AMAM Awaits ACE-Breast-02 Study Data, CNC Posts Strong Q1 Results, EXAS Boosts Outlook

The following are some of the biotech companies that reported their earnings scorecard and provided a business update on Tuesday.

1. Ambrx Biopharma Inc. (AMAM), a clinical stage biopharmaceutical company developing Engineered Precision Biologics, has a couple of data readouts lined up for this year.

The company’s lead asset is ARX788, which is in three pivotal trials, dubbed ACE-Breast-02, ACE-Breast-03, and ACE-Gastric-02.

— ACE-Breast-02 is a phase III pivotal trial of ARX788 for HER2+ metastatic breast cancer, ongoing in China.
— ACE-Breast-03 is a global phase III pivotal trial of ARX788 for HER2+ metastatic breast cancer.
— ACE-Gastric-02 is a global phase III pivotal trial of ARX788 for gastric/GEJ cancer.

Topline data from the ACE-Breast-02 study is expected by the end of 2022.

ARX788 is also being trialed in a phase I study in multiple HER2-expressing tumors, dubbed ACE-Pan Tumor-01, and in a phase II study in patients with HER2-mutated or HER2 gene amplified solid tumors, dubbed ACE-Pan Tumor-02.

According to interim results reported last April, the dose escalation portion of the ACE-Pan Tumor-01 trial had demonstrated a confirmed *ORR of 67% (2 of 3 patients) in the cohort of patients receiving the 1.5 mg/kg Q4W dose, and no confirmed responses among 8 patients in the 1.3 mg/kg Q4W cohort. (*Overall response rate, or ORR, is the proportion of patients in a trial whose tumor is killed or greatly reduced by a drug).

Additional data from the ACE-Pan Tumor-01 trial is expected in the second half of this year.

Another clinical drug candidate of the company is ARX517 that targets the prostate-specific membrane antigen expressed on prostate cancer, under a phase I trial. Interim safety data from this study is expected in the second half of this year.

The third pipeline candidate – ARX305 – is designed to target CD70 to treat a broad range of solid and hematologic tumors such as renal cell carcinoma.

The company expects to initiate a phase I dose-escalation, and dose-expansion study to evaluate the safety, pharmacokinetics and preliminary anti-tumor activity of ARX305 in adults with clear cell renal cell carcinoma who are resistant or refractory to prior standard therapies in the second half of this year.

Cash position:

The company’s cash and cash equivalents were $170.1 million as of December 31, 2021.

Ambrx Biopharma made its debut on the New York Stock Exchange on June 18, 2021, pricing its American depositary shares at $18 each.

AMAM has thus far hit a low of $3.50 and a high of $22.87. The stock closed Tuesday’s trading at $3.50, down 4.89%.

2. Chemed Corp. (CHE) has reported better-than-expected earnings for its first quarter ended March 31, 2022, while revenue fell shy of analysts’ estimate.

Chemed operates VITAS Healthcare Corp, one of the nation’s largest providers of end-of-life care, and Roto-Rooter, the nation’s largest commercial and residential plumbing and drain cleaning services provider.

On an adjusted basis, the net income for the first quarter of 2022, was $72.8 million or $4.79 per share compared to $72.4 million or $4.44 per share in the year-ago period. Revenue for the first quarter of 2022 improved slightly to $531 million from $527 million in the year-ago quarter.

Wall Street analysts were expecting the company to earn $4.47 per share on revenue of $538.57 million.

CHE closed Tuesday’s trading at $481.27, down 3.06%.

3. Centene Corp. (CNC), which reported strong first quarter results, has also provided a rosy outlook for the year.

For the first quarter ended March 31, 2022, net earnings jumped to $852 million or $1.44 per share from $697 million or $1.19 per share in the year-ago quarter. On an adjusted basis, the EPS for the first quarter of 2022 was $1.83 compared to $1.63 for the first quarter of 2021.

The company’s total revenue for the first quarter of 2022 rose to $37.2 billion from $29.9 billion in the year-earlier quarter.

Wall Street analysts were expecting the company to earn $1.68 per share on revenue of $34.5 billion for the quarter.

Looking ahead to full-year 2022, the company now expects total revenue to range between $139.9 billion and $141.9 billion, up from its prior outlook of $135.9 billion to $137.9 billion. The total revenue in 2021 was $126.0 billion.

Analysts polled by Thomson Reuters have forecast 2022 revenue in the range of $135.78 billion to $137.95 billion.

CNC closed Tuesday’s trading at $81.88, down 3.51%.

4. Exact Sciences Corp. (EXAS), which reported 21% revenue growth for the first quarter ended March 31, 2022, has boosted its revenue outlook for the year.

Total revenue for Q1, 2022 was $486.6 million compared to $402 million in the year-ago period, and well above analysts’ consensus estimate of $461.71 million.

Net loss widened to $180.9 million or $1.04 per share in the first quarter of 2022 from $31.2 million or $0.18 per share in the year-earlier quarter. Wall Street analysts were expecting the company to incur a loss of $1.07 per share for the quarter.

Looking ahead to 2022, the company now expects revenue to be in the range of $1,985 million to $2,032 million, up from its prior forecast of $1,975 million to $2,027 million. Revenue was $1,767 million in 2021.

EXAS closed Tuesday’s trading at $58.63, down 6.40%.

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