Category: Archives 2022

HALIFAX, Nova Scotia, November 14, 2022– Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced that the U.S. Department of Defense (“DOD”), via the Joint Science and Technology Office of the Defense Threat Reduction Agency (“DTRA”) in partnership with the U.S. Air Force Academy (“USAFA”), will provide at least US$14 million in funding over two years to fund  the development of ATI-1701. ATI-1701 is a potential first-in-class vaccine candidate for the prevention of infection with aerosolized Francisellatularensis,a top-priority biothreat.

Appili is expected to partner with USAFA to advance the program. This revised funding represents a 40% increase over the originally anticipated DTRA funding for this program, as announced in February 2022. With DTRA’s additional support, work on ATI-1701 is expected to include nonclinical, manufacturing, and regulatory activities to prepare for an Investigational New Drug (“IND”) application to the United States Food and Drug Administration (“FDA”).  If approved by the FDA, ATI-1701 may be eligible for a Priority Review Voucher.

“We are excited to announce the funding from DTRA in partnership with USAFA for Appili’s ATI-1701 as it will help in addressing an urgent risk to public health. This funding is expected to strengthen Appili’s foundation in infectious disease and biodefense,” said Dr. Don Cilla, Pharm.D., M.B.A., Appili’s President and CEO.

 

About ATI-1701 and DTRA Contract

Appili owns the commercial rights to, and is developing, ATI-1701 as a vaccine to prevent Francisella tularensis, which has been classified as a Category A pathogen by the U.S. National Institutes of Health due to its high rates of infectiousness and ability to cause lethal pneumonia and systemic infection. As the transmission of Francisella tularensis in the aerosolized form can be more infectious than anthrax, it is considered to be a high bioterrorism threat.

Earlier this year, Appili announced positive one-year results from its preclinical study evaluating the efficacy of biodefense vaccine candidate ATI-1701 in a lethal animal model of tularemia. A one-year survival rate of 29% (n = 2/7) was reported in the ATI-1701 vaccinated cohort, compared to 0% (n = 0/5) in mock vaccinated controls. The positive data built on previously reported efficacy results observed at 28- and 90-day challenge timepoints where there was 100% survival of ATI-1701 vaccinated animals at the 90-day challenge timepoint. These data position ATI-1701 to potentially become the first approved vaccine for the prevention of tularemia. The study was funded by DTRA and conducted by MRIGlobal.

The DTRA funding will initially be advanced to USAFA, as the prime contractor under the supervision of Dr. Balboni as principal investigator. As noted above, Appili is expected to partner with USAFA, subject to negotiating definitive documentation governing the terms of such engagement.

The expected total program funding amount is ~US$14 million, with a portion of the funding subject to future U.S. federal budget approval. This funding is expected to advance the ATI-1701 program to an IND submission to the FDA in 2024.

 

Appili Leadership Transition

As part of today’s announcement, Dr. Armand Balboni has been appointed as Chair of the Board of Directors of Appili and will continue providing oversight and guidance to Appili’s overall portfolio, with a specific focus on the ATI-1701 Program for which he will serve as Principal Investigator. Dr. Balboni will be returning to the Department of Defense as a LT. Colonel, faculty member and Director of the Life Sciences Research Center at USAFA.

Don Cilla, Pharm.D., M.B.A., who has served as Appili’s Chief Development Officer for two years, has been promoted to the position of President and Chief Executive Officer of Appili. Dr. Cilla has over 35 years of experience in the pharmaceutical industry, serving in key leadership roles across research and development in pharmaceutical, biotech and generic drug companies. In prior roles, Dr. Cilla led and participated in the global development of more than 40 products, of which six products are clinically and commercially successful.

“I am delighted to be chosen for this tremendous opportunity to build on Appili’s foundation and to renew our focus in infectious disease and biodefense treatments. We’re grateful for this funding, which will advance ATI-1701 to the next stage of development” said Dr. Cilla.

In his new role as President and Chief Executive Officer, Dr. Cilla will also join Appili’s Board of Directors. Additional Board changes include Ian Mortimer stepping down as Chair of the Board and Director and Dr. Theresa Matkovits being appointed as Lead Independent Director.

“I have forged a strong relationship with Don as the Chief Development Officer at Appili and I’m excited for Don to move into the Chief Executive Officer role given his tremendous track record in drug development,” said Dr. Balboni. “I also want to extend my gratitude to Ian Mortimer for his years of service on our Board and as Board Chair, where we have benefited greatly from his leadership and guidance.”

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About ATI-1701

Appili is developing ATI-1701 as a vaccine to combat Francisella tularensis, which is classified by the U.S. National Institutes of Health (NIH) as a Category A pathogen, an organism that poses the highest risk to national security and public health. Estimated to be 1,000-fold more infectious than anthrax, experts consider the aerosolized form to have a high potential for use in a bioterrorism attack.

 

About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including a vaccine candidate to eliminate a serious biological weapon threat, a topical antiparasitic for the treatment of a disfiguring disease, and a novel easy to use, liquid oral formulation targeting parasitic and anaerobic infections.  Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

 

Forward-Looking Statements

This news release contains “forward-looking statements”, including with respect to the anticipated funding amount, the anticipated timing of such funding, the Company’s ongoing development plans and timeline with respect to ATI-1701 and the Company’s expected cash runway. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for,” and similar expressions have been used to identify these forward-looking statements.

Forward looking statements contained in this press release are provided in reliance on certain assumptions, including with respect to the satisfaction of all conditions precedent to the advancement of the full anticipated funding (including receipt by DTRA of any requisite U.S. federal budget approvals, general development plans with respect to ATI-1701, general access to data required to support regulatory submissions,  expected PRV eligibility for ATI-1701, and the nature and scope of the services to be provided by Appili to USAFA with respect to advancing the ATI-1701 program). Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, the Company cannot give assurance that these expectations will prove to have been correct.

Forward looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, the risk that the final conditions governing the funding and the relationship of between Appili and USAFA may not be satisfactory to the Company , the final funding amount may be different than that communicated herein (including as a result of the failure to secure the requisite US government budget approvals), receipt of funding may be delayed in the event that any remaining conditions are not satisfied in a timely manner, ATI-1701 may ultimately be determined not to be PRV eligible, other standard risks associated with governmental grants of this nature and the other risk factors listed in the annual information form of the Company dated June 23, 2022 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

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

 

Investor Relations Contact:
Jenna McNeil; Corporate Affairs and Communications Manager
Appili Therapeutics
E: [email protected]

HALIFAX, Nova Scotia, November 10, 2022 – Appili Therapeutics Inc. (TSX:APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced its financial and operational results for the second quarter of its fiscal year 2023, which ended on September 30, 2022. 

“We continue to move significantly closer to being able to provide a safe and effective vaccine for the bacteria Francisella tularensis, which poses a great threat to public health and is considered by many governments to be a top-priority biothreat,” said Don Cilla, Pharm.D., M.B.A., Chief Development Officer of Appili Therapeutics. “As both biothreats and threats from infectious diseases continue to pose great challenges to communities around the world, we’re grateful for the anticipated commitment of over $US10 million in new funding from the Department of Defense’s Defense Threat Reduction Agency (DTRA).”

Second quarter and recent operational highlights include:

• Announced a commitment of over US$10 million in funding from DTRA to advance our biodefense tularemia vaccine candidate ATI-1701 to help combat the bacteria Francisella tularensis, the causative agent of tularemia and a top-priority biothreat. Appili expects this program may be eligible for a Priority Review Voucher (“PRV”) if approved by the United States Food and Drug Administration (“FDA”).
• Remain on track to seek FDA approval by the end of 2023 for ATI-1501, our liquid oral formulation of the antibiotic metronidazole which was designed to help patients burdened by difficult-to-treat bacterial infections.
• Presented an update, including Phase 3 efficacy data, on our cutaneous leishmaniasis product, topical paromomycin, ATI-1801 at the WorldLeish7 Conference in Cartagena, Colombia. ATI-1801 may be eligible for a valuable Priority Review Voucher if approved by the FDA.

 

Financial Results

The Company prepares its financial statements in accordance with IFRS as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook–Accounting. All figures are stated in Canadian dollars unless otherwise stated.

The net loss and comprehensive loss of $4 million or $0.04 loss per share for the six months ended September 30, 2022 was $14.5 million lower than the net loss and comprehensive loss of $18.5 million, or $0.30 loss per share, during the six months ended September 30, 2021. This relates mainly to a decrease in research and development expenses by $14.9 million, a decrease in general and administrative expenses by $0.3 million, and a decrease in business development by $0.5 million. These decreases were offset by an increase in financing costs by $0.2 million, an increase in foreign exchange loss by $0.4 million, and a decrease in government assistance by $0.5 million.

As of September 30, 2022, the Company had cash of $2.4 million, compared to $6.7 million on March 31, 2022. As of November 9, 2022, the Company had 121,226,120 issued and outstanding Common Shares, 8,293,040 stock options, and 49,817,879 warrants outstanding.

This press release should be read in conjunction with the Company’s unaudited interim condensed financial statements for the second quarter of the 2023 fiscal year and the related management discussion and analysis (MD&A), copies of which are available on SEDAR at www.sedar.com.

 

Appili Portfolio Reprioritization

Appili also announced plans to focus its resources on advancing its portfolio of infectious disease and biodefense assets, including ATI-1701, ATI-1801, and ATI-1501. The Company will discontinue development of its remaining portfolio programs ATI-2307, a broad-spectrum anti-fungal, and ATI-1503, a broad-spectrum antibiotic targeting multi-drug resistant Gram-negative bacteria.

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About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including a vaccine candidate to eliminate a serious biological weapon threat, a topical antiparasitic for the treatment of a disfiguring disease, and a novel, easy to use, liquid oral formulation targeting parasitic and anaerobic infections. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

 

Forward Looking Statements

This news release contains “forward-looking statements”, including with respect to the Company’s development of its products and expected funding arrangements. 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, risks and assumptions related to securing the full anticipated funding from DTRA and those risks, uncertainties and assumptions listed in the annual information form of the Company dated June 23, 2022 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

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

 

Investor Relations Contact:
Jenna McNeil, Communications Manager
Appili Therapeutics
E: [email protected]

HALIFAX, Nova Scotia, August 12, 2022 – Appili Therapeutics Inc. (TSX:APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced its financial and operational results for the first quarter of its fiscal year 2023, which ended on June 30, 2022.

“As threats from both known and emerging infectious diseases loom around the world, I’m proud that Appili is working to advance our pipeline of critical infectious disease and biodefense programs,” said Armand Balboni, M.D., Ph.D., Chief Executive Officer of Appili Therapeutics. “Following our recent presentation at WorldLeish7, we are even closer to making available ATI-1801, an urgently needed treatment for those suffering from cutaneous leishmaniasis, a disfiguring infection of the skin. We look forward to continuing this momentum and hope to announce reinforced support from the Defense Threat Reduction Agency for our biodefense tularemia vaccine candidate ATI-1701, and with the help of our partners, receive FDA Approval for ATI-1501, a liquid oral reformulation designed to help patients burdened by difficult-to-treat bacterial infections.”

First quarter and recent operational highlights include:

• Announcing commitment of over US$10 million in new funding from DTRA to advance for our biodefense tularemia vaccine candidate ATI-1701 to help combat the bacteria Francisella tularensis, the causative agent of tularemia and a top priority biothreat.
• Attending at the WorldLeish7 Conference in Cartagena, Colombia, and presenting update on new clinical program ATI-1801 for the treatment of cutaneous leishmaniasis that may be eligible for a valuable Priority Review Voucher
• Securing a non-convertible loan of US $3.6 million, and a licence and distribution agreement with Long Zone Holdings Inc.
• Completing equity financing of $4,500,000 in gross proceeds.

 

Financial Results

The Company prepares its financial statements in accordance with IFRS as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook–Accounting. All figures are stated in Canadian dollars unless otherwise stated.

The net loss and comprehensive loss of $2.32 million or $0.03 loss per share for the three months ended June 30, 2021, was $5.04 million lower than the net loss and comprehensive loss of $7.36 million or $0.12 loss per share during the three months ended June 30, 2021. This relates mainly to a decrease in research and development expenses by $5.09 million, a decrease in business development of $0.4 million, and a decrease in income tax expense of $0.01 million. These decreases were offset by an increase in general and administrative expense by $0.08 million, an increase in financing cost of $0.15 million, a decrease of government assistance of $0.22 million and a decrease in interest income by $0.01 million.

As of June 30, 2022, the Company had cash and short-term investments of $5.55 million, compared to $6.66 million on March 31, 2022. As of August 13, 2022, the Company had 121,226,120 issued and outstanding Common Shares, 8,656,905 stock options, and 49,817,879 warrants outstanding.

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

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About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including, a vaccine candidate to eliminate a serious biological weapon threat, a topical antiparasitic product for the treatment of a disfiguring disease, a broad-spectrum antifungal, 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 Company’s development of its products and expected funding arrangements. 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, 2022 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

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

 

Investor Relations Contact:
Armand Balboni, CEO
Appili Therapeutics
E: [email protected]

HALIFAX, Nova Scotia, August 2, 2022– Appili Therapeutics Inc. (TSX:APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced that Armand Balboni, M.D, Ph.D, Chief Executive Officer, and Yoav Golan, M.D, Chief Medical Officer of Appili, will participate at the seventh iteration of WorldLeish, from August 1 to 6 2022, and present an update on Appili program ATI-1801.

The presentation will include an overview of, Appili’s new late-stage program ATI-1801to treat cutaneous leishmaniasis (“CL”), the most common form of leishmania that affects hundreds of thousands of people around the world annually and is characterized by the formation of lesions and ulcers that often lead to scarring, disfigurement, and stigmatization for those infected. CL is a serious impediment to socioeconomic development, especially for women, and a priority for public health authorities and non-governmental organizations around the world.

Presentation details for Appili are as follows:

Date: August 4th , 2022
Time: 10AM COT / 11AM ET
Location: Programa de Estudio y Control de Enfermedades Tropicales of the Universidad de Antioquia, Colombia

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

 

About ATI-1801

Licensed from the U.S. Department of Defense through the U.S. Army Medical Materiel Development Activity, Appili’s ATI-1801 is a novel topical product with demonstrated safety and efficacy across multiple Phase 2 and Phase 3 studies. As current treatments are often invasive and require hospitalization, ATI-1801 has the potential to significantly reduce suffering from CL by providing patients in need with a safe and effective topical therapy that can be used in the outpatient setting.

“ATI-1801 is a unique opportunity to build on an extensive data set and bring an urgently needed treatment to patients around the world” said Dr. Armand Balboni, M.D., Ph.D., Chief Executive Officer of Appili Therapeutics. “Appili is proud to play a part in developing a solution to this long-neglected disease, and Dr. Golan and I are greatly looking forward to sharing our progress at WorldLeish7.”

 

About WorldLeish

WorldLeish is the world’s most important academic and scientific event on leishmaniasis, a disfiguring skin infection that affects hundreds of thousands of people around the world annually.

In its seventh version, WorldLeish expects the participation of 1,000 researchers, health professionals, and authorities and from all over the world who will meet to discuss and share the latest advances in research and successful experiences around neglected tropical diseases. As well as strengthening alliances between companies, governments, research and technology centers around a common interest: to be able to control, prevent and find new treatment alternatives for leishmaniasis as a global public health problem.

 

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 the potential for ATI-1801 as a treatment for CL. 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, 2022, and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

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

 

Investor Relations Contact:
Armand Balboni, CEO
Appili Therapeutics
E: [email protected]

HALIFAX, Nova Scotia, May 26, 2022 – Appili Therapeutics Inc. (TSX: APLI) (the “Company” or “Appili”) announced the closing of its previously announced public offering (the “Offering”) of units (the “Units”). The Offering was made pursuant to an agency agreement, as amended, entered into between the Company, Bloom Burton Securities Inc. (the “Lead Agent”) and Leede Jones Gable Inc. (collectively with the Lead Agent, the “Agents”).

Pursuant to the Offering, the Company issued a total of 50,000,000 Units at a price of $0.09 per Unit for aggregate gross proceeds of $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 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 $0.15 per Warrant Share until May 26, 2027.

“We are grateful for the support of our shareholders who recognize, as we do, the public health threat posed by infectious diseases and the value of developing new medicines to treat or prevent infections” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “With this new funding and the support of our partners, we will continue to advance our diversified pipeline which includes multiple clinical stage therapies and potentially three priority review voucher eligible programs, including ATI-1701, our US Department of Defense supported biodefense vaccine candidate for the prevention of tularemia.”

The Units were qualified for sale by way of a prospectus supplement dated May 20, 2022 to the short base shelf prospectus of the Company dated May 16, 2022 (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 $315,000. As additional consideration, the Agents have received 3,500,000 broker warrants (“Broker Warrants”). Each Broker Warrant is exercisable for one Common Share (a “Broker Warrant Share”) at a price of $0.095 per Broker Warrant Share until May 26, 2024.

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 as further set out in the Prospectus.

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

As partial consideration for its services in connection with the Offering, the Lead Agent received 1,189,579 Broker Warrants. Prior to the closing of the Offering, the Lead Agent together with Bloom Burton & Co. Inc. and Bloom Burton Development Corporation (collectively, “Bloom Burton”), each an affiliate of the Lead Agent, beneficially owned, directly and indirectly, an aggregate of 14,358,611 Common Shares, 280,777 share purchase warrants (the “First Previously Held Broker Warrants”) exercisable into 280,777 Common Shares at a price of $1.20 per Common Share until June 10, 2022, 128,674 share purchase warrants (the ”Second Previously Held Broker Warrants”) exercisable into 128,674 Common Shares at a price of $0.83 per Common Share until October 14, 2023, representing approximately 20.15% of the then issued and outstanding Common Shares on a non-diluted basis, and 20.60% of the then issued and outstanding Common Shares on a partially-diluted basis, assuming the exercise of the First and Second Previously Held Broker Warrants held by Bloom Burton and its affiliates only.

Immediately following closing of the Offering, Bloom Burton beneficially owns, directly or indirectly, 14,358,611 Common Shares, 280,777 First Previously Held Broker Warrants, 128,674 Second Previously Held Broker Warrants and 1,189,579 Broker Warrants, representing 11.84% of the Common Shares issued and outstanding on a non-diluted basis and 12.99% of the Common Shares issued and outstanding on a partially-diluted basis, assuming the exercise of the First Previously Held Broker Warrants, Second Previously Held Broker Warrants and the Broker Warrants held by Bloom Burton only.

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

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

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About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. 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 use of proceeds and filing of the Lead Agent’s early warning report. 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 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, 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.

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About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including a broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, 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, May 17, 2022 – Appili Therapeutics Inc. (TSX: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, today announced that it will undertake an overnight marketed public offering (the “Offering”) of units (the “Units”), comprised of Class A common shares and Class A common share purchase warrants (“Warrants”). 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 May 16, 2022 (the “Base Shelf 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 Leede Jones Gable 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 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 in the United States (as 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 in the United States.

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About Appili Therapeutics

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