OmniAb Reports Second Quarter 2024 Financial Results and Business Highlights
Conference Call with Slides Begins at
“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
Second Quarter 2024 Financial Results
Revenue for the second quarter of 2024 was
Research and development expense was
Net loss for the second quarter of 2024 was
Year-to-Date Financial Results
Revenue for the six months ended
Research and development expense was
Net loss for the six months ended
As of
2024 Financial Guidance
Second Quarter 2024 and Recent Business Highlights
During the second quarter of 2024,
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 theNational 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 inWestern Europe ,Latin America , theMiddle 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 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 andOmniAb 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 andOmniAb 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 20th AnnualPEGS 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 ofU.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 onJuly 2, 2024 and has an expected expiry ofDecember 12, 2036 . Additionally, a patent titled “Lateral Loading of Microcapillary Arrays” was issued onMay 1, 2024 inEurope as EP3890876 with an expected expiry ofDecember 5, 2039 .
In June,
Conference Call and Webcast
About
We believe the
Our proprietary transgenic animals, including OmniRat®, OmniChicken® and OmniMouse® have been genetically modified to generate antibodies with human sequences to streamline the development of human therapeutic candidates. OmniFlic® and OmniClic® are fixed or common light-chain rats and chickens, respectively, designed to facilitate the discovery of bispecific antibodies. OmniTaur™ provides cow-inspired antibodies with unique structural characteristics for challenging targets. OmnidAb™, is an in vivo platform for the discovery of single domain antibodies based upon a human VH scaffold that affinity matures in a chicken host environment to provide a functionally diverse immune repertoire unavailable from mammalian systems. Our proprietary technologies are joined with and leverage OmniDeep™, which is a suite of in silico, AI and machine learning tools for therapeutic discovery and optimization that are woven throughout our various technologies and capabilities. Additionally, an established core competency focused on ion channels and transporters further differentiates OmniAb’s technology and creates opportunities in many important and emerging target classes.
For more information, please visit www.omniab.com.
Forward-Looking Statements
Partner Information
The information in this press release regarding partnered products and programs comes from information publicly released by our partners.
CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share data) |
|||||||
|
|
|
|
||||
|
(Unaudited) |
|
|
||||
ASSETS |
|
|
|
||||
Current assets: |
|
|
|
||||
Cash and cash equivalents |
$ |
20,794 |
|
|
$ |
16,358 |
|
Short-term investments |
|
36,433 |
|
|
|
70,625 |
|
Accounts receivable, net |
|
6,876 |
|
|
|
3,844 |
|
Prepaid expenses and other current assets |
|
3,199 |
|
|
|
4,074 |
|
Total current assets |
|
67,302 |
|
|
|
94,901 |
|
Intangible assets, net |
|
147,512 |
|
|
|
155,467 |
|
|
|
83,979 |
|
|
|
83,979 |
|
Property and equipment, net |
|
17,333 |
|
|
|
18,249 |
|
Operating lease right-of-use assets |
|
18,870 |
|
|
|
19,884 |
|
Restricted cash |
|
560 |
|
|
|
560 |
|
Other long-term assets |
|
1,707 |
|
|
|
2,185 |
|
Total assets |
$ |
337,263 |
|
|
$ |
375,225 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
||||
Current liabilities: |
|
|
|
||||
Accounts payable |
$ |
2,809 |
|
|
$ |
4,411 |
|
Accrued expenses and other current liabilities |
|
4,549 |
|
|
|
7,068 |
|
Current contingent liabilities |
|
328 |
|
|
|
1,303 |
|
Current deferred revenue |
|
2,911 |
|
|
|
6,848 |
|
Current operating lease liabilities |
|
3,557 |
|
|
|
3,486 |
|
Total current liabilities |
|
14,154 |
|
|
|
23,116 |
|
Long-term contingent liabilities |
|
1,190 |
|
|
|
3,203 |
|
Deferred income taxes, net |
|
6,839 |
|
|
|
11,354 |
|
Long-term operating lease liabilities |
|
20,775 |
|
|
|
22,075 |
|
Long-term deferred revenue |
|
72 |
|
|
|
862 |
|
Other long-term liabilities |
|
52 |
|
|
|
30 |
|
Total liabilities |
|
43,082 |
|
|
|
60,640 |
|
Stockholders' equity: |
|
|
|
||||
Preferred stock, |
|
— |
|
|
|
— |
|
Common stock, |
|
12 |
|
|
|
12 |
|
Additional paid-in capital |
|
366,153 |
|
|
|
353,890 |
|
Accumulated other comprehensive income (loss) |
|
(25 |
) |
|
|
50 |
|
Accumulated deficit |
|
(71,959 |
) |
|
|
(39,367 |
) |
Total stockholders’ equity |
|
294,181 |
|
|
|
314,585 |
|
Total liabilities and stockholders’ equity |
$ |
337,263 |
|
|
$ |
375,225 |
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (in thousands, except per share data) |
|||||||||||||||
|
Three Months Ended |
|
Six Months Ended |
||||||||||||
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Revenue: |
|
|
|
|
|
|
|
||||||||
License and milestone revenue |
$ |
3,125 |
|
|
$ |
4,330 |
|
|
|
3,841 |
|
|
$ |
16,976 |
|
Service revenue |
|
4,171 |
|
|
|
2,451 |
|
|
|
6,937 |
|
|
|
6,409 |
|
Royalty revenue |
|
318 |
|
|
|
165 |
|
|
|
637 |
|
|
|
480 |
|
Total revenue |
|
7,614 |
|
|
|
6,946 |
|
|
|
11,415 |
|
|
|
23,865 |
|
Operating expenses: |
|
|
|
|
|
|
|
||||||||
Research and development |
|
13,935 |
|
|
|
14,133 |
|
|
|
28,486 |
|
|
|
27,892 |
|
General and administrative |
|
7,965 |
|
|
|
8,738 |
|
|
|
16,302 |
|
|
|
16,933 |
|
Amortization of intangibles |
|
4,543 |
|
|
|
3,380 |
|
|
|
7,955 |
|
|
|
6,749 |
|
Other operating expense (income), net |
|
(2,524 |
) |
|
|
140 |
|
|
|
(2,470 |
) |
|
|
189 |
|
Total operating expenses |
|
23,919 |
|
|
|
26,391 |
|
|
|
50,273 |
|
|
|
51,763 |
|
Loss from operations |
|
(16,305 |
) |
|
|
(19,445 |
) |
|
|
(38,858 |
) |
|
|
(27,898 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
||||||||
Interest income |
|
785 |
|
|
|
1,285 |
|
|
|
1,760 |
|
|
|
2,609 |
|
Other expense, net |
|
(9 |
) |
|
|
(4 |
) |
|
|
(9 |
) |
|
|
(4 |
) |
Total other income, net |
|
776 |
|
|
|
1,281 |
|
|
|
1,751 |
|
|
|
2,605 |
|
Loss before income taxes |
|
(15,529 |
) |
|
|
(18,164 |
) |
|
|
(37,107 |
) |
|
|
(25,293 |
) |
Income tax benefit |
|
1,898 |
|
|
|
3,436 |
|
|
|
4,515 |
|
|
|
4,465 |
|
Net loss |
$ |
(13,631 |
) |
|
$ |
(14,728 |
) |
|
$ |
(32,592 |
) |
|
$ |
(20,828 |
) |
|
|
|
|
|
|
|
|
||||||||
Net loss per share, basic and diluted |
$ |
(0.13 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.32 |
) |
|
$ |
(0.21 |
) |
|
|
|
|
|
|
|
|
||||||||
Weighted-average shares outstanding, basic and diluted |
|
101,456 |
|
|
|
99,493 |
|
|
|
101,106 |
|
|
|
99,326 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240808103022/en/
investors@OmniAb.com
Twitter @OmniAbTech
(510) 768-7760
Source: