Scilex Holding Company, a Sorrento Company, Announces Pre-Emptive Repurchase of $41.4 Million of its Senior Secured Notes

On June 3, 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 on June 3, 2022, it pre-emptively paid off and eliminated $41.4 million of the principal amount of its senior secured notes (the "Notes") (Press release, Sorrento Therapeutics, JUN 3, 2022, View Source [SID1234615489]). In connection with this payoff, the holders of the Notes agreed that Scilex can repurchase the remaining principal amount of the Notes at any time on or before September 30, 2022 for $41.4 million (subject to reduction for any quarterly royalty payments) and the holders of the Notes will forgive and discharge $28.0 million of the aggregate principal amount of the Notes.

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Scilex’s Executive Chairman and Sorrento Chairman and CEO, Henry Ji, Ph.D., stated, "We value our stockholders and our reputation as a stockholder-friendly company above all else. We have our sights set on some very big long-term objectives for Sorrento and Scilex. And we won’t get there by working against the interests of our equity holders. Paying down the Notes reduces uncertainty and further improves Scilex’s balance sheet. We look forward to identifying other opportunities to grow our stockholders’ interests and avoid unnecessary distractions in financing our progress as we move toward commercialization of additional non-opioid pain management solutions in the acute and chronic pain markets."

"As we prepare to complete our previously announced merger with Vickers Vantage Corp. I and begin our registration and pre-commercialization plans of our recently successfully completed SP-102 (SEMDEXATM) Phase 3 clinical trial program, this pre-emptive repurchase of part of the Notes is another important accomplishment of our company goals. It gives us the ability to attract new capital at competitive terms, preserve cash that would have been spent on royalty payments under the Notes, as well as being able to avoid the effects of negative debt leverage. We believe these advantages will be of significant benefit to Scilex and our stockholders as we continue to execute on our business plan," said Jaisim Shah, Chief Executive Officer of Scilex.

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 symbol "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.

Erasca Announces Trial to Evaluate ERAS-007 in Combination with KRAS G12C Inhibitor in KRAS-Driven Cancers

On June 2, 2022 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported a trial to investigate the ERK1/2 inhibitor ERAS-007 in combination with a KRAS G12C inhibitor in KRAS G12C-driven non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) (Press release, Erasca, JUN 2, 2022, View Source [SID1234639378]).

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"We look forward to ERAS-007 being evaluated in this trial, based in part on ERAS-007’s ability in preclinical studies to robustly shut down oncogenic signaling," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "This trial not only helps to broaden the therapeutic development of ERAS-007, but also complements the patient subgroups within our ongoing HERKULES-2 and HERKULES-3 master protocols. Additionally, it may provide proof-of-concept data supporting the addition of ERAS-007 as a treatment option to overcome RAS/MAPK resistance with KRAS G12C inhibitors. We look forward to potentially partnering with the team to explore the therapeutic potential of this combination."

Ryan Corcoran, M.D., Ph.D., Director of the Gastrointestinal Cancer Center Program at Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School, added, "While adaptive feedback mechanisms can overwhelm MEK inhibitors, ERK inhibitors potentially can overcome drug resistance mechanisms that involve reactivation of RAS/MAPK pathway signaling. We look forward to evaluating whether the ERK1/2 inhibitor ERAS-007 has the potential to overcome feedback mechanisms and help address the limited efficacy of single agent KRAS G12C inhibitors."

A Phase 1b clinical proof-of-concept trial will evaluate ERAS-007 in combination with a KRAS G12C inhibitor in patients with NSCLC and CRC harboring a KRAS G12C mutation. Additional preclinical and clinical laboratory research will be conducted to further understand the activity and safety of this combination in these patient populations. The trial will be led by principal investigators Scott Kopetz, M.D., Ph.D., Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center, Dr. Corcoran, and Pasi Janne, M.D., Ph.D., Professor of Medicine at Harvard Medical School. Drs. Corcoran and Kopetz recently received a grant from Stand Up To Cancer (SU2C).

About ERAS-007
ERAS-007 is a potential best-in-class ERK1/2 inhibitor being investigated alone or in combination with different inhibitors targeting upstream nodes of the MAPK pathway as part of Erasca’s MAPKlamp strategy. The extracellular signal-regulated kinases (ERK), ERK1 and ERK2, belong to a family of serine-threonine kinases that regulate cellular signaling and comprise the terminal node of the RAS/MAPK pathway. The broad therapeutic potential of ERAS-007 is being investigated initially across four HERKULES clinical trials that span multiple tumor types and include both monotherapy and combinations with approved and investigational agents, such as RTK, SHP2, RAS, RAF, and/or cell cycle inhibitors. HERKULES-1 is a Phase 1b/2 clinical trial for ERAS-007 as a single agent and in combination with the SHP2 inhibitor ERAS-601 in advanced solid tumors. HERKULES-2 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with non-small cell lung cancer. HERKULES-3 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with gastrointestinal cancers. HERKULES-4 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with hematologic malignancies.

EtiraRx’s Licensed ERX-41 Identified as a Potential New Oral Therapy for Multiple Cancers, Company Prepares for Clinical Trials

On June 2, 2022 A scientific team, led by the scientific founders of EtiraRx, reported that it has identified a small molecule, ERX-41, as a novel oral therapeutic agent that may have utility in treating multiple solid cancers, including triple negative breast cancer, glioblastoma, ovarian and pancreatic cancers (Press release, EtiraRx, JUN 2, 2022, View Source [SID1234616455]). EtiraRx, headquartered in Biolabs Pegasus Park, plans to initiate clinical trials as early as the first quarter of 2023.

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In the work, published in Nature Cancer, the researchers, led by Drs. Jung-Mo Ahn, Ganesh Raj and Ratna Vadlamudi, identified that ERX-41 dramatically enhances endoplasmic reticulum (ER) stress in cancer cells. Since aggressive cancer cells have higher basal levels of ER stress, the enhanced ER stress induced by ERX-41 is not compensated and causes cancer cell death. Normal cells have low basal of ER stress, can compensate for ERX-41 activity and do not undergo cell death after ERX-41 treatment. Using state-of-the-art molecular approaches, the team identified that the molecular target of ERX-41 is the protein encoded by the lysosomal acid lipase A (LIPA) gene and that pharmacologic inhibition of LIPA by ERX-41 enhances ER stress in cancer cells. The study set the foundation for clinical trials with patients with therapy-resistant cancers that are vulnerable to enhanced ER stress.

Said Dr. Raj, "These discoveries are exciting as they represent a novel approach to targeting the Achilles heel of many aggressive cancers- their vulnerability to enhanced ER stress. Our critical finding was that of a new therapeutic target (LIPA) and its undiscovered role in protein folding. By targeting LIPA with ERX-41, protein folding in the cancer cell was disrupted, causing ER stress and promoting cancer cell death. Our findings indicate the potential for an oral agent with a favorable therapeutic index to effectively treat patients with aggressive cancers, for whom options are limited."

EtiraRx is completing necessary preclinical studies and plans to initiate clinical trials with these compounds, which will take place the first quarter of 2023. Russell Hayward, CEO EtiraRx, said, "ERX-41 has the potential to be a first-in-class oral therapy that kills aggressive therapy-resistant cancers. We are committed to moving these drugs forward to clinical trials and make a difference in the lives of patients with lethal cancers."

CEO & COO of Prestige BioPharma Group Buys Additional Shares

On June 2, 2022 CEO Lisa S. Park and COO Michael J. Kim reported that have purchased additional shares in Prestige Biopharma and Prestige Biologics to stabilize stock prices of the two companies (Press release, Prestige BioPharma, JUN 2, 2022, View Source [SID1234616245]). Through Mason Partners, a joint investment company established by CEO Park and COO Kim, the two executive directors bought 137,420 shares of Prestige BioPharma’s stock. In addition, CEO Park and COO Kim bought 19,337 shares and 19,301 shares of Prestige Biologics’ stock respectively. Including the KRW 2 billion stock purchase previously announced on May 23, the two executive directors have purchased KRW 4 billion stock in total so far, and will consider further action to protect the market value of their companies.

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"We are confident with the value of our business and have been putting strenuous efforts towards the development and commercialization of our pipelines. The recent fall in stock price doesn’t reflect the potential value of our companies. We hope the in-house purchase would be a positive signal to the shareholders and help recover our market value. Prestige Biopharma and Prestige Biologics will continue to do the utmost to enhance future values," said Dr. Lisa S. Park, CEO of Prestige Biopharma.

Prestige BioPharma has requested European Medicines Agency (EMA) for re-examination of Marketing Authorisation Application (MAA) for the company’s Herceptin biosimilar HD201. The result is expected to be announced after 120 days. Prestige Biologics is strengthening its business as a global CDMO utilizing its state-of-the-art facilities and patented technologies.

Genprex to Present at Upcoming June Investor Conferences

On June 2, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported the Company’s participation in the following upcoming investor and industry conferences to be held in June 2022 (Press release, Genprex, JUN 2, 2022, View Source [SID1234615486]).

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Event: LD Micro Invitational

Virtual Presentation Date: Available on-demand within the virtual platform for all delegates beginning June 8 at 4:00 p.m. PT

Presenter: Ryan Confer, Genprex’s Chief Financial Officer

A recording of this presentation will be available for replay on Genprex’s website for a period of time.

Event: BIO International Convention