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Reunion Neuroscience Inc T.REUN

Reunion Neuroscience Inc. is engaged in the psychedelic drug development company that provides therapeutic solutions for mental health conditions by developing serotonin receptor agonist compounds. The Company is developing the advancement of synthetic molecules targeting serotonin 5HT2A receptors. The Company’s products include RE104 and RE200. The Company’s lead asset, RE-104, which is a psychedelic drug being developed for post-partum and treatment resistant depression as a potential fast-acting antidepressant with durable efficacy. The RE104 as a potentially fast-acting treatment for the key indications of postpartum and treatment resistant depression. The Company is developing the RE200 series, which includes compounds with potential for more selective serotonin receptor activity with reduced psych activity for potential use in more chronic treatment paradigms and indications. The Company is focused on the research and development of its RE200 molecule group.


TSX:REUN - Post by User

Post by Betteryear2on Feb 15, 2022 5:17pm
637 Views
Post# 34431681

Third Fiscal Quarter 2022 Financial Results

Third Fiscal Quarter 2022 Financial Results
  • Earned patient services revenues of $1,360,811, an increase of 50% over the prior quarter and 330% year over year.
  • At December 31, 2021, Field Trip had approximately $74.5 million in unrestricted cash and cash equivalents and short-term investments.
  • Received Notice of Allowance for US Patent Application Covering FT-104 (Isoprocin Glutarate), a more soluble, stable prodrug form of the psychedelic molecule 4-HO-DiPT.
  • Launched Site Management Organization Services (“SMO”) and appointed Stphan Ct as Head of Quality to lead the program which enables companies and researchers developing psychedelic therapies to use Field Trip’s world class facilities, and expertly trained medical and therapy teams, to conduct clinical trials.
  • Appointed Vicki Reed as Chief Growth Officer in January 2022.
  • As the largest provider of psychedelic-assisted therapies in Canada, the Company is well positioned to help Canadians access life-changing psilocybin-assisted and MDMA-assisted therapy through Health Canada’s Special Access Program (SAP).
  • Continued progress with the Company’s strategic review of the current corporate structure.

TORONTO, Feb. 15, 2022 (GLOBE NEWSWIRE) -- Field Trip Health Ltd. (TSX: FTRP; FTRP.WT; NASDAQ: FTRP) ("Field Trip"), a leader in the development and delivery of psychedelic therapies, reported its third fiscal quarter 2022 results for the three months ended December 31, 2021 and provided a business update. All results are reported under International Financial Reporting Standards ("IFRS") and in Canadian dollars, unless otherwise specified.

Key Highlights and Recent Developments

During the quarter, Field Trip progressed its strategy of building the leading psychedelic therapy company through its Field Trip Health division and continued to invest in its lead drug development program through its Field Trip Discovery division with FT-104, and its pipeline expansion, currently under the heading of FT-200 Group (Field Trip Discovery), while conducting activities associated with the Strategic Review.

Field Trip Discovery

FT-104

In January 2022, Field Trip received a Notice of Allowance for its patent application No. 17/364,047 (the “Allowed Patent”) from the U.S. Patent and Trademark Office (USPTO) for claims related to FT-104 (informally known as “Isoprocin Glutarate”), the Company’s first novel psychedelic molecule in development. FT-104 demonstrates improved stability and more importantly, improved solubility relative to 4-HO-DiPT. As a prodrug, FT-104 converts rapidly and completely to 4-HO-DiPT after administration. Combined, these properties result in improved drug absorption, more reproducible pharmacokinetic profiles and improved bioavailability relative to 4-HO-DiPT, making it a superior drug candidate. Subsequent to quarter end, the Company was made aware of possible prior art claim and is seeking advice of external counsel regarding strategy. Based on a prima facie review, this process is not expected to delay the expected Q2 issuance date for the patent.

During the quarter, the Company expanded consideration for the Phase 1 trial site to include Australia, in addition to The Netherlands, to mitigate against possible delays related to regional differences in reactions to the latest COVID surge. As of January, the Company finalized agreements with interested parties in Australia to pursue Phase 1 studies and site selection is nearly finalized.

FT-200 Group

In November, the Company announced it is expanding the scope of its development pipeline to focus on a new group of molecules termed the FT-200 Group, with the discovery of a novel molecule that has the structure of classical psychedelics and has demonstrated improved selectivity for the target serotonin 2A receptor (5HT2A) relative to FT-104 and psilocybin versus off target serotonin, 5HT1A, 5HT2B and 5HT2C receptors in in-vitro assays. The aim of this research is to reduce or eliminate specifically 5HT2B agonist activity, which has been associated with increased risk of cardiovascular toxicity. By reducing cardiovascular risk, the molecules in the FT-200 could be safer to administer more frequently, such as in chronic, intermittent repeat administration or ‘microdosing’ strategies.

During the quarter, Field Trip filed a provisional patent application in the United States to protect the composition, as well as potential formulations and uses of, the first molecule in the FT-200 group.

Joseph del Moral, Field Trip’s Co-founder and CEO, commented, “The important work we are undertaking through Field Trip Discovery is advancing us closer to the development of FT-104 as a more convenient, consistent and practical psychedelic treatment that has the potential to change the lives of those suffering from Treatment Resistant Depression and Postpartum Depression. We have also progressed clinical research to identify a lead candidate in the FT-200 Group. Improving on the safety of this class of molecules could allow more practical wide-spread usage in clinical practice. We are working to strengthen the IP portfolio around the FT-200 Group, while seeking the optimal lead candidate for preclinical development.”

Field Trip Health Centres

During the quarter, Field Trip ramped patient services revenues to $1,360,811, representing an increase of 50% over the prior quarter and 330% year over year. The Company focused on improving customer experience while driving process improvements within its clinical operations. Operational improvements within the clinics included the launch of an innovative team treatment model (“TTM”), which has increased client capacity within clinics. Field Trip also launched a new digital screening tool to facilitate booking, which is expected to decrease call centre costs and significantly improve client conversion rates.

The Company also invested in its digital platform, Portal, to allow it to communicate more efficiently with clients, collect data more easily, and make client processes more efficient. Field Trip anticipates that additional features will be released in the next quarter to allow for an improved client experience and additional client engagement in Portal.

Vicki Reed, Chief Growth Officer, said, “Since joining Field Trip, we have implemented a number of marketing and client acquisition strategies to increase conversion. The effects of these changes, along with our strong organic engagement, have led to positive growth trends and a significant improvement in our client conversions through digital acquisition channels. We achieved this despite the ongoing effect of COVID-19 along with what is typically a seasonally slower quarter. We expect to see continued improvement in our marketing efficiency and revenue growth in the coming quarters.”

During the quarter, Field Trip opened clinics in Seattle, Washington, Fredericton, New Brunswick, and San Diego, California. Subsequent to the quarter, the Company announced the opening of its Vancouver, BC and Washington DC locations. The Company’s focus on operational improvements, together with the effects of COVID, impacted the timing of the construction of our remaining clinics and the Company is evaluating the timing and scope of its expansion strategy as part of its previously announced strategic review.

Field Trip also launched its SMO Services which will enable third party companies and researchers developing psychedelic therapies to use its world class facilities, and expertly trained medical and therapy teams, to conduct clinical trials. The SMO Services will be led by Stphan Ct, who was appointed as Head of Quality.

Subsequent to the quarter end, the Company announced submission of its first application on behalf of a patient to Health Canada’s Special Access Program (“SAP”), which was amended in January to enable access to psilocybin and MDMA. The SAP provides physicians treating patients suffering “serious or life-threatening conditions” with the ability to request access to drugs that have not yet been approved for sale in Canada when conventional therapies have failed, are unsuitable, or unavailable. As the largest provider of psychedelic-assisted therapies in Canada, Field Trip is uniquely positioned to help Canadians access the SAP for psilocybin and MDMA and expects to submit additional applications for patients in the coming months.

Financial Highlights

For the third fiscal quarter ended December 31, 2021, the Company earned patient services revenues of $1,360,811 from its Toronto, New York, Santa Monica, Chicago, Atlanta, Houston, Fredericton, Seattle, San Diego and Amsterdam clinics, an increase of $1,044,482 or 330% over the comparative quarter ended December 31, 2020 of $316,329 and an increase of $452,995 or 50% over the prior quarter. The San Diego clinic began generating revenues in December 2021. Third fiscal quarter 2021 patient services revenues were generated from three clinics, Toronto, New York and Santa Monica. The quarter over quarter revenue increase was in part due to the three additional clinics as compared to the prior quarter. For the nine-month period revenue was $3,136,027 an increase of $2,701,567 or 622% over the same period of the prior fiscal year primarily due to ten operating clinics compared to three in the same period of the prior fiscal year.

Net loss for the third fiscal quarter of $14,971,170 was primarily due to total operating costs of $15,629,788, of which $2,050,547 was related to non-cash share-based compensation and $1,014,018 was related to non-cash depreciation and amortization and a foreign exchange loss $479,255. This compares with a net loss of $8,275,669 in the third fiscal quarter of 2021. The increase from the prior year primarily reflects the Company’s focus on growing the business and continued investment in its drug development pipeline and best-in-class clinic infrastructure.

Total operating costs in the third fiscal quarter were $15,629,788 and were comprised of the following: general and administration expenses of $9,120,333, patient services expenses of $2,546,763, research and development expenses of $1,421,513, sales and marketing expenses of $1,079,084, depreciation and amortization of $1,014,018 and occupancy costs of $448,077. This compares with total operating costs of $5,921,860 in the third fiscal quarter of 2021.

The year over year difference in general and administrative expenses in the third fiscal quarter is primarily due to increased operating costs due to the larger number of clinics opened as well as those under construction and an increase in public company-related expenses.

Balance Sheet

As of December 31, 2021 Field Trip had unrestricted cash and cash equivalents, funds held in trust and short-term investments of $74,469,005.

Selected Consolidated Financial Information

The following table sets forth selected financial information derived from the Company’s unaudited condensed interim financial statements for the three months and nine months ended December 31, 2021 prepared in accordance with IAS 34 in a manner consistent with the Company’s annual audited financial statements. The following information should be read in conjunction with the financial statements and management’s discussion and analysis, which are available on the Company’s website at www.fieldtriphealth.com and under the Company’s SEDAR profile at www.sedar.com.




https://www.globenewswire.com/news-release/2022/02/15/2385769/0/en/Field-Trip-Health-Ltd-Reports-Third-Fiscal-Quarter-2022-Financial-Results-and-Provides-Business-Update.html
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