ADCT Awaits Cami Trial Data, CSTL Boosts Revenue Outlook, ANNX To Report HD Trial Data In Q2

The following are some of the companies belonging to the healthcare sector that reported quarterly earnings and provided an update on their pipeline progress on Monday.

1. Adaptimmune Therapeutics plc (ADAP) is planning to seek FDA approval for its lead product candidate Afami-cel, being developed for the treatment of synovial sarcoma, in the fourth quarter.

Pooled data from Cohort 1 of the company’s SPEARHEAD-1 trial and the phase I trial of Afami-cel in patients with sarcoma are expected to be presented as a poster at ASCO.

SPEARHEAD-1 is a phase II trial of Afami-cel in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma.

As of March 31, 2022, the company’s cash and cash equivalents totaled $89.5 million.

ADAP closed Monday’s trading at $1.54, down 9.94%.

2. ADC Therapeutics SA (ADCT) has a clinical trial catalyst to watch in the coming months.

Topline results from a pivotal phase II trial of Camidanlumab Tesirine (Cami) in patients with relapsed or refractory Hodgkin lymphoma are expected to be reported in the first half of this year.

The company plans to have a pre-BLA meeting with the FDA, related to Cami, in the second half of 2022.

The first commercial product of ADC Therapeutics is ZYNLONTA, which received accelerated approval from the FDA for treatment of adult patients with relapsed or refractory large B-cell lymphoma last April. The drug generated net sales of $16.5 million in the first quarter of 2022, slightly down from $17.0 million reported in the fourth quarter of 2021.

As of March 31, 2022, the company’s cash and cash equivalents were $430.9 million.

ADCT closed Monday’s trading at $7.81, down 28.68%.

3. Amicus Therapeutics (FOLD) has two regulatory catalysts to keep an eye on in the coming months.

The FDA decision on Miglustat, a component of AT-GAA, for the treatment of Pompe disease is set for May 29, and that on Cipaglucosidase alfa, another component of AT-GAA, for Pompe disease is scheduled for July 29.

The company continues to expect the FDA to approve the applications together by the July 29, 2022 action date.

The company’s marketed drug is Galafold, an oral therapy for Fabry disease. Global Galafold revenue in the first quarter of 2022 was $78.7 million compared to $66.4 million in the first quarter of 2021.

For the full-year 2022, the company anticipates total Galafold revenue to range between $350 million and $365 million, compared to $305.5 million reported in full-year 2021.

FOLD closed Monday’s trading at $6.23, down 0.64%.

4. Annexon Inc. (ANNX) has a couple of data readouts lined up for the coming months.

The lead drug candidate is ANX005, which is being explored across a number of indications.

— A phase II trial of ANX005 in patients with Huntington’s disease (HD) has completed the six-month treatment period and three-month follow-up period, with data due this quarter.
— A phase II trial of ANX005 in patients with autoimmune disease warm autoimmune hemolytic anemia (wAIHA) is ongoing, with initial data anticipated in the second half of 2022.
— A phase II/III trial of ANX005 in patients with Guillain-Barré Syndrome (GBS) is underway, with data anticipated in 2023.
— A phase II trial of ANX005 in patients with amyotrophic lateral sclerosis (ALS) is underway, with data anticipated next year.

The other investigational drugs in the pipeline are ANX007, ANX009, ANX105, and ANX1502.

— ANX007 is under a global phase II clinical trial in patients with geographic atrophy, dubbed ARCHER, with initial data anticipated in the first half of 2023.
— ANX009 is under a phase 1b trial in patients with lupus nephritis, with initial data anticipated in the second half of 2022.
— ANX105, being developed for treatment of chronic autoimmune and neurodegenerative diseases, is under a phase I trial, with data expected in 2023.
— ANX1502, being developed or the treatment of autoimmune diseases, is expected to advance into a first-in-human trial in the second half of 2022.

ANNX closed Monday’s trading at $2.60.

5. aTyr Pharma Inc. (LIFE) is on track to initiate a planned registrational study of Efzofitimod in pulmonary sarcoidosis in the third quarter of this year.

The company recently completed a phase 1b/2a study of Efzofitimod in patients with pulmonary sarcoidosis, which demonstrated safety, tolerability and consistent dose response for Efzofitimod on key efficacy endpoints and improvements compared to placebo.

A phase 1 study of the company’s second drug candidate ATYR2810 in cancer patients is expected to be initiated in the second half of 2022.

The company ended March 31, 2022, with cash, cash equivalents and investments of $98.7 million.

LIFE closed Monday’s trading at $3.59, down 8.07%.

6. Cara Therapeutics Inc. (CARA) has a couple of catalysts to watch in the coming months.

— A phase II proof-of-concept trial of Oral KORSUVA in notalgia paresthetica is underway, with top-line data expected in the second quarter.
— A proof-of-concept phase II clinical trial of Oral KORSUVA for the treatment of pruritus in patients with hepatic impairment due to primary biliary cholangitis is ongoing, with data anticipated in the second half of 2022.

KORSUVA injection was approved by the FDA last August for the treatment of moderate-to-severe pruritus in hemodialysis patients. Its U.S. commercial launch began last month.

CARA closed Monday’s trading at $7.45, down 7.34%.

7. CareCloud Inc. (MTBC) continues to expect full-year 2022 revenue to grow in the range of 9% to 11% over the prior year.

For full-year 2022, the company has reiterated its revenue outlook range of $152 million to $155 million. Revenue was $139.6 million in 2021.

For the first quarter of 2022, the company has reported an adjusted net income of $3.5 million or $0.23 per share on revenue of $35.3 million. This compares with an adjusted net income of $2.9 million or $0.20 per share and revenue of $29.8 million in the year-ago quarter.

MTBC closed Monday’s trading at $3.47, down 10.10%.

8. Castle Biosciences Inc. (CSTL) has increased its revenue outlook for 2022, based on the first-quarter results.

The company now anticipates total revenue in 2022 in the range of $118 million to $123 million, up from its prior outlook of $115 million to $120 million. Revenue was $94.1 million in 2021.

Net loss for the first quarter of 2022 widened to $24.6 million or $0.97 per share from $4.3 million or $0.17 per share for the same period in 2021. Net revenue for Q1, 2022, climbed to $26.85 million from $22.81 million in the year-earlier quarter.

CSTL closed Monday’s trading at $19.17, down 9.36%.

9. Eagle Pharmaceuticals Inc. (EGRX), which delivered promising financial results for the first quarter ended March 31, 2022, anticipates strong growth for this year.

On a non-GAAP basis, net income soared to $52.2 million or $4.04 per share from $3.2 million or $0.24 per share in Q1 2021.

Total revenue for Q1 2022 jumped to $115.9 million from $41.2 million in the year-ago quarter, primarily reflecting strong product sales of Vasopressin and PEMFEXY.

EGRX closed Monday’s trading at $42.95, down 0.69%.

10. Establishment Labs Holdings Inc. (ESTA), a global medical technology company, which has reported 26.8% revenue growth in Q1, 2022, continues to expect full-year revenue to grow in the range of 22% to 30%.

Net loss for the first quarter of 2022 narrowed to $5.93 million or $0.24 per share from $6.95 million or $0.29 per share in the year-ago quarter. Revenue for Q1, 2022 climbed to $38.45 million from $30.33 million in Q1, 2021.

Looking ahead to full-year 2022, the company continues to expect revenue in the range of $155 million to $165 million, which is an annual growth rate of 22% to 30%.

ESTA closed Monday’s trading at $50.15, down 18.82%.

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