On November 20, 2020 Biocept, Inc. (Nasdaq: BIOC), a leading commercial provider of molecular diagnostic assays, products and services designed to provide physicians with clinically actionable information to improve patient outcomes, reported the results of a study analyzing cerebrospinal fluid (CSF) samples in patients with primary lung or breast cancer with either brain or leptomeningeal disease (Press release, Biocept, NOV 20, 2020, View Source [SID1234571492]). The findings indicate that Target Selector CSF assays are a viable and sensitive platform for circulating tumor cell (CTC) detection and molecular analysis compared to the current standard of care, CSF cytology, which is typically used to establish or confirm leptomeningeal disease when imaging findings are suspicious or equivocal. CSF cytology has limited sensitivity and provides no additional information needed for target therapy choice.

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The results were discussed yesterday in a poster presentation by Santosh Kesari, MD, PhD, Chair and Professor, Department of Translational Neurosciences, Director of Neuro-oncology at the Pacific Neuroscience Institute and John Wayne Cancer Institute, at the Society for Neuro-Oncology’s SNO2020 Virtual Conference on November 19, 2020.

"Once a tumor has metastasized to the brain, CTCs and circulating tumor DNA (ctDNA) can be found in the cerebrospinal fluid," said Dr. Kesari. "This prospective study compared the sensitivity of CTC detection and molecular analysis of Biocept’s Target Selector CSF assays to cytology (microscopic examination of conventional CSF cytology slide preps). This study highlights the potential of CSF-based diagnostics for longitudinal monitoring cancers in the central nervous system."

"Our Target Selector testing is a minimally invasive, cost-effective strategy to simultaneously confirm metastasis to the brain, while also assessing cancer biomarkers in order to qualify a patient for potential targeted therapy options," said Michael Nall, President and CEO of Biocept. "Identifying CTCs and actionable biomarkers with Target Selector can help to confirm and monitor central nervous system involvement when clinically suspected, without the risk of complications associated with surgical biopsies, which are often impossible in these cases.

"This the second major scientific conference in less than two months to accept study results from Target Selector testing in cerebrospinal fluid for presentation," added Mr. Nall. "We view neuro-oncology as an area where our technology is uniquely suited to answer questions posed by treating physicians, and we are appreciative of the Society of Neuro-Oncology’s recognition of our Target Selector testing."

About the SNO2020 Virtual Conference

The Society for Neuro-Oncology exists to advance multi-disciplinary brain tumor research, education, and collaboration to drive discovery and improve patient care. Over 2,600 neuro-oncology professionals are expected to register for the SNO2020 Virtual Conference being held November 19-21, 2020. More information can be found at soc-neuro-onc.org.

On November 20, 2020 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported it will present positive results from the Phase 3 portion of the randomized, double blind, placebo controlled, cross-over SEAL study evaluating single agent, oral XPOVIO (selinexor) versus matching placebo in patients with liposarcoma at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020) (Press release, Karyopharm, NOV 20, 2020, View Source [SID1234571490]). As previously reported, the SEAL study met its primary endpoint of a statistically significant increase in median progression-free survival (PFS) in patients with advanced unresectable dedifferentiated liposarcoma following at least two prior therapies.

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"Dedifferentiated liposarcoma is a particularly aggressive cancer that arises in the body’s fat tissue and is typically associated with high rates of metastatic recurrence and mortality. Unfortunately, there are few effective treatment options available for patients with advanced disease," said Mrinal M. Gounder, MD, Attending Physician, Sarcoma Service and Developmental Therapeutics Service, Memorial Sloan Kettering Cancer Center, and lead investigator of the SEAL study. "The data presented at CTOS 2020 demonstrated that patients treated with XPOVIO experienced a statistically significant improvement in median PFS compared to placebo in patients with at least two prior therapies. Extending PFS is an important clinical goal for these patients because the rapid progression of this disease often translates into early mortality."

"We are delighted to share these significant results from the Phase 3 portion of the SEAL study, the first, late-stage clinical data for XPOVIO in a solid tumor indication," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "We believe these data strongly support our goal of developing twice-weekly XPOVIO as an effective, convenient, novel oral therapy that can extend PFS for patients with advanced unresectable dedifferentiated liposarcoma. We are especially excited by these data because XPOVIO is the first oral therapy to show activity in patients with previously treated liposarcoma. We look forward to submitting a New Drug Application to the U.S. Food and Drug Administration (FDA) during the first quarter of 2021, requesting approval of XPOVIO to treat the patient population studied in SEAL. If approved, XPOVIO would represent the first oral, non-chemotherapy agent available for patients with dedifferentiated liposarcoma."

Results from the Phase 3 Portion of the Phase2/3 SEAL Study

The median PFS in the XPOVIO arm of the Phase 3 portion of the SEAL study was 2.83 months compared to 2.07 months in the placebo arm (hazard ratio (HR)=0.70; p=0.023). These data indicate that treatment with XPOVIO reduced the risk of disease progression or death by approximately 30%, compared to placebo. The estimated 6-month PFS survival probability was 23.9% on the selinexor arm compared to 13.9% on placebo. Additionally, the 12-month PFS survival probability was 8.4% on the selinexor arm compared to 2% on the placebo arm. Finally, 7.5% of patients on the selinexor arm had a 15% or greater reduction in their disease burden as measured by target lesion size while none of the patients on the placebo arm achieved this level of reduction. The trial allowed patients on placebo with objective progression to cross over to the XPOVIO treatment arm. The median overall survival for patients who received XPOVIO was 9.99 months compared to 9.07 months for patients who never crossed over to the XPOVIO treatment arm (HR=0.69; p=0.122).

The most common treatment-related adverse events (AEs) were cytopenias, along with gastrointestinal and constitutional symptoms and were consistent with those previously reported from other selinexor studies. Most AEs were manageable with dose modifications and/or standard supportive care. The most common non-hematologic treatment-related AEs were nausea (81%), decreased appetite (60%), fatigue (51%), and vomiting (49%) and were mostly Grade 1 and 2 events. The most common Grade 3 and 4 treatment-related AEs were anemia (19%), hyponatremia (11%), thrombocytopenia (10%) and asthenia (10%).

XPOVIO is currently approved by the FDA as a treatment for patients with relapsed or refractory multiple myeloma and relapsed or refractory diffuse large B-cell lymphoma (DLBCL). XPOVIO is currently the only XPO1 inhibitor approved by the FDA and has been extensively tested in clinical trials across numerous cancer indications worldwide since 2012. Karyopharm has also submitted a supplemental New Drug Application (sNDA) for XPOVIO that is currently under review by the FDA for the expansion of XPOVIO’s label to include XPOVIO as a treatment for patients with multiple myeloma after at least one prior line of therapy. The sNDA has been assigned an action date by the FDA of March 19, 2021 under the Prescription Drug User Fee Act. The full Prescribing Information for XPOVIO is available at www.XPOVIO.com.

Details for the oral presentation at CTOS 2020 are as follows:

Title: A Phase 2/3, Randomized, Double-Blind, Cross-Over Study of Selinexor Versus Placebo in Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)
Presenter: Mrinal Gounder, MD, Memorial Sloan Kettering Cancer Center
Paper #: 20
Session: 7. Liposarcoma
Date and Time: Friday, November 20, 2020, 10:30 a.m. to 11:30 a.m. ET

Conference Call Information

Karyopharm will host a conference call today, Friday, November 20, 2020, at 12:00 p.m. Eastern Time, to discuss the results from the SEAL study. The call will feature Dr. Gounder and another recognized sarcoma expert Sant P. Chawla, MD, FRACP, Director of the Sarcoma Oncology Center, Santa Monica, CA, along with members of the Karyopharm executive leadership team. To access the conference call, please dial (877) 870-4263 (local) or (412) 317-0790 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call, along with slides, will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source An archived webcast will be available on the Company’s website approximately two hours after the event.

About the SEAL Study

SEAL (Selinexor in Advanced Liposarcoma) is a Phase 2/3, randomized, double blind, placebo controlled, multicenter study (NCT02606461) designed to evaluate the efficacy and safety of twice-weekly, 60mg fixed dose of XPOVIO (selinexor) in patients with advanced unresectable dedifferentiated liposarcoma following at least two prior therapies. The Phase 2 portion of the study enrolled approximately 57 patients (1:1 randomization) and the Phase 3 portion enrolled approximately 285 patients (2:1 randomization). Patients on the placebo arm with confirmed progressive disease were permitted to cross over to the XPOVIO treatment arm. The primary endpoint of the study is PFS.

About Liposarcoma

Liposarcoma is a rare type of cancer that occurs in the fat cells in the body, most often in the muscles of the limbs or abdomen. Dedifferentiated liposarcoma (DDLS) is a high grade type of liposarcoma that grows more aggressively than a low grade, well differentiated liposarcoma and is associated with poorer prognosis.1 Liposarcoma accounts for approximately 20% of all soft tissue sarcomas2. In liposarcoma, the risk of recurrence and metastasis increases with higher grade disease.3

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same RRMM indication. Karyopharm’s supplemental New Drug Application (sNDA) requesting an expansion of its current indication to include the treatment for patients with multiple myeloma after at least one prior line of therapy has been accepted for filing by the FDA. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

On November 20, 2020 DNAtrix, a biotech company advancing virus-driven immunotherapies for cancer, reported that the Phase 2 CAPTIVE study evaluating treatment with DNX-2401 (tasadenoturev) and pembrolizumab in patients with recurrent glioblastoma (GBM) demonstrated a median overall survival of 12.5 months. DNX-2401 is an adenovirus-based immunotherapy that is engineered to selectively kill tumor cells and trigger a robust anti-tumor immune response .

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"We are excited by the promising activity seen in patients with recurrent GBM, which is a notoriously difficult-to-treat cancer with a high mortality rate," said Jeffrey Knapp, chief executive officer of DNAtrix. "The median overall survival of 12.5 months achieved with DNX-2401 and pembrolizumab compares very favorably against historical benchmarks for standard of care agents, lomustine and temozolomide, where our meta-analysis indicates the median overall survival achieved with either of these therapies is on the order of 7.2 months. We look forward to advancing this treatment regimen into a global, randomized Phase 3 study. Additionally, we are also evaluating DNX-2401 in a Phase 1 study for the treatment of diffuse intrinsic pontine glioma, where we have received FDA Fast Track and Rare Pediatric Disease designations. Beyond DNX-2401, we are poised to begin a Phase 1 study in patients with colorectal and other cancers with liver metastases with our second product candidate, DNX-2440, an armed oncolytic virus that induces the expression of OX40 ligand on tumor cells."

Gelareh Zadeh, M.D., Ph.D., FRCS(C), FAANS, professor and dan chair of Neurosurgery at the University of Toronto, head of the Division of Neurosurgery at Toronto Western Hospital, and president of Society-of-Neuro-Oncology added, "My clinical and research focus has been in neuro-oncology, and I have seen the devastating impact of recurrent GBM first-hand. The data we have from the Phase 2 CAPTIVE study are very promising, demonstrating prolonged survival unlike what we have seen with available therapies. I can say that having seen some of the long- responders in my own patients genuinely has me very excited about the promise this therapy holds for GBM, in particular the subset who respond well. If successful, this could represent an important treatment for patients who are in desperate need of additional therapeutic options."

The Phase 2 multicenter CAPTIVE trial studied DNX-2401 in combination with the anti-PD-1 antibody, pembrolizumab, in 49 patients with GBM at first or second disease recurrence. In the study, patients were given a single dose of DNX-2401 followed by 200 mg pembrolizumab infusions every three weeks. The median treatment duration with pembrolizumab was seven cycles. The first part of the study evaluated escalating doses of DNX-2401, and the highest dose evaluated was selected for advancement into the dose expansion phase of the study.

The median overall survival for patients treated with the full dose DNX-2401 and pembrolizumab (n=42) was 12.5 months, and the survival rate at 18 months was 20.2%. Four patients, all of whom have survived more than 23 months, continue to be followed for survival. Five patients (11.9%) had confirmed responses, including two durable ongoing complete responses and 3 partial responses. The median duration of response has not been reached. The most commonly reported adverse events were headache, fatigue, and brain edema, which were primarily mild to moderate and manageable. Detailed results were presented at a late-breaking session during SNO’s 25th Annual Scientific Meeting and Education Day.

About DNX-2401 (Tasadenoturev)

DNX-2401 is an oncolytic adenovirus engineered specifically to infect, replicate in, and directly kill cancer cells, as well as elicit a broader anti-tumor immune response. DNX-2401 is currently being evaluated as a potential treatment for highly aggressive brain tumors, including recurrent glioblastoma in adults and newly-diagnosed diffuse intrinsic pontine glioma (DIPG) in children. Clinical studies have demonstrated that DNX-2401 was well tolerated and extended survival for patients with recurrent glioblastoma. DNX-2401 has been granted Fast Track and Orphan designation by the FDA and PRIME and Orphan designation by the EMA.

About DNX-2440

DNX-2440 is an oncolytic adenovirus expressing the immune modulator OX40 ligand, a powerful costimulatory molecule known to enhance T cell responses directed to tumors. DNX-2440 is in Phase 1 clinical testing following the demonstration of anti-cancer activity in preclinical studies, including tumor reductions, immune memory, and abscopal effect.

On November 20, 2020 Spring Bank Pharmaceuticals, Inc. (Nasdaq: SBPH) ("Spring Bank"), a clinical-stage biopharmaceutical company developing novel therapeutics for oncology and inflammatory diseases, reported that at its special meeting of stockholders held earlier today, Spring Bank’s stockholders approved the issuance of shares of Spring Bank common stock to holders of share capital of F-star Therapeutics Limited ("F-star") in connection with its proposed combination with F-star (the "Exchange") (Press release, Spring Bank Pharmaceuticals, NOV 20, 2020, View Source [SID1234571488]). In connection with the Exchange, stockholders also approved a proposal to effect a reverse stock split of all outstanding shares of Spring Bank common stock at a reverse stock split ratio as mutually agreed to be Spring Bank and F-star in the range of one new share for every three to seven shares outstanding (or any number in between). Spring Bank and F-star have agreed that the exchange ratio for the reverse stock split will be one for every four shares of Spring Bank common stock outstanding (the "Reverse Stock Split"). The Reverse Stock Split will be effective for trading purposes as of the commencement of trading on Monday, November 23, 2020. At the special meeting, Spring Bank stockholders also approved a change of the corporate name of Spring Bank from "Spring Bank Pharmaceuticals, Inc." to "F-star Therapeutics, Inc." effective upon closing of the Exchange. It is anticipated that the closing of the Exchange will occur on November 20, 2020.

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As a result of the Reverse Stock Split, the number of issued and outstanding shares of Spring Bank’s common stock immediately prior to the Reverse Stock Split will be reduced into a smaller number of shares, such that every 4 shares of Spring Bank’s common stock held by a stockholder immediately prior to the Reverse Stock Split will be combined and reclassified into one share of Spring Bank’s common stock. No fractional shares will be issued in connection with the Reverse Stock Split. Stockholders of record who otherwise would be entitled to receive fractional shares because they hold a number of pre-split shares not evenly divisible by the number of pre-split shares for which each post-split share is to be reclassified, will be entitled to a cash payment equal to the product of such fraction to which the stockholder would otherwise be entitled multiplied by the closing price of Spring Bank’s common stock on the Nasdaq Capital Market on the last trading day prior to the Reverse Stock Split effective time (as adjusted to give effect to the Reverse Stock Split), rounded up to the nearest whole cent. The Reverse Stock Split will not affect the total number of authorized shares of Spring Bank common stock.

On November 20, 2020 Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, reported financial and corporate results for the third quarter ended September 30, 2020 (Press release, Aridis Pharmaceuticals, NOV 20, 2020, View Source [SID1234571487]).

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Third Quarter Highlights and Recent Developments

Announced positive preclinical efficacy data for AR-711, an inhaled, self-administered, at-home monoclonal antibody treatment ("mAb") for non-hospitalized mild-to-moderate COVID-19 patients. A clinical Phase 1/2 study is expected to be launched in 1H 2021.
Received concurrence from the U.S. Food and Drug Administration ("FDA") to streamline AR-501’s Phase 2 clinical trial design and to expand the originally planned Phase 2a protocol design into a Phase 2a/2b study for treating chronic lung infections in patients with cystic fibrosis (CF). Study completion is expected in 2H 2021.
Continued enrolling global Phase 3 clinical trial of AR-301 in patients with ventilator associated pneumonia (VAP) including patients who presented with VAP secondary to ventilator placement for COVID-19. Interim futility analysis is expected in 1H 2021; full data is expected in YE 2021.
Executed a Registered Direct offering with gross proceeds of approximately $8.5 million.
Participated in leading healthcare dedicated investor forums.
"During the quarter and over the past few weeks, we achieved multiple important milestones that impact our clinical and corporate profile, highlighted by the addition of an inhaled at-home COVID-19 treatment (AR-711) to our portfolio of product candidates," commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. "Additionally, we reached concurrence with the FDA to streamline and thus expedite the clinical and regulatory process for AR-501’s Phase 2 program in cystic fibrosis, and bolstered our balance sheet with the $8.5 million financing. These important achievements have helped position us for continued growth as we head into the final quarter of the year."

COVID-19 Program Update

AR-711: During the quarter, Aridis announced the development of a highly potent fully human mAb against SARS-CoV-2 virus. AR-711 is designed to lower the barrier to treatment coverage of non-hospitalized COVID-19 patients by using a convenient, self-administered inhaled dosage presentation. AR-711 was discovered from convalescent COVID-19 patients and targets the conserved receptor-binding domain (RBD) region of the spike protein of the original SARS-CoV2 virus and its newly emerging variants including the currently prevalent strain G614. AR-711 exhibits high affinity for the SARS-CoV-2 virus, approximately 10-fold or higher than mAb candidates currently in late stage clinical testing.

In an animal challenge study with golden Syrian hamsters, inhaled AR-711 successfully eliminated all detectable SARS-CoV-2 virus at substantially lower doses than parenterally administered (injected) COVID-19 mAb. AR-711 is engineered to be long-acting in blood for up to six to twelve months and is stabilized using a proprietary formulation designed to protect the mAb from the physical stresses imparted by commercial nebulizer delivery devices on protein drugs. The potency of AR-711 and its direct delivery to the lungs by inhaled administration may facilitate significant dose sparing not achievable by parenteral administration. A proprietary formulation enables AR-711 to be deliverable using a variety of commercially available nebulizers that can be self-administered on an outpatient basis, thus lowering the barrier to COVID-19 therapeutic treatment. Clinical trials for AR-711 are expected to commence 1H 2021.

AR-701: With the goal of treating COVID-19 patients at home with inhaled AR-711 and in the hospital with intravenous AR-701 mAb cocktail, during the quarter, Aridis continued to characterize this cocktail of fully human mAbs discovered from the Company’s in-house ʎPEXTM mAb discovery platform that are directed at multiple envelope proteins of the SARS-CoV-2 virus.

Clinical Program Update

AR-301: Thus far, the pace of the trial has been modestly impacted by the protracted COVID-19 pandemic. The Phase 3 interim futility analysis from the ongoing pivotal trial is now expected to be reported in 1H 2021 and top line data by YE 2021. It’s important to note that COVID-19 patients on prolonged mechanical ventilation in the intensive care unit (ICU) are prone to secondary infections (also called ‘superinfections’) by opportunistic pathogens such as bacteria. Superinfection is a reported complication in COVID-19 patients, which exacerbates morbidity and the rate of mortality. The AR-301 Phase 3 study allows for the enrollment of patients with baseline characteristics which are inclusive of certain COVID-19 patients. While AR-301 is not an agent to treat SARS-CoV-2 virus itself, it can potentially reduce the morbidity associated with secondary S. aureus pneumonia, which is a coronavirus complication and a contributing cause of death in such patients.

The trial, which was initiated in the first quarter of 2019, is expected to enroll 240 patients at approximately 160 clinical centers in 22 countries. Participating clinical centers that are activated continue to follow standard stringent clinical protocols and procedures for critically ill VAP patients, as is standard in the U.S. and Europe. The trial represents one of the first ever Phase 3 superiority clinical study evaluating immunotherapy with a fully human monoclonal antibody to treat acute pneumonia in the intensive care unit setting. Details of the study can be viewed on www.clinicaltrials.gov using identifier NCT03816956.

AR-301 is a fully human monoclonal IgG1 antibody specifically targeting gram-positive S. aureus alpha-toxin. It has been shown in vitro to protect against alpha-toxin mediated destruction of host cells, thereby potentially preserving the human immune response. AR-301’s mode of action is independent of the antibiotic resistance profile of S. aureus and it is active against infections caused by both MRSA (methicillin resistant S. aureus) and MSSA (methicillin sensitive S. aureus).

AR-501: During the quarter, the Company announced an agreement with the FDA to simplify AR-501’s Phase 2 trial design for the treatment of chronic lung infections associated with cystic fibrosis (CF). After reporting (June 2020) positive Phase 1 safety data in healthy adults who were exposed to a single ascending dose (SAD) or a multiple ascending dose (MAD) regimen, Aridis proposed, and the FDA has now agreed, to streamline AR-501’s forthcoming Phase 2a clinical trial in CF patients by removing the SAD and only conducting a MAD regimen. The FDA also concurred with the Company’s proposal to expand the originally planned Phase 2a protocol design into a Phase 2a/2b study. This Phase 2a/2b design will enable seamless and efficient advancement of the study from Phase 2a into Phase 2b using the same clinical study protocol. The data from the Phase 2a will inform the dose selection and sample size expansion to achieve statistical significance in efficacy in Phase 2b.

AR-501 is being developed in collaboration with the CF Foundation and has been granted Orphan Drug Designation (ODD), Fast Track and Qualified Infectious Disease Product (QIDP) designations by the FDA. In addition, the European Medicines Agency (EMA) granted ODD to AR-501. The original Phase 1/2a clinical trial was a randomized, double-blinded, placebo-controlled SAD and MAD trial investigating the safety and PK of inhaled AR-501 in healthy volunteers and cystic fibrosis patients with chronic bacterial lung infections. Details of the original Phase 1/2a clinical trial can be viewed on www.clinicaltrials.gov using identifier NCT03669614. The new Phase 2a/b study design will be available on clinicaltrials.gov within the next quarter.

Corporate Update

A key recent development was the closing of an $8.5 million financing which occurred on October 14th. The proceeds from this registered direct offering and concurrent private placement, strengthens the Company’s balance sheet to prioritize the continued advancement of AR-301’s Phase 3 VAP clinical trial, while allocating the requisite resources to AR-501’s Phase 2b cystic fibrosis clinical trial, and the ongoing development of novel COVID-19 therapies such as AR-701 and AR-711.

Throughout the third quarter, Aridis continued to increase its profile in the investment and business communities by participating in the 2020 Cantor Fitzgerald Virtual Global Healthcare Conference and the H.C. Wainwright 22nd Annual Global Investment Conference on September 15, 2020.

A replay of the Cantor Fitzgerald event can be found at View Source

Fiscal 2020 Third Quarter Results:

Cash: Total cash and cash equivalents as of September 30, 2020 was $6.2 million. The Company completed a registered direct financing in October 2020 and received gross proceeds of approximately $8.5 million.
Revenues: Revenue was zero for both periods ended September 30, 2020 and 2019.
Research and Development Expenses: Research and development expenses incurred in the quarter ended September 30, 2020 were approximately $4.2 million, a decrease of approximately $1.8 million over the same period in 2019. The decrease was primarily due to the following: a decrease in spending on clinical trial activities and drug manufacturing expenses for the Phase 2 study of our AR-105 program, that was terminated during 2019; a decrease in spending on our clinical trial activities for the Phase 3 study of our AR-301 program during the third quarter of 2020 as compared to the third quarter of 2019, which included increased study start-up costs; and a decrease in spending on clinical trial activities for the Phase 1/2a study of our AR-501 program because the Phase 1 portion of the study ended in the second quarter of 2020. These decreases were partially offset by an increase in drug manufacturing related expenses for the Phase 3 study of our AR-301 program during the third quarter of 2020 as compared to the third quarter of 2019.
General and Administrative Expenses: General and administrative expenses incurred in the quarter ended September 30, 2020 were approximately $1.6 million, an increase of approximately $247,000 over the same period in 2019 which was due primarily to increases in professional service fees, directors’ and officers’ related liabilities insurance expense, personnel related expenses, including stock-based compensation, patent related fees, and Delaware franchise taxes.
Interest Income, net: Interest income, net was approximately $6,000 for the quarter ended September 30, 2020, a decrease of approximately $84,000 over the same period in 2019. This decrease was primarily due to lower cash balances and lower interest rates during the third quarter of 2020 as compared to the third quarter of 2019.
Share of Loss from Equity Method Investment: Loss from equity method investment decreased by $282,000 for the quarter ended September 30, 2020 when compared to the same period in 2019 which was due to there being no share of losses from our equity method investment recorded in the third quarter of 2020 as the net book value of the investment was zero since March 31, 2020.
Net Loss: The net loss for the quarter ended September 30, 2020 was approximately $5.8 million, or $0.65 net loss per share, compared to a net loss of approximately $7.6 million, or $0.87 net loss per share, for the quarter ended September 30, 2019. The weighted average common shares outstanding was approximately 8.9 million and approximately 8.7 million for the third quarter of 2020 and 2019, respectively.