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HALIFAX, Nova Scotia, February 20, 2020 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”) is pleased to announce 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 between Bloom Burton Securities Inc. (the “Lead Agent”), Mackie Research Capital Corporation, Haywood Securities Inc. and Industrial Alliance Securities Inc. (together with the Lead Agent, the “Agents”) and the Company.

Pursuant to the Offering, the Company issued a total of 12,812,500 Units at a price of $0.80 per Unit for aggregate gross proceeds of $10,250,000. 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 CDN$1.10 per Warrant Share until February 20, 2023.

“Funds from this offering put Appili in a very solid position to keep delivering on the value-driving milestones in our pipeline,” said Dr. Armand Balboni, Chief Executive Officer of Appili. “Preparing our new asset, ATI-2307, for Phase 2 work; selecting a clinical candidate for our negamycin antibiotic program; delivering critical proof-of-concept one-year data on our ATI-1701 biothreat vaccine candidate; and working towards our first commercial product with our partner Saptalis Pharmaceuticals on ATI-1501, we are well-funded and galvanized to progress our assets against these urgent threats in the anti-infective space. We are especially pleased that this round welcomed a myriad of new shareholders to the Appili investor base, alongside the continued support of many of our long-standing shareholders.”

The Units were qualified for sale by way of a prospectus supplement dated February 14, 2020 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 $717,500. As additional consideration, the Agents have received 896,875 broker warrants (“Broker Warrants”). Each Broker Warrant is exercisable for one Common Share (a “Broker Warrant Share”) at a price of $0.80 per Broker Warrant Share until February 20, 2022.

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 U.S. Securities Act, and may not be offered or sold in the United States absent registration or an applicable exemption from 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.

As partial consideration for its services in connection with the Offering, the Lead Agent received 256,545 Broker Warrants. Prior to the closing of the Offering, Bloom Burton & Co. Inc. (“Bloom Burton”), an affiliate of the Lead Agent, beneficially owned, directly and indirectly, 14,350,120 Common Shares (13,896,000 of which are held by its wholly-owned subsidiary Bloom Burton Development Corporation) and 2,200 share purchase warrants (the “IPO Broker Warrants”) exercisable into 8,491 Common Shares at a price of $1.10 per Common Share until November 21, 2020 (which are held by the Lead Agent), representing approximately 42.72% of the then issued and outstanding Common Shares on a non-diluted basis, and 42.74% of the then issued and outstanding Common Shares on a partially-diluted basis, assuming the exercise of the IPO Broker Warrants held by Bloom Burton and its affiliates only.

Immediately following closing of the Offering, Bloom Burton beneficially owns, directly or indirectly, 14,350,120 Common Shares, 2,200 IPO Broker Warrants and 256,545 Broker Warrants, representing 30.93% of the Common Shares issued and outstanding on a non-diluted basis and 31.32% of the Common Shares issued and outstanding on a partially-diluted basis, assuming the exercise of the IPO Broker Warrants and the Broker Warrants held by Bloom Burton and its affiliates 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, to the extent permitted under the escrow agreement dated as of June 12, 2019 to which Bloom Burton is party.

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. 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.

About Appili Therapeutics

Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com. The head office of the Company is located at #21 – 1344 Summer St., Halifax, Nova Scotia, B3H 0A8.

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.

Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.

###

Media Relations Contact:
Andrea Cohen
Sam Brown Inc.
T: 917-209-7163
E: [email protected]

Investor Relations Contact:
Kimberly Stephens, CFO
Appili Therapeutics
TSX-V: APLI
E: [email protected]

HALIFAX, Nova Scotia, February 14, 2020 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”) is pleased to announce today that it has increased the size of its previously announced offering of equity securities (the “Offering”). Pursuant to the revised terms of the Offering, Appili will issue an aggregate of 12,812,500 Units at a price of C$0.80 per Unit (the “Offering Price”) for aggregate gross proceeds of C$10,250,000. Each Unit is comprised of one Class A common share of the Company (a “Common Share”) and one-half (1/2) 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 closing of the Offering (the “Closing”).

The Offering is being 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 led by Bloom Burton Securities Inc. and including Mackie Research Capital Corporation, Haywood Securities Inc. and Industrial Alliance Securities Inc. (collectively, 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.  The Offering will no longer be subject to an over-allotment option.

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 TSX Venture Exchange (the “TSXV”)). The Company expects the Closing to occur on or about February 20, 2020.

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 to fund planned research and development activities for the Company’s four product candidates including the newly acquired ATI-2307 antifungal program, the ATI-1701 tularemia vaccine program, the antibiotic ATI-1503 program and the out-licensed ATI-1501 reformulation program, as well as for working capital and general corporate purposes. Details as to the specific allocation of the proceeds will be disclosed in the Prospectus Supplement.

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 U.S. Securities Act, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities offered in any jurisdiction in which such offer, solicitation, or sale would be unlawful.

About Appili Therapeutics

Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

Forward looking statements

This news release contains “forward-looking statements”, including with respect to expected closing of the Offering 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 July 3, 2019 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.

Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.

###

Media Relations Contact:
Andrea Cohen
Sam Brown Inc.
T: 917-209-7163
E: [email protected]

Investor Relations Contact:
Kimberly Stephens, CFO
Appili Therapeutics
TSX-V: APLI
E: [email protected]

HALIFAX, Nova Scotia, May 18, 2022 – 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 50,000,000 units of the Company (“Units”) at a price of C$0.09 per Unit (the “Offering Price”) for gross proceeds of C$4,500,000. 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$0.15 and entitles the holder thereof to acquire one Common Share for a period of 5 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 led by Bloom Burton Securities Inc. (the “Lead Agent”) and including Leede Jones Gable Inc. (collectively with the Lead Agent, the “Agents”). In connection with the Offering, the Agents will be paid a cash commission equal to 7% of the gross proceeds of the Offering and will be issued that number of non-transferable broker warrants (“Broker Warrants”) equal to 7% 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 May 26, 2022. 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 (the “Prospectus Supplement”) to Appili’s base shelf prospectus dated May 16, 2022 (the “Base Shelf Prospectus”). 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 and the Base Shelf Prospectus 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 for working capital purposes and to fund the development of certain product candidates of the Company. 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.

+++

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, a topical antiparasitic product for the treatment of a disfiguring disease, 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, the Base Shelf 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.

###

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 12, 2020 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, has announced today that it will undertake an overnight marketed public offering (the “Offering”) of units (the “Units”), with each Unit composed of one Class A common share (each, a “Common Share”) and one-half (1/2) of one common share purchase warrant (each whole warrant, a “Warrant”). Each Warrant will be exercisable for one Common Share for a period of three years from the closing of the Offering. The Offering is to be effected on a best efforts agency basis in each Province of Canada (other than Quebec) by way of a prospectus supplement (the “Prospectus Supplement”) to the Company’s base shelf prospectus dated September 19, 2019 (together with the Prospectus Supplement, the “Prospectus”). The number of Units to be distributed, the price and composition of each Unit, and the exercise price of each Warrant will be determined in the context of the market with final terms to be determined at the time of pricing. It is expected that the Offering will be conducted through a syndicate of agents led by Bloom Burton Securities Inc., and including Mackie Research Capital Corp., Haywood Securities Inc. and Industrial Alliance Securities Inc.

​

The Offering is subject to a number of conditions, including, without limitation, receipt of all regulatory approvals. The net proceeds of the Offering will be used to fund planned research and development activities for the Company’s four product candidates, including the newly acquired ATI-2307 antifungal program, the ATI-1701 tularemia vaccine program, the antibiotic ATI-1503 program, and the out-licensed ATI-1501 reformulation program, as well as for working capital and general corporate purposes. Details as to the specific allocation of the proceeds will be disclosed in the Prospectus Supplement.

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 U.S. Securities Act, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities offered in any jurisdiction in which such offer, solicitation, or sale would be unlawful.

​

About Appili Therapeutics

Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies. 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 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 July 3, 2019 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.

Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.

###

Media Relations Contact:
Andrea Cohen
Sam Brown Inc.
T: 917-209-7163
E: [email protected]

​

Investor Relations Contact:
Kimberly Stephens, CFO
Appili Therapeutics
TSX-V: APLI
E: [email protected]

HALIFAX, Nova Scotia, January 28, 2020 – Appili Therapeutics Inc. (TSXV: APLI) (the Company or Appili), a biopharmaceutical company developing anti-infective drug candidates, today announced that Dr. Carl Gelhaus, Senior Program Manager of the Medical Countermeasures Division at MRIGlobal, will present positive interim data on Appili’s ATI-1701 program at the 2020 ASM Biothreats conference. Hosted by the American Society for Microbiology, the conference is being held from January 28–30, 2020 in Arlington, Virginia.

“These interim results add to a growing body of evidence supporting advanced development of ATI-1701 as a medical countermeasure against one of the most significant bioterrorism threats we might face,” said Dr. Armand Balboni, CEO of Appili Therapeutics. “We remain very encouraged by these results and look forward to sharing the 365-day challenge study data later this year. We are committed to working with our biodefense partners at the U.S. DOD, MRIGlobal, and the National Research Council of Canada toward the first approved vaccine for the prevention of weaponized tularemia.”

Presentation details are as follows:

Title: A ClpB Mutant of Francisella Tularensis SCHU S4 is an Effective Vaccine in Fisher 344 Rat and Cynomolgus Macaque Models of Pneumonic Tularemia
Poster Number: 083
Date: Tuesday, January 28, 2020
Time: 4:15 – 5:15 p.m. ET
Location: Independence Center, Hyatt Regency Crystal City at Reagan National Airport

The ASM poster presentation summarizes the findings from the ongoing preclinical study of ATI-1701, which showed complete (100%) protection 90 days after vaccination from a lethal exposure to the pathogen Francisca tularensis. This duration is the longest vaccine protection period tested to date in this model. Researchers will conduct an additional evaluation of vaccine efficacy up to 365 days in the same model in the first half of 2020. The U.S. Defense Threat Reduction Agency (DTRA), an arm of the U.S. Department of Defense (DOD), is funding this trial. MRIGlobal is managing the study under the DTRA contract HDTRA1-16-C-0028.

About ATI-1701

Appili is developing ATI-1701 as a vaccine to combat Francisella tularensis, which the U.S. National Institutes of Health (NIH) defines as a Category A pathogen (an organism that poses the highest risk to national security and public health). As it is 1,000 times more infectious than anthrax, experts consider the aerosolized form to have a high potential use in a bioterrorist attack.[i]  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.[ii]

About ASM Biothreats

ASM Biothreats is the leading annual conference on biodefense, biosecurity and biological threats. Hosted by the American Society for Microbiology, ASM Biothreats offers a unique program that explores the latest developments and emerging technologies in the industry. This unique meeting draws stakeholders from government, academia, and industry for an important exchange of knowledge and ideas that will shape the future of high consequence pathogen research.

About MRIGlobal

Celebrating its 75th year of business, MRIGlobal addresses some of the world’s greatest threats and challenges. Founded in 1944 as an independent, non-profit organization, MRIGlobal performs contract research for government, industry, and academia. It offers customized solutions in national security and defense and health include research and development capabilities in clinical research support, infectious disease and biological threat agent detection, global biological engagement, in vitro diagnostics, and laboratory management and operations. MRIGlobal is one of two partners in the Alliance for Sustainable Energy, LLC, which manages and operates the National Renewable Energy Laboratory (NREL) in Golden, Colo., for the U.S. Department of Energy. For more information, visit www.mriglobal.org

About Appili Therapeutics

Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this challenging disease space. Appili has built a pipeline of assets designed to address a broad range of urgent threats in global public health. ATI-2307, a novel, broad spectrum, clinical stage antifungal, is in development to address severe and difficult-to-treat invasive fungal infections. Via an in-licensing program, Appili is developing ATI-1701, a vaccine for tularemia, to mitigate the risks of a very serious biological weapons threat. ATI-1503 is a drug discovery program developing a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with the antibiotic metronidazole for the growing number of patients with difficulty swallowing. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with science and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

This news release contains “forward-looking statements” which reflect the current expectations of the Company’s management future growth, results of operations, performance and business prospects and opportunities. Such statements include, but are not limited to, statements regarding the Company’s proposed development plans with respect to its product. 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 statements reflect management’s current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions including with respect to the ability of the Company to adequately fund and implement its development plans and business strategy. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements including, without limitation, those listed in the final prospectus of the Company dated June 12, 2019 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. Although the forward-looking statements contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.

###

Investor Relations Contact:
Kimberly Stephens, CFO
Appili Therapeutics
TSX-V: APLI
E: [email protected]

[i] PHAC PSDS (2011) Anthrax; PHAC PSDS (2011) Tularemia

ii] Oyston P (2004) Nat Rev Microbiol 2: 967-979

HALIFAX, Nova Scotia, January 27, 2020 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced that it has appointed Juergen Froehlich, MD, MBA, to its Board of Directors. Dr. Froehlich’s career covers a broad range of drug development successes involving strategic planning and execution of all phases of drug development and regulatory interactions across multiple therapeutic areas, including infectious diseases. In addition, Appili announced the appointment of current board member and Xenon Pharmaceuticals President and Chief Financial Officer Ian Mortimer as Appili’s Board Chair, replacing Stephen Nicolle, who resigned today.

“We are very pleased to welcome Juergen to Appili’s Board. His background will be very valuable as the Company advances its clinical portfolio through multiple milestones, from ATI-1701’s pivotal data readout to the initiation of the Phase 2 clinical program for the newly acquired ATI-2307 asset,” said Ian Mortimer, Chair of the Board at Appili. “In particular, his successful track record with all stages of clinical development and global regulatory affairs, along with his anti-infective experience, will provide key insights for value creation from Appili’s pipeline.”

Dr. Froehlich has 30 years of experience in medical and regulatory affairs. He has worked with biologics, peptides, small molecules and RNA therapeutics at companies including Boehringer Ingelheim, Genentech, Quintiles, Bristol-Myers-Squibb, Ipsen, Vertex, and Aradigm Corporation. In his career, he was instrumental in obtaining successful marketing authorizations worldwide, including in the U.S., Canada, and the E.U. As Chief Medical Officer and Head of Regulatory Affairs of Aradigm Corporation, he initiated, oversaw, and completed a Phase 3 trial program with a liposomal formulation of ciprofloxacin for inhalation in patients with non-cystic fibrosis bronchiectasis (NCFBE) and chronic Pseudomonas aeruginosa lung infections, which resulted in a New Drug Application (NDA) and Marketing Authorization Application (MAA) submission. He was an invited panel member at a U.S. Food and Drug Administration (FDA) workshop in 2018 for inhaled antibiotics in cystic fibrosis and NCFBE.

“I am fully committed to helping companies bring novel treatments to patients with serious unmet medical needs, and I look forward to supporting Appili Therapeutics in this endeavor,” said Dr. Froehlich. “The important work the company is doing to advance anti-infectives is part of the global effort to combat resistant pathogens. I am pleased to share my insights on specific global and local regulatory requirements, clinical-stage planning, and the transition from developmental to commercial activities as the Company progresses its portfolio.”

Mr. Mortimer has served as an Appili Board Member since 2017. He is currently the President and Chief Financial Officer of Xenon Pharmaceuticals – a clinical stage biotech that develops therapeutics for neurological disorders. He continued, “Having leadership roles in multiple biotech companies in my 20-plus year career, I have been impressed with the tremendous strides Appili has made, progressing quickly from a start-up to a publicly traded entity with four dynamic pipeline assets, and I look forward to serving as the Company’s Board Chair. My fellow board members and the Appili leadership team are grateful to Steve for his leadership and guidance during his tenure as an Appili Director over these past three years.”

Stephen Nicolle joined Appili’s Board in 2017 as the Company’s first independent Director and was instrumental in the early stages of Appili’s formation and development. He served as Appili’s Board Chairman since February 2019.

The Company granted Dr. Froehlich 140,000 stock options under Appili’ Stock Option Plan as part of his role as a new director. The stock options will be exercisable at $0.815 per share and will have a term of ten years and will vest over a period of three years. The press release dated December 3, 2019, incorrectly had included these 140,000 in the total of stock options granted as well as the incorrect date of grant. On December 2, 2019, a total of 1,855,000 stock options were granted.

About Appili Therapeutics

Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies. 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, without limitation, those listed in the annual information form of the Company dated July 3, 2019 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.

Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.

Media Relations Contact:
Andrea Cohen
Sam Brown Inc.
T: 917-209-7163
E: [email protected]

Investor Relations Contact:
Kimberly Stephens, CFO
Appili Therapeutics Inc.
TSXV: APLI
E: [email protected]

January 7, 2020

Dear Appili Stakeholder:

I want to take the opportunity to thank you for your support after an incredibly active and important year at Appili Therapeutics. Since accepting the position of CEO in December, I have spoken with many stakeholders and have thoroughly enjoyed the opportunity to hear your thoughts and to continue to tell the Appili story.

The need for anti-infective innovations has never been clearer. With signals for more favorable market conditions for companies like Appili, we remain poised to deliver on our mission: identify and advance programs for urgent needs in the infectious disease space.

Appili is purposefully unique in its approach to addressing those needs and our success as a company will continue to be tied to the work we do as a team. We will continue to build a distinguishable company with great employees and a corporate culture that continually strives to solve serious problems in infectious diseases. We had a notable 2019 and look forward to continuing that success in 2020!

Key 2019 Operational Highlights

• In July, we successfully completed the transition to a public company when Appili began trading on the TSX Venture Exchange under the ticker symbol ‘APLI’
• In December, I was honored to accept the CEO title for Appili. I look forward to using my experience coordinating regulatory, government, and clinical development to spur value creation and address unmet patient needs in the anti-infective space

2019 Pipeline and Clinical Advancements

• ATI-2307: We successfully acquired a new anti-infective asset with exclusive worldwide rights (ex-Japan). With a highly differentiated mechanism of action that is not currently susceptible to existing resistance mechanisms, ATI-2307 is being developed to address drug-resistant fungal infections that pose a significant health threat and have limited treatment options
• ATI-1501: In December, we entered into a commercialization agreement with Saptalis Pharmaceuticals LLC for our taste-masked liquid oral suspension of the antibiotic metronidazole. Through this agreement, Appili is eligible to receive multiple milestone and royalty payments; Saptalis will be responsible for overseeing the regulatory review, manufacturing and preparation for the anticipated commercialization of ATI-1501 in the U.S.
• ATI-1701: Our research partners presented positive interim data on Appili’s ATI-1701 program at the Chemical and Biological Defense Science & Technology Conference (CBD S&T), which showed in preclinical models complete (100%) protection 90 days after vaccination from lethal exposure to Francisca tularensis. This promising positive incremental data are supportive of continued work towards completing the pivotal studies needed for FDA submission and approval of the first vaccine for the prevention of weaponized tularemia.
• ATI-1503: We received a $3M US grant from the US Department of Defense to continue advancing our ATI-1503 antibiotic program, which targets drug-resistant, Gram-negative bacteria also known as ‘superbugs.’ The ATI-1503 program has the ability to target 4 out of 6 “ESKAPE” pathogens, which are the leading cause of hospital acquired infections worldwide

2020: Continuing to Differentiate

At Appili, we have made a conscious choice to maintain a diversified anti-infectives portfolio to address fungal infections, protect against bioweapons, and develop novel antibiotics. We will seek to build real value by virtue of our diversified portfolio that addresses true unmet needs while also leveraging market incentives like the Priority Review Voucher program, biodefense stockpiling, and niche indications with lower barriers to entry. We will continue to seek out opportunities to further build a distinguishable product portfolio that leverages market incentives that differentiates Appili from other companies in our space.

Thank you for your ongoing support and interest. We look forward to executing on additional opportunities to tackle serious public health challenges and generate shareholder value as we strive to do well by doing good.

Armand Balboni, MD, PhD
Chief Executive Officer, Appili Therapeutics

HALIFAX, Nova Scotia, December 3, 2019 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced that it has entered into a commercialization agreement with Saptalis Pharmaceuticals LLC, a New York-based specialty pharmaceuticals company, on ATI-1501, Appili’s liquid suspension reformulation of the antibiotic metronidazole. Under the terms of the agreement, Appili is eligible to receive multiple milestone and royalty payments on the sale of ATI-1501 in the U.S. In addition, Saptalis will be responsible for overseeing the regulatory review, manufacturing and preparation for the anticipated commercialization of ATI-1501 in the U.S.

“Infectious diseases form the basis of some of the most urgent public health threats in today’s treatment landscape. Our approach to drug development is to identify overlooked infectious disease assets that address significant needs in the marketplace, and advance them through the drug development process,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “Having completed clinical development for ATI-1501 at Appili, we are pleased to find a strong partner who can take the program through FDA review and market launch, upon regulatory approval. This agreement with Saptalis is a win for our shareholders, clinicians and patients seeking better treatment options.”

ATI-1501 is a proprietary, novel, taste-masked oral liquid formulation of metronidazole – a broad-spectrum and widely prescribed antibiotic used to treat parasitic and anaerobic bacterial infections.[i] Currently, oral metronidazole is only available as a solid tablet or capsule in the U.S. and Canada; no liquid oral dose forms are approved. The tablet’s bitter taste is so pronounced that it appears as an adverse event on the drug’s label. An increasing number of patients with dysphagia (difficulty swallowing) are unable to take the tablet and require it to be crushed into food. This process amplifies the pronounced bitter taste, which can negatively impact patients’ adherence to their prescription.

Appili began developing ATI-1501 to solve a significant and growing issue for patients who cannot tolerate the current tablet formulation of metronidazole.[ii] [iii] [iv] Appili’s market research shows a potential for more than 600,000 patients in the U.S. who could benefit from the program, with additional potential upside beyond this core target market.

“We are excited to form a partnership with Appili on their ATI-1501 program, which is a good fit for Saptalis’ focus on developing difficult-to-formulate dosage forms and novel drug delivery approaches, including liquid suspensions,” said Polireddy Dondeti, PhD, Chief Executive Officer at Saptalis Pharmaceuticals, LLC.  “We have a great team and a great facility here at Saptalis with the resources to efficiently manufacture the product to commercial scale, to complete regulatory review and, ultimately, to launch the antibiotic in a timely fashion.”

“Securing this agreement with Saptalis shortly after taking Appili public is an important milestone that demonstrates Appili’s ability to identify promising opportunities, develop and add value to those programs, and monetize those opportunities for the benefit of shareholders and patients,” continued Dr. Balboni. “We look forward to executing on additional opportunities to tackle serious public health challenges and generate shareholder value as we strive to do well by doing good.”

Stock Option Grant

The Company granted 1,995,000 stock options under Appili’ Stock Option Plan to the Company’s employees, officers, directors and investor relations consultant.   The stock options will be exercisable at the closing price of the Appili common shares on Wednesday, December 4, 2020, and will have a term of ten years and will vest over a period of three years (over one year for the investor relations consultant).

About Appili Therapeutics

Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this challenging disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health. Appili acquired ATI-2307, a novel, broad spectrum, clinical stage antifungal, in development to address severe and difficult-to-treat invasive fungal infections. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, being developed to mitigate the risks of a very serious biological weapons threat. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, which are a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with science and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

About Saptalis Pharmaceuticals LLC

Saptalis Pharmaceuticals, LLC (“Saptalis”) is a rapidly growing pharmaceutical company specialized in development, manufacturing and marketing of generic and branded products in liquid and semi-solid dosage forms. The Company is focused on development of complex formulations of sterile and non sterile medicines, including nanosuspensions and microemulsions. Saptalis’ goal is to build value through commercialization of selected branded and generic prescription products. In addition to the diverse pipeline of generic products, the Company is developing innovative products, such as improved formulations of existing  medicines to address unmet patient needs.

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.

Forward looking statements

This news release contains “forward-looking statements” which reflect the current expectations of the Company’s management 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, without limitation, those listed in the annual information form of the Company dated July 3, 2019 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.

Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.

###

Appili Therapeutics Contacts:

Media:
Andrea Cohen
Sam Brown Inc.
T: 917-209-7163
E: [email protected]

Investor Relations:
Kimberly Stephens, CFO
Appili Therapeutics
TSXV: APLI
E: [email protected]

[i] IQVIATM 2014-2017 NPA, ‘metronidazole’; IQVIATM 2016-2017 CDM, ‘metronidazole’

[ii] Baguley (2012) Arch Dis Child: Prescribing for children – taste and palatability affect adherence to antibiotics: a review.

[iii] Hoppe (1996) Pharmacoeconomics

[iv] Boateng (2017) J Pharm Sci