Health Canada list identifies select companies that can supply psilocybin to approved applicants through the Special Access Program for patient treatment
VANCOUVER, BC, Jan. 27, 2022 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSX: NUMI), a mental healthcare company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, is pleased to announce that its research facility, Numinus Bioscience, has been included on Health Canada’s list of federally licensed psilocybin producers.
This list is available by request to those seeking access to psilocybin through the Special Access Program (SAP), and clinical researchers. The SAP is a federal program that allows healthcare professionals to apply for access to non-marketed medications that have not yet been approved for sale, when such medications show clinical evidence of safety and efficacy and are intended to treat patients with severe or life-threatening illness. Earlier this month, Health Canada added certain psychedelic compounds to the SAP that were previously available only through clinical trials.
“Through our inclusion, we look forward to collaborating with healthcare providers and other groups to ensure people in need receive efficacious treatments,” said Sharan Sidhu, Science Officer and General Manager, Numinus Bioscience.
At this time, Numinus Bioscience is prepared to supply psilocybin in whole mushroom form, through three packaged doses equivalent to 10, 15 and 25mg of psilocybin. These doses are produced under Good Agricultural and Collection Practices and tested for potency and impurities to support patient safety and practitioner confidence. With sufficient clinical data, Numinus may also make available other products that are currently being developed in its IP pipeline, should those meet the standards identified by Health Canada. With its Dealer’s License and research facility, Numinus Bioscience is permitted to conduct several activities in addition to the production of psilocybin, including assembly, sale, export, analytical testing and R&D of ketamine, LSD and MDMA.
“Numinus is glad to see Health Canada committing to broadened mental healthcare access, starting with those in most need,” said Payton Nyquvest, CEO and Founder, Numinus. “As clinical evidence grows, we look forward to making more treatments available and further advancing the development of psychedelic therapies and mental health innovations.”
About Numinus Numinus Wellness helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society. Learn more at numinus.com and follow us on LinkedIn, Facebook, Twitter, and Instagram.
Forward-Looking Statements Statements and other information contained in this press release about anticipated future events constitute forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek”, “anticipate”, “believe”, “plan”, “estimate”, “expect” and “intend” and statements that an event “may”, “will”, “should”, “could” or “might” occur or other similar expressions. Forward-looking statements are subject to risks and uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements. Forward-looking statements are based on estimates and opinions of management at the date the statements are made. The Company does not undertake any obligation to update forward-looking statements even if circumstances or management’s estimates or opinions should change except as required by applicable laws. Investors should not place undue reliance on forward-looking statements.
SOURCE Numinus Wellness Inc.
For further information: Investor Contact: Jamie Kokoska, Vice President, Investor Relations, jamie.kokoska@numinus.com; Media Contact: May Lee, Communications Manager, may.lee@numinus.com
VANCOUVER, BC, Jan. 25, 2022 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSX: NUMI) (OTC: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced that it will participate in Citi’s Psychedelic Drug Call Series to be hosted virtually on Wednesday, February 2, 2022.
Neena Bitritto-Garg, Citi’s Biotech analyst, will host Payton Nyquvest, Founder and CEO of Numinus, for a fireside chat at 10:00 a.m. ET.
For more information about the event, please contact your appropriate Citi representative directly, or KCSA Strategic Communications at NuminusIR@kcsa.com.
About Numinus Numinus Wellness (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.
Forward-looking statements This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are “forward-looking statements”. Forward-looking statements can be identified by the use of words such as “expects”, “does not expect”, “is expected”, “believes”, “intends”, “anticipates”, “does not anticipate”, “believes” or variations of these words, expressions or statements, that certain actions, events or results “may”, “could”, “would”, “might” or “will be” taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company’s facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company’s limited operating and profitability track record; dependence on management; the Company’s need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company’s efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws.
SOURCE Numinus Wellness Inc.
For further information: Investor Contact, Jamie Kokoska, Vice President, Investor Relations, jamie.kokoska@numinus.com; Media Contact, May Lee, Communications Manager, may.lee@numinus.com
Ended quarter with strong cash position of $53.9 million
Revenues grew 245% year-over-year to $0.8 million for the quarter
Generated gross profit of $50,965 during the quarter, representing a 6.5% gross margin
Well-positioned to offer psychedelic-assisted psychotherapy services through Canada’s newly expanded Special Access Program
Clinical trial application made to Health Canada to begin Phase 1 study for proprietary psilocybe extract
MAPS-sponsored MDMA-Assisted Therapy for PTSD study to begin shortly; approvals received from Health Canada and the Institutional Review Board
All financial results are reported in Canadian dollars unless otherwise stated.
VANCOUVER, BC, Jan. 20, 2022 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSX: NUMI) (OTC: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its fiscal first quarter results for the three months ended November 30, 2021.
“We have made significant advancements in all areas of our business over the last several months, with many exciting opportunities on the horizon,” said Payton Nyquvest, Founder and CEO. “Of note, the partnership across our lab and clinical teams has been instrumental in passing key milestones on two major clinical trials: one for a proprietary Psilocybe formulation and the other a MAPS-sponsored MDMA study. In addition, we’re continuing to make discoveries in our Bioscience lab and recently begun genetic testing on several newly-acquired psychedelic mushroom species.”
Mr. Nyquvest continued, “The recent amendments by Health Canada to the Special Access Programme further underscore the importance and growth potential of Numinus’ wellness clinic network. With facilities purpose-designed for a wide range of psychedelic-assisted psychotherapies, therapists already trained on providing Psilocybin-assisted and MDMA-assisted therapies, and a Health Canada distribution license that allows us to import, possess, produce, and distribute psychedelic compounds – Numinus is well positioned as a national leader to provide these important treatments to those who qualify. I’m encouraged by the recent changes by Health Canada and proud of everyone at Numinus for the ongoing leadership, drive and commitment to our mission over the past quarter.”
First Quarter Financial Highlights:
Cash balance of $53.9 million as of November 30, 2021
Revenues grew 244.5% year-over-year to $0.8 million in Q1 2021, due primarily to the acquisition of Mindspace. Sequentially, revenues grew 60.9% compared to Q4 2021.
Gross profit of $50,965 in Q1 2022, compared to gross loss of $38,135 in Q1 2021
Gross margin was 6.5%, compared to -16.6% in Q1 2021
Loss was $5.4 million for Q1 2022, compared to a loss of $1.9 million in Q1 2021
Operational Highlights During and Subsequent to Fiscal First Quarter 2022:
Numinus Bioscience – Laboratory Operations
Q1 2022 revenue of $141,702, a 56.4% sequential increase from Q4 2021, but a 27.7% decrease from $196,090 in Q1 2021. This year-over-year decline is primarily due to the Company ceasing cannabis related activities during 2021 to dedicate resources towards advancing psychedelic-centered service offerings – including psychedelic analytical testing and contract laboratory services, to align with the Company’s strategy and overall objectives.
On November 29, 2021, the Company announced that Numinus Bioscience developed proprietary psychedelic drug tests with new toxicity and potency scans. These new analytical tests will accelerate Numinus’ research and development capabilities and generate new revenue streams through third-party client product testing.
Phase 1 clinical trial on NBIO-01:
On October 24, 2021, Numinus announced it finalized the study design and protocol for a Phase 1 clinical trial on a naturally derived psilocybin extract (“NBIO-01”), advancing Numinus’ investigation of its first proprietary psychedelic product, which was developed using a patent-pending technology.
On January 14, 2022, the Company submitted its clinical trial application to Health Canada for its Phase 1 trial of NBIO-01. The clinical trial, named HOPE, is a two-phase study that will take place at a Vancouver based clinic. Upon approval, Numinus will begin testing the extract for bioavailability and tolerability on 20 healthy volunteers, followed by testing against a psilocybin comparator on a further 28 healthy volunteers.
MAPS-sponsored MDMA-assisted therapy for PTSD clinical trial study (“MAPPUSX”):
On November 10, 2021, the Company announced it will host the Montreal and Vancouver sites of the MAPPUSX study, which will continue to evaluate the safety of MDMA in treating severe PTSD, titled “A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD.”
On January 19, 2022, Numinus announced that it had received approvals from Health Canada and the Institutional Review Board to proceed with its clinical trial study for MAPPUSX. Enrollment for the trial is expected to begin shortly and will be open to eligible participants who were previously enrolled in the placebo arm of the parent study (“MAPP1”) or who were not able to receive treatment due to COVID-19 restrictions.
Subsequent to the quarter:
Numinus Bioscience secured several additional strains of psychedelic mushroom species and has already begun genomic analysis of these spore prints for research purposes.
Numinus Health – Numinus Wellness Clinic Network
Q1 2022 revenue of $647,915, a 61.9% sequential increase from Q4 2021, and a 1,857.6% increase compared to $33,098 during the same period last year when Numinus had only one clinic, which was impacted by COVID-19 during the quarter.
On September 23, 2021, Numinus completed the acquisition of the Neurology Centre of Toronto (“NCT”) for less than $1.0 million, allowing for the planned expansion of NCT into a comprehensive neurologic care center specialized in psychedelic neurology.
During Q1 2022, clients received a total of 6,217 appointments through Numinus clinics (including one-on-one and group therapy sessions, neurology-related appointments and Ketamine-assisted psychotherapy), representing a 91.9% increase in clinic appointments compared to the prior quarter (Q4 2021), due in part to the acquisition of NCT. On a same-store basis, excluding NCT, client appointments increased 42.0% compared to the prior quarter.
On November 10, 2021, the Company announced that it had secured two additional clinic locations in Vancouver and Montreal that will primarily be used for clinical research studies in the near-term.
Subsequent to the quarter:
Numinus has finalized a formal Ketamine-Assisted Psychotherapy (“KAP”) training program for therapists, with virtual training sessions occurring over the next two months. This training program will expand the number of Numinus therapists qualified to provide KAP sessions to clients.
As of January 20, 2022, Numinus has five wellness clinics offering services to clients (one in Vancouver, one in Toronto, and three in Montreal) that have a total of 21 treatment rooms. In addition, the Company has two dedicated research clinics where psychedelic studies are being conducted (one in Vancouver and one in Montreal).
Corporate Updates
On November 22, 2021, the Company changed its OTC ticker symbol to “NUMIF” (from “LKYSF”) to better align with its Canadian ticker symbol.
Subsequent to the quarter:
On December 16, 2021, Numinus graduated to the TSX (from the TSX-Venture), trading under the symbol “NUMI”.
Industry Updates
On January 5, 2022, Health Canada implemented amendments to the Special Access Programme (“SAP”). These amendments now enable:
Doctors and practitioners to apply for psychedelic medicines that have shown promise through Phase 2 or Phase 3 trials, on behalf of their patients, when other traditional medicines and therapies have not proven effective.
Doctors and patients to hear, within 48 hours of the application being submitted, if access to psychedelic medicines are approved for their case. If approved, doctors can refer patients to clinics – such as Numinus’ wellness clinics, to receive psychedelic-assisted psychotherapy.
Companies holding a Health Canada dealers license, including Numinus Bioscience, to act as a licensed distributor of certain psychedelic medicines for SAP approved cases.
Q1 2022 Key Performance Metrics:
For the quarter ended November 30:
2022
2021
% change
Numinus Bioscience¹ revenue
141,702
196,090
-27.7%
Numinus Health2 revenue
647,915
33,098
1,857.6%
Total Revenue
$789,617
$229,188
244.5%
Cost of revenue
(738,652)
(267,323)
176.3%
Gross Profit (Loss)
$50,965
$(38,135)
n.m.
Gross profit margin
6.5%
-16.6%
n.m.
General and administrative expenses
(3,736,890)
(1,285,448)
190.7%
Share-based compensation
(400,568)
(174,250)
129.9%
Sales and marketing expenses
(760,519)
(269,243)
182.5%
Depreciation
(51,829)
(91,261)
-43.2%
Research and development expenses
(330,626)
(89,727)
268.5%
Transaction costs
(45,092)
—
100.0%
Loss before other items
$(5,274,559)
$(1,948,064)
170.8%
Other items
(79,530)
19,327
n.m.
Loss and comprehensive loss
$(5,354,089)
$(1,928,737)
177.6%
Loss per share, basic and diluted
$(0.03)
$(0.02)
50.0%
Average number of shares outstanding, basic and diluted
203,409,202
112,364,998
81.0%
1 Numinus Bioscience consists of revenues generated through Numinus’ Laboratory Operations.
2 Numinus Health consists of revenues generated through Numinus’ clinic network.
Numinus’ condensed consolidated financial statements for the three months ended November 30, 2021 and related management’s discussion and analysis are available on Numinus’ Investor Relations website at www.investors.numinus.com and under the Company’s profile on SEDAR at www.sedar.com. These documents were prepared in accordance with IFRS and with TSX-Venture disclosure timeline requirements, as the company was listed on the TSX-Venture at quarter end.
Conference Call and Webcast Details
Interested parties are invited to participate in the Company’s Q1 2022 results conference call and webcast. On the call Numinus executives will review the Company’s performance and recent initiatives, and answer questions from analysts.
Date:
Thursday, January 20, 2022
Time:
5:30 p.m. (EST)
Dial-In:
1 (833) 989-2968 (Toll-free North America), 1 (236) 714-4028 (International)
About Numinus Numinus Wellness (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.
Forward-looking statements This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are “forward-looking statements”. Forward-looking statements can be identified by the use of words such as “expects”, “does not expect”, “is expected”, “believes”, “intends”, “anticipates”, “does not anticipate”, “believes” or variations of these words, expressions or statements, that certain actions, events or results “may”, “could”, “would”, “might” or “will be” taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company’s facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company’s limited operating and profitability track record; dependence on management; the Company’s need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company’s efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws.
SOURCE Numinus Wellness Inc.
For further information: Investor Contact, Jamie Kokoska, Vice President, Investor Relations, jamie.kokoska@numinus.com, +1 833-686-4687; Media Contact, May Lee, Communications Manager, may.lee@numinus.com
Numinus Wellness (NUMI) is enrolling patients for a multi-site study on MDMA for PTSD, which will be sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS). The study received approval from both Health Canada and the Institutional Ethics Review Board.
The trial evaluates Numinus’ first trademarked product and patent-pending production process
VANCOUVER, BC, Jan. 14, 2022 /CNW/ – Numinus Wellness Inc. (“Numinus”) (TSX: NUMI), a leader in psychedelics-focused mental healthcare, is pleased to announce that it has formally submitted the clinical trial application (“CTA”) to Health Canada for its Phase 1 study, HOPE, on a naturally derived Psilocybe extract formulation, NBIO-01. This milestone further progresses and solidifies Numinus’ long-standing work on developing safe and effective psychedelic products out of its Health Canada-licensed research facility, Numinus Bioscience.
“This application significantly advances our product development pipeline, which is aimed at broadening access to safe and effective products for psychedelic-assisted therapies,” says Sharan Sidhu, Science Officer and General Manager, Numinus Bioscience. “The trial will assess safety and bioavailability and be a stepping stone to the next stage for our IP development. This natural product has been developed to be shelf stable, minimally variable and consistently meet label claims. The trial will not only assess safety but also give us data on comparative bioavailability.”
NBIO-01 is Numinus Bioscience’s first proprietary formulation developed from extracts generated using patent-pending technology, for which a patent was earlier submitted to the US Patent and Trade Office and announced on June 24, 2021. The formulation has been developed to stably deliver psilocybin and other synergistic compounds and will be studied for safety and bioavailability.
As Numinus’ first fully autonomous clinical trial, HOPE is a two-phase study that will take place at a Numinus clinic in Vancouver. Upon approval, Numinus will begin testing the extract for bioavailability and tolerability on 20 healthy volunteers, followed by testing against a psilocybin comparator on a further 28 healthy volunteers.
“At Numinus, we are focused on developing products and services in-house to ensure that high-quality standards are maintained,” says Payton Nyquvest, Founder & CEO, Numinus. “I am very proud of the Numinus team – from our Bioscience experts who developed the product, to our clinical research team who will administer the study. We look forward to achieving more milestones in our mission to make psychedelic-assisted therapies accessible to all who wish to safely use them.”
About Numinus Numinus Wellness (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental healthcare and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.
Forward-looking statements This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are “forward-looking statements”. Forward-looking statements can be identified by the use of words such as “expects”, “does not expect”, “is expected”, , “intends”, “anticipates”, “does not anticipate”, “believes” or variations of these words, expressions or statements, that certain actions, events or results “may”, “could”, “would”, “might” or “will be” taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company’s facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company’s limited operating and profitability track record; dependence on management; the Company’s need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company’s efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws.
SOURCE Numinus Wellness Inc.
For further information: May Lee, Communications Manager, Numinus, may.lee@numinus.com; For investor inquiries: Jamie Kokoska, VP, Investor Relations, Numinus, jamie.kokoska@numinus.com
VANCOUVER, BC, Jan. 5, 2022 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSX: NUMI), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, will release its financial results for the quarter ended November 30, 2021, after market close on Thursday, January 13, 2022.
Interested parties are invited to participate in the Company’s Q1 2022 results conference call and webcast, occurring on the same day, at 5:30 p.m. Eastern time / 2:30 p.m. Pacific time. During the call, Numinus executives will review the Company’s performance and recent initiatives, and answer questions from analysts.
To participate in the live conference call, please use the following dial-in information:
1 (833) 989-2968 (Toll-free North America)
1 (236) 714-4028 (International)
Please ask to participate in Numinus’ Q1 2022 Results Call. To avoid any delays in joining the call, please dial in at least five minutes prior to the call start time. If prompted, please provide conference passcode 2670376.
A replay of the conference call can also be accessed after 8:30 p.m. Eastern time / 5:30 p.m. Pacific time on Thursday, January 13, 2022, at 1-800-585-8367 or 1-416-621-4642 (using passcode 2670376). The replay will be available until January 27, 2022.
About Numinus Numinus Wellness helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.
Forward-Looking Statements Statements and other information contained in this press release about anticipated future events constitute forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek”, “anticipate”, “believe”, “plan”, “estimate”, “expect” and “intend” and statements that an event “may”, “will”, “should”, “could” or “might” occur or other similar expressions. Forward-looking statements are subject to risks and uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements. Forward-looking statements are based on estimates and opinions of management at the date the statements are made. The Company does not undertake any obligation to update forward-looking statements even if circumstances or management’s estimates or opinions should change except as required by applicable laws. Investors should not place undue reliance on forward-looking statements.
SOURCE Numinus Wellness Inc.
For further information: Investor Contact, Jamie Kokoska, Vice President, Investor Relations, jamie.kokoska@numinus.com; Media Contact, May Lee, Communications Manager, may.lee@numinus.com
Policy amendment allows practitioners to request access to psychedelic drugs for patients with serious or life-threatening conditions on a case-by-case basis
VANCOUVER, BC, Dec. 22, 2021 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSX: NUMI), a leader in psychedelics-focused mental healthcare, commends Health Canada’s leadership for amending the Special Access Programme (SAP) to allow physicians to request patient access to psychedelic treatments, such as MDMA- and psilocybin-assisted therapy, for serious treatment-resistant or life-threatening conditions on a case-by-case basis. The amendment has the potential to positively affect the lives of people experiencing serious mental health conditions when other therapies have failed, are unsuitable or are unavailable in Canada.
“Amending the SAP and righting a historical wrong based on stigma highlights Canada’s commitment to making psychedelic-assisted therapies a possibility for the many Canadians who struggle with mental wellness,” said Payton Nyquvest, Founder and CEO, Numinus. “While we believe this is only the beginning of greater change to come, it signifies an important step towards creating expanded safe access to treatment and care in the mental health sector through psychedelic medicine. I am proud of our team who have had a longstanding role in advocating for this reform.”
Health Canada’s amendment recognizes a growing body of research, including the work that Numinus’ clinical and research teams are completing, that has consistently shown the efficacy of psychedelic-assisted psychotherapy to treat a broad range of mental health conditions that are currently extremely difficult to treat with conventional therapies. According to Health Canada, access will be provided when there is sufficient data to support the safety and efficacy of the drug for the specific condition of the patient and will be available once the regulations come into force when the amendment is published in the Canada Gazette, which is anticipated on January 5th, 2022.
“Revising the SAP to allow for a case-by-case consideration of the suitability of psychedelic-assisted psychotherapy is a critical first step towards patients having access to these potentially transformative, safe and effective treatments when other treatments have failed,” said Dr. Lindsay Farrell, Vice President of Indigenous Initiatives and Reconciliation, Numinus. “Nevertheless, new pathways ensuring equitable access to psychedelic-assisted therapies for racialized, marginalized, underserved populations and Indigenous Peoples are also urgently needed, especially in the context of sacred plants that have been used in cultural practices by Indigenous Peoples since Time Immemorial. We encourage the federal government to create regulations that acknowledge and honour the traditional use of certain sacred plants and create pathways for safe and equitable access.” .
Added Dr. Evan Wood, Chief Medical Officer, Numinus: “We applaud Health Canada and hope this is the first in a series of regulatory reforms where the federal government can provide leadership with the best interests of Canadians in mind. We know that, with all currently illegal drugs, doing nothing only creates public and patient safety concerns that can best be addressed by thoughtful regulatory approaches.”
The Special Access Programme (SAP)
The SAP was designed to allow people access to new, potentially life-saving medications before they are formally approved for routine use in healthcare.
Historically, psychedelic medications have been ineligible for Special Access Programme applications. The regulatory amendment, which is expected to come into force on January 5th, 2022, will enable Canadian physicians to apply for psychedelic therapies in a similar process as to how other investigational medications are accessed prior to formal drug approval.
A substantial body of research, including the completion of a growing number of randomized clinical trials, has demonstrated that psychedelic-assisted therapies using psilocybin and MDMA appear to be highly effective approaches for the treatment of a host of potentially life-threatening mental health conditions, including treatment-resistant depression, post-traumatic stress disorder (PTSD), substance use disorders, and severe anxiety associated with terminal diagnoses.
In addition to allowing ongoing access for research participants after a clinical trial is complete, the SAP enables physicians to apply for access on behalf of qualifying Canadians who have serious or life-threatening conditions.
Patients cannot apply to the SAP directly, and only licensed healthcare practitioners who are authorized under the laws of a province or territory to treat patients with a prescription drug may file requests through the SAP.
About Numinus
Numinus Wellness (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.
This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are “forward-looking statements”. Forward-looking statements can be identified by the use of words such as “expects”, “does not expect”, “is expected”, , “intends”, “anticipates”, “does not anticipate”, “believes” or variations of these words, expressions or statements, that certain actions, events or results “may”, “could”, “would”, “might” or “will be” taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company’s facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company’s limited operating and profitability track record; dependence on management; the Company’s need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company’s efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws.
Neither the TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this news release.
SOURCE Numinus Wellness Inc.
For further information: Hilary Strath, Director, Communications, Numinus, hilary.strath@numinus.com; For investor inquiries: Jamie Kokoska, VP, Investor Relations, Numinus, jamie.kokoska@numinus.com
TORONTO, Dec. 16, 2021 /CNW/ – Payton Nyquvest, Founder and Chief Executive Officer, Numinus Wellness Inc. (“Numinus” or the “Company”) (TSX: NUMI) and his team joined Michael Kousaie, Vice-President, Strategy and Product Innovation, TMX Group, to celebrate the Company’s new listing on Toronto Stock Exchange and open the market.
Numinus Wellness (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, they are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.
For Market Openings: Media may pick up a feed from the TOC (television operations centre) for all market open ceremonies. The feed is named TSX Transmit 1 (SD-SDI) and is produced at the TMX Broadcast Centre and sent live to the TOC. To pick up the feed via the Dejero network, please contact avservices@tmx.com. The client feature video will begin playing on the TMX media wall at approximately 9:27 a.m. ET and the markets will open with the sound of a siren at 9:30 a.m. ET
Date: Thursday, December 16, 2021
Time: 9:00am – 9:30am
Place: 120 Adelaide Street, W
SOURCE Toronto Stock Exchange
For further information: MEDIA CONTACT: Hilary Strath, Director, Communications, Hilary.Strath@numinus.com; Jamie Kokoska, VP, Investor Relations, Jamie.Kokoska@numinus.com
Numinus will ring the TSX opening bell to celebrate this milestone
VANCOUVER, BC, Dec. 14, 2021 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSXV: NUMI), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, is pleased to announce that it has received final approval from the Toronto Stock Exchange (“TSX”) to graduate its listing to the TSX from the TSX-Venture Exchange (“TSXV”). Numinus’ common shares will commence trading on the TSX under the symbol “NUMI” at market open on Thursday, December 16, 2021. Similarly, the Company’s listed warrants will commence trading on the TSX under the symbols “NUMI.WT”, “NUMI.WT.B” and “NUMI.WT.C” on the same day.
No actions are required by Numinus shareholders. There will be no change to the shares, warrants or Company share structure as a result of this listing graduation. The TSX and TSXV have published bulletins announcing the change to financial institutions.
TSX Opening Bell Ringing Numinus will celebrate this milestone by ringing the opening bell of the TSX on Thursday, December 16, 2021. Numinus Founder and CEO, Payton Nyquvest, will be joined by members of Numinus’ senior management team at the event.
About Numinus Numinus helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.
Forward-Looking Statements Statements and other information contained in this press release about anticipated future events constitute forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek”, “anticipate”, “believe”, “plan”, “estimate”, “expect” and “intend” and statements that an event “may”, “will”, “should”, “could” or “might” occur or other similar expressions. Forward-looking statements are subject to risks and uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements. Forward-looking statements are based on estimates and opinions of management at the date the statements are made. The Company does not undertake any obligation to update forward-looking statements even if circumstances or management’s estimates or opinions should change except as required by applicable laws. Investors should not place undue reliance on forward-looking statements.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
SOURCE Numinus Wellness Inc.
For further information: Investor Contact: Jamie Kokoska, Vice President, Investor Relations, jamie.kokoska@numinus.com; Media Contact: May Lee, Communications Manager, may.lee@numinus.com
Ended the year with strong cash position of $59.2 million
Revenues grew 81% year-over-year to $0.5 million for Q4 2021
Revenues grew 72% year-over-year to $1.5 million for FY 2021
Gross profit of $31,818 for Q4 2021
Completed the acquisition of the Neurology Centre of Toronto in September 2021
Two clinical trials about to launch: Phase 1 study for proprietary psilocybe extract and Phase 3 open label extension study partnership with MAPS for MDMA for PTSD
Recently received conditional approval to graduate to the TSX (from the TSX Venture)
All financial results are reported in Canadian dollars unless otherwise stated.
VANCOUVER, BC, Dec. 9, 2021 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSXV: NUMI) (OTCQX: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its fiscal fourth quarter and full year results for the periods ended August 31, 2021.
“During the fourth quarter we were focused on building the team, infrastructure, technologies and protocols that will allow us to scale our business over the next several years,” said Payton Nyquvest, Founder and CEO. “We welcomed several new key executives, began our laboratory expansion, and filed a patent for a proprietary rapid production process for psilocybe.”
Mr. Nyquvest continued: “Since the quarter ended, we have started to see the benefits of these transformative initiatives, with the expansion of our Ketamine-Assisted Psychotherapy offering, the acquisition of the Neurology Centre of Toronto, the finalization of our Phase 1 clinical trial protocols for our proprietary psilocybe extract, a partnership with MAPS to conduct the Phase 3 extension study of MDMA for PTSD, and the development of new proprietary toxicity and potency testing tools for psilocybin.”
Fourth Quarter Financial Highlights:
Cash balance of $59.2 million as of August 31, 2021
Revenues grew 81.1% year-over-year to $0.5 million in Q4 2021, due primarily to the acquisition of Mindspace.
Gross profit of $31,818 in Q4 2021, compared to gross loss of $158,222 in Q4 2020
Loss was $7.8 million for Q4 2021, which included a $1.6 million non-cash goodwill impairment charge related to the acquisition of Mindspace1.
__________
1 The impairment is primarily related to the exclusion of future revenues derived from psychedelic-assisted psychotherapies as these services are currently unregulated. As a result of IFRS standards, the Company must recognize there is uncertainty of realization of such revenues, and the impact on expected revenue growth and profitability to related services, relative to management’s forecasts.
Fiscal 2021 Financial Highlights:
Revenues grew 71.8 % year-over-year to $1.5 million in fiscal 2021, due primarily to the acquisition of Mindspace.
Gross loss of $81,538, compared to gross profit of $88,047 in fiscal 2020
Loss was $18.8 million for fiscal 2021, which included a $1.6 million non-cash goodwill impairment charge related to the acquisition of Mindspace¹, compared to a loss of $9.6 million in fiscal 2020.
Operational Highlights During and Subsequent to Fourth Quarter 2021:
Numinus Bioscience – Research and Laboratory
Q4 2021 revenue of $90,593, a decrease of 66.7% from Q4 2020. This is primarily due to the Company ceasing cannabis related activities during the year to dedicate resources towards advancing psychedelic-centered service offerings – including psychedelic analytical testing and contract laboratory services, to align with the Company’s strategy and overall objectives.
In June 2021, the Company filed a provisional patent application with the United States Patent and Trademark Office for a proprietary rapid production process for psilocybe and other psychoactive fungi species. This process dramatically increases the production of therapeutics for use in psychedelic-assisted psychotherapy and leads to standardized psychedelic extracts that are reproducible, scalable, cost-effective and commercially viable.
In July 2021, Numinus received Health Canada approval for the MAPS-sponsored, single-arm, open-label safety and feasibility study evaluating MDMA-assisted therapy for PTSD.
During the quarter, Numinus began the 7,500 ft. expansion of its psychedelics research facility, including the building of an additional laboratory. An application for federal licensing for the additional lab was submitted in September 2021. The new space (adjacent to Numinus’ existing laboratory) will be dedicated to the following services:
Bioanalytical testing,
Bioassay and in-vitro studies,
Research & development and formulation studies for several psychedelic compounds, including ketamine and LSD, and,
Small batch manufacturing.
Subsequent to Q4 2021:
On October 24, 2021, Numinus announced it finalized the study design and protocol for a Phase 1 clinical trial on a naturally derived Psilocybin extract. This major milestone advances Numinus’ investigation of its first proprietary psychedelic product, which was developed using a patent-pending technology.
On November 10, 2021, the Company announced it will host the Montreal and Vancouver sites of the MAPPUSX study, which will continue to study the safety and efficacy of MDMA in treating severe PTSD, titled “A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD.”
On November 29, 2021, the Company announced that Numinus Bioscience developed proprietary psychedelic drug tests with new toxicity and potency scans. These new analytical tests will accelerate Numinus’ research and development capabilities and generate new revenue streams through third-party client product testing.
Numinus Health and Mindspace – Wellness Clinics
Q4 2021 revenue of $400,306, a 100% increase compared to nil during the same period last year when Numinus’ only clinic at the time was closed due to COVID-19.
As at August 31, 2021, Numinus Health had four wellness clinics across Canada (one in Vancouver and three in Montreal) that had a total of 16 treatment rooms.
During Q4 2021, 650 individual clients received a total of 2,671 therapy appointments through Numinus Health clinics (including one-on-one and group therapy sessions). In the three months following (during fiscal Q1 2022) the total number of client appointments at these same clinics grew by 42% to 3,792 (including one-on-one and group therapy sessions, and Ketamine-assisted psychotherapy).
Subsequent to Q4 2021:
On September 23, 2021, Numinus completed the acquisition of the Neurology Centre of Toronto (“NCT”) for $1.0 million, allowing for the planned expansion of NCT into a comprehensive neurologic care center specialized in psychedelic neurology.
On November 10, 2021, the Company announced that it had secured two additional clinic locations in Vancouver and Montreal that will primarily be used for clinical research studies in the near-term. The locations are already fully compliant with Health Canada regulations and can be seamlessly converted to client facing wellness clinics in the future.
As of December 9, 2021, Numinus has five wellness clinics offering services to clients (one in Vancouver, one in Toronto, and three in Montreal) that have a total of 21 treatment rooms. In addition, the company has two dedicated research clinics where psychedelic studies are being conducted (one in Vancouver and one in Montreal).
Corporate Updates
During Q4 2021, Numinus expanded its management team with new executive appointments in Marketing, Clinic Operations, Human Resources and Investor Relations.
Subsequent to Q4 2021:
On November 22, 2021, the Company changed its OTC ticker symbol to “NUMIF” (from “LKYSF”) to better align with its Canadian ticker symbol.
On November 25, 2021, Numinus received conditional approval to graduate to the TSX (from the TSXV), with the first day of trading scheduled for approximately December 16, 2021.
Key Performance Metrics:
For the quarter ended August 31,
For the year ended August 31,
2021
2020
2021
2020
Numinus Bioscience¹ revenue
90,593
272,023
479,502
791,504
Numinus Health revenue
11,852
(993)²
63,008
89,674
Mindspacerevenue
388,454
–
971,160
–
Total revenue
$490,899
$271,030
$1,513,670
$881,178
Cost of revenue
(459,081)
(429,252)
(1,595,208)
(793,131)
Gross profit (loss)
$31,818
($158,222)
($81,538)
88,047
Total expenses
($7,643,606)
($3,041,299)
($18,503,774)
($7,365,258)
Loss before other items
($7,611,788)
($3,199,521)
($18,585,312)
($7,277,211)
Other items
(171,124)
(101,047)
(188,633)
(2,331,237)
Loss before income tax
($7,782,912)
($3,300,568)
($18,773,945)
($9,608,448)
Income tax recovery/ (expense)
–
7,937
–
7,884
Loss and comprehensive loss
($7,782,912)
($3,292,631)
($18,773,945)
($9,600,564)
Basic & diluted loss per share
($0.04)
($0.03)
($0.11)
($0.15)
1 Numinus Bioscience consists of revenues generated through Numinus’ laboratory and research activities.
2 During Q4 2020, Numinus’ only wellness clinic (at that time) was closed due to COVID-19. Negative revenue was recorded as a result of adjustments made during the quarter.
Numinus’ condensed consolidated annual financial statements for the period ended August 31, 2021 and related management’s discussion and analysis are available on Numinus’ Investor Relations website at www.investors.numinus.com and under the Company’s profile on SEDAR at www.sedar.com. These documents were prepared in accordance with IFRS and with TSX-V disclosure timeline requirements.
Conference Call and Webcast Details
Interested parties are invited to participate in the Company’s Q4 and 2021 results conference call and webcast. On the call Numinus executives will review the Company’s performance and recent initiatives, and answer questions from analysts.
Date:
Thursday, December 9, 2021
Time:
5:30 p.m. (EST)
Dial-In:
1 (833) 989-2968 (Toll-free North America), 1 (236) 714-4028 (International)
About Numinus Numinus Wellness (TSX-V: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.
Forward-looking statements This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are “forward-looking statements”. Forward-looking statements can be identified by the use of words such as “expects”, “does not expect”, “is expected”, “believes”, “intends”, “anticipates”, “does not anticipate”, “believes” or variations of these words, expressions or statements, that certain actions, events or results “may”, “could”, “would”, “might” or “will be” taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company’s facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company’s limited operating and profitability track record; dependence on management; the Company’s need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company’s efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.
SOURCE Numinus Wellness Inc.
For further information: Investor Contact, Jamie Kokoska, Vice President, Investor Relations, jamie.kokoska@numinus.com, 1-833-686-4687; Media Contact, May Lee, Communications Manager, may.lee@numinus.com
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