On Dec 1, 2021 the company announced they met both primary and secondary endpoints for the Dupuytrens Phase 2b trial. The company is expected to file for a BLA in 2022.
The next clinical trial scheduled is a Phase 2 for frozen shoulder. Since this trial is not a phase 3 trial which is 6-9 months from completion, this company will no longer be followed closely. Once the frozen shoulder Phase 3 trial is underway, we will follow the company again.
FN Summary: Lead asset (Adalimumab) is in a fully funded and fully enrolled Phase 2b/3 trial – Results due Q4 21. Outstanding company management and BOD oversight (10 out of 10). Cash position is good with management taking minimal salary. Government grants currently fund almost all of their clinical trials. Targeting several unmet medical needs in large markets.
Table of Contents
This company hits the right spots!
Already proven drug (Adalimumab - Humira®) being tested for new indications
Good Phase 2a
Recent Insider Buying
Decent Cash Reserve (as of Aug 2021)
Government Funded Clinical Trials
Caveat! Stock movement can be very finicky and, at times, seemingly random. This is FN's best explanation of the price movement.
Back in March 2021 ATNF was close to 60% shorted. The Short % is still high; therefore, the SP is quite erratic.
Cash on Hand
Est Cash End of Nov 2021
Until 03/2021 management was deferring their salary for stock options. They now have minimal salary based on performance.
Products & Sales Potential
For Context: 180 Life Sciences Market Cap ~ $184M as of Nov 26, 2021
This management team rivals any large-cap biotech!
Yes, we know. This is the boring part of the page. But, it is also the most important. Read this: Importance of Management
- Jim Woody has more than 25 years of pharmaceutical research and management expertise. He currently serves as Chairman of Oncomed Pharmaceuticals, where he was previously a founder and CEO; he is also a General Partner at Latterell Venture Partners, a venture capital group focusing on early-stage healthcare companies.
- He has served in a variety of health and management roles including as President of Roche Bioscience, and CSO and Senior Vice President of R&D for Centocor. At Centocor, Jim was part of the team that discovered Remicade, used to treat arthritis and which is now one of the best-selling drugs in the world.
He served as Commanding Officer and Director at the US Naval Medical Research and Development Command in Bethesda, Maryland. In this role he was responsible for the surveillance, detection and therapy for all biologic warfare agents and infectious diseases in the First Gulf War; he was awarded the US Navy Legion of Merit for his service.
See YouTube video below called “Conversations with Giants of Medicine“.
- Professor Sir Marc Feldmann, AC FAA FRS FRCP FRCPath FMedSci is a pre-eminent immunologist, and an Emeritus professor at the University of Oxford.
- At the Kennedy Institute in London in the 1980s, he identified TNF as a target in the treatment of arthritis. With his research partner, Prof Sir Ravinder Maini, they led clinical trials of monoclonal antiTNF antibody in treatment resistant rheumatoid arthritis, which Centocor had generated, and now called Infliximab, which J&J now sells as Remicade.
- This work was highly recognized, leading to many prestigious awards including the Crafoord prize of the Royal Swedish Academy, the Albert Lasker award for clinical medical research, the Canada Gairdner award, the Paul Janssen award and the European Inventor of the year award, and most recently (2020) the Tang Prize.
- Remicade was the main driver of the $4.9 billion USD acquisition of Centocor by Johnson and Johnson in 1998. Since its approval Remicade has sold over $50 billion USD worldwide, and remains J&J’s biggest selling drug. Feldmann and Maini are credited for the generation of anti-TNFs as the world’s biggest drug class since 2013, with global sales of $36 to 40B in recent years. This major impact on medical therapy led to his receiving a knighthood and also the Australian equivalent, Companion of the Order of Australia.
- Works in the neurology department at Stanford University.
- Headed the Molecular Immunology Laboratory at the Imperial Cancer Research Fund in London in 1990, where he first worked with Professor Sir Marc Feldmann. He has collaborated with Professor Lawrence Steinman since 1986, when they published the first of their 26 manuscripts together.
- Involved at a high level with start-up pharmaceuticals discovery; in 1987 he founded Amylin in San Diego and has also founded start-ups CellGate and ImmuLogic.
- Amylin was focused on the discovery, development and commercialization of drugs treating diseases including diabetes and obesity. The company was sold in 2012 to Bristol-Myers Squibb for $5.4 billion.
- Professor Nanchahal is a surgeon scientist at the University of Oxford, focused on defining the molecular mechanisms of common diseases such as fibrosis and translating his findings through to early phase clinical trials.
- His surgical background has allowed him to bring a unique insight to common, yet relatively neglected diseases. Many of his findings stem from investigations in primary human tissues, rather than relying on animal models that often fail to recreate human clinical conditions.
- He has pioneered the treatment of fibrosis of the hand (Dupuytren’s disease), which unlike fibrosis in major human tissues can be diagnosed early and samples easily obtained to discover new pathways of importance. In 2013 his group identified TNF⍺ as a target for Dupuytren’s disease, leading to a phase 2a clinical trial to determine the effective dose and preparation of anti-TNF.
- Immunologist who has held the role of Scientific Director at 180 Life Sciences in UK since September 2018.
- Since then she has carried out translational research at Imperial College London, and Kennedy Institute of Rheumatology (KIR), and has published several high impact studies with pharmaceutical companies (including Bayer Schering, Celgene, GSK) which unravel novel mechanisms of immune regulation, harnessing potential for therapeutic discovery.
- From 2011-2018, she was group leader for therapeutic target discovery in autoimmune disease and fibrosis at University of Oxford, firstly working with NovoNordisk, and secondly with a multi-national consortium of academics and pharma at KIR/SGC Oxford (EU/IMI funded).
See YouTube video below called “The Scientist“.
- Considered the ‘Father of cannabis research’, having worked on the chemistry, pharmacology and clinical effects of natural products, including cannabis for over 50 years. He isolated numerous cannabinoids, including the active constituent of cannabis, delta9-THC, and elucidated its structure. This also paved the way to his discovery of 2AG and anandamide, both endogenous cannabinoids in late 1990s.
- He has published over 400 papers in esteemed scientific journals and be awarded several notable prizes including the Israeli Prize in Exact Sciences in 2000, NIDA discovery award in 2011, 2012 Rothschild Prize in Chemical Sciences and Physical Sciences, and Lifetime achievement award at CannaMed in 2016. Currently his work focusses on generating novel cannabinoids and anandamide-like compounds which are being developed as drugs.
The takeaway: For a company this size (and market cap), this is one of the most accomplished teams in biospace.
Phase 3 Clinical Trial
Understanding the Phase 2 trial is crucial to anticipate the success of the current Phase 3 trial. In summary, the Phase 2a trial was a success.
Phase 2a was completed with 28 patients, which showed that 40mg (in 0.4ml) Adalimumab (in 8 pts) is effective at reducing fibrosis. This represents a 27.8% decrease (p=0.006) in α-SMA protein expression vs. control.
Phase 2b/3 involves 181 patients and is entirely grant funded. It applies anti-ATNF drugs to early stages of Dupuytrens’ contracture, a fibrotic disease of the hand. Currently, there is no known early treatment for the condition. See trial design below.
Insider Ownership % (not precise)
~46%+ of outstanding shares are owned by management & insiders. *
Float is ~10M shares. *
* See Slide 20 of Corp. Presentation
Recent Insider Transactions
Since going public in Nov 2020, there has been a mix of buying and selling with slightly more buying. The recent insider buys are a good sign, but they were not large.
ATNF Discussion Forums (listed in order of best DD potential)
Who is the most knowledgeable ATNF Stocktwits user to follow?
180 Life Sciences: Looking At Inflammation With Cannabis - Prof. Sir Marc Feldmann - Dr. Jonathan Rothbard, Chief Science Officer (Podcast) - Sept 8, 2021 (start at the 16 minute mark)
Notable Prof. Sir Marc Feldmann Quote (38:00): “The greatest rate-limiting step in resources is intellectual horsepower. That is everything in the end. If you’ve got the understanding, the knowledge, the rest of the pieces come in. You can raise the money, you can recruit people. So that is really it.“
Treating Distinct Inflammatory Diseases and Finding Solutions for Fibrosis and Pain with CEO Dr. Jim Woody - Sept 1, 2021
Nowhere in his talk does the CEO say early. He only says the data will be available 4th Q. Check out timestamps 7:55 and 9:35, above. [Thanks to Tutur17 of Stocktwits for this insight.].
It is our estimation that the data will be available late Oct or Nov, at the earliest. If data was coming in beginning-mid October, this would qualify as early and he would have stated it.
Interview with Jim Woody (CEO) - The Bio Report - April 8, 2021
- The potential for anti-TNF treatments started with sepsis patients
- treated 50 sepsis patients and nothing happened – this simply meant the conventional wisdom was incorrect, but left with a quite spectacular antibody
- came in contact with Dr. Marc Feldman in London and he had done experiments with human tissue that RA was driven by a series of cytokines.
- Started a trial and treated 10 patients who had RA and were in wheelchairs. Immediately after they got the drug, told us their pain and fatigue was gone. After a few days, several of them got out of their wheelchairs – it was remarkable!
- No patients left in wheelchairs across the world (due to RA) b/c the anti-TNF drugs and others that have come behind it.
- Crohn’s disease was caused by TNF and when his patients were treated by anti-TNF and they got well – same for psoriasis.
- Anti-TNF industry is a $40B per year with the 5 drugs approved in the US, takes care of the RA, Crohn’s disease, psoriasis, ulcerative colitis patients – been a phonemical success
- TNF is necessary, but if it is in large amounts it causes inflammation, and the TNF goes to joints, or other places and dries the cells to destroy the tissues by bringing in inflammatory cells and mediators and all sorts of things
- Most of the companies that have the anti-TNF agents
- Dr. Feldman and I felt that TNF is probably a ‘bad actor’ in other places.
- We found that TNF is driving fibrosis and we have programs that are address that.
- If we can block the TNF, we an block the whole fibrotic process and that is the basis for the trial
- DD is more common in Scandinavian countries (possibly a genetic condition)
- Our drug is aimed at preventing DD all together
- We filed IP around this particular indication and also how we would make a kit that would be specially tailored for addressing the hand nodules.
- We don’t intend to make a new anti-TNF drug, we will repurpose some of them that are out there
- this is the largest DD trial ever run and are now following them up
- We should have results “in about Q3 of this year”. Note: Company later issued guidance on April 20 that said topline results will be in Q4.
- We think that Frozen Shoulder is caused by anti-TNF, because about half of the Frozen Shoulder patients have DD (Timestamp 15:20)
- Injecting anti-TNF into the shoulder to eliminate the pain, and the progression to the disability
- in Nash, our scientists are looking at what are the mediators that are causing the fibrosis in the liver and looking for the targets we may be able to address.
- Later in the year, we will have some results in Nash.
Post Operative Cognitive Deficit (POCD)
- After substantial surgery, 20-30 % (especially older patients) will have mental disability after the surgery and some of the effect persists that they end up in nursing homes, because they never come back to being normal.
- What our team discovered is that the levels of TNF that are released from the surgical trauma were quite high and correlated with the level of dementia.
- We think the TNF released during the surgery can cause the dementia.
- We are hopping to prevent that with an infusion of anti-TNF right at the time of surgery and that will be starting later in the year. If it works it will be quite beneficial.
- The anti-TNF companies are happy with their profits and revenue streams for fundamental diseases.
- Our scientists are thinking far ahead into other areas that are important and we can provide patient benefit.
- Fibrosis and pain travel together
- We have programs making synthetic cannabinoid compounds – they are anti-inflammatory and anti-pain
- These will be oral drugs (pills)
- Selecting the lead candidate molecules
Additional FN Considerations
The majority of ATNF clinical trials were/are funded by US & EU governments. The management team came from academia so they know how to write for grants. They are expert grant writers and the grant writing will continue, which will benefit shareholders immensely as the company develops their pipeline. This non-dilutive financing is a significant benefit of owning ATNF that many other biotechs do not posses.
Q. Why is the stock ticker ATNF when the company name is 180 Life Sciences?
A. ATNF stands for Anti-TNF. Simple, huh?
Q. Where did the name 180 Life Sciences come from?
A. Dupuytrens Disease causes the fingers to curl in on themselves in a painful position. 180 would be the opposite state (open palm) of the fingers in a DD-free hand.
Q. Do you have any idea when in the 4th Q management will have the P3 data?
A. Due to management originally stating data will be available late in the 3rd Q, and now changing it to the 4th Q, we believe results will be released the first half of the 4th Q.
Q. Is there a Facebook group for the Dupuytrens trial?
A. Yes there is. Go here.
Q. Why does this company have such a high FN rating (9.5) considering Phase 2 results were acceptable with only 8 patients?
A. B/c management is just that good. Management are experts in fibrosis and inflammation. If they are confident they can see significant results in a P3 fibrosis trial, I am inclined to believe them.
Some FN Levity
Budgie Studying the ATNF Pipeline
We don't include TA videos.
June 10, 2021 - LD-Micro Presentation by CEO James Woody
March 31, 2021
March 27, 2021
March 8, 2021 - Emerging Growth Virtual Conference
- Many clinical trials are entirely grant funded
- Strong IP portfolio out to 2039
- 3 of us have developed drugs on the market, which each having over 1B in sales per year
- Founders of the company discovered the clinical utility of an entirely new class of drugs, which includes blockbuster Remicade, which lead to J&Js acquisition of Senecor of $4.9 B
- ‘5 major anti-TNF and 20 biosimilar’ players are involved with 180 LS
- anti-TNF market is expected to reach $150B in this decade, and we intend to be there
- If you want an anti-inflammation “dream team” this is it
- Repurposing anti-TNF drugs with very enterprising delivery concepts and indication
- We have gotten the clinical answers right
- We are developing treatment for early stage fibrosis, which is highly desirable (vs. other companies who treat it after it is debilitating)
- there are no approved therapies for the early stages of Dupuytren’s Disease (DD)
- Current therapy for DD is steroids, or collagenation injection with almost 50% recurrence rate. Patients often opt for expensive surgery with long recovery times.
- No adverse events associated with injections
- Largest trial for DD ever done
- 11M total patients in the Us + 11M in the EU. If 1/3rd are symptomatic and seek our treatment, you can see it is a significant market opportunity
- Frozen shoulder affects ~9% of the population aged 25-64 (more common in diabetics)
- Only therapy is local steroid injections which only provide some shorter term relief
- our Phase 2 drug will be injected and reduce the shoulder pain
- 9M US patients and 14M patients in the EU providing a substantial revenue opportunity
- This trial is also grant funded
Post Operative Cognitive Deficit (POCD)
- Condition that affects patients during surgical trauma. TNF is released into the blood and the levels correlate with the dementia seen in 30-40% of patients following major surgery. 300,000 hip facture repairs and 350,000 cabbage(?) procedures each year in both the US and EU.
- We feel the anti-TNF administered at the time of surgery may prevent this. Phase 2 trial will begin later this year or early next year. It could become the SOC for all significant surgeries.
- in the lead discovery format for pain and inflammation
- Recall the plant derived CBD that you may get over the counter may contain over 100 different compounds that are poorly absorbed and have erratic results
- the compounds are are developing are fully synthetic, non-psychoactive, non-addictive, be orally available and we have experiments showing the benefits of pain and inflammation models