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Nice. Thanks for sharing.
-- OJ
Great analysis and commentary. Thank you so much for sharing your expertise with us.
I, personally, am not familiar with the patent intricacies so it's great to hear from a fellow shareholder who is.
My specialty is writing about the latest and greatest forms of cancer medicine, and I'm keenly aware of the competition for market share in certain therapeutic settings among Big Pharmas like J&J, Merck, BMS, Roche, AbbVie, etc. So this is why I'm so bullish on Halo, because I see Enhanze as a way for Big Pharmas to grab market share from each other. It's like Halo sells bullets to armies on both sides of the war, and there's no cease-fire in sight. I just wish more analysts had a similarly bullish perspective.
-- OJ
Thank you for sharing your thoughts and perspectives.
As I reflect on this more, I'm thinking perhaps it has to do with the very high degree of institutional ownership. (See attached.) Apparently people like us, retail shareholders, hold only a tiny minority (0.8%) of outstanding shares. I'm guessing institutions take time to make investment decisions, do not act quickly or try to time the market. But that's just a guess.
Good luck to you.
-- OJ
Thank you for sharing your perspective.
Does anyone have any theories as to why . . .
HALO did not participate in today's strong rally that drove the price of so many small caps upward?
According to the Wall Street Journal, today the Russell 2000 index of small-cap stocks soared 3.6% in its best day since November. Some of my other small biotech stocks (I own half a dozen) jumped 5, 7, even 9%. Every darned holding in my brokerage list (roughly 14) was green EXCEPT for HALO, which was in the red, down slightly.
This defies logic, in my world. The company is becoming a cash cow. We've been held hostage, or so I thought, by the stubbornly high yield on the 10-year Treasury. But even when the 10-year yield dropped sharply today, the HALO price did not budge.
I'd be interested in what other shareholders on this board think might be the reason HALO did not participate in today's strong small-cap rally.
-- OJ
P.S. Even my utilities ETF advanced!
Got it, thanks.
My concern is that if price spikes upward on approval, LP/management will sell large quantity of shares and crush any rally before it gains any momentum.
-- OJ
Not to my knowledge, but it's hard to keep all of our many customers straight. (That's a good problem to have.)
sorry no clue
Agree with this perspective, thanks for sharing.
When you talk about P/E, are you thinking trailing 12 months (TTM) or forward 12 months (FY)? As I'm sure you know, these can be very different numbers.
-- oj
Thank you for sharing, LearningCurve2020. It seems like Xiong et al. are giving pretty short shrift to the trial we were all so excited about in late 2022. Just one short sentence. Yet the article purports to be about vaccines for glioblastoma.
Recently, a phase III trial on DC vaccine addition to SOC, DCVax-L,75
revealed a significant extension of OS in both primary and recurrent GBM patients which was well-tolerated.
This looks very interesting: 3 Halozyme employees rubbing shoulders in a professional context for half a day with employees from Roche, Sanofi, Lilly, Merck, AZ, and Novartis. Roche is already a repeat customer of Halozyme's, while Sanofi, Lilly, Merck, AZ and Novartis are all prospective customers. With no sign of any Halozyme competitors present among the presenters. How can this not be a wonderful thing for Halozyme???
Great story. Thanks for sharing!
P.S. It seems like business journalists are finally starting to understand the new HALO business model:
Halozyme's business model is relatively simple. The company licenses its technology to Big Pharma and biotech companies and they use it to develop subcutaneous versions of their biggest IV drugs. In return, Halozyme receives a royalty on sales of those products.
My analysis using Better Investing's Stock Selection Guide Plus is telling me that HALO is a buy up to about $58.50 and a sell above about $103. Annual total return is projected at 19% over the next 5 years, well above the BI recommended target of 15%, which is the rate it takes to double your money in that period of time. Mine is a conservative analysis because I took the company's EPS projected CAGR for the next 5 years of 23% and chopped it in half, to 11.5%.
very interesting, thanks for sharing
placed a couple of buy orders today, for 2 different accounts
Thank you!
Thank you!
This increased efficacy signal is so very cool.
The predefined exploratory OS analysis showed a significantly improved survival with subcutaneous versus intravenous amivantamab-lazertinib (HR for death, 0.62, nominal P=0.02). The observed benefit in the subcutaneous group was consistent across all efficacy endpoints and may be driven by better tolerability, as indicated by the longer time to treatment discontinuation. Further, the impact of subcutaneous administration on lymphatic absorption and immune stimulation is unknown but may also play a role.19-21 Although study follow-up is 7.0 months and further investigation is needed, our trial shows consistent evidence of clinically relevant improvement with subcutaneous amivantamab.
Thanks for sharing!
-- OJ
Does anyone know rough incidence and prevalence stats for CIDP? Seems like it's a pretty rare disease, so number of prescriptions sold per year could be low, and maybe royalty payments would be similarly small.
-- OJ
requirement for informed consent may not be satisfied
I don't disagree with this analysis, and I hope you're correct about the AZ drug, but I'm already pretty darned happy with the news from ASCO about SC amivantamab! It's really extraordinary that formulation appears to improve overall survival (which is stated right in the abstract). THAT is going to make front-page medical news somewhere, soon, if it hasn't already.
(I've been working on projects related to new drugs for lymphoma and breast cancer, so may have missed headlines about lung cancer.)
-- OJ
Now I really want to buy more shares!
Meeting Abstract: 2024 ASCO Annual Meeting II
FREE ACCESS
Lung Cancer—Non–Small Cell Metastatic
June 05, 2024
Subcutaneous amivantamab vs intravenous amivantamab, both in combination with lazertinib, in refractory EGFR-mutated, advanced non-small cell lung cancer (NSCLC): Primary results, including overall survival (OS), from the global, phase 3, randomized controlled PALOMA-3 trial.
Authors: Natasha B. Leighl, Hiroaki Akamatsu, Sun Min Lim, Ying Cheng, Anna Rachel Minchom, Melina Elpi Marmarelis, Rachel E. Sanborn, … SHOW ALL …, and Antonio Passaro
Publication: Journal of Clinical Oncology
Volume 42, Number 17_suppl
https://doi.org/10.1200/JCO.2024.42.17_suppl.LBA8505
Abstract LBA8505
Background: Amivantamab (ami) plus lazertinib (laz) demonstrated antitumor activity in EGFR-mutated advanced NSCLC. Subcutaneous (SC) ami administration takes ≤7 mins and has low infusion-related reaction (IRR) rates. PALOMA-3 (NCT05388669) evaluated SC ami+laz vs IV ami+laz for pharmacokinetics (PK), efficacy, and safety among pts with EGFR Ex19del or L858R-mutated advanced NSCLC and disease progression on osimertinib and platinum-based chemotherapy.
Methods: SC ami at 1600 mg (2240 mg, ≥80 kg) was manually injected weekly for the first 4 weeks, then every 2 weeks; IV ami was given at the approved dose of 1050 mg (1400 mg, ≥80 kg). Laz was orally dosed at 240 mg daily. Co-primary PK noninferiority endpoints were trough concentration (Ctrough on Cycle [C] 2 Day [D] 1 or C4D1) and C2 area under the curve (AUCD1-D15). Key secondary endpoints were objective response rate (ORR; noninferior) and progression-free survival (PFS). OS was a predefined exploratory endpoint. Prophylactic anticoagulation was recommended for the first 4 months (mo) of treatment.
Results: In total, 418 patients (pts) were randomized (SC, n = 206; IV, n = 212); 416 received ≥1 dose. Overall, median age was 61 years, 67% were female, 61% Asian, and median 2 prior lines. At a median follow-up of 7.0 mo, PALOMA-3 met both co-primary endpoints. Geometric mean ratios (GMRs) comparing SC ami+laz vs IV for Ctrough were 1.15 (90% CI, 1.04–1.26) for C2D1 and 1.43 (90% CI, 1.27–1.61) for C4D1. GMR for C2 AUCD1-D15 was 1.03 (90% CI, 0.98–1.09). ORR was 30.1% (95% CI, 24–37) in the SC arm and 32.5% (95% CI, 26–39) for IV (relative risk, 0.92; P= 0.001), meeting the noninferiority criteria. Median duration of response (DoR) was longer for SC ami+laz vs IV (median, 11.2 vs 8.3 mo among confirmed responders). A favorable PFS trend was observed for SC ami+laz over IV (median, 6.1 vs 4.3 mo; HR, 0.84; P= 0.20). OS was notably longer for SC ami+laz vs IV (HR, 0.62; 95% CI, 0.42–0.92; nominal P= 0.017). At 12 mo, 65% were alive in the SC arm vs 51% for IV. IRRs were ~5-fold lower in the SC arm: 13% vs 66% for IV, primarily grade 1-2 (0.5% vs 4% grade ≥3, respectively). Overall, 81% received prophylactic anticoagulants, with VTE reported by 9% in the SC arm vs 14% for IV. Across both arms, VTE incidence was 10% for pts who received prophylactic anticoagulants vs 21% for pts who did not. Severe bleeding risk was low among all pts receiving anticoagulants (1% grade ≥3).
Conclusions: SC ami demonstrated noninferior PK and ORR compared to IV. Unexpectedly, DoR, PFS, and OS were longer in the SC arm vs IV, suggesting that the route of administration or formulation may affect outcomes. The safety profile was improved for SC ami, with lower IRR and VTE rates. Prophylactic anticoagulation can be safely implemented and reduces VTE risk. Clinical trial information: NCT05388669.
Source: https://ascopubs.org/doi/10.1200/JCO.2024.42.17_suppl.LBA8505
News like this makes me want to buy more shares.
“As seen in the PALOMA-3 study, with its significantly shorter administration time and five-fold reduction in infusion-related reactions, alongside longer overall survival, progression-free survival and duration of response, I look forward to seeing how subcutaneous amivantamab can make a meaningful difference in clinical practice,” Natasha B. Leighl, MD, medical oncologist at the Princess Margaret Cancer Centre in Toronto, Canada, and clinical trial investigator on PALOMA-3, told Targeted OncologyTM.
Source: https://www.targetedonc.com/view/fda-considers-subcutaneous-amivantamab-in-egfr-mutated-nsclc
Thank you for sharing this, too!
-- OJ
P.S. Seems to me like now Merck MUST respond with a subQ version of pembrolizumab, ASAP.
Thank you for sharing!
-- OJ
Agree that having Linda Liau -- who is a practicing physician as well as a researcher and a teacher -- on the scientific advisory board adds prestige, looks terrific from the outside and probably is wonderful on the inside, as well.
However, Linda Liau is not in a position of senior management for NWBO. She works for UCLA.
-- OJ
How is it in your interest to encourage anybody else to throw in their hand when you are long?
This is an interesting theory. Thanks, Sir Pump!
It could help explain why there is no one with any real medical chops to be found anywhere within the ranks of senior management. I just came back home from a bike ride after work, found myself thinking (again) about who's who among senior management at NWBO, and their academic backgrounds, professional disciplines, etc. Can't think of one -- not one -- who has ever treated a patient.
Not Linda
Not Les
Not Marnix
Not Alton
Not Navid
Not Pat
Not Cofer
Yet they say their #1 top goal is to improve care for patients.
I hold shares in several other biotech companies developing cancer medicine and the best ones have physician-type doctors (in addition to PhD-type doctors) in positions of senior management.
Something doesn't add up.
-- OJ
Agree.
After reading transcript of Chancery Court judge's ruling denying the motion to dismiss the shareholder lawsuit, I have voted all my shares "No" on all proposals except to reappoint the accounting firm.
-- OJ
Any mention of new deals in the works?
Hi Fred:
Thanks for the compliment, but I really have no idea. I need to restrict my commentary to something I actually know something about.
Best regards,
OJ
We need a new SVP General Counsel.
Here is what the Hon. J. Travis Laster, Vice Chancellor, Court of Chancery for the State of Delaware, had to say regarding the role of Leslie Goldman on the true-up plan at the heart of the shareholder lawsuit:
"The plaintiffs allege that Goldman participated in every meeting where the true-up awards were discussed. Goldman is senior vice president and general counsel of the company. Goldman would inferably have been actively involved in the plan to true up the directors' equity holdings. That inference is strengthened by the amount of the grant that Goldman received.
"It's inferable, therefore, that Goldman had knowledge of and, indeed, was the architect of the true-up awards, as well as the plan to split these things up into two closely connected votes, as well as the plan to omit that factor from the proxy statement. So Goldman is sufficiently connected to all of this. The motion to dismiss Count I is denied as to Goldman."
Source: Page 29 of telephone transcript from Chancery Court's ruling on defendant's motion to dismiss, dated Friday, November 17, 2023, and included at end of packet mailed to all shareholders containing notice of upcoming shareholders meeting on June 29, 2024.
agree we need more deals, but this new patent news is a breath of fresh air while we wait
Agree.. Competition in the immune checkpoint inhibitor (ICI) marketplace is only going to heat up. I write about advanced cancer medicine every day. You should see how many ICIs -- both PD-1 inhibitors and PD-L1 inhibitors, as well as agents directed against even fancier targets like LAG3 and TIGIT -- are being developed in places like Beijing and Shanghai. Theoretically, every one of these could be a candidate for a collaboration agreement with HALO as a way to improve patient/provider convenience, increase competitive advantage, and increase market share.
From my perspective, HALO can now be called a true pick-and-shovel stock, selling competitive advantage to more and biotech prospectors, large and small, who are trying to strike it rich in the immuno-oncology drug gold rush.
This part of the Zacks article is outdated and inaccurate:
"focused on the development and commercialization of novel treatments for oncology indications by targeting tumor microenvironment."
We did get the little bounce you were hoping for, but now it seems to be fading. I'm happy to see the share price climb above $40 again.
If I heard Helen correctly, most of the conversations she's having are with big Pharmas interested in Enhanze alone, some are interested in the HVAI alone, and the fewest conversations involve both.
While listening to the recording, what excited me most was when she started talking about partners who are coming to her with proposals for collaboration with bispecific antibodies as well as antibody-drug conjugates. Both those classes of drugs are red-hot in oncology right now.
IMHO Halozyme is in a good, almost enviable position, having found a way to position itself as a company that can give a large number of drug manufacturers a credible way to improve their competitive advantage by enhancing patient convenience with respect to administration of a wide variety of different types of drugs.
To me, the long-term future outlook for this company is quite bright. The main threats seem to be competition from other companies offering a similar product, and also large manufacturers, like Merck, who choose to develop their own SC formulations in house, using a substance similar to the recombinant hyaluronidase that HALO has developed. I guess the other threat is a screw-up in the manufacturing process that results in a bad batch of Enhanze that gets mixed in with a partner's drug and then unwittingly distributed to patients, causing harm to the patients, harm to the partner's brand reputation, and the potential of a massive product liability/class action lawsuit against both HALO and the collaboration partner. Hope that never happens, but it seems like it could.
This appeared to be a high-interest item among analysts on the call, esp. the first gentleman from MorganStanley.