Lobe Sciences Announces Commercial Distribution Agreement With Pentec Health for US Launch of Altemia

Distribution Agreement Grants Pentec Exclusive Distribution Rights for Altemia Lobe's Novel Sickle Cell Anemia Medical Food

lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a biopharmaceutical company focused on developing transformative medicines to treat orphan diseases today announced it has entered into a commercial distribution agreement for the supply and distribution of Altemia™ with Pentec Health, Inc. ("Pentec Health"), a nationwide provider of clinical nutrition and specialty care services addressing complex needs for patients. Altemia™ is Lobe's proprietary formulation of emulsified docosahexaenoic acid ethyl ester ("DHA") concentration designed for patients with sickle cell disease ("SCD").

Under the terms of the distribution agreement, Pentec Health will receive the exclusive rights to distribute Altemia™ in the United States and US territories. Through Pentec Health, Altemia™ will be available to pediatric and adult patients with SCD throughout the United States.

This agreement is the first step in the global launch of Altemia™, which will be available as a medical food for the replacement of DHA in SCD patients in the United States. It is the first medical food in the United Sates designed specifically to support patients with SCD. Previous studies have demonstrated beneficial outcomes for patients while taking the primary component of Altemia™ under physician supervision, including a reduction in vaso-occlusive crises, reduction in hospital visits and improvement in critical biomarkers of inflammation ^{1, 2} .

Altemia™ is manufactured by our exclusive cGMP partner headquartered in the United States. It is expected that Altemia™ will be available to patients in the United States by the second half of 2023.

Philip Young, CEO of Lobe commented, "We are pleased to be working with Pentec Health to provide Altemia™ to this underserved but significant unmet patient need in children and adults suffering from SCD. Pentec Health is extremely well-positioned and experienced in the medical food marketplace and they will ensure it reaches key healthcare providers and patients. Leveraging its previous success managing distribution and payer interactions in the Medical Food market, working with Pentec Health will ensure a smooth launch of Altemia™."

Matthew Deans, CEO & President of Pentec Health, added, "In our mission to solve complex care challenges, the partnership with Lobe, to both distribute and provide patient support services for Altemia™, strengthens our clinical nutrition platform and bolsters our medical food offering. This collaboration to distribute Altemia™ will support Lobe in their efforts to get this important treatment to patients and caregivers. With our collective efforts alongside the physician and SCD community, we anticipate making a profound impact on the lives of sickle cell disease families across the United States."

About Altemia™

Altemia™, a Medical Food, is a proprietary oral formulation of emulsified docohexanoic acid (DHA) clinically evaluated to restore DHA levels and help reduce inflammation associated with SCD.

About Sickle Cell Disease

Sickle cell disease is a group of inherited red blood cell disorders that affect hemoglobin, the protein that carries oxygen through the body. The condition affects more than 100,000 people in the United States and 20 million people worldwide. In the U.S., SCD is most common among Black Americans, occurring in one of every 365 births. People with Middle Eastern and South Asian ancestry are also susceptible to the disease and some 45 million people around the world carry a gene for the condition, which they can pass along to their children.

In SCD patients, DHA, an essential fatty acid can metabolize by interaction with HbSS hemoglobin (not normal hemoglobin) and this metabolism results in DHA deficiency. DHA deficiency causes red blood cells to become inflamed and destroyed when the membrane breaks. This error in metabolism may be corrected by taking high amounts of DHA ^1,2 .

Normally, red blood cells are disc-shaped and flexible enough to move easily through the blood vessels. If you have sickle cell disease, your red blood cells are crescent- or "sickle"-shaped. These cells do not bend or move easily and can block blood flow to the rest of your body. The blocked blood flow through the body can lead to serious problems, including stroke, eye problems, infections, and episodes of pain called pain crises.

Daak, A. et al. (2020). Biochemical and therapeutic effects of Omega-3 fatty acids in sickle cell disease. Complementary Therapies in Medicine , 52 , 183-188.
Wandersee, N. et al. (2015). Dietary supplementation with docosahexanoic acid (DHA) increases red blood cell membrane flexibility in mice with sickle cell disease. Blood Cells, Molecules, and Diseases , 54 (2), 183-188.

About Pentec Health

For 40 years, Pentec Health has been an industry leader in providing patient-specific, compounded sterile medications. Pentec Health provides clinical nutrition formulations that are administered to patients in dialysis centers and provides in-home Intrathecal nursing services and complex pharmaceutical products to patients who require access outside of a hospital setting. Pentec Health has built a tradition of exceptional patient care by committing to quality, safety, and innovation. Pentec Health aims to be the provider of choice for outsourced products, sterile preparations, and services in the healthcare marketplace. For more information, please visit https://www.pentechealth.com .

About lobe sciences ltd.

Lobe Sciences is a biopharmaceutical company focused on developing transformative medicines to treat orphan diseases. The Company, through collaborations with industry-leading partners, is additionally engaged in drug research and development using sub-hallucinatory doses of psychedelic compounds to address unmet medical needs in orphan neurological therapeutic applications.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230517005418/en/

For further information:
lobe sciences ltd.
Investor and Media
info@lobesciences.com
Tel: (949) 505-5623

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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. (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. (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

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 Therapeutics Announces 1-for-8 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-8 reverse stock split of its outstanding shares of common stock, to be effective as of 12:01 a.m. Eastern Time on Thursday May 16, 2024.

The Company's common stock will begin trading on a reverse stock split-adjusted basis at the opening of the market on Thursday, May 16, 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, 81577F307. 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.

At the effective time of the reverse split, every 8 issued and outstanding shares of the Company's common stock will be converted automatically into one 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 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 400,000,000 shares to 50,000,000 shares and the ownership percentage of each stockholder will remain unchanged other than as a result 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 17.4 million to approximately 2.2 million.

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

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SOURCE Seelos Therapeutics, Inc.

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Compass Pathways Announces First Quarter 2024 Financial Results and Business Highlights

COMP360 phase 3 pivotal program in treatment-resistant depression (TRD) on track for top-line COMP005 trial data in fourth quarter 2024, COMP006 trial top-line data expected mid-2025
Compass announces positive phase 2 COMP360 data in post-traumatic stress disorder (PTSD)
Michael Gold to join Compass as Head of R&D
Compass enters into additional commercial collaborations, including with Reliant Medical Group, part of Optum Care
Cash position of $262.9 million at March 31, 2024
Conference call May 8 at 8:00 am ET (1:00 pm UK)

Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the first quarter 2024 and provided an update on recent business progress.

Kabir Nath, Chief Executive Officer, said, "We were pleased to see the positive results from the phase 2 PTSD study, a condition with significant unmet need and limited therapeutic options for the people who live with it. PTSD is a logical extension for COMP360 psilocybin treatment as there is significant overlap in patients living with treatment-resistant depression and PTSD. These strong data enable us to explore the optimal path forward to advance clinical development in PTSD alongside our phase 3 pivotal program in TRD, which is on track for initial data this year. We also continue to prepare for commercialization of COMP360 in TRD if approved by the FDA and have established collaborations with important mental health providers in the US to investigate models for the delivery of COMP360 psilocybin treatment at scale in diverse care settings."

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Compass Pathways announces durable improvement in symptoms through 12 weeks in open-label phase 2 study of COMP360 psilocybin in post-traumatic stress disorder

Study met primary safety endpoint; administration was well tolerated, with no serious adverse events observed
Early and clinically meaningful improvement from baseline in mean CAPS-5 total score (29.5 point reduction at week 12), with change from baseline in mean SDS total score (14.4 point reduction at week 12)
81.8% response (reduction of ≥ 15 points in CAPS-5 score), 63.6% remission (total CAPS-5 ≤ 20) rates at week 4 with 77.3% response and 54.5% remission at week 12
Measures of symptom scores relative to baseline improved following a single 25mg dose administered with psychological support (n=22)

Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating access to evidence-based innovation in mental health, today announced top-line results from an open-label phase 2 study evaluating the safety and tolerability of investigational COMP360 psilocybin treatment in 22 patients with post-traumatic stress disorder (PTSD). The study met its primary safety endpoint and available secondary efficacy endpoints. Study observations included meaningful and sustained symptom improvement from baseline in mean CAPS-5 total score, a measure of disease severity, and in Sheehan Disability Scale (SDS) score, a measure of functional impairment in daily life. Administration of COMP360 was well-tolerated, with a safety profile consistent with previous studies.

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1.	Achievement of the following milestones:
		a.	25% on or after the closing date;
		b.	25% on delivery of inventory to a Lobe designated storage facility;
		c.	25% on the first commercial sale allowing the trademark validation; and
		d.	25% on successful completion of SAN100 Tech Transfer Documentation (which includes batch records for R&D batch produced in a lab setting for use in a stability study and includes ingredients and manufacturing instructions) and Samples of SAN100 are delivered to Lobe.


	collectively, clauses (a) through (d) are referred to as a "Milestone" . Each Milestone a, b, c and d represents 19,000,000 Lobe Shares, and


2.	Within ten (10) days of Selling Member providing Lobe a written notice to release some or all of the then available shares with respect to which the applicable Milestone has been met. Each Altemia member may in such notice designate one or more third parties to receive some or all of any such Lobe Shares then available for release.

	March 31,		December 31,
	2024		2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	262,888	$	220,198
Restricted cash	389		440
Prepaid income tax	1,123		1,123
Prepaid expenses and other current assets	31,115		39,535
Total current assets	295,515		261,296
NON-CURRENT ASSETS:
Operating lease right-of-use assets	3,722		4,306
Deferred tax assets	3,659		3,336
Long-term prepaid expenses and other assets	6,097		7,049
Total assets	$	308,993	$	275,987
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable	$	9,342	$	5,892
Accrued expenses and other liabilities	7,680		11,301
Operating lease liabilities - current	2,380		2,411
Total current liabilities	19,402		19,604
NON-CURRENT LIABILITIES
Long-term debt	29,090		28,757
Operating lease liabilities - non-current	1,339		1,882
Total liabilities	49,831		50,243
SHAREHOLDERS' EQUITY:
Ordinary shares, £0.008 par value; 68,342,534 and 61,943,471 shares authorized, issued and outstanding at March 31, 2024 and December 31, 2023, respectively	699		635
Additional paid-in capital	690,222		621,645
Accumulated other comprehensive loss	(16,962)		(16,926)
Accumulated deficit	(414,797)		(379,610)
Total shareholders' equity	259,162		225,744
Total liabilities and shareholders' equity	$	308,993	$	275,987

	Three months ended March 31,
	2024		2023
OPERATING EXPENSES:
Research and development	$	24,901	$	19,035
General and administrative	13,672		12,753
Total operating expenses	38,573		31,788
Loss from operations	(38,573)		(31,788)
OTHER INCOME, NET:
Other income, net	2,388		709
Interest expense	(1,098)		—
Foreign exchange (losses) gains	(783)		2,685
Benefit from R&D tax credit	3,101		4,316
Total other income, net	3,608		7,710
Loss before income taxes	(34,965)		(24,078)
Corporate income tax expense	(222)		(130)
Net loss	$	(35,187)	$	(24,208)

Net loss per share attributable to ordinary shareholders—basic and diluted	$	(0.55)	$	(0.57)
Weighted average ordinary shares outstanding—basic and diluted	64,222,178		42,725,863

Net loss	$	(35,187)	$	(24,208)
Other comprehensive loss:
Foreign exchange translation adjustment	(36)		(578)
Comprehensive loss	$	(35,223)	$	(24,786)

Lobe Sciences Announces Commercial Distribution Agreement With Pentec Health for US Launch of Altemia

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