OmniAb, reported financial results for the three months ended March 31, 2024, and provided operating and partner program updates.

“The OmniAb team continued to make great progress this past quarter in advancing and expanding our portfolio and partnership base. We added three new platform license agreements in the first quarter, bringing our total active partners to 80, net of attrition,” said Matt Foehr, Chief Executive Officer of OmniAb. “We have built our company upon a differentiated suite of technologies and a highly scalable and leverageable business model, and our growth during the past 18 months reflects the strength of our offering to the industry. We’re off to a strong start in 2024 and we look forward to continued progress by our partners and expansion of our technology as the year progresses.”

First Quarter 2024 Financial Results

Revenue for the first quarter of 2024 was $3.8 million, compared with $16.9 million for the same period in 2023, with the decrease primarily due to the recognition in the 2023 period of a $10 million milestone related to the first commercial sale of TECVAYLI^® (teclistamab) in the EU and lower service revenue in the 2024 period as a result of the completion of discovery work on certain ion channel programs.

Research and development expense was $14.6 million for the first quarter of 2024, compared with $13.8 million for the same period in 2023, with the increase primarily due to higher personnel costs. General and administrative expense was $8.3 million for the first quarter of 2024, compared with $8.2 million for the same period in 2023.

Net loss for the first quarter of 2024 was $19.0 million, or $0.19 per share, compared with a net loss of $6.1 million, or $0.06 per share, for the same period in 2023.

As of March 31, 2024, OmniAb had cash, cash equivalents and short-term investments of $69.0 million.

2024 Financial Guidance

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

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.

First Quarter 2024 and Recent Business Highlights

During the first quarter of 2024, OmniAb signed three new license agreements including ImmunoBiochem Corporation, the University of Georgia and a stealth Boston-based venture-backed start-up. As of March 31, 2024, the Company had 80 active partners and 327 active programs, including 31 OmniAb-derived programs in clinical development or being commercialized.

First quarter 2024 and recent partner highlights include the following:

Batoclimab

• Immunovant reported that global Phase 3 clinical trials of batoclimab (anti-FcRn) in myasthenia gravis (MG) and thyroid eye disease (TED) are progressing and are on track for topline data readout in the second half of 2024 (MG) and the first half of 2025 (TED). Initial period 1 data from the Phase 2b clinical trial in chronic inflammatory demyelinating polyneuropathy are expected in the second or third quarter of 2024.
• HanAll Biopharma announced that in collaboration with Immunovant, the Phase 3 clinical study is progressing in generalized myasthenia gravis in Japan. HanAll also reported that a clinical trial notification was approved to initiate a Phase 3 clinical study of batoclimab in TED in Japan.

IMVT-1402

• Immunovant announced plans to initiate four to five potential registrational programs for IMVT-1402 (second-generation anti-FcRn) during its fiscal year ending March 31, 2025. The company also plans on initiating trials in 10 indications for IMVT-1402 over its next two fiscal years.
• Immunovant announced that the United States Patent and Trademark Office has issued U.S. Patent No. 11,926,669 (“the ‘669 patent”) for IMVT-1402. The allowed claims cover composition of matter for the binding sequence of IMVT-1402 to FcRn, method of use of the antibody for treating autoimmune disease, as well as methods for its manufacturing. Not including any potential patent term extension, the ‘669 patent will expire on June 23, 2043.

M9140

• At the American Association for Cancer Research 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.

Acasunlimab

• Genmab expects to announce 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.
• A poster titled “Acasunlimab (duobody-PD-L1x4-1BB) alone or in combination with pembrolizumab in patients with previously treated metastatic non-small cell lung cancer: Initial results of a randomized, open-label, Phase 2 trial” will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024 at 9:00 a.m. Central time on Saturday, June 1, 2024.
• In addition, Genmab plans to initiate a Phase 3 study of acasunlimab in second-line NSCLC in 2024.

Sugemalimab

• CStone announced the National Medical Products Administration of China has approved the supplemental biologics application for sugemalimab (Cejemly^®) in combination with fluorouracil and platinum-based chemotherapy as first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma with a PD-L1 expression (Combined Positive Score [CPS] ≥5). Sugemalimab is the first PD-L1 monoclonal antibody approved for this indication.
• CStone also announced that the results of the progression-free survival final analysis and the overall survival interim analysis in the registrational GEMSTONE-304 study for unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma were published in Nature Medicine.

OmniAb scientists published a peer-reviewed paper in the Journal of Immunology demonstrating that chickens can be genetically engineered to produce functional single-domain antibodies (sdAbs). This modality, produced naturally by camelids, has gained popularity as a small, robust and highly versatile building block for antibody discovery, especially in constructing multi-specifics and CAR-T cells. These data supported the feasibility of the Company’s next-generation transgenic chicken OmnidAb™ that produces fully human stabilized sdAbs. The OmnidAb platform was launched during the fourth quarter of 2023.

OmniAb will highlight some of its high-throughput single cell screening xPloration™ data at the 20^th Annual PEGS Boston Conference and Expo, where Bob Chen, Ph.D., Senior Director, Discovery Systems, will give a presentation titled “Deep Screening in Harmony with Artificial Intelligence for Bispecific Antibody Discovery” at 12:20 p.m. Eastern time on Wednesday, May 15, 2024.

The Company also expects that multiple partners will be presenting data from programs developed with OmniAb technology at the ASCO Annual Meeting taking place May 31 - June 4, 2024.