On November 13, 2020 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development, reported financial results for the three and nine months ended September 30, 2020 and announced an amended loan agreement with Oxford Finance LLC (Press release, Inhibrx, NOV 13, 2020, View Source [SID1234570945]).

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Mark Lappe, Inhibrx’s CEO commented, "Over the course of the next two years, we expect multiple data read-outs from our four clinical programs in the oncology and orphan disease space and to initiate new clinical programs. This additional debt line from Oxford extends our IPO proceeds and provides us greater optionality and the ability to complete these expected clinical milestones with appropriate runway cushion. We appreciate the strong support and our longstanding partnership from Oxford."

Third Quarter 2020 and Recent Corporate Highlights

Presented Interim Data on INBRX-109, a tetravalent agonist of DR5, for the chondrosarcoma cohort on November 11, 2020. This data will also be presented at the 2020 CTOS Virtual Annual Meeting on November 20, 2020 at 9:00 am PT.
Completed Initial Public Offering: On August 21, 2020, Inhibrx completed an initial public offering selling 8,050,000 shares of common stock, which included the full exercise by the underwriters of their option to purchase additional shares, at $17.00 per share, and net proceeds of $126 million. Gross proceeds from the IPO, excluding underwriting discounts and commissions and other estimated offering costs, were $136.9 million.
Financial Results

Cash and Cash Equivalents. Cash and cash equivalents totaled $127.7 million as of September 30, 2020, compared to $11.5 million as of December 31, 2019.
R&D Expense. Research and development expense was $19.8 million during the third quarter of 2020, as compared to $12.8 million during the third quarter of 2019. This increase was primarily due to an increase in contract manufacturing expense for scale-up activities performed by Inhibrx’s CDMO partners for its INBRX-109 and INBRX-101 programs. Additionally, CRO costs increased due to the progression of its Phase 1 trials.
G&A Expense. General and administrative, or G&A, expense remained consistent at $1.6 million during the third quarter of 2020 as compared to $1.5 million during the third quarter of 2019.
Net Loss. Net loss was $20.5 million during the third quarter of 2020, or a net loss per share of $0.77, as compared to a net loss of $20.2 million during the third quarter of 2019, or a net loss per share of $1.11.
About the Inhibrx sdAb Platform
Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary sdAb platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform allows the combination of multiple binding units in a single molecule, enabling the creation of therapeutic candidates with defined valency or multiple specificities that can achieve enhanced cell signaling or conditional activation. An additional benefit of this platform is that these optimized, multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.

On November 13, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows (Press release, Regeneron, NOV 13, 2020, View Source [SID1234570944]):

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Evercore ISI 3rd Annual HealthCONx Conference at 10:30 a.m. EST on Tuesday, December 1, 2020
Piper Sandler 32nd Annual Virtual Healthcare Conference at 8:00 a.m. EST on Wednesday, December 2, 2020
The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays of the webcasts will be archived on the Company’s website for at least 30 days.

On November 13, 2020 Cardax, Inc. (OTCQB:CDXI) reported its Q3 2020 results (Press release, Cardax Pharmaceuticals, NOV 13, 2020, View Source [SID1234570943]). Highlights:

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Financial Results. Operating loss decreased from $1,191,711 in Q3 2019 to $705,760 in Q3 2020, primarily due to a decrease in professional fees, research & development, salaries & wages, and selling, general, & administrative expenses. Net loss for the same three-month period decreased from $1,433,626 to $1,354,331 for the same reasons.

Operating loss decreased from $3,355,386 in the nine-months ended September 30, 2019, to $2,400,823 in the same period in 2020, also primarily due to a decrease in professional fees, research & development, salaries & wages, and selling, general, & administrative expenses. Net loss for the same nine-month period increased from $3,650,740 to $4,057,541, primarily due to amortization of non-cash discounts related to outstanding convertible notes.

ZanthoSyn Sales. Cardax net revenues from ZanthoSyn, the Company’s astaxanthin dietary supplement, decreased from $229,142 in Q3 2019 to $66,502 in Q3 2020, and from $439,505 in the nine-months ended September 30, 2019, to $343,836 in the same period in 2020. These decreases resulted primarily from reduced orders by the Company’s largest customer, General Nutrition Corporation ("GNC"). The Company believes the reduction in orders as well as the decrease in sell-through at GNC stores was driven by GNC’s Chapter 11 bankruptcy filing in June 2020 and COVID-19 related impacts on GNC store sales.

GNC emerged from bankruptcy in October 2020 and has resumed orders of ZanthoSyn. Cardax is also exploring additional sales channels to expand revenues.

Funding Activities. Cardax raised $640,000 in Q3 2020 and $2,101,300 in the nine-months ended September 30, 2020, through the issuance of notes and convertible notes. The Company repaid outstanding notes in the amount of $154,228 in Q3 2020 and $554,228 in the nine-months ended September 30, 2020. The remainder of the proceeds was used for general corporate purposes.

Clinical Trial Grant Application. At the invitation of a federal government agency, Cardax submitted a grant application in July 2020 for a proposed multi-center, randomized, double-blind, placebo-controlled human clinical trial to assess the time to recovery and other endpoints in hospitalized COVID-19 patients aged 65 and older. The proposed test agent is the same form of astaxanthin utilized in ZanthoSyn but would be studied at a higher dose as an investigational new drug.

The scientific rationale for testing astaxanthin in this indication is based on its potential to boost the immune system and reduce the extreme inflammatory response and oxidative stress that may lead to severe respiratory and coagulation complications in COVID-19 patients. Furthermore, astaxanthin has demonstrated excellent safety in pilot human studies and rigorous animal toxicity studies, with no evidence of immunocompromise, bleeding risk, or other clinically meaningful safety issues, even at high doses. The Company also filed a patent application in March 2020 related to this indication.

The grant application was reviewed by the agency in August 2020 and received comments and a score. In October 2020, the agency invited Cardax to submit an updated grant application based on guidance from the agency’s clinical trial advisory panel. The updated grant application is being prepared and expected to be submitted in December or January. The Company does not yet know if the grant will be funded or the timing or amount of a funding award, if any.

CHASE Study. In March 2020, Cardax suspended recruitment of new subjects and study visits for existing subjects due to the COVID-19 pandemic and the related governmental "stay-at-home" orders. The Company expects to resume clinical trial operations when permissible and safe to proceed. The Cardiovascular Health Astaxanthin Supplement Evaluation ("CHASE") study is a randomized, double-blind, placebo-controlled trial evaluating the cardiovascular health benefits of ZanthoSyn in subjects with documented cardiovascular risk factors. In a pre-specified interim look with 40 subjects, statistically significant improvements were seen in total cholesterol, LDL cholesterol, oxidized LDL cholesterol, and blood pressure, with a strong trend in reduction of the inflammatory marker, C-reactive protein, as well as triglycerides.

COVID-19 Impact. The Company believes that its operations, including revenues and any public or private offerings, will continue to be affected by the ongoing COVID-19 pandemic, although the extent of the impact is uncertain at this time.

"Despite the accelerating COVID-19 pandemic, we continue to make progress on several fronts," said David G. Watumull, Cardax CEO. "First, we are very pleased with the important next step in the review process for our invited COVID-19 clinical trial grant application and believe that the excellent safety profile and strong scientific rationale for astaxanthin support testing in a rigorous clinical trial."

"In addition, GNC’s emergence from bankruptcy and the resumption of ZanthoSyn orders is encouraging. We also continue to pursue multiple funding opportunities to support our business," Mr. Watumull added. "We would again like to thank our shareholders, employees, contractors, advisors, and professional service providers for their efforts during these difficult times. Their perseverance and commitment are key to advancing our business strategy."

Please refer to the Quarterly Report on Form 10-Q filed by the Company for additional information.

On November 13, 2020 Olema Oncology, a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported a clinical trial agreement to evaluate OP-1250, a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD), in combination with palbociclib (IBRANCE) in patients with recurrent, locally advanced or metastatic estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer (Press release, Olema Pharmaceuticals, NOV 13, 2020, View Source [SID1234570942]).

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"This agreement with Pfizer represents continued momentum toward our goal of advancing the clinical development of OP-1250," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We look forward to learning more about the potential of OP-1250 in combination with palbociclib in patients living with breast cancer."

Under the terms of the non-exclusive agreement, Olema is responsible for conducting the trial and Pfizer is responsible for supplying its study drug.

On November 13, 2020 AIM ImmunoTech Inc. (NYSE American: AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, reported that provided a business update for the third quarter ended September 30, 2020 (Press release, AIM ImmunoTech, NOV 13, 2020, View Source [SID1234570941]).

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Third Quarter 2020 Financial Highlights:

As of September 30, 2020, AIM had cash, cash equivalents and marketable securities of $54.5 million, as compared to $8.8 million as of December 31, 2019.
Research and development expenses for the three months ended September 30, 2020 were $1.10 million, compared to $1.19 million for the three months ended September 30, 2019.
General and administrative expenses for the three months ended September 30, 2020 were $2.09 million, compared to $1.85 million for the three months ended September 30, 2019.
The Company’s complete financial results are available in the Company’s September 30, 2020 Form 10-Q filed with the Securities and Exchange Commission on November 12, 2020, which is available at www.sec.gov and on the Company’s website.

Recent Clinical and Business Highlights

AIM has announced several significant clinical, research and business milestones since the start of the third quarter of 2020.

Immuno-oncology

On September 22, AIM announced receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program conducted at Erasmus University Medical Center in the Netherlands. Prof. Casper van Eijck, MD Ph.D., and his team at Erasmus MC found a statistically significantly positive survival benefit when using AIM’s drug Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy. Median survival was approximately two-fold higher, that is 200%, in the Ampligen arm as compared to the historical controls. A detailed clinical report and an article for publication are being prepared by the Erasmus MC team. AIM intends to facilitate a follow-up pancreatic cancer Phase 2/3 clinical trial based on these data.

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and COVID-19

On November 2, AIM announced the publication of statistically significant ME/CFS findings providing further support for the considerable positive impact Ampligen may have on people living with ME/CFS when administered in the early stages of the disease. The data were published in PLOS ONE. AIM researchers found, in a reanalysis of data from the earlier Phase 3 study, that the TLR3 agonist Ampligen substantially improved physical performance in a subset of early-onset ME/CFS patients. The findings potentially carry special importance for survivors of COVID-19, many of whom report classic chronic fatigue-like symptoms after recovering from the acute SARS-CoV-2 infection. These patients – who are commonly referred to as "Long Haulers" because of the persistence of these symptoms – are uniquely situated to potentially benefit from Ampligen as an early onset therapy. As part of its plan to study this potential benefit, on October 6, AIM announced the receipt of Institutional Review Board approval for the expansion of the AMP-511 Expanded Access Program clinical trial for ME/CFS to include patients previously diagnosed with SARS-CoV-2.

COVID-19

On August 27, AIM announced the identification of an effective in vitro model in which Ampligen was shown to be able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal dosage levels. This demonstration of Ampligen’s bioactivity against SARS-CoV-2 supports the company’s commitment to the development of Ampligen as both a prophylaxis and early onset intranasal therapy for COVID-19. To that end, on September 16, AIM announced that recruitment had begun in Roswell Park Comprehensive Cancer Center’s Phase 1/2a COVID-19 clinical study of the effectiveness of Ampligen in combination with interferon alpha-2b in treating cancer patients with mild or moderate COVID-19 infection. This followed the Clinical Trial Agreement between AIM and Roswell Park announced on July 9. Less than a week earlier, on July 6, AIM also announced its entry into a trilateral Material Transfer and Research Agreement with Japan’s National Institute of Infectious Diseases and Shionogi & Co., Ltd. to test Ampligen as a potential vaccine adjuvant for COVID-19. Under the agreement, AIM will provide Ampligen samples for various research projects.