Analyst Conference Summary

Biotechnology

conference date: August 08, 2024 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2023 (Q2, second quarter 2024)

Forward-looking statements

Overview: Getting ready for Phase 3 Bot/Bal trial in r/r MSS CRC. But running low on cash. Thinks getting FDA accelerated approval from more mature Phase 2 data is still possible, but early EU approval is a better bet.

Basic data (GAAP):

Revenue was $23.5 million, down sequentially from $28 million and down from $25.3 million year-earlier.

Net income was negative $55 million, down sequentially from negative $63 million, and up from negative $73 million year-earlier.

Earnings per share, diluted, (EPS) were negative $2,52, up sequentially from negative $3.04 and up from negative $3,93 year-earlier.

Guidance:

none

Conference Highlights:

CEO Garo Armen stated: "Agenus milestones this quarter include the release of interim data from our global randomized Phase 2 trial of Bot/Bal in relapsed/refractory MSS colorectal cancer, consistent with our Phase 1 results. The robust responses in this trial and across various solid tumors validate Bot/Bal's potential to address challenging cancer cases. Our data show significant and durable tumor reductions in patients who have exhausted other treatments. We are continuing to work with global health authorities and are dedicated to ensuring swift access to these life-saving therapies. We are deeply moved by the strong support from the patient advocacy and clinical communities and remain committed to accelerating the Bot/Bal program and delivering innovative therapies to patients." The FDA discouraged applying Bot/Bal for accelerated approval based on the Phase 2 data, but Agenus will try again with more mature data. But an active dose for Phase 3 was agreed on.

Agenus is pursuing potential out-licensing transactions for several of its pipeline assets. Includes AGEN1777 (Tigit), previously licensed to Bristol Myers Squibb, and AGEN2373 (CD137), for which the Gilead option period expired. The cash is needed for getting through the Phase 3 Bot trial.

In Q2 2024 entered a $100 million royalty financing agreement, backed by potential bot/bal royalies, with Ligand Pharmaceuticals (LGND). Did not state interest rate, but likely high. Received an initial $75 million in May 2024. " In return for the initial $75 million payment, Ligand will receive 18.75% of the future royalties and 31.875% of the future milestone payments related to six of Agenus’ clinical-stage partnered oncology programs, including BMS-986442 (Bristol Myers Squibb), AGEN2373 (Gilead Sciences), INCAGN2385 and INCAGN2390 (Incyte), MK-4830 (Merck), and UGN-301 (UroGen Pharma). Ligand’s portion of the milestones related to these six programs has the potential to exceed $400 million, with royalties in the low single digits. In addition, Ligand will also receive a 2.625% royalty on future global net sales generated by BOT/BAL."

Updated results from the NEST study in neoadjuvant CRC presented at ESMO GI in June demonstrated unprecedented activity of BOT/BAL in MSS CRC that has historically been poorly responsive to IO therapies. In the NEST-2 cohort of extended treatment (8 weeks), 78% (7/9) of MSS CRC patients achieved pathologic responses of at least 50% tumor reduction, with 56% (5/9) achieving complete pathologic responses (cPR). Toxicities were well managed, and no surgeries were delayed due to adverse events. New analyses presented at the ASCO Annual Meeting in June 2024 highlighted BOT/BAL activity in metastatic CRC across challenging sites of metastatic disease, including peritoneal metastases, soft tissue, bone, and brain. The ORR was consistent across favorable and unfavorable sites of disease and ranged from 18-33%, with disease control rates (DCR) ranging from 67-82%. Median OS remained consistent and ranged from 20.7 months to not reached. More Bot/Bal data is expected as the year progresses.

Agenus has engaged with the European Medicines Authority and has subsequent meetings planned for fall 2024. Agenus will explore registration paths for BOT/BAL in r/r MSS CRC with regulatory authorities in other geographies, including the UK, Canada, Australia, Israel, and Brazil. Generally feedback from these agencies has been more positive than from the FDA. Looking at conditional approval in EU.

Agenus is receiving many compassionate use requests for Bot/Bal.

Agenus is prepared to issue and sell stock, if necessary, to finance it until Bot/Bal approval.

Bot/Bal pancreatic and melanoma trials continue to mature.

Trying to minimize expenses to conserve cash.

Revenue consisted of $0 million R&D; $23 million non-cash royalty (QS-21); $1 million other.

Cost of sales was $0 million. Research and development expense was $37 million. General and administrative expense was $17 million. Cost of service revenue $0.1 million. Other loss $7 million. Non-cash interest expense of $32 million.

Cash and equivalents balance ended at $94 million, up sequentially from $53 million. Cash used in operations was not stated for the quarter, $76 million for the half.

Q&A selective summary:

FDA guidance for Phase 3? Could start within 4 months. Could enroll within a year of commencement due to patient demand. We have been approached by 'certain groups' that want to do the trial for as little as $10 million.

Timing of melanoma and pancreatic data? Maturing data, also lung cancer and neoadjuvant cancers, in coming months.

Initial interactions with EU agency? Cannot disclose much detail. Confidential. EU agency had a stance opposite to the FDA, willing to look at latest data. They gave us several pointers to meet the requirements, want rapid submission to be explored.

All colorectal data from Phase 2 is confirmed; possible upside, no downside. We now have almost 24 months of follow up from Phase 1. Trend is Phase 2 is near identical to Phase 1.

For future FDA Phase 2 discussions, what do you need? Approximately 6 more months of follow up.

Agenus web site

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