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Saturday, July 2, 2022

Running with Relmada Therapeutics Inc (OTCMKTS:RLMD)

Relmada Therapeutics Inc (OTCMKTS:RLMD) has recovered significantly since the $4.12 lows the stock saw last month. Overall however the stock has been a massive disappointment with close to 10 months of steady decline.

The Company affected a 1 for 5 reverse stock split in August and was the subject of a hard mailer promotion from Gramercy Strategic Partners LLC with a disclosed budget of $964,391; and a mailer made to look like a newspaper mock up.

Relmada Therapeutics Inc (OTCMKTS:RLMD) is a clinical-stage specialty pharmaceutical company developing novel versions of proven drug products together with new chemical entities that potentially address areas of high unmet medical need in the treatment of pain.

Relmada Therapeutics has a diversified portfolio of four lead products at various stages of development including d-Methadone, its N-methyl-D-aspartate (NMDA) receptor antagonist for neuropathic pain; MepiGel, its orphan drug designated topical formulation of the local anesthetic mepivacaine; BuTab, its oral dosage form of the opioid analgesic buprenorphine; and LevoCap ER, its abuse resistant, sustained release dosage form of the opioid analgesic levorphanol.

The Company’s product development efforts are guided by the internationally recognized scientific expertise of its research team. The Company’s approach is expected to reduce clinical development risks and costs while potentially delivering valuable products in areas of high unmet medical needs.

Back in February RLMD announced that it has filed a Clinical Trial Application (CTA) with Heath Canada to conduct a pharmacokinetic study with novel formulations of oral, enteric-coated buprenorphine (BuTab) being developed for the treatment of both chronic moderate to moderately severe pain and opioid dependence.

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The Company is planning a Phase 1 study designed to assess the safety, tolerability, and pharmacokinetics of BuTab in healthy subjects. The safety and pharmacokinetic data from this study will inform the design of subsequent clinical pharmacology studies for opioid dependence and potential regulatory filing for this indication along with the design of a Phase 3 study in chronic pain under the abbreviated 505(b)(2) regulatory pathway.

In March the Company said it has received a No Objection Letter (“NOL”) from Health Canada to conduct the first pharmacokinetic study with novel formulations of oral, enteric-coated buprenorphine (BuTab, REL-1028) being developed for the treatment of both chronic pain and opioid dependence.

CEO Sergio Traversa remarked “Following Health Canada clearance, our second product candidate is about to enter clinical trials during the second quarter of 2015. The rapid progress of our pain relief portfolio this year is a testament to the experienced and talented team we have in place at Relmada Therapeutics. If we can demonstrate that oral BuTab compares favorably with currently marketed sublingual formulations of buprenorphine, we believe that it has significant commercial potential.”

On September 9 RLMD announced U.S. Patent No. 9,125,833 was issued by the U.S. Patent and Trademark Office (USPTO) for its patent application entitled, “Multimodal abuse resistant and extended release opioid formulations.” The issued patent covers the SECUREL technology platform and Relmada’s lead product candidate, LevoCap ER (REL-1015, levorphanol extended-release, abuse deterrent capsules) as well as providing additional coverage for multiple opioid molecules that are prone to abuse.

“This newly issued patent strengthens Relmada’s overall patent portfolio,” said Sergio Traversa, CEO of Relmada Therapeutics. “With this new patent protection and levorphanol’s broad mechanism of action, LevoCap ER could be well positioned commercially in the chronic pain treatment market, if approved. We look forward to initiating a Phase III study with LevoCap ER as soon as feasible following interactions with the Food and Drug Administration (FDA) at a planned end of Phase II meeting.”

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Currently trading at a $50 million market valuation RLMD has an outstanding balance sheet with minimal debt and $31 million dollars sitting in the treasury. The stock has dropped big in recent months following the 5 for 1 reverse stock split as well as the Gramercy Strategic Partners $964,391 mailer promotion however the science behind the Company remains compelling. We will be updating on RLMD on a daily basis so make sure you are subscribed to microcapdaily.com so you know what is going on with RLMD.

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Disclosure: we hold no position in RLMD either long or short and we have not been compensated for this article.

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