On August 8, 2023 XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its second quarter 2023 financial results and highlighted recent operational achievements as XOMA accelerates its differentiated biotech royalty and milestone acquisition strategy (Press release, Xoma, AUG 8, 2023, View Source [SID1234633997]).

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"XOMA is increasingly being recognized for enabling innovative biotech companies to unlock value in the face of a challenging financing environment. To date, the team has added three new assets to XOMA’s royalty and milestone portfolio to complement the growing cash flows generated by VABYSMO (faricimab)," stated Owen Hughes, Executive Chairman of XOMA. "And over the ensuing quarters, the potential approval of arimoclomol, a first-in-class molecule for Niemann-Pick Disease Type C (NPC) and tovorafenib for relapsed or progressive pediatric low-grade glioma, as well as the expansion of IXINITY’s label into the pediatric population with Hemophilia B, should address critical unmet needs for patients and drive increasing cash flows for XOMA shareholders."

"We see a great opportunity to continue expanding XOMA’s portfolio and building shareholder value, as the biotech industry’s desire for non-dilutive capital is greater than ever. Our team has been sourcing and reviewing more royalty and milestone acquisition opportunities than ever," said Brad Sitko, Chief Investment Officer of XOMA. "We are acting quickly on these opportunities to continue building XOMA’s portfolio with value-creating acquisitions."

Second Quarter 2023 Financial Results

XOMA recorded total revenues of $1.7 million for the second quarter of 2023 and $1.0 million for the second quarter of 2022. The increase for the three months ended June 30, 2023, as compared to the same period in 2022, was primarily due to $1.1 million of milestones earned during the quarter pursuant to the license agreement with Janssen.

Research and development ("R&D") expenses were $39,000 and $40,000, respectively, for the second quarters of 2023 and 2022.

General and administrative ("G&A") expenses were $5.8 million and $5.7 million, respectively, for the second quarters of 2023 and 2022. The second quarter of 2023 included an increase of $1.3 million in stock-based compensation expense and was offset by a decrease of $1.1 million in legal and consulting costs.

As a result of the announcement by Bioasis to suspend its operations and the termination of Bioasis’ research collaboration and license agreement with Chiesi, XOMA recorded a one-time, non-cash impairment charge of $1.6 million and a reduction of $1.6 million under long-term royalty receivables in the second quarter of 2023.

In the second quarter of 2023, G&A expenses included $2.2 million in non-cash stock-based compensation expense, as compared with $0.8 million in non-cash stock-based compensation expense in the second quarter of 2022. XOMA’s net cash used in operations in the second quarter of 2023 was $7.2 million, which included a one-time arbitration settlement cost of $4.1 million, as compared with $4.3 million during the second quarter of 2022.

Other income, net was $0.6 million for the second quarter of 2023, compared to other income, net of $0.1 million in the corresponding quarter of 2022. The $0.5 million difference primarily is due to an increase of $0.4 million in investment income combined with the change in fair value of $75,000 for the contingent consideration related to Bioasis.

Net loss for the second quarter of 2023 was $5.4 million, compared to net loss of $4.7 million for the second quarter of 2022.

On June 30, 2023, XOMA had cash and cash equivalents of $31.4 million. On July 17, 2023, the Company paid cash dividends on the 8.625% Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) equal to $0.53906 per share and cash dividends on the 8.375% Series B Cumulative Perpetual Preferred Stock (Nasdaq: XOMAO) equal to $0.52344 per depositary share. The Company ended December 31, 2022, with cash and cash equivalents of $57.8 million. Due to recent communications from several partners related to delays in achieving specific milestones that are associated with payments to XOMA, the Company currently anticipates lower cash receipts from milestone payments in 2023 than previously expected. Based upon the cash flows XOMA expects to receive from VABYSMO 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.

On August 8, 2023 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, reported the publication of clinical data from an open-label, multicenter, Phase 1b/2 study of Nana-val in 55 patients with R/R EBV+ lymphoma in Blood Advances. Results showed complete responses (CRs) achieved and ongoing durable responses observed out to approximately 36 months across multiple EBV+ lymphoma subtypes, including some of the most aggressive cancers: peripheral T-cell lymphoma (PTCL), diffuse large B-cell lymphoma (DLBCL), and post-transplant lymphoproliferative disease (PTLD) (Press release, Viracta Therapeutics, AUG 8, 2023, View Source [SID1234633996]). This paper titled, "Targeted therapy with nanatinostat and valganciclovir in recurrent Epstein-Barr virus-positive lymphoid malignancies: a Phase 1b/2 study," can be found here.

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"Results from both retrospective and prospective clinical studies link EBV-positivity to significantly inferior survival in multiple lymphoma subtypes, highlighting the pressing need for novel therapies for this underserved patient population," said Pierluigi Porcu, M.D., Professor of Medical Oncology, Director of the Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation, Department of Medical Oncology at Thomas Jefferson University, and corresponding author on the paper. "The newly published Phase 1b/2 study data showcase the potential of Viracta’s innovative ‘Kick and Kill’ approach to effectively address this need, with results demonstrating Nana-val’s favorable safety and tolerability profile and promising durable signal of efficacy in heavily pre-treated patients. These data served as a catalyst for the advancement of Nana-val into the confirmatory NAVAL-1 trial, which has an elegant multi-stage design to potentially support registration."

Darrel P. Cohen, M.D., Ph.D., Viracta’s newly appointed Chief Medical Officer added, "Having these Phase 1b/2 clinical trial data peer-reviewed and published in such a prestigious journal of the American Society of Hematology (ASH) (Free ASH Whitepaper) provides important external validation for Nana-val’s therapeutic potential. The substantial number, depth, and durability of Nana-val’s clinical responses with a favorable safety profile observed in this heavily pre-treated EBV-positive lymphoma patient population are impressive, several of which are still ongoing. This publication further supports the recently announced expansion of the NAVAL-1 trial’s EBV-positive peripheral T-cell lymphoma cohort, representing an exciting time for our clinical trial program, and we look forward to providing more updates on its progress in the future."

Data published from the study showed that CRs were achieved across multiple EBV+ lymphoma subtypes, with a reported overall response rate (ORR)/CR rate of 40%/19% in 43 evaluable patients. In patients with EBV+ PTCL, which was recently established as the leading indication in Viracta’s pivotal NAVAL-1 trial, ORR/CR rates of 67%/50% were reported (n=6 including both EBV+ PTCL-not otherwise specified [PTCL-NOS] and angioimmunoblastic T-cell lymphoma [AITL] patients). Of note, one of the CRs was achieved in a patient whose disease never responded to second-line histone deacetylase inhibitor (HDACi) treatment. In 6 patients with EBV+ DLBCL, a rare aggressive and distinct B-cell lymphoma subtype characterized by an adverse clinical outcome, ORR/CR rates of 67%/33% were reported. Of note, one of the CRs was achieved in a patient whose disease never responded to first-line R-CHOP chemotherapy.

The published paper includes an additional 10-month follow-up period, which demonstrated durable response durations across multiple EBV+ lymphoma subtypes. As of the expanded data cutoff date of September 1, 2022, multiple patients remained in an ongoing durable response in excess of 30 months, with two patients in an ongoing response of approximately 36 months. The median time to response was 1.8 months, and the median duration of response was approximately 10 months in a heavily pre-treated patient population. Overall, trial participants received a median of two prior therapies before entering the trial, with 75% (41/55) being refractory to their last therapy.

Data also showed that all-oral Nana-val was well tolerated with reversible low-grade AEs. The most commonly observed treatment-emergent AEs were reversible cytopenias, low-grade creatinine elevations, and gastrointestinal symptoms. Initial data from the Nana-val Phase 1b/2 clinical trial were previously presented at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

About Nana-val (Nanatinostat and Valganciclovir)
Nanatinostat is an orally available HDACi being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing clinical trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed or refractory EBV+ lymphoma (NAVAL-1) as well as in combination with pembrolizumab in a multinational Phase 1b/2 trial in patients with recurrent or metastatic EBV+ nasopharyngeal carcinoma and other EBV+ solid tumors.

About EBV-Associated Cancers
Approximately 90% of the world’s adult population is infected with EBV. Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV+ lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden, including lymphoma, nasopharyngeal carcinoma, and gastric cancer.

On August 8, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the second quarter ended June 30, 2023 (Press release, Veracyte, AUG 8, 2023, View Source [SID1234633995]).

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"We delivered outstanding second quarter results, with revenue and test volume that exceeded our expectations. We also generated a record $17 million in cash from operations this quarter, driven by our exceptional top-line performance and strong cash collections," said Marc Stapley, Veracyte’s chief executive officer. "The compelling clinical data we shared this quarter demonstrates our focus on producing further evidence that our tests are helping to better guide patient care at pivotal moments in the race to diagnose and treat cancer."

Key Business Highlights

Increased second quarter total revenue by 24% to $90.3 million, compared to the second quarter of 2022.
Grew total test volume to 31,809, an increase of 28% compared to the second quarter of 2022.
Presented 12 abstracts for our diagnostic tests and biopharmaceutical offerings at major medical conferences. Study findings demonstrate our tests’ positive real-world impact on patient care, and also advance the scientific understanding of a number of diseases that we and our biopharmaceutical customers address.
Published real-world Decipher Prostate Genomic Classifier findings in JNCI Cancer Spectrum from a population-based study of the National Cancer Institute’s SEER program database. The findings reinforce the ability of our Decipher Prostate Genomic Classifier to help guide personalized treatment approaches for men with prostate cancer.
Generated approximately $17 million of cash from operating activities, ending the second quarter with cash, cash equivalents and short-term investments of $191 million, compared to $178 million at the end of the first quarter.
Second Quarter 2023 Financial Results

Total revenue for the second quarter of 2023 was $90.3 million, an increase of 24% compared to $72.9 million reported in the second quarter of 2022. Testing revenue was $81.7 million, an increase of 37% compared to $59.7 million in the second quarter of 2022 driven primarily by the strong performance of our Decipher Prostate and Afirma tests. Product revenue was $4.0 million, an increase of 29% compared to $3.1 million in the second quarter of 2022. Biopharmaceutical and other revenue was $4.6 million, a decrease of 55% compared to $10.0 million in the second quarter of 2022.

Total gross margin for the second quarter of 2023, including the amortization of acquired intangible assets, was 62%, compared to 59% in the second quarter of 2022. Non-GAAP gross margin, excluding the amortization of acquired intangible assets and other acquisition related expenses was 67%, compared to 66% in the second quarter of 2022.

Operating expenses, excluding cost of revenue, were $63.9 million, an increase of 19% compared to the second quarter of 2022. Non-GAAP operating expenses, excluding cost of revenue, amortization of acquired intangible assets, other acquisition related expenses and other restructuring costs, were $59.3 million compared to $49.0 million in the second quarter of 2022.

Net loss for the second quarter of 2023 was $8.4 million, an improvement of 12% compared to the second quarter of 2022. Basic and diluted net loss per common share was $0.12, an improvement of 8% compared to the second quarter of 2022. Net cash provided by operating activities in the first six months of 2023 was $14.5 million, an improvement of $23.7 million compared to the same period in 2022.

A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

2023 Financial Outlook

The company is raising full-year 2023 total revenue guidance to $342 million to $350 million, representing year-over-year growth of 15% to 18%, and an improvement compared to prior guidance of $330 million to $340 million.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call dial-in can be accessed by registering at the following link: https://register.vevent.com/register/BI62f03c15042b4d5dadeed4e37ed31fd8

On August 8, 2023 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, reported that The Journal of Urology published data from the Phase 3 ATLAS trial for investigational agent UGN-102 (mitomycin) for intravesical solution in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), that demonstrated superiority to transurethral resection of bladder tumor surgery (TURBT) with a 55% reduction of risk for recurrence, progression, or death in patients who received UGN-102 (Press release, UroGen Pharma, AUG 8, 2023, View Source [SID1234633994]). Tumor-free complete response rate at three months was 65% for patients who only received UGN-102, compared to a 64% complete response rate at three months for patients who underwent TURBT. TURBT is the current standard of care for patients with this type of cancer.

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"The publication of our ATLAS data in The Journal of Urology adds another chapter to our understanding of the potential of UGN-102 as a treatment for patients with LG-IR-NMIBC, who often face multiple surgeries due to the recurring nature of this cancer," said Mark Schoenberg, M.D., Chief Medical Officer at UroGen. "Our hope is that one day urologists may have an effective, non-surgical therapy option beyond TURBT that can be used to address this large patient population."

The Phase 3 ATLAS clinical trial, which met its primary endpoint, evaluated the efficacy, durability, and safety of UGN-102 with or without TURBT vs. TURBT alone in 282 patients with LG-IR-NMIBC. UroGen recently announced positive topline data from ATLAS and the Phase 3 ENVISION trial. The ENVISION trial evaluated the efficacy and safety of UGN-102 as a primary chemoablative therapy in 240 patients with LG-IR-NMIBC and met its primary endpoint by demonstrating that patients treated with UGN-102 had a 79.2% rate of complete response at 3-months following the initial treatment.

The Journal of Urology publication includes the following findings from ATLAS:

Tumor-free complete response 3 months after initial treatment was achieved by 92 patients (65%) who received UGN-102 and 89 patients (64%) treated by TURBT.
UGN-102 was generally well tolerated, with a side effect profile similar to that of previous clinical trials.
The estimated probability of remaining event free 15 months after randomization was 72% for UGN-102 ± TURBT and 50% for TURBT monotherapy [hazard ratio 0.45].

"While TURBT is the standard treatment for bladder cancer, the recurrent nature of LG-IR-NMIBC means that patients will undergo multiple surgeries that come with risks for this older patient population," says Sandip Prasad, M.D., M.Phil., Director of Genitourinary Surgical Oncology, Morristown Medical Center/Atlantic Health System, NJ, and Chief Investigator in the ATLAS trial. "It is exciting to consider what a potential non-surgical therapeutic alternative could mean for both patients and doctors who are eager for additional options."

Additional data evaluating the secondary endpoint of the ENVISION trial, Duration of Response, is expected in 2024. Assuming positive findings, a New Drug Application (NDA) is anticipated to be submitted to the U.S. Food and Drug Administration (FDA) in the same year.

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive findings from the durability of response endpoint from the ENVISION Phase 3 study, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024. If approved, UGN-102 would be the first non-surgical primary therapeutic to treat a subset of bladder cancer characterized by high recurrence rates and multiple surgeries.

About ATLAS

ATLAS is a global, open-label, randomized controlled Phase 3 trial designed to assess the efficacy and safety of UGN-102, with or without TURBT, vs. TURBT alone in patients diagnosed with LG-IR-NMIBC. The trial enrolled 282 patients in clinical sites in the U.S., Europe and Israel. Patients were randomized 1:1 to either UGN-102 or TURBT. Patients in the UGN-102 arm were treated with six weekly intravesical instillations of UGN-102. At the 3-month time point, patients were assessed for response. Patients who demonstrated a complete response to either UGN-102 or TURBT, were assessed for long-term follow-up for evidence of recurrence. Patients who demonstrated presence of persistent disease at 3-months, in either arm, underwent a TURBT and continued for long-term follow-up for evidence of recurrence. The primary endpoint of the study is disease-free survival. Learn more about the ATLAS trial at www.clinicaltrials.gov (NCT04688931).

On August 8, 2023 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology, non-alcoholic steatohepatitis (NASH) and obesity, reported financial results for the quarter ended June 30, 2023 and corporate updates (Press release, Terns Pharmaceuticals, AUG 8, 2023, View Source [SID1234633993]).

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"This afternoon, we reported positive data from our Phase 2a DUET clinical trial, in which TERN-501 showed dose dependent and statistically significant reductions in liver fat content and fibro-inflammation with a class-leading safety and tolerability profile," stated Erin Quirk, M.D., president and head of research and development at Terns. "These positive data underscore the potential for TERN-501 to be the THR-β monotherapy of choice and possibly a mainstay backbone of NASH combination therapies for this difficult-to-treat disease with no FDA approved treatments."

"Beyond our successful DUET clinical trial, we were also delighted to share compelling clinical updates and preclinical data that support each of our three lead development programs at key medical and scientific congresses during the second quarter. We are looking forward to initiating our Phase 1 studies with TERN-701 for chronic myeloid leukemia (CML) and TERN-601 for obesity in the second half of this year. We have a strong balance sheet to support our efforts to achieve these important milestones that bring us one step closer to our goal of bringing safe and effective new medicines to people battling serious oncologic and metabolic diseases," added Dr. Quirk.

Recent Developments and Anticipated Milestones

TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist for NASH

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Terns reported positive top-line data from the Phase 2a DUET trial of TERN-501 administered as a monotherapy or in combination with TERN-101, a liver-distributed farnesoid X receptor (FXR) agonist, for the treatment of NASH. Key takeaways from the data include:
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TERN-501 met all primary and secondary endpoints
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TERN-501 demonstrated dose dependent MRI-PDFF reductions at Week 12 as a once-daily, low dose, and combinable oral therapy
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TERN-501 (6 mg) showed statistically significant mean relative liver fat content reduction of 45% as assessed by MRI-PDFF with 64% of patients achieving >30% PDFF reduction
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All TERN-501 doses were well-tolerated with no gastrointestinal and no cardiovascular safety signals
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Terns has completed drug manufacturing to enable the initiation of a Phase 2b trial of TERN-501 in NASH
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Terns intends to submit the DUET data to a medical conference later in 2023.

TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor (TKI) for chronic myeloid leukemia (CML)

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Terns expects to initiate a clinical trial for TERN-701 in the second half of 2023, with potential interim top-line readouts from initial dose-escalation cohorts in 2024
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Terns has completed drug manufacturing to enable the initiation of its Phase 1 trial for TERN-701
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The Phase 1 trial for TERN-701 is expected to include sites from the U.S., Europe and other countries
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A poster demonstrating that TERN-701 outperformed asciminib in certain xenograft mouse models (K562 and Ba/F3T315I) at equivalent doses was presented at the American Society for Pharmacology and Experimental Therapeutics (ASPET) in May 2023
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A trial-in-progress (TiP) poster was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting (ASCO) (Free ASCO Whitepaper) in June, summarizing the ongoing Phase 1 study (NCT05367700) of TERN-701 (HS-10382) conducted by Terns’ partner, Hansoh, and highlighting the completion of enrollment of Cohort 5 of the Phase 1 dose-escalation portion of the study as of April 2023
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Management hosted a virtual Key Opinion Leader event in July 2023, with a focus on the evolving CML treatment landscape and the potential role for TERN-701. An archive of the event can be accessed here

TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist for obesity

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Terns’ lead GLP-1 receptor agonist program remains on track to initiate a Phase 1 first-in-human clinical trial in subjects with elevated body mass index (BMI) in the second half of 2023, with top-line data expected in 2024
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Data in transgenic mice expressing human GLP-1 receptor showing TERN-601 significantly improved glucose tolerance, suppressed food intake and slowed gastric emptying was presented at the American Diabetes Association’s (ADA) 83rd Annual Scientific Sessions in June 2023
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Management hosted a webinar that reviewed Terns’ obesity franchise, including the TERN-601 program and additional development efforts underway in obesity. The archive of this event can be accessed here

TERN-800: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) modulators for obesity

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Lead structural series of GIPR modulators have been identified, with lead optimization efforts underway
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Candidate nomination and initiation of IND-enabling activities expected in 2024
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GIPR modulators have the potential for combination with GLP-1 receptor agonists, such as TERN-601

Second Quarter 2023 Financial Results

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Cash Position: As of June 30, 2023, cash, cash equivalents and marketable securities were $285.6 million, as compared with $283.1 million as of December 31, 2022. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2026.
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Research and Development (R&D) Expenses: R&D expenses were $14.2 million for the quarter ended June 30, 2023, as compared with $8.7 million for the quarter ended June 30, 2022.
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General and Administrative (G&A) Expenses: G&A expenses were $7.0 million for the quarter ended June 30, 2023, as compared with $5.4 million for the quarter ended June 30, 2022.
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Net Loss: Net loss was $17.9 million for the quarter ended June 30, 2023, as compared with $13.9 million for the quarter ended June 30, 2022.