Therapeutics Candidates in Focus as Covid Data Heads Back to Front Burner (MRK, OTLC, PFE, JNJ, NVAX, BNTX, AZN, MRNA)

We are increasingly seeing signs that the pandemic is hardly over. The European Union is battling record case levels. Areas of the US are starting to see some similar dynamics. Hospitals in the developed world are beginning to fill back up with Covid patients. It’s a familiar pattern.

This shouldn’t come as a total shock as we start to move back into cold and flu season in the northern hemisphere. But the pace of the worsening of conditions may become a point of worry for market participants. And investors haven’t been paying attention.

As a result, stocks that play a large part in the Covid narrative – especially those with ties to the post-diagnostic treatment story – could become increasingly important over the near term once Mr. Market notices the theme once again. With that in mind, we take a look below at a handful of key plays that fit this description.

Pfizer Inc. (NYSE:PFE) has become perhaps the leading player in our societal battle against Covid-19. The company’s recent moves have positioned it as the big winner in the narrative at this point. But other names have been in that position at other stages of this process, and the game has changed several times.

Pfizer bills itself as a research-based global biopharmaceutical company that engages in the discovery, development, manufacture, marketing, sales, and distribution of biopharmaceutical products worldwide, working across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases.

Pfizer Inc. (NYSE:PFE) recently announced it is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, PAXLOVID™ (PF-07321332; ritonavir), for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death. This submission to the U.S. Food and Drug Administration (FDA) includes clinical data from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) interim analysis. Rolling submission of non-clinical data for PAXLOVID was initiated with the U.S. FDA in October 2021.

“With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options. The overwhelming efficacy achieved in our recent clinical study of PAXLOVID, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world.”

If you’re long this stock, then you’re liking how the stock has responded to the announcement. PFE shares have been moving higher over the past week overall, pushing about 3% to the upside on above average trading volume. Shares of the stock have powered higher over the past month, rallying roughly 19% in that time on strong overall action. 

Pfizer Inc. (NYSE:PFE) managed to rope in revenues totaling $24.1B in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 98.6%, as compared to year-ago data in comparable terms. In addition, the company is battling some balance sheet hurdles, with cash levels struggling to keep up with current liabilities ($29.7B against $41.8B, respectively).

Oncotelic Therapeutics Inc (OTC US:OTLC) is possibly both the most interesting and easiest to overlook name on this list right now. The company bills itself as an artificial intelligence driven immuno-oncology company with a robust pipeline of first in class TGF-β immunotherapies for late stage cancers such as gliomas, pancreatic cancer and melanoma. However, thanks to its recent strides on the trial side, it may also be set for stardom as one of the most important Covid-19 play as the story develops over coming weeks and months.

OT-101, the lead immuno-oncology drug candidate of Oncotelic, is a first-in-class anti-TGF-β RNA therapeutic that exhibited single agent activity in relapsed/refractory cancer patients. OT-101 also has shown activity against SARS-CoV-2 and has completed a phase 2 trial against COVID-19, with data cleaning and evaluation and datalock ongoing. 

Oncotelic Therapeutics Inc (OTC US:OTLC) most recently announced that its COVID-19 trial for OT-101 as a post-diagnosis therapeutic has successfully met its safety and efficacy endpoints. OT-101, a first-in-class anti-TGF-β ribonucleic acid therapeutic that has exhibited single agent activity in relapsed/refractory cancer patients in multiple clinical trials, has also demonstrated activity against the SARS-CoV-2 virus.

On October 18, Data lock and Study Data and Analysis Data Models (SDTMs & ADaMS Databases) were generated for a Phase 2 C001 Covid Study: “A Double-Blind, Randomized, Placebo Controlled, Multi-Center Study of OT-101 in Hospitalized COVID-19 Subjects”. The trial compares OT-101 + Standard of Care (“SOC”) versus Placebo + SOC (N= 32 pts at 2:1 randomization ratio). SOC includes dexamethasone, the only drug known to improve outcomes in severe cases of COVID-19. 

The top line data concluded that OT-101 met its endpoints as a TGF-β inhibitor in terms of both safety and efficacy, including a statistically significant reduction in mortality and viral load, compared to its placebo – with overall survival improving 3X for critical COVID-19 pts (4 days for placebo versus 14 days for OT-101, p < 0.0166).

Oncotelic Therapeutics Inc (OTC US:OTLC) CEO, Dr. Vuong Trieu, noted, “It is gratifying that the TGF-β concept that we put forward has now been validated. The data form the basis for further development of OT-101 as a viable treatment for severe respiratory viral infections, including flu and COVID-19. We thank the patients and investigators involved, especially Dr. Carbajal of Calle Mariscal Sucre, Chancay, Huaral, Lima, Peru, who drove the study to its conclusion.”

Merck (NYSE:MRK) operates as a healthcare company worldwide through its Pharmaceutical and Animal Health segments. The Pharmaceutical segment offers human health pharmaceutical products in the areas of oncology, hospital acute care, immunology, neuroscience, virology, cardiovascular, diabetes, and women’s health, as well as vaccine products. The Animal Health segment discovers, develops, manufactures, and markets veterinary pharmaceuticals, vaccines, and health management solutions and services, as well as digitally connected identification, traceability, and monitoring products. 

The company serves drug wholesalers and retailers, hospitals, and government agencies; managed health care providers, such as health maintenance organizations, pharmacy benefit managers, and other institutions; and physicians and physician distributors, veterinarians, and animal producers. It has collaborations with AstraZeneca PLC; Bayer AG; Eisai Co., Ltd.; Synthekine Inc.; and Ridgeback Biotherapeutics. It also has collaboration agreements with Hummingbird Bioscience Pte. Ltd; Gilead Sciences, Inc. to co-develop and co-commercialize investigational treatment combinations of Lenacapavir and Islatravir in HIV; Amathus Therapeutics to develop treatments for neurodegenerative diseases; Linnaeus Therapeutics, Inc. to evaluate LNS8801; Biomed X Gmbh for building on ongoing research projects in the fields of oncology and autoimmunity; NGM Biopharmaceuticals, Inc. to focus on the development of medicines in retinal and CVM diseases, as well as to develop and commercialize tests that identify genetic mutations; and IO Biotech ApS to evaluate IO102-IO103.

Merck (NYSE:MRK) recently announced that new Phase 3 data for molnupiravir, an investigational oral COVID-19 antiviral medicine, was set to be presented as a late-breaking poster (#LB-5319) at the American Society of Tropical Medicine and Hygiene (ASTMH) 2021 Annual Meeting taking place virtually from Nov. 17-21.

According to its release, the presentation will include data from the molnupiravir clinical development program, with an emphasis on the interim results from the MOVe-OUT trial, including baseline characteristics of study population and additional details on efficacy and safety. The two company previously announced positive results from a planned interim analysis of the trial, which evaluated molnupiravir 800 mg twice-daily in non-hospitalized, unvaccinated adult patients with laboratory-confirmed mild-to-moderate COVID-19, symptom onset within five days of study randomization and at least one risk factor associated with poor disease outcomes (e.g., heart disease, diabetes).

Even with that news, the action hasn’t really heated up in the stock, with shares moving net sideways over the past week.

Merck & Co. Inc. (NYSE:MRK) managed to rope in revenues totaling $13.1B in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 4.7%, as compared to year-ago data in comparable terms. In addition, the company is battling some balance sheet hurdles, with cash levels struggling to keep up with current liabilities ($10B against $23.7B, respectively).

Other key players in the Covid space include Moderna Inc. (Nasdaq:MRNA), Johnson & Johnson (NYSE:JNJ), Novavax Inc. (Nasdaq:NVAX), BioNTech SE ADR (Nasdaq:BNTX), and AstraZeneca PLC ADR (Nasdaq:AZN).

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Published by Alan Masterson

Alan has over 25 years of trading experience in the U.S. equity markets. He began his career in finance working on a program trading desk specializing in over-the-counter stocks. His career progressed from that point to his current position as senior trader on an institutional trading desk. In the evenings, Alan teaches economics at a local community college. He has contributed articles to various publications over the last six years, including feature articles for an economics magazine and various financial blogs. You may contact Alan via his email (alanmasterson@wallstreetpr.com) or his Google+ page (https://plus.google.com/103338576216002376250).