ETNB To Report ENTRIGUE Data In Q2, MDVL’s Q1 Revenue To More Than Double, OCUP On Watch

The following are some of the companies belonging to the healthcare sector that reported Q4 financial results and provided corporate updates on Thursday (Mar.24, 2022).

1. 89bio Inc. (ETNB), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of liver and cardio-metabolic diseases, has a key catalyst to watch next quarter.

A phase II trial of lead drug candidate Pegozafermin in severe hypertriglyceridemia, dubbed ENTRIGUE, is ongoing, with topline data anticipated in the second quarter of 2022.

Pegozafermin is also under a phase 2b trial in patients with fibrosis stage 2 or 3 non-alcoholic steatohepatitis, dubbed ENLIVEN, and topline data are anticipated in the first half of 2023.

The company ended the year 2021 with cash, cash equivalents, and short-term investments of $150.7 million.

ETNB closed Thursday’s trading at $3.99, up 1.27%.

2. ADMA Biologics Inc. (ADMA), an end-to-end commercial biopharmaceutical company focused on specialty plasma-derived biologics, has reported a narrower loss and higher revenue for the fourth quarter ended Dec.31, 2021.

Net loss for the fourth quarter of 2021 shrunk to $16.6 million or $0.09 per share as total revenue jumped to $26.4 million. This compared with a net loss of $19.4 million or $0.20 per share and total revenue of $13.9 million in the year-earlier quarter.

ADMA now has ten plasma collection centers in various phases of development, five of which have won FDA approval to collect normal source and Respiratory Syncytial Virus hyperimmune plasma. By the end of 2023, the company expects to secure regulatory nod for ten of its BioCenters locations.

ADMA closed Thursday’s trading at $1.50, up 2.74%.

3. Arcellx Inc. (ACLX), which completed its IPO as recently as last month, expects to advance its lead clinical program, CART-ddBCMA for the treatment of relapsed or refractory multiple myeloma to a phase II pivotal trial by the end of this year.

The company is also expected to initiate two more phase I programs utilizing its controllable and adaptable ARC-SparX technology in relapsed or refractory multiple myeloma and relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome.

ACLX closed Thursday’s trading at $15.79, up 2.87%.

4. Athira Pharma Inc. (ATHA), a late clinical-stage biopharmaceutical company developing therapies to restore neuronal health and slow neurodegeneration, has a couple of milestones to achieve in the coming months.

The company’s lead drug candidate is Fosgonimeton, which is under a phase II study in mild-to-moderate Alzheimer’s disease, dubbed ACT-AD. Enrollment in the study was completed last October, with 77 participants across 14 sites in the United States and Australia.

Top-line data from the ACT-AD are anticipated in the second quarter of 2022.

Fosgonimeton is also being evaluated in a phase III trial in mild-to-moderate Alzheimer’s disease, dubbed LIFT-AD. This study, designed to enroll about 420 participants, is expected to complete enrollment n the third quarter of 2022, with top-line data expected in the first half of 2023.

A phase II trial of Fosgonimeton in mild-to-moderate Parkinson’s disease dementia and Dementia with Lewy bodies, dubbed SHAPE, is expected to complete enrollment in the first half of 2023. This study, which was initiated in January 2022, is designed to enroll roughly 75 participants.

ATHA closed Thursday’s trading at $11.87, up 5.60%.

5. Bellicum Pharmaceuticals Inc. (BLCM), which is developing novel, controllable cellular immunotherapies for cancers, has a couple of data readouts lined up for 2023.

A phase 1/2 dose escalation clinical trial of BPX-601 GoCAR-T in patients with previously treated metastatic castration-resistant prostate cancer is ongoing, with a data update expected in the first quarter of 2023.

A phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers is underway. A data update on this study is anticipated in the first half of 2023.

The company’s cash and cash equivalents and restricted cash totaled $47.7 million as of December 31, 2021.

BLCM closed Thursday’s trading at $2.01, up 1.52%.

6. Celyad Oncology SA (CYAD), a clinical-stage biotechnology company developing chimeric antigen receptor T cell therapies for cancer, is looking forward to announcing upcoming milestones in 2022.

A phase I dose-escalation trial evaluating the tolerability and clinical activity of a single infusion of CYAD-211 following preconditioning with CyFlu (cyclophosphamide and fludarabine) in patients with relapsed/refractory multiple myeloma, dubbed IMMUNICY-1, is underway. Three out of 12 total patients evaluated for activity achieved partial response, one in each dose-level, while eight patients had stable disease, according to the company.

The next segment of the IMMUNICY-1 study will evaluate CYAD-211 following enhanced lymphodepleting (eLD) regimens. This cohort is enrolling patients and additional data is expected in the second half of 2022.

The company ended the year 2021 with cash and cash equivalents of €30.0 million ($34.0 million).

CYAD closed Thursday’s trading at $2.35, down 1.67%.

7. Co-Diagnostics Inc. (CODX), a commercial-stage molecular diagnostics company, has forecast first quarter earnings per share above analysts’ estimate.

For the first quarter of 2022, the company has forecast EPS in the range of $0.17 to $0.20 while the consensus analysts’ estimate is $0.11. The EPS was $0.26 in the first quarter of 2021.

The company expects revenue in the range of $21.0 million to $22.0 million for Q1, 2022 while the consensus analysts’ estimate is $21.28 million. Revenue was $20 million in the first quarter of 2021.

For full year 2021, the company reported revenue of $97.9 million compared to $74.5 million in 2020, primarily due to sales of Logix Smart COVID-19 Tests throughout the world.

CODX closed Thursday’s trading at $6.51, up 3.66%.

8. ContraFect Corp. (CFRX), a late clinical-stage biotechnology company developing direct lytic agents for the treatment of life-threatening, antibiotic-resistant infections, expects to conduct the planned interim futility analysis of its DISRUPT study by the end of the first half of 2022.

DISRUPT is a phase III study being conducted in the U.S. to assess the efficacy and safety of Exebacase in approximately 350 patients with Staph aureus bacteremia, including right-sided endocarditis.

ContraFect ended the year 2021 with cash, cash equivalents and marketable securities of $54.3 million.

CFRX closed Thursday’s trading at $3.78, down 0.79%.

9. Eledon Pharmaceuticals Inc. (ELDN) has a couple of clinical trial catalysts to keep an eye on in the second quarter.

The company expects topline data from its phase IIa study with lead drug candidate Tegoprubart in Amyotrophic Lateral Sclerosis in the second quarter.

A non-human primate kidney transplantation study with Tegoprubart is expected to be completed next quarter.

Catalysts to watch in Q4:

— Initial open label data from Phase 1b trial of Tegoprubart in kidney transplantation.
— Initial open label data from Phase 2a trial of Tegoprubart in IgAN.
— Initial open label data from Phase 2a trial of Tegoprubart in islet cell transplantation.

As of December 31, 2021, the company had approximately $84.8 million in cash and cash equivalents.

ELDN closed Thursday’s trading at $3.75, down 0.79%.

10. Evelo Biosciences Inc. (EVLO), a clinical stage biotechnology company focused on treatments for inflammatory diseases, looks forward to achieve the following milestones.

— Interim data from a phase Ib trial of EDP1867 in atopic dermatitis is expected in early 2Q 2022.
— Initiate registrational trials of EDP1815 in psoriasis, following the completion of meetings with health authorities this year.
— Topline data from 16-weeks of dosing in a phase II trial of DP1815 in atopic dermatitis is anticipated in the first half of 2023.

Cash and cash equivalents totaled $68.4 million at Dec.31, 2021.

EVLO closed Thursday’s trading at $4.12, up 25.99%.

11. Gain Therapeutics Inc. (GANX) expects to initiate a first-in-human Phase 1 clinical trial in its GBA1 Parkinson’s disease program in Australia this year.

The company is also planning to advance its GBA1 Gaucher disease program into regulatory toxicology studies in 2022.

The company had cash and cash equivalents of $36.88 million as of December 31, 2021.

GANX closed Thursday’s trading at $4.53, up 2.49%.

12. HOOKIPA Pharma Inc. (HOOK), which made significant progress in advancing its pipeline, has a couple of data readouts to keep an eye on in the coming months.

A phase II trial to assess HB-200 in combination with Merck’s Keytruda as 1st-line and 2nd-line treatment for head and neck cancers is underway. Preliminary data is anticipated in the second half of 2022.

Additional data from a phase I trial evaluating HB-201 as monotherapy for patients with advanced HPV16+ metastatic cancers is expected in mid-2022.

An Investigational New Drug (IND) application for HB-300, being developed for prostate cancer, is expected to be filed with the FDA in the third quarter of 2022.

HOOK closed Thursday’s trading at $1.72, up 8.86%.

13. Imago BioSciences Inc. (IMGO) is planning to initiate two investigator-sponsored clinical trials with its lead drug candidate Bomedemstat in the first half of the year.

The trials pending initiation are:

— A Phase 1 study of Bomedemstat in combination with Atezolizumab for the treatment of small cell lung cancer, and
— A Phase 2 study of Bomedemstat in combination with Ruxolitinib for the treatment of myelofibrosis.

The company is also making preparations for a registrational study of Bomedemstat for the treatment of Essential Thrombocythemia, subject to the completion of the ongoing trial and a successful End-of-Phase 2 meeting with the FDA in the second half of this year.

IMGO closed Thursday’s trading at $19.12, up 3.69%.

14. Impel NeuroPharma Inc. (IMPL) a commercial-stage pharmaceutical company, whose lead product Trudhesa was launched last October, is confident in its ability to meet the current overall expectations for this year.

Trudhesa, indicated for the acute treatment of migraine with or without aura in adults, generated over 4,200 (TRx) prescriptions, exceeding its fourth quarter 2021 guidance of 3,000-4,000 prescriptions.

The net revenues from sales of Trudhesa were $0.6 million for the fourth quarter of 2021 compared to zero in the year-ago period.

For full year 2022, the company expects Trudhesa to deliver prescriptions within the range of 70,000 – 85,000.

IMPL closed Thursday’s trading at $7.52, down 6.23%.

15. InflaRx N.V. (IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics, expects topline data from its phase III trial of Vilobelimab in severe COVID-19 by end of March.

A phase IIa exploratory study Vilobelimab in Pyoderma Gangrenosum is underway, with final data slated to be presented on March 26th at the American Academy of Dermatology Association (AAD) Annual Meeting.

Vilobelimab is also being explored in a phase II trial in cutaneous squamous cell carcinoma, with data expected in the first quarter of 2023.

Also in the pipeline is INF904, which has completed IND-enabling trial. A phase I program of INF904 is expected to be initiated in the second half of 2022, where the compound will be studied in complement-mediated, chronic autoimmune and inflammatory diseases.

IFRX closed Thursday’s trading at $2.47, up 5.56%.

16. Landos Biopharma Inc. (LABP), a clinical-stage biopharmaceutical company developing oral medicines for autoimmune diseases, expects to initiate a phase 2b study of Omilancor in ulcerative colitis later this year.

NX-13, for the potential treatment of Ulcerative Colitis, and LABP-104, for the potential treatment of systemic lupus erythematosus and/or rheumatoid arthritis, are the other investigational drugs in the pipeline.

The company has completed enrollment of phase 1b trial of NX-13 in Ulcerative Colitis and phase 1a Trial of LABP-104 in normal healthy volunteers. Top Line results from both the trials are anticipated in mid-2022.

LABP closed Thursday’s trading at $1.80, up 4.65%.

17. LAVA Therapeutics N.V. (LVTX), an immuno-oncology company, has a couple of clinical trial results worth watching in the coming months.

Earlier this month, the company had reported encouraging interim data from the first three single patient cohorts of the Phase 1 dose escalation portion of its Phase 1/2a clinical trial of LAVA-051.

Currently, the phase 1/2a clinical trial is exploring LAVA-051 in patients with relapsed or refractory chronic lymphocytic leukemia and multiple myeloma. The trial will also include acute myeloid leukemia patients later.

Additional data from the Phase 1 dose escalation phase of the trial is anticipated next quarter and data from the Phase 2a expansion cohorts are expected in the second half of 2022.

A phase 1/2a clinical trial of LAVA-1207 in patients with metastatic castration-resistant prostate cancer is ongoing, with phase I data expected in the second half of 2022 and phase 2a data anticipated in the first half of 2023.

LVTX closed Thursday’s trading at $4.94, up 3.4%.

18. MedAvail Holdings Inc. (MDVL), a technology-enabled pharmacy company, expects revenue for the first quarter of 2022 to more than double from the year-ago quarter.

For the first quarter of 2022, the company has forecast revenue to be in excess of $8.8 million, well above analysts’ consensus estimate of $7.64 million. Revenue in the first quarter of 2021 was $4 million.

For the fourth quarter ended Dec.31, 2021, net loss was $12.6 million or $0.38 per share on revenue of 47.3 million. This compares with a net loss of $12.1 million or $0.71 per share and revenue of $3.10 million in the year-earlier quarter.

MDVL closed Thursday’s trading at $1.18, up 9.26%.

19. Milestone Pharmaceuticals Inc. (MIST) is all set to report topline data from its pivotal RAPID trial in mid-second half 2022.

RAPID is a two-part, phase III trial evaluating the efficacy and safety of Etripamil nasal spray self-administered by patients who experience an episode of paroxysmal ventricular tachycardia.

A phase II proof-of-concept in-patient study of Etripamil nasal spray in patients experiencing atrial fibrillation with rapid ventricular rate, dubbed ReVeRA, is underway. The trial is being conducted in Canada.

The company’s cash, cash equivalents, and short-term investments totaled $114.1 million as of Dec.31, 2021.

MIST closed Thursday’s trading at $6.36, up 10.42%.

20. Movano Inc. (MOVE) is working towards the commercialization of its first product, the Movano Ring, which is designed to measure heart rate, heart rate variability, sleep, respiration, temperature, blood oxygen, steps and calories.

The company expects to Beta launch the Movano Ring in the second half of 2022.

As of December 31, 2021, the company’s, cash, cash equivalents and short-term investments totaled $33.6 million.

MOVE closed Thursday’s trading at $2.81, down 0.35%.

21. Nyxoah S.A. (NYXH), a medical technology company that markets Genio system to treat Obstructive Sleep Apnea, has been making considerable commercial progress in Europe.

Revenue jumped to €852,000 for the year ended Dec.31, 2021 from €69,000 in 2020.

A pivotal, Investigational Device Exemption (IDE) trial designed to support the marketing authorization of the Genio system in the United States, dubbed DREAM, is underway. It is expected to be completed in the second quarter of 2022.

A U.S. IDE study with Genio system for Complete Concentric Collapse patients is expected to commence in the fourth quarter of 2022.

NYXH closed Thursday’s trading at $19.68, up 0.15%.

22. Ocuphire Pharma Inc. (OCUP) has multiple late-stage clinical trial data catalysts to watch this year.

The company expects to report topline results from a phase III pivotal trial evaluating Nyxol Eye Drops in the reversal of pharmacologically-induced mydriasis, (dilation of the pupil) in subjects aged 12 and older, dubbed MIRA-3, by the end of this quarter (Q1).

Another pivotal study evaluating the safety and efficacy of Nyxol eye drops to reverse pharmacologically-induced mydriasis in pediatric subjects, dubbed MIRA-4, is underway, with topline results expected next quarter.

A phase III program investigating Nyxol alone and Nyxol with 0.4% LDP as adjunctive treatment in presbyopia: is expected to be initiated in mid-2022.

A phase III trial exploring Nyxol in subjects with dim light vision disturbances, dubbed LYNX-1, is ongoing, with top-line results anticipated next quarter.

Also in the pipeline is APX3330, a novel, first-in-class, twice-daily oral tablet drug candidate, being tested in a phase IIb trial in Diabetic Retinopathy and Diabetic Macular Edema, dubbed ZETA-1. Topline results from this study are expected in the second half of this year.

OCUP closed Thursday’s trading at $4.17, up 5.57%.

23. PhaseBio Pharmaceuticals Inc. (PHAS), a clinical-stage biopharmaceutical company developing novel therapies for cardiovascular diseases, is on track to file its Biologics License Application for Bentracimab in mid-2022.

Bentracimab is currently being evaluated in a phase III trial to study reversal of the antiplatelet effects of Ticagrelor with Bentracimab in patients who present with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedure.

PHAS closed Thursday’s trading at $1.20, down 14.89%.

24. Sight Sciences Inc. (SGHT), an eyecare technology company, expects revenue for the full year 2022 to grow 36% to 53% over 2021.

The company’s annual revenue in 2021 was $49.0 million compared to $28 million in 2020. Net loss for the year was $63.0 million or $2.36 per share compared to a net loss of $34.7 million or $3.71 per share in 2020.

Looking ahead to full year 2022, Sight Sciences has forecast revenue to be in the range of $67 million to $75 million.

SGHT closed Thursday’s trading at $14.75, down 1.40%.

25. Werewolf Therapeutics Inc. (HOWL) expects 2022 to be a pivotal year as it gears up to advance its compounds into clinical testing.

The company expects to file the investigational new drug (IND) application for its first candidate, WTX-124, in the second quarter of 2022, and the IND for its second candidate, WTX-330, early in the third quarter of 2022.

WTX-124 as monotherapy and in combination with Merck’s Keytruda will be tested in patients with solid tumors.

WTX-330 is also being developed for treating selected solid tumors and lymphoma.

HOWL closed Thursday’s trading at $3.71, down 4.38%.

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