Things aren't that bad!!!

Excellent post Gumnut

A very constructive point of view

I have taken the liberty of reposting with a new subject title

Hope you don't mind

Hi Teddy

I haven't looked at hotcopper for a while, or contributed. I looked just now and reading your (and others) recent posts, one could be led to believe that the world is about to end for SPL! That they are on very shaky ground! What a load of nonsense! You word it cleverly (you may claim you are only playing devil's advocate) but the tone is overwhelmingly negative.

I think too many people are panicking about a low share price and overlooking the fact (IMO) that the fundamentals for SPL are still, overwhelmingly, extremely positive! Share prices can quickly correct themselves when positives come to light.

I am not happy at all about the progress of BV and the pitiful sales (so far) nor about the rollout of Viraleze (so-far) compared to what may have been achieved. I am very disappointed with Mundipharma. Mundipharma will have had difficulty promoting the product during the pandemic through traditional methods (ie. reps) but should have pivoted and put more resources into other ways. Moving on to other poster's recent gripes, I also think management have been very well rewarded with base salaries and should not be paying themselves bonuses until we have a profitable company, deserving of bonuses. (I have no problem with the bonuses paid to the staff, they have been working incredibly hard - there is plenty of evidence for that - and, IMO, they are very deserving). There are other things I am not happy about, as well (eg. lack of sense-of-urgency to get programs up and going - such as the eye drops).

The fact is, we aren't privy to exactly what has gone on with Viraleze or with Vivagel BV. The company has been dealing with government regulators and such people can be pedantically painful. It once took me 18 months to get a simple driveway design approved by a local government authority! There are political forces at play as well. They likely have made a lot of mistakes but, looking forward, nothing that can't be overcome. I agree the company should come clean on several issues where things haven't gone well. The company is very secretive, as we know, and there is still time yet, to surprise on the upside (a BARDA Viraleze collaboration? for example) in the short term. In the very short term, we have the announcement about Omicron testing to look forward to.

In the long term, both Viraleze and the BV gel are, IMHO, excellent products that should turn out to be good earners for the company, with the eye drops eventually coming on line as well. The word will eventually get out that there is a non-antibiotic treatment (and preventive) therapy for BV, which is an incredibly common condition. I have direct (anecdotal) experience with prescribing Fleurstat BV gel for patients - it works very well, with good patient feedback - so there is nothing wrong with the product! We must all remember that COVID is here to stay - likely forever - with endless variants yet to emerge. Look at influenza A. Today's variants of influenza A are direct descendants of the Spanish Flu pandemic virus over 100 years ago! Even without COVID, there is a huge, ongoing, global market for antiviral nasal sprays for other respiratory viruses and I think ours is looking like one of the better ones being developed, if not the best (see below). Actually, I remain quite positive about Viraleze in the short to medium term. I can see it turning Starpharma into a cash-flow positive biotech in the coming year. What is not to like about that! Sure, it isn't earning 10s of millions (yet) due to a slower start than we all would have liked, but it is still a very positive thing for the company.

(My speculation) I also strongly suspect that Viraleze could be a brilliant product, not just for preventing/treating early respiratory viral infections, but also, with it's reduction in viral count in the nose, thereby reducing inflammation, as well as its action of blocking adherence of bacteria to human cells (how it treats/prevents BV) it is likely to be useful in preventing and treating sinusitis. This is yet to be tested but I am quite confident about this. It probably would not need to be tested, people would work it out for themselves. Recurrent sinusitis is a huge problem for many people and a MASSIVE market.

------------------------------------------------------------
Expanding upon the above, I believe that Viraleze is looking like the best / one of the best of the nasal sprays:

- Broad spectrum antiviral. UNLIKE monoclonal antibody nasal sprays, which would need to be constantly changed to keep up with variants

- Affordable. UNLIKE monoclonal antibody nasal sprays

- Much more effective - virucidal - than the seaweed sprays (see tests released by Starpharma)

- Viraleze should not significantly adversely impact nasal flora (as it was shown not to adversely affect vaginal flora in the trials on BV gel) . UNLIKE the more disinfectant-type action of the SaNOtize and Firebrick nasal sprays. This is a very important point that should not be overlooked as one should be reluctant to use such sprays regularly. Indiscriminate killing of local, friendly, flora is not a good thing for the body. Invariably, unfriendly organisms (bacteria, fungi) can then move in and cause ongoing problems. This is why vaginal douching is a bad thing (just one example) and using Firebrick or SaNOtize sprays is effectively nasal douching with a disinfectant product. There is widespread understanding of this issue amongst medical professionals and consumers these days. This can (and should be) a point-of-difference when advertising Viraleze compared to these other sprays (as with BV gel compared to antibiotics or vaginal douching).

- I cannot imagine that the SaNOtize and heparin sprays could not increase blood noses. (NO causes blood vessel dilation and, therefore, likely increased risk of bleeding and heparin is an anticoagulant!) Epistaxis is a side effect of many nasal sprays. Even if the increase in epistaxis amongst users of these sprays is not that high, I think it could adversely affect their brand, as people will surely make the same links regarding cause/effect and complain.

- I like the Viraleze name and packaging! I think it should sell well!
---------------------------------------------------------

And then there is DEP!.....

The DEP portfolio is what we can all be extremely positive about! We just have to wait a bit longer for the company to close some deals. There is absolutely nothing to suggest the DEP might 'turn to crap' as you state as a possibility in your last post. Of course, nothing is certain 100% in drug development (all investors should invest in biotech with caution) but there has been nothing but extremely positive news about all DEP candidates from preclinical studies right through to phase 1 and 2. Sure, it has taken a long time, but that IS an almost-certainty in biotech - that things take longer than we all might like.

May I remind everyone that the DEP versions of Docetaxel, Cabazitaxel and Irinotecan have shown clear indications to be:
(this would apply to DEP Gemcitabine as well)

- safer, with less side effects (able to be used in a wider variety of sicker, older patients not able to tolerate original drugs = bigger market)

- More efficacious. See preclinical studies and the amazing case studies released. (likely to allow patients to live longer, receiving more cycles. Expanded use to wider range of cancers = bigger market).

Remember, Docetaxel earnt over $US 3 billion dollars in 2011 prior to coming off patent. I think Cabazitaxel earnt close to $US1 billion annually, from memory (i can't find my reference just now - forgive me for any inaccuracy). What could better versions of these drugs, used more widely than the originals, earn in today's dollars? I don't know the answer but it is likely to be much higher.

They are also improved versions of extremely widely used, very well known drugs. (Well known to regulators assessing the new versions of them, to clinicians considering using them and insurers and governments paying for them) so I think that they will quickly be accepted as a safer, better alternative to the original drugs and quickly replace them in standard chemotherapy regimes. Safer drugs, with less side effects, should be embraced by insurers (not shunned, as suggested in one of Teddy's nonsense posts some time ago!) as, although they might be paying a premium, there should be huge savings to be had from less toxicity (eg. avoiding SEs such as febrile neutropenia from taxanes, severe diarrhoea from irinotecan requiring hospitalisation) and with the smaller volume IV infusions without the need for co-infusion of detergents (with side effects, one of which is life-threatening anaphylaxis)

DEP positives to look forward to in the medium term:

- (speculative possibility) From left field, a Big Pharma could launch a takeover bid at any time wanting the entire DEP platform and pipeline (likely prompting other competitive bids and a bidding war). This is my least preferred outcome, but it is quite possible.

- (likely 1H 22) signing a deal with a Big Pharma to licence one, two, or three of our internal, currently phase 2 assets. The company has been sharing the information with potential suitor/s for a while now (first mentioned at the AGM, I think, from memory). Who knows, their might also be interest in licencing DEP gemcitabine, as well, at its earlier stage of development, based on preclinical data. It is possible. What do people think the share price will be when this happens!? ( I am extremely confident this is a when not an if and could happen any time this year, perhaps soon).

- (likely this year) A further deal (perhaps licence deal) with Merck to develop Starpharma ADCs. Merck has been testing Starpharma-produced ADCs for 12 months now (they likely had access to pre-clinical data well before that time, in the leadup to the agreement)

- Astrazenica milestone payment for AZD0466 officially moving to 'phase 2'. Currently in a 'phase 1/2' trial, so I don't know when this milestone will be reached, but likely this year. Perhaps soon. It should be a lot higher than the $US3million phase 1 milestone payment.

- Astrazenica licencing further DEP candidates. They did sign a multi-product licence some years back to develop new DEP drugs. They are clearly very happy with the first one, AZD0466, so it is time to now reveal the others!

- Astrazenica licencing the DEP version of their blockbuster drug. They have been doing preclinical testing for long enough now for this to emerge from the shadows!

- Further DEP deals with other Big Pharma revealed (currently secret, undisclosed partners coming out of the shadows)

Regards to all!

Gumnut