Atea updates on late stage Covid therapy trial

 

• Global Phase 3 MORNINGSKY trial of AT-527 in the outpatient setting recently initiated for the treatment of COVID-19
  
  

• Enrollment advancing in Phase 1a trial of AT-752; drug candidate being developed for the treatment of dengue fever
  

Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today reported financial results for the quarter ended March 31, 2021 and provided a corporate update.

“Over the course of a year, we have gone from filing an Investigational New Drug Application for AT-527, an oral direct-acting antiviral for the treatment of COVID-19, to the recent initiation of a global Phase 3 trial in the outpatient setting. Working closely with our strategic partner Roche, this significant milestone represents a major advancement toward our goal of providing an easily administered and widely available oral antiviral to help in the fight against this global pandemic,” said Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals.

“In addition to the important work we are doing in COVID-19, we are utilizing the power of our proprietary nucleotide prodrug platform in other infectious diseases. Toward that end, we are very pleased to have initiated our Phase 1a study evaluating the safety, tolerability, and pharmacokinetics of AT-752. We look forward to reporting data from this study in the second half of 2021 and to furthering the development of this novel compound as an oral treatment for dengue fever, which the World Health Organization has called the most important mosquito borne viral disease in the world,” continued Dr. Sommadossi.

Conference Call and Webcast Information

Atea will host a conference call and live audio webcast to discuss the first quarter 2021 financial results and provide a corporate update Thursday at 4:30 p.m. ET. To access the live conference call, please dial (833) 301-1150 (domestic) or (914) 987-7391 (international) at least five minutes prior to the start time and refer to conference ID 8609279.

A live audio webcast of the call and accompanying slide presentation will also be available in the Investors’ Events & Presentations section of the Company's website, www.ateapharma.com. An archived webcast will be available on the Atea website approximately two hours after the event.

https://finance.yahoo.com/news/atea-pharmaceuticals-reports-first-quarter-200500829.html

Solid Biosciences Phase 1/2 trial patient has serious side effects

- Patients 7 and 8 dosed in IGNITE-DMD Phase I/II clinical trial under new clinical protocol and second-generation SGT-001 manufacturing process; patient 8 experienced a serious adverse event -

- Long-term biopsy data generated from the ongoing IGNITE DMD trial demonstrate durable microdystrophin expression as measured up to two years post dosing of SGT-001. Data to be presented today at ASGCT at 1:45 PM ET -

- Continued research and innovation in musculoskeletal therapy generates next-generation DMD gene transfer candidate, SGT-003 -

- Company ends Q1 with $268.5 million in cash; cash runway into Q4 2022 -

- Company to hold conference call at 8:30am ET today -

Conference Call Information
The company will host a conference call and webcast at 8:30 a.m. ET today to discuss the program update. Participants are invited to listen by dialing +1 866-763-0341 (domestic) or +1 703-871-3818 (international) five minutes prior to the start of the call and providing the passcode 4772539. A listen-only webcast of the conference call can also be accessed through the "Investors" tab on the Solid Biosciences website, www.solidbio.com, and a replay of the call will be available for approximately six weeks after the call.

https://finance.yahoo.com/news/solid-biosciences-provides-first-quarter-113000773.html

CorMedix updates on CRL Measures

 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced financial results for the first quarter ended March 31, 2021 and provided an update on recent business events.

Recent Business Highlights:

• CorMedix announced the appointment of Tom Nusbickel as the Company’s Executive Vice President and Chief Commercial Officer.

• CorMedix successfully completed the agreed upon protocol for the manual extraction study identified in the Complete Response Letter that FDA is requiring as confirmation of in-process controls to demonstrate that the labeled volume can be consistently withdrawn from the vials.

• CorMedix continues to focus our efforts on resolving the deficiencies sent to the third-party manufacturer in the Post-Application Action Letter. Based on our analyses, we have concluded that additional process qualification will be needed with subsequent validation to address the deficiencies identified by FDA.

• CorMedix strengthened its balance sheet via equity financing activity during the first quarter, raising net proceeds of approximately $41.5 million.

https://finance.yahoo.com/news/cormedix-inc-reports-first-quarter-200100761.html

LifeMD Q1 Revenue up 323% to $18.2M, Ups Full Year Revenue Guidance to $90-$100M

 

• 92% of Q1 2021 revenue was generated by subscriptions, up from 75% in Q1 2020
  

• Total patients and customers served nationwide surpassed 320,000

• Gross Margins of 82%, up 13% from the same year-ago period

• Total Telehealth Order volume grew by 373% versus year ago period to 164,452

 LifeMD, Inc. (“the Company”) (NASDAQ: LFMD), a leading direct-to-patient telehealth company, today reported results for the first quarter ended March 31, 2021. All quarterly comparisons are to the same year-ago period. The Company will hold a conference call at 4:30 p.m. Eastern time today to discuss the results (see dial-in information below.)

($ in 000s)	Three Months Ended March 31			Y-o-Y
Key Performance Metrics	2021	2020		% Growth
Revenue
Product (Telehealth)	$13,283	$2,956		349%
Software (LegalSimpli)	4,914	1,349		264%
Total Revenue	$18,198	$4,305		323%
Subscription Revenue as % of Total	92%	75%
Telehealth Volume
Total Telehealth Orders	164,452	34,753		373%
LegalSimpli
Active Subscribers	109,517	36,852		197%

Q1 Financial Highlights

• Revenue increased 323% to a record $18.2 million.

• 92% of Q1 2021 revenue was generated by subscriptions, up from 75% in Q1 2020.

• Telemedicine orders increased 373% to more than 164,000.

• Gross profit increased 403% to $14.9 million or 82% of revenue.

• Cash totaled $13.4 million at March 31, 2021, versus $9.2 million at December 31, 2020. Subsequent to the end of the quarter, the Company completed a private placement with net proceeds of $13.5 million.

Conference Call
LifeMD’s management will host a conference call followed by a question and answer session to discuss the company’s financial results and outlook.

Date: Thursday, May 13, 2021
Time: 4:30 p.m. Eastern time (1:30 p.m. Pacific time)
Toll-free dial-in number: 1-866-269-4260
International dial-in number: 1-720-452-9102
Conference ID: 3530318
Webcast: http://public.viavid.com/index.php?id=144808

The conference call will be webcast live and available for replay via a link provided in the Investors section of the company’s website at https://ir.lifemd.com.

https://finance.yahoo.com/news/lifemd-reports-q1-2021-revenue-200100741.html

Original Vaccitech investor: Biotech no COVID one-hit wonder

 As Vaccitech priced a $110.5 million IPO, one investor says the company has a pipeline that could address a number of killer diseases long after the headlines over the AstraZeneca vaccine’s blood clot concerns fade.

The company offered 6.5 million American Depositary Shares in the U.S. IPO at a price of $17 apiece. The shares are trading on the Nasdaq Global Market under the symbol VACC. 

Vaccitech, which originally spun out from Oxford University's Jenner Institute, was originally targeting an IPO in the range of $100 million, so the $110.5 million represents a slight over-subscription, but is very much par the course with biotech IPOs these days.

“Vaccitech, as its new Nasdaq ticker VACC implies, is a vaccine for many things,” said Douglas Hansen-Luke, executive chairman of investor Future Planet Capital, an original investor in the company. “Whenever we looked at Vaccitech, we always viewed it as a company that's doing great, great work to deal with the global challenge of COVID, but which is also making significant strides in addressing a number of other killers for the world.”

After rocketing to the public realm with its AstraZeneca-Oxford partnered COVID-19 vaccine, Vaccitech has now been wrapped up in a global hesitance to take the jab, after concerns were raised about a possible risk of blood clots in younger people. The shot has also fallen out of favor as rival products from Moderna and Pfizer-BioNTech have put up stronger efficacy data.

Like many experts in the biotech and public health world, Hansen-Luke stressed that while the vaccine does come with a slight risk of blood clots—about one in 5 million administrations—COVID is much more dangerous.

“Very clearly this isn’t ideal. It’s well understood here in the U.K. that your chances of being struck by lightning, or having deep vein thrombosis in an airplane or actually having a traffic accident are actually greater than they are of developing a blood clot,” Hansen-Luke said. “That doesn't mean that it's dismissed. It is a risk and it’s being declared as such. But it's a very low probability event.”

He noted that the labeling on the vaccine has been changed to warn of the risk and people who receive the vaccine are being educated on what to look out for.

“It's much better from a risk-reward perspective, to take a vaccine, than not to,” Hansen-Luke said.

In announcing the IPO pricing, Vaccitech did not pump up the COVID-19 vaccine, instead touting itself as a biotech that discovers and develops “novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer.”

Hansen-Luke’s firm has been an investor since 2020, following the company for years before throwing in the cash. Future Planet Capital has since doubled down amid the vaccine drama, becoming the lead investor in the vaccine's clinical trials and contributing to a $168 million Series B in March. He credits the scientific work of co-founders Sarah Gilbert, a professor of Vaccinology at the University of Oxford, and Adrian Hill, director of the Jenner Institute at Oxford University, among other accolades. When Vaccitech became a leader in the race to bring a COVID-19 vaccine to market, investors were not surprised.

“If you actually do look for the most promising companies coming from these centers of innovation, from the top universities and research establishments, you are likely to find companies that will address global challenges and to do it profitably,” Hansen-Luke said.

The company has several other assets in the pipeline, including a phase 2 checkpoint inhibitor combo called VTP-800/850 that is under development to treat prostate cancer. Another two drugs are under development for hepatitis B virus. Vaccitech has partnered with Johnson & Johnson’s Janssen on a prophylactic treatment for MERS called VTP-500, which is in phase 1 testing with readout expected this quarter.

The cancer vaccines are of particular interest to Hansen-Luke and are what attracted his firm to the biotech in the first place five years ago.

“That's why we've invested, not just for COVID but for the broader story,” Hansen-Luke said.

https://www.fiercebiotech.com/biotech/original-vaccitech-investor-sees-beyond-covid-shot-as-110m-ipo-priced

Chinese firm's COVID-19 drug claims draw skepticism

 Chinese biotech firm Kintor Pharmaceutical Limited saw its stock price jump by more than 20% the day after it announced on April 25 that it had "completed the first patient enrollment and dosing" in a late-stage U.S. clinical trial of its experimental COVID-19 treatment.

It was the company's latest announcement about the progress of the drug, Proxalutamide. The Hong Kong-listed company's stock price has nearly quadrupled since March 1 as some analysts wrote about the big sales potential for a COVID-19 treatment. Kintor has seen its market capitalization soar to HK$23.4 billion ($3 billion) from HK$6.6 billion on March 1.

But the company had not dosed any patients as of early May, according to the doctor Kintor identified as its principal clinical trial investigator in documents it posted on a U.S. trials website. The doctor - California-based gastroenterologist Zeid Kayali - also told Reuters he was "not in charge" of the trial, contradicting what the company had said in the documents describing the study. Kayali declined further comment, referring questions to Kintor.

Told of Kayali's comments, Kintor Chief Financial Officer Lucy Lu said Kayali was merely one of its trial investigators. She declined further comment on the firm's announcement on patient dosing. Lu declined as well to name a different principal investigator, or the institution overseeing the trial, calling that information "confidential."

Companies are not obliged to release such information. But many pharmaceutical firms routinely provide details about who is leading their clinical trial and which research organization or medical institution is responsible for ensuring patient safety and scientific validity.

Kintor's lack of transparency, along with inconsistencies in the company's statements, raise a "red flag" about the company's claims, said Stephen Ostroff, a former U.S. Food and Drug Administration (FDA) chief scientist and two-time acting FDA commissioner.

Another red flag: Kintor has repeatedly touted a Brazilian study of Proxalutamide that claimed an effectiveness rate so high that Ostroff and other pharmaceutical specialists say it is hard to believe.

The Brazil study said Proxalutamide showed a 92% reduction in mortality risk among hospitalized COVID-19 patients, which Ostroff said would be "breathtakingly extraordinary" if true.

Alexandre Cavalcanti, director of Sao Paulo's HCor Research Institute, called a presentation of the study's findings by its authors "amateur" and said its claimed reduction of mortality risk is too high to be credible in light of a global struggle to find effective COVID-19 treatments.

Kintor stock turned briefly negative in morning trade in Hong Kong, but was trading up more than 4% at 0303 GMT, putting it on course to its third straight session of gains.

STOCK GETS A BOOST

Proxalutamide does not have regulatory approvals and is not available for sale. The Brazil study of the drug has not been peer-reviewed or published, but the authors released a short presentation of its results during a March news conference. Kintor promoted their findings.

"Based on the positive results ... we expect Proxalutamide could become an important tool in the global fight against COVID-19," Kintor's Chief Executive Tong Youzhi said in a statement announcing the Brazilian results on March 11.

That same day, Kintor's stock price jumped by nearly 9%.

Lu, Kintor's CFO, did not answer detailed questions from Reuters about the criticisms of the Brazil study and Kintor's claims about its U.S. trial.

One of the study's authors, Brown University dermatology professor Carlos Wambier, dismissed its critics and called its results "very encouraging."

In an April 2 client note, analysts from Beijing-based brokerage China Renaissance cited Kintor's progress reports as evidence of the "potentially wider application of Proxalutamide." They gave the stock a "buy" recommendation and set a target price of HK$50.75. Kintor's stock now trades at about HK$66, having reached a record high HK$82 in late April.

"The stock price is majorly driven by the COVID-19-related clinical progress," said Sam Hu, analyst at CMB International in Hong Kong.

One of the study's authors is a consultant hired by a Brazilian Health Ministry official who is an ally of the country's President Jair Bolsonaro. The president is a vaccine skeptic and a critic of masks and lockdowns who has promoted discredited COVID-19 remedies such hydroxychloroquine. The health official, Helio Angotti, assigned a team of consultants to find evidence to support Bolsonaro's unfounded medical claims, Reuters reported in a related story https://www.reuters.com/business/healthcare-pharmaceuticals/man-behind-brazils-search-miracle-covid-19-cures-2021-05-14 today.

Angotti declined to comment. Bolsonaro's office did not respond to written questions from Reuters. The consultant who co-authored the Proxalutamide study, Ricardo Zimerman, did not respond to requests for comment.

RESEARCH AND POLITICS

Lu said Kintor is in talks with Brazilian federal health regulator Anvisa about conducting its own clinical trial. Anvisa said in a statement that Kintor had not filed any formal request to conduct a trial, but did not comment on any talks between the regulator and the company.

Two Anvisa staffers, speaking on condition of anonymity, questioned the results of the Brazilian Proxalutamide study, saying the authors' results presentation contained no detailed data or evidence. One of the Anvisa staffers characterized the presentation as more marketing than science. Brazil's Health Ministry, in a March technical note, concluded that "the available evidence for the drug is still incipient," with limited information on safety and outcomes.

Kintor originally conceived of Proxalutamide as a cancer treatment, before pivoting to COVID-19. Lu told Reuters that the FDA had allowed the firm to progress to a Phase III trial, skipping Phases I and II, after evaluating its previous oncology studies and the Brazil research. She declined to share any documentation from the FDA outlining that permission.

The FDA declined to comment on Kintor or its COVID-19 drug.Ostroff said it was concerning and atypical that Kintor used earlier-stage oncology trials, along with the questionable Brazil study, as shortcuts to a Phase III COVID-19 trial. The company's answers to basic questions about its clinical trial, he added, were evasive.

"Most pharmaceutical companies, especially related to COVID-19, will be quite open about what sorts of trials they're doing," he said.

https://news.yahoo.com/chinese-firms-covid-19-drug-013618381.html

Biogen Phase 2/3 gene therapy trial misses primary endpoint

 

• While the Phase 2/3 XIRIUS study did not meet its primary endpoint, data indicated positive trends in several prespecified secondary endpoints, such as a clinically relevant measure of visual acuity
  

• Biogen will communicate next steps for the program after analyzing the complete data set

• Currently there are no approved treatments for X-linked retinitis pigmentosa (XLRP), a rare inherited retinal disease that ultimately leads to blindness in most people with the condition
  

 Biogen Inc. (Nasdaq: BIIB) today announced topline results from the Phase 2/3 XIRIUS study of cotoretigene toliparvovec (BIIB112), a gene therapy being investigated as a one-time therapy for patients with X-linked retinitis pigmentosa (XLRP). XLRP is a rare, inherited retinal disease that is associated with progressive vision loss as the light-sensing cells of the retina gradually deteriorate. Initial symptoms are difficulty seeing at night, followed by restriction of the field of vision and eventually blindness in most people by the age of 40. Patients living with XLRP currently have no approved treatments.

The XIRIUS study did not meet its primary endpoint of demonstrating a statistically significant improvement in the proportion of treated study eyes with ≥7 dB improvement from baseline at ≥5 of the 16 central loci of the 10-2 grid assessed by Macular Integrity Assessment (MAIA) microperimetry. This assessment was performed at 12 months and compared to the study eye of patients randomized to the untreated control group. Positive trends were observed across several clinically relevant prespecified secondary endpoints.

“Although the Phase 2/3 XIRIUS study of cotoretigene toliparvovec did not meet its primary endpoint, we are encouraged by positive trends in other pre-specified clinically relevant endpoints, such as a measure of visual acuity under low light conditions,” said Katherine Dawson, M.D., head of the therapeutics development unit at Biogen. “XLRP is a serious, early-onset form of retinitis pigmentosa, and people living with it face almost certain blindness by the end of the fourth decade, commonly leading to loss of independence, depression and unemployment. We are working to further evaluate the data from the XIRIUS study before communicating potential next steps for the cotoretigene toliparvovec clinical development program.”

https://finance.yahoo.com/news/biogen-announces-topline-results-phase-113000443.html