Seelos Raises $20M, Acquires Ketamine Tech, And Announces New Drug

This article was originally published on Microdose Psychedelic Insights and appears here with permission.

While not on most people’s sexiest shroom stock list, Seelos Therapeutics has been a solid presence in the space for some time.

For those who might not know, Seelos is a biopharmaceutical company focused on the development of novel therapeutics to treat central nervous system (CNS) disorders and other rare conditions. The company has a portfolio of non-psychedelic compounds but it’s their SLS-002, an intranasal racemic ketamine, that’s made them an often overlooked but serious psychedelic player.

In 2019, the FDA granted Fast Track designation for Seelos’ SLS-002 giving the company a leg-up in the approval process, and Seelos has begun dosing patients as part of a Proof of Concept study for Acute Suicidal Ideation in patients with Major Depressive Disorder.

This week Seelos released several pieces of important news: they raised $20 million in capital, acquired a worldwide license for sublingual ketamine delivery technology, and announced the evaluation of a new SLS-003 compound for chronic pain indications and psychiatric disorders, including post-traumatic stress disorder (PTSD).

See the company’s press releases below for full details.

Seelos Therapeutics Announces Acquisition of an Exclusive License of iX Biopharma’s Proprietary Wafer-Based Delivery Platform for Sublingual Ketamine

– New SLS-003 Program Extends Seelos’ Ketamine Franchise into Additional Indications Including Chronic Neuropathic Pain and Additional Psychiatric Disorders

– Program has been Granted Orphan Drug Designation in the US for the Treatment of Complex Regional Pain Syndrome

NEW YORK, Nov. 24, 2021 /PRNewswire/ — Seelos Therapeutics, Inc. SEEL, a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced it has entered into an exclusive license agreement (License Agreement), whereby it acquired a worldwide license (excluding China, Taiwan, Macau and Hong Kong) from iX Biopharma Ltd (iX Biopharma) for Wafermine™, a sublingual racemic ketamine wafer, and a worldwide license for other sublingual ketamine wafers, delivered using a proprietary fast-dissolving wafer-based drug delivery platform technology known as WaferiX™.

Seelos plans to evaluate sublingual ketamine, now named SLS-003, in pain indications such as chronic neuropathic pain and Complex Regional Pain Syndrome (CRPS) and in additional psychiatric disorders, including post-traumatic stress disorder (PTSD).

The US Food and Drug Administration (FDA) has granted Wafermine™ Orphan Drug designation for the treatment of CRPS.

“Our licensing of this new program broadens Seelos’ ketamine franchise with a formulation that we believe will be more suitable for chronic dosing in indications like CRPS and PTSD, which are both very difficult indications to treat effectively,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “The pharmacokinetic, pharmacodynamic and safety profiles of SLS-003 that have been demonstrated to date suggest a formulation with the potential of being prescribed with less restrictions than current formulations. Our team is very excited to be developing both acute, in SLS-002, and a potentially chronic, in SLS-003, ketamine-based therapy programs. We look forward to initiating studies with SLS-003 in 2022 and our recent capital raises have accounted for the expected development costs for initiating studies.”    

“We are delighted to collaborate with Seelos Therapeutics, whose deep insights in ketamine drug development make them an ideal partner to further the development of Wafermine™ and the other sublingual ketamine products,” said Eddy Lee, Chairman and CEO of iX Biopharma. “Licensing our WaferiX™-based pharmaceutical drugs to suitable third parties for development and commercialization is a core strategy to unlock the value of our assets. We are therefore excited that this commercially significant agreement with Seelos is a validation of our ability to deliver on this strategy.”

Pursuant to the License Agreement, Seelos will pay iX Biopharma  a one-time, upfront fee of $9,000,000, comprised of $3,500,000 in cash and $5,500,000 in restricted shares of Seelos’ common stock for the worldwide license for Wafermine™ (excluding China, Taiwan, Macau and Hong Kong), the worldwide license for WaferiX™ in other ketamine formulations, and clinical supplies. Seelos will also pay iX Biopharma certain milestone payments contingent on achievement by Seelos of certain development, regulatory and commercial milestones and a low double-digit royalty on future net sales of certain licensed products.

About iX Biopharma LTD

iX Biopharma is a specialty pharmaceutical and nutraceutical company listed on the Catalist board of the Singapore Exchange Securities Trading Limited (SGX-ST), operating a fully integrated business model from drug development to manufacturing and supply, with facilities in Australia. The Group is focused on the development and commercialization of therapies for diseases of the central nervous system using novel, patent-protected formulations for sublingual delivery.

For more information about iX Biopharma LTD, please visit their website: https://www.ixbiopharma.com/.

About WaferiX™

The licensed products utilize iX Biopharma’s patented sublingual wafer technology, known as WaferiX™, to disintegrate under the tongue rapidly for faster therapeutic action and predictable dosing. In pharmacokinetic studies, sublingual delivery using WaferiX™ increased bioavailability of active compounds when compared to oral administration, while avoiding excessively high peak plasma concentrations typical of IV bolus dosing.

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 disorders. The Company’s robust portfolio includes several late-stage clinical assets targeting psychiatric and movement disorders, including orphan diseases. Seelos is based in New York, New York.

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

Seelos Therapeutics Raises $20 Million in Private Placement of Senior Secured Convertible Note

– Agreement Includes the Option of up to an Additional $30 Million of Funding Contingent on Achievement of Certain Milestones

NEW YORK, Nov. 24, 2021 /PRNewswire/ — Seelos Therapeutics, Inc. SEEL, a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced the placement of a $22.0 million senior secured convertible note (the “Note”) and shares of Seelos common stock (the “Closing Shares”) to Lind Global Asset Management V, LLC, managed by The Lind Partners, a New York institutional fund manager and an existing investor in Seelos. Seelos will receive $20.0 million in gross proceeds.

Seelos intends to use the proceeds for general corporate purposes and to advance the development of its product candidates.

“2021 has been a volatile year for the biotech sector and this financial commitment from the team at Lind further strengthens our balance sheet and provides for additional future funding,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “The team at Lind has been a terrific partner for us and their creative and innovative funding solutions are thoughtfully and strategically designed to fit the needs of their partners. We are proud to once again work together, and we look forward to the continued execution of our ongoing and future studies.”  

The following are some of the key features of the Note:

• 36-month maturity with a 0% coupon for the first year
• After the first anniversary, the Note shall bear interest at an annual rate of 5% per annum and interest payments will be required monthly thereafter
• Repayment of principal in 24 monthly payments beginning in November 2022 equal to the then-outstanding principal amount of the Note, divided by the number of months remaining until the Note’s maturity date
• Any principal and interest repayments may be made, at the Company’s sole discretion, in cash, common stock, or a combination of both
• Starting 9 months after the date of issuance of the Note, convertible at Lind’s option into shares of Seelos common stock at a fixed conversion price of $6.00 per share
• Seelos has the right to prepay (i) up to 66 2/3% of the outstanding principal amount of the Note prior to the nine-month anniversary of the issuance date of the Note, and (ii) up to the entire outstanding principal amount of the Note on or after the nine-month anniversary (or, if Seelos prepays any amount of the Note during the first nine months, the 12 month anniversary) of the issuance date of the Note, subject to Lind’s right to convert a portion of the Note at $6.00 per share in certain circumstances
• The agreement includes up to an additional $30.0 million of funding in senior secured convertible notes based on achievement of certain future milestones, which may be either at the option of Seelos or with the mutual agreement of Seelos and Lind depending on the milestone

“Lind is once again pleased to increase our investment in Seelos to help fund multiple registrational studies,” said Phillip Valliere, Managing Director at The Lind Partners. “Raj and the Seelos team have continued to execute at a very high level since our initial funding last December and we are glad to re-invest to fund further development of their pipeline.”