BNR’s Revenue To Grow 22% In 2022; CINC To Report BrigHtn Data In 2H, SCPH To Resubmit NDA On Apr.15

he following are some of the companies that reported fourth-quarter results and provided corporate updates on Tuesday.

1. 2seventy bio Inc. (TSVT), which has reshaped its operating model and taken steps to reduce its overhead costs, said it has sufficient financial foundation to carry out operations into 2025.

A spin off of bluebird bio Inc. (BLUE), 2seventy bio is an immuno-oncology cell therapy company with a cell therapy pipeline, focusing across a range of hematologic and solid tumors, and an approved drug marketed in partnership with Bristol Myers Squibb (BMY).

The marketed drug is Abecma, a first-in-class, BCMA-directed CAR T cell immunotherapy for multiple myeloma. 2seventy bio and Bristol Myers have a 50/50 U.S. commercialization partnership for Abecma.

The U.S. ABECMA revenue was $67 million in the fourth quarter and $158 million in full year 2021. For full year 2022, 2seventy anticipates total U.S. ABECMA revenues of $250-$300 million.

A phase II trial of ABECMA in subjects with relapsed and refractory multiple myeloma and in subjects with high-risk multiple myeloma, dubbed KarMMa-2, is underway. Data from the high-risk multiple myeloma cohort of the study is anticipated this year.

TSVT closed Tuesday’s trading at $17.15, up 5.28%.

2. Absci Corp. (ABSI), the Artificial intelligence powered synthetic biology company, reported a lower revenue for the fourth quarter ended Dec.21, 2021, on higher expenses.

Net loss applicable to common stockholders and unitholders was $25.2 million or $0.28 per share for the fourth quarter of 2021, on revenue of $1.5 million. This compared with a net loss applicable to common stockholders and unitholders of $5.7 million or $0.35 per share and revenue of $2.7 million for the corresponding prior year period.
The company’s total operating expenses jumped to $27.7 million for the fourth quarter of 2021 from $7.4 million in the year-earlier quarter.

In 2022, Absci expects to launch eight new Active Programs, three of which will be the consequence of the Merck deal.

ABSI closed Tuesday’s trading at $7.48, up 6.48%.

3. Avinger Inc. (AVGR), a commercial-stage medical device company, reported a 12% drop in revenue for the fourth quarter of 2021.

The company markets the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease.

The net loss applicable to common stockholders was $6 million or $1.26 per share on revenue of $2.40 million. This compared with a net loss applicable to common stockholders of $5.6 million or $1.32 per share and revenue of $2.73 million.

The company expects to file 510(k) applications for two new catheters in its peripheral product portfolio in 2022.

AVGR closed Tuesday’s trading at $3.84, down 4.00%.

4. Burning Rock Biotech Limited (BNR), a commercial-stage company focused on the application of next generation sequencing technology in the field of precision oncology, has reported nearly 12% revenue growth for the fourth quarter of 2021, and expects 22% revenue growth in full year 2022.

Net loss widened to RMB251.1 million (US$39.4 million) for the fourth quarter of 2021 from RMB156.5 million for the same period in 2020. Revenues rose 11.9% to RMB147.3 million (US$23.1 million) for the three months ended December 31, 2021, from RMB131.7 million for the same period in 2020.

Looking ahead to full-year 2022, Burning Rock expects revenues to be approximately RMB620 million (US$97.3 million), implying a 22% growth over full year 2021. Full-year 2021 revenues were RMB507.9 million (US$79.7 million) for 2021, up 18.1% from RMB429.9 million in 2020.

BNR closed Tuesday’s trading at $9.31, up 5.32%.

5. Caladrius Biosciences Inc. (CLBS), a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies designed to treat or reverse disease, expects the first patients to be treated in a phase I trial of CLBS201, being developed for diabetic kidney disease, early in the second quarter of 2022.

Top-line data from all subjects in the phase I trial of CLBS201 is expected by the first quarter of 2023.

A U.S. phase IIb trial of XOWNA for the treatment of coronary microvascular dysfunction, dubbed FREEDOM, is underway. Although it is not clear as to when enrollment will be completed, the company expects the study to run into 2023, if continued as planned. Final data from the study is expected approximately six months after last patient/last visit in the study.

CLBS closed Tuesday’s trading at $0.74, down 1.00%.

6. CinCor Pharma Inc. (CINC) has a couple of catalysts to keep an eye on in the coming months.

A phase II study of CIN-107 for resistant hypertension, dubbed BrigHtn, completed enrollment with 275 patients early this month. Topline data from this trial is expected in the second half of 2022.

A phase II trial which is evaluating CIN-107 in patients with uncontrolled hypertension, dubbed HALO, is ongoing. Topline data from this trial is expected in the second half of 2022.

A phase II trial for CIN-107 in patients with primary aldosteronism, dubbed Spark-PA, is ongoing, with topline data expected in second half of 2023.

The company’s cash and cash equivalents were $136.6 million as of December 31, 2021.

CINC closed Tuesday’s trading at $15.77, up 6.41%.

7. Codex DNA Inc. (DNAY), which reported a 59% jump in fourth-quarter revenue, expects full year 2022 revenue to increase 73% to 90%.

Codex DNA is a synthetic biology company enabling customers to rapidly, accurately and reproducibly build or “write” high-quality synthetic DNA and mRNA for wide-ranging biological applications.

Net loss was $12.5 million or $0.43 per share for the fourth quarter 2021, compared to a net loss of $5.6 million or $1.12 per share in the same period in the prior year. Revenue for Q4, 2021, rose 59% to $3.1 million from $1.9 million in the year-ago quarter.

The revenue growth was primarily driven by product sales from new product introductions, according to the company.

Looking ahead to full year 2022, the company expects total revenue to be in the range of $19 to $21 million while the consensus analysts’ estimate is $25.27 million. Revenue in full-year 2021 was $11 million.

Cash and cash equivalents were $82.8 million as of December 31, 2021.

DNAY closed Tuesday’s trading at $9.20, up 4.19%.

8. Exagen Inc. (XGN), a provider of autoimmune testing solutions, expects revenue for full-year 2022 to grow 6%-10%.

For the fourth quarter of 2021, the company’s net loss widened to $7.1 million or $0.42 per share from $3.5 million or $0.27 per share in the fourth quarter of 2020.
Revenue for the three months ended December 31, 2021 was $12.7 million, same as that reported in the comparable year-ago quarter.

Looking ahead to full year 2022, Exagen expects revenue to be in the range of $51 million to $53 million while the consensus analysts’ estimate is $56.16 million. Revenue for the full year of 2021 was $48.3 million.

XGN closed Tuesday’s trading at $8.38, up 2.32%.

9. MaxCyte Inc. (MXCT), a commercial cell-engineering company focused on providing enabling platform technologies, which reported a 19% jump in fourth quarter revenue, has forecast 22% to 25% revenue growth for full year 2022.

The net loss for the fourth quarter ended Dec.31, 2021 widened to $4.9 million or $0.05 per share even as revenue grew to $10.15 million. This compared with a net loss of $2.7 million or $0.03 per share and revenue of $8.51 million for the same period in 2020.

The company expects revenue from its core business (instruments and disposables to cell therapy and drug discovery customers) to grow between 22% and 25% over 2021. The SPL Program-related revenue for the year is anticipated to be approximately $4 million in 2022. The total revenue for 2021 was $33.9 million.

MXCT closed Tuesday’s trading at $6.90, up 3.45%.

10. scPharmaceuticals Inc. (SCPH) is all set to resubmit its New Drug Application for Furoscix by April 15, 2022.

Furoscix is being developed for the treatment of congestion due to fluid overload in adult patients with worsening New York Heart Association (NYHA) Class II and Class III heart failure who display reduced responsiveness to oral diuretics and who do not require hospitalization.

The FDA had declined to approve Furoscix in December 2020.

If all goes well as planned, and if Furoscix is approved, it could be launched in the fourth quarter of this year.

The company ended Dec.31, 2021, with cash, cash equivalents, restricted cash and investments of $75.5 million.

SCPH closed Tuesday’s trading at $5.40, up 4.65%.

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