FDA Approves J&J’s one shot Covid-19 Vaccine

Johnson & Johnson Covid vaccine granted emergency approval from FDA 

The Food and Drug Administration issued an emergency use authorization for the third vaccine for the prevention of coronavirus disease. The FDA has determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data “provides clear evidence that the Janssen COVID-19 Vaccine may be effective in preventing COVID-19,” the agency said in a statement.

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The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26. The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus, the FDA said. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness, it added. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

The EUA allows Johnson & Johnson’s (JNJ) Janssen COVID-19 vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

Meanwhile, Johnson & Johnson also announced that the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices has recommended its single-shot COVID-19 vaccine.

The ACIP recommendation will be forwarded to the Director of the CDC and the U.S. Department of Health and Human Services for review and adoption.

Johnson & Johnson has begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20M people in the U.S.

The company plans to deliver 100M single-shot vaccines to the U.S. during the first half of 2021. The U.S. government will manage allocation and distribution of the vaccine in the U.S.

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Palantir’s Bulls and Bears

Goldman Sachs upgrades the recent IPO while Citi says Sell

Palantir Technologies Inc. (PLTR) builds and deploys software platforms for the intelligence community in the United States to assist in counterterrorism investigations and operations.

It offers Palantir Gotham, a software platform for government operatives in the defense and intelligence sectors, which enables users to identify patterns hidden deep within datasets, ranging from signals intelligence sources to reports from confidential informants, as well as facilitates the handoff between analysts and operational users, helping operators plan and execute real-world responses to threats that have been identified within the platform.

The company also provides Palantir Foundry, a platform that transforms the ways organizations operate by creating a central operating system for their data; and allows individual users to integrate and analyze the data they need in one place. 

The company took the unusual route of becoming a public company by directly listing it’s shares and bypassing the brokers. Shares came public around $9 and shot up to $45 a share before pulling back. There were a number of brokers who made comments about the shares today following the company’s earnings.

Earnings

Palantir Technologies reported 4th Quarter December 2020 earnings of $0.07 per share on revenue of $322.1 million yesterday morning. The consensus earnings estimate was $0.02 per share on revenue of $300.4 million.

The company said it expects 2021 revenue of $1.42 billion or more. The current consensus revenue estimate is $1.41 billion for the year ending December 31, 2021.

Goldman Sachs

Goldman Sachs analyst Christopher #Merwin upgraded Palantir Technologies to Buy from Neutral with a price target of $34, up from $13. Palantir reported “strong” Q4 results and its Q1 guidance called for revenue growth of 45%, while fiscal 2021 revenue guidance was for 30%-plus, Merwin tells investors in a research note. The analyst is “encouraged” to see management guide to $4B of revenue in fiscal 2025, implying a 30% annual growth from fiscal 2020. With a growing backlog of $2.8B in deal value, there is increasing visibility into the achievability of that long-term target, says Merwin.

Further, the analyst believes Palantir’s recent efforts to modularize Foundry and add channel partners like IBM “should improve product market fit” for the commercial business in the coming quarters.

Morgan Stanley

Morgan Stanley analyst Keith #Weiss raised the firm’s price target on Palantir to $19 from $17, telling investors after the company’s Q4 report that Palantir’s results in FY20 showed a big expansion of existing customers, “huge leverage” in operating margins and the seeds for future distribution capability.

However, he keeps an Underweight rating on the shares as he would like to see evidence of effective investment behind the company’s opportunity to support growth and what he views as a “lofty valuation.”

Jefferies

Jefferies analyst Brent #Thill noted that Palantir reported a top and bottom line beat in Q4 along with “robust” large deal metrics and said it is targeting $4B or more in 2025 revenues, but that the stock remains under pressure due to Thursday’s lock-up expiry and the recent run-up that saw the stock up 35% year-to-date ahead of the report.

However, he views Palantir as “a highly unique story for long-term investors” given that he thinks its growth sustainability at significant scale, and “aggressive profitability ramp,” puts the stock “in rarified air” among software companies. Thill maintains a Buy rating on the stock, which he expects to “trend to $40,” his price target on Palantir shares.

RBC Capital

RBC Capital analyst Matthew #Hedberg raised the firm’s price target on Palantir to $27 from $15 and keeps a Sector Perform rating on the shares.

The company ended 2020 with a “solid” set of Q4 results while forecasting acceleration and margin improvement in Q1, the analyst tells investors in a research note. Hedberg adds however that while he is positive on Palantir’s catalysts, he remains on the sidelines due to the stock’s “full valuation”.

Citi

Citi analyst Tyler #Radke keeps a Sell rating on Palantir Technologies with a $15 price target following the company’s Q4 results.

The results featured “solid” reported revenue upside, but came with “signs of growth drivers narrowing with new customers growth still lacking and Commercial revenue missing expectations,” Radke tells investors in a research note.

The new five-year revenue target of $4B “looks high,” but ultimately may be a non-event for the stock, says the analyst. He thinks the stock is overvalued and “could be particularly volatile” into the upcoming lockup on February 18.

Insiders

Peter Thiel, Chairman, and well connected Washington insider

Several insiders have sold shares into the lockup expiry on Thursday but Peter Thiel, Chairman of the Board, reported a 5% ownership of the stock.

PLTR last traded at $28.50.

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Merck invests $1B in Seattle Genetics

Merck to acquire $1B equity stake in Seattle Genetics as part of collaborations

Seattle Genetics (SGEN) and Merck (MRK) announced two new strategic oncology collaborations.

The companies will globally develop and commercialize Seattle Genetics’ ladiratuzumab vedotin, an investigational antibody-drug conjugate, or ADC, targeting LIV-1, which is currently in phase 2 clinical trials for breast cancer and other solid tumors.

Merck presents results from Phase 3 KEYNOTE-426 study, Stockwinners
Merck bets heavily on Seattle Genetics, Stockwinners

The collaboration will pursue a broad joint development program evaluating ladiratuzumab vedotin as monotherapy and in combination with Merck’s anti-PD-1 therapy Keytruda in triple-negative breast cancer, hormone receptor-positive breast cancer and other LIV-1-expressing solid tumors.

Under the terms of the agreement, Seattle Genetics will receive a $600M upfront payment and Merck will make a $1B equity investment in 5M shares of Seattle Genetics common stock at a price of $200 per share.

Seattle Genetics scores bug with Merck

In addition, Seattle Genetics is eligible for progress-dependent milestone payments of up to $2.6B.

Separately, Seattle Genetics has granted Merck an exclusive license to commercialize Tukysa, a small molecule tyrosine kinase inhibitor, for the treatment of HER2-positive cancers, in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe.

Seattle Genetics will receive $125M from Merck as an upfront payment and is eligible for progress-dependent milestones of up to $65M.

Under the terms of the agreement, Seattle Genetics and Merck will collaborate and equally share costs on the global development of ladiratuzumab vedotin and other LIV-1-targeting ADCs.

Breast cancer drug Liv-1 is expected to do well

The companies have agreed to jointly develop and share future costs and profits for ladiratuzumab vedotin on a 50:50 basis worldwide. Merck will pay Seattle Genetics $600M upfront and make a $1B equity investment in 5M shares of Seattle Genetics common stock at a price of $200 per share.

In addition, Seattle Genetics will be eligible to receive up to $2.6B in milestone payments, including $850M in development milestones and $1.75B in sales milestones.

The companies will jointly develop and commercialize ladiratuzumab vedotin and equally share profits worldwide.

The companies will co-commercialize in the U.S. and Europe. Seattle Genetics will be responsible for marketing applications for approval in the U.S. and Canada, and will record sales in the U.S., Canada and Europe.

Merck will be responsible for marketing applications for approval in Europe and in countries outside the U.S. and Canada, and will record sales in countries outside the U.S., Europe and Canada. Including the upfront payment, equity investment proceeds and potential milestone payments, Seattle Genetics is eligible to receive up to $4.2B.

Under the terms of the agreement, Merck has been granted exclusive rights to commercialize Tukysa in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe. Seattle Genetics retains commercial rights and will record sales in the U.S., Canada and Europe.

Merck will be responsible for marketing applications for approval in its territory, supported by the positive results from the HER2CLIMB clinical trial.

Merck will also co-fund a portion of the Tukysa global development plan, which encompasses several ongoing and planned trials across HER2-positive cancers, including breast, colorectal, gastric and other cancers set forth in a global product development plan.

Seattle Genetics will continue to lead ongoing Tukysa global development planning and operational execution.

Merck will solely fund and conduct country-specific clinical trials necessary to support anticipated regulatory applications in its territory.

Seattle Genetics will receive from Merck $125M as an upfront payment and is eligible to receive progress-dependent milestones of up to $65M. Seattle Genetics will also receive $85M in prepaid research and development payments to be applied to Merck’s global development funding obligations. In addition, Seattle Genetics would receive tiered royalties on sales of Tukysa in Merck’s territory.

SGEN is up 14.8% to $172.40. MRK is up 1.4% to $85.00.

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American Airlines to fire 19,000 employees

American Airlines plans to cut 19,000 jobs if federal aid lapses, cuts to take effect October 1

In a regulatory filing, American Airlines (AAL) said:

“In short, American’s team will have at least 40,000 fewer people working Oct. 1 than we had when we entered this pandemic. We have worked to mitigate as many involuntary reductions as possible through voluntary programs.

Company says it will have 40,000 less employees on October 1

Across the mainline and regional carriers, more than 12,500 of our colleagues have made the difficult decision to leave the company permanently through early out programs or retirement.

Another 11,000 team members have offered to be on a leave of absence in October.

These are important life decisions and we respect and greatly appreciate the sacrifice these team members have made, and continue to make, for American and their fellow team members.

The pandemic has hurt airline the most

Even with those sacrifices, approximately 19,000 of our team members will be involuntarily furloughed or separated from the company on Oct. 1, unless there is an extension of the PSP…

The one possibility of avoiding these involuntary reductions on Oct. 1 is a clean extension of the PSP. Led by your labor unions, with the support of the industry, we have generated enormous bipartisan support for such an extension.

The overwhelming majority of members of both the U.S. House and Senate appreciate that saving jobs in the airline industry through this crisis will mean a quicker economic recovery in the months and years ahead.

And that preserving these essential service jobs will also mean continued commercial air service to all communities, small and large. But, despite this broad bipartisan support, a PSP extension is tied up in a larger COVID-19 relief package, which our elected officials haven’t yet been able to negotiate.

So we must prepare for the possibility that our nation’s leadership will not be able to find a way to further support aviation professionals and the service we provide, especially to smaller communities.”

AAL is down $0.45 to $13.00.

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Gilead submits New Drug Application for Covid-19 Treatment

Gilead submits NDA to FDA for Veklury for COVID-19 treatment

Gilead Sciences (GILD) announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for  Veklury® (remdesivir), an investigational antiviral for the treatment of patients with COVID-19.

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Gilead files for NDA for Veklury

#Veklury is currently available in the U.S. under an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19.

The filing is the final tier of the rolling NDA submission that was initiated on April 8, 2020.

The filing is supported by data from two randomized, open-label, multi-center Phase 3 clinical studies of Veklury conducted by Gilead and the Phase 3 randomized, placebo-controlled study of Veklury conducted by the National Institute of Allergy and Infectious Diseases.

These studies demonstrated that treatment with Veklury led to faster time to recovery compared with placebo and that a 5-day or 10-day treatment duration led to similar clinical improvement.

Across studies, Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups, with no new safety signals identified. Veklury has been approved by multiple regulatory authorities around the world, including in the European Union and Japan.

In countries where Veklury has not been approved, including the United States, Veklury is an investigational drug and the safety and efficacy of remdesivir have not been established.

Veklury has not been approved by the U.S. Food and Drug Administration (FDA) for any use.

In the United States, the FDA granted Veklury an Emergency Use Authorization (EUA) for the treatment of hospitalized patients with severe COVID-19. This authorization is temporary and may be revoked, and it does not take the place of the formal new drug application submission, review and approval process.

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U.S. orders 600M doses of Covid-19 vaccine candidate for $1.95B

Pfizer, BioNTech to supply U.S. government up to 600M doses of vaccine candidate

Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government’s Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021.

Pfizer to provide 600M doses of its vaccine candidate

Under the agreement, the U.S. government will receive 100 million doses of BNT162, the COVID-19 vaccine candidate jointly developed by Pfizer and BioNTech, after Pfizer successfully manufactures and obtains approval or emergency use authorization from U.S. Food and Drug Administration.

The U.S. government will pay the companies $1.95B upon the receipt of the first 100 million doses, following FDA authorization or approval. The U.S. government also can acquire up to an additional 500 million doses.

Americans will receive the vaccine for free consistent with U.S. government’s commitment for free access for COVID-19 vaccines. The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities.

The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world. BioNTech is the market authorization holder worldwide and will hold all trademarks for the potential product.

Both collaborators are committed to developing these novel vaccines with pre-clinical and clinical data at the forefront of all their decision-making.

Covid19 vaccine path to defeat the virus

The Pfizer/BioNTech vaccine development program is evaluating at least four experimental vaccines, each of which represents a unique combination of messenger RNA format and target antigen.

On July 1st, Pfizer and BioNTech announced preliminary data from BNT162b1, the most advanced of the four mRNA formulations. The early data demonstrates that BNT162b1 is able to produce neutralizing antibodies in humans at or above the levels observed in the plasma from patients who have recovered from COVID-19, and this was shown at relatively low dose levels.

Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. No serious adverse events were reported.

On July 20th, the companies announced early positive update from German Phase 1/2 COVID-19 vaccine study, including first T Cell response data.

Recently, two of the companies’ four investigational vaccine candidates received Fast Track designation from the U.S. Food and Drug Administration.

This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany as well as animal immunogenicity studies.

Further data from the ongoing Phase 1/2 clinical trials of the four vaccine candidates will enable the selection of a lead candidate and dose level for an anticipated large, global Phase 2b/3 safety and efficacy study that may begin as early as later this month, pending regulatory approval.

If the ongoing studies are successful, Pfizer and BioNTech expect to be ready to seek Emergency Use Authorization or some form of regulatory approval as early as October 2020.

The companies currently expect to manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021, subject to final dose selection from their clinical trial.

In addition to engagements with governments, Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations and World Health Organization that aims to provide governments with early access to a large portfolio of COVID-19 candidate vaccines using a range of technology platforms, produced by multiple manufacturers across the world.

PFE closed at $36.69, last traded at $38.45. BNTX closed at $91.60, it last traded at $97.60.

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IMV shares jump on it’s potential COVID-19 vaccine

IMV Inc. provides update on progress of COVID-19 vaccine program

IMV Inc. (IMV) provided further details on the company’s progress in developing its candidate vaccine to prevent COVID-19 infection in response to the global health threat posed by the novel coronavirus.

The company said, “We are working closely with regulatory agencies and our collaborators to initiate clinical studies as quickly as possible.

IMV updates it’s progress on Covid-19

The design of the phase 1 clinical study, agreed with Health Canada, is a randomized controlled study, assessing the safety and immunogenicity of DPX-COVID-19, in 84 healthy adults across two age cohorts: (1) adults between 18-55 years old inclusive and (2) 56 and above. Two dose levels of DPX-COVID-19 will be tested (25 undefined or 50 undefined).

We are pleased that Health Canada has welcomed the design of a phase 1 trial that includes this vulnerable population.

The rapid progress in target selection, the vaccine formulation, manufacturing and preclinical results so far not only demonstrate the potential of our delivery platform, but also build on our previously reported clinical data from a similarly designed vaccine against RSV, the respiratory syncytial virus.

Clinical results have shown our DPX-based vaccine against RSV demonstrated a unique ability to generate safe and long-lasting immune responses in older adults.

IMV’s candidate vaccine, DPX-COVID-19, is based on IMV’s first-in-class delivery platform that generates targeted and sustained immune response in vivo.

Fully synthetic, the vaccine candidate is designed to focus the immune response on the weaknesses of the virus with the goal to optimize safety and efficacy: DPX-COVID-19 is a formulation of the DPX delivery platform with four complementary peptide antigens that were selected for their high immunogenicity and ability to bind non-overlapping areas on the virus spike and impact its infective function in preclinical studies, Importantly, our selected targets are located outside of the 614 mutation which, according to recent research, has been demonstrated to increase the virus’ ability to infect cells in vitro and suggested to potentially reduce vaccine-induced immunity.

We believe our vaccine candidate would retain its potential efficacy independently from current/future mutations of the virus at this site, Areas on the virus spike identified as potentially responsible for vaccine-enhanced disease4 have been excluded from our target selection to minimize safety risk.

Since the Company announced the selection of its candidate vaccine on May 21st, the Company has made significant progress.

Preclinical studies have demonstrated the capacity of DPX-COVID-19 to induce strong immunogenicity including the binding on target to the spike protein and viral neutralization, The Company has completed the current good manufacturing practice (“cGMP”) formulation and manufacturing process development for DPX-COVID-19, and Multiple batches have been successfully produced at IMV.”

IMV closed at $3.00, last traded at $7.00.

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Mohawk shares tumble on investors lawsuit

Mississippi Retirement System sues the carpet maker

In January, the Public Employees’ Retirement System of Mississippi filed a lawsuit claiming accounting fraud at Mohawk (MHK). The suit did not get a lot of attention at the time, but new filings submitted in late June add significant details about the allegations.

According to analysts, the filing includes testimony from a former Mohawk employee who claims the company has used fictitious sales to artificially boost revenue since 2017.

JPMorgan

JPMorgan analyst Michael Rehaut noted earlier that the Public Employees’ Retirement System of Mississippi, as part of a consolidated class action complaint filing dated June 29, gave “significant incremental details” regarding claims that Mohawk engaged in channel stuffing at the end of the quarter and intentionally overproduced product.

MPERS sues Mohawk Industries

While “the veracity of these accusations will likely not be determined until after an extended legal process” of several months if not longer, Rehaut sees the lawsuit as likely to remain an overhang on the stock until this matter concludes.

He also sees the “fairly granular level of detail across the allegations” and quotes from interviews with several former employees creating a higher level of risk for the company from this lawsuit, added the analyst, who keeps a Neutral rating on Mohawk shares.

SunTrust

A shareholder lawsuit filed earlier this year has recently added new court filings that allege multiple issues inside Mohawk Industries, the most damaging allegation being its revenue recognition practices which included shipping goods on the last day of the quarter and then having those as returns in the following quarter, SunTrust analyst Keith Hughes tells investors in a research note.

The allegations being made during the company’s quiet period “have hamstrung any response,” says Hughes, who admits “it is hard to say as an outsider whether these have merit at this point.” However, given the size of Mohawk, it would need “widespread practices to boost revenues via the method” alleged, adds the analyst, who keeps a Buy rating on Mohawk with a $119 price target.

Wells Fargo

Wells Fargo analyst Truman Patterson notes that the Public Employees’ Retirement System of Mississippi has filed a Class Action Complaint against Mohawk and CEO Jeff Lorberbaum, claiming the company engaged in a “fraudulent scheme to fabricate revenues through fictitious ‘sales’ of products that were not delivered to customers and to conceal from investors the true reasons for the company’s ballooning inventory,” damaging shareholders between April 2017 and July 2019.

While Mohawk stakeholders have known about the lawsuit since early January, filings have only recently become publicly available, which the analyst believes drove shares down on Wednesday. Patterson expresses no opinion on the validity of the allegations against the company, but acknowledges that they would clearly be a negative if proven to be true, likely damaging shareholder confidence in management. The analyst has an Underweight rating and an $80 price target on the stock.

The stock is down 19% to $74.10. The question now shifts to whether the allegations will result in a full SEC investigation.

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NanoViricides shares jump on it’s potential Covid-19 drug

NanoViricides announces safety results from drug candidates against SARS-CoV-2

NanoViricides (NNVC) announced that safety and tolerability of the drug candidates it is developing against SARS-CoV-2 to treat COVID-19 spectrum of diseases was observed in an animal model.

The company said the nanoviricides drug candidates tested in this safety/tolerability study have previously shown strong effectiveness against lung infection by a SARS-CoV-2 like coronavirus, namely, hCoV-NL63, in an animal study as previously reported by the company.

Three different drug candidates at three different dosage levels and vehicle control were administered to separate groups of mice intravenously in the Safety-Tolerability study.

Clinical observations and gross post-mortem studies have been completed.

The tested drug candidates were safe and well tolerated, thereby clearing the path for further development towards a treatment for SARS-CoV-2 infection that has caused the current COVID-19 pandemic.

Nanoviricides are designed to act by a novel mechanism of action, trapping the virus particle.

Antibodies, in contrast, only label the virus for other components of the immune system to take care of. It is well known that the immune system is not functioning properly at least in severe COVID-19 patients.

Additionally, it is well known that viruses escape antibody-drugs via mutations.

The company’s “nanoviricide” drug candidates, in contrast, are designed to be broad-spectrum, and therefore virus escape by mutations is expected to be unlikely.

In this Safety/Tolerability Study, there were no clinical signs of immune or allergic reactions such as itching, biting, twitching, rough coat, etc.

Further, there were no observable changes in any organs including large intestine or colon on post mortem in gross histology. The only reportable changes observed were, in the high dosage groups of two of the three drug candidates tested, associated with the non-absorption of water, in the colon.

This is consistent with the clinical observation of very loosened stools in the same groups. In clinical usage, the drug candidates are not anticipated to be administered in such high levels. The objective of this study was to discover the dosage level at which such an effect may occur.

Sixteen mice in each group were administered one of the three drug candidates at one of the three dose levels, and additionally, one group was administered vehicle control, for seven days by daily tail-vein intravenous infusion in this blinded study with additional evaluations on eighth day.

This non-GLP safety/tolerability study was conducted under GLP-like conditions.

The company believes that loose or very loose stools at very high dosages in such a study is an expected and acceptable side effect of the polyethylene glycol, or PEG, moiety, which forms the backbone of the nanoviricides drug candidates.

PEG is used prior to colonoscopy in humans to promote loose stools and internal cleaning of the intestines, by causing non-absorption of water.

The company has previously reported that these drug candidates have shown strong effectiveness in a lethal lung infection model in rats using a coronavirus that uses the same ACE2 receptor as SARS-CoV-2 which causes COVID-19, namely hCoV-NL63.

The company has found that hCoV-NL63, which causes a milder disease than SARS-CoV-2, causes substantially similar clinical pathology in this efficacy animal model as has been reported for SARS-CoV-2 associated lung infections in humans. In this previously reported lethal direct-lung-infection model efficacy study, animals in all groups developed lung disease which later led to multi-organ failures, a clinical pathology resembling that of the SARS-CoV-2.

Reduction in loss of body weight at day seven was used as the primary indicator of drug effectiveness. Rats were infected directly into lungs with lethal amounts of hCoV-NL63 virus particles and then different groups were treated separately with five different nanoviricides drug candidates, remdesivir as a positive control, and the vehicle as a negative control.

The treatment was intravenous by tail-vein injection once daily for five days, except in the case of remdesivir wherein it was by tail-vein injection twice daily. In this efficacy study, animals treated with the five different nanoviricides showed significantly reduced body weight loss.

The body weight loss in female animals ranged from only 3.9% to 11.2% in the different nanoviricide-treated groups, as compared to 20% in vehicle-treated control group, and 15.2% in a remdesivir-treated group. The body weight loss in male animals ranged from 8% to 10.9% in the different nanoviricides-treated groups, as compared to 25% in the vehicle-treated control group, and 18.6% in remdesivir-treated group.

Smaller numbers mean less loss in body weight compared to starting body weight in the group, and indicate greater drug effectiveness.

The effectiveness of nanoviricide drug candidates in the lung-infection model is consistent with the effectiveness observed in cell culture studies against infection of both hCoV-NL63, which was used in the efficacy study, and hCoV-229E, another circulating coronavirus that uses a distinctly different receptor, namely APN. Prior to filing for human clinical trials,

NanoViricides plans on requesting a pre-IND Meeting with the FDA for regulatory guidance.

NNVC is up $2.04 to $8.97.

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National General sold for $4 billion

Allstate to acquire National General for $34.50 per share, in cash

Allstate (ALL) has agreed to acquire National General (NGHC) for approximately $4B in cash, or $34.50 per share.

The companies said in a release, “The transaction is expected to close in early 2021, subject to regulatory approvals and other customary closing conditions.

National General sold for $4B

National General provides a wide range of property-liability products through independent agents with a significant presence in non-standard auto insurance.

The company also has attractive Accident and Health and Lender-Placed Insurance businesses.

Gross premiums written were $5.6 billion, which generated operating income of $319 million in 2019.

National General shareholders will receive $32.00 per share in cash from Allstate, plus closing dividends expected to be $2.50 per share, providing $34.50 in total value per share.

Allstate will fund the share purchase by deploying $2.2 billion in combined cash resources and, subject to market conditions, issuing $1.5 billion of new senior debt.

Allstate expects to maintain its current share repurchase program.

National General’s board of directors has approved the transaction, which includes customary terms and conditions, including a breakup fee of $132.5 million.

A voting agreement has also been signed with entities controlling 40% of National General’s common shares to vote for the transaction.

MSD Capital, which owns approximately 7.4% of National General’s outstanding common shares, also supports the transaction.

NGHC closed at $20.41.

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Novavax receives $1.6B funding from Operation Warp Speed

Novavax soars after receiving $1.6B vaccine funding

Shares of Novavax (NVAX) soared after the company said on Tuesday morning that it has received $1.6B in funding from the federal government’s accelerated COVID-19 vaccine development program.

The company has been selected to participate in Operation Warp Speed, which aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 in 2021.

Novavax receives $1.6B funding from U.S. Government

The company said the funds will be used to complete late-stage clinical development of its vaccine candidate called NVX-CoV2373, including a Phase 3 trial, and to scale up manufacturing.

The company is aiming to deliver 100 million doses of the vaccine, as early as late 2020, it said.

The agreement will fund the late-stage clinical studies necessary to determine the safety and efficacy of NVX-CoV2373, including a pivotal Phase 3 clinical trial with up to 30,000 subjects beginning in the fall of 2020.

A Phase 1/2 clinical trial of NVX-CoV2373 in 130 healthy participants 18 to 59 years of age was launched in Australia in May, Novavax said, adding that preliminary immunogenicity and safety results are expected at the end of July, and the Phase 2 portion to assess immunity, safety, and COVID-19 disease reduction is expected to begin after that.

The Phase 1/2 trial is being supported by up to $388M in funding from the Oslo-based Coalition for Epidemic Preparedness Innovations Novavax President and CEO Stanley Erck said in a statement that “The pandemic has caused an unprecedented public health crisis, making it more important than ever that industry, government and funding entities join forces to defeat the novel coronavirus together.

We are honored to partner with Operation Warp Speed to move our vaccine candidate forward with extraordinary urgency in the quest to provide vital protection to our nation’s population.”

Novavax has been awarded $1.6B by the federal government to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100M doses of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate, as early as late 2020.

NVX-CoV2373 consists of a stable, prefusion protein made using its proprietary nanoparticle technology and includes Novavax’ proprietary Matrix-M adjuvant.

Under the terms of the agreement, Novavax will demonstrate it can rapidly stand up large-scale manufacturing and transition into ongoing production, including the capability to stockpile and distribute large quantities of NVX-CoV2373 when needed.

The agreement will fund the late-stage clinical studies necessary to determine the safety and efficacy of NVX-CoV2373, including a pivotal Phase 3 clinical trial with up to 30,000 subjects beginning in the fall of 2020.

The agreement also allows for a follow-on agreement with the U.S. government for additional production and procurement to support OWS’ vaccine production goal.

This latest federal funding supports Novavax plans to file submissions for licensure with the U.S. FDA.

NVAX closed at $79.44, last traded at $105.42.

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Uber buys Postmates for $2.65B

 Uber to acquire Postmates for $2.65B in all-stock transaction

Uber and Postmates announced that they have reached a definitive agreement under which Uber will acquire Postmates for approximately $2.65B in an all-stock transaction.

Uber buys Postmates

This transaction brings together Uber’s global Rides and Eats platform with Postmates’ delivery business in the U.S.

Additionally, Postmates has been an early pioneer of “delivery-as-a-service,” which complements Uber’s efforts in the delivery of groceries, essentials and other goods.

For restaurants and merchants, Postmates and Uber Eats will together offer more tools and technology to connect with a bigger consumer base.

Following the closing of the transaction, Uber intends to keep the consumer-facing Postmates app running separately.

Uber currently estimates that it will issue approximately 84M shares of common stock for 100% of the fully diluted equity of Postmates.

The boards of directors of both companies have approved the transaction, and stockholders representing a majority of Postmates’ outstanding shares have committed to support the transaction.

The transaction is subject to the approval of Postmates stockholders, regulatory approval and other customary closing conditions and is expected to close in Q1 2021.

Uber consolidates its market position by buying Postmates

Like other travel- and transportation-related businesses, Uber’s ride-hailing segment has been negatively impacted by the COVID-19 pandemic, due to shelter-in-place orders throughout the United States.

On-demand delivery, however, has grown, with people relying on services like Uber Eats to get food without leaving their homes. According to its last earnings report, Uber’s ride-hailing gross bookings dropped, but its food delivery service saw gross sales growth of 54% during its first fiscal quarter.

UBER closed at $30.68.

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Pfizer and BioNTech report promising data on Covid-19 vaccine

Pfizer, BioNTech announce early data from Phase 1/2 study of vaccine candidate

Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced preliminary U.S. data from the most advanced of four investigational vaccine candidates from their BNT162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2, the virus causing the current global pandemic.

The BNT162 program is evaluating at least four experimental vaccines, each of which represents a unique combination of mRNA format and target antigen.

Pfizer reports preliminary positive data

The manuscript describing the preliminary clinical data for the nucleoside-modified messenger RNA candidate, BNT162b1, which encodes an optimized SARS-CoV-2 receptor binding domain antigen, is available and is concurrently undergoing scientific peer-review for potential publication.

Overall, the preliminary data demonstrated that BNT162b1 could be administered in a dose that was well tolerated and generated dose dependent immunogenicity, as measured by RBD-binding IgG concentrations and SARS-CoV-2 neutralizing antibody titers.

The ongoing U.S. Phase 1/2 randomized, placebo-controlled, observer-blinded study is evaluating the safety, tolerability, and immunogenicity of escalating dose levels of BNT162b1. The initial part of the study included 45 healthy adults 18 to 55 years of age.

Preliminary data for BNT162b1 was evaluated for 24 subjects who received two injections of 10 microgram and 30 microgram, 12 subjects who received a single injection of 100 microgram, and 9 subjects who received 2 doses of placebo control.

The participants received two doses, 21 days apart, of placebo, 10 microgram or 30 microgram of BNT162b1, or received a single dose of 100 microgram of the vaccine candidate.

Because of a strong vaccine booster effect, the highest neutralizing titers were observed seven days after the second dose of 10 microgram or 30 microgram on day 28 after vaccination.

The neutralizing GMTs were 168 and 267 for the 10 microgram and 30 microgram dose levels, respectively, corresponding to 1.8- and 2.8-times the neutralizing GMT of 94 observed in a panel of 38 sera from subjects who had contracted SARS-CoV-2.

In all 24 subjects who received 2 vaccinations at 10 microgram and 30 microgram dose levels of BNT162b1, elevation of RBD-binding IgG concentrations was observed after the second injection with respective GMCs of 4,813 units/ml and 27,872 units/ml at day 28, seven days after immunization.

These concentrations are 8- and 46.3-times the GMC of 602 units/ml in a panel of 38 sera from subjects who had contracted SARS-CoV-2.

At day 21 after a single injection, the 12 subjects who received 100 microgram of BNT162b1 had an RBD-binding IgG GMC of 1,778 units/ml and a SARS-CoV neutralizing GMT of 33, which are 3-times and 0.35-times, respectively, the GMC and GMT of the convalescent serum panel.

At the 10 microgram or 30 microgram dose levels, adverse reactions, including low grade fever, were more common after the second dose than the first dose.

Following dose 2, 8.3% of participants who received 10 microgram and 75.0% of participants who received 30 microgram BNT162b1 reported fever greater than or equal to 38.0 degrees C.

Local reactions and systemic events after injection with 10 microgram and 30 microgram of BNT162b1 were dose-dependent, generally mild to moderate, and transient.

The most commonly reported local reaction was injection site pain, which was mild to moderate, except in one of 12 subjects who received a 100 microgram dose, which was severe. No serious adverse events were reported.

Given higher numbers of subjects experiencing local reactions and systemic events after a single 100 microgram dose with no significant increases in immunogenicity compared to the 30 microgram dose level, the 12 participants in the 100 microgram group were not administered a second dose.

These preliminary data, together with additional preclinical and clinical data being generated, will be used by the two companies to determine a dose level and select among multiple vaccine candidates to seek to progress to a large, global Phase 2b/3 safety and efficacy trial.

That trial may involve up to 30,000 healthy participants and is anticipated to begin in late July 2020, if regulatory approval to proceed is received.

The preliminary clinical data from this ongoing study has been submitted for potential publication in a peer-reviewed journal and is available on an online preprint manuscript server.

The BNT162b1 candidate remains under clinical study and is not currently approved for distribution anywhere in the world. If the ongoing studies are successful and the vaccine candidate receives regulatory approval, the companies expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.

In that event, BioNTech and Pfizer would work jointly to distribute the potential COVID-19 vaccine worldwide.

The Canadian company provides lipid nanoparticles or the formulation of various mRNA vaccines.

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Optinose shares soar on its potential Covid-19 treatment

Optinose announces anti-COVID-19 product candidate

Optinose (OPTN) announced initiation of development of a new product candidate, OPN-019.

OptiNose, Inc. focuses on the development and commercialization of products for patients treated by ear, nose, and throat; and allergy specialists in the United States.

OPN-019 will combine the Company’s proprietary nasal Exhalation Delivery System technology with an antiseptic that has been recently shown in vitro to kill the virus that causes COVID-19.

Because components of the drug-device combination product candidate, including both the active drug and delivery device, are currently commercially available in the U.S., the Company expects to be able to rapidly progress to a meeting with FDA to discuss an IND and then onward to clinical trials.

OptiNose uses this device to deliver its medicine

The Company is focused on supporting the initial stages of development within its current operating expense plan and intends to seek grants, partnerships, and/or other sources of capital to fund future development.

The company offers XHANCE, a therapeutic product utilizing its proprietary optinose exhalation delivery system that delivers a topically-acting and anti-inflammatory corticosteroid for the treatment of chronic rhinosinusitis with and without nasal polyps. It is also developing XHANCE, which is in Phase IIIb clinical trial for the treatment of chronic sinusitis; and OPN-300 for the treatment of Prader-Willi syndrome, a rare genetic obesity disorder, as well as autism spectrum disorder. 

Note that this company is losing money and none of its products have been approved by FDA yet.

OPTN closed at $6.42, last traded at $8.70.

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Monopar files for patent for Covid-19 treatment

Monopar, NorthStar file provisional patent for development, use of RITs

Monopar Therapeutics (MNPR) and NorthStar Medical Radioisotopes announced that a provisional patent application entitled “Precision Radioimmunotherapeutic Targeting of the Urokinase Plasminogen Activator Receptor for Treatment of Severe COVID-19 Disease” has been filed with the U.S. Patent and Trademark Office.

The patent application offers hope for Covid-19 patients, Stockwinners

This application covers novel compositions and uses of cytotoxic radioisotopes attached to antibodies that bind to uPAR, thereby creating precision targeted radiotherapeutics for the treatment of severe COVID-19 and other respiratory diseases.

Advanced COVID-19 patients frequently develop severe, life-threatening, pulmonary inflammation as a result of a viral induced cytokine storm.

The development of this cytokine storm is associated with a high rate of mortality in severe COVID-19 patients, even with oxygen support and mechanical ventilation.

A severe immune reaction in which the body releases too many cytokines into the blood too quickly. Cytokines play an important role in normal immune responses, but having a large amount of them released in the body all at once can be harmful. A cytokine storm can occur as a result of an infection, autoimmune condition, or other disease. It may also occur after treatment with some types of immunotherapy.

Signs and symptoms include high fever, inflammation (redness and swelling), and severe fatigue and nausea. Sometimes, a cytokine storm may be severe or life threatening and lead to multiple organ failure. Also called hypercytokinemia.

uPRITs have been designed with the goal of selectively destroying the aberrantly activated white blood cells responsible for causing the cytokine storm.

If successful, healthy tissue would be spared in the process as the uPAR target is primarily only present on this unique class of white blood cells and not in healthy tissue.

The co-inventors of the provisional patent application are James Harvey, Chief Scientific Officer of NorthStar, and Andrew P. Mazar, Chief Scientific Officer of Monopar.

If granted, the patent would offer exclusivity to Monopar and NorthStar for the development and potential use of uPRITs in the treatment of severe COVID-19 and other respiratory diseases.

This provisional patent application leverages the therapeutic radioisotope expertise of NorthStar and the translational expertise of Monopar to create a novel, targeted radioimmunotherapeutic.

Radioimmunotherapy uses an antibody labeled with a radionuclide to deliver cytotoxic radiation to a target cell. In cancer therapy, an antibody with specificity for a tumor-associated antigen is used to deliver a lethal dose of radiation to the tumor cells.

On June 16, 2020, Monopar and NorthStar announced a 50/50 collaboration to couple Monopar’s MNPR-101 uPAR targeting monoclonal antibody to a therapeutic radioisotope provided by NorthStar.

MNPR closed at $6.91.

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