Tag: financial results & corporate updates

IntelGenx Reports Fourth Quarter and Full-Year 2021 Financial Results

SAINT LAURENT, Quebec, March 24, 2022 (GLOBE NEWSWIRE) — IntelGenx Technologies Corp. (TSX:IGX)(OTCQB:IGXT) (the “Company” or “IntelGenx”) today reported financial results for the three- and twelve-month periods ended December 31, 2021. All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

“2021 was a transformational year for IntelGenx, during which we achieved multiple corporate milestones, entered into important strategic partnerships and made significant progress across our various development programs,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “We transitioned from a development-stage to a commercial-stage leader in pharmaceutical films with our first shipment of CBD Filmstrips to Heritage Cannabis; and graduated to the TSX, Canada’s most senior exchange. We entered into a strategic partnership and signed a second feasibility agreement with atai, solidifying our position in the burgeoning psychedelics space; established a commercial partnership for Tadalafil oral films in the U.S.; and partnered with an animal healthcare company to evaluate our VetaFilm^TM platform. Further, our commercialization partner, Exeltis Healthcare S.L., launched our migraine treatment, RIZAPORT^® in Spain. On the heels of all of that, we were pleased to start 2022 with the resumption of our Phase 2a ‘BUENA’ clinical trial. I am thrilled with our team’s progress, which positions us for continued success this year and beyond.”

2021 Fourth Quarter Financial Highlights:

• Revenue was $494,000, compared to $790,000 in the 2020 fourth quarter.
• Net comprehensive loss was $2.9 million, compared to $1.3 million in the 2020 fourth quarter.
• Adjusted EBITDA loss was $2.3 million, compared to $0.8 million in Q4-2020.

2021 Full-Year Financial Highlights:

• Revenue was $1.5 million, essentially unchanged from 2020.
• Net comprehensive loss was $9.8 million, compared to $7.1 million in 2020.
• Adjusted EBITDA loss was $7.1 million, compared to $5.3 million in 2020.

Recent Developments:

• The Company’s wholly owned subsidiary, IntelGenx Corp., received a third term loan in the amount of $3.0 million pursuant to its amended and restated secured loan agreement with atai Life Sciences (“atai”).
• Resumed patient dosing in the ongoing Phase 2a ‘BUENA’ clinical trial in patients with mild to moderate Alzheimer’s Disease under a previously amended protocol using higher doses of Montelukast VersaFilm^®.
• Initiated an arbitration proceeding against Tilray, Inc. related to an alleged breach of the parties’ 2018 license, development and supply agreement, as amended, for the co-development and commercialization of cannabis-infused VersaFilm^® products.
• Graduated to the Toronto Stock Exchange.

Financial Results:

Total revenues for the three-month period ended December 31, 2021 amounted to $494,000, a decrease of $296,000, or 37%, compared to $790,000 for the three-month period ended December 31, 2020. The change is mainly attributable to a $425,000 decrease in revenues from licensing agreements, partially offset by increases in and R&D revenues of $94,000 and product revenues of $35,000. Operating costs and expenses were $3.0 million for the fourth quarter of 2021, versus $1.8 million for the corresponding three-month period of 2020. For Q4-2021, the Company had an operating loss of $2.5 million, compared to operating loss of $1.0 million for the comparable period of 2020. Net comprehensive loss was $2.9 million, or $0.02 per basic and diluted share, for the fourth quarter of 2021, compared to net comprehensive loss of $1.3 million, or $0.01 per basic and diluted share, for the comparable period of 2020.

Total revenues for the twelve-month period ended December 31, 2021 amounted to $1.5 million, essentially unchanged from the year ended December 31, 2020. Operating costs and expenses were $9.5 million for the full year 2021, versus $7.8 million for the corresponding twelve-month period of 2020. For the twelve-month period of 2021, the Company had an operating loss of $8.0 million, compared to an operating loss of $6.3 million for the comparable period of 2020. Net comprehensive loss was $9.9 million, or $0.07 per basic and diluted share, for the twelve-month period of 2021, compared to net comprehensive loss of $7.1 million, or $0.07 per basic and diluted share, for the comparable period of 2020.

As at December 31, 2021, the Company’s cash and short-term investments totalled $9.9 million, which did not include the $3.0 million secured loan granted to IntelGenx Corp. by atai in February 2022.

Annual Filings:

The Company’s annual report on Form 10-K and financial statements for the year ended December 31, 2021, as well as the 2022 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, March 24, 2022.  

Conference Call Details:

IntelGenx will host a conference call to discuss these 2021 fourth quarter and full year financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (888) 506-0058 (Canada and the United States) or (973) 528-0135 (International); access code 503612. The call will be also be webcast live and archived on the Company’s website at www.intelgenx.com  under “Webcasts” in the Investors section.

About IntelGenx

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

IntelGenx’s superior film technologies, including VersaFilm^®, DisinteQ^™, VetaFilm^™ and transdermal VevaDerm^™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.

IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.  

Forward Looking Statements:

This document may contain forward-looking information about IntelGenx’s operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx’s plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words “may,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx’s actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk Factors” in IntelGenx’s annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.

Source:  IntelGenx Technologies Corp.

For IntelGenx:

Stephen Kilmer
Investor Relations
(647) 872-4849
stephen@kilmerlucas.com

Or

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com

atai Life Sciences to Host Conference Call and Webcast to Discuss Results for the Fourth Quarter and Full Year 2021 and Corporate Update

NEW YORK and BERLIN, March 23, 2022 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that it plans to host a webcast on Wednesday, March 30, 2022 at 8:30 a.m. ET to discuss its financial results for the fourth quarter 2021 and provide a business update.

To access the webcast, please log in at https://wsw.com/webcast/cc/atai/1358298. The live and archived webcast of this call will be available in the “Events” section of the atai Life Sciences website at ir.atai.life.

About atai Life Sciences

atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.

atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders.

atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai has offices in New York, Boston, San Diego, London and Berlin. For more information, please visit www.atai.life.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including without limitation statements regarding atai’s participation in upcoming conferences and presentations and similar statements of a future or forward-looking nature. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, as such factors may be updated from time to time in atai’s other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof and accordingly undue reliance should not be placed on such statements. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise, other than to the extent required by applicable law.

Contact Information

Investor Contact:
Greg Weaver
Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Camilla Dormer
VP, Communications
Email: camilla@atai.life 

MindMed to Host Earnings Call to Discuss Full-Year 2021 Financial Results and Provide Business Update

NEW YORK, March 21, 2022 /PRNewswire/ — Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, today announced that it will host its earnings call on Monday, March 28, 2022, at 8:30 a.m. EDT to discuss its financial results for the full year ended December 31, 2021 and provide a business update.

Individuals may participate via telephone by dialing (877) 407-0789 (domestic) or (201) 689-8562 (international) and using conference ID 13728028. The webcast can be accessed live here or on MindMed’s Investor Resources webpage. The webcast will be archived on the company’s website for at least 30 days after the conference call.

About MindMed

MindMed is a clinical-stage biopharmaceutical company developing novel products to treat brain health disorders, with a particular focus on psychiatry, addiction, pain and neurology. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine and acetylcholine systems.

MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.

For Investors: ir@mindmed.co

For Media: media@mindmed.co

SOURCE Mind Medicine (MindMed) Inc.

Wellbeing Digital Sciences Reports Financial Results for the Second Fiscal Quarter of 2022

Revenue Exceeded $1.6 Million for the Period Ended January 31, 2022

VANCOUVER, British Columbia, March 18, 2022 (GLOBE NEWSWIRE) — Wellbeing Digital Sciences Inc. (“Wellbeing” or the “Company”) (NEO: MEDI) (OTC: KONEF) (FRA: SQ2), an evidence-based healthcare company focused on innovative clinical solutions, artificial intelligence-powered digital therapeutics and contract research, is pleased to announce that it has filed its financial results for the quarter ended January 31, 2022, which is the second quarter of the Company’s 2022 fiscal year ending July 31, 2022, the highlights of which are included in this news release. The full set of Consolidated Financial Statements and Management Discussion and Analysis can be viewed by visiting the Company’s website at www.wellbeingdigital.co or its profile page on SEDAR at www.sedar.com.

Financial Highlights (all amounts expressed in Canadian Dollars unless otherwise noted)

• Revenue for the quarter ended January 31, 2022 reached $1,660,158, as compared to $nil for the same period of the prior year, which was primarily due to transitioning from an investment issuer to a single-purpose company focused on consolidating medical clinics and becoming a North American leader in mental health treatments;
• Gross loss for the quarter ended January 31, 2022 was $42,483, as compared to $nil for the same period of the prior year, due to cost of goods sold slightly exceeding revenue for the three-month period;
• Net loss for the quarter ended January 31, 2022 was $6,503,311, as compared to net loss of $997,171 reported for the same period of the prior year, primarily due to share based payments of $4,029,7765, professional fees of $645,473 and marketing expense of $549,010; and
• Total assets for the quarter ended January 31, 2022 decreased by 17% to $18,295,698 from $21,921,195 for the period ended July 31, 2021, which was mainly attributable to a decreased in cash and cash equivalents.

Management Commentary

“The second quarter of fiscal 2022 marked our first financial period as Wellbeing Digital Sciences, which began an exciting new chapter for the Company. During the period, KGK Science and IRP Health contributed appropriately and Wellbeing’s prospects for growth are encouraging,” said Adam Deffett, Interim CEO of Ketamine One. “As previously announced, our very own Najla Guthrie will become Chief Executive Officer of the Company effective March 31, 2022. I am grateful to have had the opportunity to lead an organization as dynamic and promising as Wellbeing on an interim basis over most of the last year and am confident that Najla will continue to steward it in a strong direction,” added Mr. Deffett.

‍Subsequent Highlighted Events (all amounts expressed in Canadian Dollars unless otherwise noted)

• Recent Achievements by KGK Science: On February 2, provided a corporate update highlighting the various achievements of its wholly owned subsidiary, KGK Science Inc., (“KGK” or the “CRO”). Recapping some of 2021’s highlights, KGK won contracts for 11 clinical trial service projects and 5 medical writing projects. Despite the restrictions associated with the COVID-19 pandemic, KGK was able to complete the conduct of 9 clinical trials and advanced several others towards completion. KGK’s Regulatory Division completed 19 consulting projects for clients in the nutraceutical, cannabis and psychedelic spheres. KGK received approvals for eight Product License Applications for Natural Health Products, acknowledgement letters for four unique New Dietary Ingredient Notifications and expert panel consensus that three food ingredients possess Generally Recognized As Safe status.
• Delivered its First IV Ketamine Treatment Under the Inpatient KITE Program: On February 15, announced the successful facilitation of its first intravenous (“IV”) ketamine treatment to a patient at the Victoria Wellness Mental Health Residential and Addition Treatment Centre (“VW”) in Ontario through its collaboration with iHealthOX. VW is one of the first in-patient facilities to offer ketamine-assisted therapy in Canada. Wellbeing management expects the collaboration between VW, iHealthOX and itself to experience an increase in the number of patients treated via IV ketamine infusions in the near future.
• IRP Health Received Approval from Veterans Affairs Canada for Reactivation Program: On March 3, announced that its wholly owned subsidiary, IRP Health Ltd. (“IRP”) had recently had its innovative Reactivation therapy program (“Reactivation” or the “Therapy Program”) formally approved by Veterans Affairs Canada (“VAC”) as an interdisciplinary clinic outpatient program at three locations. IRP currently has four clinic locations across Canada and is among the first operators to meet VAC’s new criteria that is aimed at providing high-quality programs for veterans. The Company expects IRP’s location in Ottawa, Ontario to also be approved to offer the Therapy Program by VAC imminently.
• Appointed Najla Guthrie as Chief Executive Officer: On March 7, announced that Najla Guthrie, the current Chief Research Officer and President of KGK Science Inc. (“KGK”), had been appointed as Chief Executive Officer (“CEO”) of Wellbeing effective March 31, 2022. Adam Deffett who was appointed Interim CEO in July of 2021, will transition out of the role but will continuing in his former capacity as Vice President of Capital Markets and Communications of the Company.

Outlook (excerpt from the Company’s Management Discussion & Analysis for the Period Ended January 31, 2022 and 2021)

The Company is dedicated to becoming a leader in clinical offerings of ketamine-enhanced treatments across North America. We have acquired 15 clinics across North America, with letters of intent signed for an additional clinic. We are building the critical infrastructure needed to provide breakthrough and life-changing mental wellness treatments through existing clinics, experienced professionals and advanced technology.

The Company will be utilizing first-of-its-kind wearable technologies to track key vitals before, during, and after psychedelic-assisted therapies. Our technology aims to empower patients in their wellness journey and provide clinicians with data to improve outcomes. Building objective data around the patient experience by measuring physical signals and responses will allow us to refine and adjust our processes, while providing great opportunities to advance psychedelic therapy research.

KGK Science, a wholly owned subsidiary of the Company, has helped hundreds of companies with custom designed clinical trials and claim substantiation strategies over the past 23 years. Equipped with state-of-the-art technologies, novel research techniques, and a seasoned team of industry experts, KGK Science is a leader in premium clinical research. It has extensive experience in pharmaceuticals, cannabis, natural health products, and more recently psychedelics.

ABOUT WELLBEING DIGITAL SCIENCES

Wellbeing Digital Sciences Inc. (formerly KetamineOne Capital Limited) is an evidence-based healthcare company focused on innovative clinical solutions, artificial intelligence-powered digital therapeutics and contract research. Its mission is supported by a network of North American clinics that provide ketamine-assisted therapies and other types of treatment to patients as well as through a contract research organization that offers clinical trials services to clients pursuing drug development. In essence, the company exists to make breakthrough treatments more accessible and to offer patients transformational experiences.

On behalf of:

WELLBEING DIGITAL SCIENCES INC.

“Adam Deffett“
Adam Deffett, Interim CEO

For further information, please contact:

Nick Kuzyk, Investor Relations
Tel: 1-844-746-6351
Email: ir@wellbeingdigital.co

Web: www.wellbeingdigital.co
Twitter: @Wellbeing_IR

Notice Regarding Forward-Looking Information:

This news release contains forward-looking statements including but not limited to statements regarding the Company’s business, assets or investments, as well other statements that are not historical facts. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. These assumptions, risks and uncertainties include, among other things, the state of the economy in general and capital markets in particular, investor interest in the business and prospects of the Company.

The forward-looking statements contained in this news release are made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. Additionally, the Company undertakes no obligation to comment on the expectations of, or statements made, by third parties in respect of the matters discussed above.

IntelGenx to Report Fourth Quarter and Full Year 2021 Financial Results on March 24, 2022 – Conference Call to Follow

SAINT LAURENT, Quebec, March 17, 2022 (GLOBE NEWSWIRE) — IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (“IntelGenx”), a leader in pharmaceutical films, today announced that it will release its fourth quarter and full year 2021 financial results after market close on Thursday, March 24, 2022.

An accompanying conference call will be hosted by Dr. Horst G. Zerbe, Chief Executive Officer, and Mr. Andre Godin, President and Chief Financial Officer, to discuss the results and provide a business update. Details of the conference call and webcast are below:

Fourth Quarter and Full Year 2021 Results Conference Call Details:
Date:	Thursday, March 24, 2022
Time:	4:30 p.m. ET
Live Call:	1-888-506-0058 (Canada and the United States)
	1-973-528-0135 (International)
Access Code:	503612

The call will also be broadcast live and archived on the Company’s website at www.intelgenx.com under “Webcasts” in the Investors section.

About IntelGenx

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

IntelGenx’s superior film technologies, including VersaFilm^®, DisinteQ^™, VetaFilm^™ and transdermal VevaDerm^™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.

IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.

Forward-Looking Information and Statements

This document may contain forward-looking information about IntelGenx’s operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx’s plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words “may,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx’s actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk Factors” in IntelGenx’s annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.

Source: IntelGenx Technologies Corp.

For IntelGenx:

Stephen Kilmer
Investor Relations
(647) 872-4849
stephen@kilmerlucas.com

Or

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com

Seelos Therapeutics Announces Year-End 2021 Business and Clinical Update

NEW YORK, March 7, 2022 /PRNewswire/ — Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced its year-end 2021 business and clinical update.

“In the second half of 2021, we continued to accomplish several significant milestones and continued to execute in the face of one of the most difficult environments for publicly-traded biotech companies that I’ve seen in my career,” said Raj Mehra Ph.D., Chairman and CEO of Seelos. “We began the placebo-controlled Part 2 of the registration directed study of SLS-002 and plan to enroll in over 30 sites. The SLS-005 IV trehalose program’s registrational study in ALS, which was accepted into the HEALEY ALS Platform Trial at Harvard, commenced dosing participants in February 2022 and our IND was accepted to study SLS-005 in spinocerebellar ataxia and its Phase IIb/III pivotal study should begin dosing in Q2 2022. We have begun additional in vivo studies with our Parkinson’s disease focused gene therapy program SLS-004 after demonstrating its capability of reducing alpha-synuclein expression. We look forward to continuing to provide meaningful updates on the current state of progress on all of our programs as well as additional initiatives.”

Seelos Clinical Update

SLS-002 (intranasal racemic ketamine)

• In July, Seelos began dosing patients in Part 2 of the registration directed, double-blind, placebo-controlled cohort in Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).  
• In June, based on feedback from a Type C meeting with the FDA, Seelos is planning to expand the size of the trial and number of sites now that this trial has been labeled registration directed.
• In October, Seelos presented a poster titled “A Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with Major Depressive Disorder at Imminent Risk of Suicide“, at the 2021 IASR/AFSP International Summit on Suicide Research Virtual Conference. SLS-002 demonstrated rapid, robust and sustained reductions on the Montgomery-Åsberg Depression Rating Scale (MADRS), the Clinical Global Impression of Severity for Suicidal Ideation and Behavior, the Patient Global Impression of severity for Suicidal Ideation and Behavior, and the Sheehan-Suicidality Tracking Scale. Additionally, the group mean met the MADRS remission criteria initially on day 6 after only 2 doses of SLS-002.

SLS-005 (IV Trehalose)

• In November, the FDA accepted Seelos’ Investigational New Drug (IND) application to study SLS-005 for the treatment of spinocerebellar ataxia (SCA). Seelos plans to initiate a Phase IIb/III registrational study in the first half of 2022.
• The FDA granted the program Fast Track designation in the U.S. for SCA, and SLS-005 has previously received Orphan Drug designation for spinocerebellar ataxia type 3 (SCA3) from the FDA and from the European Medicines Agency in the EU.
• Also in November, Seelos was an Emerald Sponsor of the 4^th Annual ALS ONE Research Symposium where Dr. Mehra presented an update of the program.
• In February 2022, Seelos commenced dosing of the first participants in a registrational Phase II/III trial in amyotrophic lateral sclerosis (ALS) as part of the HEALEY ALS Platform Trial led by Harvard Medical School at Massachusetts General Hospital at several dozen trial sites across the U.S.

SLS-004 and SLS-007 (Parkinson’s disease gene therapy programs)

• In early July, Seelos released in vivo data demonstrating down-regulation of SNCA mRNA and protein-expression from a study of SLS-004 in an in-vivo rodent model utilizing CRISPR-dCas9 gene therapy technology.
• Additional studies have commenced to explore efficacy of SLS-004 in the induced Parkinsonism in an in-vivo rodent model.
• Seelos was issued a patent covering the composition of matter for SLS-007, a potentially disease-modifying gene therapy focused on intracellular alpha-synuclein (α-synuclein) aggregation in Parkinson’s disease (PD).

Seelos Business Update

• In the second half of 2021, Seelos achieved several major clinical and financial milestones and continued to make progress on its multiple clinical stage development programs.
• As of year-end 2021, Seelos had $78.7mm of cash.
• Between August and December, Seelos presented at 8 investor conferences, multiple fireside chat format video calls for investors and 2 industry events for the scientific community.
• In September, Seelos announced the promotions of Michael Golembiewski to Chief Financial Officer and Anthony Marciano to Chief Communications Officer.
• Also in September, Seelos appointed Margaret Dalesandro, Ph.D., an accomplished biopharmaceutical executive with over 30 years of experience in drug development and commercialization, to its Board of Directors.
• In October, Seelos was the platinum level sponsor of the American Foundation for Suicide Prevention’s Out of the Darkness Westchester County Walk in Mamaroneck, NY.
• In November and December, Seelos raised $20.2 million in a private placement of senior secured convertible notes. Seelos will use the proceeds for general corporate purposes and to advance the development of its product candidates.
• Also in November, Seelos acquired a worldwide license (excluding China, Taiwan, Macau and Hong Kong) from iX Biopharma Europe Ltd for Wafermine™, a sublingual racemic ketamine wafer, and a worldwide license for other sublingual ketamine wafers, delivered using a proprietary fast-dissolving wafer-based drug delivery platform technology known as WaferiX™.

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding Seelos’ ability to complete clinical studies for its product candidates, Seelos’ ability to efficiently execute clinical and pre-clinical programs, opening additional trial sites for screening and dosing for the pivotal SLS-002 registration directed study (the “SLS-002 Study”), Seelos’ plan to initiate the SLS-005 Phase IIb/III registrational study for the treatment of SCA (with SLS-002 Study, the “Studies”). These statements are based on Seelos’ current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos’ business and plans described herein include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, or continuing or initiating the Studies, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the clinical results from the Studies are not replicated, or the risk that the clinical results from the SLS-002 Study are materially different from the topline clinical results of Part I of the SLS-002 Study), the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos’ current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos’ periodic filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:

Anthony Marciano
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2^nd Floor
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York, NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com

SOURCE Seelos Therapeutics, Inc.

Telescope Provides A Corporate Update

Vancouver, BC — March 1, 2022 — Telescope Innovations Corp. (“Telescope” or the “Company”) (CSE: TELI), a chemical technology company, is pleased to provide a corporate update summarizing the significant milestones the Company has achieved over the past year of operations. The rapidly growing Company has delivered on the following three milestones that it believes set the foundation for unlocking future value for shareholders:

1. Established a growing intellectual property portfolio on pharmaceutical manufacturing,
2. Increased in-house research capacity and proprietary research platforms, and;
3. Brought in award winning scientific leadership.

“In a little over a year, we have established Telescope as a deep tech company applying innovative chemistry technology to challenges in the pharmaceutical industry.” Said Jason Hein, CEO of Telescope. “We have discovered novel, scalable routes to manufacture psilocybin and address a huge unmet need in the treatment of mental health. Beyond this application, we are developing a robust set of technology platforms that accelerate chemistry research by leveraging robotic automation and artificial intelligence. We look forward to building out from this core foundation and deploying our systems to meet the biggest challenges in healthcare and chemical manufacturing.”

1. Established a growing intellectual property portfolio valuable for pharmaceutical manufacturing

One of Telescope’s strategic aims is to capitalize on the demand for the pharmaceutical-grade psychedelic therapeutics that are poised to address a growing US$ 16 billion market in anxiety disorders and depression treatment. While demand is growing, there is currently no regulated safe supply of psilocybin for therapeutic use. The Company has therefore focused on developing proprietary, scalable synthetic processes compatible with current good manufacturing practices (“cGMP”), with a view to sell and/or license this intellectual property to pharmaceutical companies or therapeutic providers.

Telescope has built out an intellectual property portfolio that currently consists of synthetic routes for the scalable production of pharmaceutical-grade psilocybin and psilocin (the active chemicals in psychedelic mushrooms) as well as their molecular precursors, analogs, and derivatives. These routes, in addition to a group of novel chemical entities, are captured in a Patent Cooperation Treaty Application (“PCT”) filed by Telescope in December 2021. 

Telescope’s proprietary chemical manufacturing methods have several key advantages (Figure 1):

• They require fewer synthetic steps than other available methods, reducing supply chain costs, waste streams, and investments in the isolation and purification of intermediate compounds. Shorter manufacturing cycles also accelerate deployment and help maintain a competitive position.
• Unlike existing synthetic methods, we avoid the use of highly flammable chemicals that are prohibitively hazardous at a large scale.
• We combine chemical manufacturing techniques that are standard practice in the pharmaceutical industry. This feature lowers the development costs to deploy our synthetic route and enables faster profitability.

Figure 1. Short, safe synthetic processes using industry-friendly methods (such as Telescope’s proprietary routes to psilocybin) provide significant economic benefits for commercial manufacturing.

• Our manufacturing routes are purposely flexible and easily tunable to produce valuable compounds in the same chemical family (e.g., dimethyltryptamine, harmaline, miprocin, ibogaine, melatonin, lysergic acid diethylamide, serotonin, bufotenine, etc.). The routes can also be tailored to produce novel molecules that may increase the safety, potency, or bioactivity of new psychedelic therapeutics. Even if a specific chemical compound fails to achieve FDA approval or pass regulatory milestones, Telescope’s manufacturing route can rapidly pivot to target the next generation of psychedelic drug candidates.

Within the PCT application filed in December 2021, Telescope has also captured a set of novel chemical entities (“NCEs”) to build a proprietary library of psychoactive compounds. The newly discovered molecules may perform similarly or more efficiently than psilocybin or other psychedelic medicines, and may become candidates for preclinical development as next-generation therapeutics in the future (Figure 2). NCEs may display improvements in safety, potency, specificity, or tunability, for example. To evaluate this potential, Telescope will pursue biological testing of these proprietary compounds by third-party, world-leading neurochemistry experts. Initial testing will aim to establish the effectiveness of the NCEs relative to leading psychoactive candidates.

Figure 2. Telescope’s intellectual property portfolio includes a set of novel chemical entities in the same chemical family as psilocybin. These new compounds may pave the way for accessing the next generation of psychedelic therapeutics.

Telescope plans to expand this intellectual property moat over the next year to increase the scope of proprietary chemical reactivity and accessible products. The Company is also building relationships with biotechnology and pharmaceutical companies to explore avenues for monetization.

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2. Increased in-house research capacity and proprietary research platforms

As of June 2021, Telescope occupies a dedicated laboratory facility in Vancouver, British Columbia. Here, we are developing and deploying our unique, proprietary ReACT platforms (Figures 3 and 4): robotic systems guided by artificial intelligence that increase the efficiency and quality of chemical research. We combine and integrate automation systems into a next-generation, self-guided chemistry experimentation platform that provides rapid, reliable data. This approach to research has enabled us to develop Telescope’s synthetic manufacturing processes for psilocybin in under one year.

Figure 3. Telescope’s ReACT platforms dramatically accelerate chemistry research.

ReACT is powered by our cross-disciplinary technical team of organic, process, and analytical chemists, computer scientists, and mechatronics engineers. The seamless integration of hardware, software, and chemistry knowledge is key to rapidly advancing Telescope’s technical goals.

Figure 4. A robotic arm module used in Telescope’s ReACT platforms.

Telescope’s high-level aim is to transform industrial research and development by deploying its automated platforms and chemical technology across the pharmaceutical and chemical manufacturing sectors. Over the next quarter, we aim to engage in consulting agreements and research contracts with specific, major global pharmaceutical and chemical manufacturing companies to apply our research platforms in industrial settings. These projects would generate near term cash flow while validating Telescope’s ability to break down process barriers and increase the efficiency of industrial R&D. We are also exploring relationships with global laboratory instrumentation and automation companies to commercialize Telescope’s automation platforms, aiming to manufacture, market, and sell these platforms over the next two years.

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3. Brought in award-winning scientific leadership

Telescope’s technical leadership comprises internationally renowned experts in chemical manufacturing and automation, having collectively authored over 450 academic publications and 33 patents. 

• Prof. Barry Sharpless (Senior technical advisor) received the Nobel Prize in Chemistry in 2001 for “the most important discovery in the field of synthesis during the past few decades”.  He received the Priestley Medal (the highest honour in the American Chemical Society) in 2019 and is the W.M. Keck Professor of Chemistry at the Scripps Research Institute in La Jolla, California.
• Prof. Jason Hein (CEO, Director) leads one of the largest academic chemistry research groups in Canada at the University of British Columbia. Has authored 50+ peer-reviewed articles amassing over 4,000 citations on organic chemistry, commercial manufacturing, and the role of automation, robotics and artificial intelligence in controlling pharmaceutical production.

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About Telescope

Telescope is a chemical technology company developing scalable manufacturing processes and tools for the pharmaceutical and chemical industry. The Company builds and deploys new enabling technologies including flexible robotic platforms and artificial intelligence software that improves experimental throughput, efficiency, and data quality. A key area of application for these tools is the development of scalable manufacturing processes for mental health medicines in the under-utilized tryptamine class of compounds, including psychedelic therapeutics. Our aim is to bring modern chemical solutions to meet the most serious challenges in human health. 

On behalf of the Board,

Telescope Innovations Corp.

Jason Hein, Chief Executive Officer

E: jason@telescopeinn.com 

Forward-Looking Information

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the “Risk Factors” section of the prospectus filed by the Company and available at www.sedar.com. 

Forward-looking statements in this document include expectations surrounding revenue streams from the research agreements, the patent filing process and the timing thereof, uses and viability of the intellectual property portfolio held by the Company, the performance of novel chemical entities, anticipated trends in the demand for psychedelic medical treatments and the ability of the intellectual property portfolio of the Company to respond to this demand, and all other statements that are not statements of historical fact.   

Examples of such assumptions, risks and uncertainties include, without limitation, assumptions, risks and uncertainties associated with the global COVID-19 pandemic, including the risk that the Company be deemed a non-essential business and asked to temporarily cease operations; general economic conditions; adverse industry events; future legislative and regulatory developments involving psilocybin; the Company’s ability to access sufficient capital from internal and external sources, and/or inability to access sufficient capital on favorable terms; the psilocybin industry in Canada and generally; the ability of the Company to implement its business strategies; competition; and other assumptions, risks and uncertainties.

These factors are not intended to represent a complete list of the factors that could affect the Company; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and the Company expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

The CSE has neither approved nor disapproved the contents of this news release. Neither the CSE nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.