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ADVAXIS (ADXS)

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Advaxis is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins.

DISCLAIMER: This is not an investment advice -- just sharing my impressions and my research. Do your own research. Consult a professional investment advisor for advice. The statements below are NOT Avinger's -- they're based on notes I took, and my opinions and impressions, and may be inaccurate.  You can check out their website if you want to learn more about the technology: www.advaxis.com


ADXS UPDATE  23 MAY 2020

ADXS

ADXS has a very advanced cancer treatment that extends the efficacy of the most widely used cancer drug (Merck's Keytruda). Dr. Joe turned me on to ADXS and he also owns shares. If the next couple of patients show the same positive response as the last two, ADXS's stock should do very well.

Latest PR: https://finance.yahoo.com/news/advaxis-announces-updated-positive-clinical-120010526.html

MNLO

MNLO fair price using pre-merger metric:

If you held 100 shares of FOMX per-merger, and your cost basis was 4.30, today you own 180 shares and your cost basis is 2.40.

  • So 4.30 pre-merger = 2.40 today
  • and 4.50 = 2.50
  • and 4.10 = 2.28

Now, analyst average target for FOMX was $13.

Nothing has changed in the equation as far as I can see: MNLO's trials failed. FOMX got MNLO's cash and US footprint. So that $13 target is still valid. Translate that to post merger level (*.50 and +1.205...) that $13 = $7.24. However, Cowan upped that to $10. Today's price: 2.24. I think even a first grader can see MNLO is VERY VERY UNDERVALUED.

Also see new article: https://seekingalpha.com/article/4349547-should-fda-approve-menlo-therapeutics-latest-therapy-shares-should-well

AVGR

Corona hurt Avinger a lot, but as the world goes back to normal, Avinger's sales should ramp up. This week AVGR filed a 510(k) with FDA for pre-marketing clearance of Ocelaris, a next generation chronic total occlusion (CTO) crossing system utilizing Avinger's proprietary image-guided technology platform.

Very interesting science. Dr. Joe turned me on to AVGR. He also owes shares. Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during an atherectomy or CTO crossing procedure by using an imaging modality called optical coherence tomography.

I've spoken to AVGR's CFO. They're a very committed management team and are regularly buying shares in the open market.

Latest PR: https://finance.yahoo.com/news/avinger-announces-510-k-filing-123000751.html

ARNA

ARNA is cooking. CEO Amit Munshi just cashed in around $3.5 million of stock options. Stock has gone to upper 50's due to a number of reasons including failure of competitor drug.


This is not an investment advice. Do your own research.

Best Regards

Reza Ganjavi


UPDATE 29 April 2020, Talk with CEO and CFO

As you read this, keep in mind that Merck's Keytruda generated $12 billion revenue last year and is projected to generate $22.5 billion in revenue by 2025 -- it's the top selling drug, and most successful oncology agent in world -- and Advaxis's drug makes Keytruda even better! 

On 29 April 2020 I got an email from Advaxis saying the CEO and CFO like to have a call from me. I knew why. I had voted NO on everything. They were obviously trying to get me to change my vote.

It was a pleasure speaking with Mr. Ken Berlin, and Ms. Molly Henderson.

They started home office before the NJ mandatory lock down. Everything can be done from home except lab work, the CEO said.

I expressed why I voted NO. I am not happy with the stock price / shareholder value which the management needs to drive. Though I know the CFO has done a good job of cutting costs, and they've made good progress. I don't expect management to do magic but I wanted to send a signal of my discontent.

CEO confirmed that the buck stops there. Him and the CFO and CMO joined the company about 2 years ago to focus the company and turn things around. He explained the two market opportunities, in prostate and lung cancer. Extending the cash runway allows the company to let the science show, generate data and prove that it works.

They asked me to reconsider the options plan since it's a way to get people from large pharma to join them. Without options, we can't attract the right people since we don't have the big cash to pay them.

I asked about partnership. He reiterated that Merck is their collaborator in the study that has shown some intriguing data in prostate cancer, by elongating life in advanced PC patients:

Median overall survival of 16.4 months for advanced prostate cancer patients with visceral metastases treated with ADXS-PSA in combination with KEYTRUDA® compared to an estimated 11 months with Standard of Care

Median overall survival of 33.7 months in all patients treated with ADXS-PSA in combination with KEYTRUDA®

[Excerpt] Feb. 13, 2020 -- Advaxis, Inc. (Nasdaq: ADXS) today announced updated results from the combination arm of KEYNOTE-46 (Part B), the Company’s ongoing Phase 1/2 study investigating ADXS-PSA with KEYTRUDA® (pembrolizumab) in patients with metastatic, castrate-resistant prostate cancer (mCRPC). The KEYNOTE-46 trial was conducted in conjunction with Merck and evaluated ADXS-PSA, alone and in combination with KEYTRUDA®, Merck’s anti-PD-1 therapy.

“The presented survival data in patients with visceral metastases strengthens our confidence that ADXS-PSA in combination with KEYTRUDA® has the potential to provide meaningful increases in median overall survival in patients with advanced, metastatic, castration-resistant prostate cancer. Importantly, these demonstrated impacts on survival have not been previously observed with immunotherapy in this advanced patient population..."

He confirmed they're in discussion with Merck about what to do next on the PC study.

He also explained the lung cancer study in combination with KEYTRUDA. First 2 patients have shown favorable results. UCLA etc. have seen good enrollment. If this works it's a big opportunity for patients and company.

A key upcoming catalyst is the data on the lung cancer study which should be coming in a matter of weeks.

Molly, CFO, said institutional ownership is around 20%.

Regarding IR, Molly said it's funny I mentioned LifeSci / proactiveness, since of the 5 companies she evaluated they're the most proactive. That's not been my experience. She said a factor is who you get (within LifeSci) and how you manage the relationship, to put it in my words. The cost is around 150k to 200k / year. They can hire someone internally for that much money.

She said institutions are heavily focused on data and Molly is focused on only spending money on value drivers, i.e., data.  She's had a number of calls with institutions, even during the shutdown. There's a lot of interest which is on the sideline. As the N gets higher on lung cancer, over 3 (now it's 2), institutions may take a more active role.

CEO said institutions have said, you have N=2, if you get some more, we'd be interested. So the upcoming data on more patients is critical. If the trend continues, with N growing, the company will be in a much better place. 

The first patients were on Keytruda for 2 years - the best response they got was the tumor didn't grow much and didn't shrink - it stayed the same.

  • With the first patient, after 2 years, the tumor started to progress. Advaxis succeeded to get the tumor to get stable again -- it stopped growing. Updated data coming in the coming weeks.
  • The second patient, 2 years on Keytruda, the tumor was stable. Advaxis made it shrink 60%.

Fingers crossed -- if we get the same results in a couple of more patients, limelight!

I asked about mechanism of action. CEO said the new data will help us understand the mechanism, which is very complicate, better.

I revised my vote. I voted YES for the stock options because the last plan is running out and we need to be able to offer our people options. I also voted YES for the CEO, and NO to everyone else. If this Board can drive shareholder value, I'll vote YES next year. In general I've not had a positive experience with Board who are usually overpaid and under-worked.

See: Corporate Presentation



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