Category: Archives 2022

HALIFAX, Nova Scotia, April 13, 2022– Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, today announced the addition of ATI-1801, a clinical stage topical paromomycin product to treat cutaneous leishmaniasis, to its development pipeline. Licensed from the US Department of Defense (“DOD”) via the US Army Medical Materiel Development Activity (“USAMMDA”), ATI-1801 is a novel topical product with demonstrated safety and efficacy in a Phase 3 study. Appili will be working with international partners to complete the remaining development activities to enable registration with global regulatory authorities, including the US Food and Drug Administration (“FDA”).

Cutaneous leishmaniasis is a disfiguring infection of the skin that affects hundreds of thousands of people around the world annually, characterized by the formation of lesions and ulcers that often lead to scarring, disfigurement, disability, and stigmatization of the infected. The disease is a serious impediment to socioeconomic development, especially for women, and a priority for governments and non-governmental organizations (“NGOs”) around the world. Current treatments are often invasive, toxic and/or require hospitalization, limiting access.

ATI-1801 has the potential to significantly reduce the burden of the disease by providing patients with a safe and effective topical therapy that can be used in the outpatient setting. Appili holds the full clinical dossier for ATI-1801, including the results of a randomized, double-blind, vehicle-controlled Phase 3 study which evaluated the safety and efficacy of ATI-1801 for the treatment of cutaneous leishmaniasis in Tunisia. The study met its primary endpoint, with ATI-1801 administered topically once daily for 20 days demonstrating a significant improvement in the rate of clinical cure of the index lesion compared to vehicle (82% vs 58%; p-value < 0.001).

Appili plans to meet with the FDA later this year to discuss the previously generated Phase 3 data and agree on the necessary registration package 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.

“We are excited to be working with our partners at the US DOD to complete the development of and ultimately make available a product urgently needed to address the disability and inequity caused by cutaneous leishmaniasis,” said Dr. Armand Balboni, CEO of Appili Therapeutics. “This is a unique opportunity to build on an extensive data set and bring a treatment that has already demonstrated Phase 3 efficacy to patients around the world. This is exactly the type of mission that Appili was built to take on and I look forward to applying our expertise, capabilities, and partner network to this effort.”

Appili believes that ATI-1801 may be eligible for a priority review voucher (“PRV”), if approved by the FDA. The PRV program was developed to incentivize drug development in US government priority areas including medical countermeasures and tropical diseases such as leishmaniasis. Once issued, a PRV can be used by its holder to accelerate the review of a subsequent drug submission. PRVs are transferrable and the secondary market for PRVs is well established with over 20 transactions reported publicly and recent transactions often exceeding US$100 million. The Company is actively evaluating the eligibility of ATI-1801 for a PRV which, if confirmed, would make ATI-1801 the third PRV eligible program at Appili, joining ATI-1701, a leading and potential first-in-class vaccine to prevent infection by top priority biothreat Francisella tularensis, and ATI-2307, Appili’s novel clinical stage antifungal candidate.

About ATI-1801

Appili’s ATI-1801 is a novel topical paromomycin product already evaluated in Phase 3 study for the treatment of cutaneous leishmaniasis, a disfiguring infection of the skin that affects hundreds of thousands of people around the world annually and is characterized by the formation of lesions and ulcers that often lead to scarring, disfigurement, and stigmatization for those infected.  The disease is a serious impediment to socioeconomic development, especially for women, and a priority for governments and non-governmental organizations around the world. Appili intends to work with these various stakeholders to help complete remaining development activities, secure regulatory approvals, and ultimately make the product available worldwide.

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 broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, and two novel antibiotic programs. 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 plans with respect to ATI-1801, the potential for ATI-1801 to treat cutaneous leishmaniasis, expected non-dilutive funding and partnership opportunities and the potential PRV eligibility of 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. Forward looking statements contained in this press release are provided in reliance on certain assumptions. 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 ATI-1801 may prove to be ineffective for the treatment of cutaneous leishmaniasis, the risk that the Company may never secure all requisite regulatory to develop and commercialize ATI-1801, the risk that ATI-1801 may ultimately be determined not to be PRV eligible, and the other risk factors listed in the annual information form of the Company dated June 23, 2021, and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

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Media Contact:
Danielle Raabe/APCO Worldwide
T: 1-646-717-9915
E: [email protected]

Investor Relations Contact:
Stéphane Paquette; Vice President, Corporate Development
Appili Therapeutics
E: [email protected]

HALIFAX, Nova Scotia, March 29, 2022– Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, today announced that it has entered into a senior secured loan and exclusive license and distribution agreement (the “Agreement”) with Long Zone Holdings Inc. (“LZH”), led by Jonathan Ross Goodman, founder of both Paladin Labs Inc. and Knight Therapeutics Inc. (TSE: GUD). The US$3.6 million senior secured loan will be used by Appili to retire the previously announced senior convertible funding agreement with The Lind Partners and for working capital purposes.

Under the terms of the Agreement, LZH will issue a secured loan of US$3.6 million bearing a minimum interest rate of 8.5% per year, compounded quarterly, with a maturity date of March 28, 2025. Appili expects to receive net proceeds of approximately US$3.5 million from the funding (after deducting aggregate fees of US$108,000, including in respect of a work fee and origination fee payable to LZH). LZH will also be issued 1,500,000 cash-exercise warrants, exercisable for seven years, with a warrant exercise price of C$0.115, equal to the 5-day volume weighted average price (“VWAP”) immediately prior to execution of the Agreement.

In addition, Appili shall grant LZH an exclusive license to commercialize Appili’s future approved products in Latin America, Canada, and Israel (collectively, the “Territory”), excluding ATI-1501 in Latin America, which was recently licensed to existing partner Saptalis Pharmaceuticals. Appili will receive a supply price for products sold by LZH or its sublicensees, as well as royalties on net sales.

“We are excited to announce this non-dilutive funding agreement and partnership to help advance our pipeline and, ultimately, bring our products to the Canadian, Israeli, and Latin American markets,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “Infectious diseases are a global threat and the funding from LZH, in addition to over US$10 million in expected non-dilutive funding from the US Department of Defense, help bring Appili that much closer to delivering its portfolio of innovative medicines to patients around the world.”

The loan will be secured against all of the assets and property of the Company pursuant to a general security agreement. The transaction contemplated under the Agreement has been conditionally approved by the Toronto Stock Exchange.

“Appili is focused on some of the most challenging infectious disease threats in the world, as evidenced by the fact that two of Appili’s programs in development will, if approved by the FDA, be eligible to receive a Priority Review Voucher. Priority Review Vouchers have sold for as low as US$67 million and as high as US$350 million. Knight was blessed to sell its Priority Review Voucher for US$125 million to Gilead in November 2014. We are excited to partner with Appili to help address these urgent unmet public health needs while creating significant shareholder value in the process,” said Jonathan Ross Goodman, Long Zone Holdings Inc.

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

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About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including a broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, and two novel antibiotic programs. 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 Long Zone Holdings Inc.

Long Zone Holdings Inc. is based in Montreal, Canada and founded by Jonathan Ross Goodman with his proceeds from the $3.2 billion sale of Paladin Labs Inc.. Long Zone Holdings Inc. is named after the first letters of Jonathan’s 3 young children to reflect Long Zone’s investment horizon. Long Zone holds a number of significant positions in pharmaceutical and health related companies including specialty pharma Knight Therapeutics Inc. (TSE: GUD) and IBS gut friendly privately held Fody Foods Company Inc. (www.fodyfoods.com).

Forward looking statements

This news release contains “forward-looking statements”, including with respect to the proposed use proceeds, future development and commercialization plans, future funding (including from the US Department of Defense) and potential eligibility of certain Company programs for a Priority Review Voucher. 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 relating to the development, regulatory approval (including availability of Priority Review Voucher) and commercialization of any approved product, risks relating to ability of the Company to secure future funding, and the other risks listed in the annual information form of the Company dated June 23, 2021 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

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Media Contact:
Danielle Raabe/APCO Worldwide
T: 1-646-717-9915
E: [email protected]

Investor Relations Contact:
Stéphane Paquette; Vice President, Corporate Development
Appili Therapeutics
E: [email protected]

HALIFAX, Nova Scotia, March 9, 2022 – Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, today announced that Stéphane Paquette, Vice President, Corporate Development, will present live at the upcoming OTC Markets Life Sciences Investor Forum at virtualinvestorconferences.com on March 10, 2022.

DATE: March 10, 2022
TIME: 2:30-3:00 pm ET
LINK: https://bit.ly/3LRhCdu

This will be a live, interactive online event where investors are invited to ask the company questions in real-time. If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event.

It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates.

Learn more about the event at www.virtualinvestorconferences.com.

Recent Company Highlights

The Company will provide an update on its pipeline of novel anti-infectives and recent operational highlights, including:

• Over US$10M in new funding from the US Department of Defense to advance biodefense vaccine candidate ATI-1701, a leading and potential first-in-class option to prevent infection by top priority biothreat Francisella tularensis

• Expansion of its commercial agreement with Saptalis Pharmaceuticals to add European and Latin American markets and increase global access to ATI-1501, Appili’s proprietary taste-masked liquid suspension reformulation of metronidazole scheduled for submission to the US Food and Drug Administration later this year

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About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including a broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, and two novel antibiotic programs. 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 Virtual Investor Conferences® 

Virtual Investor Conferences (VIC) is the leading proprietary investor conference series that provides an interactive forum for publicly traded companies to seamlessly present directly to investors.

Providing a real-time investor engagement solution, VIC is specifically designed to offer companies more efficient investor access.  Replicating the components of an on-site investor conference, VIC offers companies enhanced capabilities to connect with investors, schedule targeted one-on-one meetings and enhance their presentations with dynamic video content. Accelerating the next level of investor engagement, Virtual Investor Conferences delivers leading investor communications to a global network of retail and institutional investors.

Forward looking statements

This news release contains “forward-looking statements”, including with respect to anticipated funding from the US Department of Defense. 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 23, 2021 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:

Appili Therapeutics
Stéphane Paquette
Vice President, Corporate Development
Appili Therapeutics
[email protected]

Virtual Investor Conferences
John M. Viglotti
SVP Corporate Services, Investor Access
OTC Markets Group
(212) 220-2221
[email protected]

HALIFAX, Nova Scotia, February 28, 2022 – Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, today announced that the U.S. Department of Defense (“DOD”), via the Joint Science and Technology Office of the Defense Threat Reduction Agency (“DTRA”), has selected for funding an Appili proposal that would provide over US$10 million to advance the Company’s biodefense vaccine candidate ATI-1701, a potential first-in-class vaccine candidate for the prevention of infection with Francisella tularensis, the causative agent of tularemia and a top-priority biothreat.

The new funding is designed to replace and expand upon a prior contract awarded to one of Appili’s development partners. Appili will serve as prime contractor and oversee a comprehensive development program for ATI-1701 that includes nonclinical, manufacturing, and regulatory activities to support an IND submission to the FDA. The expected total funding amount of over US$10 million will fund this expanded scope of work. The award is subject to successful negotiations between the DTRA contracting division and Appili. The total funding amount will be confirmed upon contract execution.

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 aerosolized form can be more infectious than anthrax, it is considered to have a high potential for use in a bioterrorist attack.

“We are grateful for the continued support from DTRA to help us further develop ATI-1701 and deliver on our mission to address a variety of urgent unmet needs in infectious disease,” said Dr. Armand Balboni, CEO of Appili Therapeutics. “Advancing ATI-1701 could have a transformative impact on mitigating this high risk to national security and public health. We look forward to continuing to advance this vaccine candidate and further strengthening our partnerships with government agencies around the world to address this urgent bioterrorism threat.”

Last month, 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. A survival rate of 29% (n = 2/7) was reported in the ATI-1701 vaccinated cohort, compared to 0% (n = 0/5) in mock vaccinated controls. The positive one-year data built on previously reported efficacy observed at 28- and 90-day challenge timepoints, including 100% survival of ATI-1701 vaccinated animals at the 90-day challenge timepoint, and 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 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 bioterrorist attack. Several countries may already have operational weapons programs leveraging this pathogen, making the need for a vaccine to counter this biological weapons threat exceedingly important.

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 broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, and two novel antibiotic programs. 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 expected finalization and execution of a definitive agreement, the anticipated funding amount and the Company’s ongoing development plans with respect to ATI-1701. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. Forward looking statements contained in this press release are provided in reliance on certain assumptions, including with respect to finalizing the definitive funding documentation with DTRA and being in a position to secure the full anticipated funding. 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 final approval for the funding may not be secured on terms satisfactory to the Company or at all, the final funding amount may be different than that communicated herein, and the other risk factors listed in the annual information form of the Company dated June 23, 2021 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

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Media Contact:
Danielle Raabe/APCO Worldwide
T: 1-646-717-9915
E: [email protected]

Investor Relations Contact:
Stéphane Paquette; Vice President, Corporate Development
Appili Therapeutics
E: [email protected]

HALIFAX, Nova Scotia, February 14, 2022– Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, today announced its financial and operational results for the third quarter of its fiscal year 2022, which ended on December 31, 2021.

“Over the past few months, we made meaningful progress fortifying partnerships to accelerate and expand our diversified portfolio, including expanding the scope of our commercial partnership with Saptalis to bring our near-market antibiotic product to global markets, and kickstarting an exciting new chapter on our path to become a global biotechnology company and leader in the fight against infectious diseases,” said Armand Balboni, M.D., Ph.D., Chief Executive Officer of Appili Therapeutics. “There is still a lot of work to be done to better protect society from emerging healthcare threats, and that’s why I’m incredibly proud of all that we have accomplished this quarter to enhance our portfolio of critical infectious disease treatments and address unmet needs in healthcare.”

Third quarter and recent operational highlights include:

• Expansion of commercial agreement with Saptalis Pharmaceuticals to add European and Latin American markets and increase global access to ATI-1501, Appili’s proprietary taste-masked liquid suspension reformulation of metronidazole scheduled for submission to the US Food and Drug Administration later this year
• Announced positive one year challenge results for biodefense vaccine candidate ATI-1701, a leading and potential first-in-class option to prevent infection by top priority biothreat Francisella tularensis
• Updated Appili’s funding agreement with The Lind Partners with a voluntary prepayment of $1 million
• Discontinued further investment in development activities related to COVID-19 antiviral candidate Avigan®/Reeqonus™ (favipiravir) and issued notice of termination of strategic alliance and equity transaction to AiPharma following announcement of top-line results for Phase 3 PRESECO trial

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 $21.7 million or $0.33 loss per share for the nine months ended December 31, 2021 was $12.4 million higher than the net loss and comprehensive loss of $9.3 million or $0.16 loss per share during the nine months ended December 31, 2020. This relates mainly to an increase in research and development costs of $13.4 million, an increase in business development of $0.25 million, an increase in financing costs of $0.37 million and an increase in income tax expense of $0.04 million. These increases were offset by an increase in revenue and interest income of $1.3 million, an increase of government assistance of $0.15 million, and a decrease in general and administration expenses of $0.12 million.

As of December 31, 2021, the Company had cash and short-term investments of $9.4 million, compared to $16.1 million on March 31, 2021. As of February 14, 2022, the Company had 71,266,120 issued and outstanding Common Shares, 9,745,239 stock options, and 21,343,530 warrants outstanding.

This press release should be read in conjunction with the Company’s unaudited interim condensed financial statements for the third quarter of the 2022 fiscal year and the related management discussion and analysis (MD&A), copies of which are available on SEDAR at www.sedar.com.

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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 broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, and two novel antibiotic programs. 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”. 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 23, 2021 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

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Media Contact:
Danielle Raabe/APCO Worldwide
T: 1-646-717-9915
E: [email protected]

Investor Relations Contact:
Stéphane Paquette; Vice President, Corporate Development
Appili Therapeutics
E: [email protected]

HALIFAX, Nova Scotia, February 8, 2022 – Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, announced today it has amended its agreement with Saptalis Pharmaceuticals LLC (“Saptalis”), a New York-based specialty pharmaceuticals company, to expand the territories in which Saptalis will commercialize ATI-1501, Appili’s liquid oral reformulation of the antibiotic metronidazole. Under the terms of the amended agreement, Saptalis will assume responsibility for development and commercialization of ATI-1501 in Europe and Latin America (collectively, the “Expanded Territories”). Appili will be eligible to receive royalties on the sale of ATI-1501 in the Expanded Territories for a specified term, in addition to milestone payments and royalties on sales in the United States described in the original agreement.

Metronidazole is a broad-spectrum antibiotic widely used for the treatment of parasitic and anaerobic bacterial infections. Although oral metronidazole is heavily prescribed globally there are no or few liquid oral dose formulations in many countries around the world, in part due to challenges managing metronidazole’s pronounced bitter taste. Saptalis and Appili are developing ATI-1501 to provide a ready-to-use, taste-masked liquid oral dose form of metronidazole for the growing number of patients with difficulty swallowing.

Saptalis is planning to complete all remaining development activities to support a New Drug Application (“NDA”) submission to the United States Food and Drug Administration (“FDA”) later this year. Appili has agreed to fund a portion of the remaining clinical development activities to support such NDA filing.

Appili recently invoiced a milestone payment for the successful manufacture and stability of ATI-1501 registration batches and expects to receive additional development milestone payments in 2022 based on Saptalis’ proposed NDA submission timeline.

“Difficulty swallowing tablets and capsules should not be a barrier to accessing appropriate antibiotic therapy. We are proud to be working with Saptalis to make metronidazole more accessible and easier to take for all patients, in particular elderly patients and children who sometimes have difficulty taking solid oral medicines,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “Saptalis has proven to be the ideal partner for ATI-1501. Their expertise in novel formulations has helped us overcome various manufacturing challenges and puts us on track for a NDA submission in 2022. We also share a global vision for ATI-1501 and are excited to be expanding our commercialization agreement to reach more patients in need.”

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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 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 broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, and two novel antibiotic programs. 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 expected development plan for ATI-1501, the filing of the NDA and the timing and eligibility of various milestone and royalty payments. 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 23, 2021 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

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Media Contact:
Danielle Raabe/APCO Worldwide
T: 1-646-717-9915
E: [email protected]

Investor Relations Contact:
Stéphane Paquette; Vice President, Corporate Development
Appili Therapeutics
E: [email protected]