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LEVATIRACETAM.
"We are thrilled to associate with SOHM and look forward to having a meaningful long-term association with SOHM, Inc., Said Mr. Vijay Shah, Chairman of Stallion Laboratories Pvt. Ltd. Further Mr. Vijay Shah, Chairman says Stallion Laboratories Pvt. Ltd. owns the ANDA, but have an exclusive distribution agreement with SOHM, Inc. for the USA for the distribution. The product shall be manufactured at our US FDA-approved facility in Ahmedabad, India, and distributed under SOHM's label and NDC numbers, Mr. Vijay Shah, Chairman added."
https://www.otcmarkets.com/stock/SHMN/news/SOHM-Inc-Signed-an-Exclusive-Distribution-Agreement-with-India-based-Stallion-Laboratories-Pvt-Ltd-for-Levetiracetam-for?id=398070
___
No Manufacturing Facility needed in the U.S. for LEVATIRACETAM.
Stock the shelves. Ship the Product.
LEVATIRACETAM is a big part of the Answer to your Questions, imo.
And this: https://www.otcmarkets.com/stock/SHMN/news/SOHM-Announces-Business-Outlook-for-2024?id=423706
hL shmn
That's a good reminder regarding the 3 Million.
It seems the framework is in place.
They have the Team.
They have the Facilities.
They have the Product Pipeline.
They will be presenting ABBIE at Scientific Conferences in APR/MAY.
They've filed a Provisional Patent on ABBIE’s ‘Smart Gene-Editing.'
They are Collaborating with the University of Arizona Center for Innovation.
They have one of the best IP Attorneys in the Nation.
They have the seed money/funding.
They showed increasing sales in 3Q 2023.
What will 4Q 2023 be like?
Website and Investor Communication showing promise.
Now they need to execute, imo.
hL shmn
(Above Edited for corrections.)
Yes woops, sorry I'll correct. 2023 went too fast for me.
That's a good reminder regarding the 3 Million.
It seems the framework is in place.
They have the Team.
They have the Facilities.
They have the Product Pipeline.
They will be presenting ABBIE at Scientific Conferences in APR/MAY.
They've filed a Provisional Patent on ABBIE’s ‘Smart Gene-Editing.'
They are Collaborating with the University of Arizona Center for Innovation.
They have one of the best IP Attorneys in the Nation.
They have the seed money/funding.
They showed increasing sales in 3Q 2022.
What will 4Q 2022 be like?
Website and Investor Communication showing promise.
Now they need to execute, imo.
hL shmn
SHMN "SOHM Files Provisional Patent on ABBIE’s ‘Smart Gene-Editing’ That Uses Latest Enzymes and Guide RNA to Resolve Off-Target Gene-Editing Limitations"
https://www.globenewswire.com/news-release/2024/01/09/2806400/0/en/SOHM-Files-Provisional-Patent-on-ABBIE-s-Smart-Gene-Editing-That-Uses-Latest-Enzymes-and-Guide-RNA-to-Resolve-Off-Target-Gene-Editing-Limitations.html
Agree on the packaging, very nice imo. Also, the actual "stuff" and flavors/vitamin combinations in the bottle look good too. Looks well thought out.
Will be nice if it translates to profit, and another step to self sufficiency without the use of shares.
Also got your note about Tony's "degree." He still says "Harvard/Economics" on his LinkedIn page. Who knows if he's splitting hairs or not, but the interview I posted shows he's no slouch to Finance and Market Cap..and his compensation history seems to indicate he's valuable potentially.
HL. Shmn
I hope not. LEVETIRACETAM is what I'm looking for here:
"Levetiracetam contracts being formalized with distributors."
We are happy where things are today with the Year-end FDA approval of our Carlsbad manufacturing facility which will set our company up for a bright 2024 outlook.$SHMN pic.twitter.com/tehLBtiVNs
— SOHM, Inc. (@sohminc) December 31, 2023
"Sohm Inc presents our line of branded chewables"
https://www.globenewswire.com/news-release/2023/11/14/2780208/0/en/SOHM-OTC-Self-care-Launches-Suite-of-13-New-SOHM-Nutrients-Brand-Chewables.html
___
Shows they are available on the website.
hL shmn
Tony Tontat:
Interview (formerly Kiromic/KMBP) April 13, 2021:
https://schwabnetwork.com/video/tony-tontat-talks-kiromic-biopharma-krbp-?redirect=true
https://www.linkedin.com/in/tony-tontat-49976/
On the Negative side...just doing some DD:
https://www.andrewjowett.net/2022/02/02/houston-biopharma-misled-investors-in-40-million-offering/
"For good measure, the Special Committee also found that Mr. Tontat lied to the company about his educational background. Instead of a BA in Economics from Harvard University, he received a Bachelor of Liberal Arts, a degree conferred by the Harvard Extension School.
Mr. Tontat resigned as CFO in October 2021, with Dan Clark, VP of Finance, promoted to interim CFO. The SEC filing announcing Mr. Tontat’s resignation stated that it was due to personal reasons and did not relate to any disagreement with the operations, policies or practices of the Company on any matters."
https://ir.kiromic.com/node/6941/html
https://www.nasdaq.com/press-release/kiromic-biopharma-announces-chief-financial-officer-transition-2021-10-05
"In a separate matter, on or about August 17 and 23, 2021, Tony Tontat, who at the time was the Chief Financial Officer and a member of the Board, submitted substantially identical reports (the “Complaints”) through the Company’s complaint hotline. These Complaints, alleged, among other topics, risks associated with the Company’s public disclosures in securities filings and in statements made to the public, investors, and potential investors regarding (i) the anticipated timing of the FDA authorization of the IND applications and (ii) the anticipated timing of human clinical trials. These Complaints were subsequently submitted to the Audit Committee of the Board.
After receiving the Complaints, the Audit Committee recommended that the Board form, and the Board did in turn form, a Special Committee comprised of three independent directors (the “Special Committee”) to review the Complaints and other related issues (the “Internal Review”). The Special Committee retained an independent counsel to assist it in conducting the Internal Review."
https://capedge.com/filing/1792581/0001558370-23-009941/KRBP-10Q-2023Q1
___
Kiromic (and Tony and other execs) appears to have had, and is having, some roller coaster moments, imo.
hL shmn
Thank you. Sorry so late, I've only been working part time this week.
It sure looked like their website design, colors, etc. But I didn't look to see the link address. How did you find it? HL
Looks like it's missing from the website now too?
He never left, imo. But who knows, maybe they'll address it.
Hl. Shmn
That Team section still needs work. Rushing/others are missing, and hopefully they use the person's real photograph after the website is completed.
HL. Shmn
Gabapentin vs. Levetiracetam. The differences:
Did Sohm abandon Gabapentin (anticonvulsant, non opioid) for Levetiracetam (antiepileptic, non opioid)?
https://www.goodrx.com/compare/neurontin-vs-keppra
Or do they still plan to offer gabapentin for the nerve "pain"?
SOHM is pleased to announce its newest private label Rx offering of Gabapentin Capsules. It is an anti-epileptic medication that is used to relieve the pain associated with neuropathic conditions. According to data, the US market for Gabapentin is approximately US $270 Mn. $SHMN pic.twitter.com/L8RfeBGyin
— SOHM, Inc. (@sohminc) May 10, 2022
New Sohm Website on LEVETIRACETAM :
https://sohm.tndc8ws005.techienetworks.com/rx-generic/
Daily Med also showing all dosages 250mg/500mg/750mg/1000mg :
https://dailymed.nlm.nih.gov/dailymed/search.cfm?adv=1&labeltype=all&query=%28sohm%29+
__
We apparently have the stuff...how about the orders?
hL shmn
The timing is hard to dissect, as many PR's were only on the old Sohm website, and now they can't be accessed as they've been removed from the new website. Brainwise was technically a little before Aguilar and Rushing were appointed as advisors, might have been a little limited in what they could "say" or contribute...though as you're pointing out they were "advisors." Also as you point out, now they may have more teeth as Officers/Employees/Management/Leadership.
They still seem to be interested in a Brainwise "product" as the most recent quarterly includes an "Omega 3 Oral syrup." (?)
However, whatever happened to Gabapentin? What did Aguilar say about it?
Gabapentin isn't in the Quarterly as a "saleable product." Have they abandoned Gabapentin?
TIA. hL shmn
(Edit)...and I would add that everyone's risk tolerance is different. I'm not encouraging anyone to buy/sell/hold/fold. I don't care what anyone else does with their shares. Personally I tend to be cautious and not go all in on anything. I don't have a ton of shares in SHMN right now. I hope that changes though.
hL shmn
Edit...but I am bidding at the moment. Hoped to grab more shares in December, but we didn't get the updates I was looking for so I held off. Also, shares are being held pretty tightly, and there aren't large chunks available. December volume has been low. If they have good updates in January, it might be interesting to see how many shares are available in the teens. It all depends on the company delivering.
Same story with most OTC stocks. Verify/Investigate, before trusting. SHMN is no different, and it will be that way because they have had so many prior swings and misses. Nothing wrong with caution. My viewpoint is different at the moment, with Aguilar, Rushing, Bhat, and others. Aguilar and Rushing have long and verifiable backgrounds in Pharma and FDA.
I'm withholding judgement on them until they have adequate time to prove themselves. Proof will be in sales over time, reflected in filings.
We've seen pictures of our management, and videos of Facilities, in San Diego and Arizona. Proof of activity.
We have verifiable proof from the FDA site that they have registered San Diego and Carlsbad.
We need patience and should expect some delays. We can't expect to snap our fingers and get results.
They know they are accountable. Let's see if they deliver.
hL shmn imo.
Baron/David...we need an update on LEVETIRACETAM:
We have exciting news to share with you. We have received the second installment of the investment and have begun paying for the ABBIE technology acquisition. ABBIE is a revolutionary non-viral gene-editing platform that can transform genetics and biotechnology.
— SOHM, Inc. (@sohminc) November 8, 2023
We have also…
Thanks for clarifying. I haven't tried calling either companies at that address (and don't plan to now) so you guys are ahead of me, but thanks to all for bringing their dd to the board. hL shmn
Good to know, thanks for doing that. hL shmn
Thanks for the info. hL shmn
Cool thank you. I saw that Company name in my search, but didn't look into them. They might still be there?
Their 2023 website still shows that address. https://universalsequencing.com/pages/contact
__hL shmn
Good info. It used to be "Capella Flavors."
(As seen in the old picture from Google Maps, which also showed it up for Lease in 2020)
https://www.capellaflavors.com/company (Pictures of the facility inside/outside also)
https://www.capellaflavors.com/
https://opencorporates.com/companies/us_ca/3081807
https://netrition.com/products/capella-flavor-drops?variant=41339416117430&msclkid=4b92074984351628f63562c5d399a01a&utm_source=bing&utm_medium=cpc&utm_campaign=%5BBING%5D%20Desktop%20-%20Standard%20Shopping&utm_term=4585032215033801&utm_content=All%20Products
Not sure if Capella moved, or where they are...
...but that's our new facility now.
Previous FDA Labs as you've shown. (For Food/Concentrates production.)
It's good to know the address, imo.
__
hl shmn
fdaspecialist.com: "Once my establishment is registered, it is considered FDA-approved? If not, what do I need to do for FDA to approve it?
Registration of an establishment does not constitute an FDA approval of the establishment. FDA does not approve establishments. FDA uses the registration information to keep track of its regulated facilities, locate the facilities in the event a problem is found in their products, and to schedule routine inspections of the facilities to determine if they are complying with FDA regulations such as good manufacturing practices (GMPs). FDA may take enforcement action against facilities/establishments if FDA finds any violations during an inspection, but FDA does not approve the facility or establishment."
"Richard Chiang worked for the FDA for 13 years beginning as a field investigator and entry reviewer and later worked at the FDA’s headquarters Center for Food Safety and Applied Nutrition (CFSAN) "
https://fdaspecialist.com/fda-specialist-news/fda-registration
___
hL shmn
$shmn FDA Facility Registration: "Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States. "
https://www.fda.gov/industry/fda-basics-industry/registration-and-listing
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/electronic-drug-registration-and-listing-system-edrls
"Owners or operators of drug manufacturing establishments are required to register their establishments with FDA. Registrants are also required to list each drug manufactured at their establishment(s) intended for commercial distribution and submit updated drug listing information to FDA twice each year, in June and December, notifying FDA if this information has changed."
"Complete, accurate and up-to-date establishment registration and drug listing information is essential to promote patient safety. FDA relies on establishment registration and drug listing information for several key programs, including:
Drug establishment inspections
Post market surveillance
Counterterrorism
Recalls
Drug quality reports
Adverse event reports
Monitoring of drug shortages and availability
Supply chain security
Drug import and export
Identification of products that are marketed without an approved application "
https://www.accessdata.fda.gov/scripts/cder/drls/getdrls.cfm
___
hL shmn
Thank you. hL shmn
"SOHM Announces Business Outlook for 2024"
CHINO HILLS, Calif., Dec. 05, 2023 (GLOBE NEWSWIRE) -- via IBN -- SOHM, Inc. (OTC PINK: SHMN) (the “Company”), a pharmaceutical, nutraceutical and cosmeceutical Company that manufactures and markets generic drugs covering numerous treatment categories, announced:
SOHM Announces Business Outlook for 2024 for each of its Business Units.
SOHM, Inc. is organized into the following business units:
-- OTC Self-care (over-the-counter nutraceuticals and cosmeceuticals)
-- Branded Generics (off-patent prescription pharmaceuticals)
-- CDMO, Contract Development Manufacturing (contract manufacturing services)
-- ABBIE, Gene-editing Bio-kits
For each business unit, the Company will provide a 2024 outlook along with relevant business unit-specific status on: market backgrounds, business strategy, business model, branding strategy, sales channels, and commercial status.
Business Unit: OTC Self-care
Market Background and Overview
OTC Self-care products are sold by brick-and-mortar pharmacies, retail chain stores, C-stores and online. These products are sold without a prescription.
In 2022, the Consumer Healthcare Products Association (“CHPA”) reported that medicinal OTC product sales reached $41 billion with the average household spending $338 annually. (Source: CHPA 2022 Link.)
Business Strategy, Products and Approaches
In Q4-2023, the Company launched a suite of 13 SOHM Nutrients’ chewable. These chewable are vitamin and mineral supplements formulated for everyday health maintenance. The Company intends to expand the product portfolios in Q1-2024 and anticipates deriving 20-25% of its revenues from nutraceutical and OTC cosmeceutical products during the year 2024.
SOHM Nutrients’ Chewable will also be available for retail and bulk purchasing through Amazon.com.
Business Unit: Branded Generics
Market Background and Overview
Pharmaceuticals require a prescription from a doctor for the consumer to buy and use. Each year, several pharmaceutical products come off patents (i.e. patent expired). When a pharmaceutical product's patent expires, manufacturers have the opportunity to utilize the patent and produce the identical product by utilizing the previously patented chemical composition. These products are commonly referred to as generic drugs. Many generic manufacturers go the extra step by branding their generic products, hence the term “branded generics.”
The branded generics market size in the USA is $238 billion and growing, per Global Market Insights. (Source: GMI 2022 Link.)
Business Strategy, Products and Approaches
The Company confirms it has the necessary requisites to become a branded-generic manufacturer, including: scientific personnel, FDA-approved manufacturing facilities, as well as an appropriate marketing and sales strategy.
The Company aims to finish 2024 with a total of 20 branded generics in the market and manufacturing of its branded generic lineup. The Company anticipates deriving 50-55% of its revenues from the branded generic business division during the year 2024.
Business Unit: CDMO Services
Market Background and Overview
CDMO (Contract Development Manufacturing Organization).
SOHM’s CDMO business unit consists of contractors to drug developers who specialize in providing contract development and manufacturing services to the pharmaceutical industry.
The USA CDMO market is reported to be $136 billion in 2022 per Vision Research Reports (Source: VRR 2022 Link) with a CAGR (compounded annual growth rate) of 6.13%.
Outlook 2024: CDMO Services
The Company already has orders for its CDMO services and will launch two units to perform the manufacturing for these CDMO clients by 4Q-2023 and into 2024.
The Company anticipates deriving 20-25% of its revenues from its CDMO business unit during the year 2024.
Business Unit: Biotech Gene-Editing Kit
Market Background and Overview
Gene-editing is a scientific method for inserting genetic materials into the DNA of a cell. One can compare this process to rewriting code in a software application.
Gene-editing companies are valued in the billions, with their gene-editing technologies licensed for billions. Even start-ups in gene-editing are raising capital at $50 million for early research.
The gene-editing market is reported to be worth $5.3 billion in 2023 and projected to reach $10.6 billion by 2028 with a CAGR of 15%. (Source: PR Newswire 2023 Link.)
The global biotechnology kit market is estimated at $593 billion in 2022 with a 10.9% CAGR between 2023 and 2030. (Source: 2023, GrandViewResearch.com.)
The Company acquired a gene-editing technology called ABBIE as previously announced. SOHM intends to develop ABBIE into a gene-editing kit for biotech companies, academic institutions and pre-clinical testing companies, which will allow them to deliver genetic materials to a specific locus on a target cell’s DNA.
In the Business-to-Business model, the ABBIE gene-editing kits can be:
-- Sold as off-the-shelf kits, or
-- Licensed out
Product Development
As of Nov 2023, the Company is expanding on its research and development of ABBIE generated pre- clinical data conducted in isolated human T cells. In Q3-2024, the Company initiated a development collaboration with UACI, a leading science and tech startup incubator that is directly connected to the University of Arizona.
Facilities
The Company will be manufacturing its ABBIE gene-editing kit at its manufacturing facilities in San Diego and Carlsbad.
Interim scientific results from R&D will be available during SOHM’s participation at:
April 2024: American Association of Cancer Research 2024 in San Diego, CA
May 2024: SynbioBeta 2024 in San Jose, CA
Outlook 2024: ABBIE, Gene-editing Bio-kits
The Company is planning to commence its first ABBIE kit manufacturing within 2024.
The Company is expanding its revenue growth in various pharmaceutical and biotech sectors. It has set a 2024 target and is taking steps to achieve it. It wants to excel in cell therapy and gene editing. It expects to earn several million from its business units, including ABBIE. This estimate is based on its internal actions, current opportunities, licensing deals, and kit adoption. This was announced by Mr. Baron Night, CEO and president, and Dr. David Aguilar, COO.
About SOHM, Inc.
SOHM, Inc. is a growing generic pharmaceutical manufacturing and marketing Company with a vision of “Globalè Prospèro” that aims to build continuous growth. SOHM manufacturing and marketing targets rapidly growing healthcare segments such as nutraceuticals, cosmeceuticals and other major therapeutic segments. SOHM is headquartered in North America with manufacturing alliances in India and strategic alliances with U.S. manufacturing facilities. Although SOHM’s generic pharmaceuticals are exported globally and were introduced to the USA in early 2013, SOHM continues its focus on distribution to emerging markets in Africa, Latin America and Southeast Asia.
To learn more about SOHM, Inc., visit www.SOHM.com
Safe Harbor Statement:
This news release contains “forward-looking statements,” which are statements that are not purely historical and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, the development, costs and results of new business opportunities. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new projects and development-stage companies. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report for the most recent fiscal year and our quarterly reports uploaded from time to time on OTCMarkets.com.
For more information, please contact:
SOHM, Inc.
+1 (714) 522-6700
Corporate Communications:
InvestorBrandNetwork (IBN)
Los Angeles, California
www.InvestorBrandNetwork.com
+1 310.299.1717 Office
Editor@InvestorBrandNetwork.com
https://www.otcmarkets.com/stock/SHMN/news/SOHM-Announces-Business-Outlook-for-2024?id=423706
https://www.globenewswire.com/news-release/2023/12/05/2791056/0/en/SOHM-Announces-Business-Outlook-for-2024.html
Mods, could you please post the update for 2024. I'll follow up with the link, and news. Thx.
hL shmn
Tweet: FDA Registered Facilities:
We would like to share with everyone our FDA registration of both the facilities.
— SOHM, Inc. (@sohminc) December 26, 2023
All our operation and actions are ongoing even during the holiday season.
We are all excited about the upcoming year '24.$SHMN pic.twitter.com/gNzWzgFLxU
Ok support at .0011 at the moment. So much for higher lows. Pretty low volume this week though.
Need an update imo.
https://www.barchart.com/stocks/quotes/SHMN/technical-chart?plot=CANDLE&volume=total&data=DO&density=O&pricesOn=1&asPctChange=0&logscale=0&indicators=BBANDS(20,2);PTP(50);STOSL(14,3);STOFA(14,3);RSI(14,100);CHKMF(20);CHKMF(10);CHKOSC;ACCUM;OBV;MFI(14,100);SMA(20);SMA(50);MACD(12,26,9);SMA(200)&sym=SHMN&grid=1&height=500&studyheight=200
hL shmn
12.19.23 Back to Pink Current: https://www.otcmarkets.com/stock/SHMN/disclosure
hL shmn
12.18.23 Still Pink Limited: https://www.otcmarkets.com/stock/SHMN/disclosure
hL shmn
Attorney Letter posted last night: https://www.otcmarkets.com/otcapi/company/financial-report/389170/content
https://www.otcmarkets.com/stock/SHMN/disclosure
Tweet Re: "Pink Limited": "The management team is fully cognizant of the current status with OTC Markets (OTCM) and is actively collaborating with OTCM to rectify the situation. It appears there has been a discrepancy in the interpretation of our financial statements. After an extended period of nearly seven to eight months, OTCM has requested modifications to these financials. Consequently, we are in the process of submitting an amended attorney letter bearing the current date. Our legal counsel is diligently preparing the necessary documentation and anticipates uploading it to the OTCM system either today or tomorrow, contingent upon receipt from the attorney."
The management team is fully cognizant of the current status with OTC Markets (OTCM) and is actively collaborating with OTCM to rectify the situation. It appears there has been a discrepancy in the interpretation of our financial statements. After an extended period of nearly…
— SOHM, Inc. (@sohminc) December 12, 2023
Baron/David, what else does OTC want if anything?
We have updated the statement of stockholder’s equity pages as per the OTCM compliance dept.'s request and published the changes. the changes are for Annual report 2022, 1st Qtr., 2nd Qtr., and 3rd Qtr., 2023.$SHMN
— SOHM, Inc. (@sohminc) November 27, 2023
We're "Pink Limited" for some reason: https://www.otcmarkets.com/stock/SHMN/disclosure
🚨 $SHMN
— OTC Updates (@OtcUpdates) December 12, 2023
💰0.0014
Pink Limited, AS: 3.0B, OS: 1.6B, US: 1.3B
Tier Updated:
🔴 Pink Current Information
🟢 Pink Limited Information
https://t.co/5zcUyDqf1O
While we agree on things often, I don't share the same "bottom line" summary. I'm only one insignificant trader, but I wouldn't even put today's Sohm into the same universe as the previous "forward looking statements" team.
I think SLCJD makes good points too, the proof will be in the filings...which our last 3Q ending in September was a pleasant surprise...to me it's evidence that we're heading into a good 4Q.
We've also seen videos of the SanDiego facility, and the University of Arizona Collaboration for ABBIE.
We've seen many more good things, including that SOHM has listed Eric Furman (one of the best IP Attorneys in the Nation)...which shows me they are serious about that pursuit, and that we don't have hacks running SOHM.
We're not in the same Universe anymore, imo. Don't get me wrong, I understand the frustration, and you're entitled to it MP.
Hump day bourbon tomorrow. :)
hL