Lobe Sciences Ltd (LOBEF) increases its portfolio with several new chemical entities (NCEs)

January 19 06:04 2023
Psychedelic Stocks In Focus

Several companies in the psychedelic pharmaceutical industry are working on developing drugs that comply with legal regulatory standards for approval. These drugs, including psilocybin, show great potential in treating conditions such as depression and schizophrenia. These publicly traded companies are gaining more attention from investors.

One such company that we would like to draw your attention to is Lobe Sciences Ltd. (CSE: LOBE) (OTC US: LOBEF)

Lobe Sciences Ltd. (CSE: LOBE) (OTCQB: LOBEF), a North American Biopharmaceutical company committed to discovering and developing patient focused psychedelic derived medicines for neurologic and brain disease today announced an updated overview for 2023.

Mr. Philip Young, Chairman and Chief Executive Officer of the Company, stated, “2022 was a productive year for Lobe Sciences. We increased our intellectual property portfolio with several new chemical entities (NCEs) derived from well-known psychedelic compounds, adding two of these, L-130 and L-131, to our development program. We solidified relationships with outstanding research and development teams, who affirmed their support for Lobe by taking an equity stake in the Company. Research collaborations with contract research organizations (CRO) were penned and we began work on a human Phase I Safety and Pharmacokinetics program to ascertain the bioavailability and metabolism of L-130. This trial will be the first of three similar trials that will determine the highest concentration of this NCE without an hullucinagenic effect. International Regulatory filings were completed and accepted in 2022. We expect to begin enrollment in early 2023.”

The Company presented the following timeline for 2023:

L-130
  • In January 2023, obtain cGMP clinical supplies and transfer these supplies to the international CRO for oral administration to humans in Phase I studies.
  • In the first quarter of 2023, commence Phase I Safety and Pharmacokinetics Studies. Data is expected to be available in early in the second quarter of 2023.
  • In the first quarter of 2023, commence USFDA required preclinical studies which are expected to be completed by the end of the second quarter of 2023. We have executed a contract with our international preclinical CRO and the active pharmaceutical ingredient (API) export license from US DEA is awaited. Our manufacturing partner has manufactured sufficient quantities of L-130 which will be shipped once required DEA export documents are approved.
  • A pre-IND submission package will be filed to confirm that our entire regulatory pathway, which utilizes the 505(b)2 route to approval is appropriate.
  • In anticipation of a successful identification of the highest dose having minimal or no hallucinogenic effect, the Company has begun preparation of the Phase II protocol which will utilize that dose. Initial designs for the study are being refined with a second international CRO (iNGEnu).
  • In the 2023, the Company anticipates a US IND filing.

L-131

  • Synthesis of L-131 has produced sufficient material for preclinical investigation in a pediatric neurological orphan drug application.
  • In the first half of 2023, an efficacy evaluation of L-131 utilizing a validated model of the orphan disease application will be initiated following receipt of the DEA export license the preclinical CRO.
  • In the second half of 2023, an Orphan Drug Designation filing and a Priority Review Application (a pediatric application of L-131) will be submitted to US FDA following successful completion of the preclinical investigation noted above.
  • In the first half of 2023, a pre-IND filing to US FDA will occur to confirm the regulatory strategy being planned for L-131 and its orphan application.
  • Preclinical safety and toxicokinetic studies will be initiated following the completion of preclinical pharmacology late in the first half or early in the second half of the year.

Lobe Sciences (OTC:US) expects to file an IND with the USFDA in the second half of the year. In a final comment, Mr. Young said, “Our plans for 2023 are ambitious but doable. By year end, we should have two active INDs, one of which may be designated as an orphan drug and an ongoing Phase II trial assessing L-130 as a therapeutic to treat a refractive neurological disorder. We will release details of each of these trials and the indication being treated as our patents are published.”

 

Video Link: https://www.youtube.com/embed/NgkYOqgoiLI

Let’s take a look at top analyst upgrades and downgrades for Wednesday:

1. BMO initiates CrowdStrike (NASDAQ:CRWD) as outperform

2. Citi opens a catalyst watch on Qualcomm (NASDAQ:QCOM) and Intel (NASDAQ:INTC)

3. Morgan Stanley upgrades Gap (NYSE:GPS) to equal weight from underweightMorgan Stanley downgrades Skechers to equal weight from overweight

4. Morgan Stanley names Apple (NASDAQ:AAPL) a top 2023 pick

5. Mizuho upgrades Oatly (NASDAQ:OTLY) to buy from neutralCowen downgrades Yeti (NYSE:YETI) to market perform from outperform

Other companies in Compass Pathways’s space includes: Kezar Life Sciences (NASDAQ:KZR), Precigen (NASDAQ:PGEN), Centessa Pharmaceuticals (NASDAQ:CNTA), Eagle Pharmaceuticals (NASDAQ:EGRX) and Inovio Pharmaceuticals (NASDAQ:INO).

Source: https://finance.yahoo.com/news/lobe-sciences-provides-2023-milestones-120000347.html

 

About InvestorBrandMedia.com – The team at InvestorBrandMedia has decades of strategy-driven, extensive media experience in helping navigate our clients through the everchanging Digital Landscape. We specialize in a variety of marketing strategies that help promote our client visibility across multiple channels helping them expand their digital footprint in an ever-complex environment. InvestorBrandMedia.com specializes in ticker tagging services. Targeting the right audience is essential. Without effective distribution, a company’s message will fall on deaf ears or play to an empty room. Our growing distribution network consists of a diverse network of finance-focused blogs and websites, producing a robust mix of organic and cultivated interest. Let us help you jumpstart a rich following of qualified leads you can build on. Ticker Tagging is the process wherein your company is included with other sector-related NASDAQ, NYSE, and AMEX companies showcasing your news within a ticker-tagged PR. The ticker tags are distributed to approximately 400 business and financial news portals including Benzinga, Yahoo, Google News, Digital Journal, and MarketWatch. Companies looking for IR/PR services can contact us directly at investorbrandmedia@gmail.com or call us at (954) 593-5597‬.

 

Disclaimer: InvestorBrandMedia is not operated by a licensed broker, a dealer, or a registered investment adviser. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. Our reports/releases are commercial advertisements and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The information made available in this article is not intended to be, nor does it constitute investment advice or recommendations. The contributors may buy and sell securities before and after any particular article, report, and publication. In no event shall InvestorBrandMedia be liable to any member, guest, or third party for any damages of any kind arising out of the use of any content or other material published or made available by InvestorBrandMedia ., including, without limitation, any investment losses, lost profits, lost opportunity, special, incidental, indirect, consequential or punitive damages. Past performance is a poor indicator of future performance. The information in this video, article, and in its related newsletters, is not intended to be, nor does it constitute investment advice or recommendations. InvestorBrandMedia.com strongly urges you to conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D. For some content, Investor Brand Media, its authors, contributors, or its agents, may be compensated for preparing research, video graphics, and editorial content. As part of that content, readers, subscribers, and website viewers are expected to read the full disclaimers and financial disclosures statement that can be found on our website by visiting InvestorBrandMedia.com/Disclaimer. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward-looking statements. Forward-looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties, which could cause actual results or events to differ materially from those presently anticipated. Forward-looking statements in this action may be identified through the use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quotes; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor’s investment may be lost or impaired due to the speculative nature of the companies profiled. 

InvestorBrandMedia has been compensated twelve hundred dollars by a 3rd party for the content, research, dissemination, and syndication pertaining to LOBEF for a period of one week starting Jan 17th, 2023 to Jan 20th, 2022. We own zero shares of LOBEF

Media Contact
Company Name: Investor Brand Media
Contact Person: Ash K
Email: investorbrandmedia@gmail.com
Phone: (954) 593-5597
Country: United States
Website: https://investorbrandmedia.com/

  Categories: