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Friday, April 16, 2021

Short-Seller’s Note is Short on Credibility: LifeMD

  LifeMD, Inc. (“the Company”) (NASDAQ: LFMD), a leading direct-to-patient telehealth company, released a letter to shareholders today in response to an error-ridden “research note” published by an entity called Culper Research. Culper is an anonymous short-seller that refuses to disclose the individuals or entities behind it.

“LifeMD uses technology to make health care more accessible to people from all walks of life. By directly providing telemedicine to patients, we help them confront the health issues that dramatically impact the quality of their lives,” said Justin Schreiber, LifeMD’s Chairman and CEO.

“We pursue this mission with transparency and integrity, so it is troubling that an anonymous short-seller would make reckless allegations about our company seemingly with the sole intent of causing a drop in our share price for his or her own personal gain. The author of this report is utterly lacking in credibility, as its numerous errors, distortions and half-truths show.”

Schreiber and the company’s CTO Stefan Galluppi jointly issued an open letter to shareholders on the company’s website (link here), in which they addressed Culper’s meritless allegations in detail. It identifies numerous errors and basic problems with the report’s credibility, including:

  • Culper distorts Galluppi’s and Schreiber’s relationship with Redwood Scientific. Schreiber held a passive investment and non-controlling interest in the company, and Galluppi left the company two and a half years before it was investigated by the Federal Trade Commission.

  • Culper lies about LifeMD’s licensing practices. LifeMD takes the utmost care in creating an environment that fosters the highest standard of care for our patients. LifeMD’s physician network consists of nearly 90 board-certified and monitored doctors who legally dispense prescription medications; LifeMD has never allowed an unlicensed physician to perform a telehealth consult for any of its brands. In the rare instance we discover that one of the doctors in our network has a regulatory issue, we remove that doctor immediately – as we did in the case of Dr. Badii. In the case of Dr. Kalter, he was mistakenly described as a California physician on our website. When we became aware of the web design error, we fixed it immediately. Dr. Kalter never wrote a single prescription for us in California.

  • Culper misrepresents the facts about Veritas MD, the platform we used for ~25% of all telehealth consults in Q1 and expect to be using for 100% of consults by the end of Q2. Apparently under the misimpression it was intended to be a consumer-facing app, Culper fails to understand it is our technological backbone, driving the complete and full lifecycle of patient engagement. This process extends from patient intake, patient queries and follow-ups, doctor engagement, and pharmacy services to billing. Everything we have disclosed about our LifeMD digital health platform, also known as VeritasMD, is accurate.

Schreiber took exception to the dishonest way in which Culper writes about LifeMD’s treatment of its shareholders. “LifeMD began as a start-up, financed through multiple rounds of venture capital funding. In doing so, some of the most sophisticated institutional investors and advisors in the world have conducted countless hours of extensive due diligence validating LifeMD prior to investing,” he said.

Horizon: New Long-Term Data for UPLIZNA for Neuromyelitis Optica Spectrum Disorder

 -- Presentation at American Academy of Neurology’s 73rd Annual Meeting shows no new safety signals with prolonged use of UPLIZNA --

-- UPLIZNA continues to lower the rate of NMOSD attacks throughout the four-year open-label period (OLP) --

-- Results from NMOSD patient survey describe long and daunting journey to diagnosis --

https://finance.yahoo.com/news/long-term-data-uplizna-inebilizumab-123000650.html

Iovance started at Buy by Goldman

 Target $97

https://finviz.com/quote.ashx?t=IOVA

CureVac readies mRNA doses for deployment

 The European Union is looking to shake up its COVID-19 vaccination game plan following a turbulent start to the rollout, presenting an opportune moment for mRNA vaccine developer CureVac to enter the scene. Eying a potential market debut in the coming months, the biotech has already started vaccine production.

CureVac, which has started a rolling review process for its two-dose vaccine with the European Medicines Agency, plans to release late-stage trial results in the coming weeks, CEO Franz-Werner Haas said on a call with analysts Thursday. Depending on the results, the company expects that EU authorization for its shot, CVnCoV, could come in the beginning of June, Haas told CNBC last week.

The company’s most critical phase 2/3 trials are now fully enrolled, Haas said Thursday. The data produced should be enough for the company to finalize its application with the EMA in the second quarter. 

The Tübingen, Germany-based biotech has several European partners helping produce its shot, including GlaxoSmithKline, Bayer and Novartis. The company is now predicting an output of 1 billion doses in 2022, up from its previous estimate of 600 million, Haas said.

For this year, meanwhile, CureVac plans on producing 300 million doses of CVnCoV. Europe has already claimed 225 million initial doses, with an option for an additional 180 million under a supply deal signed last year. 

“We are already producing CVnCoV doses at risk to readily supply CVnCoV at the time of a potential market authorization,” Haas said Thursday. 


The timing of CureVac’s vaccine is critical for Europe, which has stumbled to administer jabs from AstraZeneca and J&J following reports of rare and serious blood clots. J&J halted its vaccine deliveries to the EU earlier this week following the recommendation from top U.S. health agencies to put its shot on hold while experts investigate the cases. 

The decision bewildered officials in Europe, who sought more clarification about the “completely unexpected” announcement, Reuters reported Tuesday. Italian newspaper La Stampa subsequently reported Wednesday that the commission has opted against renewing its vaccine contracts with AstraZeneca and J&J once they expire at the end of the year. 

The bloc will now likely lean more on mRNA vaccines, a source from the Italian health ministry told the newspaper. On Wednesday, EU Commission President Ursula von der Leyen said Pfizer will supply the bloc with an additional 50 million doses during the second quarter this year. More supply deals could be coming, von der Leyen said.

While CureVac’s two-dose shot is months behind those produced by Pfizer/BioNTech and Moderna, its storage requirements aren't as stringent as the authorized mRNA shots.

"There is much more vaccines needed than available, and certainly we are talking ... primarily with the governments but also international organizations," Haas said, referring to COVAX, the global vaccine distribution effort looking to deploy doses in low-income countries. 


Since the vaccine’s late-stage clinical trials began in December as variants of Sars-CoV-2 began to emerge, it’s likely those mutations will affect the results, Ulrike Gnad-Vogt, CureVac’s interim chief development officer, said on the call. The company is also testing its shot alongside an influenza vaccine to determine if they’re compatible, Gnad-Vogt said. 

https://www.fiercepharma.com/pharma/europe-s-vaccine-rollout-slagging-after-j-j-and-az-holdups-curevac-readies-doses-for

J&J asked rival COVID-19 vaccine makers to probe clotting risks

 Johnson & Johnson had reached out to rival COVID-19 vaccine makers to join in an effort to study the risks of blood clots, the Wall Street Journal reported on Friday, citing people familiar with the matter.

AstraZeneca, which had been buffeted by similar blood-clotting concerns for weeks, agreed, while Pfizer Inc and Moderna executive declined, saying their vaccines appeared safe, the report said. (https://on.wsj.com/2Q7E4Ho)

The U.S. federal health agencies had on Tuesday recommended pausing use of Johnson & Johnson's vaccine for at least a few days after six women under the age of 50 developed rare blood clots after receiving the shot.

Last week, European regulators said they were reviewing rare blood clots in four recipients of the J&J shot in the United States, after which, the WSJ report said, the company began to reach out to other vaccine makers.

Pfizer and Moderna also objected because they did not see the need to duplicate the efforts of agencies and companies that were already looking for blood-clot cases and investigating the cause, according to the report.

The specific adverse event has not been reported by those who received the Pfizer and Moderna vaccines, the companies had said.

J&J, AstraZeneca, Pfizer and Moderna were not immediately available for comments on the report.

https://finance.yahoo.com/news/1-johnson-johnson-asked-rival-113528640.html

TG Therapeutics: Positive Results from Phase 3 Trials of Ublituximab in MS

 Ublituximab demonstrated superiority versus teriflunomide in reducing annualized relapse rates and MRI brain lesions

Ublituximab was generally well tolerated, with no unexpected safety signals

BLA submission targeted in Q3 2021

Webcast to be held today, Friday, April 16, 2021 at 8:30 AM ET

Live Webcast: http://ir.tgtherapeutics.com/events (also archived for future review)

https://finance.yahoo.com/news/tg-therapeutics-announces-positive-results-113000006.html

Recursion Pharma prices IPO

 Recursion Pharmaceuticals, Inc. ("Recursion" or "we") today announced the pricing of its initial public offering of its Class A common stock at a price to the public of $18.00 per share. Recursion is offering 24,242,424 shares of its Class A common stock. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Recursion, are expected to be $436.4 million, excluding any exercise of the underwriters' option to purchase additional shares. The shares are expected to begin trading on the Nasdaq Global Select Market on April 16, 2021 under the symbol "RXRX" and the offering is expected to close on April 20, 2021, subject to customary closing conditions. In addition, Recursion has granted the underwriters a 30-day option to purchase up to an additional 3,636,363 shares of its common stock at the initial public offering price, less the underwriting discounts and commissions.

Goldman Sachs & Co. LLC and J.P. Morgan are acting as lead book-running managers for the offering. BofA Securities, SVB Leerink, Allen & Company LLC, and KeyBanc Capital Markets are acting as book running managers for the offering.

https://finance.yahoo.com/news/recursion-pharmaceuticals-announces-pricing-initial-041300254.html