On March 3, 2021 Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, reported annual financial results for the year ended December 31, 2020 and provided a corporate overview / business update (Press release, Ampio, MAR 3, 2021, View Source [SID1234576036]).

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Mr. Michael Macaluso, President and CEO, noted, "The FDA has recently responded to our requests to expand our IV and Inhalation Covid-19 studies, utilizing Ampion, by recommending we conduct a randomized, double-blinded, placebo-controlled Phase II trial in each. They also indicated that their recommended trial design for both will allow for an effective and efficient review of data results, determine the safety and statistical significance and effectiveness of Ampion in comparison to Standard of Care, all of which are necessary for the FDA to objectively determine that the known and potential benefits of Ampion outweigh the known and potential risks and, consequently, Ampion may be considered for emergency use authorization (EUA).

In addition, we have provided a detailed proposal to the FDA in response to their recent guidance regarding the status of our Osteoarthritis of the Knee (OAK) Phase III clinical trial, which is paused as a result of the COVID pandemic. In summary, our response proposes analysis of the existing data in a reduced level of patients who had completed the 12-week study regimen for submission. It is important to note that this response is part of an ongoing active dialog with the FDA and until the FDA renders a final decision, this trial data will continue to remain paused and blinded to ensure clinical trial integrity.

Ampion is a platform biologic and, as such, is agnostic to whether it is treating a COVID patient or an osteoarthritis auto- immune condition. Simplified, Ampion directly and effectively addresses inflammation. Consequently, our ongoing and continued research and clinical trials may be applicable to a significant number of additional disease complications, not just COVID."

Mr. Michael Macaluso, President and Chief Executive Officer, Dr. David Bar-Or, Director and Founder, Ms. Holli Cherevka, Chief Operating Officer and Mr. Daniel Stokely, Chief Financial Officer will be hosting a Conference Call for the Investment Community this afternoon beginning at 4:30 PM ET (see details below).

The key areas of focus will be as follows:

COVID-19 Platform / Pipeline Overview and Update

AP-014 (inhaled) and AP-016 (intravenous) clinical trial update
Possibility of obtaining an Emergency Use Authorization (EUA) from the FDA for inhaled and intravenous Ampion
OAK Clinical Trial 2021 Timeline / Update

Ampio’s Osteoarthritis of the Knee (OAK) Phase III trial being conducted under a Special Protocol Assessment (SPA) with the FDA
Ampio harmonizes steps for OAK Phase III trial with the FDA guidance during the COVID-19 health emergency and submitted an SPA amendment to the FDA
PASC/Long Hauler and Other Clinical Trial 2021 Timelines / Updates

Status of PASC/Long Hauler Study
Kidney Disease
Pediatric diseases
Financial Results for Year Ended December 31, 2020

Cash and cash equivalents totaled $17.3 million at December 31, 2020, compared to $6.5 million at December 31, 2019. The increase is attributable to net proceeds received from the utilization of our at-the-market (ATM) equity offering and warrant exercises totaling $25.6 million, partially offset by cash used to fund operating activities of $14.7 million.

Research and development expenditures for the year ended December 31, 2020 were $9.2 million, compared to $12.6 million for the same period in 2019. The decrease in research and development expenses for the year ended December 31, 2020 compared to the amounts for the same period in 2019 was primarily due to the AP-013 study being temporarily paused in April 2020 as a result of the stay-at-home mandates issued by state and federal governments in response to the COVID-19 pandemic and travel restrictions implemented by the Company’s contracted Clinical Research Organization (CRO), partially offset by expenses associated with the inhaled Ampion safety study, the AP-014 (inhaled Ampion) Phase I study and the AP-016 (intravenous Ampion) Phase I study, which were all initiated during the 2020 period.

General and administrative expenses for the year ended December 31, 2020 were $6.7 million, compared to $6.0 million for the same period in 2019. The increase in general and administrative expenses for the year ended December 31, 2020 compared with the same period for 2019 is primarily due to the increase in directors and officer’s insurance premiums, which was consistent with the overall market for coverage, and an increase in stock-based compensation expense as a result of the issuance and repricing of stock options.

Other expense was negligible for the year ended December 31, 2020 compared to other income of $5.0 million for the same period in 2019. In fiscal 2019, a derivative gain was recorded from previously issued investor warrants as a result of (i) the current year exercise of investor warrants and (ii) the overall increase in the price of the Company’s stock at December 31, 2020. This was partially offset by the income recognized in the current year from the Payroll Protection Funding Program, whereby the Company believes it is probable that the loan will be forgiven by the Small Business Administration as the loan has already been forgiven by the Company’s lending institution.

Net loss for the year ended December 31, 2020 was $15.9 million, or $0.09 on a fully diluted per share basis, compared to a net loss of $13.6 million, or $0.14 on a fully diluted per share basis, for the same period in 2019. The higher net loss reported for the year ended December 31, 2020 compared to the same period for 2019 is primarily attributable to a reduction in other income as a result of the recognition of a derivative loss on previously issued investor warrants, partially offset by a reduction in clinical trial and related costs as a result of pausing the AP-013 study in early 2020 due to the COVID-19 pandemic.

The total shares of common stock outstanding were 193,378,996 at December 31, 2020, compared to 158,644,757 at December 31, 2019.

Financial Guidance

Based on its current operating plans and expected access to equity financing, Ampio expects to have cash and access to external sources of liquidity sufficient to fund research and development programs and operations through the first quarter of 2022.

Conference Call and Webcast

Ampio will host a conference call today at 4:30pm EST (1:30 pm PST) to discuss these 2020 annual results and provide a corporate business update.

The conference call will also be available from the Investors Relations section of the Company’s website at www.ampiopharma.com and will be archived there shortly after the live event.

Receipt of Audit Opinion with Going Concern Qualification

Pursuant to the disclosure requirements of the NYSE American Company Guidelines Sections 401(h) and 610(b), Ampio is reporting that its audited financial statements for the fiscal year ended December 31, 2020, included in Ampio’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 3, 2021, contains an audit opinion from its independent registered public accounting firm that includes an explanatory paragraph related to Ampio’s ability to continue as a going concern. This announcement does not represent any change or amendment to the Company’s financial statements or to its Annual Report on Form 10-K for the fiscal year ended December 31, 2020.

On March 3, 2021 BioTheryX, Inc., a clinical-stage company focused on degrading proteins to create life-saving medicines, reported that Rob Williamson, President and CEO, will present a company overview and will participate virtually in the following investor conferences (Press release, BioTheryX, MAR 3, 2021, View Source [SID1234576035]):

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Barclays Global Healthcare Conference
Tuesday, March 9th, 4:10 pm EST
Credit Suisse Solebury Trout Healthcare Innovators Private Company Showcase
Thursday, March 11, 2021, 12:20 pm PST

On March 3, 2021 DURECT Corporation (Nasdaq: DRRX) reported that it will partipate in three upcoming investor conferences, taking place in March 2021 (Press release, DURECT, MAR 3, 2021, https://www.prnewswire.com/news-releases/durect-corporation-to-participate-in-three-investor-conferences-in-march-2021-301240108.html [SID1234576033]). All conferences will take place virtually.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Details are as follow:

H.C. Wainwright Life Sciences Conference: March 9 – 10

Presentation Date:

March 9

Time:

Available on demand from 7:00 am (EST)

Webcast:

Register Here

ROTH Conference: March 15 – 17

Presentation Date:

March 5

Time:

Available on demand from 5:00 pm (EST)

Webcast:

Register Here

Oppenheimer & Co. Healthcare Conference: March 16 – 18

Presentation Date:

March 17

Time:

11:20 a.m. EST

Webcast:

Register Here

The webcast links and replay links of the presentations will also be available by accessing DURECT’s homepage at www.durect.com and clicking on the "Investors" tab. If you are unable to participate during conferences, the calls will be archived on DURECT’s website under "Event Calendar" in the "Investors" section.

On March 3, 2021 Pfizer Inc. reported The U.S. Food and Drug Administration (FDA) approved supplemental New Drug Application (sNDA) for LORBRENA (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (Press release, Pfizer, MAR 3, 2021, View Source [SID1234576031]). LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test. The FDA action also converts the 2018 accelerated approval to full approval. The application was approved under the FDA’s Real-Time Oncology Review (RTOR) pilot program.

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"For more than a decade, Pfizer has been a pioneer in delivering biomarker-driven therapies and addressing the diverse and evolving needs of people with non-small cell lung cancer," said Andy Schmeltz, Global President, Pfizer Oncology. "LORBRENA has been a transformative medicine for people with ALK-positive advanced NSCLC, and this FDA approval in the first-line setting means that we can now extend hope to even more people."

LORBRENA is a third-generation ALK inhibitor specifically designed to inhibit the most common tumor mutations that drive resistance to current medications and to address metastases in the brain, a frequent site for disease progression in ALK-positive NSCLC. Up to 40% of people with ALK-positive metastatic NSCLC present with brain metastases at initial diagnosis.1,2,3

The expanded approval of LORBRENA is based on the results from the pivotal Phase 3 CROWN trial, which showed a 72% reduction in risk of progression or death vs. XALKORI (crizotinib) in a previously untreated patient population (HR 0.28: 95% CI, 0.19 to 0.41; p<0.0001) as assessed by blinded independent central review (BICR). Central nervous system (CNS) involvement was assessed in all patients. There were 17 patients in the LORBRENA arm and 13 in the XALKORI arm with measurable brain metastases based on baseline brain imaging. A prespecified exploratory analysis showed that among these patients, the intracranial objective response rate (IC-ORR), as assessed by BICR, was 82% (95% CI, 57 to 96) in the LORBRENA arm and 23% (95% CI, 5 to 54) in the XALKORI arm. The intracranial duration of response (IC-DOR) was 12 months or longer in 79% (n=11) and 0% of patients in the LORBRENA and XALKORI arms, respectively.

The most common adverse events (AEs) of any Grade and Grade 3-4 worsening laboratory abnormalities occurring in ≥20% of people treated with LORBRENA were edema (56%), weight gain (38%), peripheral neuropathy (35%), cognitive effects (21%), diarrhea (21%), dyspnea (20%), and hypertriglyceridemia (22%). Serious AEs occurred in 34% of people treated with LORBRENA; the most frequently reported serious AEs were pneumonia (4.7%), dyspnea (2.7%), respiratory failure (2.7%), cognitive effects (2.0%), and pyrexia (2.0%). Fatal AEs occurred in 3.4% of people treated with LORBRENA and included pneumonia (0.7%), respiratory failure (0.7%), cardiac failure acute (0.7%), pulmonary embolism (0.7%), and sudden death (0.7%). Permanent discontinuation of LORBRENA due to AEs occurred in 6.7% of people. AEs leading to dose interruptions and dose reductions occurred in 49% and 21% of people treated with LORBRENA, respectively. Detailed results from the CROWN study were published in the November 2020 issue of the New England Journal of Medicine.

"The CROWN data have shown LORBRENA can significantly improve outcomes in the first-line treatment of ALK-positive non-small cell lung cancer, including those that present with brain metastases," said Benjamin Solomon, M.D., Department of Medical Oncology, Peter MacCallum Cancer Centre. "This approval is meaningful for my patients because we now have a highly effective treatment option that can delay the progression of a typically aggressive disease."

In 2018, the FDA approved LORBRENA for the treatment of patients with ALK-positive metastatic NSCLC whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. This indication was approved under accelerated approval based on tumor response rate and duration of response. Based on the CROWN data, the FDA has also converted the accelerated approval to full approval.

This sNDA was also reviewed by the FDA under Project ORBIS, an initiative introduced in 2019, which provides a framework for potential concurrent submissions and collaborative review with health authorities in Canada, Singapore, Switzerland, Australia, Brazil and the United Kingdom. Under Project ORBIS, collaboration among international regulators may allow people with cancer to receive earlier access to products in other countries. The European Medicines Agency is also reviewing a Type II variation application for LORBRENA in the first line indication.

About the CROWN Trial

CROWN is a Phase 3, randomized, open-label, parallel 2-arm trial in which 296 people with previously untreated advanced ALK-positive NSCLC were randomized 1:1 to receive LORBRENA monotherapy (n=149) or XALKORI monotherapy (n=147). Patients were required to have an ECOG performance status of 0-2 and ALK-positive NSCLC as identified by the VENTANA ALK (D5F3) CDx assay. The primary endpoint of the CROWN trial is PFS based on BICR. Secondary endpoints include overall survival (OS) and tumor assessment related data by BICR, including ORR, and DOR. In patients with measurable CNS metastases at baseline, additional outcome measures were IC-ORR and IC-DOR by BICR.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the number one cause of cancer-related death around the world.4 NSCLC accounts for approximately 80-85% of lung cancers,5 with ALK-positive tumors occurring in about 3-5% of NSCLC cases.6 In 2020, an estimated 228,820 new cases of lung cancer were diagnosed in the U.S.7

About LORBRENA (lorlatinib)

LORBRENA is a tyrosine kinase inhibitor (TKI) that has been shown to be highly active in preclinical lung cancer models harboring chromosomal rearrangements of ALK. LORBRENA was specifically developed to inhibit tumor mutations that drive resistance to other ALK inhibitors and to penetrate the blood brain barrier.

LORBRENA is approved in the U.S. for the treatment of adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

IMPORTANT LORBRENA (lorlatinib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION

Contraindications: LORBRENA is contraindicated in patients taking strong CYP3A inducers, due to the potential for serious hepatotoxicity.

Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers: Severe hepatotoxicity occurred in 10 of 12 healthy subjects receiving a single dose of LORBRENA with multiple daily doses of rifampin, a strong CYP3A inducer. Grade 4 ALT or AST elevations occurred in 50% of subjects, Grade 3 in 33% of subjects, and Grade 2 in 8% of subjects. ALT or AST elevations occurred within 3 days and returned to within normal limits after a median of 15 days (7 to 34 days); median time to recovery in subjects with Grade 3 or 4 or Grade 2 ALT or AST elevations was 18 days and 7 days, respectively. LORBRENA is contraindicated in patients taking strong CYP3A inducers. Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to initiating LORBRENA.

Central Nervous System (CNS) Effects: A broad spectrum of CNS effects can occur; overall, CNS effects occurred in 52% of the 476 patients receiving LORBRENA. These included seizures (1.9%, sometimes in conjunction with other neurologic findings), psychotic effects (7%; 0.6% severe [Grade 3 or 4]), and changes in cognitive function (28%; 2.9% severe), mood (including suicidal ideation) (21%; 1.7% severe), speech (11%; 0.6% severe), mental status (1.3%; 1.1% severe), and sleep (12%). Median time to first onset of any CNS effect was 1.4 months (1 day to 3.4 years). Overall, 2.1% and 10% of patients required permanent or temporary discontinuation of LORBRENA, respectively, for a CNS effect; 8% required dose reduction. Withhold and resume at same or reduced dose or permanently discontinue based on severity.

Hyperlipidemia: Increases in serum cholesterol and triglycerides can occur. Grade 3 or 4 elevations in total cholesterol occurred in 18% and Grade 3 or 4 elevations in triglycerides occurred in 19% of the 476 patients who received LORBRENA. Median time to onset was 15 days for both hypercholesterolemia and hypertriglyceridemia. Approximately 4% and 7% of patients required temporary discontinuation and 1% and 3% of patients required dose reduction of LORBRENA for elevations in cholesterol and in triglycerides in Study B7461001 and Study B7461006, respectively. Eighty-three percent of patients required initiation of lipid-lowering medications, with a median time to onset of start of such medications of 17 days. Initiate or increase the dose of lipid lowering agents in patients with hyperlipidemia. Monitor serum cholesterol and triglycerides before initiating LORBRENA, 1 and 2 months after initiating LORBRENA, and periodically thereafter. Withhold and resume at same dose for the first occurrence; resume at same or reduced dose of LORBRENA for recurrence based on severity.

Atrioventricular (AV) Block: PR interval prolongation and AV block can occur. In 476 patients who received LORBRENA at a dose of 100 mg orally once daily and who had a baseline electrocardiography (ECG), 1.9% experienced AV block and 0.2% experienced Grade 3 AV block and underwent pacemaker placement. Monitor ECG prior to initiating LORBRENA and periodically thereafter. Withhold and resume at reduced or same dose in patients who undergo pacemaker placement. Permanently discontinue for recurrence in patients without a pacemaker.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe or life-threatening pulmonary adverse reactions consistent with ILD/pneumonitis can occur. ILD/pneumonitis occurred in 1.9% of patients, including Grade 3 or 4 ILD/pneumonitis in 0.6% of patients. Four patients (0.8%) discontinued LORBRENA for ILD/pneumonitis. Promptly investigate for ILD/pneumonitis in any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, and fever). Immediately withhold LORBRENA in patients with suspected ILD/pneumonitis. Permanently discontinue LORBRENA for treatment-related ILD/pneumonitis of any severity.

Hypertension: Hypertension can occur in patients receiving LORBRENA. Hypertension occurred in 13% of patients, including Grade 3 or 4 in 6% of patients. Median time to onset of hypertension was 6.4 months (1 day to 2.8 years). 2.3% of patients temporarily discontinued LORBRENA for hypertension. Control blood pressure prior to initiating LORBRENA. Monitor blood pressure after 2 weeks and at least monthly thereafter. Withhold and resume at reduced dose or permanently discontinue based on severity.

Hyperglycemia: Hyperglycemia can occur in patients receiving LORBRENA. Hyperglycemia occurred in 9% of patients, including Grade 3 or 4 in 3.2% of patients. Median time to onset of hyperglycemia was 4.8 months (1 day to 2.9 years). 0.8% of patients temporarily discontinued LORBRENA for hyperglycemia. Assess fasting serum glucose prior to initiating LORBRENA and monitor periodically thereafter. Withhold and resume at reduced dose or permanently discontinue based on severity.

Embryo-fetal Toxicity: LORBRENA can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective non-hormonal method of contraception, since LORBRENA can render hormonal contraceptives ineffective, during treatment with LORBRENA and for at least 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with LORBRENA and for 3 months after the final dose.

Adverse Reactions: In the pooled safety population of 476 patients who received 100 mg LORBRENA once daily, the most frequent (≥ 20%) adverse reactions were edema (56%), peripheral neuropathy (44%), weight gain (31%), cognitive effects (28%), fatigue (27%), dyspnea (27%), arthralgia (24%), diarrhea (23%), mood effects (21%), and cough (21%). The most frequent (≥ 20%) laboratory abnormalities in patients receiving LORBRENA were hypercholesterolemia (21%) and hypertriglyceridemia (21%).

In previously untreated patients, serious adverse reactions occurred in 34% of the 149 patients treated with LORBRENA; the most frequently reported serious adverse reactions were pneumonia (4.7%), dyspnea (2.7%), respiratory failure (2.7%), cognitive effects (2.0%), and pyrexia (2.0%). Fatal adverse reactions occurred in 3.4% of patients and included pneumonia (0.7%), respiratory failure (0.7%), cardiac failure acute (0.7%), pulmonary embolism (0.7%), and sudden death (0.7%). In previously treated patients, serious adverse reactions occurred in 32% of the 295 patients; the most frequently reported serious adverse reactions were pneumonia (3.4%), dyspnea (2.7%), pyrexia (2%), mental status changes (1.4%), and respiratory failure (1.4%). Fatal adverse reactions occurred in 2.7% of patients and included pneumonia (0.7%), myocardial infarction (0.7%), acute pulmonary edema (0.3%), embolism (0.3%), peripheral artery occlusion (0.3%), and respiratory distress (0.3%).

Drug Interactions: LORBRENA is contraindicated in patients taking strong CYP3A inducers. Avoid concomitant use with moderate CYP3A inducers, strong CYP3A inhibitors, and fluconazole. If concomitant use of moderate CYP3A inducers cannot be avoided, increase the LORBRENA dose as recommended. If concomitant use with a strong CYP3A inhibitor or fluconazole cannot be avoided, reduce the LORBRENA dose as recommended. Avoid concomitant use of LORBRENA with CYP3A substrates and P-gp substrates, which may reduce the efficacy of these substrates.

Lactation: Because of the potential for serious adverse reactions in breastfed infants, instruct women not to breastfeed during treatment with LORBRENA and for 7 days after the final dose.

Hepatic Impairment: No dose adjustment is recommended for patients with mild hepatic impairment. The recommended dose of LORBRENA has not been established for patients with moderate or severe hepatic impairment.

Renal Impairment: Reduce the dose of LORBRENA for patients with severe renal impairment. No dose adjustment is recommended for patients with mild or moderate renal impairment.

On March 3, 2021 NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company’’), a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that Laurent Levy, Chief Executive Officer, will speak during a fireside chat at the H.C. Wainwright Global Life Science Conference, being held virtually on March 9-10, 2021 (Press release, Nanobiotix, MAR 3, 2021, View Source [SID1234576030]).

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Event Details:

Title: H.C. Wainwright Global Life Sciences Conference
Date: Tuesday, March 9, 2021 to Wednesday, March 10, 2021
Time: Available on Demand
Registration: View Source
Members of the Nanobiotix management team will also be available to participate in virtual one-on-one meetings with investors who are registered to attend the conference. The Company’s corporate presentation can be downloaded here.

About NBTXR3

NBTXR3 is a first-in-class radioenhancer composed of sterile, functionalized, crystalline hafnium oxide nanoparticles. The product candidate is designed to increase the radiotherapy energy deposit inside tumor cells through the nanoparticles’ high atomic number core packaged in the space for interaction with ionizing radiation, and subsequently increase of tumor cell death when compared to radiotherapy alone—without adding toxicity to adjacent healthy tissues. NBTXR3 requires a single, intratumoral administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The primary physical mechanism of action of NBTXR3 activated by radiotherapy could be universal, making it potentially applicable across any solid tumor indication where radiotherapy is a part of standard of care including head and neck, lung, prostate, liver, colorectal, and esophageal cancers. The biological secondary mechanism of action of NBTXR3 activated by radiotherapy has been shown in preclinical studies to prime adaptive immune response, which would potentially bring a new dimension to cancer immunotherapies.