On March 8, 2024 XOMA Corporation (Nasdaq: XOMA), the biotech royalty aggregator, reported its fourth quarter and full year 2023 financial results and highlighted portfolio activities expected to drive long-term shareholder value (Press release, Xoma, MAR 8, 2024, View Source [SID1234640970]).

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"Over the course of 2023, we continued to build the foundation for future growth, spearheaded by the $140 million royalty-backed financing of VABYSMO in the fourth quarter," stated Owen Hughes, Chief Executive Officer of XOMA. "We entered 2024 with the strongest cash position in the Company’s history, several key upcoming clinical and regulatory events, including the potential approvals of Day One’s tovorafenib and Zevra Therapeutics’ arimoclomol NDAs, and a growing pipeline of asset opportunities."

Key Fourth Quarter Events

Partner

Event

Day One Biopharmaceuticals
•  Tovorafenib NDA accepted by U.S. Food and Drug Administration (FDA), resulting in XOMA’s receipt of a $5 million milestone payment from Viracta

•  Tovorafenib data presented at the Society of Neuro-Oncology Annual Meeting and published in Nature Medicine

Zevra Therapeutics Resubmitted the arimoclomol NDA with FDA
Medexus Pediatric label expansion application for IXINITY accepted for review by FDA
Rezolute
•  Launched RZ358 Phase 3 study

•  Received Priority Medicines (PRIME) eligibility from European Medicines Agency

AstraZeneca Launched and dosed first patient in rilvegostomig Phase 3 study
LG Chem (AVEO Oncology) Launched ficlatuzumab Phase 3 study
Organon Announced intent to terminate ebopiprant License Agreement
Anticipated 2024 Events of Note

Partner

Event

Day One Biopharmaceuticals April 30, 2024 – FDA action date for tovorafenib NDA
Zevra Therapeutics September 21, 2024 – FDA action date for arimoclomol NDA
Medexus FDA decision regarding IXINITY pediatric label expansion
Financial Results

XOMA recorded total revenues of $1.8 million and $4.8 million for the fourth quarter and full year of 2023, respectively. In 2023, XOMA recognized $2.5 million in milestone payments received from two partners, whereas the Company reported revenues of $6.0 million in 2022, of which $4.0 million were milestone payments received from four partners.

General and administrative ("G&A") expenses were $7.3 million for the fourth quarter and $25.6 million for the full year of 2023. In the fourth quarter and full year of 2022, G&A expenses were $7.6 million and $23.2 million, respectively. The increase of $2.4 million between the two full-year periods was primarily due to a $5.5 million increase in stock-based compensation, partially offset by a $2.1 million decrease in consulting and legal expenses, and a $0.9 million decrease in salaries and related expenses.

In the fourth quarter of 2023, G&A expenses included $2.6 million in non-cash stock-based compensation expense, compared with $1.0 million in the fourth quarter of 2022. For the full year of 2023, G&A expenses included $9.1 million in non-cash stock-based compensation, compared with $3.6 million for the full year of 2022.

XOMA received cash payments of approximately $5.7 million from royalties and milestone payments in the fourth quarter of 2023, as compared to $0.8 million in the comparable period in 2022. During the full year of 2023, the Company received cash payments of approximately $15.5 million from royalties and milestone payments, as compared to $7.2 million in 2022. XOMA’s net cash used in operations during the fourth quarter of 2023 was $3.9 million and $18.2 million for the full year, as compared with $3.9 million used during the fourth quarter of 2022 and $12.9 million used for the full year of 2022.

XOMA incurred one-time arbitration settlement costs of $4.1 million in 2023, related to an arbitration proceeding settlement with one of its licensees.

For the year ended December 31, 2023, XOMA recorded $15.8 million in impairment charges, as a result of the discontinuation of operations at Bioasis ($1.6 million) and Organon’s decision to terminate its License Agreement for ebopiprant ($14.2 million).

Other income, net was $1.6 million for the full year of 2023 and $0.3 million for the full year of 2022. The increase in other income, net between periods is primarily due to an increase in investment income. 

In 2023, net loss for the fourth quarter and year ended December 31, 2023, was $20.1 million and $40.8 million, respectively. In 2022, the net loss for the fourth quarter was $6.0 million and $17.1 million for the full year.

On December 31, 2023, XOMA had cash and cash equivalents of $159.6 million (including $6.3 million in restricted cash). In 2023, XOMA’s royalty interests generated cash payments of $7.3 million from Roche related to VABYSMO sales and $1.7 million from Medexus related to IXINITY sales. The Company also received a $5.0 million milestone payment from Viracta related to the FDA’s acceptance of Day One Pharmaceuticals’ NDA for tovorafenib. These cash receipts from royalty and milestone acquisitions reduced XOMA’s short-term royalty and commercial payment receivables by $14 million. On October 16, 2023, the Company paid total cash dividends of $1.4 million on the 8.625% Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) and on the 8.375% Series B Cumulative Perpetual Preferred Stock (Nasdaq: XOMAO). In December 2023, XOMA drew $130.0 million from its royalty-backed loan with certain funds managed by the credit platform of Blue Owl Capital. On December 31, 2022, the Company reported cash of $57.8 million. Based upon the cash flows XOMA expects to receive from VABYSMO, DSUVIA, and IXINITY sales in addition to its current cash position, the Company continues to believe its current cash position will be sufficient to fund XOMA’s operations for multiple years.

Subsequent Events

On January 2, 2024, the Company announced a stock repurchase program of up to $50 million through January 2027.

On January 7, 2024, Owen Hughes was appointed as Chief Executive Officer and Jack Wyszomierski was named Chairman of the Board of Directors.

On January 18, 2024, XOMA acquired an economic interest in DSUVIA (sufentanil sublingual tablet) from Talphera, Inc., for $8 million. DSUVIA is commercialized by Alora Pharmaceuticals. XOMA will receive 100 percent of all royalties and milestones related to DSUVIA sales until it receives $20 million. Thereafter, XOMA will receive a 15 percent royalty associated with DSUVIA commercial sales, a 37.5 percent royalty on DoD purchases and 50 percent of the remaining $116.5 million in potential milestone payments due from Alora Pharmaceuticals.

On February 16, 2024, XOMA announced its intention to acquire Kinnate Biopharma for between $2.3352 and $2.5879 in cash per share plus a contingent value right (CVR). XOMA anticipates it will add approximately $9.5 million to its cash balance at the closing of the acquisition, which is expected to occur in April 2024.

On March 8, 2024 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that it has streamlined its executive leadership to further focus on advancing the Company’s clinical programs while optimizing resource allocation (Press release, Sellas Life Sciences, MAR 8, 2024, View Source [SID1234640969]). As part of this effort, Senior Vice President, Chief Commercial Officer, Robert Francomano and Executive Vice President, General Counsel and Corporate Secretary, Barbara Wood, will be departing the Company.

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"As part of our efforts to rapidly advance our clinical pipeline, we continue to streamline our operations to effectively and efficiently deliver on our key business objectives," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "As I mentioned on the January shareholder call, our focus remains on shareholder value through the development of our assets and tight financial stewardship and exploration of commercial partnerships with the assistance of Stifel Financial Corp. I am confident that SELLAS has the right leadership in place to drive forward all of our clinical programs and I look forward to upcoming interim analysis of the Phase 3 REGAL trial of GPS in AML and reporting topline data from our Phase 2a SLS009 r/r AML trial this quarter and additional data in the second quarter, and topline data from the Phase 1b/2 study of SLS009 in PTCL in the second quarter. Additionally, we made significant strides in commercial market access, pricing strategies, and reimbursement initiatives positioning SELLAS for continued success in the Phase 3 REGAL trial of GPS and its potential as a new treatment for AML patients."

Dr. Stergiou continued: "I would like to thank Robert and Barbara for their leadership, dedication, and unwavering contributions to help bring SELLAS to this point of development. I wish them the very best in their future endeavors."

In line with the Company’s commitment to maintaining operational excellence, SELLAS is engaging the expertise of a seasoned commercial consultant with a proven track record of success, including launching Venetoclax. Stacy Yeung, recently promoted to Vice President, Associate General Counsel, and Head of Compliance, with 20 years of relevant experience will lead the Company’s legal and compliance functions.

On March 8, 2024 Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing immunogenic small molecule approaches in oncology, reported that it has completed enrollment of its Phase 2 clinical trial of lead therapeutic candidate, PT-112, reaching its target enrollment of 109 patients with late-line metastatic castration-resistant prostate cancer (mCRPC) (ClinicalTrials.gov Identifier: NCT02266745) (Press release, Promontory Therapeutics, MAR 8, 2024, View Source [SID1234640968]).

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The study is evaluating PT-112 in patients who have been treated with at least three prior life-prolonging therapies for mCRPC, and who exhibited radiographic evidence of disease progression at study entry. Patients with bone-only metastatic disease are also included in the study. These requirements create a representative treatment population following standard of care of androgen receptor signaling inhibitors, taxane chemotherapies, and any other drug approved by FDA on the basis of overall survival. The clinical trial enrolled patients across leading sites in the United States (23) and France (9).

"This clinical trial is the largest study to date of PT-112 and will establish the optimal dose in line with the FDA’s Project Optimus, as well as proof of concept in our late-line mCRPC patient population," said Promontory Therapeutics Chief Medical Officer Johan Baeck, MD. "Data from our earlier Phase 1/2 studies have shown that PT-112 is clinically safe and active, and promotes immunogenic cancer cell death induced by the inhibition of ribosomal biogenesis, which is a promising mechanism of action for late-stage patients with prostate cancer — an ‘immune-cold’ disease with no broadly approved and effective immunotherapy."

Promontory Therapeutics plans for a Type C meeting with the FDA in the second half of 2024, followed by an End-of-Phase 2 meeting with FDA and further engagement with European regulatory authorities. In addition to safety and efficacy findings among late-stage metastatic patients, the study aims to generate meaningful supportive data via correlative research, including on immune activation by PT-112 monotherapy as evaluated by the propagation of new T cell populations, as well as reductions in circulating tumor cells and ctDNA.

"Promontory is grateful to our clinical partners across the U.S. and France, including Gustave Roussy Paris, for completing enrollment of this critical Phase 2 study. We are confident in PT-112’s potential as an effective treatment for patients with mCRPC who have progressed on androgen receptor directed therapy, chemotherapy or radioligand therapy and who lack any effective immunotherapy," said Promontory Therapeutics Chief Executive Officer Robert Fallon. "We look forward to presenting topline safety, efficacy, and correlative data at relevant research and medical conferences later this year."

About PT-112
PT-112 is the first small-molecule conjugate of pyrophosphate in clinical development in oncology. PT-112 has numerous advantages — including its tolerability and inhibition of ribosomal biogenesis which leads to immunogenic cell death, through the release of damage associated molecular patterns that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents a highly potent inducer of this immunological form of cancer cell death. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients and data were published in eClinicalMedicine, part of The Lancet. The combination Phase 1b dose escalation study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in a mini-oral presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress, and the Phase 2a dose confirmation cohort in non-small cell lung cancer patients was reported at ESMO (Free ESMO Whitepaper) I-O 2022. The Phase 1 study in patients with relapsed or refractory multiple myeloma presented at ASH (Free ASH Whitepaper) 2020 is the third completed Phase 1 study of PT-112. Monotherapy Phase 2 development is ongoing in mCRPC, and includes the Phase 2 proof of concept study in thymic epithelial tumors under the company’s formal CRADA with the NCI. Interim data from the NCI study were published at ASCO (Free ASCO Whitepaper) 2023.

On March 8, 2024 Nerviano Medical Sciences S.r.l. (NMS), a member of NMS Group S.p.A and a clinical stage biotech discovering and developing innovative therapies for the treatment of cancer, reported its participation to the World ADC 2024 summit that will be held in London, UK (World ADC Europe) from March 12th to March 15th, 2024, with a poster presentation entitled (Press release, Nerviano Medical Sciences, MAR 8, 2024, View Source [SID1234640967]):

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"A payload-linker generating machine to quickly move from small molecules to characterized tool ADCs and PDCs"

NMS, leveraging on its proprietary chemical collection and applying a rigorous screening funnel, generated a portfolio of characterized payload linkers with diversified MoAs to target different tumor types.

Pillars of available technology are: 1) NMS-P945, a ‘plug-and-play’ thienoduocarmycin, active in chemoresistant cells, showing bystander effect and immunogenic cell death properties, highly efficacious in vivo in preclinical models and greater nonclinical safety profile, 2) next generation anthracycline payload linkers with improved stability and safety profile, both DNA damaging agents, 3) novel payloads.

NMS seek for collaborations with partners having an established expertise in biologics to launch new innovative projects.

On March 8, 2024 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update (Press release, Janux Therapeutics, MAR 8, 2024, View Source [SID1234640966]).

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"2023 was a critical year for Janux as we tested the potential power of our TRACTr platform in the clinic. We believe the data recently presented from both of our clinical programs displays the profound impact we can have on patients through our tumor-activated approach. We are excited to be helping cancer patients who need novel therapies and with our substantial cash runway we feel well-positioned to execute on our clinical plan," said David Campbell, Ph.D., President and CEO of Janux.

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

•
Presented positive updated interim Phase 1 clinical trial data for PSMA-TRACTr JANX007 in prostate cancer in February 2024. As of February 12, 2024:
•
Increasing depth of PSA declines and RECIST responses at higher doses were observed, while a favorable safety profile was maintained.
•
83% (5/6) of subjects achieved PSA50 declines with first step dose ≥ 0.2mg.
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56% (10/18) of subjects achieved PSA50 declines with first dose ≥ 0.1mg.
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No CRS > Grade 2 observed in heavily pre-treated late stage mCRPC population.
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Majority of non-CRS treatment-related adverse events (TRAEs) were Grade 1 or 2.
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Low incidence of Grade 3 TRAEs, and no Grade 4 or 5 events were observed.
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JANX007 has been administered at doses up to 3mg, significantly exceeding the anticipated maximum tolerable dose for the parental T cell engager, while the maximum tolerable dose for the TRACTr has not yet been established.

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Also presented positive interim Phase 1 clinical trial data for EGFR-TRACTr JANX008 in solid tumors. As of February 12, 2024:
•
A subject with NSCLC achieved a RECIST PR maintained through 18-weeks with 100% target lung lesion reduction and elimination of liver metastasis with no CRS or TRAEs.
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No CRS greater than Grade 1 observed in any cohort.
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Majority of non-CRS TRAEs were Grade 1 or 2.
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No treatment related SAEs or DLTs have been observed.
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Net proceeds of approximately $320.2 million (after deducting underwriting discounts, commissions and other estimated offering expenses) raised in an underwritten offering of common stock and pre-funded warrants in March 2024.

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Janux plans to deploy these funds to expand development of clinical programs, advance additional preclinical programs and extend corporate runway.

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JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449).

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JANX008 continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622).

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Co-founder Dr. Tommy DiRaimondo promoted to Chief Scientific Officer. Tommy was instrumental in successfully transitioning Janux’s PSMA-TRACTr and EGFR-TRACTr programs from research into clinical trials. Tommy continues to manage the internal and external research operations and plays an integral role in managing the IP, discovery, creation, optimization and expansion of Janux’s preclinical pipeline.

An update on JANX007 data and doses selected for expansion cohorts is anticipated in the second half of 2024.

FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS:

•
Cash and cash equivalents and short-term investments: As of December 31, 2023, Janux reported cash and cash equivalents and short-term investments of $344.0 million compared to $327.0 million at December 31, 2022.

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Research and development expenses: Research and development expenses were $12.2 million for the quarter and $54.9 million for the year ended December 31, 2023, compared to $15.4 million and $53.4 million for the same quarter and year in 2022.

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General and administrative expenses: General and administrative expenses were $6.4 million for the quarter and $26.1 million for the year ended December 31, 2023, compared to $5.7 million and $22.3 million for the same quarter and year in 2022.

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Net loss: Net loss was $11.8 million for the quarter and $58.3 million for the year ended December 31, 2023, compared to $16.1 million and $63.1 million for the same quarter and year in 2022.

Janux’s TRACTr and TRACIr Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets PSMA and is being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC). Janux’s second clinical candidate, JANX008, is a TRACTr that targets EGFR and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma. We are also generating a number of additional TRACTr and TRACIr programs for potential future development, some of which are at development candidate stage or later. We are currently assessing priorities in our preclinical pipeline.