On August 8, 2024 OmniAb, Inc. (NASDAQ: OABI) reported financial results for the three and six months ended June 30, 2024, and provided operating and partner program updates (Press release, OmniAb, AUG 8, 2024, View Source [SID1234645644]).
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"Second quarter results were in-line with our expectations and support our view of the full year. We advanced our business by adding new partnerships and programs as existing partners made important clinical progress in their respective programs," said Matt Foehr, Chief Executive Officer of OmniAb. "With recent momentum in business development, 2024 has the potential to be a record year in terms of deal flow, which we believe is driven by the quality and differentiation of our technology platforms and by the superior execution of our team."
Second Quarter 2024 Financial Results
Revenue for the second quarter of 2024 was $7.6 million, compared with $6.9 million for the same period in 2023, with the increase primarily due to the accelerated recognition of deferred service revenue related to the discontinuation of a GSK ion channel program.
Research and development expense was $13.9 million for the second quarter of 2024, compared with $14.1 million for the same period in 2023. General and administrative expense was $8.0 million for the second quarter of 2024, compared with $8.7 million for the same period in 2023, with the decrease primarily due to lower share-based compensation expense as well as nonrecurring prior-year costs associated with ERP system implementation. Amortization of intangible assets increased in the second quarter of 2024 due to a $1.2 million impairment related to assets associated with two legacy unpartnered Ab Initio programs. Other operating income for the second quarter of 2024 includes a $2.6 million reduction in contingent liabilities primarily attributed to changes in partner ion channel programs.
Net loss for the second quarter of 2024 was $13.6 million, or $0.13 per share, compared with a net loss of $14.7 million, or $0.15 per share, for the same period in 2023.
Year-to-Date Financial Results
Revenue for the six months ended June 30, 2024 was $11.4 million, compared with $23.9 million for the same period in 2023, with the decrease primarily due to the recognition in the 2023 period of various milestones, including a $10 million milestone related to the first commercial sale of TECVAYLI (teclistamab) in the European Union.
Research and development expense was $28.5 million for the six months ended June 30, 2024, compared with $27.9 million for the same period in 2023, with the increase primarily due to higher contract research costs partially offset by lower share-based compensation. General and administrative expense was $16.3 million for the six months ended June 30, 2024, compared with $16.9 million for the same period in 2023, with the decrease primarily due to non-recurring consulting and other outside service expenses incurred in 2023 related to the Company’s spin-off. Amortization of intangible assets increased for the six months ended June 30, 2024 due to a $1.2 million impairment related to assets associated with two legacy unpartnered Ab Initio programs. Other operating income for the six months ended June 30, 2024 includes a $2.6 million reduction in contingent liabilities attributed to changes in partner ion channel programs.
Net loss for the six months ended June 30, 2024 was $32.6 million, or $0.32 per share, compared with a net loss of $20.8 million, or $0.21 per share, for the same period in 2023.
As of June 30, 2024, OmniAb had cash, cash equivalents and short-term investments of $57.2 million.
2024 Financial Guidance
OmniAb now expects total operating expenses in 2024 to be slightly less than total operating expenses in 2023.
OmniAb continues to expect its cash use in 2024 to be relatively similar to its cash use 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.
Second Quarter 2024 and Recent Business Highlights
During the second quarter of 2024, OmniAb entered into new platform license agreements with DAAN Bio and Topaz Therapeutics, and expanded its technology access license relationship with HanAll Biopharma. As of June 30, 2024, the Company had 83 active partners and 333 active programs, including 32 OmniAb-derived programs in clinical development or being commercialized. OmniAb also recently entered into new platform license agreements with 92Bio, Inc. and Memorial Sloan Kettering Cancer Center. Additionally, OmniAb recently entered into a joint antibody drug conjugate asset discovery and material transfer agreement with Redwood Bioscience, Inc., a wholly owned subsidiary of Catalent, Inc.
Second quarter 2024 and recent partner and business highlights include the following:
IMVT-1402
In the second quarter, Immunovant disclosed that it expects to advance IMVT-1402 in further studies for indications such as myasthenia gravis, Graves’ disease and chronic inflammatory demyelinating polyneuropathy, all with ongoing studies using batoclimab. The decision of whether to advance IMVT-1402 to a registrational study for thyroid eye disease (TED) will be made after disclosing topline data for batoclimab in TED in the first half of 2025.
Batoclimab
Harbour Biomed announced that it has resubmitted the Biologics License Application of batoclimab (HBM9161) to the National Medical Products Administration of China for the treatment of generalized myasthenia gravis.
Acasunlimab
Genmab announced initial data from the Phase 2 GCT1046-04 trial evaluating acasunlimab (DuoBody-PD-L1x4-1BB), an investigational bispecific antibody also known as GEN1046/BNT311, as monotherapy and in combination with pembrolizumab in patients with PD-L1-positive metastatic non-small cell lung cancer who had disease progression following one or more prior lines of anti-PD-L1-containing treatment. The results showed a 12-month overall survival rate of 69%, a median overall survival of 17.5 months and a 30% overall response rate (confirmed ORR 17%) at the time of data cut-off in patients treated with the combination of acasunlimab and pembrolizumab every six weeks. Data from this ongoing Phase 2 study will inform the planned pivotal Phase 3 trial, which is expected to start before year-end 2024.
Sugemalimab
CStone recently announced European approval for sugemalimab, an anti-PD-L1 monoclonal antibody (mAb) for first-line treatment of both squamous and non-squamous non-small cell lung cancer. CStone is actively preparing to submit additional Marketing Authorization Applications to the European Medicines Agency for new indications, including Stage III non-small cell lung cancer, first-line gastric cancer, first-line esophageal cancer, and relapsed/refractory extranodal natural killer/T-cell lymphoma.
CStone announced that it entered into a strategic commercial collaboration with Ewopharma. Under the licensing and commercialization agreement, Ewopharma gained the commercial rights for sugemalimab in Switzerland and 18 Central Eastern European countries. CStone also disclosed that discussions for commercial partnerships in Western Europe, Latin America, the Middle East, Southeast Asia, etc., are progressing well and are expected to conclude soon.
Zimberelimab
Arcus announced the completion of patient enrollment for STAR-221, a Phase 3 study in collaboration with Gilead Sciences evaluating the combination of the Fc-silent anti-TIGIT antibody domvanalimab plus the anti-PD-1 mAb zimberelimab and chemotherapy in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma.
ALTA-002
Tallac Therapeutics disclosed U.S. Food and Drug Administration clearance of its investigational new drug application for ALTA-002, a SIRPα targeting toll-like receptor agonist antibody conjugates (TRAAC), in patients with advanced solid tumors.
M9140
At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, Merck KGaA presented data on M9140, a novel antibody-drug conjugate with topoisomerase 1 inhibitor payload targeting carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expressing tumors. M9140 demonstrated high potency, strong antitumor activity and bystander effect in preclinical models.
A first-in-human Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary clinical activity of M9140 in patients with advanced solid tumors is ongoing.
CSX-1004
Cessation announced the presentation of preliminary data from its Phase 1a first-in-human study of CSX-1004, an investigational mAb for prophylaxis against fentanyl-related overdose, showing that CSX-1004 is safe and well-tolerated under the conditions tested. The exposure data were also predictive of efficacy for blocking fentanyl-induced respiratory depression.
Small Molecule Ion Channel Program Updates
In the second quarter, GSK discontinued its work on a small molecule Nav1.1 sodium channel modulator program. OmniAb retains co-ownership of all intellectual property for the program. GSK and OmniAb maintain a collaboration on a small molecule ion channel preclinical-stage program for neurological disease.
Subsequent to the second quarter, OmniAb was notified that Roche is returning its rights to a pre-clinically differentiated small molecule targeting Kv7.2. The termination is not due to scientific reasons. Roche and OmniAb maintain collaborations on two additional small molecule ion channel programs for potential treatment of central nervous system disorders.
xPloration Technology Platform Recent Events
OmniAb presented an overview of xPloration, its high-throughput single B-cell screening microcapillary platform that leverages machine learning and AI, in a presentation titled "Deep Screening in Harmony with Artificial Intelligence for Bispecific Antibody Discovery" at the 20 th Annual PEGS Boston Conference and Expo. This presentation highlighted the technical synergies between xPloration, OmniFlic , OmniClic and OmniDeep to enable new bispecific antibody discovery workflows for OmniAb’s current and future partners.
OmniAb disclosed the issuance of U.S. Patent number 12,024,705 B2 entitled "Methods and Systems for Screening Using Microcapillary Arrays." The patent was issued by the United States Patent and Trademark Office on July 2, 2024 and has an expected expiry of December 12, 2036. Additionally, a patent titled "Lateral Loading of Microcapillary Arrays" was issued on May 1, 2024 in Europe as EP3890876 with an expected expiry of December 5, 2039.
In June, OmniAb announced the publication of a peer-reviewed paper titled "Chickens with a Truncated Light Chain Transgene Express Single-Domain H Chain-Only Antibodies" in the Journal of Immunology demonstrating that chickens can be genetically engineered to produce functional heavy chain-only single-domain antibodies. sdAbs are produced naturally by camelids and have gained popularity as small, robust and highly modular building blocks for antibody discovery.
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 (800) 549 8228 using the conference ID 01718. Slides, as well as the live and replay webcast of the call, are available at View Source .