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.

 

###

 

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.

HALIFAX, Nova Scotia – April 18, 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 Dr. Don Cilla, Appili President and Chief Executive Officer, will present at the Bloom Burton & Co. Healthcare Investor Conference taking place on April 25 and 26, 2023.

The presentation will include an update on Appili’s pipeline of novel anti-infectives; ATI-1701, a vaccine for tularemia being funded by the U.S. Government through IND submission and ATI-1801, a treatment for cutaneous leishmaniasis, a disfiguring infection of the skin. Appili believes that both programs may be eligible to receive FDA Priority Review Vouchers upon approval.

Presentation details are as follows:

Date: Wednesday, April 26, 2023
Time: 3:30 pm ET
Location: Metro Toronto Convention Centre, 255 Front St W, Toronto, Ontario

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

About Bloom Burton & Co. Bloom Burton & Co. is a firm dedicated to accelerating returns in the healthcare sector for both investors and companies. Bloom Burton has an experienced team of medical, scientific, industry and capital markets professionals who perform a deep level of diligence, which combined with our creative and entrepreneurial approach, assists our clients in achieving the right monetization events. Bloom Burton and its affiliates provide capital raising, M&A advisory, equity research, business strategy and scientific consulting, as well as advisory on direct investing, company creation and incubation services. Bloom Burton Securities Inc. is a member of the Investment Industry Regulatory Organization of Canada (IIROC) and is also a member of the Canadian Investor Protection Fund (CIPF).

 

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 potential PRV eligibility for ATI-1701 and ATI-1801. 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 29, 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.

 

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]

Accomplished biopharmaceutical executive brings more than 25-years of experience leading vaccine and antibody product development for infectious disease indications

Dr. Nabors representing Appili at the World Vaccine Congress in Washington, D.C.

 

HALIFAX, Nova Scotia – April 3, 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 it has appointed biopharmaceutical industry veteran Gary Nabors, Ph.D., to serve as Appili’s Chief Development Officer. Dr. Nabors joins Appili effective April 3, 2023, and will lead the advancement of programs through development, regulatory submission and key commercialization milestones.

“Dr. Nabors brings an exceptional wealth of experience and established results to Appili, and he will play a critical role in advancing our programs and our business,” said Dr. Don Cilla, President and Chief Executive Officer of Appili Therapeutics. “Gary’s expertise in infectious disease will be instrumental in driving forward the development of our programs; ATI-1701, a vaccine for tularemia being funded by the U.S. Government through IND submission and ATI-1801, a treatment for cutaneous leishmaniasis (CL), a disfiguring infection of the skin. Both programs we believe may be eligible to receive FDA Priority Review Voucher (“PRV”) upon approval and his leadership in progressing candidates through these next crucial stages will be instrumental to our growth.”

Dr. Nabors joins Appili from Integrated BioTherapeutics Inc. (IBT) where, in his role as Executive Vice President and Chief Development Officer, he was responsible for leading the company’s vaccine and immunotherapeutic candidates through bioanalytical development, IND-enabling studies, GMP manufacturing and into clinical studies. Prior to that he served as President of DynPort Vaccine Company Inc. (a subsidiary of General Dynamics) where he was responsible for the overall success of the company, overseeing P&L responsibility and 800 staff, and establishing the technical, strategic, and regulatory direction for all projects in the company’s portfolio.

Over his accomplished 25-year career, Dr. Nabors has also held progressively senior roles with Sanofi Pasteur, Emergent BioSolutions, and the National Biodefense Analysis and Countermeasures Center (NBACC) within the U.S. Department of Homeland Security. He has played a central role in product development from pre-clinical stages through to Phase 3, for development of vaccines and therapeutics for pediatric, adult, and biodefense markets. He has also managed corporate subsidiaries of 120 employees, served on executive-level management committees and presented before Food and Drug Administration (FDA) advisory committees.

“The work being done in anti-infectives at Appili is important and I am eager to help further establish us as a key player in the fight against infection.” said Dr Nabors.

Dr. Nabors will be representing Appili at the World Vaccine Congress, the premiere event for R&D and strategic partnering for the global vaccine industry, in Washington, D.C., from April 3rd to 6th, 2023. Dr. Nabors will be participating in scientific sessions to identify current trends in vaccine development and to network with key contacts that Appili may be able to work with to help advance its programs.

“The World Vaccine Congress provides a great opportunity to learn how others are progressing  their vaccine development programs, and to have the opportunity to meet with key leaders in the industry,” adds Dr. Nabors, “I am looking forward to bringing this knowledge back to Appili to help us continue driving our pipeline forward.”

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 potential PRV eligibility for ATI-1701 and ATI-1801.e. 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 29, 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.

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]