XOMA Reports Full Year 2021 Financial Results and Highlights Recent Operational Events

On March 8, 2022 XOMA Corporation (Nasdaq: XOMA), a biotech royalty aggregator playing a distinctive role in helping companies achieve their goal of improving human health, reported its 2021 financial results and provided a recent operations update (Press release, Xoma, MAR 8, 2022, View Source [SID1234609682]).

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"XOMA’s milestone and royalty aggregator business model really began to demonstrate its potential in 2021 and in the first few months of 2022. In 2021, we received $36.2 million in milestone payments, which allowed XOMA to report positive operating cash-flow for the second consecutive year. The anti-TGFß asset we licensed to Novartis in 2015 entered Phase 3 development in 2021, a milestone that resulted in us receiving a $35 million payment. In the past two years, this asset, NIS793, has provided us with a total of $60 million in milestone revenue. Last October, we announced a significant transaction for XOMA, the purchase of rights to a 0.5% commercial payment on faricimab, a BLA-review-stage asset, for a $6 million upfront payment plus potential future milestone payments to Affitech SA. In late January 2022, the FDA gave commercialization approval to this novel bispecific antibody for the treatment of nAMD and DME. This is the first asset under our royalty aggregator model to receive commercialization approval. We recently paid $5 million in milestone payments to Affitech, triggered by these FDA approvals. Another advancement in January 2022 came as Rezolute dosed the final patient

with RZ358 in its Phase 2 congenital hyperinsulinism (CHI) study, which triggered a $2 million milestone payment to XOMA. Given our history with RZ358 and the connections we made with the CHI community, we are looking forward to seeing the clinical results when they are announced publicly," stated Jim Neal, Chairman and Chief Executive Officer of XOMA.

"These are just a few of the advances we’ve seen in our portfolio over the past year. We wish all our partners success in their clinical development efforts, as there are patients in need of additional therapeutic options.

"Our team continues to identify and acquire milestone and royalty licenses to expand and diversify XOMA’s portfolio, with eight assets added in 2021. With a strong foundation firmly established and an outstanding team in place, I decided it was the right time for the Company to proactively initiate a CEO succession plan, and we have launched a formal search. In the meantime, I will remain as CEO and continue to help shape XOMA’s future as Chairman of the Board. I believe 2021 and these first few months of 2022 are just the beginning of what’s to come," Mr. Neal concluded.

Financial Results

XOMA recorded total revenues of $35.9 million for the fourth quarter of 2021, compared with $27.6 million in the fourth quarter of 2020. The increase for the three months ended December 31, 2021, as compared to the corresponding period of 2020, was primarily due to the $35.0 million milestone earned under the Company’s Anti-TGFß Antibody License Agreement with Novartis International. For the full year of 2021, XOMA recorded revenues of $38.2 million, compared to $29.4 million for the full year of 2020. In 2021, XOMA received milestone revenue of $35.0 million earned under its Anti-TGFß Antibody License Agreement with Novartis, $0.5 million under its license agreement with Compugen, and $0.7 million under its license agreement with Janssen. Revenues for the full year of 2020 reflect $25.0 million in milestone revenue earned under the Company’s Anti-TGFß Antibody License Agreement with Novartis International and $2.0 million earned under XOMA’s collaboration agreement with Takeda.

Research and development ("R&D") expenses were $42,000 and $36,000, respectively, for the fourth quarters of 2021 and 2020. R&D expenses for the full years of 2021 and 2020 and were $0.2 million.

General and administrative ("G&A") expenses were $5.5 million for the fourth quarter of 2021, compared to $3.7 million for the fourth quarter of 2020. The increase of $1.8 million for the three months ended December 31, 2021, as compared to the corresponding period of 2020, was due primarily to a $1.1 million increase in stock compensation expense related to a grant of options in connection with Mr. Neal’s amended employment agreement and the reversal of $1.4 million in bad debt expense in the fourth quarter of 2020, partially offset by a decrease of $0.5 million in legal and consulting costs. G&A expenses were $20.5 million for the full year of 2021, compared to $16.8 million for the full year of 2020. The increase of $3.7 million in 2021 as compared with 2020 was primarily due to a $2.2 million increase in stock compensation expense, $0.8 million increase in salary and related expenses, $0.4 million increase in legal and consulting costs and $0.2 million increase in insurance costs.

In the fourth quarter of 2021, G&A expenses included $1.7 million in non-cash stock-based compensation expense, compared with $0.7 million in the fourth quarter of 2020. For the full year of 2021, G&A expenses included $6.2 million in non-cash stock-based compensation expense, compared with $3.9 million of non-cash stock-based compensation expense in 2020. XOMA’s net cash provided by operations in the fourth quarter of 2021 was $30.7 million, as compared with $17.7 million during the fourth quarter of 2020.

XOMA’s net cash provided by operations for the full year of 2021 was $22.7 million compared to $10.1 million in 2020.

In June 2021, the Company repaid its outstanding debt obligations to Silicon Valley Bank and Novartis in full. For the full year of 2021, interest expense was $0.5 million, compared with $1.8 million reported in the full year of 2020. The decrease in interest expense during 2021 reflects the extinguishment of XOMA’s debt obligations.

Other expense, net was $0.4 million for the fourth quarter of 2021, compared to other expense, net of $0.8 million in the corresponding quarter of 2020. Other expense, net was $0.9 million for the full year of 2021, compared to other income, net of $1.2 million for the corresponding period of 2020. The fluctuation in other (expense) income, net for the quarter and year ended December 31, 2021, as compared to the same periods in 2020, is primarily due to the change in the fair value of equity securities XOMA holds in Rezolute, Inc.

Net income for the fourth quarter of 2021 was $29.8 million, compared to net income of $22.7 million for the fourth quarter of 2020. For the full year of 2021, net income was $15.8 million, as compared to $13.3 million for the full year of 2020.

On December 31, 2021, XOMA had cash and restricted cash of $95.4 million. The Company ended December 31, 2020, with cash and restricted cash of $85.8 million. After paying its remaining debt obligations in the second quarter of 2021, XOMA has no debt on its balance sheet. The Company continues to believe its current cash position will be sufficient to fund XOMA’s operations for multiple years.

Genmab Announces U.S. Food and Drug Administration Granted Orphan-Drug Designation to Epcoritamab (DuoBody®-CD3xCD20) in Follicular Lymphoma

On March 8, 2022 Genmab A/S (Nasdaq: GMAB) reported that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to the investigational medicine, epcoritamab (DuoBody-CD3xCD20), for the treatment of follicular lymphoma (FL) (Press release, Genmab, MAR 8, 2022, View Source [SID1234609681]). Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV).

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Orphan drug status is designated by the FDA to medicines and biologics that are defined as those intended for the prevention, diagnosis, or treatment of a rare disease or condition affecting less than 200,000 people in the U.S.i

Approximately 2.7 per 100,000 people in the U.S. are newly diagnosed with follicular lymphoma (FL)ii every year and the median age of patients at diagnoses with FL is 63.iii,iv,v FL is typically a slow-growing or indolent form of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes.vi Although FL is an indolent lymphoma, patients who relapse or become refractory are incurable with conventional therapy and there is a need for additional treatment options.vii,viii Globally, FL is the second most common form of NHL, accounting for approximately 25 percent of adult NHL.ix

"This orphan drug designation is an important milestone for epcoritamab," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "With AbbVie, we remain committed to further developing epcoritamab in this patient population, as well as in patients diagnosed with other B-cell hematologic malignancies."

Epcoritamab is currently being evaluated as a treatment option for patients with FL in several clinical trials, including the phase 1/2 EPCORE NHL-1 evaluating the efficacy and safety of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (B-NHL), including diffuse large B-cell Lymphoma (DLCBL), follicular lymphoma (FL), and mantle cell lymphoma (MCL) (NCT: 03625037). Additional trials evaluating epcoritamab in patients with FL include a phase 1b/2, open-label, multinational, interventional trial to evaluate the safety and preliminary efficacy of epcoritamab in combination with other standard of care (SOC) agents across different lines of therapy in patients with DLBCL or FL (NCT: 04663347) and a phase 1/2 trial evaluating the safety and efficacy of epcoritamab in Japanese patients with relapsed/refractory B-NHL (NCT: 04542824).

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to tumors to elicit an immune response towards malignant cells. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T cell mediated killing of lymphoma B cells.x CD20 is a clinically validated therapeutic target, and is expressed on many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.xi,xii Epcoritamab is an investigational medicine not currently approved by the FDA. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration.

Precision BioSciences to Report Fourth Quarter and Fiscal Year 2021 Results on March 15, 2022

On March 8, 2022 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported that it will publish financial results for the fourth quarter and fiscal year 2021 and provide a business update on March 15, 2022 (Press release, Precision Biosciences, MAR 8, 2022, View Source [SID1234609680]).

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Calithera to Present Data Highlighting Newly Discovered Synthetic Lethal Target VPS4 at AACR 2022 Annual Meeting

On March 8, 2022 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision oncology biopharmaceutical company, reported that it will present the first data from its preclinical synthetic lethality pipeline at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting, being held April 8-13, 2022, in New Orleans, LA (Press release, Calithera Biosciences, MAR 8, 2022, View Source [SID1234609679]).

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The accepted poster will detail Calithera’s discovery of a novel series of vacuolar protein sorting-associated protein 4A (VPS4A) inhibitors that are currently advancing through lead optimization. VPS4A and VPS4B are paralog ATPases essential for remodelling intracellular organelle membranes. Membrane remodelling is an essential cellular function and loss of function of both VPS4 paralogs is lethal to cells. The preclinical data demonstrate that VPS4A genetic inhibition in cell lines with loss of VPS4B preferentially showed profound death in cancer cells.

"The data being shared at the AACR (Free AACR Whitepaper) annual meeting suggest that inhibition of VPS4A is a promising approach to treat cancers across a wide variety of cancer types that harbor VPS4B deletions. We believe the discovery of this series of VPS4A inhibitors is a significant step forward in our efforts to expand our pipeline of targeted therapies to ultimately treat patients with high unmet need," said Susan Molineaux, chief executive officer of Calithera. "Additionally, we are excited about the progress we have made in advancing these discoveries as we focus on lead optimization. Synthetic lethal cancer therapies are highly promising, and we look forward to contributing to this rapidly advancing field with this novel mechanism."

Calithera is building a robust preclinical pipeline of additional synthetic lethality targets with a continuing focus on paralog genes. Gene paralog pairs represent a promising class of synthetic lethal cancer targets. When a tumor cell loses one paralog, the cell is dependent on the second paralog to carry out an essential cellular process, since loss of both paralogs leads to tumor cell death. Calithera researchers have confirmed VPS4A and VPS4B as synthetic lethal paralog pairs, noting that both homozygous and heterozygous loss of VPS4B in cancer cells makes them vulnerable to VPS4A inhibition. VPS4B is lost in a heterozygous fashion in the majority of colorectal cancer, pancreatic ductal adenocarcinoma, ovarian, esophageal and head & neck cancers and is deleted in large numbers of other tumor types. At AACR (Free AACR Whitepaper) 2022, Calithera will report the discovery of a series of novel, small-molecule VPS4A inhibitors which have potential in the treatment of VPS4B-deleted tumors.

Details of the abstract accepted for presentation at AACR (Free AACR Whitepaper) 2022 (#1816) are as follows:

Title: Identification of novel VPS4A inhibitors for the treatment of VPS4B-deleted cancers
Session Category: Experimental and Molecular Therapeutics/Drug Targets
Session Title: Drug Targets
Date and Time: Monday Apr 11, 2022, 1:30 PM – 5:00 PM
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 23
Poster Board Number: 14
Permanent Abstract Number: 1816
Presenter: Meredith Kuo, Ph.D.
This abstract is currently available on the AACR (Free AACR Whitepaper) website, and the poster will be available on Calithera’s website on April 8, 2022.

Kura Oncology Announces Multiple Abstracts Accepted for Presentation at AACR Annual Meeting

On March 8, 2022 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that four abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held in New Orleans from April 8-13, 2022 (Press release, Kura Oncology, MAR 8, 2022, View Source [SID1234609678]).

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"We look forward to showcasing the four abstracts for tipifarnib, including a late-breaking presentation highlighting the opportunity for our next-generation farnesyl transferase inhibitor program," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We are excited about this emerging opportunity, focused on delaying the onset of drug resistance and look forward to sharing more detailed information at AACR (Free AACR Whitepaper) next month. In the meantime, we intend to perform initial clinical evaluation with tipifarnib in non-small cell lung cancer while in parallel advancing KO-2806, the lead development candidate in our next-generation farnesyl transferase inhibitor program, through IND-enabling studies."

Session titles and information for the four abstracts are listed below and are now available on the AACR (Free AACR Whitepaper) online itinerary planner.

Tipifarnib prevents emergence of resistance to osimertinib in EGFR-mutant NSCLC
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 1 / Chemistry
Session Date and Time: Monday Apr 11, 2022; 1:30 PM – 5:00 PM CT
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 16
Abstract / Poster: LB080 / 5

A Phase 1/2 trial to evaluate the safety and antitumor activity of tipifarnib and alpelisib for patients with HRAS-overexpressing and/or PIK3CA mutated/amplified recurrent/metastatic head and neck squamous cell carcinoma (The KURRENT trial)
Session Title: Phase I Trials in Progress 2
Session Date and Time: Wednesday Apr 13, 2022; 9:00 AM – 12:30 PM CT
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 35
Abstract / Poster: CT253 / 14

Tipifarnib potentiates the antitumor effects of PI3Ka blockade in HNSCC via convergent inhibition of mTOR activity
Session Title: Experimental and Molecular Therapeutics – Mechanisms of Drug Action 3
Session Date and Time: Monday Apr 11, 2022; 9:00 AM – 12:30 PM CT
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 24
Abstract / Poster: 1120 / 10

Translating genotype to immunophenotype in HRAS mutated head and neck squamous cell carcinoma (HNSCC) to identify effective Tipifarnib partners for optimal patient outcomes
Session Title: Tumor Biology – Models and Technical Approaches to Analyze and Examine the Tumor Microenvironment
Session Date and Time: Wednesday Apr 13, 2022; 9:00 AM – 12:30 PM CT
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 14
Abstract / Poster: 3882 / 27

Copies of the presentations will be available on Kura’s website at www.kuraoncology.com/pipeline/publications/ following presentation at the meeting.