Scilex Holding Company, a Sorrento Company, Has Entered A Term Sheet to Acquire Ancora Medical Inc.

On July 7, 2022 Scilex Holding Company ("Scilex"), a nearly 100% (or over 99.9%) majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), a commercial biopharmaceutical company focused on developing and commercializing non-opioid therapies for patients with acute and chronic pain, reported that it has entered a term sheet to acquire Ancora Medical Inc. ("Ancora"), a privately held medical technology company with anchoring catheter and needle combo technology that was approved by the FDA in February 2020 (Press release, Sorrento Therapeutics, JUL 7, 2022, View Source [SID1234616540]).

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The Ancora Nerve Block Catheter Set is indicated for surgical pain management during the pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The device allows physicians to locate peripheral nerves by transferring electrical impulses from a nerve stimulator and/or through ultrasound visualization of the device. The catheter may remain in dwelling for up to 72 hours (Section 510k Number: K191290).

The global continuous peripheral nerve block catheter market is estimated to surpass $740.7 million by 2027.1 Increasing incidence of trauma and accidental injuries is expected to propel growth of the global continuous peripheral nerve block, according to Coherent Market Insights 2020.1 This market also has additional opportunity in different segments of the market such as interventional pain clinics and ambulatory surgical.1 These segments are fast growing and Ancora’s technology has the potential to offer increased efficiency and a reduction in procedural cost and the high usage of opioid treatments.

The global needle market will reach $8.47 billion by 2022 and $15.9 billion by 2026 and the nerve block needle market is valued at $600 million.2 According to Reportlinker.com February 2022, the growth in the medical needles market is primarily driven by factors including the rise in incidence of infectious diseases, prevalence of chronic diseases such as cancer and diabetes, and surgery volumes and increasing prevalence of spine-related disorders and an aging population. Other factors impacting demand include advancements in product designs, favorable demographic trends, increased emphasis on preventing hospital-acquired infections, and improving healthcare infrastructure and services across developing countries.

"We are pleased to enter into the proposed transaction and are confident that Scilex is the ideal fit to build the AnCora franchise given their commitment to and proven track record of expanding patient access to non-opioid options," said Chunyuan Qiu, M.D., Chief Executive Officer of Ancora.

"We believe the Ancora technology has tremendous potential as a platform and in pain management. With the proposed transaction, we continue to move toward our goal for 2022 to build out our non-opioid product portfolio, by acquisitions, in-licensing, and internal product development," said Henry Ji, Ph.D., Executive Chairman of Scilex and Chairman and Chief Executive Officer of Sorrento.

"We are excited to announce this proposed transaction, which is highly complementary to our product portfolio and underscores our corporate mission to provide opioid alternatives to as many patients as possible," said Jaisim Shah, Chief Executive Officer of Scilex. "We believe the Ancora catheter and needle system has significant growth opportunity given the key role it can play in the management of pain with a non-opioid multimodal regimen that can help mitigate or even eliminate the use of opioids for managing pain before, during and after surgery. We will be working to leverage our commercial infrastructure, market access partnership network, including our substantial commercial collaboration with Sorrento, and deep domain expertise to drive widespread adoption of this exciting treatment."

Scilex’s acquisition of Ancora is subject to execution of a definitive agreement, which will contain customary closing conditions. This proposed acquisition builds upon the Scilex’s strategy to create a global company and would add to the sales and marketing capabilities of the company.

Scilex Holding Company and Vickers Vantage Corp. I (Nasdaq: VCKA) ("Vickers"), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, have entered into a definitive business combination agreement ("BCA") on March 17, 2022. Upon the closing of the transaction, the combined company (the "Combined Company") will be renamed Scilex Holding Company, and its common stock and warrants to purchase common stock are expected to be listed on Nasdaq under the ticker symbols "SCLX" and "SCLXW", respectively. The boards of directors of each of Vickers, Scilex and Sorrento have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur by the third quarter of 2022, is subject to the approval of Vickers’s shareholders and the satisfaction or waiver of certain other customary closing conditions.

QIAGEN N.V. to Release Results for Q2 2022 and Hold Webcast

On July 7, 2022 QIAGEN N.V. (NYSE: QGEN) (Frankfurt Stock Exchange: QIA) reported its plans to release results for the second quarter of 2022 (Press release, Qiagen, JUL 7, 2022, View Source [SID1234616539]).

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Conference call date / time: Thursday, July 28, at 15:30 Frankfurt time / 14:30 London time / 09:30 New York time.

Three options for joining the conference call

A conference call replay will be available by using the following link:
View Source;tp_key=b55d95ed6e

Nurix Therapeutics Reports Fiscal Second Quarter 2022 Financial Results and Provides a Corporate Update

On July 7, 2022 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs, reported financial results for the second quarter ended May 31, 2022 and provided a corporate update (Press release, Nurix Therapeutics, JUL 7, 2022, View Source [SID1234616537]).

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"In the second quarter of 2022, we reported promising data in our Phase 1 trial of NX-2127 with clinical responses in CLL patients harboring tumor mutations that confer resistance to current BTK inhibitor therapies," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "Our oncology drug discovery engine continues to hit on all cylinders. We are recruiting patients into clinical trials in all four of our wholly-owned programs, and we anticipate a data-rich second half of this year with information from each of the four clinical studies."

Recent Business Highlights

Announced Phase 1b expansion of the NX-2127 clinical trial for patients with chronic lymphocytic leukemia (CLL). Based on positive efficacy, safety, pharmacokinetic (PK), and pharmacodynamic (PD) data from the Phase 1a dose escalation portion of the trial, Nurix initiated a Phase 1b expansion cohort in patients with CLL, which represents the first of several potential expansions. Relevant clinical and biomarker data supporting the decision were presented at the company’s first R&D Day, which was held in New York on May 26th (an archived webcast of the event can be accessed via the Events and Presentations page of the Investor section of the Nurix website). The dose-finding Phase 1a stage of the clinical trial of NX-2127 continues in other non-Hodgkin lymphoma subtypes.
Provided a deep dive into Nurix’s platform and progress in its targeted protein modulation programs at the company’s first R&D Day. In addition to providing an update on each of Nurix’s four wholly owned clinical programs and highlighting the company’s DELigase R&D platform, which serves as the source of current and future programs, Nurix’s R&D Day featured a presentation by Anthony Mato M.D., MSCE, Director of the CLL program at Memorial Sloan Kettering Cancer Center. Dr. Mato outlined the unmet medical need in CLL and the growing problem of resistance and intolerance to current and next generation Bruton’s tyrosine kinase (BTK) inhibitors including the emergence of new drug resistance mutations that may be addressed by Nurix’s portfolio of BTK degraders (NX-2127 and NX-5948). An archived webcast of the event can be accessed via the Events and Presentations page of the Investor section of the Nurix website.
Announced dosing of the first patient in its Phase 1a/1b study to evaluate NX-5948 in patients with relapsed B-cell malignancies. The Phase 1 study of NX-5948, a potent and selective degrader of BTK, is a dose escalation and expansion trial at multiple clinical sites in the United Kingdom. The trial is designed to evaluate the safety and tolerability of NX-5948 in adults with relapsed or refractory B-cell malignancies.
Presented data and clinical trial information at key oncology meetings. Data and clinical trial design presentations for each of Nurix’s wholly owned programs were made at major oncology clinical and scientific meetings including the annual meetings of the American Academy of Cancer Research (AACR) (Free AACR Whitepaper) in April, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June, the European Hematology Association (EHA) (Free EHA Whitepaper) in June, and the Translational Research Cancer Centers Consortium (TRCCC) in June. The presentations can be found in the Scientific Presentations section of the Events and Presentations page of the Investor section of the Nurix website.
Upcoming Program Highlights*

NX-2127: Nurix’s lead drug candidate from its protein degradation portfolio, NX-2127, is an orally bioavailable degrader of BTK with immunomodulatory activity for the treatment of patients with relapsed or refractory B-cell malignancies. Nurix is conducting its Phase 1 clinical trial of NX-2127 at multiple clinical sites in the United States. Nurix anticipates presenting additional clinical results from the Phase 1a portion of the trial in the second half of 2022. Additional information on the clinical trial can be accessed at clinicaltrials.gov (NCT04830137).
NX-5948: Nurix’s second drug candidate from its protein degradation portfolio, NX-5948, is an orally bioavailable BTK degrader designed without immunomodulatory activity for certain B-cell malignancies and autoimmune diseases. Nurix is evaluating NX-5948 in a Phase 1 clinical trial in adults with relapsed or refractory B-cell malignancies and expects to have initial safety and PK/PD data from the Phase 1a portion of the study in the second half of 2022. Additional information on the clinical trial can be accessed at clinicaltrials.gov (NCT05131022).
NX-1607: Nurix’s lead drug candidate from its targeted protein elevation portfolio, NX-1607, is an orally bioavailable inhibitor of the E3 ligase CBL-B for immuno-oncology indications including a range of solid tumor types. Nurix is evaluating NX-1607 in an ongoing, Phase 1 dose escalation and expansion trial in adults with a variety of oncology indications at multiple clinical sites in the United Kingdom and expects to have initial PK/PD data from the Phase 1a stage of the study, including biomarker and safety data, in the second half of 2022. Additional information on the clinical trial can be accessed at clinicaltrials.gov (NCT05107674).
DeTIL-0255: Nurix’s lead candidate in its cellular therapy portfolio, DeTIL-0255, is a drug-enhanced adoptive cellular therapy. Nurix is evaluating DeTIL-0255 in a Phase 1 trial in adults with gynecological malignancies including ovarian cancer, cervical cancer, and endometrial cancer. Nurix anticipates providing a clinical update from the run-in portion of the DeTIL-0255 Phase 1 study in the second half of 2022. Additional information on the clinical trial can be accessed at clinicaltrials.gov (NCT05107739).
* Expected timing of events throughout the press release are based on calendar year quarters.

Fiscal Second Quarter 2022 Financial Highlights

Collaboration revenue for the three months ended May 31, 2022, was $11.4 million compared to $7.1 million for the three months ended May 31, 2021. The increase was primarily due to increased effort resulting in a higher percentage of completion of performance obligations under Nurix’s collaborations with Gilead and Sanofi in the current period. The increase was also due to changes in transaction price that resulted in higher revenue recognized in each period and impacted the cumulative catch up in revenue for activities satisfied in previous periods. In the three months ended May 31, 2022, Nurix achieved a research milestone under its collaboration with Gilead and anticipates a payment of $1.5 million in the third fiscal quarter of 2022.

Research and development expenses for the three months ended May 31, 2022, were $47.5 million compared to $26.0 million for the three months ended May 31, 2021. The increase was primarily related to an increase of $7.2 million in compensation and related personnel costs and an increase of $2.0 million in non-cash stock-based compensation expense attributable to higher headcount. The increase in non-cash stock-based compensation expense was also attributable to the issuance of restricted stock units. There was also an increase of $10.0 million in supplies, contract research, contract manufacturing and clinical trial costs.

General and administrative expenses for the three months ended May 31, 2022, were $9.7 million compared to $7.5 million for the three months ended May 31, 2021. The increase was primarily related to an increase of $0.6 million in compensation-related expenses and an increase of $0.9 million in non-cash stock-based compensation expense, both of which were primarily attributable to higher headcount. There was also an increase of $0.6 million in professional service expenses, including legal and accounting expenses related to infrastructure improvements.

Net loss for the three months ended May 31, 2022, was $45.4 million, or ($1.01) per share, compared to a net loss of $26.4 million, or ($0.60) per share for the three months ended May 31, 2021.

Cash, cash equivalents and investments: As of May 31, 2022, Nurix had cash, cash equivalents and investments of $348.8 million compared to $385.7 million as of February 28, 2022.

Leidos Schedules Second Quarter 2022 Earnings Conference Call for August 2, 2022 at 8 a.m. (ET)

On July 7, 2022 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology leader, has scheduled a conference call for Tuesday, Aug. 2, 2022, at 8 a.m. (ET) reported its second quarter 2022 financial results for the period ending July 1, 2022 (Press release, Leidos, JUL 7, 2022, View Source [SID1234616536]). The company plans to issue its quarterly earnings press release before the conference call on Aug 2, 2022.

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The details for the earnings conference call follow:

The company offers a live and replay audio broadcast of the conference call with corresponding supplemental information at View Source

A telephone playback of the first quarter 2022 earnings conference call is scheduled to be available beginning at 11:30 a.m. (ET) on Aug. 2, 2022, through 11:59 p.m. (ET) on Aug. 9, 2022. The replay will be accessible by calling 877-660-6853 (International callers: +1-201-612-7415) and entering conference ID 13731269.

An archived version of the webcast will be available on the Leidos Investor Relations website at View Source

Kiromic BioPharma Achieves Milestone with Timely Completion of Expanded cGMP Manufacturing Facility to Support Cell Therapy Oncology Pipeline

On July 7, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence and data mining platform to develop cell and gene therapies with a focus on immuno-oncology, reported the timely completion of construction on its expanded current good manufacturing practice (cGMP) manufacturing facility in Houston (Press release, Kiromic, JUL 7, 2022, View Source [SID1234616535]). This significant milestone was accomplished within the timeline established by the Company, specifically June 30, 2022.

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The expanded facility located at Kiromic’s headquarters is one of the conditions required for the Company to begin the activation of its cell therapy clinical trial for the Deltacel product candidate by the end of this year. The completion also addresses a key component in the clinical hold communication the Company received from the U.S. Food and Drug Administration (FDA) in June 2021.

"The on-time completion of our cGMP manufacturing facility is one of the conditions necessary to begin the activation of the Deltacel clinical trial by the end of this year," stated Pietro Bersani, Kiromic BioPharma’s Chief Executive Officer. "The facility supports an expanding product pipeline of cell therapies designed to target solid tumors, furthering our commitment to delivering lifesaving treatments to patients with cancer who have limited therapeutic options. We believe our allogeneic, off-the-shelf manufacturing process will result in shorter lead times and lower costs, thereby increasing the availability of these promising cellular therapies for oncology patients."

The expanded 34,000-square-foot facility includes flexible cellular therapy and viral vector suites, a dedicated cGMP microbiology lab, a dedicated cGMP quality control (QC) lab, a research and development laboratory, and an FDA Code of Federal Regulations (CFR-9) compliant vivarium.