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Field Trip Health Ltd. Reports Second Fiscal Quarter 2022 Financial Results and Provides Business Update

Field Trip Health Ltd. Reports Second Fiscal Quarter 2022 Financial Results and Provides Business Update

  • Announced plans to advance FT-104, its novel psychedelic compound, to clinic for Treatment-Resistant Depression and Postpartum Depression as the lead indications.
  • Initiated a new pipeline research program focused on discovering novel psychedelics with a reduced cardiovascular risk profile compared to classic psychedelics (the “FT-200 Group”) and filed a provisional patent in connection to the composition of matter for the first molecule identified in the FT-200 Group.
  • Continued to invest in best-in-class clinical infrastructure, with nine clinics currently in operation and nine locations under construction or about to commence construction.
  • Commenced trading on the NASDAQ Global Select Market (“NASDAQ”) under the ticker symbol “FTRP”.
  • As at September 30, 2021, Field Trip had approximately $88 million in unrestricted cash and cash equivalents and short-term investments.
  • Commenced a strategic review of the current corporate structure to assess options to maximize the value of the drug development and therapy delivery business units.

TORONTO, Nov. 15, 2021 (GLOBE NEWSWIRE) — Field Trip Health Ltd. (TSX: FTRP; FTRP.WT; NASDAQ: FTRP) (“FieldTrip“), a leader in the development and delivery of psychedelic therapies, reported its second fiscal quarter 2022 results for the three months ended September 30, 2021 and provided a business update. All results are reported under International Financial Reporting Standards (“IFRS“) and in Canadian dollars, unless otherwise specified.

Key Highlights and Recent Developments

During the quarter, Field Trip progressed its strategy of building a leading psychedelic therapy company (Field Trip Health) and continued to invest in its drug development pipeline and program expansion (Field Trip Discovery).

Field Trip Discovery

FT-104

During the quarter, it was announced that the lead indications for FT-104, Field Trip’s lead novel psychedelic compound in development (patent pending), will be Treatment Resistant Depression and Postpartum Depression. FT-104 is a novel, synthetic 5HT2A receptor agonist compound. It is currently advancing through preclinical studies with the in vivo portion completed, and final results from safety pharmacology and GLP toxicology are expected in calendar Q4 2021. To date, GLP toxicology, cardiovascular, pulmonary, and neurological safety pharmacology studies, as well as genotoxicity potential, all continue to be encouraging. In addition, final manufacturing of clinical trial material is scheduled for production to enable FT-104 to move into Phase 1 clinical trials in the first half of calendar 2022. The Company has experienced, and may continue to experience, delays in initiating Phase 1 clinical trials due to the ongoing COVID pandemic and delays at its contract manufacturing organization.

FT-200 Group: Introducing Field Trip’s Second Novel Psychedelic Program

The Company also announced the discovery of a novel molecule that, based on in vivo assay details, has the structure of classical psychedelics and has demonstrated improved selectivity for the target serotonin 2A receptor (5HT2A) relative to FT-104 and psilocybin versus off target serotonin, 5HT1A, 5HT2B and 5HT2C receptors. This is meaningful because off-target 5HT2B activity has been associated with increased risk of cardiovascular toxicity. Based on this discovery, the Company is expanding the scope of its development pipeline to focus on a new group of molecules termed the FT-200 Group, (which includes the molecule mentioned above), that have the structure of classical psychedelics, with similar potency at the 5HT2A receptor as FT-104 and psilocybin, but with reduced or the absence of activity at the off-target 5HT2B receptor. The aim of the work is that by reducing or eliminating 5HT2B activity it may allow molecules like those in the FT-200 Group to be administered more frequently, such as more chronic or chronic intermittent administration or ‘microdosing’ strategies.

“The first molecule identified in the FT-200 Group demonstrates significant promise to maintain 5HT2A activity while reducing off-target serotonin receptor activity. We are continuing to conduct preclinical work on this molecule and will explore structural analogs within the FT-200 Group to better refine and optimize this new family of substances, understand their properties better and work towards identifying a lead candidate”, said Joseph del Moral, Field Trip’s Co-founder and CEO.

On October 29, 2021 the Company filed a provisional patent application in the United States to protect the composition, as well as potential formulations and uses of the first molecule in the FT-200 group.

Field Trip Health Centres

Leveraging the growing awareness of Field Trip’s psychedelic-assisted therapy clinics, Field Trip announced on August 31, 2021 the launch of the KAP Co-operative Program (“KAP Co-op”), a program that enables eligible independent psychedelic therapists to provide ketamine-assisted psychotherapy (and, in the future, other legal, psychedelic-assisted therapies) at its Field Trip Health Centres. Field Trip also announced the launch of training programs designed to provide interested psychotherapists or other qualified mental health professionals and clinicians with access to best-in-class training on KAP.

The Company continues to invest in its clinics and during the quarter, entered into lease agreements for locations in Dallas, TX, Miami, FL and Scottsdale, AZ. Subsequent to the quarter end, the Company announced the opening of the Seattle, WA clinic, its sixth in the United States and ninth overall, along with the recent opening of a location in Fredericton, NB, and the imminent opening of a location in Vancouver, BC.

Hannan Fleiman, Field Trip’s Co-Founder and President, said, “We continue to see strong growth in our clinic business and our team is proud of the outcomes we are helping our patients achieve. We have continued to make significant investments in building out the leading platform for the delivery of psychedelic therapies and to position our clinics to be at the absolute forefront of our industry in establishing the critical infrastructure for the current and emerging psychedelic therapies with 9 clinics now in operation and 9 locations under construction or about to commence construction. Importantly, the clinics enable Field Trip to capture significant amounts of patient data on clinical outcomes which we expect to help inform future clinical development and treatment strategies.”

From a brand perspective, Field Trip continues to be a globally recognized company in the industry. During the quarter, the Company was featured in many top-tier print and broadcast media outlets, including Forbes, Vox Media, Insider, People and others, generating nearly 2 billion total potential media impressions. Field Trip’s brand presence and reach continues to generate strong website traffic and patient interest in the KAP treatments offered by the Company.

NASDAQ Listing

On July 29, 2021, Field Trip’s Common Shares commenced trading on the NASDAQ Global Select Market (“NASDAQ”) under the ticker symbol “FTRP”, providing the Company with greater access to capital. The Common Shares continue to trade in Canada on the TSX under its current symbol FTRP. Concurrent with the NASDAQ listing, Field Trip’s Common Shares ceased to be quoted on the OTCQX. The Company previously completed the process to ensure its shares are eligible for electronic clearing and settlement through the Depository Trust Company (DTC). In addition, Ronan Levy and Ellen Lubman joined the Compensation Committee and Mujeeb Jafferi and Dr. Ryan Yermus resigned as directors of the Company. Mr. Jafferi and Dr. Yermus continue to serve as Field Trip’s Chief Operating Officer and Chief Clinical Officer, respectively.

Mr. del Moral, continued, “The milestone of listing on NASDAQ during the quarter was testament to the rapid progress we have made and increased our visibility in the marketplace, improving trading liquidity and ultimately enhancing long term shareholder value as we further strengthen our leadership position in the psychedelic medicine industry.”

Strategic Review of Corporate Structure

The Company has commenced a strategic review designed to ensure that each operating unit is best positioned, optimally resourced, and focused to provide maximum long-term value to all stakeholders.

Mr. Joseph del Moral, said, “With the FT-104 nearing the clinic, the expansion of discovery efforts around our FT-200 Group, and the growing number of opportunities for Field Trip Health Centers we believe it is the correct time to review all strategic options to ensure we continue to maximize the growth potential and value of each business unit.”

The Company has engaged Bloom Burton Securities Inc. as its financial advisor in connection with the strategic review.

Financial Highlights

For the second fiscal quarter ended September 30, 2021, the Company earned patient services revenues of $907,816 from its Toronto, New York, Santa Monica, Chicago, Atlanta, Houston and Amsterdam clinics, an increase of $813,284 or 860% over the comparative quarter ended September 30, 2020 of $94,532 and an increase of $40,416 or 5% over the prior fiscal first quarter. The Amsterdam clinic began generating revenues in September 2021. Second fiscal quarter 2021 patient services revenues were generated from only two clinics, Toronto and New York. The modest quarter over quarter revenue increase was in part due to the COVID-19 Delta variant and seasonality associated with the slower summer months. Revenues in the first part of the third quarter indicate a clear upward trend as a result of recent process optimizations to accelerate patient on-boarding and increase clinic capacity.

Net loss for the second fiscal quarter of $13,019,280 was primarily due to total operating costs of $15,638,596, of which $2,055,890 was related to non-cash share-based compensation and $848,712 was related to non-cash depreciation and amortization. This was partially offset by a foreign exchange gain of $1,856,088. This compares with a net loss of $3,932,444 in the second fiscal quarter of 2021. The increase from the prior year primarily reflects the Company’s focus on growing the business and continued investment in its drug development pipeline and best-in-class clinic infrastructure. As the Company continues to scale, it is optimizing and streamlining the development of its psychedelic-assisted therapies.

Total operating costs in the second fiscal quarter were $15,638,596 and were comprised of the following: general and administration expenses of $8,917,717, research and development expenses of $2,102,787, patient services expenses of $1,917,451, sales and marketing expenses of $1,315,434, depreciation and amortization of $848,712 and occupancy costs of $536,495. This compares with total operating costs of $3,810,177 in the second fiscal quarter of 2021.

The difference in general and administrative expenses in the second fiscal quarter also included $596,055 in non-recurring expenses primarily related to the NASDAQ uplisting, $1,330,847 in recurring public company costs as well as non-cash share-based payments of $1,380,398.

Balance Sheet

As of September 30, 2021 Field Trip had unrestricted cash and cash equivalents, funds held in trust and short-term investments of $87,526,034.

Selected Consolidated Financial Information

The following table sets forth selected financial information derived from the Company’s unaudited condensed interim financial statements for the three months and six months ended September 30, 2021 prepared in accordance with IAS 34 in a manner consistent with the Company’s annual audited financial statements. The following information should be read in conjunction with the financial statements and management’s discussion and analysis, which are available on the Company’s website at www.fieldtriphealth.com and under the Company’s SEDAR profile at www.sedar.com.

FIELD TRIP HEALTH LTD

STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

3 months ended 3 months ended 6 months ended 6 months ended
September 30,
2021		 September 30,
2020		 September 30,
2021		 September 30,
2020
$ $ $ $
Revenue
Patient services 907,816 94,532 1,775,216 118,131
907,816 94,532 1,775,216 118,131
Operating Expenses
General and administration 8,917,717 2,092,593 16,260,688 3,366,948
Occupancy costs 536,495 111,877 913,110 175,660
Sales and marketing 1,315,434 281,185 2,379,561 435,940
Research and development 2,102,787 806,536 3,555,901 1,601,898
Depreciation and amortization 848,712 269,578 1,464,195 479,338
Patient services 1,917,451 248,408 3,375,272 321,665
Total Operating Expenses 15,638,596 3,810,177 27,948,727 6,381,449
Other Income (Expenses)
Interest income 111,934 2,589 243,549 4,838
Interest expense (256,522 ) (60,962 ) (403,109 ) (98,195 )
Other income (expense) 1,856,088 (158,426 ) 783,396 (534,673 )
Net Loss (13,019,280 ) (3,932,444 ) (25,549,675 ) (6,891,348 )
Net Loss per Share – Basic and Diluted (0.23 ) (0.16 ) (0.44 ) (0.28 )

 

As at
September 30,
2021
$		 As at
March  31,
2021
$
Cash and cash equivalents 22,388,946 38,469,057
Funds held in trust – 795,516
Restricted cash 619,127 588,041
Short-term investments 65,137,088 72,552,870
Accounts receivable 2,464,223 813,761
Total Assets 119,912,854 126,450,005
Total Non-Current Financial Liabilities 18,102,184 6,426,484

Certain comparative figures have been reclassified where necessary to conform with current period presentation.

Conference Call

The Company will conduct a conference call and webcast to discuss its results the following morning, Tuesday, November 16 at 8:30 am ET. To access the call, please dial 1-877-407-9716 (within the U.S.) or 1-201-493-6779 (outside the U.S.) and provide conference ID 13724604. A live webcast of the conference call can be accessed via the Events and Presentations section of the Field Trip Health Investor Relations website here.

For those unable to attend the live call, a telephonic replay will be available until 11:59 pm ET on Tuesday, November 30, 2021. To access the replay of the call dial 1-844-512-2921 (within the U.S.) or 1-412-317-6671 (outside the U.S.) and provide conference ID 13724604. An archived copy of the webcast will be available on the Events and Presentations section of the Field Trip Health Investor Relations website after the conclusion of the call.

About Field Trip Health Ltd.

Field Trip is a global leader in the development and delivery of psychedelic therapies. With our Field Trip Discovery division leading the development of the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics and our Field Trip Health division building centres for psychedelic therapies opening across North America and Europe along with the digital and technological tools that will enable massive scale, we help people in need with a simple, evidence-based way to heal and heighten engagement with the world.

Learn more at https://www.meetfieldtrip.com, https://www.fieldtriphealth.com and https://www.fieldtriphealth.nl.

Follow us on Twitter and Instagram: @fieldtriphealth.

To receive company updates about Field Trip and to be added to the email distribution list please sign up here.

Cautionary Note Regarding Forward-Looking Information  

This release includes forward-looking information (within the meaning of Canadian securities laws and within the meaning of the United States Private Securities Litigation Reform Act of 1995) regarding Field Trip and its business. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such statements are based on the current expectations and views of future events of the management of Field Trip and are based on assumptions and subject to risks and uncertainties. Although the management of Field Trip believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies, including the timing, completion and potential outcomes of the Strategic Review, the funds available to Field Trip and the use of such funds, the ability of Field Trip to operate its clinics, the construction and commencement of construction of additional clinics, the development, patentability and viability of FT-104 and the FT-200 Group, the ability of Field Trip to complete an investigational new drug application and obtain regulatory approvals, as required, prior to initiating clinical trials for FT-104 and molecules within the FT-200 Group, the ability of Field Trip to meet eligibility requirements for clinical testing and through to more complex clinical trials, the ability of Field Trip to obtain regulatory approvals prior to each clinical trial and the ability of Field Trip to generate patient member growth, interest in the training program, interest in the KAP Co-Op Program, uptake of the KAP Co-Op Program by therapists and patients, the ability of management to sustain and continue optimization of its clinical operations, the timing and results of its research and development programs, approval of phase 1 human trials, if any, the risk that future clinical studies may not proceed as expected or may produce unfavorable results, the opening of additional clinics, the COVID-19 epidemic, the medical clinic industry, market conditions, economic factors, management’s ability to manage and to operate the business and the equity markets generally. Although Field Trip has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Field Trip does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Additional information relating to Field Trip, including its Annual Information Form, can be located on the SEDAR website at www.sedar.com and on the EDGAR section of the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities.

Neither the Toronto Stock Exchange, nor its Regulation Services Provider, have approved the contents of this release or accept responsibility for the adequacy or accuracy of this release.

CONTACTS:

Media contacts:
Rachel Moskowitz
Autumn Communications
202-276-7881
press@fieldtriphealth.com

Nick Opich / McKenna Miller
KCSA Strategic Communications
212-896-1206 / 347-487-6197
press@fieldtriphealth.com

Investor contacts:
Kathleen Heaney / Tim Regan
KCSA Strategic Communications
fieldtripIR@kcsa.com

SOURCE Field Trip Health Ltd.

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Filament Health Reports Third Quarter 2021 Financial Results and Operational Highlights

Filament Health Reports Third Quarter 2021 Financial Results and Operational Highlights

FDA Authorization of Historic Phase I Clinical Trial Using All-Natural Psychedelic Compounds and Direct Psilocin Administration for the First Time

Granted First and Only Patent for Extraction and Standardization of Natural Psilocybin

Health Canada Dealer’s License Enables Production and Distribution of All Natural cGMP-Grade Psychedelic Supply from its Facilities

Vancouver, British Columbia, November 15, 2021  – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical-stage natural psychedelic drug development company, released its third quarter financial results and operational highlights for the period ended September 30, 2021.

 

Third Quarter and Post Period Operational Highlights:

FDA authorization of phase I clinical trial using naturally-sourced psychedelic substances and direct administration of psilocin (both orally and sublingually) for the first time in FDA history;

  • First and only patent granted for the extraction and standardization of natural psilocybin;
  • Over 20 patent applications to-date, including three international Patent Cooperation Treaty (PCT) applications covering extraction, standardization, purification and delivery of botanical drug candidates;
  • Completed industry-first export of current good manufacturing practices (“cGMP”)-quality natural psychedelic substances to the United States;
  • Psilo Scientific Ltd., Filament’s wholly-owned subsidiary received an amendment to Health Canada Dealer’s License for its facility, allowing the possession, production, and delivery of all controlled natural psychedelic substances;
  • Produced pharmaceutical-grade batches of natural psilocybin extracts including leading drug candidates which will be entered into upcoming FDA clinical trials.

Third Quarter and Post Period Financial and Capital Markets Highlights

  • Uplisted to the OTCQB Market under the symbol FLHLF on October 12, 2021;
  • Received Depository Trust Company (“DTC”) eligibility on October 12, 2021;
  • Listed on the Frankfurt Stock Exchange (“FSE”) under the symbol FSE:7QS on October 15, 2021;
  • Cash and cash equivalents of $6.4 million as of September 30, 2021.

Commentary and Outlook

“To-date, we have distinguished ourselves as a leader in the extraction and drug development of all-natural psychedelic compounds through our patent-protected botanical extraction process and recent FDA approval of the first-ever clinical trial using all-natural psychedelics to treat a variety of mental health disorders,” said Benjamin Lightburn, Chief Executive Officer. “Our team continues to quickly execute on Filament’s operational milestones, supported by our industry partnerships, extraction expertise and long-term IP strategy. Our goal is to continue our momentum by advancing our novel psilocybin and psilocin compounds through clinical trials, further building out our IP protection, and establishing ourselves as a unique provider of all-natural pharmaceutical-grade psychedelics to the industry. We are committed to maintaining this pace of innovation in order to support the treatment of mental health conditions with safe, natural psychedelics as soon as possible.”

 

ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary technology platform enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on Twitter, Instagram and LinkedIn.

 

MEDIA CONTACT

Anna Cordon, Director of Communications
778.245.9067
anna@filament.health

 

INVESTOR RELATIONS CONTACT

KCSA Strategic Communications
Tim Regan/Adam Holdsworth
347.487.6788
KCSA-investor-relations@filament.health

 

FORWARD LOOKING INFORMATION

Certain statements and information contained herein may constitute “forward-looking statements” and “forward-looking information,” respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward-looking statements or information. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. The forward-looking statements discussed in this press release may include, but are not limited to, information concerning Filament’s upcoming clinical trials; strategic and growth plans of the Company including intellectual property; and the impact, timing and accessibility of psychedelic treatments. Forward-looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including capital expenditures and other costs. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.15

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MindMed Announces Financial Results for the Third Quarter 2021 and Business Highlights; Cash Balance of $145.9 USD ($185.4 CAD) to Execute on Diverse Clinical Pipeline

MindMed Announces Financial Results for the Third Quarter 2021 and Business Highlights; Cash Balance of $145.9 USD ($185.4 CAD) to Execute on Diverse Clinical Pipeline

MindMed (Nasdaq: MNMD, NEO: MMED, DE: MMQ), a leading biotech company developing psychedelic-inspired therapies, has announced its quarterly financial results for the quarter ended September 30, 2021.

Third Quarter 2021 Financial Highlights (in USD)

  • Cash Balance. Total assets as of September 30, 2021 were $178.6 million, including $145.9 million in cash, as compared to $85.6 million, including $80.1 million in cash, as of December 31, 2020
  • Net Cash Used in Operating Activities. Net Cash Used in Operating Activities of $10.8 million and $31.9 million for the three and nine months ended September 30, 2021, as compared to $5.8 million and $16.5 million for the three and nine months ended September 30, 2020, respectively
  • Net Loss. Net and comprehensive loss of $24.3 million and $74.6 million for the three and nine months ended September 30, 2021, as compared to $8.6 million and $21.4 million for the three and nine months ended September 30, 2020

Third Quarter 2021 Business Highlights

  • Announced the Appointment of Andreas Krebs and Carol Vallone as Board Directors and the Transition of Bruce Linton
  • Appointed three new members to its Scientific Advisory Board: Dr. Maria Oquendo, Ruth Meltzer Professor and Chairman of Psychiatry at University of Pennsylvania and Psychiatrist-in-Chief at the Hospital of the University of Pennsylvania; Dr. Bob Dworkin, Professor of Anesthesiology and Perioperative Medicine, Neurology, and Psychiatry, and Professor in the Center for Health + Technology, at the University of Rochester School of Medicine and Dentistry; and Dr. Bryan Roth, University of North Carolina Psychiatrist and Pharmacologist
  • MindMed and Liechti Lab Provided Results from the Psilocybin Research and Development (R&D) Collaboration
  • Joined the Clinical Trials Transformation Initiative and Critical Path Institute’s Patient-Reported Outcome Consortium
  • Announced a Strategic Research Collaboration with Sphere Health
  • MindMed and BioXcel Therapeutics Published an International Patent Application Describing a System for Identifying Agitation Episodes
  • Announced Collaboration with Forian to Advance Development of Personalized Psychiatry for Anxiety Disorders

Management Update & Earnings Call

Management will host an earnings call to review the third quarter financials and business developments on Wednesday, November 17th, 2021, at 8:00 am EST. Details are below:

https://mindmed-co.zoom.us/webinar/register/WN_Tp–QUSPS9u17HCQwxlc4Q

Complete financial statements along with related management’s discussion and analysis can be found in the System for Electronic Document Analysis and Retrieval (SEDAR), the electronic filing system for the disclosure documents of issuers across Canada at www.SEDAR.com and on the Electronic Data Gathering, Analysis, and Retrieval system (EDGAR), the electronic filing system for the disclosure of documents of issuers in the United States at www.sec.gov.

About MindMed

MindMed is a clinical-stage biotech company that discovers, develops, and deploys psychedelic inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed’s approach to developing the next generation of psychedelic inspired medicines and therapies.

MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ. For more information: www.mindmed.co

Forward-Looking Statements

Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release include, but are not limited to, statements regarding the start of MindMed’s Phase 1 clinical trial of dimethyltryptamine (DMT), the business and the therapeutic potential of MindMed’s product candidates, the ability to successfully execute and delivery on the R(-)-MDMA Program, the ability to achieve success with our collaborations with Sphere Health and Forian, the successful outcome of the Phase 1 clinical trial of DMT, the ability to initiate a Phase 2 clinical trial of DMT, regulatory approvals, the effects of DMT, subject enrollment and the administration method of DMT. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Company. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described under the headings “Risk Factors” in the Company’s filings with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results and future events could differ materially from those anticipated in such information. Although the Company has attempted to identify important risks, uncertainties and factors that could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend and does not assume any obligation to update this forward-looking information.

Media Contact: mindmed@150bond.com

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Cybin Inc. Reports its Second Quarter Financial Results and Recent Business Highlights

Cybin Inc. Reports its Second Quarter Financial Results and Recent Business Highlights

– Company to host conference call at 4:30pm EST today –

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, today reported unaudited financial results for its second quarter ended September 30, 2021.

“The first half of the year has been a transformative period for Cybin that included significant and swift advancements in our research and development pipeline and overall business. Through CYB003, we believe that we have identified a potentially safer treatment option for patients with depression and addiction disorders that we expect to have strong intellectual property protection and a positive pharmacokinetic profile for patients, providers and payers. We plan to move through the ongoing, remaining preclinical studies quickly and submit an investigational new drug application and clinical trial application in the second quarter of 20221, in the U.S. and the U.K., respectively,” said Doug Drysdale, Chief Executive Officer of Cybin.

Drysdale continued, “In addition, we continue to evolve our value-driving, patient-centered approach to potential treatments for mental health and addiction through our commitment to advancing programs such as EMBARK, that aims to facilitate psilocybin-assisted psychotherapy for frontline workers impacted by the COVID-19 pandemic, as well as targeted research using the Kernel Flow neuroimaging technology that we expect will allow us to quantitively understand the psychedelic experience in the brain as it is happening. We believe these programs combined with our proprietary psychedelic new chemical entities have the potential to transform the treatment landscape for various psychiatric and neurological conditions.”

Recent Business and Pipeline Highlights:

  • Announced preclinical data for its novel deuterated psilocybin analog, CYB003, for the potential treatment of major depressive disorder and alcohol use disorder. The data demonstrated that CYB003 may provide significant treatment benefits to address the challenges and limitations of oral psilocybin, including improved safety through less patient variability, reduced clinic times through faster onset of action and shorter duration of effect, and lower dosing through improved brain penetration, which may result in fewer side effects, ultimately offering an improved patient experience. Cybin expects to complete the ongoing preclinical studies of CYB003 in Q1 2022 and submit an investigational new drug application (“IND”) to the U.S. Food and Drug Administration (the “FDA”), and a clinical trial application with the U.K. Medicines and Healthcare Products Regulatory Agency in Q2 20222.
  • Granted a Schedule I manufacturing license from the U.S. Drug Enforcement Agency for the Company’s Boston-area research lab that is expected to allow the Company to expand its internal research and development capabilities.
  • Received approval from the FDA for its IND application to proceed with a Company-sponsored feasibility study using the Kernel Flow quantitative neuroimaging technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics.
  • Launched the EMBARK Psychedelic Facilitator Training Program in collaboration with the University of Washington in preparation for the first clinical trial of psilocybin-assisted psychotherapy to address COVID-19 related distress in frontline healthcare professionals.
  • Welcomed Dr. Amir Inamdar as Chief Medical Officer for European Operations; Dr. Geoff Varty as Head of Research and Development; and Leah Gibson as Vice President of Investor Relations.

Second-Quarter Financial Highlights

  • Cash and cash equivalents totaled to C$75.2 million as of September 30, 2021.
  • Net loss was C$17.6 million for the quarter ended September 30, 2021 of which non-cash expenses totaled C$6.0 million and cash-based operating expenses totaled C$11.6 million.

Conference Call and Webcast Details

DATE:

Monday, November 15, 2021

TIME:

4:30 p.m. (EST)

DIAL-IN

1-844-200-6205 (U.S. toll free) or 1-833-950-0062 (Canada toll free)

CODE

727873

WEBCAST

https://events.q4inc.com/attendee/747515026

The live and archived webcast will also be available on the Company’s Investor Relations site under the Events & Presentations page.

Business Update

Cybin has decided not to proceed with its nutraceutical product line in order to focus its efforts on the research and development of its psychedelic molecules. Further, the Company no longer anticipates conducting business activities in Jamaica, as the Company focuses on the new Deuterated Psilocybin Analog Program. The Company intends to complete future clinical trials in the U.S. and the U.K.

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in the United States, United Kingdom and Ireland. The Company is focused on progressing psychedelics to therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Cautionary Notes and Forward-Looking Statements

Certain statements in this news release related to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company’s development of innovative drug delivery systems, statements regarding the potential benefits of the Company’s novel deuterated psilocybin analog, CYB003, statements regarding the Company’s completion of preclinical studies of CYB003 in Q1 20223 and the submission of a new drug application and clinical trial application in Q2 20224, statements regarding the Company’s EMBARK Psychedelic Facilitator Training Program, statements regarding the anticipated results of using Kernel Flow technology in the Company’s research, and statements regarding the expansions of the Company’s internal research and development capabilities under its Schedule I manufacturing license.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in each of the Company’s management’s discussion and analysis for the three and six month periods ended September 30, 2021, the Company’s annua l information form for the year ended March 31, 2021, and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward- looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward- looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

_________________

1 Based on a calendar year-end.

2 Based on a calendar year-end.

3 Based on a calendar year-end.

4 Based on a calendar year-end.

 

Investor & Media Contact:
Leah Gibson
Vice President, Investor Relations
Cybin Inc.
leah@cybin.com

Source: Cybin Inc.

Posted on

atai Life Sciences Reports Third Quarter 2021 Financial Results and Corporate Update

atai Life Sciences Reports Third Quarter 2021 Financial Results and Corporate Update

-Positive topline results from COMP360’s Phase 2b study-

-RL-007 Phase 2a topline data in cognitive impairment associated with schizophrenia expected end of Q4-

-Continued progress across 11 therapeutic programs, including initiation of Perception’s Phase 2a and DemeRx’s Phase 1/2 trials as well as interim Phase 2a RL-007 readout of first cohort-

-Launch of atai Impact, a philanthropic program to harness the power of innovative mental health approaches for social change-

-Company to host a webcast and conference call today at 08:30am EST-

BERLIN and NEW YORK, Nov. 15, 2021 (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 reported its financial results for the third quarter ended September 30, 2021, and provided its corporate update.

“Following our IPO in June, we continue to see positive momentum. We have 11 therapeutic programs underway and each clinical development milestone marks progress towards achieving our vision to heal mental health disorders so that everyone, everywhere can live a more fulfilled life,” said Florian Brand, CEO and Co-Founder.

“In response to the heterogeneity of the mental health patient population, we are developing a pharmacologically diverse array of treatments. We intend to support these treatments with innovative digital therapeutics and robust insights from our multi-modal data approach. Our ultimate goal is to tailor our treatments to individual patient needs by using a diverse set of biomarkers. We anticipate further growth of our drug development pipeline and our enabling technologies through our ‘buy and build’ approach and will remain highly active in business development.

“We recently initiated two new clinical trials: a Phase 2a trial with PCN-101 (R-ketamine) for treatment-resistant depression and a Phase 1/2 trial with DMX-1002 (ibogaine) in opioid use disorder. In terms of clinical readouts, just last week we saw positive Phase 2b data from COMPASS Pathways, the first company we funded to rigorously research the potential of psychedelics. This clinical trial demonstrated the rapid onset of effect, large effect size, and durability of COMP360 (a proprietary synthetic formulation of psilocybin) in treatment-resistant depression. We expect another important clinical readout before the end of the year for RL-007 in cognitive impairment associated with schizophrenia.

“The narrow focus on mental health treatments means that every single trial result offers important insights not only for the program in question but for all our programs, allowing us to accelerate the development of novel treatments for patients in need.”

Program Updates

COMP360 (psilocybin):
Program Details: COMP360 is a proprietary formulation of synthetic psilocybin, a 5-HT2A-R agonist being developed as an oral, potentially rapid-acting antidepressant.

Recent Advancements:

  • In November, COMPASS announced positive topline results from its Phase 2b randomized, controlled, double-blind, dose-controlled trial of COMP360 psilocybin therapy for treatment-resistant depression.
  • The 233-patient study met its primary endpoint, showing a 6.6-point reduction on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to 3 weeks when comparing the 25mg dose to the 1mg dose.
  • COMP360 also showed both rapid response and durability of efficacy. Rapid onset of action with statistically significant treatment differences between the 25mg vs 1mg groups were apparent the day after COMP360 psilocybin administration. Responder rates at week 12 based upon a ≥50% decrease in MADRS total score from baseline were 32.9% and 16.4% for psilocybin doses of 25mg and 1mg respectively. Remitter rates at week 12 based upon a MADRS total score ≤10 were 26.6% and 11.4% for psilocybin doses of 25mg and 1mg respectively.
  • COMP360 was generally well tolerated.

Upcoming Milestones:

  • A pivotal Phase 3 study is anticipated to launch in 2022.

Affiliate: COMPASS Pathways

PCN-101 (R-ketamine):
Program Details: PCN-101 is a parenteral formulation of R-ketamine, a glutamatergic modulator being developed as a potentially rapid-acting antidepressant, with the potential for at-home treatment.

Recent Advancements:

  • In September 2021, Perception Neuroscience initiated the Phase 2 trial of PCN-101 (R-ketamine) for TRD. This randomized, double blind, placebo-controlled trial is designed to assess the efficacy, safety, dose response and duration of action in patients with TRD.

Upcoming Milestones: 

  • Topline data are expected at the end of 2022.

Affiliate: Perception Neuroscience

RL-007:
Program Details: RL-007, a cholinergic, glutamatergic and GABA-B receptor modulator, is an orally available compound that is being developed for the treatment of cognitive impairments associated with schizophrenia (CIAS). The currently active open-label, multi-dose, biomarker-focused Phase 2a trial of RL-007 in patients with CIAS is designed to evaluate the compound’s safety, tolerability and its impact on electroencephalogram-based biomarkers.

Recent Advancements:

  • Following the encouraging results of a recently completed interim analysis of Quantitative Electroencephalogram (qEEG) data from the eight patients in the first cohort, atai advanced a portion of a future milestone payment aiming to accelerate initiation of the subsequent trial, which, broadly, will be a double-blind, placebo controlled, proof-of-concept study focused on more traditional cognitive endpoints, including subsets of the MATRICS battery.

Upcoming Milestones: 

  • Topline data are expected by the end of 2021.

Affiliate: Recognify Life Sciences

GRX-917 (deuterated etifoxine):
Program Details: GRX-917 is an oral formulation of a deuterated version of etifoxine, a mitochondrial translocator protein agonist, designed to provide potentially rapid anxiolytic activity with improved tolerability compared to current treatments for anxiety in the United States.

Recent Advancements:

  • The Phase 1 randomized, double blind, placebo-controlled trial of GRX-917 is designed to evaluate the compound’s safety, tolerability, pharmacokinetics, as well as pharmacodynamics using qEEG. We have recently completed the single ascending dose (SAD) component of the trial, and dosing in the multiple ascending dose (MAD) component is ongoing.

Upcoming Milestones:

  • Topline data are expected in mid-2022.

Affiliate: GABA Therapeutics

DMX-1002 (ibogaine):
Program Details: DMX-1002 is an oral formulation of ibogaine, a cholinergic, glutamatergic and monoaminergic receptor modulator being developed for the treatment of opioid use disorder (OUD).

Recent Advancements:

  • In September 2021, DemeRx IB dosed the first subject in a Phase 1/2a trial of DMX-1002. This trial is designed to assess the safety, tolerability, pharmacokinetics, and efficacy of DMX-1002 and will inform future studies in patients with OUD.

Upcoming Milestones

  • Topline safety data are expected in early 2022.

Affiliate: DemeRx IB

Q3 and Recent Corporate Updates
Discovery Programs

  • Launched PsyProtix, a precision psychiatry company creating new chemical entities targeting mitochondrial dysfunction related to TRD and other mental health conditions. PsyProtix is currently engaged in discovery and preclinical development and expects to launch clinical trials in 2023.
  • Created and pharmacologically tested over 250 novel compounds at EntheogeniX based upon structures generated using computational chemistry approach. Lead candidate selection is currently ongoing.

Formulation Technologies

  • Entered into an expanded agreement with strategic partner IntelGenx, building on positive early feasibility data, to support IntelGenx’s graduation from the TSX Venture Exchange to the Toronto Stock Exchange. As part of the strategic partnership, IntelGenx has exclusively partnered with atai to develop formulations of compounds for the prevention or treatment of mental health disorders.
  • Completed a proof-of-principle study demonstrating that InnarisBio’s sol-gel based excipient technology can effectively transport compounds from the nose directly to the brain in an animal model. InnarisBio is developing its nose-to-brain excipient technology to facilitate potentially rapid, non-invasive entry into the brain for use across various drug candidates in atai’s pipeline, including Revixia, Neuronasal, and DemeRx.

Digital Therapeutics

  • Initiated a user acceptability testing of our digital therapeutics (DTx) app, one of our key enabling technologies, in patients with TRD receiving ketamine treatment.
  • In addition, we have assembled a proof-of-concept, EEG- and VR-based digital therapeutic device to support patients undergoing psychedelic therapy, and we have kicked off user feedback testing to optimize across product parameters.
  • Both technologies are expected to be implemented in Viridia and Revixia Phase 1 trials and DemeRx IB Phase 2 trial starting next year.

New Initiatives

  • Launched atai Impact, atai’s philanthropic program, established to support and collaborate with nonprofits and institutions that share atai Life Sciences’ vision, with the key pillars of: advancing education, expanding access, and supporting the wider ecosystem of mental health care. atai Impact has an initial focus on the psychedelics sector, given its emerging potential in tackling the growing mental health crisis. Its formation is underpinned by atai’s belief that harmonization across commercial and non-profit entities represents the best path forward to harness the power of innovative mental health approaches for positive social change. The atai Impact program will be initially funded by 1% of the gross proceeds from our June 2021 IPO and founders’ and shareholders’ contributions.

Third Quarter 2021 Financial Results

Cash and Cash Equivalents
Cash and cash equivalents totaled $430.3 million as of September 30, 2021, compared to $97.2 million as of December 31, 2020. The nine month increase of $333.1 million is attributed to net proceeds of $231.6 million from atai’s IPO, net proceeds of $166.4 million from Series C and Series D and common stock issuances, $20.0 million of license revenue proceeds, and $10.1 million proceeds from the sale of investments and issuance and conversion of convertible notes. Offsetting were cash payments of $32.6 million for investments in platform companies and other assets, and $62.4 million in net operating expenses and effect of foreign exchange rate changes.

Operating Costs and Expenses
Research and development (R&D) expenses were $13.4 million and $35.0 million for the three and nine months ended September 30, 2021, respectively, as compared to $3.1 million and $8.1 million for the same prior year periods. The increase of $10.3 million and $26.9 million, respectively, were attributable to personnel costs, including stock-based compensation expense, and increased contract research organization expenses related to advancements in atai’s R&D programs.

atai recorded acquisition of in-process R&D expense of $9.0 million for the nine months ended September 30, 2021, relating to its investments in Neuronasal and InnarisBio.

General and administrative expenses for the three and nine months ended September 30, 2021 were $20.3 million and $66.9 million, respectively, as compared to $4.3 million and $8.7 million in the same prior year periods. The increases of $16.0 million and $58.2 million, respectively, were attributable to personnel costs, including stock-based compensation expense, professional fees, and other costs related to support of atai’s platform growth and public company requirements.

Total stock-based compensation expense for the three and nine months ended September 30, 2021 was $12.2 million and $50.0 million, respectively, as compared to $2.1 and $2.2 for the comparable prior year periods, reflecting the recognition of expense related to the achievement of IPO performance-based partial vesting conditions.

Net loss attributable to atai shareholders for the three and nine months ended September 30, 2021 was $31.2 million and $78.9 million, respectively, as compared to $83.2 million and $83.2 million for the comparable prior year periods.

Conference Call Information
atai will host a conference call and live audio webcast today at 08:30am EST to discuss its financial results and provide a corporate update. To access the live conference call, please dial 877-407-3982 from the United States, or +1 (201) 493-6780 internationally, using the conference ID: 13724750. 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. An archived copy of the webcast will be available on the atai website for at least 30 days after the conference call.

About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. 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 is headquartered in Berlin, with offices in New York and London. 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, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, our future operating results and financial position; the success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials and related milestones; the commercialization of our current product candidates and any other product candidates we may identify and pursue, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current product candidates and any other product candidates we may identify and pursue; the timing of and our ability to obtain and maintain regulatory approvals; our business strategy and plans; potential acquisitions; and the plans and objectives of management for future operations and capital expenditures. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: we are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future; we will require substantial additional funding to achieve our business goals, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our limited operating history may make it difficult to evaluate the success of our business and to assess our future viability; we have never generated revenue and may never be profitable; our product candidates contain controlled substances, the use of which may generate public controversy; clinical and preclinical development is uncertain, and our preclinical programs may experience delays or may never advance to clinical trials; we rely on third parties to assist in conducting our clinical trials and some aspects of our research and preclinical testing, and those clinical trials, including progress and related milestones, may be impacted by several factors including the failure by such third parties to meet deadlines for the completion of such trials, research, or testing, changes to trial sites and other circumstances; we currently rely on qualified therapists working at third-party clinical trial sites to administer certain of our product candidates in our clinical trials and we expect this to continue upon approval, if any, of our current or future product candidates; if third-party sites fail to recruit and retain a sufficient number of therapists or effectively manage their therapists, our business, financial condition and results of operations would be materially harmed; we cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized; research and development of drugs targeting the central nervous system, or CNS, is particularly difficult, and it can be difficult to predict and understand why a drug has a positive effect on some patients but not others; we face significant competition in an environment of rapid technological and scientific change; third parties may claim that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent or delay our development and commercialization efforts; a change in our effective place of management may increase our aggregate tax burden; we identified material weaknesses in connection with our internal control over financial reporting; and a pandemic, epidemic, or outbreak of an infectious disease, such as the COVID-19 pandemic, may materially and adversely affect our business, including our preclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results. Other risk factors include the important factors described in the section titled “Risk Factors” in our final prospectus, dated June 17, 2021, filed with the Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b) under the Securities Act, and in our other filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements.

Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations.

Contact Information

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

Investor Contact:
Chad Messer
VP, Investor Relations, atai Life Sciences
Email: chad@atai.life

 

ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2021 2020 2021 2020
License revenue $ 266 $ – $ 20,146 $ –
Operating expenses:
Research and development 13,363 3,058 34,974 8,056
Acquisition of in-process research and development – – 8,934 120
General and administrative 20,264 4,328 66,868 8,749
Total operating expenses 33,627 7,386 110,776 16,925
Loss from operations (33,361 ) (7,386 ) (90,630 ) (16,925 )
Other income (expense), net 6,887 (13,942 ) 2,608 6,352
Net loss before income taxes (26,474 ) (21,328 ) (88,022 ) (10,573 )
Provision for income taxes (368 ) (4 ) (432 ) (4 )
Gain on investment dilution – – 16,923 –
Losses from investments in equity method investees, net of tax (4,800 ) (61,862 ) (9,440 ) (73,693 )
Net loss (31,642 ) (83,194 ) (80,971 ) (84,270 )
Net income (loss) attributable to redeemable noncontrolling
interests and noncontrolling interests (484 ) 1 (2,040 ) (1,021 )
Net loss attributable to ATAI Life Sciences N.V. stockholders $ (31,158 ) $ (83,195 ) $ (78,931 ) $ (83,249 )
Net loss per share attributable to ATAI Life Sciences N.V. stockholders– basic and diluted $ (0.21 ) $ (0.92 ) $ (0.59 ) $ (0.92 )
Weighted average common shares outstanding attributable to ATAI Life Sciences N.V.
stockholders — basic and diluted		 151,130,212 90,709,312 134,334,685 90,709,312

 

ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED BALANCE SHEET
(Amounts in thousands)
September 30, December 31,
2021 2020
(unaudited) (1)
Assets
Cash and cash equivalents $ 430,308 $ 97,246
Prepaid expenses and other current assets 11,551 2,076
Short term notes receivable – related party – 226
Property and equipment, net 138 71
Deferred offering costs – 1,575
Equity method investments 15,086 –
Other investments held at fair value 6,816 –
Other investments 14,256 8,044
Long term notes receivable 908 911
Long term notes receivable – related parties 3,784 1,060
Other assets 1,262 339
Total assets $ 484,109 $ 111,548
Liabilities and Stockholders’ Equity
Accounts payable $ 1,974 $ 3,083
Accrued liabilities 13,075 9,215
Current portion of contingent consideration liability – related parties 50 –
Deferred revenue 180 –
Short-term notes payable 38 –
Non-current portion of contingent consideration liability – related parties 1,947 1,705
Convertible promissory notes – related parties, net of discounts and deferred issuance costs 800 1,199
Convertible promissory notes and derivative liability – 978
Other liabilities 3,285 –
Total stockholders’ equity attributable to ATAI Life Sciences N.V. stockholders 453,186 90,822
Noncontrolling interests 9,574 4,546
Total liabilities and stockholders’ equity $ 484,109 $ 111,548
(1) The condensed consolidated financial statements as of and for the year ended December 31, 2020 are derived from the audited consolidated financial statements as of that date.
Posted on

Silo Pharma Reports Third Quarter Results and Operating Highlights

Silo Pharma Reports Third Quarter Results and Operating Highlights

Englewood Cliffs, NJ, Nov. 11, 2021 (GLOBE NEWSWIRE) — Silo Pharma, Inc. (OTCQB: SILO), a development-stage biopharmaceutical company focused on the use of psychedelics as a therapeutic, today reported its financial results for the third quarter 2021 and gave an update on recent progress in its business.

Operating Highlights

  • Entered sponsored research agreement with Columbia University to develop psychedelic therapeutics for Alzheimer’s Disease and received an option to license assets currently under development
  • UMB awarded notice of allowance from the U.S. Patent and Trademark Office for central nervous system homing peptide patent on Silo’s licensed technology
  • Zylo Therapeutics and Silo Pharma’s joint venture received DEA Approval to advance the Patented Z-Pod technology to deliver ketamine
  • Advancement of sponsored research and option agreement with The University of Maryland, Baltimore for novel joint homing peptide for rheumatoid arthritis
  • Advancing with up-listing plan to the Nasdaq Stock Market
  • Total working capital approximately $11.0 million

Mr. Eric Weisblum, Chief Executive Officer of Silo Pharma, commented, “We are making progress in our efforts to advance research in psychedelics as a therapeutic and achieved several key milestones in the third quarter of 2021. We materially strengthened our balance sheet to advance our platform and accelerate our development plans. Additionally, we remain focused on our goal to uplist our shares to the Nasdaq, and believe the uplisting will strengthen long term shareholder value and serve as a catalyst to further diversify our shareholder base.”

About Silo Pharma

Silo Pharma is a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as depression, PTSD, Alzheimer’s, Parkinson’s, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the health care industry. For more information, visit www.silopharma.com

Safe Harbor and Forward-Looking Statements
This news release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential” and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events, or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.

Investor Relations Contact:
Hayden IR
Brett Maas
646-536-7331
Email: brett@haydenir.com

Posted on

IntelGenx Reports Third Quarter 2021 Financial Results

IntelGenx Reports Third Quarter 2021 Financial Results

SAINT LAURENT, Quebec, Nov. 11, 2021 (GLOBE NEWSWIRE) — IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or “IntelGenx”) today reported financial results for the third quarter ended September 30, 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 Third Quarter Financial Summary:

  • Revenue was $593,000, compared to $510,000 in the 2020 third quarter.
  • Net comprehensive loss was $2.2 million, compared to $1.6 million in Q3-2020.
  • Adjusted EBITDA loss was $1.4 million, compared to $1.2 million in the 2020 third quarter.

Third Quarter and Recent Developments:

  • Resumed patient screening in the ongoing ‘BUENA’ Montelukast VersaFilm® Phase 2a clinical trial in patients with mild to moderate Alzheimer’s Disease (“AD”) following Health Canada’s issuance of a No Objection Letter in response to the Company’s amended Clinical Trial Application.
  • Graduated to the Toronto Stock Exchange.
  • Announced that its co-development and commercialization partner for Tadalafil oral films for the treatment of erectile dysfunction (ED) and benign prostatic hyperplasia (BPH), Aquestive Therapeutics, Inc. (NASDAQ:AQST), entered into a definitive license and supply agreement with an undisclosed leading men’s health company.
  • Announced that atai Life Sciences AG (“atai”) committed $6.0 million in future financial support to IntelGenx via amendments to the loan facility between the parties.
  • Announced that Exeltis Healthcare S.L., the Company’s commercialization partner in the European Union for RIZAPORT®, a unique treatment for acute migraines, launched the product in Spain.
  • Completed an initial shipment of CBD Filmstrips in support of Heritage Cannabis Holdings Corp.’s (CSE:CANN) Canadian market launch of its “CB4 Control” branded product.
  • Closed a $2.1 million private placement of 8% convertible notes due July 31, 2025, which the Company intends to use to finance its BUENA trial of Montelukast in AD.
  • Increased the size of the Board of Directors from six to eight with the appointments of Srinivas (Srini) G. Rao, M.D., Ph.D. and Frank Stegert.

“The past few months have been a very productive and exciting period for IntelGenx, marked by the achievement of five major milestones,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “Our graduation to the TSX, Canada’s most senior exchange, came on the heels of our successful transition from a development-stage to a commercial-stage leader in pharmaceutical films as well as our transformational partnership with atai. We were also pleased to resume patient screening in our ongoing ‘BUENA’ Montelukast VersaFilm Phase 2a clinical trial in patients with mild to moderate AD. Having executed on many elements of our growth strategy this quarter, we look forward to continuing to advance our portfolio of innovative film products and product candidates.”

Financial Results:

Total revenues for the three-month period ended September 30, 2021 amounted to $593,000, an increase of $83,000, or 16%, compared to $510,000 for the three-month period ended September 30, 2020. The change is mainly attributable to increases in sales milestone revenues of $320,000, product revenues of $70,000, partially offset by a $308,000 decrease in revenues from licensing agreements.

Operating costs and expenses were $2.2 million for the third quarter of 2021, versus $1.9 million for the corresponding three-month period of 2020. The increase for the three-month period ended September 30, 2021 is mainly attributable to increases of $26,000 in R&D expense, $255,000 in manufacturing expenses, $37,000 in selling, general and administrative expenses, $17,000 in depreciation of tangible assets.

For the third quarter of 2021, the Company had an operating loss of $1.6 million, compared to an operating loss of $1.4 million for the comparable period of 2020.

Net comprehensive loss for the three-month period ended September 30, 2021 was $2.2 million, or $0.01 per basic and diluted share, compared to net comprehensive loss of $1.6 million, or $0.01 per basic and diluted share, for the comparable period of 2020.

As at September 30, 2021, the Company’s cash and short-term investments totalled $12.0 million.

Conference Call Details:

IntelGenx will host a conference call to discuss these third quarter 2021 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) and (973) 528-0135 (International), access code 995615. The call will 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 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

IntelGenx Technologies Corp.

Consolidated Balance Sheet
(Expressed in Thousands of U.S. Dollars ($000’s) Except Share and Per Share Data)
(Unaudited)

September 30, 2021 December 31, 2020
Assets
Current
Cash $ 6,019 $ 1,205
Short-term investments 6,013 1,038
Accounts receivable 1,162 260
Prepaid expenses 116 162
Investment tax credits receivable 407 635
Contract asset – 354
Security deposits 204 407
Inventories 68 244
Total current assets 13,989 4,305
Leasehold improvements and equipment, net 5,348 5,851
Security deposits 252 252
Operating lease right-of-use-asset 1,050 710
Total assets $ 20,639 $ 11,118
Liabilities
Current
Accounts payable and accrued liabilities 2,304 1,989
Current portion of long-term debt – 561
Current portion of operating lease liability 248 141
Current portion of finance lease liability 35 25
Deferred revenue 192 166
Convertible notes – 1,486
Convertible debentures 5,317 –
Total current liabilities 8,096 4,368
Long-term debt 2,500 171
Convertible notes 3,965 1,505
Convertible debentures – 5,461
Operating lease liability 691 482
Finance lease liability 92 84
Deferred income tax liability 82 –
Total liabilities 15,426 12,071
Contingencies
Subsequent event
Shareholders’ equity
Capital stock, common shares, $0.00001 par value; 450,000,000 shares authorized; 150,627,761 shares issued and outstanding (2020: 111,429,532 common shares) 1 1
Additional paid-in capital 61,589 48,453
Accumulated deficit (55,005) (48,551)
Accumulated other comprehensive loss (1,372) (856)
Total shareholders’ equity (deficit) 5,213 (953)
$ 20,639 $ 11,118

IntelGenx Technologies Corp.

Consolidated Statement of Comprehensive Loss
(Expressed in Thousands of U.S. Dollars ($000’s) Except Share and Per Share Data)
(Unaudited)

For the Three-Month Period
 For the Nine-Month Period
Ended September 30,
 Ended September 30,
2021 2020 2021 2020
Revenues $ 593 $ 510  $ 1,041 $ 754
Total revenues 593 510  1,041 754
Expenses
Research and development expense 874 848 1,910 2,300
Manufacturing expenses 499 244 1,598 1,042
Selling, general and administrative expense 662 625 2,419 2,167
Depreciation of tangible assets 199 182 589 536
Total expenses 2,234 1,899 6,516 6,045
Operating loss (1,641) (1,389) (5,475) (5,291)
Finance and interest income 1 3 152 405
Financing and interest expense (365) (274) (1,134) (881)
Net financing and interest income (expense) (364) (271) (982) (476)
Loss before income taxes (2,005) (1,660) (6,457) (5,767)
Deferred income tax 3 – 3 –
Net loss (2,002) (1,660) (6,454) (5,767)
Other comprehensive (loss) income
Foreign currency translation adjustment (175) 40 (518) (108)
Change in fair value 4 51 2 79
(171) 91 (516) (29)
Comprehensive loss $ (2,173) $ (1,569) $ (6,970) $ (5,796)
Basic and diluted weighted average number of shares outstanding 150,590,729 110,259,652 131,576,774 107,818,057
Basic and diluted loss per common share $ (0.01) $ (0.01) $ (0.05) $ (0.05)
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AIkido Pharma Announces Third Quarter Highlights and Corporate Update

AIkido Pharma Announces Third Quarter Highlights and Corporate Update

Highlights recent investments in Electric Vehicles, Cannabis, Tele-health & Innovative Sports Businesses with near term monetization and liquidity events forthcoming

  • Cash and investments exceeding $104 million reflecting very low cash burn over Q2
  • Monetization and liquidity event in DatChat representing over 600% ROI
  • Investment in Tevva Motors electric truck producer, a space with recent Rivian Automotive IPO, ticker symbol RIVN.
  • Investment in Kerna Health, fast growth tele-health business with recurring revenue and large contract backlog with possible liquidity event in 2022
  • New investment in Slinger Bag, displaying strong progress and potential near-term monetization
  • New investment in Kaya Holdings, first U.S. publicly traded company to hold and operate state-issued “touch-the-plant” licenses for the retail, cultivation, and production of cannabis

Anthony Hayes , CEO of AIkido, noted, “We are excited about our current pipeline portfolio, upcoming milestones and pending catalysts. This past quarter showcased our monetization strategy exemplified by a 600% ROI liquidity event in DatChat which went public over the summer. Additionally, we actively invested in several exciting high growth industries such as Electric Vehicles and Tele-health and we continue to actively pursue additional high growth interests with near term monetization events to help enhance shareholder value. We are pleased to also announce today our recent investments in the Cannabis and innovative sports industries that have strong growth potential. We are also working diligently to grow our drug platform through additional licensing efforts and are currently working on partnerships with academic institutions and private enterprise to find, fund and advance new drug compounds that can be brought to commercialization. We continue to maintain an extremely low cash burn and note that our valuation does not currently reflect the value of our assets. With our strong balance sheet, we have pulled our registration statement and we look forward to continued shareholder value creation.”

Third Quarter Highlights

DatChat
On August 17, 2021 , DatChat closed its initial public offering at an initial offering price to the public of $4.15 per share under the ticker DATS. On September 22, 2021 , the Company sold 167,084 shares of DatChat common stock for net proceeds of approximately $0.9 million . As of September 30, 2021 , the Company continued to hold 357,916 shares of DatChat valued at approximately $4.9 million .

Tevva Motors
On September 22, 2021 , the Company agreed to purchase 29,004 Interests of Tevva Motors for approximately $1.0 million . Subsequently, on September 30, 2021 , the Company entered into a second securities purchase agreement to purchase an additional 29,004 Interests of Tevva Motors for approximately $1.0 million . Tevva Motors Ltd is a UK-based, leading developer of modular electrification systems for medium duty commercial vehicles. This is an exciting space, with companies such as Rivian Automotive recently going public with very high valuations.

Kerna Health,
On September 15, 2021 , the Company entered into a securities purchase agreement with Kerna Health Inc. Under Agreement, the Company agreed to purchase 1,333,334 shares of common stock of Kerna for $1.0 million . Kerna health is a fast-growing tele-health business with recurring revenue and large contract backlog and has the potential to lead to a liquidity event in 2022.

Slinger Bag
On August 6, 2021 , the Company entered into a securities purchase agreement with Slinger Bag Inc. Under the Agreement, the Company agreed to pay $1.4 million to Slinger Bag for the issuance of a convertible promissory note in the principal amount of $1.4 million and a common stock purchase warrant. Slinger Bag which is currently listed on the OTC market under symbol SLBG, is a fast-growing leading connected sports company focused on delivering innovative, game improvement technologies and equipment across tennis and other ball sports.

Kaya Holding Corp
On September 29, 2021 , the Company entered into a securities purchase agreement with Kaya Holding Corp. Under the Agreement, the Company agreed to purchase 8,325,000 shares of common stock of Kaya for approximately $0.7 million . Kaya Holding Corp is currently listed on the OTC market under the symbol KAYS and is the first U.S. publicly traded company to hold and operate state-issued “touch-the-plant” licenses for the retail, cultivation and production of cannabis.

Drug Development Pipeline Update
The Company’s pipeline consists of patented technology from leading universities and researchers and is currently in the process of developing its innovative therapeutic drug pipeline through strong partnerships with world renowned educational institutions, including the University of Texas at Austin , the University of Maryland, Baltimore and Wake Forest University .

The Company is also developing a broad-spectrum antiviral platform, in which the lead compounds have activity in cell-based assays against multiple viruses including Influenza virus, Ebolavirus and Marburg virus, SARS-CoV, MERS-CoV, and SARS-CoV-2, the cause of COVID-19.
Convergent Therapeutics
In January 2021 , the Company invested in Convergent Therapeutics, which has exclusive rights to technology related to next-generation dual-action peptide receptor radionuclide therapy (“PRRT”) for prostate cancer covered by multiple issued U.S. and foreign patents. Convergent is currently conducting advanced human trials relating to prostate cancer treatments utilizing PRRT that targets the prostate-specific membrane antigen (“PSMA”) present on prostate cancer cells. The technology was developed under the direction of Dr. Neil Bander, Professor of Urologic Oncology at Weill Cornell Medicine.

Silo Pharma
In January 2021 , the Company entered into an exclusive patent license agreement with Silo Pharma where Silo Pharma granted the Company a worldwide exclusive, sublicensable, royalty-bearing license to certain Silo Pharma owned provisional patent applications directed to the use of psilocybin in cancer treatment. The license is for “Field of Use” of “treatment of cancer and symptoms caused by cancer, including but not limited to pain, nausea, neuroinflammation, brain and neural dysfunction, depression, seizures, confusion, dizziness, numbness/tingling, dysfunction of the senses and all other symptoms that are caused by cancer of any type.”

About AIkido Pharma Inc.

AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anti-cancer therapeutics. The Company’s platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore . Our diverse pipeline of therapeutics includes therapies for pancreatic cancer and prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV (coronavirus), MERS-CoV, Ebolavirus and Marburg virus.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the SEC, not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Contact:

Investor Relations:

Hayden IR
Brett Maas , Managing Partner
Phone: (646) 536-7331
Email: brett@haydenir.com
www.haydenir.com

AIkido Pharma Inc.
Phone: 212-745-1373
Email: investorrelations@aikidopharma.com
www.aikidopharma.com

CisionView original content to download multimedia: https://www.prnewswire.com/news-releases/aikido-pharma-announces-third-quarter-highlights-and-corporate-update-301422204.html

SOURCE AIkido Pharma Inc.

Posted on

Goodness Growth Holdings Announces Third Quarter 2021 Financial Results

Goodness Growth Holdings Announces Third Quarter 2021 Financial Results

VIEW ALL NEWS

Posted on

The results from the world’s biggest psilocybin trial are in!

COMPASS Pathways announces positive topline results from groundbreaking phase IIb trial of investigational COMP360 psilocybin therapy for treatment-resistant depression

COMPASS Pathways’ (CMPS) stock dropped nearly 30% after announcing mixed study findings and Q3 financial results on Monday.

The company conducted a trial on 233 patients to determine the best psilocybin dose for treatment-resistant depression (TRD).

All three groups showed improvements the day after receiving the dose. The group with the largest dose had the best results, with 36.7% of patients showing at least a 50% decrease in depression scores and 29.1% in remission at week 3. A quarter of the patients showed sustained improvements until week 12.

Unfortunately, 12 patients experienced serious adverse events such as suicidal ideation or self harm, but these behaviours are common in patients with TRD.

The company is preparing for a larger trial beginning next year.

COMPASS also announced that it lost $15.8 million or $0.38 per share in Q3, an improvement compared to its $1.30 loss per share in Q3 of last year.

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