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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]

HALIFAX, Nova Scotia, December 23, 2021 – Appili Therapeutics Inc. (TSX: APLI) (the “Company” or “Appili”) announced today a correction to its press release entitled “Appili Therapeutics Announces Update to Funding Agreement with The Lind Partners” which was issued on December 22, 2021 (the “Initial Press Release”).

The Initial Press Release incorrectly stated that Lind had agreed to a standstill period expiring on March 18, 2021. The correct expiry date for the standstill period is March 18, 2022. This correction does not change any other information reported in the Initial Press Release.

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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 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.

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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, December 22, 2021 – Appili Therapeutics Inc. (TSX:APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, announced today that the Company and Lind Global Fund II, LP, an investment entity managed by The Lind Partners, a New York based institutional fund manager (together “Lind”), have agreed to amend certain terms of the previously announced senior convertible funding agreement (the “Funding Agreement”).

Under the previously disclosed Funding Agreement, Appili issued to Lind a secured convertible security with a face value of $4.095 million and a 24-month maturity date. Under the revised terms, Appili has agreed to make a voluntary prepayment of $1 million towards the principal amount outstanding under the Funding Agreement. In exchange, Lind has agreed to a standstill period expiring on March 18, 2021 during which Lind shall not be entitled to convert any of the remaining principal amount outstanding into Appili shares, which is now approximately $3 million.

“Today’s agreement is an important part of Appili’s near-term strategy to maximize balance sheet flexibility and ultimately grow shareholder value” said Dr. Armand Balboni, CEO of Appili Therapeutics. “We are grateful for the continued support from our partners at Lind as we look to expand and advance our diversified anti-infective pipeline of four potential products through key development milestones in 2022, including a Phase 2 start for our novel antifungal ATI-2307. In addition, we believe that two of our programs come with the additional potential for obtaining priority review vouchers, which could add significant, non-dilutive value to our shareholders in the event these programs are successful.”

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 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 The Lind Partners

The Lind Partners is an institutional fund manager and leading provider of growth capital to small- and mid-cap companies publicly traded in the US, Canada, Australia and the UK. Lind makes direct investments ranging from US$1 to US$30 million, invests in syndicated equity offerings and selectively buys on market. Lind has completed more than 100 direct investments totaling over US$1 Billion in value and has been a flexible and supportive capital partner to investee companies since 2011. For more information, please visit www.thelindpartners.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. Such forward looking statements include statements with respect to the Company’s development plans with respect to its product portfolio and expectations with respect to priority review voucher eligibility. 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, (i) risks relating to unforeseen events that may delay or impede the Company’s development plans with respect to its product portfolio, (ii) the risk that a product may ultimately not be priority review voucher eligible and (iii) the risks and assumptions 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, November 19, 2021 – Appili Therapeutics Inc. (TSX:APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, today announced positive one year challenge 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 results reported today are from the final challenge timepoint in a preclinical study evaluating the efficacy of ATI-1701 28 days, 90 days, and one year after vaccination. At each challenge timepoint, cohorts of vaccinated and unvaccinated animals received a lethal exposure of aerosolized Francisella tularensis, the causative agent of tularemia. In January 2020, Appili had reported 90-day efficacy results, with 100% of ATI-1701 vaccinated animals surviving exposure compared to 0% of the controls. Both 28- and 90-day efficacy data have also been presented previously by Appili’s partners MRIGlobal at biodefense conferences in the U.S. The study was funded by the U.S Defense Threat Reduction Agency (“DTRA”) and conducted by MRIGlobal.

“We are excited to see signals of protection and survival benefit as far out as one year post vaccination. Efficacy under these stringent conditions is a compelling differentiator and positions ATI-1701 as a leading candidate to be the first approved vaccine for the prevention of tularemia,” said Dr. Armand Balboni, CEO of Appili Therapeutics. “We are grateful for the support of DTRA and our partners to achieve this significant milestone and look forward to making continued progress on manufacturing and IND-enabling activities to advance ATI-1701 into the clinic.”

The Company also announced today that Josef Vejvoda has resigned from the Company’s Board of Directors to pursue other endeavours.

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 times more infectious than anthrax, experts consider the aerosolized form to have a high potential 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. As part of a global consortium, Appili recently sponsored a late-stage clinical trial evaluating the antiviral Avigan/Reeqonus for the treatment of COVID-19. The Company is also 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 use of proceeds. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. Such forward looking statements include statements with respect to the Company’s development plans relating to ATI-1701. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, the 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; Senior Director, Corporate Development
Appili Therapeutics
E: [email protected]

HALIFAX, Nova Scotia, November 12, 2021 – Appili Therapeutics Inc. (TSX:APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company developing anti-infective drug candidates, today announced its financial and operational results for the second quarter of its fiscal year 2022, which ended on September 30, 2021.

“Although the top-line results of our Phase 3 PRESECO trial were not what we had hoped for, I am incredibly proud of all that our team accomplished this quarter which continues to demonstrate Appili’s ability to rapidly execute and achieve key development milestones,” said Armand Balboni, M.D., Ph.D., Chief Executive Officer of Appili Therapeutics. “I am excited to deploy our expanded drug development infrastructure to tackle the many other infectious disease threats in front of us and advance our broader anti-infective pipeline including our novel, clinical-stage antifungal ATI-2307 slated to enter Phase 2 next year, and our first-in-class biodefense vaccine candidate ATI-1701.”

Second quarter and recent operational highlights include:

• In September, announcing last patient enrolled in the Phase 3 PRESECO clinical trial evaluating Avigan®/Reeqonus™ for mild-to-moderate COVID-19 and its viral shedding sub-study, and subsequently reporting top-line results for the study.
• Announcing a closing of public offering of $7,000,220 and entering into an agreement with the Lind Partners for $3.5 million in funding to further strengthen the Company’s momentum as a fully integrated, infectious disease specialized company.
• Entering into a data transfer agreement with FUJIFILM Toyama Chemical Co., Ltd., that will provide funding support of $1,000,000 USD for the Phase 3 PRESECO trial.
• Entering into a strategic alliance and equity transaction with existing consortium partner AiPharma to enhance complementary skills and create global reach with expanded resources.
• Preparing for ATI-2307 clinical trial drug product GMP manufacturing runs to be initiated in December 2021.

Kimberly Stephens, CPA, CA, who has been the Company’s Chief Financial Officer since 2016, has chosen to leave Appili for personal reasons effective November 16, 2021. Kenneth G. Howling, who has over 25 years of experience in senior financial positions across several healthcare and pharmaceutical companies, will be joining Appili Therapeutics as Acting Chief Financial Officer this fall.

“On behalf of our entire team, I would like to thank Kimberly for her commitment and contribution to Appili Therapeutics,” continued Armand Balboni, CEO of Appili Therapeutics. “Since joining Appili in 2016, Kimberly has been an integral part of our executive team leading Appili through many of our biggest milestones, including taking the company public and up-listing to the Toronto Stock Exchange. We wish her well in her future endeavors.”

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 $18.5 million or $0.30 loss per share for the six months ended September 30, 2021 was $13.5 million higher than the net loss and comprehensive loss of $5.1 million or $0.09 loss per share during the six months ended September 30, 2020. This relates mainly to an increase in research and development expenses by $13.4 million, an increase in business development of $0.2 million and an increase in accreted interest of $0.2 million. These increases were offset by a decrease in general and administration expenses by $0.2 million increase of government assistance of $0.3 million.

As of September 30, 2021, the Company had cash and short-term investments of $10.0 million, compared to $16.1 million on March 31, 2021. As of November 12, 2021, the Company had 71,266,120 issued and outstanding Common Shares, 6,621,489 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 second 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. As part of a global consortium, Appili recently sponsored a late-stage clinical trial evaluating the antiviral Avigan/Reeqonus for the treatment of COVID-19. The Company is also 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 use of proceeds. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, the risk that the Company may not be able to continue as a going concern and those 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; Senior Director, Corporate Development
Appili Therapeutics
E: [email protected]

HALIFAX, Nova Scotia, November 12, 2021 – 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 Phase 3 PRESECO (PREventing SEvere COVID-19) clinical trial evaluating oral antiviral Avigan®/Reeqonus™(favipiravir) for the treatment of mild-to-moderate COVID-19 did not achieve statistical significance on the primary endpoint of time to sustained clinical recovery. Additional analyses of the trial data are ongoing. The clinical trial enrolled 1,231 patients with mild-to-moderate COVID-19 from 38 study sites across the United States, Mexico, and Brazil.

“While we are disappointed by the topline results of the PRESECO trial, we remain steadfast in our belief that safe and effective oral antivirals are urgently needed for patients who are still struggling to overcome COVID-19. We wish to thank all the patients who participated, and hope that information obtained from our trial can help guide research and development around more potential treatment options for COVID-19,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “Appili remains committed to addressing the challenges posed by infectious diseases and we will continue developing our pipeline to improve patient lives around the world.”

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About the PRESECO Clinical Trial

The Phase 3 PRESECO (PREventing SEvere COVID-19 Disease) study is a double-blind, placebo-controlled, randomized, multi-center, global superiority trial investigating the safety and efficacy of oral Avigan/Reeqonus in the early treatment for adults infected with COVID-19 and showing mild-to-moderate symptoms. Participants were enrolled at multiple clinical trial sites in the United States, Brazil and Mexico. Participants were outpatients with mild-to-moderate symptoms who have had a recent positive COVID-19 test (within 72 hours of enrollment). Participants self-administered the drug regimen in their homes, with clinical investigators monitoring patients remotely.

About Avigan/Reeqonus

Avigan/Reeqonus is a broad-spectrum antiviral in oral tablet form. It is a selective inhibitor of viral RNA-dependent RNA polymerase (RdRP) with potent antiviral activity against single-stranded RNA viruses, including coronaviruses. Developed by FUJIFILM Toyama Chemical Co., Ltd. (FFTC) and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza. Unlike most other interventions that researchers are evaluating in COVID-19, Avigan/Reeqonus has already been thoroughly studied in human trials and has a well-known safety profile, with over 3,000 subjects receiving at least one dose of the drug. Avigan/Reeqonus’ oral tablet form is shelf-stable and has an established commercial manufacturing process, which may provide advantages over other COVID-19 interventions, which often require temperature-controlled storage and/or injection or intravenous administration.

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. As part of a global consortium, Appili is sponsoring late-stage clinical trials evaluating the antiviral Avigan/Reeqonus for the worldwide treatment and prevention of COVID-19. The Company is also 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,” which reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities. 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 involve significant known and unknown risks, uncertainties and assumptions, including 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 under the Company’s profile on SEDAR 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.

The Company is not making any express or implied claims that it has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time.

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Media Contacts
Danielle Raabe
APCO Worldwide
T: 1-646-717-9915
Email: [email protected]

Investor Relations Contacts
Stéphane Paquette; Senior Director, Corporate Development
Appili Therapeutics
E: [email protected]

HALIFAX, Nova Scotia, October 14, 2021 – Appili Therapeutics Inc. (TSX: APLI) (the “Company” or “Appili”) announced the closing of its previously announced public offering (the “Offering”) of units (the “Units”). The Offering was made pursuant to an agency agreement entered into with a syndicate of agents led by Bloom Burton Securities Inc. (the “Lead Agent”) and including iA Private Wealth Inc., Leede Jones Gable Inc., Research Capital Corporation, and Richardson Wealth Limited (collectively with the Lead Agent, the “Agents”) and the Company.

Pursuant to the Offering, the Company issued a total of 8,434,000 Units at a price of $0.83 per Unit for aggregate gross proceeds of $7,000,220. Each Unit is comprised of one Class A common share of the Company (a “Common Share”) and one-half of one Common Share purchase warrant of the Company (each whole Common Share purchase warrant, a “Warrant”). Each Warrant entitles the holder thereof to acquire one Common Share (a “Warrant Share”) at an exercise price of $1.10 per Warrant Share until October 14, 2024.

“This funding will play a critical role in continuing our momentum as we work to improve patient lives, expand our global reach, and build out a fully integrated, infectious disease specialized company,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “With the COVID-19 pandemic continuing to evolve, the need for at-home oral antivirals remains urgent. As Appili rapidly approaches the top-line readout from our Phase 3 PRESECO trial, which is evaluating the oral antiviral Avigan®/Reeqonus™ (favipiravir) for the treatment of mild-to-moderate COVID-19, this funding will support us as we move aggressively to deliver this critically needed medicine and hopefully change the trajectory of this pandemic.”

The Units were qualified for sale by way of a prospectus supplement dated October 8, 2021 to the short base shelf prospectus of the Company dated September 19, 2019 (collectively, the “Prospectus”). A copy of the Prospectus is available under the Company’s profile at www.sedar.com.

In connection with the Offering, the Company has paid the Agents an aggregate cash consideration of $490,015.40. As additional consideration, the Agents have received 590,380 broker warrants (“Broker Warrants”). Each Broker Warrant is exercisable for one Common Share (a “Broker Warrant Share”) at a price of $0.83 per Broker Warrant Share until October 14, 2023.

The net proceeds of the Offering will be used primarily towards funding research and development activities for oral COVID-19 antiviral candidate Avigan®/ReeqonusTM (favipiravir), including costs associated Appili’s global Phase 3 trial evaluating Avigan/Reeqonus for the treatment of mild-to-moderate COVID-19 (PREventing SEvere COVID-19; PRESECO). Net proceeds of the Offering will also be used to support business development initiatives to expand the Company’s portfolio of programs, as well as fund development costs for the Company’s other product candidates, including the ATI-2307 antifungal program, and for working capital and general corporate purposes. Details as to the specific allocation of the proceeds were disclosed in the Prospectus Supplement.

The securities described herein have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state securities laws, and accordingly, may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as each such term is defined in Regulation S under the U.S. Securities Act), except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities requirements or pursuant to exemptions therefrom. This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the Corporation’s securities to, or for the account or benefit of, persons in the United States or U.S. Persons.

As partial consideration for its services in connection with the Offering, the Lead Agent received 128,674 Broker Warrants. Prior to the closing of the Offering, the Lead Agent together with Bloom Burton & Co. Inc. and Bloom Burton Development Corporation (collectively, “Bloom Burton”), each an affiliate of the Lead Agent, beneficially owned, directly and indirectly, an aggregate of 14,358,611 Common Shares, 256,545 share purchase warrants (the “First Previously Held Broker Warrants”) exercisable into 256,545 Common Shares at a price of $0.80 per Common Share until February 20, 2022, and 280,777 share purchase warrants (the ”Second Previously Held Broker Warrants”) exercisable into 280,777 Common Shares at a price of $1.20 per Common Share until June 10, 2022, representing approximately 22.85% of the then issued and outstanding Common Shares on a non-diluted basis, and 23.51% of the then issued and outstanding Common Shares on a partially-diluted basis, assuming the exercise of the First and Second Previously Held Broker Warrants held by Bloom Burton and its affiliates only.

Immediately following closing of the Offering, Bloom Burton beneficially owns, directly or indirectly, 14,358,611 Common Shares, 256,545 First Previously Held Broker Warrants, 280,777 Second Previously Held Broker Warrants and 128,674 Broker Warrants, representing 20.15% of the Common Shares issued and outstanding on a non-diluted basis and 20.89% of the Common Shares issued and outstanding on a partially-diluted basis, assuming the exercise of the First Previously Held Broker Warrants, Second Previously Held Broker Warrants and the Broker Warrants held by Bloom Burton only.

The Lead Agent received the Broker Warrants in the normal course of its business as a registered investment dealer. The Broker Warrants and the other securities of the Company beneficially owned, directly or indirectly, by Bloom Burton, are held for investment purposes. Bloom Burton has a long-term view of the investment and may acquire additional securities including either in the open market or through private acquisitions or sell the securities including either on the open market or through private dispositions in the future depending on market conditions, reformulation of plans and/or other relevant factors.

An early warning report relating to this transaction will be filed on SEDAR under the Company’s profile at www.sedar.com. To obtain a copy of such report, please contact Sonia Yung at (416) 640-7575 or at [email protected]. Bloom Burton is a company existing under the laws of Ontario specializing in the healthcare investment industry with its head office at 65 Front Street East, Suite 300, Toronto, Ontario, M5E 1B5.

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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. As part of a global consortium, Appili is sponsoring late-stage clinical trials evaluating the antiviral Avigan/Reeqonus for the worldwide treatment and prevention of COVID-19. The Company is also 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 use of proceeds. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in the Prospectus 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 Contacts
Danielle Raabe
APCO Worldwide
T: (646) 717 9915
E: [email protected]

Investor Relations Contacts
Stéphane Paquette; Senior Director, Corporate Development
Appili Therapeutics
E: [email protected]

HALIFAX, Nova Scotia, October 7, 2021 – Appili Therapeutics Inc. (TSX: APLI) (the “Company” or “Appili”) is pleased to announce today that it has priced its previously announced overnight marketed offering of equity securities (the “Offering”). Pursuant to the Offering, Appili will issue 8,434,000 units of the Company (“Units”) at a price of C$0.83 per Unit (the “Offering Price”) for gross proceeds of C$7,000,220. Each Unit is comprised of one Class A common share of the Company (a “Common Share”) and one-half of one Common Share purchase warrant (each whole warrant, a “Warrant”). Each Warrant is exercisable at a price of C$1.10 and entitles the holder thereof to acquire one Common Share for a period of 3 years following the date of the closing of the Offering (the “Closing Date”).

The Offering will be conducted on a best efforts agency basis pursuant to the terms and conditions of an agency agreement to be entered into between the Company and a syndicate of agents lead by Bloom Burton Securities Inc. (the “Lead Agent”) and including iA Private Wealth Inc., Leede Jones Gable Inc., Research Capital Corporation, and Richardson Wealth Limited (collectively with the Lead Agent, the “Agents”). In connection with the Offering, the Agents will be paid a cash commission equal to 7.0% of the gross proceeds of the Offering and will be issued that number of non-transferable broker warrants (“Broker Warrants”) equal to 7.0% of the number of Units sold in the Offering). Each Broker Warrant will be exercisable to acquire one Common Share at the Offering Price for a period of 24 months from the Closing Date.

The Company expects the Closing Date to occur on or about October 14, 2021. The Offering is subject to the satisfaction of certain customary closing conditions, including, but not limited to, the receipt of all necessary regulatory and stock exchange approvals (including, for certainty, the approval of the Toronto Stock Exchange).

The Offering is to be effected by way of a prospectus supplement to Appili’s base shelf prospectus dated September 19, 2019 (collectively, the “Prospectus Supplement”). The Prospectus Supplement will be filed in each Province of Canada (other than Quebec) and a copy of the Prospectus Supplement will be available under the Company’s profile at www.sedar.com. This news release does not provide full disclosure of all material facts relating to the Units. Investors should read the Prospectus Supplement for disclosure of those facts, especially risk factors relating to the Offering, before making an investment decision.

The net proceeds of the Offering will be used primarily towards funding research and development activities for oral COVID-19 antiviral candidate Avigan®/ReeqonusTM (favipiravir), including costs associated Appili’s global Phase 3 trial evaluating Avigan/Reeqonus for the treatment of mild-to-moderate COVID-19 (PREventing SEvere COVID-19; PRESECO). Net proceeds of the Offering will also be used to support business development initiatives to expand the Company’s portfolio of programs, as well as fund development costs for the Company’s other product candidates, including the ATI-2307 antifungal program, and for working capital and general corporate purposes. Details as to the specific allocation of the proceeds will be disclosed in the Prospectus Supplement.

The securities described herein have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state securities laws, and accordingly, may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as each such term is defined in Regulation S under the U.S. Securities Act), except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities requirements or pursuant to exemptions therefrom. This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the Corporation’s securities to, or for the account or benefit of, persons in the United States or U.S. Persons.

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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. As part of a global consortium, Appili is sponsoring late-stage clinical trials evaluating the antiviral Avigan/Reeqonus for the worldwide treatment and prevention of COVID-19. The Company is also 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 terms of the Offering, the anticipated closing date and the proposed use of proceeds. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, 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 Contacts
Danielle Raabe
APCO Worldwide
T: (646) 717 9915
E: [email protected]

Investor Relations Contacts
Stéphane Paquette; Senior Director, Corporate Development
Appili Therapeutics
E: [email protected]