Category: Archives 2019

Archives Archives 2019

Appili Therapeutics Enters Commercial Agreement With Saptalis Pharmaceuticals for Anticipated Launch of ATI-1501 Antibiotic Candidate in the U.S.

Post author By rajarshi
Post date December 3, 2019

NDA filing expected within 18 months for liquid metronidazole to support the growing number of patients who cannot tolerate current oral tablet formulation

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

Archives Archives 2019

Appili Therapeutics Names Dr. Armand Balboni as Chief Executive Officer

Post author By rajarshi
Post date December 2, 2019

HALIFAX, Nova Scotia, December 2, 2019 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a clinical stage biopharmaceutical company developing anti-infective drug and vaccine candidates, announced that, effective today, it has appointed Dr. Armand Balboni to serve as its new Chief Executive Officer. As part of a planned transition, Dr. Balboni will replace former Chief Executive Officer Kevin Sullivan, who has resigned to pursue other opportunities. Dr. Balboni has served as Appili’s Chief Scientific Officer and a member of the Company’s board since 2018 and brings over 20 years of clinical and regulatory experience to the role of Appili CEO.

“Having assembled an impressive portfolio of anti-infective drug candidates under the stewardship of Kevin Sullivan, the Board believes that it is the right time to transition leadership to Dr. Balboni,” said Stephen Nicolle, Chair of the Board at Appili. “Armand’s caliber and experience, including his familiarity with Appili and extensive previous work with successful preclinical and clinical therapeutic programs, make him an optimal fit to lead the Company through its next stage of drug development milestones and value creation. We are grateful to Kevin for his leadership in bringing Appili to this pivotal point and wish him well in his future endeavours.”

Dr. Balboni’s healthcare experience includes medical and drug development acumen in both civilian and military organizations. He is a founding partner and served as the senior advisor on scientific, regulatory, and medical affairs for the investment advisory firm Bloom Burton & Co., advising some of the most recent promising Canadian biotech companies. Dr. Balboni is also a Commissioned Officer in the U.S. Army with 17 years of military service including as the Deputy Director, Office of Regulated Activities (ORA),U.S. Army Medical Materiel Development Activity (USAMMDA). Dr. Balboni’s work in the ORA focused on regulatory filings (Emergency Use Authorizations, meetings, pre-sub filings etc.) for military-relevant medical products across all therapeutic areas. In addition, he completed a U.S. Department of Defense fellowship at the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) in the Division of Anti-infective Products, and in the Office of Counterterrorism and Emerging Threats (OCET). He also served as the Chief, Office of Research and Technology Application (ORTA), at the U.S. Army Research Institute of Infectious Disease (USAMRIID). Under his leadership, this office was responsible for the oversight of all strategic partnerships between USAMRIID and universities, U.S. and foreign government agencies, and biotechnology and pharmaceutical companies. Dr. Balboni has held various academic teaching positions including at Westfield State University, the University of Maryland University College, and the United States Military Academy at West Point. He completed his doctoral work in the MD/PhD program at the Icahn School of Medicine at Mount Sinai and his law degree (JD) at Brooklyn Law School.

“Appili’s steadfast mission is to help address the seemingly intractable threats created by infectious diseases worldwide, and I am eager to step into the CEO role at a very interesting time in the Company’s corporate maturation,” said Dr. Balboni. “We have a skilled team that comes to work every day committed to developing novel therapeutics in areas of significant unmet medical need. We have a strong network of shareholders whose ongoing support we value greatly. I firmly believe that Appili’s unique strategy to advance promising anti-infective candidates will make a significant impact on the underserved infectious disease treatment landscape.”

“I am proud of what our team at Appili built in under three years, going from a start-up to a publicly traded biotech with four strong programs, including the recent acquisition of the antifungal candidate ATI-2307,” said Mr. Sullivan. “I have enjoyed working with Armand over the past few years and have full confidence in his capable leadership to bring Appili through the next step in its corporate evolution. The time is now right for me to focus my skillset on new start-ups, which is where my passion is. My heartfelt thanks to the many dedicated Appili team members who have been crucial to our success thus far, and who will continue our mission to become a global leader in infectious disease.”

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 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. 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 2, 2019 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

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

###

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

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

Archives Archives 2019

Appili Therapeutics Reports Financial Results for Second Quarter of Fiscal Year 2020

Post author By rajarshi
Post date November 27, 2019

HALIFAX, Nova Scotia, November 27, 2019 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today reported its financial and operational results for the second quarter of its fiscal year 2020, ending September 30, 2019.

“Appili is built to capitalize on the current market inefficiencies in infectious disease by identifying and acquiring promising assets where our expert team can unlock significant value,” said Kimberly Stephens, Chief Financial Officer of Appili Therapeutics. “Since becoming a public company, we demonstrated our ability to execute on this mission by negotiating the purchase of ATI-2307 from FUJIFILM Toyama Chemical Co., Ltd. This agreement was executed with no up-front payments, adding immediate incremental value to the company.”

Second quarter and recent operational highlights include:

Acquiring ATI-2307, a novel, clinical stage antifungal candidate from pharmaceutical company FUJIFILM Toyama Chemical Co., Ltd.; ATI-2307 is in development to address the growing number of resistant and difficult-to-treat invasive fungal infections and has successfully completed three Phase 1 clinical trials
Generating positive interim preclinical data on ATI-1701, the Company’s biodefense vaccine candidate, showing complete (100%) protection from exposure to the dangerous pathogen Francisella tularensis 90 days after vaccination (the longest vaccine protection period tested to date in this model)
Key team enhancements, including the appointment of Myriam Triest, PhD, to Senior Director, Drug Development and promotion of Stéphane Paquette, PhD, to Director, Business Development

“With the U.S. Centers for Disease Control and Prevention recently releasing a report showing that multidrug resistant infections are an even stronger threat to public health than previously estimated, our mission is more critical than ever,” continued Ms. Stephens. “We will continue to be part of the solution to global public health issues that threaten our way of life as we address unmet patient needs while supporting our shareholders’ interests.”

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 dollar figures are $CAN unless otherwise noted.

The net loss and comprehensive loss of $2,948,832 or $0.09 loss per share for the six months ended September 30, 2019 was $1,132,225 higher than the net loss and comprehensive loss of $1,816,607 or $0.06 loss per share during the six months ended September 30, 2018. This relates mainly to a $1,149,319 decrease in government assistance, a $420,657 increase in general and administrative expenses, and a $260,215 increase in business development expenses, and a reduction of accreted interest by $112,937, offset by a $810,903 decrease in research and development (R&D) expenses.

As of September 30, 2019, the Company had cash and short-term investments of $3,071,631, compared to $5,451,578 at March 31, 2019.

As of November 26, 2019, the Company had 33,588,947 Class A common shares (“Common Shares”) issued and outstanding. In addition, the Company had 2,716,025 stock options and 934,251 warrants outstanding as of November 26, 2019.

The Company’s unaudited interim condensed financial statements for September 30, 2019 and the management discussion and analysis (MD&A), are available on SEDAR at www.sedar.com.

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 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. 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 2, 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.

###

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]

Archives Archives 2019

Appili Therapeutics Acquires Clinical Stage Antifungal Program From FUJIFILM Toyama Chemical

Post author By rajarshi
Post date November 21, 2019

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, 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.

###

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

Archives Archives 2019

Researchers Present New Positive Interim Data on Appili Therapeutics’ ATI-1701 Biodefense Program at 2019 Chemical and Biological Defense Science & Technology Conference

Post author By rajarshi
Post date November 18, 2019

New data demonstrates durable protective response for Appili’s vaccine candidate against Francisella tularensis, a Category A pathogen and potential biological weapons threat

Presentation provides additional safety and efficacy data supporting use of ATI-1701 as a medical countermeasure, supports ongoing development under U.S. Food and Drug Administration’s medical countermeasure development guidelines

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.

###

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

Archives Archives 2019

Appili Therapeutics Announces Voting Results of Annual and Special Meeting of Shareholders

Post author By rajarshi
Post date September 26, 2019

HALIFAX, Nova Scotia, September 26, 2019 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced the voting results from its annual and special meeting of shareholders held on Thursday, September 26, 2019.

Based on the proxies received and the votes on a show of hands, all resolutions were accepted, including the election of the following directors for the ensuing year: Stephen Nicolle, Brian M. Bloom, Ian Mortimer, Theresa Matkovits, Armand Balboni, and Kevin Sullivan.

Shareholders also approved the re-appointment of PricewaterhouseCoopers, LLP, Chartered Accountants, as independent auditor of the Corporation for the ensuing year and that the directors of the Company be authorized to fix their remuneration.

In addition, the shareholders approved amendments to the Company’s stock option plan as described in Schedule A of Appili’s management information circular dated August 22, 2019.

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, 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.

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.

###

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]

Archives Archives 2019

Appili Therapeutics Retains BND Projects for Strategic Investor Relations Services

Post author By rajarshi
Post date September 16, 2019

HALIFAX, Nova Scotia, September 16, 2019 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced that it has retained BND Projects Inc. (“BND”) to provide strategic investor relations services. BND will aid the Company in building awareness in the financial community by introducing, maintaining and protecting relationships between the management of the Company and professional investors.

“We maintain a strong commitment to our shareholders, and expanding our investor base bolsters our ability to create awareness of the important work we are doing,” said Kevin Sullivan, CEO of Appili Therapeutics. “Working with BND will allow us to broaden and deepen the market’s understanding of Appili’s value proposition as we work towards multiple near-term milestones.”

BND, based in the Greater Toronto Area, was founded by Christina Cameron. Ms. Cameron, a life sciences capital markets expert with over 15 years of experience in investor relations and investment banking, will be providing the services under the agreement. Under the terms of the consulting agreement with BND (the “Agreement”), the Company has agreed to pay BND a monthly fee of CDN $8,500. The Agreement also contemplates the Company granting BND the option to purchase common shares of the Company, the terms of which will be disclosed when granted.

The Agreement is subject to the approval of the TSX Venture Exchange. The Agreement has an initial term of six months but may be extended by the parties. The Company and BND act at arm’s length and BND has no present interest, directly or indirectly, in the Company or its securities. The fees paid by the Company to BND are for its services only.

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.

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 2, 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.

###

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]

Archives Archives 2019

Appili Therapeutics Reports Financial Results for First Quarter of Fiscal Year 2020

Post author By rajarshi
Post date August 21, 2019

HALIFAX, Nova Scotia, August 21, 2019 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today reported its financial and operational results for the first quarter of its fiscal year 2020, which ended June 30, 2019.

Operational highlights include:

Successfully completing the process of a direct listing on the TSX Venture Exchange (“TSXV”), trading under the ticker APLI
Receiving a $475,000 CAD contribution from the Atlantic Canada Opportunities Agency’s (ACOA) Regional Economic Growth through Innovation (REGI) program to support its anti-infective programs
The United States Department of Defense (DOD) awarding Appili a $3M USD grant in support of the ATI-1503 program

“In the first quarter of our fiscal year, Appili Therapeutics experienced one of the most significant changes in our company’s history: publicly listing on the TSXV exchange, which opens channels to new capital and resources and expands our ability to address additional unmet needs in the marketplace,” said Kevin Sullivan, CEO of Appili Therapeutics. “Support from organizations like ACOA and the U.S. DOD demonstrates confidence in our ability to bring urgently needed anti-infectives to market. Our team is well positioned to realize the value in these opportunities, and to continue to fulfill our mission to become a global leader in infectious disease solutions that provide benefits for our patient community and value to our shareholders.”

Financial Results

The net loss and comprehensive loss of $1,799,012 or $0.06 loss per share for the quarter ended June 30, 2019 was $1,315,246 higher than the net loss and comprehensive loss of $483,766 or $0.01 loss per share during the quarter ended June 30, 2018. This relates mainly to a $886,943 decrease in government assistance, a $377,317 increase in general and administrative expenses, and a $291,589 increase in business development expenses, and a reduction of accreted interest by $109,181, offset by a $349,785 decrease in research and development (R&D) expenses.

As of June 30, 2019, the Company had cash and short-term investments of $4,205,816, compared to $5,451,578 at March 31, 2019.

As of August 22, 2019, the Company had 33,588,947 Class A common shares (“Common Shares”) issued and outstanding. In addition, the Company had 2,737,898 stock options and 992,740 warrants outstanding as of August 22, 2019.

The Company’s unaudited interim condensed financial statements for June 30, 2019 and the management discussion and analysis (MD&A), are available on SEDAR at www.sedar.com.

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, 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. 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 2, 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.

###

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]

Archives Archives 2019

Researchers to Present New Data on Appili Therapeutics Infectious Disease Programs at the 2019 Military Health System Research Symposium

Post author By rajarshi
Post date August 20, 2019

ATI-1701 data demonstrate safety and efficacy of the Francisella tularensis vaccine candidate in preclinical studies andsupport ongoing accelerated development under FDA’s ‘Animal Rule’

ATI-1503 research identifies a potential Gram-negative antibiotic candidate for clinical development from Appili’s negamycin program

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

###

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]

Archives Archives 2019

Appili Therapeutics Announces FY 2019 Financial Results

Post author By rajarshi
Post date July 3, 2019

HALIFAX, Nova Scotia, July 3, 2019 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced its financial and operational results for the year ended March 31, 2019.

Operational highlights include:

Announcing results in its completed Phase 1 study for ATI-1501, a pivotal relative bioavailability trial that met its primary objective by demonstrating that ATI-1501 achieved equivalent systemic drug levels as a metronidazole tablet; it was also well tolerated, consistent with the known safety profile of metronidazole
Securing a $3.6M in funding via a special warrant private placement round enabling the Company to complete a direct listing on the TSX Venture Exchange (“TSXV”)
Expanding the leadership team to include Armand Balboni, MD, as Chief Development Officer and Myriam Triest, PhD, as Director, Manufacturing and Pharmaceutical Development
Expanding its Board of Directors with the appointment of Global Infectious Disease Pharmaceutical Executive Dr. Theresa Matkovits

“FY2019 was a great year for Appili Therapeutics as we advanced our pipeline, expanded our team, and laid the groundwork for long term operational and financial success,” said Kevin Sullivan, CEO of Appili Therapeutics. “We achieved a major milestone by listing on the TSXV last month; are well funded to near term milestones; and looking forward to the next stage in our growth. We are energized about the opportunities on our horizon and remain committed to our mission: provide value to patients and shareholders by delivering solutions to address the global threat of infectious diseases.”

Annual Financial Results

The net loss and comprehensive loss of $4,300,984 or $0.14 loss per share for the year ended March 31, 2019 was $354,869 higher than the net loss and comprehensive loss of $3,976,115 or $0.16 loss per share during the year ended March 31, 2018. This relates mainly to a $751,629 increase in general and administrative expenses, a $621,226 decrease in government assistance and a $126,446 increase in business development, offset by a $894,253 decrease in research and development (R&D) expenses and a $250,179 increase in accreted interest.

At March 31, 2019, the Company had cash and short-term investments of $5,451,578 and working capital of $5,405,447, compared to $5,751,820 and $5,866,482, respectively at March 31, 2018.

As of July 2, 2019, the Company had 33,588,947 Class A common shares (“Common Shares”) issued and outstanding. In addition, the Company had 725,967 stock options and 259,877 and warrants exercisable into 2,737,898 and 1,003,117 Common Shares, respectively.

The Company’s audited annual consolidated financial statements for 2019 and the management discussion and analysis (MD&A), are available on SEDAR at www.sedar.com.

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, 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 and business strategy. 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 annual information form of the Company dated July 2,2019 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.

###

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]

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