On March 29, 2023 Sorrento Therapeutics, Inc. (OTC: SRNEQ, "Sorrento"), a biopharmaceutical company dedicated to the development of life-saving therapeutics to treat cancer, intractable pain, and infectious disease, reported that the U.S. Bankruptcy Court for the Southern District of Texas granted final approval of Sorrento’s $75 million debtor-in-possession (DIP) financing from JMB Capital Partners, in connection with Sorrento’s chapter 11 case that was filed on February 13, 2023 (Presentation, Sorrento Therapeutics, MAR 29, 2023, View Source [SID1234629513]).

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This follows the Court’s interim approval of the DIP financing, granted on February 21, 2023 with respect to $30 million of the DIP financing. Today’s final approval provides Sorrento with an additional $45 million of liquidity so that it can continue operating its business during its chapter 11 case.

Dr. Henry Ji, Ph.D., Chairman and Chief Executive Officer of Sorrento, commented: "We are pleased that the Court has granted final approval for this financing. Sorrento will continue operating our business throughout this process, including paying employee wages and benefits and advancing innovative therapies for patients struggling with cancer, intractable pain, infectious disease, and more."

As previously disclosed, due to the possibility of certain actions by a litigation creditor, Sorrento and its wholly-owned, non-operating subsidiary Scintilla Pharmaceuticals, Inc. sought chapter 11 relief to safeguard its business and ensure the continuation of business operations, while protecting and maximizing value for stakeholders. On March 17, 2023, as previously disclosed, the LA County Superior Court confirmed an arbitration award of $125 million in damages, to be paid to Sorrento by NantPharma, LLC.

Latham & Watkins LLP and Jackson Walker LLP are serving as legal counsel to Sorrento. M3 Partners is serving as restructuring advisor. Moelis & Company is serving as financial advisor and investment banker.

On March 29, 2023 Athos Therapeutics, Inc. ("Athos"), a clinical stage biotechnology company pioneering the development of artificial intelligence-based precision small molecule therapeutics for patients with immune-mediated diseases and cancer, reported that it has been granted a CTN acknowledgement from the Australian Therapeutic Goods Administration and has received Human Research Ethics Committee ("HREC") approval to commence a Phase I clinical trial of ATH-063 in Australia (Press release, Athos Therapeutics, MAR 29, 2023, View Source [SID1234629512]).

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HREC approval is confirmation that Athos has successfully completed all pre-clinical, safety and animal model efficacy testing required to commence a Phase I clinical trial in Australia. In addition to the main safety assessment goals of the trial, Athos will also perform multi-omic molecular and genetic analyses to demonstrate additional proof-of-principal of drug activity to guide the design of future studies.

"The TGA’s acknowledgement of our application to initiate clinical evaluation of ATH-063 brings us one step closer to introducing a potentially paradigm-shifting treatment for people living with Inflammatory Bowel Disease," said Dimitrios Iliopoulos, PhD, MBA, President & CEO, CEO of Athos. "The initiation of the ATH-063 clinical development program after only three and a half years of development marks an important milestone for Athos and is illustrative of our innovative approach to drug discovery and demonstrates the best-in-class capabilities of the Athos team. I am proud of Athos’ record of accomplishment for rapid execution in bringing novel precision medicines to patients," added Iliopoulos.

"We are thrilled to obtain clearance to advance ATH-063 into the clinic and are excited about the prospects of what this new class of medicines may mean for patients in need," said Allan Pantuck, MD, MS, FACS, Chairman, Founder & CMO. "This is an important milestone for Athos, representing our first program to receive regulatory clearance to enter the clinic and the first ever clinical trial to evaluate this novel genomic controller. This new class of therapeutics leverages our groundbreaking science and has broad potential applicability in many therapeutic areas, including IBD, other autoimmune disorders, and cancer."

About ATH-063

ATH-063 is a first-in-class, oral, small molecule, genomic regulator in development for the treatment of Inflammatory Bowel Diseases, other autoimmune diseases and solid cancers. The ATH-063 gene target is a central hub on a gene network that was identified by the Athos computational engine through the integration of molecular and clinical data from Athos’ large IBD patient biorepository. ATH-063 acts both by suppressing pro-inflammatory responses and inducing direct mucosal healing through regulation of tight junction proteins. Blood-based proteomic and microbiome biomarker signatures are also being developed by Athos to correlate with ATH-063 effectiveness.

On March 29, 2023 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported business highlights and financial results for the fourth quarter and year ended December 31, 2022 (Press release, Arcellx, MAR 29, 2023, View Source [SID1234629511]).

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"2022 was a stellar year for Arcellx, both from a business and clinical perspective. We completed a successful IPO in February, secured additional capital through a follow-on offering in June, and ended the year announcing a global partnership with Kite to co-develop and co-commercialize CART-ddBCMA in multiple myeloma. In parallel, we initiated two Phase 1 studies utilizing our dosable and controllable CAR-T technology, ARC-SparX, and our Phase 2 iMMagine-1 pivotal study and presented robust long-term data from our Phase 1 expansion study of CART-ddBCMA in multiple myeloma at ASCO (Free ASCO Whitepaper) and ASH (Free ASH Whitepaper). We also made significant progress on the manufacturing front, setting us up for scalable manufacturing in the future," said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. "Leveraging our balance sheet of $580 million positions us to continue building on our strong foundation as we advance our pipeline programs. Our team, in collaboration with our colleagues at Kite, remains focused on completing enrollment of iMMagine-1, initiating iMMagine-2 in earlier multiple myeloma lines, and presenting longer-term data from our Phase 1 expansion study of CART-ddBCMA. We’re also beginning commercial planning as we prepare for U.S. market entry with the goal of meeting the demand of the many patients in need."

Recent Business Highlights

Announced strategic collaboration with Kite, a Gilead Company, to co-develop and co-commercialize the company’s late-stage clinical CART-ddBCMA program in multiple myeloma. On December 9, 2022, Arcellx and Kite, a Gilead Company, announced a strategic collaboration to co-develop and co-commercialize its lead product candidate, CART-ddBCMA, for the treatment of patients with relapsed or refractory multiple myeloma (rrMM). The collaboration, which closed in January 2023, leverages expertise across both companies, including Kite’s global cell therapy leadership and industry-leading reliable manufacturing. Arcellx received an upfront payment of $225 million and a $100 million equity investment. Kite and Arcellx will co-commercialize and split profits in the United States and Arcellx will receive low to mid-teen royalties outside the U.S.

Presented continued robust long-term responses from lead product candidate, CART-ddBCMA, being evaluated in a Phase 1 expansion trial in patients with relapsed or refractory multiple myeloma at the 64th ASH (Free ASH Whitepaper) Annual Meeting and Exposition and provided additional pipeline progress. On December 11, 2022, Arcellx presented new clinical data from its ongoing Phase 1 expansion study of its novel, autologous CART-ddBCMA therapy for the treatment of patients with rrMM during a presentation at the 64th ASH (Free ASH Whitepaper) Annual Meeting and Exposition. The data demonstrated 100% ORR and deep and durable responses were observed in patients with poor prognostic factors. Overall, 27 of 38 (71%) evaluable patients reached CR/sCR and 20 of 25 patients (80%) dosed >12 months ago or had their 12-month follow-up visit by November 22, 2022, had reached CR/sCR. Additionally, CART-ddBCMA continued to be relatively well tolerated with no delayed neurotoxicity or parkinsonian-like events reported. Arcellx also announced that it had dosed patients in its pivotal iMMagine-1 Phase 2 clinical trial and that it had initiated its Phase 1 clinical trial of ACLX-002 for the treatment of patients with AML/MDS.

Fourth Quarter and Full Year 2022 Financial Highlights

Cash, cash equivalents, and marketable securities:
As of December 31, 2022, Arcellx had cash, cash equivalents, and marketable securities of $254.8 million. In January 2023, Arcellx and Kite closed its agreement to co-develop and co-commercialize Arcellx’s late-stage clinical program CART-ddBCMA in multiple myeloma. Upon closing the agreement, Arcellx received a $225 million upfront payment from Kite and a $100 million equity investment from Gilead. Arcellx expects that the cash on hand, subsequent to the closing, will fund its operations through BLA filing of CART-ddBCMA planned for the first half of 2025.

R&D expenses:
Research and development expenses were $25.9 million for the quarter ended December 31, 2022, compared to $13.4 million for the quarter ended December 31, 2021, an increase of $12.5 million. Research and development expenses were $149.6 million for the year ended December 31, 2022, compared to $46.9 million for the year ended December 31, 2021, an increase of $102.7 million. This increase for the year was primarily driven by the accounting for an expense of $63.3 million related to manufacturing services agreements, of which the majority represents a non-cash expense. In accordance with ASC 842, the Company was required to expense the related right of use asset associated with an embedded lease which was determined to have no alternative future use. Other increases were related to higher external costs associated with the advancement of the company’s CART-ddBCMA clinical program, other pipeline candidates, and increased headcount.

G&A expenses:
General and administrative expenses were $14.1 million for the quarter ended December 31, 2022, compared to $7.3 million for the quarter ended December 31, 2022, an increase of $6.8 million. General and administrative expenses were $41.7 million for the year ended December 31, 2022, compared to $18.1 million for the year ended December 31, 2021, an increase of $23.6 million. These increases were driven by increased headcount and professional services costs such as legal, audit services, and consultants.

Net loss:
Net loss was $39.0 million and $20.7 million for the quarters ended December 31, 2022, and 2021, respectively; and $188.7 million and $65.0 million for the years ended December 31, 2022, and 2021, respectively.

On March 29, 2023 ImmVira reported that its oncolytic virus product MVR-C5252 targeting malignant glioma obtained the approval from National Medical Products Administration ("NMPA") for Phase I clinical trial in China on March 29, 2023 (Press release, Immvira, MAR 29, 2023, View Source [SID1234629510]). Previously, MVR-C5252 also obtained Orphan Drug Designation from U.S. Food and Drug Administration in August 2022.

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In July 2022, the Company entered into a cooperative agreement with China Resource Biopharma ("CRBio") to jointly develop MVR-C5252 in the Greater China area, leveraging CRBio’s rich clinical resources to accelerate clinical progress. The Company is also planning to jointly carry out clinical research on MVR-C5252 with Duke University in the U.S., and for the first time to use Convection Enhanced Delivery ("CED") as the administration method. Diversified cooperation modes not only reflect the recognition of ImmVira’s oncolytic virus products by well-known domestic and foreign pharmaceutical companies and leading scientific research institutions, but also facilitate the Company’s clinical development in both China and the U.S., striving to provide new treatment options for tumor patients as soon as possible.

Malignant glioma has a poor prognosis with a high recurrence rate of nearly 100% and a median survival time of only 1.5 years, creating urgent needs for a more effective treatment option. Developed on ImmVira’s OVPENS (Open Vector + Potent, Enabling, Novel & Safe) platform, MVR-C5252 is designed specifically for the treatment of central nervous system tumors. This product has been further precisely attenuated to achieve on-target malignant gliocyte killing while maintaining safety profile; and the product also carries specific therapeutic exogenous genes to promote the immune response of tumor microenvironment for further anti-tumor activity. On June 11, 2021, Daiichi Sankyo Company, Limited’s oncolytic therapy Delytact received conditional and time-limited approval from the Ministry of Health, Labour and Welfare of Japan (MHLW), for the treatment of malignant glioma, becoming the world’s first OV therapy approved for brain tumors and another strong validation of HSV-1 modality.

On March 29, 2023 Delcath Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that it has closed its previously announced private placement (the "Private Placement"), for gross proceeds of approximately $25.0 million from the issuance and sale of shares of the Company’s common stock and shares of its Series F Convertible Preferred Stock and warrants, before deducting the fees paid to the placement agent and the financial advisors of the Private Placement and other financing expenses payable by the Company (Press release, Delcath Systems, MAR 29, 2023, View Source [SID1234629509]).

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The Company intends to use the net proceeds from the Private Placement for working capital purposes and other general corporate purposes.

The Private Placement was led by Vivo Capital with participation from Logos Capital, BVF Partners LP, Stonepine Capital Management, LLC, Serrado Capital LLC and supported by existing investor, Rosalind Advisors.

The Private Placement is expected to enable the Company to have sufficient cash past its anticipated PDUFA date of August 14, 2023, and fund the commercialization of HEPZATO, if approved.

About the Private Placement

Pursuant to a securities purchase agreement, the Company has issued to purchasers an aggregate $24.9 million in shares, consisting of 24,900 shares of the Company’s Series F-1 Convertible Preferred Stock, par value $0.01 per share, that are convertible into approximately 7.6 million shares of common stock at a conversion price of $3.30 per share, and two tranches of warrants that are exercisable as follows:

Tranche A warrants for an aggregate exercise price of approximately $34.9 million are exercisable for an aggregate of up to 34,860 shares of Series F-3 Convertible Preferred Stock, par value $0.01 per share, at an exercise price of $1,000 per share (and convertible into an aggregate of up to approximately 7.8 million shares of common stock at a conversion price of $4.50 per share) until the earlier of 3/31/2026 or 21 days following the Company’s announcement of receipt of FDA approval for HEPZATO; and
Tranche B warrants for an aggregate exercise price of $24.9 million are exercisable for an aggregate of up to 24,900 shares of Series F-4 Convertible Preferred Stock, par value $0.01 per share, at an exercise price of $1,000 per share, (and convertible into an aggregate of up to approximately 4.2 million shares of common stock at a conversion price of $6.00 per share) until the earlier of 3/31/2026 or 21 days following disclosure of the Company’s public announcement of recording at least $10 million in quarterly U.S. revenue from the commercialization of HEPZATO.
The shares of Series F-1 Convertible Preferred Stock, and accompanying warrants, were issued at a price of $1,000.00 per share. Conversion of the Series F-1 Convertible Preferred Stock into shares of common stock of the Company, and the exercisability of the warrants, is subject to approval by the Company’s stockholders.

Pursuant to a separate securities purchase agreement, the Company has issued to the Company’s Chief Executive Officer 19,646 shares of the Company’s common stock and Tranche A and Tranche B warrants to purchase shares of common stock for an aggregate of $0.1 million, exercisable into an aggregate of up to approximately 48,000 shares of common stock across both tranches.

All of the securities in this Private Placement were offered by the Company.

Canaccord Genuity acted as the placement agent for the Private Placement. BTIG and Roth Capital Partners acted as financial advisors.

The securities sold and issued in connection with the Private Placement described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. The Company has agreed to file a resale registration statement with the U.S. Securities and Exchange Commission ("SEC") for purposes of registering the resale of the common stock issued or issuable in connection with the Private Placement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

For further information, please see the Company’s current report on Form 8-K to be filed with the SEC.