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Nuvation Bio Reports Second Quarter 2021 Financial Results and Provides Business Update

On August 12, 2021 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported financial results for the second quarter ended June 30, 2021, and provided a business update (Press release, Nuvation Bio, AUG 12, 2021, View Source [SID1234586482]).

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"The second quarter of 2021 marked multiple achievements for Nuvation Bio. With the appointment of David C. Hanley, Ph.D., as Chief Technical Operations Officer, we are advancing our supply chain, product development and manufacturing efforts. For our pipeline, we continue to enroll and dose patients in our ongoing Phase 1/2 study of NUV-422 and have recently expanded the study to include additional cohorts for patients with recurrent glioblastoma, hormone receptor-positive breast cancer and metastatic castration-resistant prostate cancer, further reinforcing the potential of NUV-422," said David Hung, M.D., founder and chief executive officer of Nuvation Bio. "We look forward to advancing our ongoing study of NUV-422, and the entirety of our pipeline of therapies for difficult-to-treat cancers, towards clinical development."

Recent Business Highlights

Enrollment ongoing in Phase 1/2 multiple expansion cohort study of NUV-422. During the second quarter of 2021, Nuvation Bio submitted a protocol amendment to the U.S. Food and Drug Administration (FDA) to expand the population of its Phase 1/2 study of lead investigational compound, NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor. The expanded population will allow for enrollment of patients with recurrent glioblastoma, hormone receptor-positive metastatic breast cancer (with and without brain metastases) and metastatic castration-resistant prostate cancer. Enrollment is ongoing and data from the Phase 1 portion of the study is expected in 2022.

Appointment of David C. Hanley, Ph.D., as Chief Technical Operations Officer. In June 2021, Nuvation Bio announced the appointment of David C. Hanley, Ph.D., as Chief Technical Operations Officer, joining the Company’s executive management team. In this capacity, Dr. Hanley will oversee all early- and late-stage pharmaceutical development and operations, including supply chain, product development and manufacturing efforts, and work closely on commercial planning with Quality, Regulatory Affairs, Clinical Development and Clinical Operations teams.
Second Quarter Financial Results

As of June 30, 2021, Nuvation Bio had cash, cash equivalents and marketable securities of $806.6 million.

For the three months ended June 30, 2021, research and development expenses were $14.0 million, compared to $7.3 million for the three months ended June 30, 2020. The increase of $6.7 million was primarily due to a $4.7 million increase in third-party costs related to research services and manufacturing to advance our current preclinical programs and Phase 1/2 clinical trial, as well as a $2.0 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation.

For the three months ended June 30, 2021, general and administrative expenses were $6.4 million, compared to $1.7 million for the three months ended June 30, 2020. The increase of $4.7 million was due to an increase in personnel-related costs driven by an increase in headcount and stock-based compensation, as well as increases in insurance, professional fees, other miscellaneous expenses and legal fees.

For the three months ended June 30, 2021, Nuvation Bio reported a net loss of $19.3 million, or $(0.09) per share. This compares to a net loss of $8.6 million, or $(0.10) per share, for the comparable period in 2020.

Citius Pharmaceuticals, Inc. Reports Third Fiscal Quarter 2021 Financial Results and Provides General Business Update

On August 12, 2021 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on anti-infective products in adjunct cancer care, unique prescription products and stem cell therapy, reported financial results for the third fiscal quarter of 2021 ended June 30, 2021, and provided a general business update (Press release, Citius Pharmaceuticals, AUG 12, 2021, View Source [SID1234586481]).

Third Fiscal Quarter 2021 and Recent Business Highlights

Received third positive recommendation from independent Data Monitoring Committee to continue the Mino-Lok Phase 3 clinical superiority trial as planned without modifications; no safety concerns identified;
Characterization and expansion of NoveCite’s i-MSC accession cell bank (ACB) underway at Waisman Biomanufacturing at the University of Wisconsin-Madison to create a cGMP master cell bank (MCB);
Received FDA guidance on proprietary Halo-Lido patient-reported outcome (PRO) tool; preparing to submit an investigational new drug (IND) application during the fourth quarter of 2021;
Advanced Mino-Wrap chemistry, manufacturing and controls (CMC) development;
Issued 11.2 million shares of Citius common stock upon the exercise of warrants during the quarter for aggregate proceeds of $16.9 million, and a total of $127.6 million in financing activities during the first half of 2021;
Announced that on June 21, 2021 stockholders approved an increase in authorized shares from 210,000,000 to 410,000,000 and an increase in authorized common shares from 200,000,000 to 400,000,000; and,
Reported $115.7 million in cash and cash equivalents as of June 30, 2021.
"During the quarter, we made progress with all of our programs despite the ongoing challenges of conducting preclinical work and clinical trials during the extended COVID-19 pandemic. We remain encouraged by the positive recommendation of the independent DMC to continue the Mino-Lok Phase 3 pivotal superiority trial as planned and are fully committed to submitting an NDA for the treatment of infected catheters, a potentially life-threatening condition for the nearly 500,000 patients with catheter-related bloodstream infections in the U.S. each year. Given rising COVID-19 infection rates across the U.S., hospitals are, understandably, prioritizing COVID-19 patients and studies. Consequently, we expect recruitment for our Mino-Lok trial will be slower in the near term than we had originally planned. To address this, we are exploring multiple paths to support our patient recruitment and randomization efforts and are confident that we have the resources in place to complete the trial in a timely manner. We look forward to updating you on these efforts in due course," stated Myron Holubiak, President and Chief Executive Officer of Citius Pharmaceuticals.

"The persistence of COVID-19 is a reminder that treatment of acute respiratory distress syndrome (ARDS) will continue to be an important need worldwide. Accordingly, we remain focused on further developing our engineered stem cell program, which holds the potential to offer a novel and scalable therapy for all causes of ARDS. We have initiated a pilot study in mice and are completing our proof-of-concept sheep study, for which we expect to have topline results by the end of this quarter. Additionally, our IND submission for Halo-Lido is on track for later this year and in vitro CMC work for Mino-Wrap is underway. With a solid balance sheet to support our activities, we are now better positioned than ever before to execute our strategy and deliver value to patients and shareholders," added Mr. Holubiak.

Third Fiscal Quarter 2021 Financial Results:

Liquidity

As of June 30, 2021, the Company had $115.7 million in cash and cash equivalents. During the three months ended June 30, 2021, the Company issued 11.2 million shares of Citius common stock upon the exercise of warrants for aggregate proceeds of approximately $16.9 million. During the nine months ended June 30, 2021, the Company received $31.1 million in proceeds from the exercise of common stock warrants.

In January 2021, the Company closed a private placement for common stock and warrants totaling gross proceeds of approximately $20 million. In February 2021, the Company closed a registered direct offering of its common stock and warrants for gross proceeds of approximately $76.5 million.

On June 21, 2021, stockholders approved an amendment to the Company’s Articles of Incorporation to increase the authorized number of shares from 210,000,000 to 410,000,000 and the authorized number of common shares from 200,000,000 to 400,000,000. As of June 30, 2021, the Company had 145,979,429 common shares issued and outstanding.

During the first half of 2021, the Company raised a total of $127.6 million through financing activities. We estimate that we will have sufficient funds for our operations through March 2023.

Research and Development (R&D) Expenses

R&D expenses were $2.2 million and $9.9 million for the three and nine months ended June 30, 2021, respectively, compared to $2.6 million and $7.3 million for the comparable periods in 2020. The decrease in research and development expenses for the quarter ended June 30, 2021, compared to the prior-year quarter reflects decreases in R&D expenses for our Mino-Lok and Halo-Lido product candidates, offset by an increase in R&D expenses for Mino-Wrap and our proposed novel stem cell therapy for acute respiratory distress syndrome (ARDS).

The increase in research and development expenses for the nine months ended June 30, 2021 compared to the prior year period is primarily due to a $5.5 million increase in R&D expenses related to our proposed novel stem cell therapy for ARDS, offset by decreases in R&D expenses for our other pipeline products, including a decrease in manufacturing research and development costs for registration batches of Mino-Lok and a decrease in R&D expenses associated with manufacturing development and our patient reported outcome tool for Halo-Lido.

We expect that research and development expenses will increase in fiscal 2021 as we continue to focus on our Phase 3 trial for Mino-Lok, progress the Halo-Lido product candidate, and continue our research and development efforts related to ARDS and Mino-Wrap.

General and Administrative (G&A) Expenses

G&A expenses were $3.4 million and $7.4 million for the three and nine months ended June 30, 2021, respectively, compared to $1.9 million and $5.7 million for the comparable periods in 2020. The primary reason for the increase is incremental costs associated with investor relations and legal services, as well as additional compensation costs for new employees and performance bonuses. General and administrative expenses consist primarily of compensation costs, professional fees related to our capital raising activities, corporate development services, and investor relations.

Stock-based Compensation Expense

For the three months ended June 30, 2021, stock-based compensation expense was $0.4 million as compared to $0.2 million for the three months ended June 30, 2020. For the nine months ended June 30, 2021, stock-based compensation expense was $1.0 million as compared to $0.6 million for the nine months ended June 30, 2020. The increase reflects expenses related to new grants made by Citius and the recently adopted NoveCite stock option plan.

Net loss

Net loss was $5.8 million and $18.1 million for the three and nine months ended June 30, respectively, compared to a net loss of $4.7 million and $13.4 million for the comparable periods in 2020. The increase in net loss is primarily due to the increase in general and administrative expenses and an increase in our research and development activities related to ARDS.

CytRx Comments on Quarterly Results and Recent Strategic Initiatives

On August 12, 2021 CytRx Corporation (OTCQB:CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, reported on its results for the second quarter ended June 30, 2021 (Press release, CytRx, AUG 12, 2021, View Source [SID1234586480]). In addition, CytRx recapped corporate developments as well as matters pertaining to its agreements with ImmunityBio, Inc. (NASDAQ:IBRX) ("ImmunityBio") and Orphazyme A/S (NASDAQ:ORPH) ("Orphazyme"). The Company’s 10-Q was filed today.

Steven A. Kriegsman, Chairman and Chief Executive Officer of CytRx, commented:

"We took important steps to enhance our capital position and further strengthen our corporate governance during the second quarter. By raising gross proceeds of $10 million from our recent financing, we have obtained valuable working capital that can help us maintain stability as we efficiently manage our portfolio of licensing agreements and high-potential assets. We continue to believe in the long-term promise of our licensed drugs and Centurion Biopharma. We look forward to monitoring Orphazyme’s pursuit of European regulatory approval for arimoclomol in Q4 2021 and ImmunityBio’s Q1 2022 release of Cohort C survival data from its QUILT 88 study, which is a Phase 2 pancreatic cancer trial that includes aldoxorubicin."

First Quarter Financial Overview

CytRx concluded the quarter ended June 30, 2021 with cash on hand of approximately $8.4 million.
The Company recorded a net loss of $1.2 million for the quarter ended June 30, 2021, compared to a net loss of $1.3 million for the same period in 2020.
General and administrative expenses were $1.2 million for the quarter, compared with $1.4 million for the same period in 2020.
Recent Developments

Corporate Highlights

Last month, CytRx entered into a securities purchase agreement with a healthcare-focused institutional investor, resulting in aggregate gross proceeds of approximately $10 million. The investor is independent of the Company’s Board of Directors and management team. The Company intends to use the net proceeds for working capital purposes.
Last month, Jennifer K. Simpson, Ph.D joined the Company’s Board of Directors. Dr. Simpson is the Chief Executive Officer and a Director of Panbela Therapeutics Inc. (NASDAQ: PBLA), a clinical stage drug development company. Shortly after joining Panbela Therapeutics, Dr. Simpson led a public financing with an uplist to the NASDAQ exchange. She has more than 13 years’ experience in pharmaceutical executive leadership, global marketing and product commercialization.
With respect to Centurion Biopharma, Mr. Kriegsman and Lead Director Louis Ignarro, PhD continued pursuing strategic partnership opportunities to advance clinical testing for the platform’s assets. Discussions with prospective partners under confidentiality agreements are ongoing. There are no formal updates to report at this time.
CytRx maintains federal and state net operating loss ("NOL") carryforwards of $327.6 million and $252.6 million, respectively, available to offset against future taxable income. Of this amount, $258.3 million of federal NOLs and $252.6 million of state NOLs are unrestricted.
ImmunityBio Highlights

ImmunityBio announced during the quarter that Cohort C of its QUILT 88 study in pancreatic cancer, which includes aldoxorubicin and patients who have previously failed two lines of standard-of-care therapy, is expected to be completed in the third quarter of 2021. An early readout of survival data is expected in the first quarter of 2022.
Orphazyme Highlights

Orphazyme announced during the quarter that it received a Complete Response Letter ("CRL") from the Food and Drug Administration ("FDA") following its review of the new drug application for arimoclomol. Orphazyme disclosed that the FDA issued the CRL based on needing additional evidence to further substantiate the validity and interpretation of the 5-domain NPC Clinical Severity Scale and, in particular, the swallow domain. Further, the FDA noted in the CRL that additional data is needed to bolster confirmatory evidence beyond the single phase 2/3 clinical trial to support the benefit-risk assessment of the NDA.
Subsequently, Orphazyme announced 24-month interim results of an open-label extension ("OLE") trial of arimoclomol for the treatment of NPC. Orphazyme provided efficacy and safety data for its investigational treatment arimoclomol in NPC for up to 36 months. The results demonstrate that arimoclomol provided a sustained benefit to study participants by reducing NPC progression as measured by the 5-domain NPC Clinical Severity Scale (5D-NPCCSS).
Orphazyme is expecting prospective European regulatory approval for arimoclomol in the treatment of NPC by the end of 2021.

Humanigen Reports Second Quarter 2021 Financial Results

On August 12, 2021 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called "cytokine storm’" with its lead drug candidate, lenzilumab, reported financial results for the second quarter and six months ended June 30, 2021 (Press release, Humanigen, AUG 12, 2021, View Source [SID1234586479]).

Update on Status of Emergency Use Authorization ("EUA") Application

On May 28, 2021, Humanigen submitted an EUA application for lenzilumab in patients hospitalized with COVID-19. Since that time, the company has responded to several requests from the U.S. Food and Drug Administration ("FDA") regarding the application. No formal timelines exist for the FDA to complete their review of our EUA application and as a result the company is unable to give guidance on the timing of a decision by the FDA.

"We remain firm in our belief the results of our LIVE-AIR Phase 3 study warrant lenzilumab being granted emergency use authorization. The achievement of the primary endpoint for the overall patient population, and the recent supplemental subset analysis which showed significant response to treatment by Black and African-American patients in the study, support our view of the potential benefit lenzilumab could bring to patient care if authorization were to be granted," said Cameron Durrant, MD, Chief Executive Officer, Humanigen.

Timothy Morris, CFO and COO, Humanigen, noted, "While the review of the EUA application continues, we are preparing for potential launch in the U.S., and simultaneously working to complete, before the end of the third quarter 2021, the submission of the Marketing Authorization Application ("MAA") to the Medicines Healthcare products Regulatory Agency ("MHRA") in the U.K. We have initiated the MAA process to the European Medicines Agency ("EMA") and anticipate the appointment of rapporteurs in the near term."

Second Quarter and Recent Highlights:

Lenzilumab in hospitalized COVID-19

Submitted an application to the FDA for an EUA for lenzilumab for the treatment of patients hospitalized with COVID-19.
Initiated filing and received acknowledgement the UK submission for Marketing Authorization for lenzilumab in COVID-19 has been accepted for expedited COVID-related rolling review by the MHRA. The submission is expected to be completed by September 30, 2021.
Initiated the process to make a submission to the European Medicines Agency for Marketing Authorization of lenzilumab in COVID-19.
The company’s commercial partners in South Korea and the Philippines, KPM Tech and Telcon RF Pharmaceutical, received approval from South Korea’s Ministry of Food and Drug Safety, the South Korean equivalent of FDA, to conduct a Phase 1 clinical study of lenzilumab, to enable submission and potential approval in South Korea.
Announced analysis of results from our Phase 3 LIVE-AIR study of lenzilumab in hospitalized patients with COVID-19 suggesting Black and African-American patients having a CRP<150 mg/L may be the highest responders to treatment, with a nearly 9-fold increase in likelihood of survival without ventilation ("SWOV") [n=51, p-value=0.0418]. In the overall population with CRP<150 mg/L, LIVE-AIR Phase 3 results show patients treated with lenzilumab demonstrated a 2.5-fold increased likelihood of SWOV [mITT, n=351, p-value=0.0009].
Entered into manufacturing agreement with Chime Biologics to produce lenzilumab bulk drug substance and drug product to be sold, with requisite regulatory authorization, in regions outside the United States.
Corporate

Completed underwritten public offering of common stock, raising net proceeds of $94.2 million.
The company was added to the Russell 3000 Index in June 2021.
Ken Trbovich was appointed to the newly-created role of SVP Investor Relations.
ACTIV-5 Update

In August 2021, the National Institutes of Health ("NIH") announced the expansion of the Accelerating COVID-19 Therapeutic Interventions and Vaccines ("ACTIV-5") and Big Effect Trial, in the "B" arm of the trial ("BET-B"), referred to as ACTIV-5/BET-B. Following feedback from and consultation with the company, the NIH advanced the study to a Phase 2/3 study with target enrollment of at least 400 patients and amended the protocol for ACTIV-5/BET-B in a manner that aligns with the design of the company’s LIVE-AIR trial. As a result of the advancement to a Phase 2/3 and amended protocol, the company anticipates that ACTIV-5/BET-B may serve as a second confirmatory study required for submission to FDA as part of a Biologics License Application ("BLA") that the company would submit if the ACTIV-5/BET-B data further validate the benefits of lenzilumab in COVID-19 patients.

Second Quarter and Six Months Ended June 30, 2021 Financial Results

Net loss for the three months ended June 30, 2021 was $70.8 million or $1.20 per share as compared to $24.0 million or $0.79 per share for the three months ended June 30, 2020. The net loss for the six months ended June 30, 2021 was $136.4 million or $2.45 per share as compared to $26.5 million or $1.00 per share for the six months ended June 30, 2020. The increase in net loss for both periods was largely due to an increase in total expenses, mainly Research and Development ("R&D") expense which rose significantly as the company accelerated its efforts to manufacture lenzilumab for potential commercialization upon a regulatory authorization. R&D expense increased $41.9 million from $21.1 million for the three months ended June 30, 2020, to $63.0 million for the three months ended June 30, 2021, and increased $101.1 million from $21.8 million for the six months ended June 30, 2020, to $122.9 million for the six months ended June 30, 2021. The manufacturing expense included in R&D was $57.1 million for the second quarter of 2021 as compared to $17.1 million for the prior year quarter, and $107.1 million for the six months ended June 30, 2021, as compared to $17.4 million for the prior year period. The costs incurred to produce lenzilumab will continue to be included in R&D expense until lenzilumab is authorized or approved for commercial use, at which point the amounts expended for production would be reclassified as inventory. A meaningful portion of these expenses are associated with initiation of manufacturing processes on a site-by-site basis.

Cash and Cash Equivalents

Net cash used in operating activities, net of balance sheet changes, was $103.8 million for the six months ended June 30, 2021. During the same period, the company raised net proceeds of $36.1 million from the sale of shares of common stock under its At-the-Market offering program, drew the first tranche of $25.0 million under its credit facility with Hercules Capital, providing net proceeds of $24.4 million, and completed a public offering of common stock with net proceeds of $94.2 million. As of June 30, 2021, the company had cash and cash equivalents of $120.5 million. The company expects to continue to use its funds on the manufacturing of lenzilumab in anticipation of its potential commercialization under EUA in the US or conditional marketing authorization in the UK. For the third quarter of 2021 the company anticipates the R&D expense related to lenzilumab production will be same level as the second quarter of 2021. If an EUA or CMA for lenzilumab is not received in the third quarter of 2021, the company would seek to decrease its spending on lenzilumab production.

A summary of key financial highlights as of and for the three and six months ended June 30, 2021 and 2020 is as follows ($ in thousands):

bioAffinity Technologies Publishes Sputum Processing and Innovative High-Throughput Analysis Methods

On August 12, 2021 bioAffinity Technologies, a privately held company focused on early diagnostics and cancer therapeutics, announced publication in the peer-reviewed Journal of Visualized Experiments (JoVE) (Press release, BioAffinity Technologies, AUG 12, 2021, View Source [SID1234586478]). The paper, entitled Quality-Controlled Sputum Analysis by Flow Cytometry, presents an efficient and effective method to analyze sputum on a flow cytometric platform, allowing for development of high-throughput diagnostic tests for lung cancer and other lung diseases.

"Sputum provides a superior sample in which to analyze cellular content and other microenvironmental features. Analysis of sputum by the method we describe opens a new and exciting window of opportunity for determining the health of an individual’s lungs," bioAffinity President and CEO Maria Zannes said. "The processing method provided in JoVE describes an innovative and highly efficient method to process sputum for use with flow cytometry, an approach that can rapidly analyze a sample for the presence of diseases such as COPD, asthma and lung cancer."

bioAffinity Technologies has developed CyPath, a platform technology to diagnose cancer. The Company’s first product is CyPath Lung, a non-invasive and cost-effective test for the early detection of lung cancer that allows patients to collect their sputum sample at home.

bioAffinity Technologies recently completed a test validation trial of CyPath Lung evaluating sputum from people at high risk for lung cancer, including patients with the disease and others who were cancer-free. The trial resulted in 92% sensitivity and 87% specificity in the group of patients who had no or smaller than 2 cm nodules in the lung.

CyPath Lung uses flow cytometry, a method able to interrogate an individual cell in a fraction of seconds, and automated analysis to identify parameters indicative of cancer. Unlike genomic or other molecular markers used in many liquid biopsies, bioAffinity’s CyPath technology does not collect genetic material for evaluation. CyPath uses flow cytometry to investigate the lung micro-environment by identifying cell populations including those preferentially labeled by the porphyrin TCPP that are indices of cancer.