Lobe Sciences, Ltd. Enters Collaborative Clinical Research Agreement with Integrative Headache Medicine of New York to Study the Effects of L-130 in the Treatment of Chronic Cluster Headache

Lobe Sciences, Ltd. Enters Collaborative Clinical Research Agreement with Integrative Headache Medicine of New York to Study the Effects of L-130 in the Treatment of Chronic Cluster Headache

Dr. Lauren R. Natbony to be Principal Investigator

lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American Biopharmaceutical company committed to discovering and developing patient-focused psychedelic-derived medicines for neurologic and brain disease, today announced that it has signed an Investigator Initiated Research Agreement with Lauren R. Natbony, MD, FAHS, Founder and Medical Director of Integrative Headache Medicine of New York, to study the tolerability and efficacy of our proprietary psilocin compound L-130, in patients suffering from Cluster Headaches ("CH").

Mr. Philip J. Young, Chairman and Chief Executive Officer of the Company, stated, "This is an exciting opportunity to evaluate L-130's effect on the intensity, frequency, and duration of these debilitating headaches. One in every thousand people suffers from this condition, also called "Suicide Headaches," due to the pain, frequency of attacks, and lack of effective treatments. Partnering with Dr. Natbony is a great opportunity for Lobe. As a board-certified neurologist and fellowship-trained headache specialist, she has dedicated her career to treating chronic headache and facial pain disorders, including cluster headache. We anticipate Dr. Natbony will file a physician-initiated IND, and when cleared by the US FDA, she can begin dosing CH patients with L-130 to evaluate safety, tolerability, and efficacy. CH is recognized as an Orphan Drug indication, which we intend to pursue."

Dr. Natbony stated, "We are very excited to evaluate the impact of Lobe's psilocin compound, L-130, in treating these devastating headaches. Data reported in the literature supports the use of psilocybin in these patients. Since L-130 is the active metabolite of psilocybin, it appears to be an efficient way of delivering non-psychedelic doses of psilocin with potentially better bioavailability and consistency. Using sub-psychedelic dosing may allow physicians a therapeutic solution to a devastating condition where treatment options are limited."

About Cluster Headaches

Cluster headache is a rare but severe primary headache disorder, impacting 0.1% of the general population, and characterized by excruciating one-sided pain around the eye. The pain is so intense that it usually causes restlessness and agitation during an attack with the need to pace or rock in place. Attacks can happen up to eight times a day and last between 15 minutes and 3 hours. Accompanying the attacks are one-sided autonomic symptoms, such as eye redness, eye tearing, nasal congestion, runny nose, or a droopy eyelid. Cluster headache, in its episodic form, occurs in episodes lasting between 7 days and one year with pain-free periods lasting at least three months. In contrast, cluster headache is classified as chronic once attacks are present for more than one year, either without interruption or with short intermissions lasting less than three months. Chronic cluster headache is more resistant to current prophylactic pharmaceutical treatments, thus resulting in profound limitations in normal daily functioning. To learn more about Dr. Natbony please click www.integrativeheadacheny.com.

About lobe sciences ltd.

Lobe Sciences is a biopharmaceutical company focused on developing patient-friendly, practical psychedelic medicines. The Company, through collaborations with industry-leading partners, is engaged in drug research and development using sub-hallucinatory doses of psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness. Each of our New Chemical Entities, L-130 and L-131, are being developed to address unmet medical needs in neurological therapeutic applications.

About Integrative Headache Medicine of New York, PLLC

Integrative Headache Medicine of New York (IHMNY), founded and directed by Dr. Lauren R. Natbony, is a comprehensive, multidisciplinary, and cutting-edge institute dedicated to treating patients with complex headache and facial pain disorders. Dr. Natbony is an internationally recognized expert in headache medicine and established IHMNY to offer traditional medical therapies in conjunction with evidence-based complementary and integrative modalities. Integrative Headache Medicine of New York is committed to providing personalized patient care, educating the public about headache medicine, and developing groundbreaking therapies for treating chronic, disabling headaches.

For further information please contact:

lobe sciences ltd.
Philip J Young, CEO
info@lobesciences.com
Tel: (949) 505-5623

NEITHER THE CSE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS RELEASE.

This does not constitute an offer to sell or a solicitation of offers to buy any securities.

Forward-Looking Statements

This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact included in this news release (including, without limitation, statements regarding the future plans and objectives of the Company, research and development using psychedelic compounds, and the development of innovative devices and delivery mechanisms to improve mental health and wellness) are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Readers are cautioned that assumptions used in the preparation of the forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including changes to the regulatory environment; that the Company's drug research and development activities may be unsuccessful; that drugs and medical devices produced by, or on behalf of, the Company, may not work in the manner intended or at all, and may subject the Company to product liability or other liability claims; that the Company may not be able to attain the Company's corporate goals and objectives; and other risk factors detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at www.sedar.com. As a result, the Company cannot guarantee that any forward-looking statement will materialize and the reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made only as of the date of this news release and the Company does not intend to update any of the included forward-looking statements except as expressly required by applicable Canadian securities laws.

Drug development involves long lead times, is very expensive and involves many variables of uncertainty. Anticipated timelines regarding drug development are based on reasonable assumptions informed by current knowledge and information available to the Company. Every patient treated on future studies can change those assumptions either positively (to indicate a faster timeline to new drug applications and other approvals) or negatively (to indicate a slower timeline to new drug applications and other approvals). This news release may contain certain forward-looking statements regarding anticipated or possible drug development timelines. Such statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Company's development efforts to date. In addition to the risk factors set out above and those detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at www.sedar.com, other factors not currently viewed as material could cause actual results to differ materially from those described in the forward-looking statements. Although Lobe has attempted to identify important risks and factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors and risks that cause actions, events or results not to be anticipated, estimated or intended. Accordingly, readers should not place any undue reliance on forward-looking statements.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/152553

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Lobe Sciences Provides Update on L-130 Clinical Program

Lobe Sciences Provides Update on L-130 Clinical Program

Phase 1 results show significantly increased bioavailability for its stable psilocin compared to psilocybin

L-130 Phase 2 Trial Planned for 2024

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Lobe Sciences Provides Update on L-130 Oral Psilocin Compound

Lobe Sciences Provides Update on L-130 Oral Psilocin Compound

L-130 passes 12 months ongoing stability

lobe sciences ltd. (OTCQB: LOBEF) (CSE: LOBE) ("Lobe" or the "Company"), a biopharmaceutical company focused on developing transformative medicines to treat rare diseases today announced the Company's lead clinical asset, L-130, a proprietary stabilized psilocin conjugate drug candidate, recently surpassed the 12-month stability milestone with no signs of degradation. The Company believes the updated stability report for L-130 is significant, as to date, no manufacturer of psilocin has reported a formulation of psilocin stable enough to be administered in a shelf-stable orally available formulation.

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Lobe Sciences, Ltd. Announces The Appointment Of Mathew Lee As CFO

Lobe Sciences, Ltd. Announces The Appointment Of Mathew Lee As CFO

lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American Biopharmaceutical Company committed to discovering and developing patient-focused medicines for Orphan and Rare diseases announced today that Mathew Lee will join the organization as Chief Financial Officer, effective September 18, 2023.

"Appointing Mathew is part of our overall long-term strategy of enlisting top talent to lead our senior executive team while supporting our ongoing R&D and commercialization initiatives," said Phil Young, Chairman and Chief Executive Officer of Lobe. "Mathew's proven financial experience in the capital markets will play a direct role in allowing us to achieve our business goals. I also want to thank Brian Zasitko for his work as CFO over these last three years. We are very pleased to have him continuing on as advisor during the transition."

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Lobe Sciences, Ltd. Announces Amendment to the Acquisition of Altemia & Company

Lobe Sciences, Ltd. Announces Amendment to the Acquisition of Altemia & Company

lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American Biopharmaceutical Company committed to discovering and developing patient-focused medicines for Orphan and Rare diseases announced that on August 30, 2023 it signed an amendment to the share purchase agreement to acquire a 100% interest in Altemia™ & Company, LLC (" Seller ") which includes all assets, know-how, intellectual property and commercial inventory of the Seller to manage patients suffering from Sickle Cell Disease (the " Amendment ") as originally announced on April 18, 2023.

Terms of the Amendment

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Lobe Sciences Announces Additional Details Regarding the Acquisition of Altemia & Company

Lobe Sciences Announces Additional Details Regarding the Acquisition of Altemia & Company

  • Move Affirms Lobe's Position as an Orphan/Rare Disease Drug Development Company and expands portfolio to include 4 Orphan Disease Programs
  • The Company expects to Launch Altemia™, a Medical Food, and Generate Commercial Revenue in the Second Half of 2023
  • Acquisition also Includes an International License Agreement With Double Digit Royalty and Milestone Payments and Commercial Inventory and Intellectual Property.

lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American Biopharmaceutical Company committed to discovering and developing patient-focused medicines for Orphan and Rare diseases today announced as a result of a review by the British Columbia Securities Commission, we are issuing the following press release to clarify our disclosure with respect to the acquisition of Altemia & Company, LLC ("Altemia") on April 18, 2023. The Company has also refiled the material change report with respect to the Altemia acquisition to reflect the information presented in this press release.

Mr. Philip J. Young, Chairman and Chief Executive Officer of the Company, stated, "Starting in the second half of 2023 we will launch our first commercial product, a medical food called Altemia™ for the management of SCD. This product has been well studied in human clinical trials. It is a proprietary, patent pending formulation based on decades of research and will add commercial revenue this year and beyond. By targeting the 55 major SCD clinics in the United States we will be able to efficiently provide support and education for clinicians and other health care providers charged with addressing this vulnerable population. As we prepare for launch and commercialization, I will be able to call upon my previous successes launching and selling Orphan Drugs in specialty markets. Altemia™ will be positioned as a cost-effective medical food option for patients and payers seeking alternatives to drug products with significant side effects. We will be announcing further information related to our commercial plans shortly. In addition to Altemia™ we have acquired a clinical stage asset, SAN100, developed as a drug alternative for the treatment of SCD uniquely in children. This indication may qualify for the Pediatric Priority Review Voucher."

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Seelos Announces Postponement of its Annual Meeting of Stockholders

Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that its 2024 Annual Meeting of Stockholders (the "Annual Meeting"), which was originally scheduled to be held on September 27, 2024 has been postponed. The Annual Meeting is now scheduled to be held virtually, via live webcast at www.virtualshareholdermeeting.comSEEL2024 on Friday, October 25, 2024 at 8:00 a.m., Eastern Time . The record date for the Annual Meeting August 19, 2024 is unchanged and applies to the postponed Annual Meeting.

(PRNewsfoto/Seelos Therapeutics, Inc.)

The Annual Meeting has been postponed due to an anticipated lack of quorum, and to provide further time to solicit proxies from the Company's stockholders. Seelos' Board of Directors unanimously recommends that you vote FOR the Board of Director nominees and FOR all other proposals identified in the Company's proxy statement for the Annual Meeting. Stockholders who have already cast their votes do not need to take any action, unless they wish to change or revoke their prior proxy or voting instructions, and their votes will be counted at the postponed Annual Meeting. For stockholders who have not yet cast their votes, we urge them to vote their shares now, so they can be tabulated prior to the postponed Annual Meeting.

About Seelos Therapeutics

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases.

For more information, please visit our website: https://seelostherapeutics.com , the content of which is not incorporated herein by reference.

IMPORTANT ADDITIONAL INFORMATION

Seelos has filed a definitive proxy statement with the Securities and Exchange Commission (the "SEC") on August 20, 2024 . STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) FILED BY SEELOS AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT ANY SOLICITATION. Stockholders may obtain a free copy of the proxy statement and the other relevant materials, and any other documents filed by Seelos with the SEC, at the SEC's web site at http://www.sec.gov or on the "SEC Filings" section of Seelos' website at https://seelostherapeutics.com .

Participants in the Solicitation

Seelos, its directors and executive officers and other members of management and employees will be participants in the solicitation of proxies with respect to a solicitation by Seelos. Information about Seelos' executive officers and directors, including information regarding the direct or indirect interests, by security holdings or otherwise, is available in Seelos' definitive proxy statement for its Annual Meeting, which was filed with the SEC on August 20, 2024 . To the extent holdings by our directors and executive officers of Seelos securities reported in the proxy statement for the Annual Meeting have changed, such changes have been or will be reflected on Statements of Change in Ownership on Forms 3, 4 or 5 filed with the SEC. These documents are or will be available free of charge at the SEC's website at http://www.sec.gov .

Forward-Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements related to Seelos for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements are based on Seelos' current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business and plans described herein include, but are not limited to, the risk of not receiving stockholder approval of any of the proposals to be presented at the Annual Meeting, the risks related to raising capital to fund its development plans and ongoing operations and risks related to Seelos' current stock price, as well as other risk factors and matters set forth in our periodic filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023 , subsequent Quarterly Reports on Form 10-Q, including Seelos' Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 . Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

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

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

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/seelos-announces-postponement-of-its-annual-meeting-of-stockholders-302260282.html

SOURCE Seelos Therapeutics, Inc.

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Seelos Therapeutics Announces 1-for-16 Reverse Stock Split

Seelos Therapeutics, Inc. (Nasdaq: SEEL ) ("Seelos" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that its Board of Directors approved a 1-for-16 reverse stock split of its outstanding shares of common stock, to be effective as of 12: 01 a.m. Eastern Time on Friday September 27, 2024.

(PRNewsfoto/Seelos Therapeutics, Inc.)

The Company's common stock, par value $0.001 , will begin trading on a reverse stock split-adjusted basis at the opening of the market on Friday, September 27, 2024. Following the reverse stock split, the Company's common stock will continue to trade on the Nasdaq Capital Market under the symbol "SEEL" with the new CUSIP number, 81577F 406. The reverse stock split is intended for the Company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market. The reverse stock split was approved by the Company's Board of Directors pursuant to Section 78.207 of the Nevada Revised Statutes and was effectuated by the filing of a Certificate of Change with office of the Nevada Secretary of State.

At the effective time of the reverse split, every sixteen (16) issued and outstanding shares of the Company's common stock will be combined automatically into one (1) share of the Company's common stock without any change in the par value per share. No fractional shares will be issued in connection with the reverse stock split, and any fractional shares resulting from the reverse stock split will be rounded up to the nearest whole share. The reverse stock split will reduce the number of authorized shares of the Company's common stock from 50,000,000 shares to 3,125,000 shares and the ownership percentage of each stockholder will remain unchanged other than as a result of the rounding of fractional shares. In addition, the reverse stock split will apply to the Company's common stock issuable upon the exercise of the Company's outstanding warrants and stock options, with proportionate adjustments to be made to the exercise prices thereof and under the Company's equity incentive plans, as applicable.

The reverse stock split will reduce the number of issued and outstanding shares of the Company's common stock from approximately 9.2 million to approximately 581 thousand.

About Seelos Therapeutics:
Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington's disease, Alzheimer's disease, and Parkinson's disease.

Forward-Looking Statements:
Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the reverse stock split and the timing thereof, the potential impact of the reverse split on the bid price of the Company's common stock, the potential for the Company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market and the expected number of shares of common stock to be outstanding following the reverse stock split. These statements are based on our current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties involved include those associated with general economic and market conditions, as well as other risk factors and matters set forth in our periodic filings with the SEC, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q . Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL )
300 Park Avenue, 2 nd Floor
New York , NY 10022
(646) 293-2136
anthony.marciano@seelostx.com

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

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/seelos-therapeutics-announces-1-for-16-reverse-stock-split-302257773.html

SOURCE Seelos Therapeutics, Inc.

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FDA Finds Kratom Capsules Safe, but Questions About Concentrated Forms Remain

An initial US Food and Drug Administration (FDA) study on kratom, a plant-based substance long consumed in Southeast Asia, has found that the compound appears safe when used in capsule form, even at high doses.

However, a Tuesday (September 17) Bloomberg article notes that the FDA's research did not include kratom-infused drinks or concentrates, which are more common in the US and may carry different risks.

Kratom, a botanical product derived from the leaves of Mitragyna speciosa, has been used in Southeast Asia for centuries, with users traditionally chewing the leaves for its mind-altering effects.

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Compass Pathways to participate in three investor conferences in September

Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will participate in the following September investor conferences:

  • Morgan Stanley 22nd Annual Global Healthcare Conference: fireside chat at 7:45 am ET on September 4, 2024, and host investor meetings
  • H. C. Wainwright 26th Annual Global Investment Conference: fireside chat at 9:30 am ET on September 10, 2024, and host investor meetings
  • Cantor Global Healthcare Conference: fireside chat at 2:30 pm ET on September 17, 2024, and host investor meetings

A live audio webcast of these events will be accessible from the "Events" page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event.

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COMPASS Pathways to participate in Canaccord Genuity 44th Annual Growth Conference

Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will participate in the Canaccord Genuity 44th Annual Growth Conference: presentation at 4:30pm ET on August 13, 2024 and host investor meetings.

A live audio webcast of this event will be accessible from the "Events" page of the Investors section of the Compass website. A replay of this webcast will be accessible for 30 days following such event. For more information, please visit investor section of compasspathways.com.

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Psychedelics Market Update: H1 2024 in Review

The global psychedelics market will likely experience continued growth and interest in the coming years.

According to findings from FactMR, the sector's value is projected to surpass US$603.1 million in 2024, with further growth expected at a CAGR of 7 percent. By 2034, the psychedelics industry is projected to be worth US$1.18 billion.

The field of psychedelics-based therapies has shown significant growth in the past few years as medical companies focus on developing alternative treatments for various mental health conditions, including depression, post-traumatic stress disorder (PTSD), major depressive disorder (MDD), generalized anxiety disorder (GAD), addiction and other ailments.

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