jondoeuk
5月前
(OT) BlueSphere Bio, a T-cell receptor (TCR) T-cell therapy company utilizing a powerful TCR discovery platform to identify novel therapeutic candidates for patients with hematologic malignancies and solid tumors, today announced a strategic collaboration with the National Cancer Institute (NCI), part of the National Institutes of Health. The collaboration will seek to advance a novel TCR T-cell therapy targeting recurrent respiratory papillomatosis (RRP), a rare orphan disease.
Under the terms of a Cooperative Research and Development Agreement (CRADA), BlueSphere will collaborate with the Center for Cancer Research (CCR) at the NCI. The clinical studies contemplated under the CRADA will be conducted under the leadership of Clint Allen, M.D. and Scott Norberg, D.O. at the CCR, NCI. An earlier Material Transfer Agreement had granted BlueSphere access to HPV+ tumor samples collected by the NCI, with which BlueSphere leveraged its proprietary high-throughput TCR discovery platform, TCXpress™, to identify multiple TCRs with a high affinity for human papilloma virus (HPV) 6 and 11, strains of the virus intricately linked to RRP.'' https://finance.yahoo.com/news/bluesphere-bio-establishes-strategic-collaboration-140000958.html
jondoeuk
2年前
More preclinical data! https://www.abstractsonline.com/pp8/#!/10828/presentation/3388
Considering the other (preclinical) data for PRGN-3005, 3006 and 3007, I wouldn't read much, if anything into it. Also, by now, you would think that the company would have translational data from the two ongoing trials, which could help inform them as to why genes they might silence next, using (from memory) miRNA.
jondoeuk
2年前
JPM presentation https://investors.precigen.com/static-files/bd82c7b7-e8b9-4b19-be44-6a9de4165ae6
Some quick thoughts.
Slide 4: Despite AG019 being listed they did not provide an update.
Slide 8: The internal assessment leaves a lot to be desired. Focusing on iPSC-derived, it allows for a company to create multiplexed engineered, clonal master cell lines, which are a renewable source that enables routine, mass production of immune cells that are off-the-shelf (on-demand availability). Also, allows for broad patient access as it can scale. For example, FATE created over 300 doses of FT500 for around $3,000 per dose. PGEN on the other hand has never disclosed any (projected) COGM.
As for auto, GILD's Kite has a median manufacturing time (from apheresis to finished product) of 16 days in the US, but are hoping to reduce this to just a few days. BMY and others are following suit. For COGM (one paper puts it in the $160-170,000 range), it could be cut in at least half with automation alone.
Slide 11: Talk about apples to oranges! Not only do they compare auto to allo (both iPSC- and donor-derived), but CAR-T to CAR-NK as well! Typically, NK do not expand upon encounter with antigen and have (very) limited persistence.
Slide 12: If the depth and duration of response (from the dose expansion) is as poor as it has been no more time and money should be wasted on it.
Slide 15: Again, they have switched to giving the therapy via IV (plus LD chemo), so there is no known safety (on target, off tumour toxicities, CRS and/or ICANS) or efficacy profile. Also, the ORR (when given via IP) was zero. In addition, those treated at DL3 did worse (despite better expansion and persistence) than those treated at DL1 and DL2.
Slide 17: True, gene therapies have the potential to revolutionise medicine, but I very much doubt any company will be using the AdenoVerse platform to deliver them.
Slide 24: Totality of the data is what matters, not a single patient. I hope the update for PRGN-2012 isn't like the last time!
Slide 27: The ORR for the vaccine alone was zero. As for the combo, 30%, but just three out of ten. Based on that, they shouldn't have continued with the current trial.
Slide 29: Major milestones? The only updates for this year will be PRGN-2012 and PRGN-2009 (+/- M7824).
jondoeuk
2年前
PRGN-3005: They moved forward with testing DL3 plus LD chemo prior to IV infusion. Also, are able to incorporate repeat dosing. Based on the previous data, as well as this, I don't hold out much hope.
PRGN-3006: Another year has passed and only nine additional patients have been treated. Worse still, none have responded.
PRGN-3007: Not only haven't they dosed the first patient, but the trial isn't even listed on the clinicaltrials website.
Rubraquercus
2年前
The cash runway is now much longer with the sale of transova and a $100 million shelf with Cantor Fitz. Sadly, hell-in flat lied in the recent conf call about raising money, and then 24hrs later we get the shelf, unreal.
<<Jennifer Kim with Cantor Fitzgerald. Please go ahead.
Hey, everyone.... And then my second question is broader, with the Trans Ova divestiture, has anything changed in your mind in terms of portfolio prioritization and added flexibility to explore opportunities that you weren't able necessarily to consider beforehand?
Answer; As Harry mentioned, we have a solid runway well to the fourth quarter of 2023, which has allowed us to basically go through our – some of the clinical timelines that we have for reporting the data. And I think that's going to be very good. And we basically do not have to take anything from the financial strength that we have, or I should say the money that we have, currently that is dedicated to our clinical trial and be diverting this for our convertible notes. And that's – obviously it's a huge, I think, pressure off at this point, especially during this financial times and not diluting our investor base. So we are very happy about that.
We have prioritized portfolio as we have mentioned in our slides and according to the three pillar of a strategy that we have and we mentioned for instance, even in regard to our AG019, which is a very exciting program for a type 1 diabetes, we feel that this has served best with partnership, which the discussions on our partnerships are ongoing and we look forward to report on that in the near future.>>
jondoeuk
2年前
''Meanwhile, Precigen faces a different type of problem: a $201m convertible debt comes due for repayment in July 2023, but the group has just $142m in cash, and its market cap has fallen to $260m.
With little chance of an equity raise at the current valuation and in the current market Precigen has mooted selling off non-core assets to raise the necessary cash. Wells Fargo analysts suggest that Precigen’s lead Actobiotics asset, AG019 for type 1 diabetes, could be the first to go.
The company could also try to renegotiate the debt, but equity investors seldom come out well from such moves.'' https://www.evaluate.com/vantage/articles/news/deals/ataras-latest-setback-troubled-field
jondoeuk
3年前
Thanks. I had issues with the target for PGEN-3006, as back during an ISCT '17 presentation, Dr. Saar Gill suggested that just hitting CD123, or CD33 in AML was a non-starter, and smarter approach needed. Based on that and the comments from the PI, I think the company should discontinue the program.
jondoeuk
3年前
AG019: Doesn't work as well as some think, and would require much larger PhIIb (and possibly PhIII) trials. Resources the company probably doesn't have.
PRGN-3005: It has taken 2-2.5+ years to enrol not even half a dozen patients, with efficacy being very minimal (I'm being generous!). No patients have been enrolled in the IV arm (that I'm aware of).
PRGN-3006: While encouraging (in those that got the therapy with LD chemo), only a small number have been treated, and now the PI says it could be a bridge to a transplant.
PRGN-3007: The first patient hasn't been dosed. Also, it will face competition from the likes next-gen versions, such as LYEL's.
INXN-4001: Looks dead.
PRGN-2009: Mono is likely dead as not a single patient responded. As for the combo, too early to say, but the former should say it all.
PRGN-2012: Looks to me like they are trying to cherry-pick the best responses, as they didn't disclose the data from the others treated to date.
Finally, mbIL-15 isn't working as expected, and going forward, it seems they won't be giving the CAR-T's without LD chemo as they once hoped. Also, there is talk about redosing!
Oxonius
3年前
A reminder of the GenVec days:
Researchers Look to Reverse Hearing Loss With Regenerative Hair Therapy
Over 5% of the world’s population is affected by disabling hearing loss, a condition that is largely irreversible. One biotech company, Frequency Therapeutics, has set out to change that. The company’s scientists have found a way to help hair cells in the ear regenerate, in turn increasing a patient’s ability to hear. “[Hearing] connects people to their community and cultivates a sense of identity,” said one of the founders, Jeff Karp. “I think the potential to restore hearing will have enormous impact on society.”
So far, they have treated more than 200 patients during three clinical trials and are gearing up for another one with 124 people. Karp said he hopes this innovation will eventually make reversing hearing loss a simple, fast, and accessible procedure. Co-founder Robert Langer added: “Some of these people [in the trials] couldn’t hear for 30 years, and for the first time they said they could go into a crowded restaurant and hear what their children were saying. It’s so meaningful to them.”
make it happen
3年前
Negative triple digit percent profitability, high negative returns in all aspects, revenue per share $0.56 cents, huge debt over $184,000,000 and cash flow is negative $100,000,000. Hemorrhaging everything.
Profitability
Profit Margin -134.74%
Operating Margin (ttm) -89.28%
Management Effectiveness
Return on Assets (ttm) -13.45%
Return on Equity (ttm) -79.97%
Income Statement
Revenue (ttm) 97.85M
Revenue Per Share (ttm) 0.56
Quarterly Revenue Growth (yoy) -17.90%
EBITDA -72.59M
Net Income Avi to Common (ttm) -104.77M
Balance Sheet
Total Cash (mrq) 105.69M
Total Cash Per Share (mrq) 0.51
Total Debt (mrq) 184.12M
Total Debt/Equity (mrq) 105.33
Current Ratio (mrq) 5.71
Book Value Per Share (mrq) N/A
Cash Flow Statement
Operating Cash Flow (ttm) -65.66M
Levered Free Cash Flow (ttm) -34.93M
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