Did you expect the Avid BOD to be keyed into today's HALO news? I don't think Halo employees were clued in. I listened to Halo's update call. Their plans on restructuring are works in progress... they have lots of cash and they are trying to figure out how to give it back.... buybacks over three years is the plan... The plan to focus on Enhanze and expand that program...They did mention two key drivers waiting on FDA approval... Janssen Darzalex and the Roche Perjeta... also said expected inventory builds for clients... If anything the enhanze program expands.... Janssen has four phase threes in play including the one filed with FDA.... The halo commercial product was prob a year away from launching if it didn't fail. the readout was supposed to be in dec and then they would have to file which would have been sometime first half of year and then and await approval....

only comment made on today's halo update call related to manuf was in response to analysts question about cap ex moving forward. response was halo contracts for manuf so no cap ex for manuf and they expect inventory build for clients.

and focus on enhanze where avid is supplier... halo already recovering in sp...

Is the call in price $25 per share? It has been trading above par due to yield. Price could be a canary in the coal mine for redemption imo.... what if a thermo fisher type investment for shares to pay down preferred and fund expansion? .... everybody wins... fill finish biz/ other equip.... lots of opp for a thermo .....thermo just had cc... likes what it sees in cdmo market.... says it's healty and they said they look at it with many lenses given the biz at Brammer and Pantheon

https://finance.yahoo.com/news/edited-transcript-tmo-earnings-conference-142354421.html

"So our bioproduction business is doing great, right, and it really is performing at a very high level. Our customers appreciate the strong positions we have in cell culture media and single-use technologies where we're the industry leader. We had a great quarter, so that's continuing.

But in terms of how we see the market, we, of all the companies, probably have the best insight because we have our bioproduction business, which gives you one lens. We obviously have a biologics CDMO, which gives you another lens. And then we have these very deep relationships across the biotech and pharmaceutical industry. And what we're seeing is a very robust pipeline of activities. So we feel good about what the future holds."

agree and the catalysts imo will be fda/eu visibility on avid client submitted drugs from halo related products.... there are enough analysts following the company and industry... the Stephens analyst just put out a report on Catalent, the other halo manufacturer... so they can read the tea leaves and the tea leaves will be very public in terms of pdufa dates/approval etc... and the SC version of drug delivery is heating up... and given the comment from the ASM about manufacturing drugs upon approval to prepare for launch makes sense... i think you will see interest from the analysts on behalf of clients increase as the story unfolds (caveat if the story unfolds as i see it assuming the three commercial process validations completed amount to success)

also, with the WeWork bust, the unicorn aura is on the downswing.... capital will be chasing cash flow companies and not pipe dreams of cash flow companies

having several hundred mil in fed/state nol's combined with positive cash flow will be a good thing...

all imo

progress... slow but progress..

https://bioprocessintl.com/bioprocess-insider/facilities-capacity/avid-expands-californian-pd-and-lab-capabilities/

two new analysts this week

if you build it they will come... field of dreams

lately it has been field of screams..

looked at recent JNJ and Roche qtrly earnings presentations... both mention SC versions of drugs Darzalex-JNJ and the Roche perjeta/herceptin combo SC version (halo enhanze) being submitted to fda/eu for approval and are expected to be big rev producers... lots of eyes watching this unfold and heavy demand in place for both drugs with 4 hour infusion times cut to 5 minutes.... more eyes paying attention to all players involved ie Halo, Genmab etc and Avid...

all this should start gaining traction over the next six months all imo...

today is option exp day so anything can happen... can the seller of the calls put their thumb on the scale today? can the buyer of the calls do likewise?

Roche provides pipeline update Oct 16 2019

https://www.roche.com/dam/jcr:ee1e9c3d-cbcb-4fbd-ad4c-54e52c8bfe8d/en/irp191016.pdf

Page 23...H+P FDC-SC eBC, 1L HER2+ BC 2019/20

H+P FDC-SC is the halo product Avid produces

per Roche graphic, filing 2019/2020 and greater than $1 bil market opportunity

https://s21.q4cdn.com/250105458/files/doc_presentations/2019/09/Halozyme-Corporate-Presentation-September-2019-FINAL2.pdf

my experience w/ mgmt is double check.. the def of registrational is all over the place....

w respect to ongoing trials, oncologie along with merck just started a phase 2

https://clinicaltrials.gov/ct2/show/NCT04099641?term=bavituximab&rank=1

and oncologie announced first patient enrolled...

https://oncologie.international/oncologie-announces-first-patient-enrolled-in-global-phase-2-study-of-bavituximab-plus-keytruda-pembrolizumab-for-advanced-gastric-or-gastroesophageal-cancer/

so is there a milestone coming? mgmt will not respond to me... anybody else having trouble with responses?

analyst had good ratings in health care...

Craig-Hallum also has M&A Advisory group ... so mgmt is just a phone call away from help...

as the clouds clear with respect to rev visibility, the more institutional analysts covering, the more activity (one way or the other) in volume and SP... JNJ just reported and Darzalex is going strong... JNJ mentioned in highlights the FDA/EU darzalex sc (halo biz) submittals in July....

The fruit is starting to get ripe...

One other thing to think about... the hiring of Richieri as chief operations officer is what they needed .... I doubt they even try to get a ceo if they are thinking of buyout down the road which they should consider given too much biz will be concentrated with one customer ie halo... for a small company the market will take that into account... if Avid is just a division of a themo fisher, then there are all kinds of opportunity for add on value w/ larger bioreactors and fill finish opportunities.... and the rev concentration is a non issue...

And w/ Richieri's contacts w/ Samsung... Avid could be a great footprint for Samsung in USA to funnel biz to the big plants in Asia...

We have a company with both bod and senior mgmt wired into key players in an industry that is still consolidating and good biologic manuf target is a rare bird...

the one close to approval is janssen darzelex sc... filed a supplemental bla july 12... approval should happen soon imo....

https://www.jnj.com/janssen-submits-application-to-u-s-fda-seeking-approval-of-new-darzalex-daratumumab-subcutaneous-formulation

agree.... not pleased w/ current situation... hoping we are a buyout candidate now... even a hostile one ....

hard to provide guidance on drugs not approved yet and your next big revenue stream is hopefully manufacturing drugs not approved yet... see the slight problem?

I listened to the ASM..... basic blocking and tackling and building the biz... they have folks that know what they are doing and putting the platform together.... takes time but I think they are getting there.... my second take was there is no urgency to create a higher sp? no desire to promote progress of IP...

If you are setting up team w/ options and readjusting workforce participation per mention in last call, a lower sp works for the interim... given the past crew really took care of themselves in option land and avid was probably the red haired stepchild, it could be a smart move to get folks some equity going forward.... helps in retention also i think accumulation is going on while under the radar...

I heard confirmation of three commercial process validations... per last two cc's, they were completed for existing clients halo and roche... halo had three phase 3's close to the commercialization phase.... darzelex sc... filed w fda july, roche's phase 3 success and filing early 2020 and halo's own drug w/ celgene... readout in dec....

Darzelex is already a $4 bil drug w/ 4 hr infusion times... the sc version should fly of the shelves with 5 min infusion time and capture a big chunk of mkt share... and Janssen has 6 phase 3's with Halo going on and numerous other clients w/ trials...

So the real inflection point won't happen until more visibility on the halo activity.... given the mention of downstream capabilities with regard to client needs, fill and finish could be in the cards...

So we are six months out but we also have a larger institutional base and more analyst coverage that will sniff out the progress as it unfolds.. all imo

oncologie news...

https://oncologie.international/oncologie-announces-first-patient-enrolled-in-global-phase-2-study-of-bavituximab-plus-keytruda-pembrolizumab-for-advanced-gastric-or-gastroesophageal-cancer/

“Initiating our first sponsored trial is a key milestone for Oncologie as it represents and highlights the progress we’ve made this year,” said Laura E. Benjamin, PhD, President and Chief Executive Officer at Oncologie. “This Phase 2 study is intended to further evaluate the antitumor activity and safety of bavituximab plus pembrolizumab in a gastric cancer population. We look forward to evaluating the potential this combination may provide globally.”

good reason for some IP questions at the ASM... milestone questions anyone... Laura thinks it's a milestone...

we know from contract payment due within 30 days of milestone achievement...

overall status of IP and relationship... manuf biz if any... etc...

the milestone payment could be only twenty dollars so the impact is yet to be determined.... my guess and this is a wag is that it is at least $2 mil based on 9 potential milestones totaling $95 mil .... granted the higher milestones are geared towards phase 3's and fda submittals/approvals etc...

yes... and the "soft" 2nd qtr could change quite easily with a milestone payment.... given the timing of merck trial start of sept 23 date and 30 day milestone payment timing, will the milestone come qtr 2 or will they move it to qtr 3? Even a $2 mil milestone is equivalent to $10 mil in rev from manuf using a 20% margin... Don't know what the milestone would be but we know $95 mil in total milestones... it should have an impact...

Shareholders at the ASM should press mgmt on the IP updates... mgmt seemed to have buried the IP as if has no impact on the value of AVID... just disclose the facts and relationship, particularly when Merck has three phase 2 trials going on with bavi.... they must be seeing something...

68% naked short... good volume and up for the day... accumulation?

halo presentation...

lots going on...

http://wsw.com/webcast/cantor10/halo/index.aspx

one of the reasons BP going with enhanze is patent extensions on existing blockbuster drugs coming off patent ... coformulation patents (can add 20 yrs) ... about 16:30 time on presentation...

darzalex fda app filed july has 6 phase 3's going... roche filing early 2020... and halo w/ celgene... ready to go with commercial side if approved... readout in dec .... she mentioned trial with two already approved drugs and biomarkers used to screen patients ...

avid could get pretty busy in the next 6 months...

I listened to the halo wells fargo presentation... the addition of enhanze to roche's blockbusters that have come off patent are a key strategy that many of the bp's are following....

https://s21.q4cdn.com/250105458/files/doc_presentations/2019/09/Halozyme-Corporate-Presentation-September-2019-FINAL2.pdf

look at page 4 of their presentation...

the ceo talked about the interest from bp's...

not only does the combo make the drug better, it makes it easier to deliver... minutes vs hours of IV...

Halo is going to be very busy .... darzelez sc in front of FDA now... roche's trial was success w/ plans to file with fda... halo's own product w/ celgene combo trial results soon...

Avid completed three commercial process validations for halo per previous two cc's

given it will most likely be a combo drug, there is a chance the clock could restart with the combo... halo's enhanze is doing that for some roche drugs past patent exp

73% naked short today

https://nakedshortreport.com/company/CDMO?index=PPHM

just pointing out what was stated on the last cc in q&a part

Last comment... Rev for Q2 ending Oct 31 per conference call was predicted to be light given maintenance shut down.... how will rev and eps change if milestone pmt for qtr 2 ending Oct 31st? A milestone flows right to bottom line ....

interesting times.... no wonder the hit piece from zacks...

One other thing.... one of the items on the shareholder proxy is to amend employee stock plan at the ASM Oct 9th ... so do we need to wait until the table is set before the meal is served? no complaints just watching the events unfold... human nature is human nature...

Given the new bavi trial is recruiting and the contract between Avid and Oncologie states a milestone payment be made within 30 days. So when is the technical start date? Posted on clinicaltrials.gov on Sept 23.

https://www.clinicaltrials.gov/ct2/show/NCT04099641?term=bavituximab&rank=1

From the contract:
https://www.sec.gov/Archives/edgar/data/704562/000168316818001961/avid_ex1011.htm

Milestone Payments. One-time payments upon the achievement of the milestones (each, a “Milestone” and collectively, the “Milestones”) described in this Section 3.1(b), by wire transfer of immediately available funds within thirty (30) calendar days after the achievement of each such Milestone (each, a “Milestone Payment” and collectively, the “Milestone Payments”):

And we know all 9 milestones have been blanked out for confidentially reasons.. (keep potential acquirers in the dark to stay below radar? ... do another underhanded deal with the rights to the IP?)

So the question is whether starting a phase 2 is a milestone? If so, how much. We know when it is supposed to be paid.

IMO I would call this a milestone likely on the blanked out list. And a material event given zero value is associated with the IP at this time. Mgmt has been sent several emails by several folks pointing out the trial start and importance of the IP to company value and the lack of support thereof.


So by Oct 23 (assuming the start date is milestone date) IMO mgmt will need to disclose milestone payment. The ASM is Oct 9th so we may not hear anything. I would think it would be a topic of discussion at the ASM and I would encourage attendants to ask the tough question. I also think mgmt needs to be aware of the lack of "coverage" of the IP on the cc's.

Doing some research I came across a few articles which included discussions of milestones: Here is a typical example:

https://bioscibd.com/biopharma-milestone-payments/#1

Our definitions of the various financial terms utilized in this analysis are as follows:

Total Development and Regulatory Milestones (Total Dev/Reg) – the total milestone amount to be paid to the licensor through launch in all jurisdictions for the first product indication (sum of 2-12 below);
IND Filing – payment on Investigational New Drug filing, typically with the FDA;
Phase I Start – payment on first human treated in a clinical setting;
Phase II Start – payment on commencement of a human clinical trial to determine safety and preliminary design of additional efficacy studies;
Phase III Start – payment on commencement of a pivotal human clinical trial;
FDA Filing – payment on filing of a New Drug Application with the FDA;
1st Approval – payment(s) on FDA or other 1st major market approval and/or launch;
EU Filing – payment on filing of a marketing approval application in the EU;
Major EU Approval – payment(s) on EU approval, pricing and/or launch;
Japan+ Filing – payment on filing of a marketing approval application in Japan or other Asia;
Japan+ Approval – payment(s) on Japan or other Asia approval and/or launch;
Other Dev Milestones – typically payments on early R&D, toxicology, development candidate designation or license option exercise;

back to 70% naked shorting.... the zacks art was meant to shake shares free.... good try.... all is good... hang tight...

agree.... when a $1.3 mil "miss" on earnings due to a one time severance payout causes a $100 mil plus drop in market cap (22% change in value on one day), mgmt can't make a claim that the IP is not material to the value of the company. Particularly when Merck has three ongoing trials with bavituximab which are all phase 2. In addition Oncologie bought the rights to varisacumab (r84) from Avid:

https://oncologie.international/our-pipeline/varisacumab/

In addition to the $95 mil, Avid can get up to $21 mil in milestones from r84 drug and royalties as well.

From annual report:

I cannot find any PR in Sept or Oct 2018 mentioning sale of r84...

http://ir.avidbio.com/static-files/62a843b4-8779-47fa-91c2-75fbcae06828

As a result of the sale of our r84 and PS-targeting technologies in September 2018 and February 2018, respectively (as described in Note 10 to the
accompanying consolidated financial statements), the abandonment of our remaining research and development assets, and the strategic shift in our corporate
direction to focus solely on our CDMO business, the operating results of our former research and development segment have been excluded from continuing
operations and reported as income (loss) from discontinued operations, net of tax, in the accompanying consolidated financial statements for all periods
presented. The gains of $1,000 and $8,000, respectively, which were recorded in connection with the aforementioned sales of our r84 and PS-targeting
technologies, which are included in income (loss) from discontinued operations, net of tax, in the accompanying Consolidated Statements of Operations and
Comprehensive Loss for the fiscal years ended April 30, 2019 and 2018, respectively.

agree... the previous ISS score for PPHM was 10 (worst a company could get) based on BOD composition, independence, compensation. Along with the poison pill was the golden parachute issue. The old BOD and mgmt thought they were the untouchables. Even the settlement in DE court allowed them to keep the BOD like it was until bavi approval (which was years away). BTW I submitted a response to the court which was referenced by the judge.

The damage by the old BOD by not expanding the BOD really hurt the advancement of the IP imo.

My concern now is the new BOD has no mention of the IP assets on the website. Granted the IP needs further development but I believe the asset or rights to the $95 mil in development milestones and mid teen royalties are material to the company's value.

IMO mgmt needs to be pressured into disclosing the relationship on the website. Several folks have tried with very lame responses. (or no response at all)

For some reason mgmt is not representing the complete picture of the companies potential value. Why?

oncologie news from their china website... might have to use the translate feature...

https://dinghangyiyao.cn/xwg/info.aspx?itemid=94

on another note, now that the poison pill is gone, look for the games to start... i don't think mgmt is going to help the retail shareholders.... hang on to your shares... the float is shrinking and they (mm's and accumulator shares) will have to work hard to get shares imo...

imo there has been no effort to support share price by mgmt (listen to last cc) nor associate any relationship of the potential monetary benefits of the oncologie relationship.... where on the website is any mention of the oncologie relationship or link to oncologie? just the potential milestones of $95 mil can add up to $1.70 per share or 29% of current share price. mgmt needs to know enough shareholders will not be screwed this time around.

new bavi trial recruiting...

https://clinicaltrials.gov/ct2/show/NCT04099641?term=bavituximab&rank=1

oncologie and merck sponsors...

milestone payment coming? when and how much?

may explain the 86 k block premarket and 162 k after mkt... will be interesting to see finra naked short numbers today

weren't that many options open across the board that were in the money...

my guess is accumulation by someone....

tell that to USCF... and Merck

http://cancer.ucsf.edu/gi/clinical-trials

CC#194514: A Phase 2 Multicenter, Open-Label, Non-Randomized Study of Bavituximab Plus Pembrolizumab in Patients with Advanced Gastric or Gastroesophageal Cancer Who Have Progressed On or After At Least One Prior Standard Therapy

yes very much so...

look at page 29...

http://d18rn0p25nwr6d.cloudfront.net/CIK-0001159036/00137d05-411a-4336-984f-57559985ccc0.pdf

this is one of the three validations Avid mentioned in last two cc's... all three related to halo (read the last two cc's... they don't spell it out for you)

given they only had three trials close to commercialization and thus needing commercial process validation, they have two ready for approval... janssen filed for darazlex in july, now roche will file on perjeta/herceptin and halo is waiting for results in dec for their product/abraxane..

the info you provided explains this... Peter on both boards htg and oncologie...

https://www.htgmolecular.com/news-events/2018-08-03/htg-molecular-diagnostics-and-oncologie-inc.-complete-master-agreement-to-partner-on-biomarker-development-for-immuno-oncology-drug-development

imagine a board member connecting with someone else in the industry and bringing parties together to advance something...

we had es, cj and yes dp shoppling sound systems... imagine if we had a legit bod with connections and experience... Thorpe's work was basically thrown down the drain because these guys wanted to protect their gravy train...

it was not added... they talked about planning for expansion and the use of the space including additional downstream capability (fill/finish? which would make sense for commercial production)... if i can recall lias said in a presentation the new space can add $100 mil in manuf revenue and the process dev (PD) can add rev as well... i want to say lias wanted to see 25% to 30% rev coming from PD... if they do fill finish it would prob eat into manuf capacity but produce revenue from fill finish...

note catalent is expanding the old cook facility in bloomington as we speak...

tee this sucker up and sell ... and imagine the margins and EBITA if you don't need all senior mgmt overhead if it is just another plant in a larger CDMO portfolio.... they don't need a CEO and they know it imo...


more pr from oncologie

https://www.fiercebiotech.com/biotech/oncologie-reels-80m-to-push-clinical-programs-build-pipeline