AXLA Awaits Data Readouts In Q3, ICVX On Watch, PHR Sees 27%-29% Revenue Growth

The following are some of the biotech companies that provided corporate updates and outlook on Wednesday.

1. Acutus Medical Inc. (AFIB), an arrhythmia management company, expects revenue for the first quarter of 2022 to be slightly lower than the revenue reported in the comparable year-ago quarter and well below analysts’ estimate.

For the first quarter of 2022, the company expects revenue in a range of $3.2 million to $3.5 million while the consensus analysts’ estimate is $4.51 million. Revenue reported in the first quarter of 2021 was $3.6 million.

AFIB closed Wednesday’s trading at $1.93, up 1.58%.

2. Adagio Therapeutics Inc. (ADGI) is all set to submit an Emergency Use Authorization application in the second quarter of 2022 for drug candidate Adintrevimab for both the prevention and treatment of COVID-19.

The company’s ongoing phase II/III clinical trial evaluating Adintrevimab as a pre-and-post-exposure prophylaxis of Covid-19, dubbed EVADE, and a phase II/III clinical trial of Adintrevimab in treatment for COVID-19, dubbed STAMP, have met primary endpoints with statistical significance.

ADGI closed Wednesday’s trading at $5.02, up 30.39%.

3. Alaunos Therapeutics, Inc. (TCRT), a clinical-stage oncology-focused cell therapy company, expects to dose the first patient in its phase I/II TCR-T Library trial targeting KRAS, TP53, and EGFR mutations across six solid tumor indications next quarter (2Q).

The study, which will be conducted at MD Anderson Cancer Center, will treat patients in one of three dosing cohorts: 5 x 109, 40 x 109, or 10 x 1010 TCR-T cells. The trial will enroll patients with non-small cell lung, colorectal, endometrial, pancreatic, ovarian, and bile duct cancers.

TCRT closed Wednesday’s trading at $0.66, down 4.42%.

4. Axcella Therapeutics (AXLA), a clinical-stage biotechnology company, has a couple of catalysts to watch this year.

A phase IIa trial investigating AXA1125 as a potential oral treatment for patients with exertional fatigue related to Long COVID is ongoing, with topline results expected in the third quarter.

AXA1125 is also being tested in a phase IIb clinical trial in patients with biopsy-confirmed F2/F3 NASH, dubbed EMMPACT. Interim results from this study are anticipated in the third quarter.

AXLA closed Wednesday’s trading at $2.70, down 3.57%.

5. BioNTech SE (BNTX) expects COVID-19 vaccine revenues for full year 2022 to range between €13 billion and €17 billion compared to €18.9 billion in 2021.

The company expects to authorize a share repurchase program of up to $1.5 billion over the next two years and will propose a special cash dividend of €2.00 per share, pending approval at the Annual General Meeting.

BNTX closed Wednesday’s trading at $174.78, up 1.39%.

6. Centessa Pharmaceuticals plc (CNTA), a clinical-stage pharmaceutical company, has a number of clinical trial events to watch in the coming months.

A pivotal phase III clinical trial evaluating Lixivaptan as a potential treatment for autosomal dominant polycystic kidney disease, dubbed ACTION, is underway. Enrollment in this trial is expected to be completed in the second half of 2023.

A registrational study that will evaluate the efficacy and safety of prophylactic SerpinPC in subjects with severe Hemophilia B without inhibitors is expected to be launched in the second half of 2022.

Another registrational study that will evaluate the efficacy and safety of prophylactic SerpinPC in subjects with severe Hemophilia B with inhibitors is also expected to be launched in the second half of 2022.

A phase I trial of CBS001 in healthy volunteers is expected to begin in the second quarter of 2022. CBS001 is being developed in the treatment of inflammatory/fibrotic diseases.

CNTA closed Wednesday’s trading at $9.03, up 0.44%.

7. Centogene N.V. (CNTG), a commercial-stage company involved in the diagnosis and research around rare diseases, expects total revenues for full year 2022 to be in the range of €68 million to €70 million compared to €189.9 million in 2021 due to decrease of the COVID-19 testing business.

The portion of total revenues derived from COVID-19 testing in 2022 is expected to decline to approximately €18 million from €146.4 million in 2021.

However, the company expects year-over-year growth in Core Business revenues (i.e., revenues derived from the Pharma and Diagnostics segments) to be between 15% and 20% in 2022. Revenues from Core Business were €43.5 million in 2021, an increase of 11% from €39.1 million reported in full-year 2020.

CNTG closed Wednesday’s trading at $4.09, up 1.24%.

8. Crinetics Pharmaceuticals Inc. (CRNX) expects topline data from its phase III trials of lead drug candidate Paltusotine, dubbed PATHFNDR-1 and PATHFNDR-2, to be available next year.

PATHFNDR-1 is a phase III study evaluating Paltusotine in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.
PATHFNDR-2 is a phase III trial evaluating Paltusotine in subjects with non-pharmacologically treated acromegaly.

CRNX closed Wednesday’s trading at $19, down 3.41%.

9. Icosavax Inc. (ICVX), a biopharmaceutical company, has a near-term catalyst to watch.

A phase 1/1b clinical trial of IVX-121, a VLP displaying a Respiratory Syncytial Virus stabilized pre-fusion F antigen, in healthy adults and older adults, is ongoing. Topline interim data from this trial is expected in the second quarter.

The company plans to initiate a phase I study of its first combination vaccine candidate, IVX-A12, for Respiratory Syncytial Virus and human metapneumovirus during the second half of this year.

ICVX closed Wednesday’s trading at $5.33, down 1.84%.

10. Miromatrix Medical Inc. (MIRO) expects filing of IND application for MiroliverELAP, a bioengineered liver graft, in the second half of 2022.

The company expects to initiate a phase 1 clinical trial shortly upon clearance of the IND by the FDA.

Miromatrix Medical is developing a revolutionary method for bioengineering completely transplantable human organs to enable patients live longer and healthier lives.

MIRO closed Wednesday’s trading at $3.78, up 1.61%.

11. NANOBIOTIX (NBTX), a late clinical stage biotechnology company, has completed enrollment, with 44 evaluable patients, in its Expansion Study 102.

Expansion Study 102 is a phase I study evaluating NBTXR3 as a single agent activated by radiotherapy (RT) in high-risk, elderly locally advanced head and neck squamous cell carcinoma (LAHNSCC) patients ineligible for Cetuximab and intolerant to Cisplatin.

The last treatment visit for the final patient in the Expansion Study 102 is expected in the second quarter of 2022, with one year follow-up data expected in mid-2023.

A pivotal phase III global registration study evaluating NBTXR3 as a single-agent activated by radiotherapy for elderly patients with LA-HNSCC intolerant to Cisplatin is ongoing. The trial is actively enrolling patients across multiple European sites with U.S. site activation anticipated in mid-2022.

NBTX closed Wednesday’s trading at $7.44, up 3.77%.

12. Phreesia Inc. (PHR) expects revenue for the full fiscal year 2023, ending January 31, 2023, to be between $271 million and $275 million, reflecting year-over-year growth of 27% to 29%.

The company provides healthcare organizations a suite of robust applications to manage the patient intake process.

Revenue rose 43% to $213.2 million in fiscal year 2022.

Cash and cash equivalents as of January 31, 2022 totaled $313.8 million.

PHR closed Wednesday’s trading at $29.38, down 1.84%.

13. ProPhase Labs Inc. (PRPH), a diversified diagnostics and genomics company, which reported financial results for the fourth quarter and full year ended December 31, 2021, yesterday, expects to report even stronger results in the first quarter of 2022.

Net income for the fourth quarter of 2021 was $10.6 million, or $0.68 per share on revenue of $45.2 million. This compared with a net loss of $1.0 million or $0.09 per share and revenue of $5.2 million in the year-ago quarter.

PRPH closed Wednesday’s trading at $7.05, down 2.08%.

14. RVL Pharmaceuticals plc (RVLP), a commercial-stage specialty pharmaceutical company, expects net sales of its flagship product, Upneeq, to grow 77% to 94% sequentially in the first quarter of 2022.

Net product sales were $3.1 million in the fourth quarter of 2021, compared to $0.9 million in the year-ago period.

For the first quarter of 2022, RVL Pharma expects net sales of Upneeq to range between $5.5 and $6.0 million.

Looking ahead to the fourth quarter, the company is targeting net sales of Upneeq to range between $20 million and $25 million.

Upneeq, a once-daily ophthalmic solution, was approved by the FDA in July 2020 for the treatment of acquired blepharoptosis, or ptosis, a condition characterized by the abnormal drooping of the upper eyelid.

RVLP closed Wednesday’s trading at $1.75, unchanged from the previous day’s close.

15. vTv Therapeutics Inc. (VTVT) expects to start two pivotal, placebo-controlled clinical trials of TTP399 in subjects with type 1 diabetes in the third quarter.

The studies will recruit a total of roughly 1000 patients and at least one of the studies will be one year of treatment.

As of December 31, 2021, the company’s cash on hand totaled $13.4 million.

VTVT closed Wednesday’s trading at $0.71, up 0.37%.

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