IMAB On Watch, GTH Expects 2022 Revenue To Grow 10-20%, PHVS To Report HAE Trial Data In Q4

The following are some of the companies belonging to the healthcare sector that reported fourth quarter results and provided an update on their pipeline progress on Tuesday.

1. Adverum Biotechnologies Inc. (ADVM), a clinical-stage gene therapy company, is expected to initiate a phase II trial of ADVM-022 for wet age-related macular degeneration. The first patient is expected to be dosed in the phase II trial in the third quarter of 2022.

Cash, cash equivalents and short-term investments were $305.2 million at year-end 2021.

ADVM closed Tuesday’s trading at $1.39, up 0.72%.

2. Akouos Inc. (AKUS), a precision genetic medicine company developing potential gene therapies for hearing loss, is working towards submitting an investigational new drug application for its lead product candidate AK-OTOF in the first half of 2022.

AK-OTOF is a gene therapy intended for the treatment of otoferlin gene (OTOF)-mediated hearing loss.

The company is also planning for an IND submission in 2022 for AK-antiVEGF, a gene therapy candidate in preclinical development for the potential treatment of patients with vestibular schwannoma, a benign tumor that grows in the ear.

AKUS closed Tuesday’s trading at $4.82, up 2.77%.

3. BioCardia Inc. (BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, has a couple of catalysts to watch in the coming months.

Two pivotal studies with CardiAMP cell therapy are ongoing – CardiAMP Cell Therapy Heart Failure Trial and CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial.

The Data Safety Monitoring Board is all set to review the CardiAMP Cell Therapy Heart Failure Trial in the third quarter. Safety data from the roll-in cohort of the CardiAMP Chronic Myocardial Ischemia trial is anticipated this year.

The company expects its application for Phase I/II program of its allogeneic Neurokinin-1 Receptor Positive Mesenchymal Stem Cells (NK1R+ MSC) to be accepted in the fourth quarter. NK1R+ MSC is intended for the treatment of ischemic heart failure, intended initially for those patients excluded from the CardiAMP Cell Therapy Heart Failure Trial.

BCDA closed Tuesday’s trading at $2.12, up 3.41%.

4. Candel Therapeutics Inc. (CADL), a clinical stage biopharmaceutical company developing oncolytic viral immunotherapies, has multiple data readouts across its product candidates scheduled over the next 12 months.

The company expects to present initial data from an ongoing phase II trial of CAN-2409 and Valacyclovir combined with PD-1 or PD-L1 targeting agents in patients with non small cell lung cancer in June 2022.

Data from a phase 1b clinical trial of CAN-2409 in combination with Opdivo combined with standard of care first line treatment in patients with newly diagnosed high-grade glioma are expected in the fourth quarter of this year.

Data from a phase I clinical trial of CAN-3110 in recurrent high-grade glioma is also expected in the fourth quarter of 2022.

CADL closed Tuesday’s trading at $2.12, up 3.41%.

5. Cue Health (HLTH), a revenue generating healthcare technology company, reported a profit for the fourth quarter ended Dec.31, 2021, as revenue jumped multifold.

Net income for the fourth quarter of 2021 was $34.2 million or $0.22 per share compared to a net loss of $19.5 million or $1.16 per share in the fourth quarter of 2020. Revenue soared to $192.5 million for the fourth quarter of 2021 from $13.3 million in the year-ago period.

For the first quarter 2022, the company expects revenues to be in the range of $170 million to $180 million.

Cue Health made its debut on the Nasdaq Global Select Market on September 24, 2021, pricing its shares at $16 each.

HLTH closed Tuesday’s trading at $6.70, down 0.59%.

6. Genetron Holdings Ltd. (GTH), a precision oncology platform company in China, reported a wider loss for the fourth quarter ended Dec.31, 2021 on higher operating expenses even as revenue improved more than 9%.

The loss attributable to owners of the company widened to RMB165.3 million or RMB1.79 per ADS for the fourth quarter of 2021 from RMB73.2 million or RMB0.80 per ADS for the same period of 2020.

The company’s total revenue increased by 9.6% to RMB146.9 million in the fourth quarter of 2021 from RMB133.9 million in the year-ago period.

Operating expenses surged by 54.7% to RMB267.5 million in the fourth quarter of 2021 from RMB173.0 million in the same period of 2020.

For the first quarter of 2022, Genetron Health expects to report revenue of approximately RMB106 million, or around 15.1% year-over-year growth.

Looking ahead to full year 2022, the company has forecast total revenue to be around RMB585 million to RMB638 million, representing 10-20% growth over its revenue in 2021. Total revenue in 2021 was RMB532.0 million.

GTH closed Tuesday’s trading at $2.72, down 6.85%.

7. IGM Biosciences Inc. (IGMS), a clinical-stage biotechnology company developing IgM antibodies is making significant progress in advancing its pipeline.

Two phase II studies assessing the safety and efficacy of two doses of IGM-2323, 100 mg and 300 mg, in patients with diffuse large B cell lymphoma and follicular lymphoma are underway. If all goes well as planned, data from these studies could potentially be used as the basis for accelerated review and approval of IGM-2323, according to the company.

A phase I study of IGM-8444 as a single agent and in combination in subjects with relapsed and/or refractory solid and hematologic cancers is underway. IGM expects to report initial monotherapy and combination data in solid tumors from the dose escalation portion of this trial in 2022.

Investigational New Drug Applications for IGM-7354 in solid tumors and for IGM-2644 in multiple myeloma are expected to be filed this year.

The company inked a global collaboration agreement with Sanofi (SNY) for oncology, autoimmune and inflammation targets, sending its shares as much as 140% higher to $35.98 in intraday trading.

IGM closed Tuesday’s trading at $29.49, up 96.73%.

8. Humacyte Inc. (HUMA), a clinical-stage biotechnology platform company, expects to file a Biologics License Application for its lead program human acellular vessels in the indication of vascular trauma in 2022 or 2023.

A phase II/III trial of HAV (human acellular vessels) for the treatment of vascular trauma has so far enrolled 50 patients. A very low rate of infection (approximately 2%), no reports of amputation related to the HAV, and high patency rates have been observed in the study.

A phase III trial of the HAV for AV access for hemodialysis is nearly complete, with more than 210 patients having been enrolled out of a total of 240 patients. The company currently expects to file a BLA for this indication in 2023.

HUMA closed Tuesday’s trading at $6.73, up 5.65%.

9. I-Mab (IMAB), a clinical-stage biopharmaceutical company, has multiple clinical trial events lined up for this year.

The company expects to start one or two registrational trials with Lemzoparlimab in Acute Myeloid Leukemia/Myelodysplastic Syndrome/Non-Hodgkin’s lymphoma this year.

Uliledlimab, another investigational drug, is advancing in two phase II clinical trials in both the U.S. and China in selected tumor types for clinical proof-of-concept.

Also in the pipeline are Felzartamab, a differentiated CD38 antibody for the treatment of relapsing and refractory multiple myeloma and potentially autoantibody-mediated autoimmune diseases such as systemic lupus erythematosus; Eftansomatropin alfa, a differentiated long-acting growth hormone for pediatric growth hormone deficiency; Efineptakin alfa, being developed as monotherapy for treatment of cancer patients with lymphopenia; Enoblituzumab, a humanized B7-H3 antibody as an immuno-oncology treatment agent; Plonmarlimab, a monoclonal antibody to treat patients with severe COVID-19; and TJ210/MOR210, a novel monoclonal antibody for cancers, to name a few.

IMAB closed Tuesday’s trading at $19.39, up 15.07%.

10. Infinity Pharmaceuticals Inc. (INFI), a clinical-stage biotechnology company, is expected to report the following study updates and data in the second half of this year.

— A study update on MARIO-3, an ongoing phase II study of Eganelisib in a novel triple combination with Tecentriq and Abraxane in unresectable locally advanced metastatic triple negative breast cancer.
— A study update on MARIO-275, a phase II study evaluating Eganelisib in combination with Opdivo in platinum-refractory, I/O naïve patients with locally advanced or metastatic urothelial cancer.
— Data from the renal cell carcinoma cohort of the MARIO-3, trial.

The company also expects to initiate the following trials.

— A pivotal trial of Eganelisib in combination with chemotherapy and a checkpoint inhibitor in metastatic triple negative breast cancer patients, dubbed MARIO-4, is expected to be initiated by year-end 2022.
— MARIO-P, a platform study to evaluate the clinical benefit of Eganelisib to support the initiation of future registration focused studies across various solid tumor indications, is expected to be initiated on a rolling basis in the third quarter of this year.

INFI closed Tuesday’s trading at $0.99, up 0.52%.

11. Monte Rosa Therapeutics Inc. (GLUE), a biotechnology company developing novel molecular glue degrader medicines, anticipates significant pipeline progress this year.

The company is planning to submit its Investigational New Drug application to the FDA for lead candidate MRT-2359 in mid-2022.

In preclinical trials, MRT-2359 demonstrated anti-tumor activity in L- and N-Myc-positive non-small cell lung cancer patient-derived xenograft (PDX) models.

The company expects to present new preclinical data supporting MRT-2359 program in a poster presentation at the upcoming American Association for Cancer Research Annual Meeting, hosted April 8-13, 2022.

GLUE closed Tuesday’s trading at $12.68, up 16.33%.

12. Pharvaris (PHVS), a clinical-stage company developing therapies to treat and prevent HAE attacks, has a key catalyst to watch in the coming months.

The lead compound is PHVS416, under phase II clinical development for treatment of hereditary angioedema (HAE) a rare genetic condition that causes accumulation of fluid under the skin in the stomach, face, feet, etc.

A phase II study of PHVS416 for the on-demand treatment of HAE attacks, dubbed RAPIDe-1, is underway, with topline data anticipated in the fourth quarter of 2022.

A phase II clinical trial of PHVS416 for the prophylactic treatment of HAE attacks, dubbed CHAPTER-1, is ongoing, with topline data expected in the fourth quarter of this year.

PHVS closed Tuesday’s trading at $18.40, unchanged from the previous day’s close.

13. Rani Therapeutics Holdings Inc. (RANI) expects topline data from its phase I trial of RT-102 for the potential treatment of osteoporosis in the second half of this year.

RT-102, an oral formulation of the human parathyroid hormone analog PTH (1-34) is orally delivered by the RaniPill capsule to the small intestine.

The RaniPill capsule, developed by the company, is a novel, proprietary and patented platform technology, intended to replace subcutaneous injection of biologics with oral dosing.

RANI closed Tuesday’s trading at $14.02, down 0.71%.

14. SCYNEXIS Inc. (SCYX) plans to seek expanded FDA approval for Brexafemme in recurrent vulvovaginal candidiasis and anticipates receiving the regulatory nod for this label expansion by the end of 2022.

Brexafemme was approved by the FDA last June for use in patients with vulvovaginal candidiasis, also known as vaginal yeast infection. The drug generated $0.6 million in net sales in fourth quarter 2021 and $1.1 million in total net sales in 2021.

SCYX closed Tuesday’s trading at $4.09, down 12.98%.

15. SomaLogic Inc. (SLGC), a commercial-stage AI-data driven proteomics technology company, expects revenue for 2022 to grow 29% to 35% over the prior year.

For full year 2022, the company expects revenue to range between $105 million and $110 million, which represents 29% to 35% growth over last year. Revenue for the full year 2021 was $81.6 million.

Net loss was $87.5 million or $0.64 per share in full year 2021 compared to a net loss of $53.0 million or $0.81 per share in the prior year.

SLGC closed Tuesday’s trading at $8.34, up 7.06%.

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