Author: rajarshi

HALIFAX, Nova Scotia, May 11, 2020 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced that it will sponsor the first clinical trial evaluating FUJIFILM Toyama Chemical’s (FFTC) drug favipiravir for the prevention of COVID-19, a respiratory infection caused by the novel SARS-CoV-2 coronavirus. Favipiravir is approved in Japan as the anti-influenza drug Avigan. With FFTC providing support through donated drug product, the phase 2 study will be conducted at long-term care facilities in Ontario. Appili has filed the clinical trial application (CTA) with Health Canada and expects to initiate the trial as soon as possible following receipt of regulatory clearance.

“As the world races to address the COVID-19 pandemic, Appili is proud to support this endeavour that is looking at this problem specifically in Canada’s most vulnerable patients, establishing a world-class clinical program and significant contribution to the global dataset that is needed to help address this crisis,” said Armand Balboni, MD, PhD, Chief Executive Officer, Appili Therapeutics. “Appili was built to tackle the most urgent needs in infectious diseases in innovative ways that no other organization could or would be willing to take on. This program illustrates our commitment to leverage our relationships and expertise to do the right thing for patients and public health.”

Favipiravir is a broad-spectrum antiviral developed by FFTC and approved in Japan under the brand name Avigan. Japanese health authorities provided approval to FFTC in 2014 to use Avigan as a treatment in a pandemic influenza outbreak. Favipiravir was also used in a clinical trial to address the Ebola outbreak in Guinea. FFTC is actively supporting several controlled clinical trials for favipiravir to investigate its use against COVID-19. Recent studies suggest favipiravir may have potential utility for the treatment of COVID-19.     Researchers in Wuhan, China, reported in early February that favipiravir demonstrated anti-viral activity in vitro against SARS-CoV-2. Small-scale trials conducted in China have also indicated that favipiravir may provide clinical benefit in patients with COVID-19.

“We have an ongoing relationship with Appili and are pleased to support the company in its efforts to assess favipiravir for the potential benefit of Canadian patients,” said Junji Okada, President of FFTC. “We are well-aligned with Appili in our commitment to innovative R&D work that may address public health crises by mitigating the threat of deadly infections.”

The cluster randomized placebo-controlled trial (cluster-RCT) will recruit patients at multiple long-term care facilities throughout Ontario. The primary endpoint will be the safety and efficacy of favipiravir in the prevention of further outbreak in long-term care facilities. Secondary endpoints will assess favipiravir’s potential to inhibit disease progression in this subject population. As of May 2020, the majority of deaths in Canada resulting from COVID-19 have occurred in long-term care facilities, making this population especially vulnerable to the pandemic.

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, including statements with respect tothe scope,parameters and particulars of the proposed clinical trial and the likelihood that the clinical trial will be consummated on the terms and timeline provided herein or at all. 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: securing all requisite regulatory approvals (including Health Canada approval) and funding for the clinical trial;  finalizing a mutually acceptable clinical trial agreement and related agreements with the applicable clinical research organizations relating to this clinical trial; the state of the current market conditions and their anticipated impact on the Company’s business; and other expectations and assumptions concerning the proposed clinical trial.  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, economic, competitive, political and social uncertainties; known and unknown risks and liabilities relating to the ongoing COVID-19 pandemic; risks relating to the inability of Appili to secure any requisite rights to manufacture and commercialize favipiravir in Canada on favourable terms or at all; unforeseen events, developments, or factors causing any of the aforesaid expectations and assumptions not to be correct; and the other risk factors 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.

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[i] Cai et al (2020) Experimental Treatment with Favipiravir for COVID-19: An Open-Label Control Study. Engineering. https://doi.org/10.1016/j.eng.2020.03.007

[ii] Chen et al (2020) Favipiravir versus arbidol for COVID-19: A Ranomized Clinical Trial. medRxiv preprint doi: https://doi.org/10.1101/2020.03.17.20037432

Media Relations Contact:
Canadian Media:
Chantal Allan
Sam Brown Inc.
T: 805-242-3080
E: [email protected]

American/Trade Media:
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, April 21, 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 Yoav Golan, MD, to serve as the Company’s first Chief Medical Officer (CMO). Dr. Golan has spent his 25+ year-career as an infectious disease (ID) medical specialist, most recently serving as an attending physician in the Division of Geographic Medicine and Infectious Diseases at Tufts Medical Center, and as an associate professor at Tufts University School of Medicine in Boston. In his role as Appili’s CMO, Dr. Golan will be responsible for the clinical development strategy and execution across all of Appili’s pipeline assets, which is comprised of a broad spectrum of antimicrobial candidates. In particular, he will be a leadership resource for applying medical and scientific rigor to Appili’s clinical programs.

“As Appili’s pipeline assets progress toward active clinical trials, and our focus expands to include multiple types of antimicrobial programs, now is the optimal time to add patient-centered medical expertise to our leadership team,” said Armand Balboni, MD, PhD Chief Executive Officer, Appili Therapeutics. “We are thrilled to have an executive with Yoav’s caliber to lead our clinical programs; his lifelong commitment to patients and the breadth and depth of his infectious disease acumen will be invaluable resources for our work.”

Dr. Golan has conducted extensive research in the ID space, publishing several books and over 50 peer-reviewed studies in journals including The New England Journal of Medicine and The Lancet Infectious Diseases. His research focuses on hospital-acquired infections with emphasis on ICU infections, the impact of antibiotic resistance on outcomes, and development of early culture-independent treatment strategies. Dr. Golan’s recent work has focused on C. difficile infections as well as invasive candidiasis. He has been involved in the development of multiple anti-infectives, including, fidaxomicin, ceftaroline and bezlotuximab.

In addition to his work at Tufts, he has served several executive positions at biotechnology companies, including as Chief Scientific Officer of Profility Inc. and as Chief Executive Officer, ExArca Pharmaceuticals. He is on the peer review committee of multiple medical and scientific journals and is a member of numerous medical societies, including the Infectious Disease Society of America and the American Society for Microbiology. Dr. Golan is a graduate of the Hadassah School of Medicine at the Hebrew University in Jerusalem, Israel. He completed a medicine residency and Infectious Diseases fellowship at the Tel Aviv Sourasky Medical Center, followed by a transplant ID fellowship and masters in statistics and modeling at Tufts University School of Medicine.

“Now more than ever, we need strong, creative, and viable solutions to address the increasing threat of emerging infections,” said Dr. Golan. “Appili is doing excellent work to advance critical programs in the infectious disease space, and I look forward to continued work with the Board and the Company’s leadership team to advance research and help the patients who need better anti-infective options.”

Dr. Golan has served Appili in an advisory capacity since the Company’s inception in 2016. He will initially join Appili’s leadership team in a part time role and plans to maintain his work with Tufts Medical Center, also in a part-time capacity.

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
TSX-V: APLI
E: [email protected]

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.

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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 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.

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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.

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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.

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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.

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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.

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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]