Relmada Therapeutics Inc. (RLMD)

[VictorMasonIsRight]

Typo ‘Johnson...’

Here is my most recent correspondence about RLMD. I’m not hearing anything from the management about PIPE or phase 2 other than ‘progressing’. Sent this to Bob the former FDA CRO consultant. He has no first hand info on RLMD TEST but joined me in the October PIPE


Subject: Johnson & Johnson NMDA drug approved

Estimate JNJ up 10-15 Billion in last month on anticipated approval (approved yesterday) of their Esketamine inhaler drug
with
1) a big price,
2) already has generic competition,
3) requires clinic visits and observation.

Both JNJ’s drug and the generic Ketamine are life savers. RLMD will prove to be better but this proves the efficacy of the NMDARA mechanism of action
“Esketamine is a non-competitive and subtype non-selective activity-dependent N-methyl-D-aspartate (NMDA) receptor antagonist, which has a novel mechanism of action, meaning it works differently than currently available therapies for depression. The program in treatment-resistant depression is currently in Phase 3, with six ongoing clinical trials.”

Janssen division of JNJ said the cost of the treatment will depend on the dose used per session and how many sessions a person will need, both of which can vary. The wholesale acquisition cost: between $590 and $885 per treatment session. That means the wholesale acquisition cost for the first month of treatment — which includes two sessions a week — will range from $4,720 to $6,785 per month.
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At least 2 others testing NMDA pathway drugs:
“Relmada’s (RLMD)drug, d-Meth, is a lot more potent and clean compared to dextromethorphan and should do better. It’s beneficial that more NMDA drugs show efficacy in depression to show that Relmada’s d-meth is clearly best in class.”

Relmada CEO Dr. Sergio Traversa on the $2 billion appreciation of SAGE on news of their NMDA drug in phase 3 and AXSM's 100mm jump on phase 2 news on their NMDA drug

link to an 18 minute presentation they gave Jan. 7th in SF:

https://event.webcasts.com/starthere.jsp?ei=1226547&tp_key=6f6a3c5607

https://stock-charts.com/h-sc/ui?s=RLMD

10Q Especially read ‘Business Overview’ most of the rest is standard:

https://www.marketwatch.com/press-release/10-q-relmada-therapeutics-inc-2018-05-14
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Three guys much smarter than me are in big: RLMD Director Paul Kelly retired top ranked biotech analyst ($750K@ .90) E. S., PhD MIT left Wall Street to be CFO of 3.9B biotech ($300K @.90 in same PIPE I did in Oct.)also smartest guy I met in 28 years on Wall Street($200K open mkt)



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Next purchase will have to be on a pullback or in the next private placement if they have one, no info. Or does it matter if it hits $10? I always regret using limit orders.
My estimate:
Any warrants they might attach are worth about .45 ( friend’s estimate - Black and Scholes pricing formula? ) unit might be $1.10-1.20 if it holds up here. 1/2 warrant worth .225/ per unit = .80 /.90 cost basis per unit including the warrants.

In ICU now sitting w brother in law, doing better
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Maybe hold out for $50/share?
License agreement:
https://www.sec.gov/Archives/edgar/data/1553643/000121390018000707/f8k011618ex10-1_relmada.htm

RLMD BETTER: RLMD’s Sergio Traversa and Paul Kelly comment:

Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in Phase 2 Trial in Major Depressive Disorder
Paraphrased comments from Paul Kelly and Sergio Traversa of Relmada regarding comparable profile of Axsome.
 
Paul:  “Dextromethorphan, Axsome’s drug,  is a weak NMDAR antagonist, which is why I think we see a relatively slow onset of activity compared to Esketamine (the difference between Dextromethorphan/Bupropion and Bupropion alone is barely significant at the end of one full week and much better at the end of 6 weeks).  The fact that a weak NMDAR antagonist such as Dextromethorphan shows additive activity to baseline antidepressant therapy I would view as very encouraging for Relmada’s prospects with our more potent antagonist, d-meth.”
 
Sergio: “I am in line with Paul’s comment about dextromethorphan.  It has a short half-life and is not a very potent NMDA.  The fact that it showed some efficacy works well for us. Relmada’s drug, d-Meth, is a lot more potent and clean compared to dextromethorphan and should do better.  It’s beneficial that more NMDA drugs show efficacy in depression to show that Relmada’s d-meth is clearly best in class.
 There are some limitations in the study of Axsome.  The majority of patients do not have resistant depression which is where NMDAs are mostly tested and it is more difficult to treat.  A major issue is that Axsome’s drug is a combination of two generic drugs.  The FDA does not like combinations (see Alkermes.  In any case, Axsome added $100M in market cap with a P2 trial which is a good proxy for Relmada.”

AXSOME THERAPEUTICS, INC.
Robust AXS-05 MDD Phase 2 Trial Results Announced; Increase PT to $45
 
https://ladenburg.bluematrix.com/sellside/EmailDocViewer?encrypt=a913a897-dcbc-40f7-9d50-50eb7ec6974b&mime=pdf
The stock price of SAGE Therapeutics has risen from $85 to $160 (roughly an increase in market cap of $2bil) in a few days due to positive interim data on Postpartum Depression
 
Sage Therapeutics, Inc. (SAGE): Overweight
Clear Win as SAGE-217 Knocks It Out of the PPD Park
Danielle C. Brill, Pharm.D., Sr. Research Analyst, ?212 284-5025?, [e-mail]
CLICK HERE FOR FULL REPORT
CONCLUSION
This morning, Sage announced positive results from the pivotal PPD trial with SAGE-217. The data were impressive and looked clean across the board. Our key takeaways include: 1) Statistically significant efficacy was demonstrated across all major endpoints and drug-effect size was in-line with our expectations (placebo adj. HAM-D score improvement of 4.2 vs our 4 point estimate); 2) Statistically durable efficacy of 217 out to 4-weeks exceeded our expectations, and addressed one of the main concerns highlighted to us by experts; 3) Safety was extremely clean as overall sedation rates were very low and no loss-of-consciousness episodes were observed.

These data highlight the robust safety and efficacy of 217 for mood-disorders and we would expect some positive read-through to the ongoing pivotal MDD trial. We anticipate >50% upside for SAGE shares today (see here) and reiterate OW.

This indicates the potential for a depression drug even a subset such as PPD.

https://apple.news/AExvNBEQMSQSgCX73KGr9iA
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From: Les  Clements <[e-mail]>
Date: February 20, 2019 
Subject: RLMD update 

1) next raise should be $7-9mm ($1/share plus warrants ? ) and should close by the end of March, and be uplisted to NASDAQ following a reverse split to $4/ share NASDAQ initial minimum

2) JNJ’s Esketamine anti depression drug will probably be approved 12-2 vote ( approved Monday ) but has serious hallucinogenic side effects
( and that’s bad? kidding )  Clinic visit required and no driving for 24 hours.

I still think JNJ will buy RLMD after phase 2 results are released (May?) $500-$600mm? $11-15/ share?
 
Recognized his name in the S1:
3) One of the investors in the October PIPE that we bought into is Eric S. , he left Wall Street to become CFO of ($3.9b  biotech company ) 
Eric S, Ph.D., is Chief Financial Officer of  (3.9B biotech). He was previously Managing Director and Senior Biotechnology Analyst at C and Company. During his two decades there, he was a highly trusted industry analyst whose work was recognized in polls conducted by Alpha Magazine, Institutional Investor, Reuters and The Wall Street Journal.  Prior to joining XXXXX in 1998,    Eric  was a Vice President and Research Analyst covering the biotechnology sector for UBS Securities. Before joining UBS, he founded a scientific consulting and research firm. He holds a B.A. in chemistry from the University of Pennsylvania and a Ph.D. in biochemistry from the Massachusetts Institute of Technology, where he serves on the Visiting Committee for the Department of Biology.

4)  Bob: Between you, XXXX (200K), director Paul Kelly, a highly regarded retired biotech analyst (750 K) and E. S. ($300 K) we’ve got pretty good sponsorship and expertise voting with their $$$.   
One of the Cornell scientist/ patent holders invested $400,000. (750?) Good endorsement

5) Stock will probably sell off a little as the terms of the possible PIPE get firmed up and word gets out

(Since 2/20 It did sell off to 1.15 briefly but on 3/4 it bounced to $2/ share closed at $1.80. Only thing announced was S1 change of SIC code to correct )

People may try to sell their stock at $1.30 and buy the PIPE at $1 AND get warrants. IS that Kosher? I thought about it but it’s very thin and I wouldn’t want to be without my unrestricted stock if it gets volatile.