On March 20, 2024 OmniAb, Inc. (NASDAQ: OABI) reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates (Press release, OmniAb, MAR 20, 2024, View Source [SID1234641298]).

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"2023 was a year of significant expansion of OmniAb’s partnership base and pipeline programs as we continued to execute against our plan, while key partner programs made significant progress despite last year’s sector-related headwinds. Partners exceeded our expectations regarding the number of new programs entering the clinic, with a total of six new entrants last year," said Matt Foehr, Chief Executive Officer of OmniAb. "In addition, we successfully launched two new technologies and expanded our business development function, now with a presence in the U.S., EU and Asia Pacific. We look forward to meaningful advancements in 2024 and in the coming years, as we are now staffed and resourced to efficiently leverage the future growth of the business."

Fourth Quarter 2023 Financial Results

Revenue for the fourth quarter of 2023 was $4.8 million, compared with $35.3 million for the same period in 2022, with the decrease primarily due to the recognition of a $25.0 million milestone payment in the prior-year period related to the first commercial sale of TECVAYLI (teclistamab) in the U.S. and lower service revenue as a result of the completion of discovery work on certain ion channel programs.

Research and development expense was $14.8 million for the fourth quarter of 2023, compared with $12.9 million for the same period in 2022, with the increase primarily due to higher personnel costs. General and administrative expense was $7.9 million for the fourth quarter of 2023, compared with $10.2 million for the same period in 2022, with the decrease primarily due to one-time expenses related to the spin-off of OmniAb into a separate public company in the prior-year period partially offset by increases in personnel costs.

Net loss for the fourth quarter of 2023 was $14.1 million, or $0.14 per diluted share, compared with net income of $6.8 million, or $0.07 per share, for the same period in 2022.

Full Year 2023 Financial Results

Revenue for 2023 was $34.2 million, compared with $59.1 million for 2022, with the decrease primarily due to the recognition of TECVAYLI milestones of $10.0 million in 2023 compared with $25.0 million in 2022. Service revenue was lower primarily related to the completion of work on certain ion channel programs and an adjustment related to the extension of one of our programs with GSK, partially offset by the recognition of a portion of a research progression milestone.

Research and development expense for 2023 was $56.5 million, compared with $48.4 million for 2022, with the increase primarily due to headcount and facility costs. General and administrative expense for 2023 was $33.3 million, compared with $24.9 million for 2022, with the increase primarily due to higher personnel costs and expenses related to being an independent publicly traded company.

Net loss for 2023 was $50.6 million, or $0.51 per share, compared with a net loss of $22.3 million, or $0.26 per share, for 2022. Cash provided by operating activities was $2.3 million for 2023.

As of December 31, 2023, OmniAb had cash, cash equivalents and short-term investments of $87.0 million.

2024 Financial Guidance

OmniAb expects operating expense in 2024 to be approximately the same as in 2023, and is now staffed and resourced to leverage the future growth of the business.

OmniAb expects its cash use in 2024 to be relatively similar to its cash used in 2023, excluding the $35 million TECVAYLI milestone payment received in 2023. Given the expected progression of the existing partnered pipeline, OmniAb expects its cash use in 2025 to be substantially lower than in 2024. OmniAb’s current cash balance and cash from operations are expected to provide sufficient capital to fund operations for the foreseeable future.

Fourth Quarter 2023 and Recent Business Highlights

The Company signed 10 new licenses in 2023, including three in the fourth quarter, with Enable Life Sciences, Mirador Therapeutics, and a global pharma company. In addition, six new OmniAb-derived antibodies entered the clinic in 2023. As of December 31, 2023, the company had 77 active partners and 325 active programs, including 32 OmniAb-derived programs in clinical development, or being commercialized.

OmniAb launched two new technologies during 2023 including OmniDeep and, during the fourth quarter, OmnidAb . OmniDeep is a suite of in silico tools for therapeutic discovery and optimization that are woven throughout OmniAb’s various technologies and capabilities. These tools include structural modeling, molecular dynamics simulations, large multi-species antibody databases, artificial intelligence, machine learning, deep learning models and more. OmniDeep facilitates rapid identification of candidates with the right affinity, specificity and developability profiles intended to make drug development more effective and efficient. The OmnidAb transgenic chicken novel host system builds upon the success of the Company’s OmniChicken legacy by expressing an optimized single-domain human framework that can generate modular building blocks well suited to support a variety of therapeutic modalities. OmnidAb antibodies target distinct epitopes and have favorable developability profiles with high expression levels in mammalian cells. Compared with traditional antibodies, sdAbs produced by OmnidAb chickens have a compact format that opens new opportunities and broad clinical applications.

Fourth quarter 2023 and recent partner highlights include the following:

Batoclimab

Immunovant reported positive initial results for batoclimab in Graves’ disease (GD). The company announced that results from the initial cohort of patients in an ongoing 24-week Phase 2 clinical trial meaningfully exceeded a 50% response rates.
Immunovant also reported that global Phase 3 clinical trials of batoclimab in myasthenia gravis (MG) and thyroid eye disease (TED) are progressing and on track for topline data in the second half of 2024 (MG) and the first half of 2025 (TED). Initial period 1 data from the Phase 2b clinical trial of batoclimab in chronic inflammatory demyelinating polyneuropathy (CIDP) are expected in the second or third quarter of 2024.
IMVT-1402

Immunovant announced initial data from the 600 mg multiple-ascending-dose cohort of a Phase 1 clinical trial of IMVT-1402 in healthy adults. The results show that four subcutaneously administered doses of 600 mg produced a mean IgG reduction similar to high-dose batoclimab, but with minimal changes in albumin and LDL-C similar to those in placebo, confirming the potential of IMVT-1402 as a best-in-class neonatal fragment crystallizable receptor (FcRn) inhibitor.
In addition, Immunovant announced plans to initiate four to five potentially registrational programs for IMVT-1402 over the next fiscal year. The company also plans on initiating trials in 10 indications for IMVT-1402 over the next two fiscal years.
Acasunlimab (formerly GEN1046)

Genmab expects to announce additional acasunlimab (GEN1046: PD-L1 x 4-1BB) Phase 2 data in second-line non-small cell lung cancer (NSCLC) in the first half of 2024.
In addition, Genmab plans to initiate a Phase 3 study of acasunlimab in a second-line NSCLC indication in 2024.
JNJ-79635322

Johnson & Johnson presented preclinical data for JNJ-79635322, a trispecific antibody comprised of an anti-CD3 binding domain, an anti-BCMA binding domain and an anti-GPRC5D binding domain, concluding that it is a potential first-in-class trispecific antibody with the ability to deplete dual- and single-target expressing multiple myeloma clones in preclinical studies in vitro and in vivo. A Phase 1 dose-escalating study of JNJ-79635322 in myeloma patients is ongoing.
Zimberelimab

Arcus and Gilead have reprioritized the joint domvanalimab + zimberelimab development program to focus on advancing, and potentially accelerating, the Phase 3 studies of STAR-121 (lung cancer) and STAR-221 (gastrointestinal cancer), which are both expected to be fully enrolled by year-end 2024. The companies also plan to initiate STAR-131, a new registrational Phase 3 lung cancer study that includes the domvanalimab + zimberelimab regimen.
Arcus presented preliminary data from the dose-escalation portion of its ARC-8 Phase 1/1b study, evaluating the safety and tolerability of AB680 + NP/Gem + zimberelimab in metastatic pancreatic cancer. The results included a 41% objective response rate observed to-date across the first four cohorts in the Phase 1 dose-escalation portion of ARC-8, comparing favorably to the current standard of care.
Sugemalimab

CStone announced the National Medical Products Administration of China (NMPA) has approved the supplemental BLA for sugemalimab (Cejemly) in combination with fluorouracil and platinum-based chemotherapy as first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma. Sugemalimab becomes the world’s first anti-PD-L1 monoclonal antibody approved for this indication in the first-line setting.
OmniAb was added to the Nasdaq Biotechnology Index (NBI) in the fourth quarter. The inclusion became effective as of December 18, 2023.

Conference Call and Webcast

OmniAb management will host a conference call with accompanying slides today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (888) 259-6850 using the conference ID 72611636. Slides, as well as the live and replay webcast of the call, are available at View Source