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Post by JHam on Jul 16, 2019 2:32:17 GMT
About the Sanofi collaboration, from an interview last year: www.lsxleaders.com/blog/dyadic-international-working-to-change-the-game-in-biopharma-manufacturing"Dyadic has established a number of industry partnerships to explore the potential of its technology across different healthcare applications. In September 2018, it announced a proof-of-concept research collaboration with Sanofi-Aventis Deutschland GmbH, part of the Sanofi group, to examine the potential of the C1 platform to express multiple genes for vaccine and drug applications. The research is due to conclude in 2H19."Then the latest about Sanofi from Mark on the last call: "The Sanofi-Aventis project started in October 2018; we continue to be encouraged with the results and progress we have achieved to-date in our research collaboration with Sanofi. The expression levels for several of the Sanofi targeted proteins have already exceeded the target levels we were initially providing, and we believe that significantly higher expression levels can and will be achieved. We continue to receive very positive feedback during our bimonthly or monthly conference calls related to the data and results presented during these calls with Sanofi. Overall, we believe that program is going well and hope that this will lead to an expanded research collaboration and an eventual opportunity to license the C1 gene expression platform to Sanofi."
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Post by lcd on Jul 16, 2019 14:35:04 GMT
I wasn't expected the pps to dip below $5 so I increased my position by about 50% at $5.06 this morning. I could have saved a few dollars if I waited but I did significantly lower my average.
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Post by selluwud on Jul 16, 2019 15:18:11 GMT
Very tempting to add, but I've got all I want to risk already invested. Will wait it out.
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Post by actcrazy on Jul 17, 2019 2:05:28 GMT
I accumulated a big for me core position here and a medium size trading pile. I will hold off trading till north of 8.2 my core is staying put for a couple years unless bought out. The rest of me has gone to pot. GLTA
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Post by JHam on Jul 17, 2019 2:33:49 GMT
I don’t have much cash available at the moment, so I’m debating whether or not to do some pruning of other stocks or send some “reinforcement” cash to my Ameritrade account. I have a pretty solid position, but hate missing out on these dips.
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Post by JHam on Jul 17, 2019 22:36:17 GMT
Still looking to add here. I’m not totally convinced that this down spin is finished yet. It’s like trying to catch a falling knife. The volume drying up today is a good sign though that the end is near, imo.
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Post by actcrazy on Jul 18, 2019 2:24:55 GMT
That knife is so sharp it cut right thru my words, that I was done buying. Note; sold more GE to put here and a little pot stock. New avg. DYAI 5.5 even. If this drops much further....I'll do it again. Best to all here!
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Post by JHam on Jul 31, 2019 1:21:01 GMT
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Post by JHam on Aug 14, 2019 0:48:08 GMT
Very good call today. Here are some highlights:
・On August 12, 2019, Dyadic signed a fully funded research collaboration with a top tier pharmaceutical company to express three different types and classes of proteins. Has the potential to be huge.
・Balance sheet remains a source of strength with approximately $38.8 million in cash and investment grade securities, no debt and complemented by partner funded on-going R&D collaborations.
・"Based on the number of additional non-disclosure agreements we have signed year to date and our ongoing discussions with several pharma and biotech companies, we look forward to sharing additional new developments as the second half of the year unfolds"
・Entering the second phase with Sanofi
・They hope to have good news on glycolic engineering by end of this year or 1st quarter 2020
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Post by JHam on Aug 14, 2019 0:49:34 GMT
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Post by JHam on Aug 14, 2019 0:54:23 GMT
This is what was said about human-glyo:
"We hope by the end of this year or Q1 to be able to announce that we have reached that human life G0 human life glycosylation pattern that would be a major milestone"
This would be HUGE. It would greatly add to the value of the C1 if they could do this.
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Post by tailwindsresearch on Aug 14, 2019 3:54:50 GMT
Hey all, Dan from Tailwinds here. Just joined the group. Interesting discussion on DYAI. The call was excellent today. Suggest you listen to the replay when you have the time.
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Post by actcrazy on Aug 14, 2019 4:22:25 GMT
Welcome here Dan! Your input is much appreciated. Will listen to replay soon. Thanks!
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Post by JHam on Aug 14, 2019 10:45:50 GMT
Hey all, Dan from Tailwinds here. Just joined the group. Interesting discussion on DYAI. The call was excellent today. Suggest you listen to the replay when you have the time. Dan, thanks again for joining (already thanked you once in the CATS forum 😅). I agree, this call was really good. Lots of info garnered during the Q&A. I’m gonna jot down a few more highlights in a little bit, but hope that everyone interested in this company takes the time to listen to this call.
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Post by JHam on Aug 14, 2019 11:39:18 GMT
A few more important notes from the Q&A session:
* Ping said that she anticipates the already-good cash position to increase *this year* due to a) improvement in interest rates (DYAI invests most of their cash in securities and corporate bonds) and b) Future licensing agreements/collaborations. She also said due to the AMT tax credits elimination they have already received a half-million dollar refund.
* This dialogue between Mark (CEO) and an analysts says it all:
Ahu Demir “...I know you don't give guidance, but when do you expect to get milestone royalty payments do we expect that to happen in 2020 or is it going to be further along in the year?”
Mark Emalfarb Well, we hope to get at least one if not more research license and potential commercial license or a research license with an option for commercial license from one or more of these agreements either with Sanofi or one of the ones we just signed. The one we signed this week, for example, so we have our fingers crossed it will be in 2020, it's possible it could be this year. We could be surprised but we will see.
* Per Mark. A lot of the projects they are working on with collaboration partners, like Sanofi, are situations where the partner cannot move forward with the current standard (CHO). If DYAI “can open up some of those doors, just one or two of those, that would be just revolutionary for everybody and create a lot of value for Dyadic and bring medicine to global population that otherwise won't get there, let alone cost advantages.”
* By working with Serum, a lot of potential institutions, like the NIH, and foundations, like the Gates Foundation, have their eyes on DYAI - which can potentially help in the future for funding. Mark even threw us a bone by saying; “And we might have actually met with some of them in conjunction with that Serum deal and otherwise.”
* DYAI works on their own terms when it comes to signings NDAs. They are in the driver’s seat and reject deals with companies who don’t have the funds to see a project through to the end. They only need to work with the people already in the pipeline and realize those deals in order to be successful. The groups they are working with want to work with microorganisms and get off of CHO.
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Post by JHam on Aug 14, 2019 21:56:47 GMT
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Post by JHam on Aug 20, 2019 5:01:38 GMT
Nice movement over the past few days, with really good volume today. Institution ownership has also grown as well.
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Post by JHam on Aug 21, 2019 1:13:38 GMT
Another big volume day today, although we went the wrong direction. There is some speculation swirling around that Thermo Fisher could be the new partner that was announced the other day. I think it is plausible because on the call Mark said that Serum as well as this new partner cannot continue forward with CHO and are "running into bottlenecks" to cure disease. So they need a new system. This seems like it would fit with what Thermo is doing right now. Also, fueling the speculation, DYAI and Thermo are doing a joint presentation on Sept. 10th at BioProcess International in Boston. Mark has talked about how one of these new partners could eventually acquire DYAI if they have success with C1. He also said this new partner is a top tier big pharma. Thermo had $20B in revenue last year so I don't think the speculation is unfounded.
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Post by JHam on Aug 22, 2019 4:21:55 GMT
Here's a good article from last year I just came across on the status and future of CHO and Dyadic's game changing potential: www.biocompare.com/Editorial-Articles/353588-CHO-Cells-Beginning-of-the-End-or-End-of-the-Beginning/... While it’s too early to predict that CHO’s days are numbered, the biopharmaceutical industry is clearly looking for a next-generation expression platform to address sky-high production costs. In a July speech at the Brookings Institution, U.S. FDA Commissioner Scott Gottlieb, M.D., criticized biopharma on several points: “Less than two percent of Americans use biologics, but they [the medicines] account for 40 percent of total spending on prescription drugs. They also represent 70 percent of the growth in drug spending from 2010 to 2015 and are expected to be the fastest growing segment of drug spending.”
Regulators are not the only ones dissatisfied. Last year, Biogen’s vice president of international manufacturing, Eliana Clark, explained that her company was looking for alternatives to CHO. “How do we really lower the cost of manufacturing to a place where we can actually make affordable medicines for people? We did a lot of modeling with MIT, and we realized the CHO cell line won’t get us there.”
Meanwhile, Biopharma Reporter’s 2017 survey suggests that nearly half of biomanufacturing experts believe that the industry is “too reliant on Chinese hamster ovary expression systems.”
Alternative expression hosts
Over the years numerous protein expression systems have cropped up, each promising untold efficiencies, cost- and time-savings, improved patient safety, and access. Among the more interesting is the C1 system from Dyadic, based on the fungus Myceliophthora thermophila.
(read the article for more on Dyadic)
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Post by JHam on Aug 22, 2019 4:35:58 GMT
This bit right here is the crossroads we're at. Once there is some success (even one) with current big pharma collaborators and their use of C1, then I believe we start to see the true valuation of DYAI realized in the market:
Unsurprisingly, Freeman is less sanguine about wide-scale adoption of CHO alternatives. “Any new entrant to the market would initially need to demonstrate that it can generate safe therapeutics that are acceptable to regulators. They must also demonstrate that any benefit is significant enough to warrant changing their manufacturing platform.”
...
This is exactly what DYAI is doing.
A good place to begin, Freeman says, is for products for which CHO is unsuitable, which would allow time and create the imperative for processes and regulators to adjust. “But this will take time. Many systems have been proposed over the years, from insect cells to modified yeasts, but the benefits have never proven significant enough to displace CHO, which is still the first port of call for producing complex biotherapeutics.”
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