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Friday, December 18, 2020

The sellside has picked a winning Covid-19 vaccine – for now

 An almost unanimously positive US panel vote yesterday sets up Moderna’s Covid-19 vaccine, mRNA-1273, for emergency use authorisation later today. The scrutiny of mRNA-1273 and Biontech/Pfizer’s candidate, BNT126b2, does not stop here, however. Future analyses into whether these jabs prevent asymptomatic transmission and severe disease remain important, as does their emerging safety profile in wider swathes of the population, and durability of protection. All of these attributes will help determine which candidates have market longevity, although the world will be relying on these two mRNA options for now. mRNA-1273’s less onerous storage stipulations will certainly be welcomed; the need to deep-freeze BNT126b2 means that Biontech/Pfizer option is for now relatively inconvenient. What additional vaccines might come in the longer term remains unclear, but four others are in phase III. Enthusiastic biotech analysts are already forecasting sales for Novavax’s candidate, before data due in the first quarter of 2021. Big pharma analysts have proven more reluctant to model demand ahead of pivotal data – hence the lack of a reliable consensus for projects from Astrazeneca and J&J, for example. That could change if J&J’s single-shot candidate shows promise. Data are due in January.

$bnDemand for Covid-19 vaccines: the sellside's current viewmRNA-1273 (Moderna)NVX-CoV2373 (Novavax)BNT162b2 (Biontech/Pfizer)202020212022202320242025202601k2k3k4kEvaluatePharma

Note: reliable consensus is not available for Astrazeneca's AZD1222, J&J's Ad26.COV2-S, or Curevac's CVnCoV, all of which are in pivotal development. 

https://www.evaluate.com/vantage/articles/news/snippets/sellside-has-picked-winning-covid-19-vaccine-now

Deerfield Healthcare SPAC to combine with Caremax, IMC Medical

  • Deerfield Healthcare Technology Acquisitions (NASDAQ:DFHT), a blank-check firm sponsored by an affiliate of Deerfield Management, has announced a business combination with CareMax Medical Group and IMC Medical Group Holdings.
  • DFHT expects to be renamed CareMax and will remain listed on the Nasdaq under a new ticker symbol; combined firm will operate 26 wholly owned medical centers in south and central Florida serving seniors and will own the CareOptimize technology platform.
  • Total consideration for CareMax Medical Center’s business, including Care Optimize, will be ~$364M; net of debt, the current equity holders, who are primarily the founders and executives, will receive 68% in cash and 32% in shares
  • Consideration to IMC Health equity holders will be $250M cash and 55% in shares.
  • Equity holders of IMC Health include Comvest Partners and Athyrium Capital Management.
  • Current equity holders of CareMax Medical Centers and IMC Health will be entitled to receive an earn out of up to 6.4m shares of CareMax common stock, with vesting based on the share price.
  • Investors including Deerfield, Fidelity Management & Research, Eminence Capital, funds and accounts managed by BlackRock and Maverick have committed to purchase over $400M of shares at $10 each through a private placement in public entity.
  • DFHT estimates that, assuming no redemptions of DFHT shares, the combined company will have an initial market cap of ~$800M with ~$233M of cash on the balance sheet.
  • https://seekingalpha.com/news/3645806-deerfield-healthcare-spac-to-combine-caremax-imc-medical

Karyopharm wins label expansion for XPOVIO in Multiple Myeloma

 

  • Karyopharm Therapeutics (NASDAQ:KPTI) announced that FDA has approved XPOVIO in combination with bortezomib and dexamethasone for patients with multiple myeloma after at least one prior therapy.
  • XPOVIO, a first-in-class, oral Selective Inhibitor of Nuclear Export medicine was earlier approved for adult patients with relapsed or refractory MM who have received at least four prior therapies/ at least two proteasome inhibitors/ at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
  • The label expansion was based on Phase 3 BOSTON study, which was recently published in the medical journal, The Lancet.
  • In addition to MM, XPOVIO is also approved for adults with relapsed or refractory diffuse large B-cell lymphoma, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.
  • Michael G. Kauffman, MD, PhD, the CEO of Karyopharm said, "We plan to immediately launch XPOVIO in this earlier-line indication by leveraging our established commercial infrastructure and growing account base of academic institutions and community-based oncology practices."
  • The company earlier noted the inclusion of three different Xpovio combination regimens in National Comprehensive Cancer Network guidelines for previously treated MM, prompting the RBC analyst Brian Abrahams to note “with key combos now immediately reimbursable by many plans -- we could see shares start to appreciate.”
  • After a brief halt, trading of Karyopharm is to resume from 12PM ET.
  • https://seekingalpha.com/news/3645797-karyopharm-wins-label-expansion-for-xpovio-in-multiple-myeloma

Misonix's TheraSkin to be covered by U.S. commercial payer

 

CytoDyn Inc.: Understanding Leronlimab

 

Investment Thesis:

CytoDyn (OTCQB:CYDY) has the very promising large molecule (biologic) Leronlimab in Phase 1-3 for various indications including HIV, Cancer, and Immunology (Covid-19). The stock has been a battleground between bullish and bearish views. Recent setbacks in use for Covid-19 helped to fuel negative perceptions but I believe this was the logical attempt by regulators to find an effective therapy and the company to further its progress in case it proved effective for Covid-19. It does appear that Leronlimab is a therapy that will prove effective in treatment of one or more disease states.

The treatment of HIV appears to be where the most clinical progress has been made in the US and internationally and a large potential market exists. In my view, the company is relatively high risk even for a clinical stage biotech company for a few reasons including: approval needed for indication, strong and entrenched competition within the HIV treatment space, and a current valuation that reflects some of the potential of Leronlimab. That said there is large potential for positive investment outcomes if Leronlimab is approved and is acquired or can compete effectively against current standards of care dominated by Gilead (GILD) and Viiv Healthcare, a joint venture between Pfizer (PFE), GlaxoSmithKline (GSK) and Shionogi (OTCPK:SGIOY).

There is also the possibility that indications are expanded into cancer or immunology which could prove to be very beneficial to patients, the company and investors. My focus will be on HIV as a grounding point. The company is currently traded on the US OTC market and tradeable options for limiting risk are not available. I recommend that the risk-tolerant investor add CytoDyn to their portfolio for upside potential but manage position size carefully to minimize risk.

CytoDyn Inc.

CytoDyn Inc. is a clinical stage biotechnology company that is focused on developing and commercializing large molecules (biologics) for human use. Its lead product is Leronlimab (PRO 140), an anti-viral agent that has shown strong promise in the treatment of HIV. The company has a history dating back to 2002 and at some point, was almost insolvent. CytoDyn is headed by Nader Z. Pourhassan, Ph.D. who is a mechanical engineer by training but was important in the acquisition of Leronlimab which has changed the potential fortunes of the company. The company is based in Vancouver, Washington.

What is Leronlimab

Leronlimab is a large molecule (biologic) monoclonal antibody that targets CCR5 receptors which are thought to be important in the viral spread of HIV within the body. CCCR5 deficiency (lack of CCR5) is believed to have resulted in the only 2 cases of HIV “cure” in the world via gene transplantation. Leronlimab is a self-administered subcutaneous injection (not tablet, capsule). As a biologic, it is not generated from chemicals like many “small molecule” products but rather from the growth of proteins from living cells that create the same substance that exist naturally in the human body. If CytoDyn gets Biologic License Approval “BLA” from the FDA, its trade name will be Vyrologix™.

Patient Need:

HIV (human immunodeficient virus) harms your immune system by destroying a type of white blood cell that helps your body fight infection. AIDS (Acquired Immune Deficiency Syndrome) is the final stage of HIV, not all people who have HIV get AIDS. According to the World Health Organization, there are an estimated 38 million people worldwide that have acquired HIV. Unlike many years ago, the current prognosis for HIV is actually pretty good. Antiretroviral medications therapies or “ART” mean that HIV can be managed and that “viral load” levels can be suppressed to reduce the risk of spreading HIV to others. That said there are complications and drawbacks with the current ART regimens that patients undertake.

Limitations of Existing Therapies

Some of the key limitations as I see it can be listed as follows:

  • Drug resistance to one or more of the ART or HAART (highly active antiretroviral therapy) is reportedly common and an important factor for patients.
  • Adverse reactions or loss of therapy effectiveness due to drug interaction with other drugs taken by the patient.
  • Risk of liver damage/impairment particularly with patients that also have Hepatitis.
  • Immune Reconstitution Syndrome whereby your body generates a strong autoimmune response when you begin ART therapy. This can make your condition worse at least temporarily.
  • Dosing regimen and patient adherence. Typically, patients required to take one or more tablets daily for life. This appears to be less of a drawback than in the past as there are one tablet options available rather than multi-drug cocktails.
  • I've linked the package insert for Gilead Sciences' product Biktarvy which describes risks associated with drug resistance, liver damage and Immune Reconstitution Syndrome for reference.

    Potential Benefits of Leronlimab

    Some of the benefits as outlined by CytoDyn are as follows:

    • According to CytoDyn, there have been no drug resistance generated in over 800 patients in the last 4 years. This makes sense as Leronlimab is a biologic generated from living cells and meant to mimic your body's natural function and not a chemically-derived drug as are most current therapies.
    • No serious adverse events during their clinical trials.
    • Leronlimab appears to not have high liver toxicity associated with ART/HAART therapies and if confirmed risk of renal impairment is greatly diminished.
    • Leronlimab is currently designed to be injected once a week. This in theory makes compliance easier as it is not a daily tablet. I’ll note that a once-a-day tablet such as the Gilead product BIKTARVY does not seem onerous in my opinion and some patients do not like needle injection.
    • Potential Drawbacks of Leronlimab

      • The main issue I see at this point with Leronlimab is that it is currently designed to be a combination therapy with other existing therapies. This does not provide additional patient compliance ease but adds another step to their therapy. It is currently designated for patients who are facing drug resistance.
      • There is discussion that the FDA may look at Leronlimab as a monotherapy for HIV which would be very positive as it would not be part of a larger regimen to treat HIV for patients.
      • Some patients will not like self-injection.
    • In summary, it does appear that Leronlimab can provide HIV patients with significant benefit. In my view, the key positive attributes are that the risk of developed or acquired drug resistance appears to be low and liver toxicity for Leronlimab appears to be better than existing therapies. If Leronlimab was approved as a monotherapy (sole therapy needed) for HIV, I believe this would also be a significant benefit. That said current products on the market do appear to be effective in limiting viral load for HIV and most no longer require a multi-dose “cocktail” regimen. Less than daily dose administration is a benefit as well, but some patients will be averse to self-injection.

      Clinical Status

    • Leronlimab currently has several ongoing trials for several indications including cancer and immunology. 
  •  CytoDyn has on-going studies for a wide range of indications. The company provided a comprehensive virtual update on its pipeline on December 10, 2020.

    From my perspective at this point, the most important non-HIV updates are the start of a Phase 2 clinical trial for Leronlimab for treatment of non-alcoholic steatohepatitis "NASH" and continued patient recruitment progress on a Phase 3 clinical trial for treatment of mild to moderate respiratory symptoms of respiratory disease caused by Covid-19 (so-called “Long Haul Covid-19”).

    CytoDyn has indicated that Leronlimab may be approved for Covid-19 in the Philippines in the near term (as early as January 2021) and this would be significant.

  • Cancer and Immunology are potentially large market indications with patient need so future progress on these would be very welcome by CytoDyn investors.

  • https://seekingalpha.com/article/4395017-cytodyn-inc-understanding-leronlimab-and-hiv

Tenet sells Urgent Care Platform to FastMed

 

  • Tenet Healthcare (NYSE:THC) and FastMed Urgent Care announced today that they have entered into a definitive agreement under which the latter will purchase the former's urgent care platform, which is operated under the CareSpot and MedPost brands and managed by Tenet's United Surgical Partners subsidiary.
  • The transaction will add 87 CareSpot and MedPost centers, increasing patient access to FastMed's healthcare services in Arizona and Texas thereby enabling the company to expand into Florida and California where most of the acquired centers are located.
  • Transaction expected to be completed in 1Q21.
  • https://seekingalpha.com/news/3645733-tenet-sells-urgent-care-platform-to-fastmed

NY nursing homes STILL ‘acutely vulnerable’ to COVID-19: report

 New York’s coronavirus-ravaged nursing homes are still “acutely vulnerable” to the deadly illness — more than nine months into the pandemic, according to a report on Thursday.

Between Oct. 25 and Nov. 29, nursing home residents accounted for a quarter of all COVID-19 deaths statewide, despite making up less than half of 1 percent of the population, the Empire Center for Public Policy found.

“It seems like they’re more vulnerable than ever,” said Bill Hammond, senior fellow for health policy at the independent think-tank.

During that five-week span, there were 268 coronavirus deaths at the facilities, according to federal data reviewed by Hammond. That number represents 26 percent of all virus fatalities reported by the state Health Department during that time period.

Nursing homes in upstate New York were hit far worst than those in the Big Apple, which accounted for 18 of the deaths, the data showed.

For instance, the states Southern Tier, which includes Binghamton, Corning and Elmira, saw 84 COVID-19 fatalities in those weeks — making up 71 percent of the region’s number.

The disturbing details come despite the state implementing strict restrictions on nursing homes — such as limited visitation and weekly testing for staff — after the spring wave of infections.

Hammond said he had believed “that nursing homes were better protected than ever,” but after finishing his analysis found, “it doesn’t seem like that.”

“I think it’s extremely difficult to protect nursing home residents from this virus because they’re so acutely vulnerable,” he told The Post.

“Although they themselves are cut off from the rest of the world, they have frequent intimate contact with staff… and those people are out in the world to some extent and are inevitably exposed to the virus.”

While the state’s rate of coronavirus fatalities — both in and out of nursing homes — remains lower than in April and May, Hammond said the troubling trend needs to be addressed.

“It’s puzzling to me that this issue, this trend has not been addressed by the governor or his people in the daily briefings,” he said.

“It is a huge percentage in the deaths especially upstate in nursing homes and we were aware they were taking a lot of special care and protections.” 

Gov. Andrew Cuomo has been facing criticism for months that policy directives issued by his Health Department in the early days of the pandemic fueled outbreaks in hard-hit nursing homes. 

A later-rescinded March 25 directive required nursing homes to accept recovering COVID-19 patients from hospitals, a controversial policy that the governor claimed followed federal guidance.

The Cuomo administration has publicly reported roughly 6,500 deaths from COVID-19 in long-term care facilities across the state since March — but have refused to say how many died after they were taken to hospitals for emergency care.

Lawmakers and the Empire Center have submitted Freedom of Information Law requests and sued the state for refusing to release those figures. That suit is pending.

Cuomo critics and health care experts have ripped the governor and his state health commissioner, Dr. Howard Zucker, for issuing the directive, which required nursing homes to allow COVID-positive residents to return from hospitals if they were not in need of intensive care.

They argue the mandate helped to fuel outbreaks at long-term care facilities, which are home to the elderly and infirm — some of those most vulnerable to the deadly disease.

And an Associated Press analysis of data indicates the count provided by the state of total nursing home deaths may be grossly underreported. Some 323 nursing home residents died between early June and mid-July, according to the AP’s review of federal data — 65 percent higher than the 195 deaths tallied by the state in that same period.

If that rate is indicative of reporting disparities for the duration of the pandemic, it could account for thousands of additional coronavirus-linked deaths in nursing homes.

The state DOH released an internal report in July saying the virus was spread through the facilities primarily by staffers.

But the self-review, which attempted to vindicate the department’s highly criticized policies, was slammed by experts who said it was riddled with holes.

“There are no more excuses. We know these facilities are most vulnerable to COVID and Governor Cuomo and his administration still can’t figure out how to protect them. It’s either he doesn’t care, he is incapable of governing, or both. It’s time we consider removing his powers,” Assemblyman Ron Kim (D-Queens), a frequent critic of the state’s nursing home policies, said Thursday.

But Gary Holmes, DOH spokesman, defended his boss’s decisions claiming “the right wing political machine” is “ignoring science, data and facts” — despite the figures cited are reported to the feds by New York’s own nursing homes.

“What we’ve said from the beginning is happening in all 50 states – when this virus gets into a community, it also gets into nursing homes, generally through asymptomatic staff or visitors.”

He added: “New York continues to do everything possible to protect our nursing home residents and staff, including a restriction on visitation in red and orange zones, a return to twice weekly testing in all micro cluster zones, and in the coming days, a comprehensive program that has nursing home residents and staff among the New Yorkers first in line to receive the COVID-19 vaccination.”

https://nypost.com/2020/12/17/nys-nursing-homes-still-acutely-vulnerable-to-covid-19-report/