Spectrum Pharmaceutecals Inc (SPPI)

[Frankestin]

So the costs have also collapsed?
Cash, cash equivalents and marketable securities of $75 million at 12/31/2022, which is expected to extend cash runway through 2024

[Frankestin]

Come on let us dance!

[dcaf7]

Launching drug in the middle of 4thQ is not easy. Unexpected surprise from Spectrum. They also updated all their Poziotinib trials on ClinicalTrials.gov. Most intriguing is a Phase 3 PINNACLE trial.
Recruitment Status: Suspended (The study has not enrolled any patients. The study design is under discussion and will likely be redesigned in consultation with the FDA). It is not terminated and looks like Spectrum is considering a possibility to run it in future. They need a pipeline. Why not to return back to Pozi when they are in better financial shape?

[Chuckalo]

Most posters remaining at YMB are from outside the United States.

[BarrellofHay]

Back out cash and this is trading at 50 million market cap. with no pipeline, I give this a >90% chance of buyout within the next 6 months

[BarrellofHay]

Buyout next? I know AMGN has their own but they could have two products and market them differently. Big bio without the product could pick this up cheap and have a new revenue stream with little effort beyond sales and big bio sales will be more efficient. I would be happy with $2.50. It only has a 130 million market cap

[Gogh9]

Rolvedon sales for the 4th quarter of $10 million exceeds average analyst estimates by 2.5 times with the high estimate being a bit over $5 million and the low at $1.5 million. Also that is almost 2 times the estimate for the 1st quarter 2023. This is a great start. If they can follow through on this, 2023 may be a good year for SPPI's PPS.

[olibavoli]

CTIC with quarterly sales of 12 million and cash of 50 capitalizes 700 million 7 times SPPI ……. I would say that on these data you can buy …. good gain to all

[Frankestin]

ROLVEDON™ (eflapegrastim-xnst) Injection and Announces Unaudited Fourth Quarter 2022 Financial Results

-- Preliminary unaudited Q4 2022 net sales expected to be approximately $10 million --

-- Cash, cash equivalents and marketable securities of $75 million at 12/31/2022, which is expected to extend cash runway through 2024 -

very good

[dcaf7]

Remember Renazorb?
Jan 3, 2023
Unicycive's pivotal trial of rival to Takeda kidney drug hits main goal, clearing path to FDA filing.
Faced with well-established incumbents, Unicycive, like Shire before it, has identified reduced pill burden as a way to muscle in on the market. Unicycive’s prospect, Renazorb, is another phosphate-binding agent, but it is potentially differentiated through nanotechnology.
To enter the market, Unicycive ran a randomized, open-label, two-way crossover study that enrolled 40 subjects per treatment arm to establish pharmacodynamic bioequivalence between Renazorb and Fosrenol. The study met its primary endpoint.
Buoyed by the data, Unicycive plans to file for FDA approval around the middle of the year. The plan is based on feedback from the FDA that a single bioequivalence study in healthy volunteers can meet the clinical regulatory requirements for filing via the 505(b)(2) pathway.
Unicycive, which acquired Renazorb from Spectrum Pharmaceuticals in 2018 (I think, in 2020), sees the smaller pill size, lower number of pills and improved palatability of its challenger combining to improve compliance and disease management.
Could bring some money to Spectrum.
Dec 14, 2020, 09:30 ET
Unicycive Therapeutics, Inc., a clinical-stage biotechnology company developing therapies for patients with kidney disease, announced it has entered a licensing agreement with Spectrum Pharmaceuticals for Renazorb (lanthanum dioxycarbonate), a late-stage asset for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD).
"Renazorb, a compelling potential treatment for patients with complications from chronic kidney disease, was not a good strategic fit with Spectrum's focus on oncology," said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We are pleased to have licensed this product to Unicycive which is developing treatments for kidney diseases and is well-suited to carry out the development work for this product."
Under the terms of the asset purchase agreement, Unicycive has acquired global rights for Renazorb and all its trademark and associated patents, and Spectrum has received an equity interest in Unicycive along with milestone and royalty payments.
Global Hyperphosphatemia Market is $2.5B, US market is $1.12B

[Tartiaboy]

Yes the growth rate, month over month, quarter over quarter, will be the real tell. Not sure how $45M in 2023 will be perceived for a company with no pipeline. I think they need to identify a new pipeline drug in a hurry.

[dcaf7]

This year Rolvedon sales estimate from "The 3 Best Biotech Stocks Under $1 to Buy for January"
"Spectrum is expected to report earnings on March 16. Analysts are hoping for revenue of $45 million in 2023. That’s not enough for a profit, but could spark interest in the company if its sales growth remains high".

[Tartiaboy]

I ran into the YMB's new woke algorithm..

[Gogh9]

What did you do now Tartia?

[Limey42]

You should post on Stocktwits as well.

[Tartiaboy]

Or you could say only one out of 30 met the required sales incentive threshold. Assuming this is a sales target reward rather than an incentive award. Just don't read too much into it. SPPI should report sales in the quarterly.

[Johnny R]

I understand, however this particular announcement was that 1 of the salesman out of the 30 that they hired has actually now qualified to receive 20,000 shares under the incentive program. That wouldn't happen unless that salesman met the required sales incentive threshold. All I'm saying is that there is at least some sales activity/momentum out there

[Tartiaboy]

A grant of this type is used to entice a new hire or retain a current hire. It only signals SPPI is willing or needs to use stock as an incentive for non-executive employee. I don't think you can interpret it as indicative of good or bad sales at this time.

BTW: I am a new victim of Yahoo message board WOKE activism and can no longer post on their boards. You will find me posting on Ihub boards going forward.

[Johnny R]

First Rolvedon sales incentive stock grant has been issued to 1 salesman. That's gotta be good news

[dcaf7]

Fair summary from UpToDate under "What's new in drug therapy"

Eflapegrastim for chemotherapy-induced neutropenia (September 2022)

The US Food and Drug Administration has approved eflapegrastim, a novel long-acting formulation of granulocyte colony stimulating factor (G-CSF), to decrease the incidence of infection in adult patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia [31]. Approval was based on two separate trials of patients with early-stage breast cancer treated with docetaxel plus cyclophosphamide and randomized to eflapegrastim or pegfilgrastim. Efficacy was comparable, but despite the lower G-CSF dose with eflapegrastim, the incidence of adverse events (ie, bone pain, injection site reactions) was not lower in either trial. Given the available data, these two medications appear clinically similar, and agent selection may depend largely on institutional formulary and insurance constraints.

[dcaf7]

From a person on Stocktwits who is working with open insurance claims files (his/her words).
"They only sell the 4 people in November 1 person in December. Total 5. 25,000 revenue… Amgen sold 10,676 neulasta during the same period… bummer!" It is about Rolvedon. Not sure it is reliable information.

[RRS440]

Possibly exploring third line treatment market?

[Gogh9]

I guess Heymach is still a believer.

[dcaf7]

It is Ph2 study run by MDA for a long time.

[Gogh9]

What study is that the Phase !!!? They need to try to find a prtner to fund further stuedies.

[dcaf7]

Poziotinib study conducted by MDACC was recently updated. Updated version shows that they are still recruiting patients. What is the point?

[dcaf7]

I am fine. Thanks.
My plan is to return to YMB when issues are resolved. Although I won't be as frequent poster as before. As you know, my interest in Spectrum was mostly associated with Poziotinib. Possibly, some time down the road they will license a new drug/compound and become more exciting company. We'll see.

[Gogh9]

Hi dcaf,

Sorry you are having trouble posting on the Yahoo board. This board is pretty quite partucularly since anthema stopped posting. I hope you are doing well.

[dcaf7]

Yahoo is blocking my attempts to post. Will use iHub for now.

[bwrbad]

SPPI Rolvedon (eflapergrastim), for treating chemotherapy-induced neutropenia in cancer patients, received FDA approval.
this neutropenea treatment therapy and product will earn $15000 per cancer patient. Someone I know suffering from pancreas cancer receiving this treatment and it is providing great result. 10% of cancer patient receiving this will yield few billion in revenue.
company practically have no debt. this will go 1000%+ up within next couple of Q.
They currently deprioritize final stage development activities of oral tyrosine kinase inhibitor poziotinib to allot resources in favor ROLVEDON market launch.

[Frankestin]

LOL so many went short

[Frankestin]

So no surprises!
Sorry for the sick, let's hope they find someone to finance but cost cutting is needed here now!
it's time to earn with ROLO

[Frankestin]

Strange date to give an answer!
I play this game.. I see it hard but... a miracle is needed every now and then
fingers crossed
Happy Thanksgiving!

[cuggegrosse]

Thanks,it looks like it won't happen

[antihama]

If Pozi looked like it would be approved then it would be a no brainer buy but B Riley gives it a 11.5% of approval, Here's what they have to say as per SA

B Riley has downgraded Spectrum Pharmaceuticals (NASDAQ:SPPI) to neutral from buy citing uncertainty over the approval of poziotinib later this month and a challenging near-term pipeline catalyst profile.
The firm also lowered its price target to $1 from $1.50 (~92% upside based on Tuesday's close).
Shares are down ~9% in Wednesday afternoon trading.
Analyst Mayank Mamtani gives an 11.5% chance of approval for poziotinib in non-small cell lung cancer (NSCLC) with certain mutations.
Even if poziotinib is granted approval by the FDA action date of Nov. 24, Mamtani noted it would face competition from AstraZeneca's (AZN) Enhertu (trastuzumab), which was approved for NSCLC in August.
And while Mamtani said that there are encouraging signs from the launch of Rolvedon (eflapegrastim) for neutropenia this year, it faces competition from a biosimilar as well as stalwart Neulasta Onpro (pegfilgrastim) from Amgen (AMGN).

https://seekingalpha.com/news/3908816-spectrum-downgraded-to-neutral-at-b-riley-on-doubts-over-approval-of-poziotinib?mailingid=29719852&messageid=2900&serial=29719852.21227&utm_campaign=rta-stock-news&utm_content=link-3&utm_medium=email&utm_source=seeking_alpha&utm_term=29719852.21227

[cuggegrosse]

What's your opinion to-day?

[cuggegrosse]

ALL THIS IS Because this company has morons in charge

[cuggegrosse]

Lotto play is just about right,this is a very poorly run company,chaces to win 1 in 100 ml or more ?????

[harry crumb]

Loaded some of this lotto play. Sit an wait like with all of them $$$

[gail]

grabbed a few here. hi all.

[subslover]

Maybe today

[subslover]

Maybe today

[carusso]

Need some MOJO here...

[antihama]

Who knows but I was never in the camp that Amgen would be interested. They have their own drug. Getting a 2nd one that is not superior to their own wouldn't accomplish that much, IMO.

[BarrellofHay]

I wonder if this could be a quick easy buyout. AMGN could scoop this up for $3/share or about 550 million minus whatever cash is less. seems like a good deal and at this point I think shareholders would be happy

[BarrellofHay]

Thank you

[GPha]

Well, it is the first time I post here in the SPPI forum. However, I agree there are delays, but it is a part of small biotech companies due to the lack of resources, staff, experience...etc. I'm kinda biased and optimistic as well about the future of this company I think they well are capable to generate enough revenue with Roveledon to continue their growth or they going to be acquired. I hope you share with us your thought regarding SPPI's future growth.

-GPha

[antihama]

Back when Roveledon would have been the first drug competing w Neulasta, 500M in sales was a no brainer for me. Even when Udenyca in Nov 2018 was approved (and after that got a CRL initially)I thought 300M was doable but with all these delays I don't know and it definetely will be a show me attitude. If Roveledon can get same day dosing that would be huge. And I used to give credance that Roveledon having its own J code would have an advantage over biosimilars. (I read an article years ago that brand name drugs had a big advantage over generics because the buying entities had to buy the brand name drugs. This might have changed w the revision in the drug law a couple of years ago).

It's painful to think of all the delays SPI 2012/Rolontis/Roveledon had. I remember Dr Raj, questioned by analysts, asking if it really only needed one trial for approval, and he said yes. Four - six months later we find out that a 2nd trial was needed or at least it popped up in the Presentations.The 2nd trial released TLD back in June 2018. [EDIT - adding a little color to that - they finished dosing their last patients near the end of 2017 so 1 is thinking 1 month to get to primary endpoint and another month or 2 for TLD but many months later it was released] Waiting for the BLA to be submitted was like waiting for Godot. They didn't submit it till very end of Dec 2018 (hey, they met their bonus goals) but then had to withdraw a poorly written documents in March of 2019. Meanwhile Coherus' Udencya got 83M in rev that second Q. We resubmit (Oct 2019), get a PDUFA date of Oct 24,2020 and find out, around that time, the review was postponed because they couldn't inspect the site in Korea. Then they finally have the inspection (~June 2021), and it fails inspection in Aug 2021! Geez. Eleven months later we pass inspection and we get approval in Sept 2022. Many years of revenue wasted.

[BarrellofHay]

Hi Anti. Remind me of your Roveledon revenue projections! Can this company survive with one drug. I would try to sell the company at this point

[antihama]

I don't believe it (but I do).

UPDATE 1-U.S. FDA panel votes against Spectrum's lung cancer drug

SPPI
0.00%
Thu, September 22, 2022 at 1:07 PM

Sept 22 (Reuters) - Advisers to the U.S Food and Drug Administration on Thursday voted against recommending Spectrum Pharmaceuticals' experimental drug for the treatment of patients with a form of non-small cell lung cancer.

The FDA panel voted 9 to 4 against the oral drug, poziotinib, citing uncertainties around efficacy and side effects.

The decision of the panel was in-line with briefing documents released by the FDA on Tuesday that raised concerns over the efficacy of the treatment compared with existing drugs like Daiichi Sankyo's and AstraZeneca's Enhertu.

In the documents, the FDA said that given the concerns over efficacy, toxicity, and significant delay in confirmation of benefit, if the treatment is granted accelerated approval it would be "the least effective targeted therapy for lung cancer approved to date."

The regulator is expected to make the final decision on the drug by Nov. 24. The FDA is not mandated to follow the advise of its independent experts, but usually does.

Poziotinib is intended to treat non-small cell lung cancer (NSCLC) with a rare genetic mutation that affects 2-4% of total patients with NSCLC.