On August 9, 2022 Celularity Inc. (Nasdaq: CELU) ("Celularity"), a clinical-stage biotechnology company developing placental-derived allogeneic cell therapies, reported financial results for the second quarter ended June 30, 2022, and provided a corporate update (Press release, Celularity, AUG 9, 2022, View Source;utm_medium=rss&utm_campaign=celularity-reports-second-quarter-2022-financial-results-and-corporate-update [SID1234617989]).

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"We achieved another exciting milestone during the second quarter with the treatment of our first gastric cancer patient with CYNK-101, which we are evaluating as an add-on therapy to the current standard of care that we believe could extend progression free survival for patients," said Robert J. Hariri, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Celularity. "We continue to make good progress with all three of our ongoing Phase 1 clinical trials, which includes the CYNK-101 gastric cancer trial and CYNK-001 trials in AML and glioblastoma multiforme. We look forward with anticipation to the second half of the year, during which we plan to report multiple data readouts. Celularity remains committed to demonstrating the potential clinical advantages of our unique approach and leading the next evolution of cellular therapies for the treatment of cancer, infectious and degenerative diseases using our proprietary placental-derived cell therapy platform."

Second Quarter Clinical and Regulatory Highlights

CYNK-001 for the Treatment of Acute Myeloid Leukemia (AML) and Glioblastoma Multiforme (GBM):

CYNK-001 is Celularity’s unmodified cryopreserved natural killer (NK) cell therapy candidate that is derived and expanded from human placental CD34+ cells. CYNK-001 is currently being investigated in a Phase 1 clinical trial in AML and in a Phase 1/2a clinical trial in GBM, with data readouts expected in the second half of 2022.
Celularity continues to enroll new cohorts in both the minimal residual disease (MRD) and relapsed/refractory (R/R) arms of the Phase 1 AML study with clinical trial protocol adjustments communicated in December 2021, including a fourth dose on day 21 that increases the overall dosage of NK cells.
In June 2022, Celularity presented a Trials in Progress poster at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for the ongoing Phase 1/2a clinical trial to assess the safety and efficacy of CYNK-001 in combination with recombinant interleukin 2 (IL-2) in adults with resection eligible IDH1 wild-type glioblastoma.
CYNK-101 for the Treatment of G/GEJ Cancers:

CYNK-101 is a novel allogeneic off-the-shelf human placental CD34+-derived NK cell therapy candidate that is genetically modified to express high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant to drive antibody-dependent cell-mediated cytotoxicity. CYNK-101 is currently being investigated in the Phase 1 portion of a Phase 1/2a clinical trial in advanced HER2 positive G/GEJ cancers.
In July 2022, Celularity announced that the first patient had been treated with CYNK-101 in the Phase 1 portion of the Phase 1/2a clinical trial in G/GEJ cancers.
Earlier this year, the U.S. Food and Drug Administration (FDA) granted both a Fast Track designation and an Orphan Drug Designation to CYNK-101 for the treatment of G/GEJ cancers.
CYCART-19 for the Treatment of B-Cell Malignancies:

CYCART-19 is an allogeneic Chimeric Antigen Receptor (CAR) engineered human placental-derived T cell therapy candidate in B-cell malignancies.
Celularity submitted an investigational new drug application (IND) for CYCART-19 in the first quarter of 2022 and in May 2022, the FDA requested additional information before Celularity can proceed with the planned first-in-human Phase 1/2 clinical trial of CYCART-19. Celularity is in the process of working with the FDA to resolve the agency’s questions as promptly as possible, and, if the IND is cleared, plans to commence a Phase 1/2 clinical trial of CYCART-19 in B-cell malignancies in 2023.
Second Quarter Corporate Highlights

Entered into a preclinical research collaboration with Antengene to evaluate the potential therapeutic synergy of combining Antengene’s bispecific antibody with Celularity’s cryopreserved human placental hematopoietic stem cell-derived NK cell therapy platform.
Named industry leader Diane Parks to its Board of Directors, bringing to the company experience with commercialization of novel immuno-oncology therapies. Ms. Parks has led the successful launch of numerous hematology and cancer therapies at large pharmaceutical and biotech companies, including Kite Pharma, Inc. (now part of Gilead Sciences, Inc.), Amgen Inc., and Genentech, Inc. (now part of Roche Holdings, Inc.).
Closed a private placement priced at-the-market under Nasdaq rules, resulting in net proceeds of approximately $27.5 million after deducting placement agent commissions and other offering expenses.
Added to the Russell 3000 Index and the Small-Cap Russell 2000, effective after the U.S. market opened on June 27, 2022.
Second Quarter and Year to Date 2022 Financial Results

Cash and Cash Equivalents

Cash and cash equivalents were $38.0 million as of June 30, 2022, compared to $37.2 million as of December 31, 2021. In May 2022, we received net cash proceeds of approximately $27.5 million from a private placement of 4,054,055 shares of our Class A common stock and warrants to purchase up to 4,054,055 shares of our Class A common stock.

Net revenues

Net revenues for the three months ended June 30, 2022 increased by approximately $0.6 million compared to the prior year period. The increase was primarily driven by an increase in license, royalty and other revenues driven by increased product sales to our distribution partners.
Net revenues for the six months ended June 30, 2022 increased by approximately $3.9 million, compared to the prior year period. The increase was primarily driven by an increase of $4.1 million in license, royalty and other revenues driven by increased product sales to our distribution partners.
Research and Development

Research and development expenses for the three months ended June 30, 2022 increased by $2.4 million compared to the prior year period. The increase was driven by higher clinical trial costs and higher personnel costs as we continue to enroll new cohorts in both arms of the Phase 1 AML study for CYNK-001 and continue advancing the Phase 1 portion of a Phase 1/2a clinical trial in advanced HER2 positive G/GEJ cancers for CYNK-101.
Research and development expenses for the six months ended June 30, 2022 increased by $7.1 million, compared to the prior year period. The increase was primarily driven by technology platform fees, higher personnel costs, and laboratory supplies to support cell therapy process development.
Selling, General and Administrative

Selling, general and administrative expenses for the three months ended June 30, 2022 decreased by $13.3 million compared to the prior year period. The decrease was primarily driven by a reduction in stock-based compensation expense of $24.3 million related to prior year awards granted to our board of directors and senior management, a portion of which was allocated to research and development expense, offset by higher personnel, professional services and, insurance costs to support operations of a public company.
Selling, general and administrative expenses for the six months ended June 30, 2022 decreased by $4.5 million compared to the prior year period. The decrease was primarily driven by a reduction in stock-based compensation expense of $22.8 million related to prior year awards granted to our board of directors and senior management, a portion of which was allocated to research and development expense, offset by higher personnel, professional services and, insurance costs to support operations of a public company.
Net Income (Loss)

Net income for the three months ended June 30, 2022 was $47.8 million, or $0.34 per share (basic) and $0.32 per share (diluted). Net loss for the three months ended June 30, 2021 was $64.5 million, or $(2.69) per share (basic and diluted). The increase to net income was primarily related to gain recognized from the change in the fair value of the warrant liabilities and contingent liability.
Net loss for the six months ended June 30, 2022 was $15.0 million, or ($0.11) per share (basic and diluted). Net loss for the six months ended June 30, 2021 was $146.0 million, or $(6.09) per share (basic and diluted). The decrease in net loss was primarily related to gain recognized from the change in the fair value of the warrant liabilities and contingent liability.

On August 9, 2022, Asieris Pharmaceuticals, a global biopharmaceutical company specializing in the discovery and development of innovative drugs for the treatment of genitourinary tumors and other major diseases, reported that the multinational Phase III Clinical Trial of APL-1702 (Cevira), a novel non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), has successfully enrolled 402 patients in the study two months ahead of schedule (Press release, PhotoCure, AUG 9, 2022, View Source [SID1234617971]). Additionally, Photocure received a $1 million milestone payment from Asieris related to the ongoing clinical development of Cevira.

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APRICITY is a multicenter, prospective, double-blind, randomized controlled Phase III study further evaluating the efficacy and safety of the integrated drug-and light-delivery device Cevira in the treatment of HSIL. The clinical trial was approved by the National Medical Products Administration (NMPA) in July 2020 and was conducted simultaneously at 65 sites in 8 countries including China, Germany, Hungary and the Netherlands. The first patient was dosed in November 2020.

Cervical cancer is the fourth most common cancer in women worldwide1. In 2020, 604,000 new cases and 342,000 deaths worldwide were attributed to cervical cancer.1,2 Current treatments of HSIL of the cervix are based on invasive surgical interventions, compromising cervical competence and functionality. Currently, no non-surgical approach is available for the treatment of precancerous cervical lesions.

Read Asieris’ full press release here: View Source

1. Cervical cancer. Available from: View Source

2. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-49

Note to editors:

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA

About Cevira:

Cevira is a breakthrough photodynamic drug-device combination product that is being developed for non-surgical treatment of high-grade precancerous lesions of the cervix. Cevira holds the potential to serve the high unmet medical need for non-invasive treatment options for patients with HSIL in an outpatient setting, especially for young women of reproductive age. Asieris Pharmaceuticals entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to obtain the worldwide development and commercialization of Cevira in July 2019. Cevira is a registered trademark of Photocure ASA, based in Oslo, Norway.

On August 9, 2022 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to diagnose and treat cancer and life threatening infectious diseases, reported financial results for its first quarter ended June 30, 2022 and provided an update on recent developments (Press release, Aethlon Medical, AUG 9, 2022, View Source [SID1234617969]).

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Company Updates

Aethlon Medical is continuing the research and clinical development of its Hemopurifier, a therapeutic blood filtration system that can bind and remove life-threatening viruses and harmful exosomes from blood. This action has potential applications in cancer, where cancer associated exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases, including removal of COVID-19 virus, associated variants, and related exosomes.

We recently published a peer-reviewed manuscript demonstrating that Aethlon’s proprietary GNA affinity resin, a key component of the Hemopurifier, was able to bind seven clinically relevant SARS-CoV-2 variants in vitro, including the Delta and Omicron variants. Viral capture efficiency with the GNA affinity resin ranged from 53% to 89% for all variants tested. The findings from this paper suggest that the Hemopurifier should be able to bind any future SARS-CoV-2 variants that may potentially arise. The manuscript is titled "Removal of Clinically Relevant SARS-CoV-2 Variants by An Affinity Resin Containing Galanthus Nivalis Agglutinin" and was published in PLOS ONE on July 28, 2022.

We continue to advance our severe COVID-19 clinical trial for the Hemopurifier under our open Investigational Device Exemption (IDE) for life-threatening viral infections. Since our last update, the first patient has completed the study. Our active sites continue to actively screen patients along with our contract research organization (CRO), PPD, Inc. On July 6, 2022, the U.S. Food and Drug Administration (FDA) approved a supplement to our COVID-19 trial. The newly approved protocol supplement eliminates the inclusion criteria that patients must have a dialysis catheter in place and have tolerated dialysis at the time of screening. This change should improve the feasibility of enrolling new patients into our study. The active sites are currently submitting this supplement to their IRBs, and we expect to have their approvals in August and September 2022.

Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India, has enrolled one patient in our COVID-19 trial in India and continues to actively screen patients. Our CRO, Qualtran LLC, has identified additional potential sites for the trial in India and is currently assessing feasibility.

In addition to our work with COVID-19, we continue to screen patients for our IDE clinical trial in head and neck cancer. We have submitted a protocol supplement to the FDA to request the inclusion of patients who have failed platinum chemotherapy in the trial. If accepted by the FDA, this change would increase the eligible population for the study. We are currently drafting a protocol for a new clinical trial to allow us to examine the effects of the Hemopurifier in multiple tumor types where the cancer has progressed, following a two-month period of checkpoint inhibitor therapy.

Given the ongoing outbreak of monkeypox virus (MPXV), Aethlon is commissioning a new in vitro binding experiment to confirm that the Hemopurifier effectively captures the current strain of that virus. In 2008, we conducted an in vitro study that demonstrated that the Hemopurifier effectively bound and removed MPXV. We believe that the Hemopurifier’s ability to bind the current MPXV strain should not be affected because the mutations present in this strain do not change the mannose sugar in the viral envelope, which is recognized by the GNA within the Hemopurifier resin.

For more context regarding the 2008 study, we commissioned Battelle Memorial Institute to run an MPXV in vitro study using a miniature version of our Hemopurifier. This study demonstrated that high concentrations of MPXV, approximately 35,000s GPUs per mil, were rapidly depleted from cell culture fluids when circulated through the Hemopurifier. The study indicated that the Hemopurifier removed 44% of monkeypox virus in the first hour of testing, 82% after six hours, and 98% after 20 hours. The studies were conducted in triplicate and data verification was provided by real time polymerase chain reaction (PCR).

We continue to monitor MPXV caseload and disease severity. We have contacted the FDA and confirmed the process by which we could provide the Hemopurifier to requesting physicians for single patient emergency use. On August 4, 2022, the U.S. Department of Health and Human Services (DHHS) officially declared Monkeypox a health emergency. An Emergency Use Authorization (EUA) declaration has not yet been made. We plan to submit a pre-EUA package to the FDA so as to be prepared in the event this declaration occurs.

Financial Results for the First Quarter Ended June 30, 2022

As of June 30, 2022, Aethlon Medical had a cash balance of approximately $14.9 million.

Consolidated operating expenses for the three months ended June 30, 2022, were approximately $2.91 million, compared to $2.23 million for the three months ended June 30, 2021. This increase of approximately $680,000, or 30%, in the 2022 period was due to increases in our general and administrative expenses of approximately $402,000, in our professional fees of approximately $261,000 and in our payroll and related expenses of approximately $13,000.

The $402,000 increase in our general and administrative expenses in the June 30, 2022, quarter was primarily due to the combination of a $161,000 increase in our clinical trial expenses, a $97,000 increase in supplies, a $91,000 increase in our rent expense and a $27,000 increase in our insurance expense.

The $261,000 increase in our professional fees was primarily due to the combination of a $154,000 increase in our contract labor expense associated with product development and analytical services and a $95,000 increase in professional fees associated with regulatory strategy services

The $13,000 increase in our payroll and related expenses was due to an increase in our stock-based compensation expense of $95,000. Our cash-based compensation expense decreased by $82,000 because our CEO received a $215,000 bonus in the June 2021 period for achieving certain contractual milestones in his employment agreement and there were no bonuses paid out in the June 2022 period.

Aethlon did not record any revenue related to our government contracts with the NIH in the three months ended June 30, 2022, compared to approximately $132,000 in the three months ended June 30, 2021. As of June 30, 2022, the Company had approximately $459,000 of deferred revenue related to those contracts as a result of not achieving certain milestones in those contracts.

As a result of the changes in revenues and expenses noted above, Aethlon’s net loss before noncontrolling interests increased to approximately $2.9 million for the three months ended June 30, 2022, from approximately $2.1 million for the three months ended June 30, 2021.

During the three months ended June 30, 2022, the Company raised approximately $619,000 in net proceeds under our ATM agreement with H.C. Wainwright & Co., pursuant to sales of our common stock. In July and August 2022 to date, the Company raised approximately $8.3 million under our ATM agreement through sales of our common stock.

The unaudited condensed consolidated balance sheet for June 30, 2022, and the unaudited condensed consolidated statements of operations for the three months ended June 30, 2022 and 2021 follow at the end of this release.

Conference Call

The Company will hold a conference call today, Tuesday, Aug. 9, 2022, at 4:30 p.m. EDT to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question-and-answer session.

Interested parties can register for the conference by navigating to View Source

Please note that registered participants will receive their dial in number upon registration.

A replay of the call will be available approximately one hour after the end of the call through July 28, 2022. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 2740523.

On August 9, 2022 Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotechnology company focused on developing novel drugs for cancer, fibrosis and inflammation, reported that promising interim clinical data from its Phase I study of BBT-176, a fourth-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) (Press release, Bridge Biotherapeutics, AUG 9, 2022, View Source [SID1234617968]). The data, presented at the International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer (IASLC WCLC 2022), show promising early evidence of efficacy and favorable tolerability in patients with non-small cell lung cancer (NSCLC).

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The oral presentation delivered by Sun Min Lim, M.D., Ph.D., assistant professor at Yonsei University College of Medicine, discussed the correlation between molecular response and radiologic response in patient participants in the study. One patient with advanced NSCLC showing C797S triple mutations, confirmed as one of the partial response (PR) cases, showed up to 53 percent decrease of EGFR mutant allele frequency compared to the baseline. Data from the five patients who had been treated with BBT-176 over 100 days suggested that circulating tumor DNA (ctDNA) analysis enabled with liquid biopsy may be useful not only in identifying those most likely to benefit from fourth-generation EGFR TKI treatments such BBT-176, but also monitoring therapeutic response with treatment of a fourth-generation EGFR TKI.

The study also confirmed the preliminary efficacy of BBT-176 in treating advanced NSCLC patients harboring an EGFR mutation who had previously been treated with at least one EGFR TKI. Adverse events were primarily low grade, with GI toxicities and skin rash being most common, necessitating dose modifications in some patients. The pharmacokinetic profile of BBT-176 was shown to be dose-proportional in the study.

As the study continues, investigators will explore the recommended Phase 2 dose (RP2D) based on the overall safety, efficacy and tolerability information collected. Upon determination of the RP2D, investigators are expected to initiate the Phase 2 study next year.

Session and Presentation Information
Title: BBT-176, a 4th-generation EGFR TKI, for Progressed NSCLC after EGFR TKI Therapy: PK, Safety and Preliminary Efficacy from Phase 1 Study
Session Title: Overcoming Resistance to EGFR Inhibitors
Session Number: MA07.09
Presentation Session: August 8, 2022, 12:52 pm CET
Presenting Author: Sun Min Lim, M.D., Ph.D., Yonsei University College of Medicine
Session Discussant: Pasi A. Jänne, M.D., Ph.D., Dana-Farber Cancer Institute

On August 9, 2022 Catalent, Inc. (NYSE: CTLT), the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, reported that it has reached an agreement to acquire Metrics Contract Services (Metrics), a full-service specialty Contract Development and Manufacturing Organization (CDMO) with a facility in Greenville, North Carolina, for $475 million from Mayne Pharma Group Limited (ASX: MYX) (Mayne Pharma) (Press release, Catalent, AUG 9, 2022, View Source [SID1234617965]). Upon completion, the acquisition will strengthen Catalent’s capabilities in integrated oral solid formulation development, manufacturing, and packaging to help customers simplify and accelerate their programs, while also expanding Catalent’s capacity to handle highly potent compounds.

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The 333,000 square-foot Greenville facility features comprehensive capabilities to accelerate and de-risk customer programs from early development through commercial launch through a streamlined one-site solution. Over the past five years, the facility has seen more than $100 million in capital improvements and now includes 16 manufacturing suites, with 11 designed to handle highly potent compounds, as well as two packaging lines that can support a large variety of development and commercial supply programs. The facility’s estimated annual production capacity exceeds one billion oral solid dose units.

"This acquisition will further expand Catalent’s ability to meet our customers’ expectations in fast-growing areas of the business and patient need. The experienced team and consistently improved, state-of-the-art facility in Greenville will provide Catalent’s customers with immediate, fit-for-scale capacity for in-demand highly potent drugs and other oral solid small-to-mid-size batch needs. This capacity is particularly important for customers with R&D pipelines featuring accelerated, orphan, and rare disease programs for oncology and other important therapeutic areas," said Dr. Aris Gennadios, Group President of Catalent’s Pharma & Consumer Health segment.

"Over the past several years, Metrics has undergone a period of transformational change to expand its footprint and service offering, becoming a global end-to-end novel oral solid CDMO. Catalent, a global leader in advanced drug development and manufacturing, is well-positioned to continue to invest in and accelerate the growth of Metrics and we believe this transaction will be extremely positive for our Greenville team and customers," said Scott Richards, Chief Executive Officer of Mayne Pharma.

The new facility will seamlessly integrate into Catalent’s industry-leading oral development and manufacturing network, which includes flagship sites for large-scale and controlled release oral solids manufacturing in Winchester, Kentucky; softgel development and manufacturing in St. Petersburg, Florida; and additional facilities with bioavailability enhancement technologies and complex oral solids manufacturing platforms.

The acquisition is expected to close before the end of this calendar year, subject to customary closing conditions, and the entire team of over 400 employees will join Catalent. Mayne Pharma and Catalent have also agreed on the terms of a long-term supply agreement whereby the Greenville facility will continue to manufacture multiple Mayne Pharma products. Catalent will pay the purchase price for this all-cash acquisition using a combination of cash on hand, existing credit facilities, and, depending on market conditions, potentially new debt financing. The closing of the acquisition is not contingent on any financing activity.