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Appili Therapeutics Announces Closing of Public Offering of $15,525,000 and Concurrent Private Placement of $1,440,000

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Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”) announced the closing of its previously announced public offering (the “Public Offering”) of units (the “Units”). The Public Offering was made pursuant to an agency agreement entered into with a syndicate of agents led by Bloom Burton Securities Inc. (the “Lead Agent”) and including Mackie Research Capital Corporation, Industrial Alliance Securities Inc., Haywood Securities Inc., and Richardson GMP Limited (collectively with the Lead Agent, the “Agents”) and the Company.

Pursuant to the Public Offering, the Company issued a total of 12,937,500 Units at a price of $1.20 per Unit for aggregate gross proceeds of $15,525,000, which includes the exercise in full by the Agents of their over-allotment option to purchase 1,687,500 additional Units for additional gross proceeds of $2,025,000. 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 $1.50 per Warrant Share until June 10, 2023.

“Appili has entered the global effort to solve the COVID-19 pandemic, and our team, along with our partners, including Fujifilm Toyama Chemical and Sinai Health, are working diligently to advance this randomized controlled trial as quickly and as thoroughly as possible,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “Appili was built to solve infectious disease problems, and we believe that favipiravir will be an important part of the arsenal that ultimately addresses this coronavirus pandemic. With the continued support from the investment community, the results of this fundraise bolsters our capacity to push forward our Phase 2 program, which is designed to address a critical unmet need for the most vulnerable COVID-19 patients.”

The net proceeds of the Public Offering will be used primarily towards funding planned research and development activities for the clinical trial sponsored by the Company evaluating FUJIFILM Toyama Chemical Inc.’s (“FFTC”) drug favipiravir in long-term care facilities as a potential preventative measure against COVID-19.

Health Canada Clears Appili Therapeutics’ Phase 2 Clinical Trial Evaluating Favipiravir as a Prophylactic Agent Against COVID-19 Outbreaks

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Appili Therapeutics Inc., a biopharmaceutical company focused on anti-infective drug development, today announced that Health Canada provided regulatory clearance for Appili’s Phase 2 study evaluating FUJIFILM Toyama Chemical’s (FFTC) favipiravir as a preventative measure against COVID-19 outbreaks. Dr. Allison McGeer, senior clinician scientist at Sinai Health’s Lunenfeld-Tanenbaum Research Institute in Toronto, Ontario is the study’s primary investigator. Appili expects trial recruitment to begin imminently. Researchers will enroll approximately 760 subjects, both residents and staff, at 16 long-term care homes (LTCHs) in Ontario. The National Institute on Ageing has estimated that as of May 6, 2020, 82 percent of deaths related to COVID-19 in Canada were associated with long-term care facilities.[i]

“Given the severity of COVID-19 amongst the elderly, and the evidence of ongoing transmission with severe outcomes in LTCHs, it is critical to develop interventions that minimize the spread of disease in this setting. As vaccines and treatment for COVID-19 remain unavailable, we must explore all possible solutions,” said Dr. McGeer. “We look forward to working with Appili on this study, as the pandemic continues to present devastating consequences for LTCH residents and their families.”

Appili Therapeutics Acquires Clinical Stage Antifungal Program From FUJIFILM Toyama Chemical

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Novel clinical-stage asset shows activity against drug-resistant fungal infections that pose a significant health threat and have limited treatment options

HALIFAX, Nova Scotia–(BUSINESS WIRE)–Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a publicly traded biopharmaceutical company focused on anti-infective drug development, announced today it has signed an agreement with FUJIFILM Toyama Chemical Co., Ltd. to acquire and develop the novel antifungal drug T-2307, which will now be called ATI-2307. This drug candidate is a novel broad-spectrum antifungal agent that has been evaluated in multiple preclinical studies and three human Phase I clinical trials. Today’s agreement with FUJIFILM Toyama Chemical assigns Appili exclusive worldwide rights (ex-Japan) to develop and commercialize this antifungal candidate. With the execution of the agreement, FUJIFILM Toyama Chemical is eligible to receive from Appili future regulatory and commercial milestones payments, as well as a royalty on future net sales.

“Appili was founded with the purpose of identifying, acquiring, and rapidly advancing the most promising anti-infective technologies,” said Appili CEO Kevin Sullivan. “The acquisition of this highly differentiated, clinical-stage program added immediate incremental value to the Company and is an exciting step forward as we continue to build our portfolio and deliver on our commitment of growing shareholder value and meeting patient needs by addressing urgent and underserved public health threats.”

ATI-2307 is a novel broad-spectrum antifungal with a highly differentiated mechanism of action that is not currently susceptible to existing resistance mechanisms. FUJIFILM Toyama Chemical researchers developed the compound internally. It exhibits broad-spectrum antifungal activity both in vitro and in vivo against multiple high priority and clinically important fungi, including Cryptococcus and the multi-drug resistant Candida species. FUJIFILM Toyama Chemical advanced ATI-2307 into clinical development and completed three Phase I clinical studies that demonstrated the drug candidate to be well tolerated in humans at anticipated therapeutic dose levels.

“FUJIFILM Toyama Chemical is excited to announce this agreement with Appili Therapeutics,” said Junji Okada, President and Chief Operating Officer of FUJIFILM Toyama Chemical. “Appili has demonstrated deep expertise in accelerating anti-infective drug development that is well aligned with FUJIFILM Toyama Chemical’s focus on innovative R&D in the area of infectious disease. FUJIFILM Toyama Chemical is committed to solving public health issues through innovation, high-value drug development, and accretive partnership. We are confident that Appili is the right partner to help maximize the potential of ATI-2307 and address the urgent threat of invasive and difficult-to-treat fungal infections.”

ATI-2307 has demonstrated activity against multiple difficult-to-treat fungi, including Cryptococcus and Candida species. Appili will initially focus on developing ATI-2307 for the treatment of cryptococcal meningitis. Cryptococcal meningitis is an opportunistic fungal infection that is a major cause of mortality worldwide.i ii The largest burden of the disease is found in immunocompromised patients in sub-Saharan Africa, South, and Southeast Asia, and is a growing problem in the North America and Europe with increasing numbers of solid organ transplant and cancer therapy treatments.iii iv In-hospital acute mortality from cryptococcal meningitis continues to remain high despite current therapies. The current standard of care for cryptococcal meningitis, which is amphotericin B in combination with flucytosine, is associated with significant toxicity, including the potential for kidney failure. v vi

“For many patients, standard-of-care antifungal agents are toxic and outcomes are poor,” said Dr. Armand Balboni, Appili’s Chief Development Officer. “Rising rates of antifungal resistance and the emergence of intrinsically resistant pathogens threaten to further erode an already inadequate antifungal armamentarium. Additionally, population aging and growing utilization of immunosuppressive therapies increasingly put patients at increased risk of fungal infections that are difficult to treat and cause severe strain on hospital resources and increase patient morbidity and mortality.

“Cryptococcal meningitis is a devastating disease with great unmet medical need. We think that ATI-2307 has great potential to provide a more effective and safer therapeutic option for patients with these invasive fungal infections,” continued Dr. Balboni.

In addition to cryptococcal meningitis, Appili is exploring development options for the treatment of refractory, resistant, or otherwise difficult to treat Candida infections. Despite the widespread availability of front-line azole and candin class antifungals, important segments of patients are infected with highly resistant or multi-drug resistant Candida species in which outcomes are poor.vi

About Appili Therapeutics

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

About FUJIFILM Toyama Chemical Co., Ltd

FUJIFILM Toyama Chemical was launched by merging FUJIFILM RI Pharma Co., Ltd., a company that conducts research, development, manufacture, and sales of radiopharmaceuticals, and TOYAMA CHEMICAL CO., LTD., a company that conducts research, development, manufacture, and sales of small molecule pharmaceutical products. FUJIFILM Toyama Chemical dedicates efforts to developing innovative diagnostic and therapeutic radiopharmaceuticals and therapeutic drugs with unique action mechanisms in the fields of “oncology,” “central nervous system diseases,” and “infectious diseases” where significant unmet medical needs still exist, with close collaboration with FUJIFILM Corporation, which focuses on research of new medicines. It will also advance the development of new medicines utilizing drug delivery system (DDS) technologies that deliver the required amount of a drug in a timely manner to a specific body area. Also, by exploring synergy with in vitro diagnostic (IVD) devices and reagents owned by Fujifilm group companies, the company will expand its offering of comprehensive solutions from “diagnosis” to “treatment.”

For more information of FUJIFILM Toyama Chemical, please visit http://fftc.fujifilm.co.jp/en/

Forward looking statements

This news release contains “forward-looking statements” which reflect the current expectations of the Appili’s management future growth, results of operations, performance and business prospects and opportunities. Wherever possible, words such as “may “, “would “, “could “, “should”, “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. Forward-looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in the annual information form of the Company dated July 3, 2019 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

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

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i Global burden of disease of HIV-associated cryptococcal meningitis: an updated analysis. Rajasingham R, Smith RM, Park BJ, Jarvis JN, Govender NP, Chiller TM, Denning DW, Loyse A, Boulware DR. Lancet Infect Dis. 2017 Aug;17(8):873-881. doi: 10.1016/S1473-3099(17)30243-8. Epub 2017 May 5

ii Cryptococcal infections in non-HIV-infected patients. Pappas PG. Trans Am Clin Climatol Assoc. 2013;124:61-79

iii Estimation of the current global burden of cryptococcal meningitis among persons living with HIV/AIDS. Park BJ, Wannemuehler KA, Marston BJ, Govender N, Pappas PG, Chiller TM. AIDS. 2009 Feb 20;23(4):525-30

iv Epidemiology of cryptococcal meningitis in the US: 1997-2009. Pyrgos V, Seitz AE, Steiner CA, Prevots DR, Williamson PR. PLoS One. 2013;8(2):e56269

v Clinical practice guidelines for the management of cryptococcal disease: 2010 update by the infectious diseases society of america. Perfect JR, Dismukes WE, Dromer F, Goldman DL, Graybill JR, Hamill RJ, Harrison TS, Larsen RA, Lortholary O, Nguyen MH, Pappas PG, Powderly WG, Singh N, Sobel JD, Sorrell TC. Clin Infect Dis. 2010 Feb 1;50(3):291-322

vi Renal impairment and amphotericin B formulations in patients with invasive fungal infections. Saliba F, Dupont B. Med Mycol. 2008 Mar;46(2):97-112

Contacts

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

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

Appili Therapeutics Signs $3M USD Grant Contract with the United States Department of Defense to Develop Antibiotics that Target Superbugs

Appili’s multi-drug resistant antibiotic program has the potential to address public health threats for both military and civilian populations worldwide.

HALIFAX, Nova Scotia, July 2, 2019 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, announced today that  the United States Department of Defense, (DOD) Congressionally Directed Medical Research Programs, Peer Reviewed Medical Research Program (PRMRP) has completed the contract awarding the Company a $3.0 million USD grant.

Appili will use the funds to continue advancing its ATI-1503 antibiotic program, which targets drug-resistant, Gram-negative bacteria also known as ‘superbugs.’ The ATI-1503 program has the ability to target 4 out of 6 “ESKAPE” pathogens, which are the leading cause of hospital acquired infections worldwide [i]. PRMRP grants support military health-related research that has the potential to make a strong impact on patient care.

​“Multi-drug-resistant bacteria continue to spread throughout the world, making them one of the most urgent public health threat we are facing worldwide,” said Kevin Sullivan, CEO of Appili Therapeutics. “We believe that the ATI-1503 program has the potential to address several of the most dangerous superbugs for the military and civilians alike, and we are grateful for PRMRP’s continued support of this promising novel antibiotic class.”

​According to the World Health Organization, drug-resistant bacteria, particularly the superbugs that are resistant to most or sometimes all available anti-infectives, are among the highest threats to human health worldwide. The U.S. Centers for Disease Control and Prevention (CDC) report that they are responsible for more than 2 million infections and 23,000 deaths each year in the U.S. alone. In addition to the widespread civilian vulnerabilities that they present, these superbugs pose serious challenges in both internationally deployed troops and domestic military personnel in veterans’ hospitals. The significance of these threats, and their prevalence worldwide, have made solutions to multi-drug resistant bacteria a priority research area for the Department of Defense (DOD).

​Appili’s ATI-1503 program is a new class of antibiotics based on the negamycin scaffold, which is a naturally occurring compound with intrinsic Gram-negative antibacterial activity.  The class has broad spectrum activity, which allows it to potentially address the deadliest Gram-negative bacteria, including the superbugs Klebsiella pneumoniae, Acinetobactor baumannii, and Pseudomonas aeruginosa.  These are high priority pathogens for the CDC and WHO because of the lack of effective antibiotic treatment options for the most resistant strains [ii][iii].

About the PRMRP Grant

This work is supported by the DOD Congressionally Directed Medical Research Programs through the PRMRP under Award No. W81XWH1910308. As previously disclosed, Appili was informed of the PRMRP grant in February 2019, but such grant remained subject to finalizing the definitive agreement.. Under the terms of PRMRP grants, the investigators conducting this research will adhere to the laws of the United States and regulations of the Department of Agriculture, as well as the CDC-NIH Guide for Biosafety in Microbiological and Biomedical Laboratories. For more information, visit http://cdmrp.army.mil.

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 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. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, being developed to mitigate the risks of a very serious biological weapons threat. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, which are a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, 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 ATI-1503 and the proposed use of proceeds from the PRMRP grant. 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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Media Relations Contacts:
Andrea Cohen, Sam Brown Inc.
T: 917-209-7163
E: [email protected]

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

ENTREVESTOR: Atlantic Canadian startups eyeing the stock market like never before

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The stock market is looming larger in the Atlantic Canadian startup community than it ever has before, as several leading companies are choosing public markets as the best option to secure long-term financing.

Just in the past week, Metamaterial Technologies Inc. of Dartmouth announced that it will seek a listing on the Canadian Stock Exchange, with a goal of raising more than $10 million. And shares of Halifax-based drug discovery company Appili Therapeutics began trading on the TSX Venture exchange.

In fact, stock markets have been a fruitful source of funding for the region’s high-growth innovation companies for the past 18 months, and the moves by MTI, Appili and others will only add fuel to a growing trend.

Atlantic Canadian companies raised more than $24 million by selling shares and derivatives on the stock markets in calendar 2018. That’s almost as much as the $29.4 million raised from angel investors, which invested at record levels in Atlantic Canada last year.

There are not a lot of transactions by the publicly listed companies, but the recent ones have been noteworthy: Last August, Halifax-based Sona Nanotech listed on the Canadian Securities Exchange, choosing the alternative exchange rather than the TSX Venture exchange. The company raised $2 million during the listing. Kraken Robotics of St. John’s closed a $2.3 million sale of shares and warrants to its customer Ocean Infinity in June last year. The company then raised further capital in December when it sold $6 million worth of shares. In February 2018, Halifax-based IMV announced that it had closed a bought deal to raise $14.4 million. In March 2019, IMV closed another share sale, which raised an additional $26.7 million.

And other companies like BlueDrop Performance Learning of St. John’s and Exeblock, a Halifax blockchain companies, are also listed.

The driving force behind this interest in public listings is the longevity and strength of the current bull market. Eleven years have past since the financial crisis and the stock market seems like a dependable and profitable place to raise capital. Of course, a market crash and/or recession would likely put the brakes on further companies move toward the public markets.

In recent years, Canadian tech shares have performed well and investors are looking for small tech companies the way they used to look for penny stocks in the mining and oil and gas sectors. And IMV, after years of a languishing share price, has finally been resurrected and is leading the way for other Atlantic Canadian stocks to test the markets.

For Appili Therapeutics, which has 30.3 million shares outstanding and a market capitalization as of the close Monday of $24.2 million, the public listing is a crucial step in its mission to find cures for antibiotic-resistant diseases.

“According to both the World Health Organization and the U.S. Centers for Disease Control and Prevention, there remains an increasing need for innovations to combat the mounting threats of infectious diseases,” said CEO Kevin Sullivan in a statement. ”Our public listing marks an important inflection point in our ability to deepen our reach into this market and demonstrate that it is possible to invest in a compelling and attractive social mission and business opportunity in parallel.”

ENTREVESTOR: Appili Starts Trading on TSXV

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Shares of Halifax drug discovery company Appili Therapeutics Inc. begin trading on the TSX Venture exchange today.

The company, whose long-term goal is to produce drugs that can combat antibiotic-resistant viruses, issued a statement Monday evening saying  the Toronto Stock Exchange had accepted its application for an initial public offering.

Appili is not raising new funds in the listing as it meets the TSX Venture requirements for capital, with enough money in the bank to last until mid-2020. The company raised $3.6 million earlier in the year via a sale of warrants. Since inception, the company has raised a total of $15.4 million in equity funding and $19 million in non-dilutive funds, and decided last autumn that its best long-term route to capital would be found in public markets.

“This public listing is an important part of our evolution as we look to continue to build our pipeline of products that treat the most serious threats to human health,” said Appili CEO Kevin Sullivan in an email Monday night. “It really is an exciting part of our life cycle/growth strategy that we are keen to show the markets.”