The following are some of the companies that reported fourth-quarter results and provided corporate updates on Monday.
1. Caribou Biosciences Inc. (CRBU), which successfully completed its IPO last year, is working towards achieving a couple of milestones in 2022.
The company’s lead investigational product is CB-010 under a phase I trial in patients with relapsed or refractory B cell non-Hodgkin lymphoma, dubbed ANTLER.
CB-010 is an allogeneic anti-CD19 CAR-T cell therapy derived from healthy donor T cells that have been engineered using Caribou’s chRDNA technology to reduce the risk of graft versus host disease (GvHD) and knock out PD-1 to boost the persistence of CAR-T cell antitumor activity.
The company expects to present initial data from the ongoing ANTLER trial this year.
Also in the pipeline is CB-011, which is under IND-enabling studies. This product candidate is being developed for the treatment of patients with relapsed or refractory multiple myeloma. The company is planning to submit an IND application for CB-011 this year.
Caribou shares began trading on the Nasdaq Global Select Market on July 23, 2021, priced at $16 per share.
CRBU closed Monday’s trading at $9.15, down 6.35%.
2. Cellectar Biosciences Inc. (CLRB) continues to make significant strides in its clinical trials as it enrolls patients in its ongoing Iopofosine trials in Waldenstrom’s macroglobulinemia and multiple myeloma.
Iopofosine is in a pivotal study in Waldenstrom’s macroglobulinemia, with top-line data anticipated in the second half of this year.
Waldenstrom’s macroglobulinemia (WM) is a rare type of blood cancer.
A phase IIb study of Iopofosine in highly refractory multiple myeloma, dubbed CLOVER, is also underway.
As of December 31, 2021, the company had $35.7 million in cash.
CLRB closed Monday’s trading at $0.62, up 15.81%.
3. DICE Therapeutics Inc. (DICE) has a clinical trial catalyst to keep an eye on in the coming months.
The lead drug candidate is DC-806, an orally-available, small molecule antagonist of the pro-inflammatory cytokine, interleukin-17 (IL-17), which is a validated drug target for the treatment of a variety of immunological diseases.
A phase I trial of DC-806 is underway. It is being conducted in three overlapping cohorts: Phase 1a (single ascending dose) and Phase 1b (multiple ascending dose) in healthy volunteers, and a proof-of-concept Phase 1c in psoriasis patients.
Topline data across all three cohorts of the phase I trial of DC-806 are expected in mid-2022.
The company’s cash, cash equivalents and marketable securities totaled $319.3 million at December 31, 2021.
DICE closed Monday’s trading at $18.99, down 2.57%.
4. Graphite Bio Inc. (GRPH) is focused on the execution of its CEDAR clinical trial this year.
CEDAR is a phase I/II trial of GPH101, an investigational therapy designed to directly correct the genetic mutation responsible for sickle cell disease. The trial is currently enrolling participants and the company now plans to dose its first patient in the second half of 2022, with initial proof-of-concept data anticipated in 2023.
GRPH closed Monday’s trading at $6.89, down 15.15%.
5. Marinus Pharmaceuticals Inc. (MRNS) expects to make its recently approved ZTALMY commercially available in the U.S. through a specialty pharmacy beginning in July.
ZTALMY oral suspension was approved by the FDA as recently as March 18 for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder, a rare form of genetic epilepsy, in patients two years of age and older.
The drug is also under review in Europe and the European Medicines Agency’s Committee for Medicinal Products for Human Use opinion on the Marketing Authorization Application is expected by the end of this year.
The company expects to resume recruitment for its phase III clinical trial of intravenous (IV) Ganaxolone in refractory status epilepticus, dubbed RAISE, by end of May. If all goes well as planned, topline phase III data readout is anticipated in the second half of 2023.
A phase II trial of adjunctive Ganaxolone in established status epilepticus, dubbed RESET, is planned to begin U.S. enrollment in the second half of 2022. Topline data from this study is anticipated by year end 2023.
A phase I trial evaluating second generation Ganaxolone formulation is underway, with topline data on track for mid-2022 readout. If the phase I data supports further clinical development, the company expects to start a phase II Lennox-Gastaut Syndrome trial in the second half of 2022 utilizing second generation formulation.
MRNS closed Monday’s trading at $8.74, down 12.60%.
6. ORIC Pharmaceuticals, Inc. (ORIC) has pulled the plug on the development of ORIC-101 as interim analysis did not demonstrate sufficient clinical activity to warrant further development.
ORIC-101 was in phase Ib studies in combination with nab-paclitaxel in various solid tumors and in combination with enzalutamide in metastatic prostate cancer.
The company has decided to focus on advancing its three single agent phase I programs, ORIC-533 in multiple myeloma, ORIC-114 in EGFR/HER2 cancers, and ORIC-944 in prostate cancer. Initial data from the three programs are expected in the first half of 2023.
Cash, cash equivalents and investments totaled $280.4 million as of December 31, 2021.
ORIC closed Monday’s trading at $6.68, down 1.47%.
7. STRATA Skin Sciences Inc. (SSKN), a commercial-stage medical technology company, has reported a 30% revenue growth for the full year 2021.
The company incurred an annual net loss of $2.71 million or $0.08 per share on revenue of $30 million in 2021. This compared with an annual net loss of $4.41 million or $0.13 per share and revenue of $23.1 million in 2020.
Looking ahead to full year 2022, STRATA expects revenue to be between $33.0 million and $35.0 million, representing 10% – 17% growth over 2021.
SSKN closed Monday’s trading at $1.52, down 0.97%.
8. TELA Bio Inc. (TELA), a commercial-stage medical technology company, believes it is well positioned for significant growth in 2022.
Net loss widened to $8.6 million or $0.59 per share in the fourth quarter of 2021, from $7.8 million or $0.54 per share in the same period in 2020. Revenue was $8.4 million in the fourth quarter of 2021, up from $5.7 million in the year-ago quarter.
The company attributed the 48% quarterly revenue growth to the expansion of the commercial organization and a faster productivity ramp from its most recent sales hires stemming from its “Playbook90” training and performance measurement program.
For full year 2022, the company projects revenue to range from $40 million to $45 million, representing a 36% to 53% growth over full year 2021. Revenue was $29.5 million for the full year 2021, up 62% over 2020.
TELA closed Monday’s trading at $12.77, up 2.16%.
9. UroGen Pharma Ltd. (URGN), a revenue generating biotech company developing therapies for urothelial and specialty cancers, expects important commercial and clinical milestones in the year ahead.
The company generated net product revenue of $16.2 million for the fourth quarter of 2021, compared to nearly $8 million in the year-ago period. The marketed drug is Jelmyto indicated for low-grade upper tract urothelial cancer.
The net loss narrowed to $28.5 million or $1.27 per share for the fourth quarter 2021 from $30.5 million or $1.38 per share for the same period in 2020.
For full year 2022, net product revenue from Jelmyto is expected to be in the range of $70 to $80 million. Net product revenue was $48.0 million for the full year 2021.
A pivotal phase III trial of UGN-102 for the treatment of low-grade, intermediate risk non-muscle invasive bladder cancer, dubbed ENVISION, is expected to complete enrollment by the end of 2022. The study is designed to enroll approximately 220 patients across 90 sites.
The company plans to initiate a first-in-human, multi-arm, phase I clinical study of UGN-301, in the first half of 2022. UGN-301 is being developed for the treatment of recurrent non-muscle invasive bladder cancer.
URGN closed Monday’s trading at $9.02, up 0.11%.
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