Pipeline Therapeutics

We need some good news now to keep us hopeful and alive...

 

Now that's almost a philosophical question. On the one hand of course, we all need hope and optimism -- something to look forward to.

On the other hand, what is the point in having suffering patients running around like a headless chicken pursuing and paying for cures that damage their pocket-books and worse, might damage their health or even their hearing or all three?

 

I can see that you are what is called a true believer". But life is technical. Just imagine, just suppose that it all comes down to some form of inflammation within the cochlea. In my particular case what killed me (so-to-speak) is that I felt so healthy -- didn't feel sick at all... but the little sound kept getting louder and louder week by week and took away my beauty sleep.

I would agree that the cadaver dissections seem to point towards synapse, hair cell loss though.

 

Most of us aren’t running anywhere yet... A little bit of hope could mean some of us decide to try their best efforts, or at least bother to check lumps on the neck...

 

Okay @Justin Mills.

Well we'll find out, won't we.

For the record, my tinnitus is also noise induced; so I sincerely hope that you are right and I am wrong.

 

Pipeline just posted a job position for an Accounting Manager on LinkedIn. Part of what they're looking for includes someone who can provide "assistance with SEC filing (10-Q and 10-K)". They want someone with "At least 5 - 7 years’ experience in accounting, preferably at a public biotech company". I'm guessing that they plan on going public sometime within the next year.

 

Do you reckon that the reason for hiring this account manager is because the results for PIPE-505 Phase 1 results were good?

 

That's my assumption. Their other main drug won't have results until next summer. I've been checking in on the job postings for a lot of these companies (Otonomy has been doing a lot of hiring - not sure if that's good or bad), and Pipeline hasn't posted anything recently until now. The job going up late Friday is strange timing. The study's been over for 6 weeks. Maybe they were in a meeting discussing the results and decided they were good enough to move forward with taking the company public.

Of course, there could be a more benign explanation, but the fact that the job posting makes clear that assistance with SEC filings are important shows that going public is on their mind. And going public will be hard if they have something that doesn't work.

 

They should call Lucchino for advice.

 

Pipeline Therapeutics are taking awhile to release the results for PIPE-505. I really do hope they announce positive results but this long wait to release them is making me anxious that the results might not be good.

 

Same here, but I maintain hope. Now, if September rolls around and still no results, then I'll be worried.

 

Here's the Accounting Manager job description from LinkedIn:

Position Summary

The Accounting Manager will be responsible for a wide variety of accounting responsibilities. The position requires that the candidate be a hands-on professional with a strong understanding of the application of Generally Accepted Accounting Principles (GAAP) and financial reporting. This position will be an integral part of the month-end close including assistance with technical accounting compliance, adoption of new accounting standards and assistance with SEC filing (10-Q and 10-K). Strong organizational, analytical and problem-solving skills and desire and ability to maintain strong SOX-compliant processes are also important. This position reports to the Senior Director, Corporate Controller.


Responsibilities:

• Responsible for completing month-end close processes, including preparing and posting journal entries and maintaining balance sheet reconciliations, in an accurate and timely manner.
• Calculate accurate expense recognition for month-end close, including clinical trial and other R&D accruals. Review new and amended contracts to determine appropriate accounting treatment and coordinate with internal stakeholders regarding costs and activities incurred.
• Lead monthly meetings with project managers to obtain and review accrual information for month-end close.
• Oversee Accounts Payable function, ensuring all transactions and cash disbursements are consistent with our accounting policies and procedures.
• Prepare monthly actual-to-budget analysis, including monthly projections.
• Responsible for establishment, operation and updating of internal controls, including narrative standard operating procedure documentation and communication thereof with employees.
• Prepare quarterly financial statements, including BS and P&L flux analysis to support MD&A.
• Correspond with external auditors regarding quarterly review and annual audit testing procedures.
• Assist in system implementation projects to streamline processes.
• Perform other duties as assigned.

Minimum Qualifications:

• Bachelor’s Degree in Accounting or a related field
• At least 5 - 7 years’ experience in accounting, preferably at a public biotech company
• Advanced experience with Microsoft Excel
• Strong organization and time management skills
• A high attention to detail
• Strong written and verbal communication skills
• Ability to work independently, managing multiple priorities to meet deadlines
• Strong knowledge of US GAAP, including accrual-based accounting

Preferred Qualifications

• CPA strongly preferred
• Public company experience strongly preferred
• Public accounting experience (Big 4 preferred)
• Experience in an accounting role with a biotech/pharmaceutical company
• Experience preparing or reviewing clinical trial accruals strongly preferred
• Experience working in a Sarbanes-Oxley compliant control environment

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There's several things on here that scream that they're getting ready to go public. However, I just realized that they also recently finished up a study for PIPE-307 in July.

The goal was probably always to go public, so I'm guessing there's good results for either PIPE-307 (Multiple Sclerosis) or PIPE-505 (Hearing Loss / Speech in Noise), or both. The PIPE-307 study had significantly more patients (72 vs 28), so I'm guessing that's the more important study for them.

I don't think we'll know the results for either trial until the company gears up to go public. I assume they'll want the good news about their studies to coincide with the news that they're now offering stock.

 

I wonder what the holdup is. Are they waiting until September when everyone is back at work to release the results? That's the only explanation I can come up with.

 

It’s nearly the end of September and still no results even though the trial finished in June. I’m getting very nervous right now.

 

That sucks.

 

Study completion date is September.

 

Where are you getting that? It says June on the clinical trials website.

 

On the clinical trials website it was stated that June 17th is the study completion date. It has been over 3 months since. Something must have gone wrong if they haven’t released the results yet.

 

4 months now... Man, I wish Pipeline Therapeutics would come out and say something; anything at this point. Can you imagine them not saying anything this year; possibly having to wait until 2022?

 

I think this trial is a flop. It’s been 3-4 months since the trial was completed. If it succeeded they would have released the results by now.

 

Maybe or maybe not that July date was for estimated completion, no date given for actual completion so maybe stuff got delayed.

 

This could be the case but isn’t necessarily true. There's a bunch of other possibilities. I wouldn’t jump to conclusions until the data is out. Unfortunately, taking such a long time to release data could mean they are posturing and getting ready for windfall from the bad news.

 

Did anyone mail the company? If not, I'll send a mail later today.

 

Yes please do. Pipeline Therapeutics' drug and OTO-413 are our best two shots right now.

 

Unfortunately I do not think that they will respond to emails about asking for information relating to clinical trials, as they usually have to keep things closed until they release the data.

 

All I'm gonna ask is if they can give an indication when they will release the results. But yeah, it's a long shot. I'm really tired so might be tomorrow

 

Can you not just fly over to their office and ask?



10578 Science Center Dr Ste 200, San Diego

¯\_ (・_・)_/¯

 

Yea maybe the study completion date is wrong on the ClinicalTrials website. I just hope we hear from them soon.

 

I think that the benefit with the Otonomy medicines might end up being their delivery method.

Not guaranteed but if their last dose got done in July and Otonomy tests up to three months after the dosing, then this means that October would be when this happens.

No evidence to confirm that this might be a reason for the lack of results presently, however it would be logical to assume that this could be one reason.

 

What do you know! They replied already!