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Sunday, July 21, 2024

Damaged Biotech, Quirky Accounting, Potential Worth Nuggets


The dumpster diving continues, this one is a bit messier and riskier.

Pieris Prescribed drugs (PIRS) is a medical stage biotechnology firm focusing on remedies for respiratory illnesses and most cancers indications.  In late June, the corporate introduced that their companion, AstraZeneca (AZN), of their lead product candidate, elarekibep, discontinued its Part 2a trial and this week we came upon that AstraZeneca additionally terminated their R&D collaboration settlement with Pieris.  Getting a learn out on elarekibep’s Part 2a trial was the corporate’s prime strategic precedence, a lot in order that they restricted funding of their different belongings, now with out that partnership, the corporate is left in a troublesome place the place they’re burning money and may’t elevate capital within the present surroundings.

In comes the strategic alternate options announcement the place they disclosed a 6/30 money stability of $54.9MM and a discount in workforce of 70%.  The CEO’s (4.8% proprietor) feedback have been fairly particular:

“We’re pursuing strategic choices throughout three foremost areas following the latest developments which have impacted our capacity to independently advance our respiratory packages,” commented President and CEO Stephen Yoder. “One monitor is accelerating partnering discussions of PRS-220 and PRS-400. A second focal space is diligently choosing the absolute best growth companion and deal construction to re-initiate medical growth of cinrebafusp alfa, our former lead immuno-oncology asset, which has proven 100% ORR in 5 sufferers in a HER2+ gastric most cancers trial that was discontinued for strategic causes. Third, we are going to discover whether or not our stability sheet, place as a public firm, and different belongings are of strategic worth to a variety of third events.” Mr. Yoder continued, “Whereas the challenges we not too long ago skilled throughout our respiratory franchise have compelled us to make very troublesome personnel selections, I can not specific sufficient gratitude to our departing colleagues for his or her dedication, collaborative spirit and integrity.”

I recognize the honesty of “place as a public firm” being of strategic worth, that factors to a reverse merger being excessive on the record, which is not ultimate.

Pieris has plenty of partnerships, along with AstraZeneca, Pieris has present collaboration offers with Genentech (now a part of Roche), Seagen, Boston Prescribed drugs and Servier.  These are along with the belongings talked about within the above quote.  PRS-220 and PRS-400 are wholly owned and managed, PRS-220 is at present in a Part 1 trial in Australia and PRS-400 continues to be pre-clinical.  Plus they’ve cinrebafusp alfa (do not ask me to pronounce that) which beforehand had a profitable Part 1 examine, they have been initiating a Part 2, however stopped to redirect company sources to the failed AstraZeneca program.  In PIRS’s personal phrases within the newest 10-Q, earlier than the strategic alternate options announcement:

In July 2022, we acquired quick monitor designation from FDA for cinrebafusp alfa. In August 2022, we introduced the choice to stop additional enrollment within the two-arm, multicenter, open-label part 2 examine of cinrebafusp alfa as a part of a strategic pipeline prioritization to focus our sources. Cinrebafusp alfa has demonstrated medical profit in part 1 research, together with single agent exercise in a monotherapy setting, and within the part 2 examine in HER2-expressing gastric most cancers, giving the Firm confidence in its broader 4-1BB franchise. In April 2023, medical knowledge displaying an unconfirmed 100% goal response fee and promising rising sturdiness profile was offered on the American Affiliation of Most cancers analysis annual assembly. These knowledge supplied encouraging proof of medical exercise for this program and we’re contemplating a variety of transaction to facilitate the continuation of cinrebafusp alfa, together with an immuno-oncology centered spinout to conventional partnering transactions. 

Between the strategic alternate options press launch and the language within the 10-Q, it does not seem Pieris is simply starting the method, however fairly they have been in search of methods to lift capital all alongside by promoting these three belongings (as a result of they wanted money to get to their earlier mid-2024 AstraZeneca readout timeline), right here there is likely to be faster asset sale catalyst than others within the damaged biotech basket.

However as typical, I’ve no actual ideas on the science behind any of this, however among the many partnerships and the wholly owned packages, there is likely to be some worth nuggets above and past the money on the stability sheet.

The partnerships do create some quirky accounting. Pieris has acquired upfront funds in every of those offers for the licensing rights and a few R&D collaboration on future growth, they account for the upfront fee by making a deferred income line merchandise for the income acquired however the place providers have not been carried out (like R&D spend).  Whereas this exhibits up as a legal responsibility, as you learn via the prolonged description of every partnership, it seems (be happy to push again on this) like their companions cannot claw again funds and its not a real debt or legal responsibility.

One might most likely work out the margin on this deferred income over time by performing some knowledge mining, however with the 70% discount in workforce, possible over listed to the R&D workforce, it does not seem the corporate is simply too involved about not having the ability to acknowledge this income or having it clawed again.

Working via my again of the envelope math, I give you the next liquidation estimate (reminder, that is possible not a liquidation):

The shares excellent quantity is a bit wonky, the corporate has most well-liked inventory excellent to their largest investor, Biotechnology Worth Fund, that’s convertible at 1,000 shares of widespread for every pref share.  I consider that is totally transformed within the 93.6MM quantity that was reported in BVF’s newest 13D.  However please verify my math, I’ve low confidence in that quantity, nevertheless it’s hopefully proper inside just a few million shares.

With the intention to account for the deferred income, I put in 2 quarters of 30% R&D burn for ongoing partnership work.  Whereas this one does not look tremendous engaging on my typical math, with all of the totally different irons within the hearth, I am guessing there’s some worth to their IP (would possibly make an attention-grabbing CVR in a reverse merger).  I made this a small place this week.

Disclosure: I personal shares of PIRS

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