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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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

On March 20, 2024 NuCana plc (NASDAQ: NCNA) reported financial results for the fourth quarter and year ended December 31, 2023 and provided an update on its broad clinical development program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, MAR 20, 2024, View Source [SID1234641294]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As of December 31, 2023, NuCana had cash and cash equivalents of £17.2 million compared to £17.8 million as of September 30, 2023 and £41.9 million as of December 31, 2022. NuCana continues to advance its various clinical programs and reported a net loss of £7.7 million for the quarter ended December 31, 2023, as compared to a net loss of £15.2 million for the quarter ended December 31, 2022. Net loss for the year ended December 31, 2023 was £27.6 million, compared to a net loss of £32.0 million for the year ended December 31, 2022. Basic and diluted loss per share was £0.14 for the quarter and £0.53 for the year ended December 31, 2023, as compared to £0.29 per share for the comparable quarter and £0.61 for the year ended December 31, 2022.

"In 2023, we announced data that demonstrated encouraging signals of efficacy and favorable safety profiles for our ProTides, NUC-3373 and NUC-7738," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "Working towards our mission of improving treatment outcomes for patients with cancer by developing more effective and safer medicines, we look forward to providing important data readouts across our pipeline in 2024."

Mr. Griffith continued: "Our development programs for both NUC-3373 and NUC-7738 are progressing well. NUC-3373, our ProTide transformation of 5-FU, is being evaluated in three ongoing clinical studies. Our randomized Phase 2 study is comparing NUC-3373 in combination with irinotecan, leucovorin and bevacizumab (NUFIRI + bev) with the standard of care, 5-FU in combination with irinotecan, leucovorin and bevacizumab (FOLFIRI + bev) for the second-line treatment of patients with advanced colorectal cancer. We have now fully recruited all 171 patients to the study and we remain on track to announce data from this study in 2024. Additionally, we are completing our Phase 1b/2 study of NUFIRI + bev and NUFOX + bev in patients with metastatic colorectal cancer. We recently presented data from this study demonstrating that NUFIRI + bev and NUFOX + bev showed a favorable safety profile and encouraging signs of efficacy, including tumor volume reductions. In addition, several patients achieved a longer progression-free survival (PFS) on NUC-3373-based regimens as compared to the PFS achieved in their first-line treatment with 5-FU-based therapy. Lastly, we remain on track to announce data in 2024 from our Phase 1b/2 study of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer."

Mr. Griffith continued: "Moving to NUC-7738, we recently presented data from the Phase 2 part of the Phase 1/2 study of NUC-7738 in combination with pembrolizumab in patients with melanoma. These data showed tumor volume reductions and prolonged time on treatment and indicated that NUC-7738 may potentiate the activity of anti-PD-1 agents in patients who were refractory to, or progressed on, prior immunotherapy, including anti-PD-1 therapy. We look forward to sharing additional updates from this study in 2024."

Mr. Griffith concluded, "With a cash runway that is expected to extend into 2025, we look forward to providing a number of important data updates in the coming year as we continue to advance our pipeline of ProTides."

2024 Anticipated Milestones

NUC-3373 (a ProTide transformation of 5-FU)
In 2024, NuCana expects to:

Announce data from the randomized Phase 2 (NuTide:323) study of NUFIRI + bev compared to the standard of care FOLFIRI + bev for the second-line treatment of patients with advanced colorectal cancer;
Announce data from the Phase 1b/2 (NuTide:302) study of NUFIRI + bev and NUFOX + bev for the second-line treatment of patients with advanced colorectal cancer; and
Announce data from the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer.
NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)
In 2024, NuCana expects to:

Announce data from the Phase 2 part of the Phase 1/2 study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with melanoma.

On March 20, 2024 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it has entered into a definitive agreement with Lonza, under which Lonza will acquire the Genentech manufacturing facility in Vacaville, California, USA, for USD 1.2 billion in conjunction with a manufacturing agreement and related quality services and warehousing (Press release, Hoffmann-La Roche, MAR 20, 2024, View Source [SID1234641293]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, the approximately 750 Genentech employees at the Vacaville facility will be offered employment by Lonza and the products currently produced at the site by Roche will continue to be supplied by Lonza for a transition period.

"We decided to divest our Vacaville site as part of our long-term network strategy and optimisation plan, to deliver a more diversified portfolio including new drug modalities," Susanne Hundsbaek-Pedersen, Global Head of Pharma Technical Operations, stated. "Having gone through a competitive diligence process with multiple potential strategic partners for the facility, we believe that Lonza is the ideal owner for the Vacaville site to continue producing innovative medicines for patients in need. We are particularly pleased that the employees at the site will be offered employment by Lonza."

Subject to the completion of applicable regulatory approvals and subsequent transition preparations, the transaction is expected to close by H2 2024.

On March 20, 2024 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported the closing of the previously announced private placement with certain accredited investors comprised of existing investors, Delcath Executives and members of its Board of Directors, for a private placement transaction (the "Private Placement") (Press release, Delcath Systems, MAR 20, 2024, View Source [SID1234641292]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Delcath issued and sold 876,627 shares of its common stock (the "Common Stock") at a price per share of $3.72, and, to certain investors, in lieu of shares of Common Stock, 1,008,102 pre-funded warrants to purchase up to 1,008,102 shares of Common Stock (the "Pre-Funded Warrants") at a price per Pre-Funded Warrant of $3.71. The Pre-Funded Warrants have an exercise price of $0.01 per share of Common Stock, be immediately exercisable and remain exercisable until exercised in full.

Delcath received gross proceeds from the Private Placement of approximately $7 million before deducting offering expenses payable by Delcath. Delcath intends to use the net proceeds from the Private Placement for working capital purposes and other general corporate purposes.

The securities to be sold in the Private Placement, including the shares of common stock underlying the Pre-Funded Warrants, have not been registered under the Securities Act of 1933, as amended, or state securities laws as of the time of issuance and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. Delcath has agreed to file one or more registration statements with the SEC registering the resale of the Common Stock and the shares issuable upon exercise of the Pre-Funded Warrants purchased in the Private Placement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 20, 2024 Bristol Myers Squibb (NYSE: BMY) reported the Phase 3 CheckMate -9DW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for patients with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy met its primary endpoint of improved overall survival (OS) compared to investigator’s choice of sorafenib or lenvatinib at a pre-specified interim analysis (Press release, Bristol-Myers Squibb, MAR 20, 2024, View Source;9DW-Trial-Evaluating-Opdivo-nivolumab-Plus-Yervoy-ipilimumab-Meets-Primary-Endpoint-of-Overall-Survival-for-the-First-Line-Treatment-of-Advanced-Hepatocellular-Carcinoma/default.aspx [SID1234641291]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The dual immunotherapy combination of Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in OS compared to investigator’s choice of sorafenib or lenvatinib. The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified.

"Advanced stage liver cancer patients remain in need of additional treatment options that may help improve survival," said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb. "The overall survival benefit demonstrated by the combination of Opdivo plus Yervoy in the CheckMate -9DW trial demonstrates its potential to improve outcomes compared to well-established TKI treatment options."

The company will complete a full evaluation of the data and work with investigators to share the results with the scientific community at an upcoming medical conference, as well as discuss with health authorities.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -9DW clinical trial.

About CheckMate -9DW

CheckMate -9DW is a Phase 3 randomized, open-label trial evaluating the combination of Opdivo plus Yervoy compared to investigator’s choice of sorafenib or lenvatinib monotherapy in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.

Approximately 668 patients were randomized to receive Opdivo plus Yervoy (Opdivo 1mg/kg plus Yervoy 3 mg/kg Q3W for up to four doses, followed by Opdivo monotherapy 480 mg Q4W) infusion, or single agent sorafenib or lenvatinib as oral capsules in the control arm. The primary endpoint of the trial is overall survival and key secondary endpoints include objective response rate and time to symptom deterioration.

About Hepatocellular Carcinoma

Liver cancer is the third most frequent cause of cancer death worldwide. Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and accounts for 90% of all liver cancers. HCC is often diagnosed in an advanced stage, where effective treatment options are limited and are usually associated with poor outcomes.

Up to 70% of patients experience recurrence within five years, particularly those still considered to be at high risk after surgery or ablation. While most cases of HCC are caused by hepatitis B virus (HBV) or hepatitis C virus (HCV) infections, metabolic syndrome and nonalcoholic steatohepatitis (NASH) are rising in prevalence and expected to contribute to increased rates of HCC.