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Cerus Corporation (CERS)

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  • G
    George
    FYI....Bringing you the very best of mediocre news.

    Cerus Corporation Celebrates World Blood Donor Day 2021
    6/14/2021 8:30:00 AM EDT

    June 2021 also marks the 40th anniversary of the first report of AIDS cases by the CDC

    CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS), a leader in safeguarding the global blood supply, is proud to announce its celebration of this year’s World Blood Donor Day.

    World Blood Donor Day, first established by the World Health Organization in 2005, highlights the critical role safe blood and blood products play in treating a wide variety of patients throughout the world and recognizes the donors who help make these products regularly available. As blood centers compete for the time and attention of donors around the globe, the pool of donors remains relatively small. This year’s “Give blood and keep the world beating” campaign reinforces the global call for more people, especially younger demographics, all over the world to donate blood regularly and contribute to better health.

    According to the WHO, more than 118.5 million blood donations are collected each year worldwide with 40% collected in high-income countries, which is home to 16% of the global population and typically has an older pool of regular donors.1 In the U.S., only 5% of eligible donors present for donation and among that group, roughly one-fifth are subsequently deferred.2

    “World Blood Donor Day is an annual reminder of the teamwork that exists between blood centers and the donors who are so critical in supplying blood products for patients in need around the globe,” stated William ‘Obi’ Greenman, president and chief executive officer of Cerus Corporation. “As we saw over the last year, disruptions in the blood supply create a significant strain on health systems and their patients who rely on these lifesaving therapeutics. At Cerus, we are focused on providing blood centers with an ‘always on’ technology that will protect patients from known and unknown contaminants and expand donor eligibility.”

    June 2021 also marks 40 years since the Centers for Disease Control and Prevention (CDC) reported on five cases of Pneumocystis carinii pneumonia, in a Morbidity and Mortality Weekly Report.3 While acquired immunodeficiency syndrome (AIDS) and the underlying human immunodeficiency virus (HIV) would not be defined and fully understood for several more years, this report is widely viewed as the first official description of AIDS.

    “The AIDS pandemic was the impetus for Cerus,” stated Dr. Laurence Corash, Cerus’ chief scientific officer and co-founder. “With over 75 million cases and 32 million deaths over the last four decades, HIV/AIDS fundamentally changed medicine, and in particular, transfusion medicine. While the development of testing has helped restore security to the blood supply against HIV/AIDS, in the years since, there have been several other novel pathogens that have emerged. With COVID-19 as the most recent, we are constantly reminded that the blood supply needs protection from a wide range of pathogens, including those that have not yet been identified.”

    “The COVID-19 pandemic disrupted many aspects of our everyday lives, but it also had a significant impact on transfusion medicine as blood centers and hospitals faced blood component shortages,” continued Greenman. “This ongoing reminder of the importance blood donors play is cause to celebrate their direct contributions to patients who rely on these lifesaving blood products even amid a pandemic.”

    During the month of June, Cerus Corporation is hosting or sponsoring various events to mark these two milestones, including a sponsored in-house blood drive and social media awareness campaign on LinkedIn.

    World Health Organization. https://www.who.int/news-room/fact-sheets/detail/blood-safety-and-availability
    Lennie To, MS, Tyler Dunnington, MS, Christy Thomas, MS., et al. The United States’ potential blood donor pool: updating the prevalence of donor exclusion factors on the pool of potential donors. Transfusion. 2019. doi:10.1111/trf.15573
    Centers for Disease Control (CDC). Pneumocystis pneumonia—Los Angeles. MMWR Morb Mortal Wkly Rep. 1981;30:250–2.PubMed https://pubmed.ncbi.nlm.nih.gov/6265753/]
    Bullish
  • G
    George
    FYI.... My feelings, once again Solana casts needed light on CERS.
    Nothing Earth shaking here but any recognition by even a small group is welcome during this stagnation.
    Dated today 6/15/2021

    Medical Device Market Overview

    Expanding Market Opportunity: Aging global populations coupled with accelerated healthcare research has created a unique and growing opportunity for a global focused healthcare company. Small US companies with outstanding products want to tap the global market.
    High Margin IP Driven Businesses Command Superior Multiples: IP-driven medical device companies (Salona Global acquisition candidates) have strong margins. As a result, peers listed on presentation, trade in the range of 6-15 times revenue on Nasdaq.
    Further information available at www.salonaglobal.com/investors
    EXCHANGE COMPANY REVENUE
    MULTIPLE 2020 REVENUE MARKET CAP REV GROWTH EBITDA
    NASDAQ Utah Medical 7.2 US$42.2M US$304.8M -10% 33%
    NASDAQ Cerus Corp 8.7 US$114.2M US$990.5M 22% -47%
    NASDAQ Zynex Inc 6.9 US$80.1M US$556.2M 76% 13%

    They just made their first acquisition of South Dakota Partners, a 12 million dollar company (no big whoopie here folks).
    But, the more good exposure, the better.
    Bullish
  • M
    Moscuba
    Here are the links to the FDA documents and key dates of the two primary studies for RBC.

    Study in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections (RedeS)
    https://clinicaltrials.gov/ct2/show/NCT03037164?term=Redes
    Actual Study Start Date : December 5, 2018
    Estimated Primary Completion Date : December 31, 2021
    Estimated Study Completion Date : January 30, 2022

    Responsible Party: Cerus Corporation
    ClinicalTrials.gov Identifier: NCT03037164
    Other Study ID Numbers: CLI 00126

    Key Record Dates:
    First Posted: January 31, 2017
    Last Update Posted: April 2, 2021
    Last Verified: March 2021

    Complex Cardiac Surgery Patients (ReCePI)
    https://clinicaltrials.gov/ct2/show/NCT03459287?term=Recepi+and+RBCs&rank=1
    Actual Study Start Date : May 11, 2017
    Estimated Primary Completion Date : December 31, 2021
    Estimated Study Completion Date : January 30, 2022

    Responsible Party: Cerus Corporation
    ClinicalTrials.gov Identifier: NCT03459287
    Other Study ID Numbers: CLI 00125

    Key Record Dates:
    First Posted: March 8, 2018
    Last Update Posted: May 27, 2021
    Last Verified: May 2021
    INTERCEPT Blood System for RBCs Study in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections - Full Text View.
    INTERCEPT Blood System for RBCs Study in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections - Full Text View.
    clinicaltrials.gov
  • G
    George
    FYI... CERS on their list. Posted the full article but it was taken down, so I chopped it up.
    Salona Global Medical Device Corporation Provides Update in Advance of Commencement of Trading
    6/1/2021 11:09:59 AM EDT

    The Salona Global team believes it has the capacity to close two acquisitions per quarter starting Q2 2021.

    Medical Device Market Overview

    Expanding Market Opportunity: Aging global populations coupled with accelerated healthcare research has created a unique and growing opportunity for a global focused healthcare company. Small US companies with outstanding products want to tap the global market.
    High Margin IP Driven Businesses Command Superior Multiples: IP-driven medical device companies (the Salona Global acquisition candidates) have strong margins. As a result peers, listed on presentation, trade in the range of 6-15 times revenue on Nasdaq.
    EXCHANGE COMPANY REVENUE
    MULTIPLE 2020 REVENUE MARKET CAP REV GROWTH EBITDA
    NASDAQ Utah Medical 7.4 US$42.2M US$312.8M -10% 33%
    NASDAQ Cerus Corp 8.5 US$114.2M US$973.7M 22% -47%
    NASDAQ Zynex Inc 6.6 US$80.1M US$530.4M 76% 13%
    NASDAQ Tandem Diabetes Care 10.7 US$498.8M US$5.341B 38% -5%
    NASDAQ iRhythym Technologies 8.3 US$265.2M US$2.200B 24% -16%
    Source: Yhoo 5/28/21

    “We have a very powerful business model, where we can leverage several advantages by virtue of our listing on the TSXV,” said Les Cross, Chairman & interim CEO of Salona Global. “First, we have developed a deep pipeline of IP-driven medical device companies with the potential to acquire at attractive private
    Bullish
  • G
    George
    FYI...Exhibit A, underwhelming evidence there is life at Cerus...

    Cerus Issues Public Comment on HHS Notice
    6/18/2021 4:03:24 PM EDT

    WASHINGTON, June 18 -- Richard Benjamin, chief medical officer at Cerus, Concord, California, has issued a public comment on the Department of Health and Human Services notice entitled "Developing the National Public Health Strategy for the Prevention and Control of Vector-Borne Diseases in Humans". The comment was written on June 10, 2021, and posted on June 14, 2021:

    * * *

    Cerus appreciates and supports the substantial effort being undertaken to develop a national strategy on prevention and control of vector-borne diseases. Many of these vector-borne pathogens are also transfusion transmitted, necessitating inclusion of a strategy to address potential contamination of the blood supply.

    Processes and technologies for protection of the blood supply are continually under development to meet new challenges. The Food and Drug Administration (FDA) sets minimum standards for safety but independent blood centers have discretion in the methods they deploy; in other words, there is no single national strategy to address issues of blood contamination and availability. Additionally, no one solution can sufficiently tackle the enormity of a novel threat. To avoid contaminated units, one might defer donors potentially exposed to infectious agents, but this can severely limit donations and curtail blood availability for patients. Testing is only effective when available and sufficiently sensitive to be useful for donor screening. Pathogen reduction (PR) is a proactive method for mitigating a broad spectrum of viruses, bacteria and parasites; today, PR is FDA-approved for use with apheresis platelets and plasma but not yet available for red blood cells. Nonetheless, PR has and can continue to play a critical role in securing blood safety and availability.

    In 2014 in the French Antilles, for example, an outbreak of Chikungunya virus (CHIKV) threatened the self-sufficiency of local blood operations./1

    Testing was implemented as CHIKV is confirmed to be transfusion transmissible, but with testing came delays and as many as 1 out of every 55 donors tested positive./2

    Red blood cells were able to be quarantined while test results were pending, but platelets have only a few days of shelf-life. The utilization of PR became essential to preserve a ready supply of platelets. Once treated with PR, platelets were able to be released without testing and without concerns for viral transfusion transmission. In fact, it was determined in a retrospective assessment that 12 PR-platelets from CHIKV positive donations and 30 Zika virus (ZIKV) positive donations were transfused to recipients with no clinical evidence of viral transmission./3

    Similarly in French Polynesia, PR was implemented in anticipation of CHIKV and Dengue outbreaks threatening the blood supply. Unexpectedly, the islands were confronted instead with an outbreak of ZIKV. During the 12 weeks needed for development and implementation of an in-house screening assay platelets were protected by PR./4

    When a pandemic closes borders and isolates regions and countries from one another, even the largest hubs of economic and travel activity can become an island.

    FDA has issued multiple Guidance for Industry documents that recognize PR as a viable alternative to other safety measures (i.e. donor deferral or testing). In February 2016, as the ZIKV was rapidly overtaking Puerto Rico and threatening the southern continental U.S., FDA issued guidance that allowed 3 options to protect the blood supply in endemic areas: 1. discontinue collections, 2. initiate individual donation nucleic acid testing (ID NAT), or 3. treat blood products with FDA-approved PR./5

    Similarly, in May 2019, FDA issued guidance for reducing the transmission of babesiosis through transfusion that allows for use of PR "as an alternative to testing or donor questions."/6

    Robust PR processes can enable blood collection and ensure blood product availability during an outbreak./7,/8,/9

    Only a portion of blood centers across the U.S. currently have PR in use. Without national adoption of the technology, however, gaps or inconsistencies in response could result in contaminated units or substantial product shortages. While recognizing protection of the blood supply was not identified as a primary objective of the mandate from Congress, we urge you to include recommendations for the safety and availability of blood products in the national public health strategy.

    Sincerely,

    Richard Benjamin, MD PhD FRCPath

    Chief Medical Officer
    Bullish
  • M
    Moscuba
    Cerus Timeline from the Q1 21 Earnings Call

    As of May 4, 2021

    July 2021: 7 day INTERCEPT platelets in the U.S., application submission to the FDA (ramp up strong now)

    July 2021: EU Red Blood (RBC): Fourth and final module submitted for approval. Stock bump?

    Sep/Oct 2021: FDA blood Pathogen testing/mitigation recommendations are in force

    January 2022: 7 day shelf life approval “expected” (180 fast track process)

    Sep2022: EU RBC Production starts (focused on specific patient populations is possible)

    USA RBC Phase 3 completion is now unknown due to testing slowdown due to COVID. Possible March-June 2022 completion (my estimate). Originally it was hoped for completion at the end of 2021

    Take aways
    Unfortunately the changes to the EU approval process leaves RBC decision date (approval) an unknown. It will be much longer than before and no fast track like in the USA.

    The 7 day shelf life will dilute product sales growth. If the waste reduction is at least 10% (should be) the Cost benefit for the producers and providers improves (good for new sales) but they would need to consume less of Cerus products. In over simple analysis, based on 2020 USA sales that could mean a reduction of $3.5M of product revenue normally earned with shorter shelf life. It seems that with the improved CBA for the clients and the FDA guidance in effect new sales could increase enough to mitigate that.

    Since sales growth doesn't seem to have an impact on this stock the approval should have a bigger impact on the stock than a slowing of revenue growth.

    JD??? Opinion please
    Bullish
  • G
    George
    FYI..... Exhibit B (slightly better than exhibit A?),

    Cerus Corp. Files SEC Form 4, Statement of Changes in Beneficial Ownership of Securities: (Jun. 3, 2021)
    6/18/2021 5:26:35 PM EDT

    2021 JUN 18 (NewsRx) -- By a News Reporter-Staff News Editor at Health & Medicine Business Daily -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a U.S. Securities and Exchange Commission (SEC) filing by Cerus Corp. (Form 4) was posted on June 3, 2021.

    The SIC code for this company is 3841, Surgical and Medical Instruments and Apparatus.

    The SEC file number is 0001209191-21-037957.
    Bullish
  • O
    Outperform
    Curious about management and spending at this company. Do they deliver? People have been on staff for a long time. Is this the Post Office? Are they retired in place or hungry to grow share price.
  • M
    Moscuba
    If Biogen pops 50% on an approval for a drug that some say has limitations in efficacy what will happen to little CERS if RBC gets approved?
    Bullish
  • j
    jdfich
    Canada on board for platelets.
    Another $10-20 million in eventual revenues (my estimate)
    Another confirmation of Intercept’s lock on the market
    Another confirmation of the inevitability of Pathogen Reduction
    More blood banking and hospital system partners for expansion of Cryo and RBC products
    Slow. Steady. Inevitable.
  • M
    Moscuba
    Wow! Friday, up and went up the last minutes. Very unusual and welcome. I never thought I’d say we might hit $6 on the way up. Long way from the $6.50 I thought this should stop at. Oh well.
  • G
    Gearhead
    Hmmm, Baker Bros. show no change in holding for 3/31/21.
  • T
    Taylor Knows
    Time to pay attention!!!!!!!! Bought a few more thousands here in the 5.40s and would advise that it is alright to nibble here. Still think we are going to see prices under 5.25 so I am going to going to wait to load up with the intention of unloading next year at > 6.50 up to 7. Then rinse and repeat late next year when we are back in the $5 range.
  • G
    Gearhead
    Institutional Holdings, many more have reported for 1st Qtr. One very notable addition:
    Wasatch Advisors increased by 3.06 million shares (103%). They are now #8 on the list.
  • P
    Paladin
    SEC form SD filed after close today re "Conflict Minerals Disclosure". What's this about? Can't be good with the cheesy time frame release.
  • T
    Taylor Knows
    Got a nice bunch of shares @ 5.42 this morning but I think there are better buys ahead. Remember buy at $5 and below, sell at $6 and above. Take your profits because this is not along term investment. $5 stock 10 years ago, $5 stock in 2030. Stock float and operational expenses will always out grow revenue growth.
  • b
    breadguy
    held this turd for years, stock price hasn't changed. Dont believe the boards, if price rises they'll issue secondary to tank the price, its happened before, will happen again
  • D
    DLP
    How am I feeling about Cerus?🤮 Not going to live long enough to be proven wrong!
  • G
    Gearhead
    OK, Ark put out their numbers:
    down 4 million shares, 13.6%
    Primecap, down 247,000 shares, 2.3 %
    Vanguard, up 271,000, 3.1%
    Geode, up 246,000, 9.2%

    Baker Bros. not released yet, probably later today.
  • M
    Moscuba
    Friday, options expiration = OK day.

    Only 2 of my 30 puts got called. I’d have taken the $6 puts and lived with the $.33 loss on the $7 puts. So, the cash is locked up. Monday I hunt put contracts to sell.
    Bullish