Author: Development

FDA approves ATI-1501 for Metronidazole Oral Suspension 500mg/5mL and its brand name LIKMEZ™

Appili received an additional funding commitment from the U.S. Air Force Academy for ATI-1701, bringing the total program funding awarded to US$14 million

Appili Therapeutics Appoints Seasoned Biopharma Executive Mr. Prakash Gowd to its Board of Directors

 

HALIFAX, Nova Scotia, November 13, 2023 – Appili Therapeutics Inc. (TSX:APLI; OTCQB: 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 second quarter of its fiscal year 2024, which ended on September 30, 2023. All figures are stated in Canadian dollars unless otherwise stated.

“Notably, the Company’s most advanced asset ATI-1501, received U.S. Food and Drug Administration (“FDA”) approval on September 22, 2023, along with its brand name LIKMEZ. The approval 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 Therapeutics, “Importantly, ATI-1701 recently received an additional funding commitment from USAFA, bringing the total program funding awarded to US$14 million. At Appili, we are proud of our strong government partnerships which enable us to advance this biodefense program towards an Investigational New Drug (“IND”).”

 

Operational Highlights

The Company has made significant operational progress during this quarter. The Company received FDA approval for LIKMEZ (ATI-1501) for the treatment of anaerobic bacterial infections on September 22, 2023. Appili expects to receive additional milestone payments and royalties from its partner, Saptalis Pharmaceuticals (“Saptalis”) based on this FDA approval and Saptalis’ commercialization. Saptalis is preparing for commercial launch in late 2023. On October 13, 2023, the Company’s recently issued U.S. patent related to LIKMEZ with coverage through 2039, U.S. Application No. 18/072,154 was listed in the FDA publication, “Approved Drug Products with Therapeutic Equivalence Evaluations”, commonly known as the “Orange Book”.

Appili’s development program ATI-1701, for the prevention of F. Tularensis, has received awards totalling US$14 million from the U.S. Air Force Academy (“USAFA”). Under the terms of the recently modified agreement with USAFA governing such awards, Appili will be reimbursed for subcontractor and vendor costs necessary to carry out the technical tasks. Additionally, Appili will be reimbursed for direct labour costs associated with budgeted program activities, including a portion of its overhead costs. During our second fiscal quarter, Appili progressed early-stage development activities and regulatory activities.    In addition, Appili successfully completed a knowledge transfer and executed a technology transfer for the ATI-1701 drug substance manufacturing process to the Phase 1 Contract Manufacturing Organization (“CMO”).

With respect to Appili’s ATI-1801 program, for the treatment of cutaneous leishmaniasis, the Company plans to request a meeting with the FDA later this year to discuss the previously generated Phase 3 data and agree on the registration package necessary to support a New Drug Application (“NDA”) 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.

 

Upcoming Milestones

• Appili anticipates receiving royalty and milestone payments from its partner Saptalis, based on LIKMEZ NDA approval and commercialization.
• Appili plans to hold a pre-IND meeting with the FDA to discuss ATI-1701’s regulatory, CMC, toxicology, and Phase 1 strategies.
• Appili expects the ATI-1701 CMO to successfully produce engineering batches.
• Appili plans to request a meeting with the FDA later this year to discuss the previously generated ATI-1801 Phase 3 data and agree on the necessary registration package to support an NDA submission.

 

Corporate Update

Today the company announced that it has appointed Prakash Gowd, MBA, BSc. Pharm, C.Dir., to its Board of Directors. Mr. Gowd’s career covers a broad range of commercial successes involving corporate development, fundraising, and marketing across multiple business models and therapeutic areas.

“We are very pleased to welcome Prakash to Appili’s Board. His background in corporate finance, product development and strategic planning will be very valuable as we advance our programs through multiple milestones, from ATI-1701’s IND submission, to the FDA interactions for our ATI-1801 asset,” said Dr. Armand Balboni, Chair of the Appili Board. “We are thrilled to have Prakash as a Board member and look forward to his leadership experience as we progress our candidates through these next crucial stages.”

 

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 $1.0 million or $0.01 loss per share for the three months ended September 30, 2023, was $0.6 million lower than the net loss and comprehensive loss of $1.6 million or $0.02 loss per share during the three months ended September 30, 2022. This relates mainly to an increase in milestone revenue of $0.3 million, an increase in government assistance of $1.0 million, a decrease in foreign exchange losses of $0.2 million and a decrease in general and administrative expenses of $0.1 million. These decreases were offset by an increase in research and development expenses of $0.8 million and an increase in financing costs of $0.2 million.

As of September 30, 2023, the Company had cash of $0.4 million, compared to $2.5 million on March 31, 2023.

As of November 13, 2023, the Company had 121,266,120 issued and outstanding Common Shares, 7,842,000 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 second 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]

 

Additional US$6.6 million funding commitment for ATI-1701 brings the total program funding awarded to approximately US$14 million

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 2024

The company also announces a change to it’s Board of Directors

 

HALIFAX, Nova Scotia, October 25, 2023– Appili Therapeutics Inc. (TSX: APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced that the company secured a commitment for the second stage of funding for ATI-1701 from the  U.S. Air Force Academy (“USAFA”), who is working in partnership with the Defense Threat Reduction Agency (“DTRA”), the funding agency. ATI-1701 is the Company’s potential first-in-class vaccine candidate for the prevention of infection with Francisella tularensis, the causative agent of tularemia and a top-priority biothreat.

With this additional US$6.6 million award, Appili’s ATI-1701 program has been awarded the total US$14 million in USAFA funding commitments announced on May 8, 2023.

“Being awarded this additional funding commitment from USAFA, in partnership with DTRA further strengthens Appili’s foundation in biodefense and enables us to scale-up our efforts to develop an urgently needed vaccine for this serious bioterrorism threat,” said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili. “This level of funding commitment should further support nonclinical, manufacturing, and regulatory activities for ATI-1701, and should enable us to continue to advance this program towards an Investigational New Drug (“IND”).”

Appili will continue to oversee a comprehensive development program for ATI-1701, which includes nonclinical studies, manufacturing, and regulatory activities to support an IND submission. In May 2023, Appili was awarded the first stage of funding commitment from USAFA of US$7.3 million. The initial commitment was used to kick-off ATI-1701 early-stage development and regulatory activities, which are currently ongoing. Under the terms of the agreement with USAFA, Appili will be reimbursed for the subcontractor and vendor costs necessary to carry out the technical tasks. Additionally, Appili will be reimbursed for direct labour costs associated with budgeted program activities, including a portion of its overhead costs. Appili has also entered into an agreement with its lender whereby if needed, Appili has obtained temporary waivers of a minimum cash balance requirement. Further waivers may be necessary from time to time depending on the timing of reimbursements for expenses submitted to USAFA.

 

Corporate Update

It is with great sadness that the Company must announce that one of its Directors, Rochelle Stenzler, has passed away. The Company plans on seeking a new independent Director to join its Board in the coming months.

 

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About ATI-1701

Appili is developing ATI-1701 as a vaccine to combat Francisella tularensis, which is classified by the U.S. National Institutes of Health (NIH) as a Category A pathogen, an organism that poses the highest risk to national security and public health. Estimated to be 1,000-fold more infectious than anthrax, experts consider the aerosolized form to have a high potential for use in a bioterrorism attack.

 

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

 

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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]

 

 

 

HALIFAX, Nova Scotia – September 27, 2023 – Appili Therapeutics Inc. (TSX: APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced the results from its annual meeting of shareholders held earlier today.

 

Results of Annual Meeting

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

Voting results for each director are summarized below:

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

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

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

 

Corporate Update

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

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

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

 

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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 a vaccine candidate to eliminate a serious biological weapon threat, a topical antiparasitic for the treatment of a disfiguring disease, and a novel easy to use, liquid oral formulation targeting parasitic and anaerobic infections. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

 

Forward-Looking Statements

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

 

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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]

Recently announced Funding Commitment from U.S. Air Force is expected to advance ATI-1701 Biodefense Vaccine Candidate to IND

 

HALIFAX, Nova Scotia, September 27, 2023– Appili Therapeutics Inc. (TSX: APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced that Carl Gelhaus, Ph.D., Director of Non-Clinical Research, and key members of Appili’s scientific team, will participate at the 10^th International Tularemia Conference, from September 24 to 26, 2023. Dr. Gelhaus will present an update on Appili’s biodefense vaccine program ATI-1701.

“The International Tularemia Conference is the premier tularemia conference in the world, and we look forward to sharing the progress we have made on ATI-1701 over the past several years and strengthen relationships with leading tularemia clinicians and researchers,” said Dr. Gelhaus. “We remain encouraged by recently announced U.S. government funding commitments for ATI-1701 and look forward to collaborating with other tularemia experts toward the first approved vaccine for the prevention of weaponized tularemia.”

The presentation will include an overview of ATI-1701, Appili’s potential first-in-class vaccine candidate for the prevention of infection with F. tularensis, the causative agent of tularemia and a top-priority biothreat. 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.

In May 2023, Appili announced a commitment of funding for ATI-1701 from the U.S. Air Force (“USAFA”), who is working in partnership with the Defense Threat Reduction Agency (“DTRA”), the funding agency.

 

Presentation details are as follows:

Title: ATI-1701: A Live Attenuated Tularemia Vaccine Based on a SCHU S4 ΔclpB Mutant

Date: Thursday, September 28

Time: 2:30 – 2:45p.m. CEST

Appili management will also be conducting in-person meetings throughout the conference. To request a meeting, please register for the conference here.

 

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About ATI-1701

Appili is developing ATI-1701 as a vaccine to combat Francisella tularensis, which is classified by the U.S. National Institutes of Health (NIH) as a Category A pathogen, an organism that poses the highest risk to national security and public health. Estimated to be 1,000-fold more infectious than anthrax, experts consider the aerosolized form to have a high potential for use in a bioterrorism attack.

 

About Triennial International Tularemia Conference

The International Conferences fulfill a major purpose of the Tularemia International Society, namely to facilitate the assembly, acquaintance, and association of scientists engaged in tularemia research.  Tularemia meetings focus on fundamental, clinical, and applied research regarding any aspect of Francisella tularensis.  Research uncovers not only the biology of this fascinating bacterium, but also provides the basis for future development of treatments, preventive interventions, and disease diagnosis.

 

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.

 

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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 approves LIKMEZ as the brand name for Metronidazole Oral Suspension (LIKMEZ is a Trademark of Saptalis Pharmaceuticals, LLC)

Currently LIKMEZ is the only liquid oral suspension of metronidazole approved in the U.S.

Patent coverage provides drug market exclusivity through at least 2039

HALIFAX, Nova Scotia, September 25, 2023 – Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”) ”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced that its manufacturing and commercialization partner, Saptalis Pharmaceuticals, LLC (“Saptalis”) received approval from the U.S. Food and Drug Administration (“FDA”) for Metronidazole Oral Suspension 500mg/5mL (ATI-1501). ATI-1501, Appili’s liquid oral reformulation of the antibiotic metronidazole, has been licensed to Saptalis for commercialization in the U.S., and other selected territories. The FDA also approved LIKMEZ™ as the brand name for ATI-1501.

“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,” said Don Cilla, Pharm.D., M.B.A., Appili’s President and CEO. “Difficulty swallowing tablets and capsules should not be a barrier to accessing appropriate antibiotic therapy. LIKMEZ provides a convenient alternative for patients who have difficulty taking solid oral medicines”. Dr. Cilla adds “Appili was formed to develop ATI-1501 and it is exciting to see our first development project make it to market. This is a tremendous team accomplishment. We are all delighted that the product will soon be available to patients and we look forward to bringing additional products to market that tackle serious global challenges in infectious disease.”

“We are pleased with the approval of the NDA for LIKMEZ,” said Polireddy Dondeti, Ph.D., President and CEO at Saptalis. “We are proud of our team which, using Appili’s taste masking technology, has successfully developed a commercial product approved by the FDA. LIKMEZ will address a clear market need in a more convenient dosage form of metronidazole, and we are prepared to initiate marketing and distribution activities in the very near future.”

Metronidazole is a widely used frontline oral treatment with over 10 million prescriptions written in the United States every year to help treat parasitic and anaerobic bacterial infections. The current tablet form of metronidazole is the only other approved oral form on the U.S. market, but its bitter taste and lack of appropriate dosage forms for patients with difficulty swallowing often presents treatment compliance challenges.

Appili expects to receive milestone payments and royalties from Saptalis based on this FDA approval and Saptalis’ commercialization plans.

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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 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.

About Saptalis Pharmaceuticals, LLC
Saptalis Pharmaceuticals, LLC is a rapidly growing pharmaceutical company specialized in development, manufacturing, and commercialization of generic and innovative products in liquid and semi-solid dosage forms.

Located in the Hauppauge Industrial Park on Long Island, NY, USA, Saptalis has fully equipped Research & Development Laboratories and state of the art commercial scale manufacturing facility designed to meet FDA cGMP requirements. For more information, visit www.Saptalis.com.

About LIKMEZ™
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 and avoids risks associated with drug compounding, and discontinuation related anti-microbial resistance.

Forward looking statements
This news release contains “forward-looking statements”, including with respect to the commercialization plans for LIKMEZ and the timing of any milestone and/or royalty payments in respect to ATI-1501. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. Forward-looking statements contained in this press release are provided in reliance on certain assumptions, including with respect to the commercialization plans for LIKMEZ. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, the Company cannot give assurance that these expectations will prove to have been correct.

Forward looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, customary risk relating to the development and commercialization of LIKMEZ which may have an impact on the quantum and timing of any milestone payments to the Company, and the other risk factors listed in the annual information form of the Company dated June 22, 2023 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

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

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

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

 

HALIFAX, Nova Scotia-June 29, 2023–Appili Therapeutics Inc. (TSX: APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced that it has entered into a definitive agreement with respect to an unsecured C$300,000 bridge loan (the “Bridge Loan”) from Bloom Burton & Co. Inc. (the “Lender”).

As previously announced, Appili entered into a cooperative agreement (the “USAFA Cooperative Agreement”) with the United States Air Force Academy (“USAFA”) for initial funding of US$7.3 million.  Under the terms of the USAFA Cooperative Agreement, Appili will be reimbursed for direct costs and labour associated with budgeted program activities, plus will recover a portion of its overhead costs. The Bridge Loan is intended to be used by Appili for working capital purposes in the event that reimbursements under the USAFA Cooperative Agreement are delayed.

The Bridge Loan bears interest at 1% per annum for the first month increasing to 2% thereafter, and matures on the earlier of September 28, 2024, and the date on which Appili receives aggregate reimbursements from USAFA of not less than C$2,500,000.  The Bridge Loan is being funded in two equal tranches, with the first tranche already advanced and the second tranche being advanced on or before July 7, 2023.

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.sedar.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 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 the timing of the second tranche, the proposed use proceeds and expected access to funding under the USAFA Cooperative Agreement. 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 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. In particular, the Company has made certain assumptions regarding the timing of expense reimbursement under the USAFA Cooperative Agreement (as well as the scope of qualifying expenditures).  Should such funding be materially delayed or reduced, the Company may be required to secure additional funding in the near term, including by means of debt or equity financing. There can be no certainty that such additional funding will be available to the Company on satisfactory terms or at all. For further details, including with respect to the ability of the Company to continue as a going concern,  please refer to the Company’s management’s discussion and analysis for the fiscal year ended March 31, 2023 (which may be viewed under the Company’s profile on SEDAR at www.sedar.com). 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.

 

Contacts

Media:

Jenna McNeil, Communications Manager

Appili Therapeutics

E: [email protected]

 

Investor Relations:

Don Cilla, Pharm.D., M.B.A., President and CEO

Appili Therapeutics

E: [email protected]

Executed US$7.3M initial contract with U.S. Air Force Academy for ATI-1701

 

Upcoming PDUFA date of September 23, 2023 for ATI-1501

HALIFAX, Nova Scotia, June 23, 2023 – Appili Therapeutics Inc. (TSX:APLI; OTCQB: 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 fiscal year ended March 31, 2023, and provided an update on the Company’s strategy for fiscal 2024. All figures are stated in Canadian dollars unless otherwise stated.

“During this fiscal year, the Defense Threat Reduction Agency (“DTRA”) in partnership with the U.S. Air Force Academy (“USAFA”) approved approximately US$14 million in funding over two years for the advancement of ATI-1701, our vaccine against Tularemia, a top-priority biothreat. Recently, we executed an agreement with USAFA for an initial amount of this funding. With this funding and the additional strength added to our senior leadership team, we have the resources in place to continue the advancement of this program and to execute our strategy in advancing our infectious disease assets forward.” said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili Therapeutics. “In addition, we recently received patent coverage providing exclusivity through at least 2039 for ATI-1501, our taste-masked liquid oral suspension formulation of Metronidazole. This is a key achievement prior to the upcoming FDA PDUFA date of September 23, 2023.”

 

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

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.

In May 2023, Appili executed the initial contract with USAFA (the “USAFA Cooperative Agreement”) for the previously announced funding of the ATI-1701 program. This contract represents the first stage of funding from the previously announced award from the U.S. Department of Defense (“DOD”).  This initial funding, in the amount of US$7.3 million, will be used to kick-off ATI-1701 early-stage development and regulatory activities. As the initial activities progress, Appili will be engaging USAFA for additional tranches of funding to continue development through IND. Under the terms of its agreement with USAFA, Appili will be reimbursed for direct costs and labour associated with budgeted program activities, plus will recover a portion of its overhead costs. Appili has submitted its first invoice for such costs and anticipates receiving payment by the end of June 2023.

If approved by the FDA, Appili may be well placed to receive stockpiling contracts and if ATI-1701 is approved by the FDA as a countermeasure for the prevention of tularemia, it is the Company’s expectation that the program may be eligible for a priority review voucher (“PRV”).

 

ATI-1801, demonstrated safe and effective across Phase 3 studies.

ATI-1801 is Appili’s topical paromomycin product with demonstrated Phase 3 efficacy used to treat cutaneous leishmaniasis, a disfiguring infection of the skin that affects hundreds of thousands of people around the world annually. It is an infection characterized by the formation of lesions and ulcers often leading to scarring, disfigurement, and stigmatization for those infected.

Appili selected a Contract Drug Manufacturing Organization to produce the topical cream which will allow them to meet with the FDA to discuss the previously generated Phase 3 data, the topical cream formulation, and agree on the necessary registration package to support an NDA submission. The development timelines for ATI-1801 will be driven by the FDAs feedback on the required bridging study design. 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 the 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 PRV which, if confirmed, would make ATI-1801 the second PRV eligible program at Appili, joining ATI-1701.

 

ATI- 1501, with Patent Coverage through 2039

ATI-1501 is a taste-masked liquid oral suspension formulation of an antibiotic, metronidazole. Metronidazole is a front-line antibiotic currently only available in a large tablet dosage form for the treatment of anaerobic bacterial and parasitic infections. Metronidazole has a strong bitter and metallic taste that is exacerbated by crushing and can reduce patient adherence to treatment. ATI-1501 is aimed at making it easier for patients with difficulties swallowing and sensitivity to taste to take metronidazole, improving compliance and supporting clinical outcomes.

In December 2019, Appili entered into a development and commercialization agreement with Saptalis for the manufacturing, development, and commercialization of ATI-1501. Appili is eligible to receive multiple milestone and royalty payments on the development and sale of ATI-1501 in the United States. It is expected that the FDA review will be complete in Q3 2023, and commercialization would commence shortly after approval. The Company expects to receive milestone payments in Q3 2023 and Q4 2023 based on Saptalis’ proposed NDA submission timeline and commercialization plans.

Appili recently received US$250,000 in milestone payments from Saptalis in 2023 and expects to receive additional milestone payments in Q3 2023 and Q4 2023 based on Saptalis’ NDA submission and commercialization plans.

In May 2023, the United States Patent and Trademark Office published patent claims for ATI-1501 under the U.S. Application No. 18/072,154 filed on November 30, 2022, and titled “Oral Formulations of Metronidazole and Methods of Treating an Infection Using Same“. The patent covers the composition and preparation methods for the drug through 2039.

 

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 $9.2 million or $0.08 loss per share for the year ended March 31, 2023, was $15.9 million lower than the net loss and comprehensive loss of $25.1 million or $0.38 loss per share during the year ended March 31, 2022. This relates mainly to a $17 million decrease in research and development (R&D) expenses, $0.2 million decrease in general and administrative expenses, $0.5 million decrease in business development expenses and $0.5 million decrease in financing costs, offset by $0.4 million increase in exchange loss and a $1 million decrease in government assistance and $1.1 million decrease in revenue.

On March 31, 2023, the Company had cash of $2.5 million compared to $6.7 million on March 31, 2022.  The Company has included a going concern note in its financial statements for the fiscal year ended March 31, 2023.  In particular, the Company is dependent in large part on receiving all DOD 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 maintain a minimum cash balance as required in its long term debt arrangements with Long Zone Holdings. 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 fiscal year ended March 31, 2023.

As of June 22, 2023, the Company had 121,266,120 issued and outstanding Common Shares, 7,842,000 stock options and 58,247,879 warrants outstanding.

This press release should be read in conjunction with the Company’s audited annual consolidated financial statements for the fiscal year ended March 31, 2023, and the related MD&A, copies of which are available under the Company’s profile on SEDAR at www.sedar.com.

 

+++

 

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 the funding commitment from USAFA, further anticipated milestones and the timing thereof, the Company’s development plans with respect to ATI-1501, ATI-1701 and ATI-1801, the timing of any milestone and/or royalty payments in respect of ATI-1501, potential Priority Review Voucher eligibility for ATI-1701 and ATI-1801 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.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.

 

###

 

Media Contact:

Jenna McNeil, Communications Manager

Appili Therapeutics

E: [email protected]

Investor Relations Contact:

Don Cilla, President and CEO

Appili Therapeutics

E: [email protected]

Upcoming PDUFA date of September 23, 2023

 

HALIFAX, Nova Scotia, May 24, 2023 – Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced that the United States Patent and Trademark Office (“USPTO”) has published patent claims for ATI-1501 under the U.S. Application No. 18/072,154 filed on November 30, 2022 and titled “Oral Formulations of Metronidazole and Methods of Treating an Infection Using Same”. The patent covers the composition and preparation methods for the drug through 2039.

 

Metronidazole is a widely used frontline oral treatment with over 10 million prescriptions written in the United States every year to help treat parasitic and anaerobic bacterial infections. The current tablet form of metronidazole is the only approved oral form on the U.S. market, but its bitter taste and lack of appropriate dosage forms for patients with difficulty swallowing often presents treatment compliance challenges.

 

“We believe our liquid oral reformulation solves a significant and growing issue for patients who cannot tolerate the current tablet formulation of metronidazole, especially for the elderly and children who often have difficulty taking solid oral medicines” said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili Therapeutics. “This patent recognizes innovative research by Appili Therapeutics to fill this significant gap in the treatment paradigm, and further strengthens ATI-1501’s position as a more convenient antibiotic treatment option on the market. The market potential is significant and receiving this patent coverage prior to the upcoming FDA PDUFA date of September 23, 2023, should provide our oral reformulation metronidazole drug market exclusivity through at least 2039.”

The FDA established ATI-1501 a Prescription Drug User Fee (“PDUFA”) action date of September 23, 2023.

 

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 the proposed development and commercialization plans for ATI-1501 and the atnicipated PDUFA date. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. Forward looking statements contained in this press release are provided in reliance on certain assumptions, including with respect to the FDA application and approval process for ATI-1501.  Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, the Company cannot give assurance that these expectations will prove to have been correct.

Forward looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, the risk that the New Drug Application for ATI-1501 may ultimately not be approved by the FDA, and the other risk factors listed in the annual information form of the Company dated June 23, 2022 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.

 

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]

 

Funding will enable Appili to advance it’s Biodefense Vaccine Candidate ATI-1701 to IND –

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

 

HALIFAX, Nova Scotia, May 8, 2023– Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced that the Company has executed the initial contract with the U.S. Air Force Academy (USAFA) for the previously announced funding of the ATI-1701 program.  This contract represents the first stage of funding from the previously announced award from the U.S. Department of Defense (“DOD”).  This initial funding, in the amount of US$7.3 million, will be used to kick-off ATI-1701 early-stage development and regulatory activities.  As the initial activities progress, Appili will be engaging USAFA for additional tranches of funding to continue development through IND.  ATI-1701, our biodefense vaccine candidate, is the Company’s potential first-in-class vaccine candidate for the prevention of infection with Francisella tularensis, the causative agent of tularemia and a top-priority biothreat.

 

“Successfully securing the first stage of funding from the DOD marks another exciting milestone for Appili and enables us to ramp-up our efforts to develop an urgently needed vaccine for this serious bioterrorism threat,” said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili. “In addition to providing Appili with certain direct labor reimbursement and overhead recovery, this support is a clear indication of the importance of this program to the DOD and will further strengthen nonclinical, manufacturing and regulatory activities around ATI-1701, helping Appili deliver on our mission to address a variety of urgent unmet needs in infectious disease and biodefense”

 

Francisella tularensis has been classified as a Category A pathogen by the U.S. National Institutes of Health due to its high rates of infectiousness and ability to cause lethal pneumonia and systemic infection. As the transmission of Francisella tularensis in the aerosolized form is more infectious than anthrax, it is considered to be a high bioterrorism threat.

 

Earlier this year, the Company announced positive one-year results from its preclinical study evaluating the efficacy of biodefense vaccine candidate ATI-1701 in a lethal model of tularemia. In a 1-year NHP study, ATI-1701 exhibited significant efficacy at Days 28 and 90, with 100% of ATI-1701 vaccinated animals surviving a lethal aerosol challenge at Day 90, while no unvaccinated animals survived.  The 1-year data demonstrates that a single vaccination with ATI-1701 can provide sustained protection.  At the 1-year time point, there was a statistically significant improvement in survival in ATI-1701 vaccinated animals (n = 2/7) compared to mock vaccinated controls (n = 0/5).  This positive one-year data, in addition to the significant efficacy demonstrated at earlier time points, well positions ATI-1701 to become the first approved vaccine for the prevention of tularemia. The study was funded by DTRA and conducted by MRIGlobal.

 

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About USAFA Contract

USAFA is the prime contractor to DTRA for this program.  Dr. Balboni, Assistant Professor and Director at the Life Sciences Research Center of USAFA is the principal investigator. The contract with USAFA establishes Appili as the top-tier performer, managing the development activities through IND.  The anticipated total program funding amount is expected to be ~US$14 million, depending on U.S. federal budget funding activities, with the first tranche of US$7.3 million authorized with this contract.  This, and other tranches of planned funding, are expected to advance the ATI-1701 program to an IND submission to the FDA in 2024.

 

About ATI-1701

Appili is developing ATI-1701 as a vaccine to combat Francisella tularensis, which is classified by the U.S. National Institutes of Health (NIH) as a Category A pathogen, an organism that poses the highest risk to national security and public health. Estimated to be 1,000-fold more infectious than anthrax, experts consider the aerosolized form to have a high potential for use in a bioterrorism attack.

 

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.

 

###

 

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: [email protected]

 

Forward-Looking Statements

This news release contains “forward-looking statements”, including with respect to the anticipated funding amount, the anticipated timing of such funding, the Company’s ongoing development plans and timeline 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. Forward looking statements contained in this press release are provided in reliance on certain assumptions, including with respect to the satisfaction of all conditions precedent to the advancement of the full anticipated funding (including receipt by DTRA of any requisite U.S. federal budget approvals, general development plans with respect to ATI-1701, general access to data required to support regulatory submissions, the nature and scope of the services to be provided by Appili to USAFA with respect to advancing the ATI-1701 program and the timing, scope and budget of additional contracts with USAFA). Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, the Company cannot give assurance that these expectations will prove to have been correct. Forward looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, the risk that the final conditions governing the funding and the relationship between Appili and USAFA may not be satisfactory to the Company , the final funding amount may be different than that communicated herein (including as a result of the failure to secure the requisite US government budget approvals or the failure to secure additional contracts with USAFA on terms satisfactory to the Company or at all), receipt of funding may be delayed in the event that any remaining conditions are not satisfied in a timely manner, other standard risks associated with government grants and contracting of this nature and the other risk factors listed in the annual information form of the Company dated June 23, 2022 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.