Analyst Conference Summary

Biotechnology

conference date: August 8, 2023 Press release only
for quarter ending: June 30, 2023 (Q2, second quarter 2023)

Forward-looking statements

Overview: Development of cancer therapies continues.

Basic data (GAAP):

Revenue was $25 million, up sequentially from $23 million and up from $21 million year-earlier.

Net income was negative $73 million, down sequentially from negative $71 million, and down from negative $49 million year-earlier.

Earnings per share, diluted, (EPS) were negative $0.20, up sequentially from negative $0.22 and down from negative $0.17 year-earlier.

Guidance:

none

Conference Highlights:

CEO Garo Armen stated: "Botensilimab, alone or in combination with balstilimab, continues to display remarkable clinical activity in over 600 patients treated across nine late-stage, treatment resistant solid tumor cancers, demonstrating great potential to revolutionize the role of immunotherapy in cancer treatment. Agenus is committed to advancing our diverse clinical pipeline with a focus on expediting our first regulatory submission for the botensilimab/balstilimab combination in colorectal cancer. Our data has demonstrated an unprecedented survival benefit over what has been reported for standard of care, underscoring this combination as an important potential treatment option for patients with non-MSI-high colorectal cancer, which represents 85% of the population of patients with colorectal cancer"

On May 1, 2023 Agenus, a majority holder of its spin-off MiNK Therapeutics (INKT) distributed a dividend of 5 million shares to Agenus shareholders.

Next-Gen CTLA-4 agent, botensilimab (AGEN1181) reported updated data at ESMO-GI June 2023. In 69 evaluable patients with non-MSI-High CRC without active liver metastases, results demonstrated a meaningful improvement over standard of care in both overall response rate (ORR%) and median overall survival (mOS) of 20.9 months, compared to 12.9 months for standard of care. ORR was 23%, comparing to 2.8% for standard of care. Phase 2 updated Ovarian cancer botensilimab/balstilimab combination showed overall response rate of 33% and disease control rate of 63%, much better than comparators; a Phase 3 trial should start in 2023. Sarcoma data showed 46% overall response rate. R/R NSCLC data showed a 50% overall response rate and 75% disease control rate. All trials will coninue, with melanoma and pancreatic cancer Phase 2 trials expectd to complete enrollment in 2023. Had initiated Phase 2 trials for advanced refractory MSS colorectal cancer and for melanoma patients who failed prior PD1 and/or CTLA4 therapy in Q3 2022. A trial in pancreatic cancer began in December 2022. Botensilimab is designed to delete T-regs and increase priming. It also overcomes the genetic polymorphism displayed by about 40% of the target cancers (which makes Yervoy unresponsive). Both monotherapy and combination therapy were well-tolerated. The combination is also showing potential for the adjuvant setting.

In April 2023, the FDA granted Fast Track designation to the bot/bal combination for patients with non-MSI-H/dMMR metastatic CRC without active liver metastases.

The combination study of AGEN2373 (CD137 agonist) and botensilimab in melanoma patients who have relapsed or are refractory to PD1 therapy continues to enroll. Monotherapy results for Phase 1 was presented on June 3, 2023 at ASCO. Responses in metastatic prostate cancer, ampullary carcinoma, and vulvar squamous cell carcinoma were reported. Data from the combination portion of the study will be presented later in 2023.

Bali/Zali combination will continue to be developed for possible use in ex-US territories.

Incyte therapies licensed from Agenus continue to advance in the clinic. Three Incyte partnered programs had presentations at ASCO 2023.

Shingrix is the most effective shingles vaccine; GSK commercial sales have exceeded projections. Agenus licensed GSK QS-21 Stimulon, a component of Shingrix. It is also a component of GSK's Mosquirix vaccine, against malaria, which has received regulatory approval in Africa. SaponiQx subsidiary was launched to provide SQ-21 and next-generation agents, collaborating with Phyton Biotech and Ginkgo Bioworks. Will use a plant-cell based technology. SQ-21 Stimulon is also a component of the GSK RSV vaccine that was approved by the FDA in May 2023.

Revenue consisted of $2.5 million R&D; $22.1 million non-cash royalty (QS-21); $0.7 million other.

Cost of sales was $0 million. Research and development expense was $59 million. General and administrative expense was $20 million. Cost of service revenue $0 million. Other expense $1 million. Non-cash interest expense of $20 million. Fair value adjustment $ million.

Cash and equivalents balance ended at $158 million, down sequentially from $189 million. $na million cash used in operations. No debt. Raised $13.6 million in Q2 with at-market sales. Raised another $20.3 million in Q3 so far.

Q&A selective summary:

none

Agenus web site

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: