement and the dedication of substantial resources of Appili to the completion of the Proposed Transaction could have an impact on its business and strategic relationships, operating results and activities in general, and could have a material adverse effect on its current and future operations, financial condition and prospects. Consequently, the reader is 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:

Jenna McNeil, Communications Manager

Appili Therapeutics

E: [email protected]

 

Investor Relations:

Don Cilla, President and CEO

Appili Therapeutics

E: [email protected]

A review of Russian and English literature suggests that Appili’s biodefense program ATI-1701 may have a role in preventing tularemia in Ukraine

 

HALIFAX, Nova Scotia, March 12, 2024 – Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced a publication in the journal Frontiers in Bacteriology on the prevention of tularemia. Appili’s Director of Non-Clinical Research, Dr. Carl Gelhaus, Ph.D., together with medical doctors from the United States Uniformed Services University of the Health Sciences and Ukrainian researchers published a perspective manuscript “Considerations for prevention of and emergency response to tularemia outbreaks in Ukraine: vaccine involvement”.

 

“Appili has been developing ATI-1701, a biodefense vaccine, to protect warfighters from tularemia.” said Carl Gelhaus, Ph.D., Director of Non-Clinical Research of Appili Therapeutics. “With the help of our Ukrainian colleagues and U.S. Army physicians, we have assessed the potential risk for tularemia outbreaks in Ukraine, by reviewing the literature of previous wartime outbreaks in Eastern Europe. Many of the conditions for tularemia outbreaks now exist in Ukraine, and their warfighters need protection. We suspected that rodent populations would explode and carry tularemia into war-affected areas. Even as we were preparing the manuscript, “Mouse fever”, an infection of unknown etiology, was reported in news outlets, underscoring the urgency of making sure Ukrainians are protected from the risk of many infectious diseases, including tularemia. The acceptance and publication of this perspective article recognizes that the epidemiological, medical, military, and scientific tularemia experts should prepare to prevent and respond to tularemia outbreaks in wartime Ukraine.”

 

The perspective manuscript explores the current war in Ukraine and the increased risk for outbreaks of tularemia. Several wartime tularemia outbreaks have been documented, as far back as the Siege of Stalingrad in WWII. Furthermore, F. tularensis was weaponized and stockpiled as an offensive agent, and experts consider tularemia to have a high potential use in a biological weapons attack. Russia administers its own tularemia vaccine, but that vaccine is not available in Ukraine. Furthermore, the legacy Russian vaccine is unlikely to meet the rigorous FDA and EMEA standards for safety and efficacy.

 

ATI-1701 is the Company’s potential first-in-class vaccine candidate for the prevention of infection with F. tularensis. Since it is a highly infectious pathogen capable of causing severe illness, medical counter measures for F. tularensis are a top biodefense priority for governments around the world.

 

There is currently no approved vaccine for the prevention of tularemia in the United States or other major global markets, strengthening ATI-1701’s position as a potentially valuable vaccine that is urgently needed on the market.

 

Appili is working hard to develop our ATI-1701 vaccine that could potentially help protect the Ukrainian people living in what United Nations Secretary-General Antionio Guterres described as “an epicenter of unbearable heartache and pain”. Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili adds “At Appili, we hope that our products can alleviate that kind of human suffering”.

 

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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 counter measures 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.

 

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

 

 

About Appili Therapeutics

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

 

Forward looking statements

This news release contains “forward-looking statements”, including with respect to any potential outbreak of tularemia in the Ukraine, the funding commitment from USAFA, further anticipated milestones and the timing thereof and the Company’s development plans with respect to ATI-1701. 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 risk that ATI-1701 may never become an approved vaccine for the prevention or treatment of tularemia, and the other risks listed in the annual information form of the Company dated June 22, 2023, and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). 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, Communications Manager

Appili Therapeutics

E: [email protected]

 

Investor Relations Contact:

Don Cilla, President and CEO

Appili Therapeutics

E: [email protected]

 

 

 

 

 

FDA approved LIKMEZ™ (ATI-1501) for Metronidazole Oral Suspension 500mg/5mL

 

Additional USAFA funding commitment from the U.S. Air Force Academy, intended to advance the ATI-1701 program toward an IND submission to the FDA

 

Engaging regulatory authorities to align on ATI-1801 development plans 

 

HALIFAX, Nova Scotia, February 13, 2024 – Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced its financial and operational results for the third quarter of its fiscal year 2024, which ended on December 31, 2023. All figures are stated in Canadian dollars unless otherwise stated.

 

In recent months, we’ve achieved significant milestones by solidifying ATI-1701 government partnerships, engaging regulatory authorities for ATI-1801, and bringing our most advanced innovative asset, LIKMEZ™ (ATI-1501) to market through our partner. Beginning 2024, Appili’s skilled team stands with a clear vision, and committed funding enabling us to  execute on our infectious disease program priorities, said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili. “Additionally, the issuance of the patent claims for ATI-1701, shortly after receiving an additional funding commitment from USAFA, strengthens the programs position in biodefense and the new methods are expected to allow Appili to further develop a valuable vaccine that is urgently needed on the market”.

 

 

Operational Highlights

 

LIKMEZ™ ATI-1501: FDA Approved Product,

In September 2023, Appili announced the FDA approval of LIKMEZ™ (ATI-1501), our proprietary taste-masked liquid suspension reformulation of metronidazole, through our U.S. partner, Saptalis Pharmaceuticals LLC.

 

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.

 

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 earned US$600,000 in milestone payments in fiscal 2024. Appili expects to receive sales-based milestone payments and royalties from Saptalis based on sale of the product.

 

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

 

ATI-1701 is 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 oversees 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 was granted a pre-IND meeting with the FDA to discuss ATI-1701’s regulatory, CMC, toxicology, and Phase 1 strategies and expects to receive feedback in early 2024.

 

ATI-1801, our Licensed 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 January 2024, Appili requested a meeting with the FDA to discuss the previously generated Phase 3 data and agree 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.

 

 

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. All figures are stated in Canadian dollars unless otherwise stated.

 

The net loss and comprehensive loss of $0.2 million or $0.00 loss per share for the three months ended December 31, 2023, was $2.4 million lower than the net loss and comprehensive loss of $2.6 million or $0.02 loss per share during the three months ended December 31, 2022. This relates mainly to an increase in milestone revenue of $0.5 million, an increase in government assistance of $2.0 million and a decrease in general and administrative expenses of $0.9 million. These decreases were offset by an increase in research and development expenses of $0.9 million and an increase in financing costs of $0.2 million.

 

As of December 31, 2023, the Company had cash of $0.6 million, compared to $2.5 million on March 31, 2023.

 

As of February 13, 2024, the Company had 121,266,120 issued and outstanding Common Shares, 7,957,000 stock options, and 44,856,874 warrants outstanding.

 

This press release should be read in conjunction with the Company’s unaudited interim condensed financial statements for the third quarter of the 2024 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 a biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infectious diseases. 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, 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,  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 22, 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, Communications Manager

Appili Therapeutics

E: [email protected]

  

Investor Relations Contact:

Don Cilla, President and CEO

Appili Therapeutics

E: [email protected]