Author: rajarshi

January 7, 2020

Dear Appili Stakeholder:

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

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

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

Key 2019 Operational Highlights

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

2019 Pipeline and Clinical Advancements

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

2020: Continuing to Differentiate

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

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

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

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

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

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

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

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

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

 

Stock Option Grant

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

 

About Appili Therapeutics

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

 

About Saptalis Pharmaceuticals LLC

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

Located in the Hauppauge Industrial Park on Long Island, NY, USA, Saptalis has fully equipped Research & Development Laboratories and state of the art commercial scale manufacturing facility designed to meet FDA cGMP requirements. For more information, visit www.Saptalis.com.

 

Forward looking statements

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

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

###

Appili Therapeutics Contacts:

 

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

 

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

 

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

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

[iii] Hoppe (1996) Pharmacoeconomics

[iv] Boateng (2017) J Pharm Sci

HALIFAX, Nova Scotia, November 21, 2019 – 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.

###

Appili Therapeutics Contacts:

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]

 

[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

HALIFAX, Nova Scotia, November 18, 2019 – Appili Therapeutics Inc. (TSXV: APLI) (the Company or Appili), a biopharmaceutical company focused on anti-infective drug development, 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 Chemical and Biological Defense Science & Technology Conference (CBD S&T). The conference is being held from November 18-21 at the Duke Energy Convention Center in Cincinnati, Ohio.

The poster presentation at CBD S&T will summarize the latest 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 time period 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 H1 2020.  The U.S. Defense Threat Reduction Agency (DTRA), an arm of the U.S. Department of Defense (DOD), is funding this trial. MRI Global is managing the study under the DTRA contract HDTRA1-16-C-0028.

“Together with our partners at the DOD, MRIGlobal, and the National Research Council of Canada, we are greatly encouraged by results from the 90-day vaccine challenge study,” said Kevin Sullivan, CEO of Appili Therapeutics. “Although results are preliminary, they add to a growing body of evidence supporting advanced development of ATI-1701.  We look forward to sharing the 365-day challenge results next year, and working with our biodefense partners to potentially produce the first FDA-approved vaccine for the prevention of tularemia.”

 

Presentation details are as follows:

Title: Development of Francisella Tularensis SCHU S4 DeltaclpB as a Vaccine for the Prevention of Pneumonic Tularemia in the Warfighter
Session: Medical Countermeasures in the Context of a Layered Medical Defense
Date: Wednesday, November 20, 2019
Time: 4:00 p.m. – 6:00 p.m. ET

 

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 the Chemical and Biological Defense Science & Technology Conference (CBD S&T)

DTRA will host the 2019 CBD S&T Conference at the Duke Energy Convention Center, in Cincinnati, Ohio, November 18-21, 2019. The conference provides the opportunity to collaborate with more than 1,500 scientists, program managers and leaders from across the globe who are committed to making the world safer by confronting chemical and biological defense challenges. Attendees will also network with DTRA science and technology managers as well as other members of DTRA’s Chemical and Biological Defense team.

 

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, we perform contract research for government, industry, and academia. Our 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 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 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 its product. Wherever possible, words such as “may “, “would “, “could “, “should”, “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These statements reflect management’s current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions including with respect to the ability of the Company to adequately fund and implement its development plans and business strategy. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements including, without limitation, those listed in the final prospectus of the Company dated June 12, 2019 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

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

###

Investor Relations Contact:
Kimberly Stephens, CFO
Appili Therapeutics
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, August 20, 2019 – Today, Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, will present updated data on the company’s ATI-1701 and ATI-1503 programs at the Military Health System Research Symposium (MHSRS). The conference is currently being held from August 19-22 at the Gaylord Palms Resort and Convention Centre in Kissimmee, Florida.

“Through ongoing partnerships with federal agencies, including the U.S. Department of Defense (DOD), we have been able to advance our anti-infective programs that address urgent infectious disease-related needs in military and civilian healthcare settings,” said Kevin Sullivan, CEO of Appili Therapeutics. “From transformational programs that address the most threatening multidrug resistant bacteria to preparing medical countermeasures for potential bioterrorism threats, I am very proud of our team’s work to advance our tularemia vaccine research and gram-negative antibiotic programs. There remains a tremendous unmet medical need to develop programs that addresses the significant gaps in the anti-infective landscape, and we are excited to share our progress with our DOD counterparts at the MHSRS. Although these results are preliminary, they encouraging and headed in the right direction.”

Presentation details include:

Title: ATI-1701, a live attenuated Francisella tularensis vaccine for the prevention of pneumonic tularemia in the Warfighter
Session: Innovative Countermeasures and Diagnostics for Emerging Infectious Diseases
Date: Tuesday, August 20, 2019
Time: 10:00 a.m. – 12:00 p.m.
Location: Exhibit Hall, Section Florida DEF

Title: ATI-1503, a Novel Negamycin Analogue for the Treatment of Multi Drug Resistant Gram-negative Infection
Session: Non-vaccine Approaches to Prevent or Treat Militarily Related Infections
Date: Tuesday, August 20, 2019
Time: 10:00 a.m. – 12:00 p.m.
Location: Exhibit Hall, Section Florida DEF

 

About the Military Health System Research Symposium (MHSRS)

The Military Health System Research Symposium (MHSRS) is the U.S. Department of Defense’s premier scientific meeting. It provides a venue for presenting new scientific knowledge resulting from military-unique medical research and development. The MHSRS is the principal military or civilian meeting that focuses specifically on the unique medical needs of the Warfighter.

The MHSRS provides a collaborative setting for the exchange of information between military providers with deployment experience, research and academic scientists, international partners, and industry on research and related health care initiatives.  The theme for the 2019 MHSRS is Research for Readiness.  The scientific presentations will focus on four critical areas – Warfighter Medical Readiness, Expeditionary Medicine, Warfighter Performance, and Return to Duty.

 

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]