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Cytokinetics Reports Fourth Quarter 2020 Financial Results

On February 25, 2021 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the fourth quarter and full year 2020. Net loss for the fourth quarter was $43.9 million or $0.62 per share and the net loss for the year 2020 was $127.3 million or $1.97 per share (Press release, Cytokinetics, FEB 25, 2021, View Source [SID1234575776]). Net loss for the fourth quarter of 2019 was $30.6 million or $0.52 per share and net loss for the year 2019 was $121.7 million or $2.11 per share. Cash, cash equivalents and investments totaled $501.0 million at December 31, 2020.

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"In the fourth quarter, we were pleased to present the results of GALACTIC-HF which demonstrated a positive effect on the primary composite endpoint of cardiovascular death or heart failure events in patients receiving standard of care plus omecamtiv mecarbil, with potentially larger treatment effects in patients with increasingly lower ejection fractions. In the next few weeks, we plan to discuss the results of GALACTIC-HF with FDA as may inform a potential registration path," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "In addition, we recently progressed REDWOOD-HCM to Cohort 2 following a positive interim analysis and we completed enrollment promptly afterwards. Results from both cohorts are expected mid-year. We believe that we are well positioned for what may be a transformational year for the company as we approach potential commercialization of our first medicine for patients with heart failure and we hope to advance two other programs into pivotal clinical trials."

Q4 and Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 clinical trial of omecamtiv mecarbil, were presented and published online.

GALACTIC-HF demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of cardiovascular (CV) death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure) compared to placebo in patients treated with standard of care.

No reduction in the secondary endpoint of time to CV death was observed and no other secondary endpoints were met in accordance with the prespecified statistical analysis.

Adverse events and treatment discontinuation of study drug were balanced between the treatment arms. In general, the overall rates of myocardial ischemia, ventricular arrhythmias and death were similar between treatment and placebo groups.

The effect of omecamtiv mecarbil was consistent across most prespecified subgroups and with a potentially greater treatment effect suggested in patients with a lower left ventricular ejection fraction (LVEF).

Supplemental analyses from GALACTIC-HF were presented that demonstrated a greater treatment effect of omecamtiv mecarbil in patients with lower LVEF as well as characteristics that may indicate advanced heart failure, such as being hospitalized within the last 3 months, higher N-terminal-pro brain natriuretic peptide levels and lower blood pressures.

Continued conduct of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil.

Presented findings from analyses of claims data and electronic health records related to heart failure, including analyses of the high spending and unmet need, underscoring the growing economic burden of this disease.

Conducted market research with physicians and payors and continued other commercial planning activities for omecamtiv mecarbil.
CK-3828136 (CK-136 (formerly referred to as AMG 594), cardiac troponin activator)

Analyzed data from the completed Phase 1 study of CK-136 conducted by Amgen to inform next steps in its development.
CK-3773274 (CK-274, cardiac myosin inhibitor)

Progressed REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial designed to determine the safety and tolerability of CK-274 in patients with obstructive hypertrophic cardiomyopathy (oHCM), to Cohort 2 following the conduct of an interim analysis of data from Cohort 1. In December, we opened Cohort 2 in REDWOOD-HCM to screening and it completed patient enrollment in February.

The interim analysis of data from Cohort 1 showed that patients experienced substantial reductions in the average resting left ventricular outflow tract gradient (LVOT-G) as well as the post-Valsalva LVOT-G. These clinically relevant decreases in pressure gradients were achieved with only modest decreases in average LVEF; there were no dose interruptions due to LVEF falling below 50%. Pharmacokinetic data were similar to data from Phase 1.

Safety and tolerability data were supportive of continued dose escalation with no serious adverse events attributed to study treatment reported by the investigators.

Received approval of IND submitted in China for conduct of a Phase 1 study of CK-274 under the License and Collaboration Agreement between Cytokinetics and Ji Xing Pharmaceuticals Limited.

Presented preclinical data for CK-274 showing that it reduced contractility and left ventricular outflow tract peak pressure gradient in cats with naturally occurring HCM and left ventricular outflow tract obstruction.
CK-3772271 (CK-271, second cardiac myosin inhibitor)

Presented preclinical data for CK-271 demonstrating that, in the Dahl/Salt sensitive rat model of heart failure with preserved ejection fraction (HFpEF), CK-271 attenuated the development of fibrosis and diastolic dysfunction.

Completed the planned Phase 1, single-dose pharmacokinetic evaluation and tolerability assessments of CK-271 in healthy volunteers and determined it to be suitable for further development. We are evaluating its potential for further development in connection with plans to conduct a broad development program for our cardiac myosin inhibitor(s) in HCM and other indications.
Skeletal Muscle Program

reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))

Additional data from FORTITUDE-ALS, the Phase 2 clinical trial of reldesemtiv in patients with ALS, were presented showing that the effect of reldesemtiv was more apparent in faster progressing patients, supporting the rationale and design of COURAGE-ALS, the planned Phase 3 clinical trial of reldesemtiv in patients with ALS.

The design of COURAGE-ALS was also presented, and we conducted readiness activities in preparation for the potential start of the trial.
Pre-Clinical Development and Ongoing Research

Continued to develop new chemical entities and to conduct IND enabling studies with the expectation of our potentially advancing 1-2 potential drug candidates in development.

Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators under a joint research program extended through March 31, 2021.

Continued research activities directed to our other muscle biology research programs which we expect to continue in 2021.
Corporate

Announced we will regain worldwide rights to develop and commercialize omecamtiv mecarbil and CK-136 in May 2021.

Named Nancy Wysenski and Muna Bhanji to the company’s Board of Directors.

Received $85 million upon the closing of the sale of a royalty on mavacamten, being developed by Bristol-Myers Squibb Company (formerly by MyoKardia, Inc.), to RTW Royalty Holdings Designated Activity Company.
2021 Corporate Milestones

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Plan to meet with FDA to discuss GALACTIC-HF in Q1 2021.

Expect enrollment in METEORIC-HF to be completed in 1H 2021.

Develop a "go-to-market" strategy and potential commercial launch plan in 1H 2021.
CK-3773274 (CK-274, cardiac myosin inhibitor)

Expect a Phase 1 study of CK-274 in China, conducted under the License and Collaboration Agreement between Cytokinetics and Ji Xing Pharmaceuticals Limited, to start in Q1 2021.

Expect to begin an open label extension study for patients who complete REDWOOD-HCM in Q2 2021.

Expect to announce results from both cohorts in REDWOOD-HCM by mid-year 2021.

Plan to engage regulatory authorities regarding a potential registration path in 2H 2021.

Expect to begin a potential Phase 3 clinical trial of CK-274 by the end of 2021.
Skeletal Muscle Program

reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))

We expect to conduct start-up activities for COURAGE-ALS in 2021 and may open the trial to enrollment in 2H 2021, subject to our plans relating to advancing omecamtiv mecarbil towards commercialization and CK-274 to a potential Phase 3 clinical trial in patients with oHCM.
Financials

Revenues for the three and twelve months ended December 31, 2020 were $6.7 million and $55.8 million, respectively, compared to $5.2 million and $26.9 million for the corresponding periods in 2019. The increase in revenues for the year ended December 31, 2020 was primarily due to $36.5 million of license revenue recognized in the third quarter 2020 for the RTW transactions.

Research and development expenses for the three and twelve months ended December 31, 2020 increased to $29.2 million and $97.0 million, respectively, compared to $18.3 million and $86.1 million for the same periods in 2019, respectively, due primarily to increased spending for our cardiac myosin inhibitor programs and increased spending on readiness for reldesemtiv offset by a study that concluded on reldesemtiv in 2019.

General and administrative expenses for the three and twelve months ended December 31, 2020 increased to $13.9 million and $52.8 million from $10.6 million and $39.6 million in 2019 due primarily to an increase in personnel related costs including stock-based compensation and higher outside spending for commercial readiness.

2021 Financial Guidance

The company reported financial guidance for 2021. The company anticipates revenue will be in the range of $23 to $28 million, operating expenses will be in the range of $195 to $205 million, and net cash utilization will be approximately $160 to 170 million. Our current cash balance of $501 million represents more than two years of forward cash based on our projected operating expenses and this net cash utilization range. The net cash utilization range includes approximately $35 million of non-recurring, building construction and related costs; it also includes receipt of a potential $45 million from RTW Royalty Holdings Designated Activity Company in exchange for a low single digit royalty on CK-274 in connection with the funding agreement signed in July 2020, subject to conditions for payment being fulfilled. Should we not exercise our option to receive the $45 million, we expect our net cash utilization range will be increased. We expect to revise our financial guidance mid-year once we finalize strategies and potential commercial launch plans for omecamtiv mecarbil. Significant additional expenses may arise from our executing on those strategies and plans that are not included in the current financial guidance.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s fourth quarter 2020 results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or +1 (706) 679-3078 (international) and typing in the passcode 6555297.

An archived replay of the webcast will be available via Cytokinetics’ website until March 11, 2021. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or +1 (404) 537-3406 (international) and typing in the passcode 6555297 from February 25, 2021 at 7:30 PM Eastern Time until March 11, 2021.

Celsion Corporation Provides Clinical Update on Phase I/II OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer Including Encouraging Interim Resection Scores

On February 25, 2021 Celsion Corporation (NASDAQ: CLSN), a clinical-stage development company focused on DNA-based immunotherapy and next-generation vaccines, reported an update on its Phase I/II OVATION 2 Study with GEN-1 in patients with advanced ovarian cancer, including interim observations (Press release, Celsion, FEB 25, 2021, View Source [SID1234575744]). GEN-1 is Celsion’s DNA-mediated interleukin-12 (IL-12) immunotherapy designed using TheraPlas, its proprietary, synthetic, non-viral nanoparticle delivery system platform.

The OVATION 2 Study combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three adjuvant cycles of chemotherapy and up to nine additional weekly GEN-1 treatments, the goal of which is to delay progression and improve overall survival. The OVATION 2 Study is an open-label, 1-to-1 randomized trial, 80% powered to show the equivalent of a 33% improvement in progression-free survival (PFS) (HR=0.75), the primary endpoint, when comparing the treatment arm (standard of care + GEN-1) with the control arm (standard of care alone).

To date, the Company has enrolled approximately one-third, or 34 patients, of the anticipated 110 patients to be enrolled into the OVATION 2 Study, of which 20 are in the treatment arm and 14 are in the control. Currently, 27 patients have had their interval debulking surgery with the following results:

12 of 15, or 80%, of patients treated with GEN-1 had a R0 resection, which indicates a microscopically margin-negative complete resection in which no gross or microscopic tumor remains in the tumor bed.
7 of 12 patients, or 58%, of patients in the control arm had an R0 resection.
This interim data represents a 38% improvement in R0 resection rates for GEN-1- patients compared with control arm patients and is consistent with the reported improvement in resection scores noted in the encouraging Phase I OVATION I Study, the manuscript of which has been submitted for peer review publication.
"As the goal for surgical debulking is to eliminate microscopic disease, more ovarian cancer patients require neoadjuvant chemotherapy. However, little progress has been made in adding additional efficacious immunotherapy agents to standard neoadjuvant chemotherapy," said Premal H. Thaker, M.D., MSc., Professor in Gynecologic Oncology and Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine in St. Louis and lead Principal Investigator for the OVATION 2 Study. "The results seen to date in the OVATION 2 Study are exciting and impactful for ovarian cancer patients."

The Company further reports that 22 clinical sites in the U.S. and Canada have been initiated, with three more sites expected to be added by the end of the first quarter. Clinical investigators met in early February in a virtual meeting and expressed excitement about the potential for GEN-1 to treat advanced ovarian cancer and, despite the challenges and earlier delays posed by the COVID-19 pandemic, they remain committed to completing enrollment in the study during the second half of 2021.

Commenting on the interim patient reports, Dr. Nick Borys, chief medical officer of Celsion, said, "We are gratified that such a high proportion of GEN-1 patients had no residual disease at the time of their debulking surgery. These results are consistent with what we observed in our Phase I (OVATION I) study. This is great news for the patients and the surgeons in our study as a R0 resection suggests a good clinical outcome. We are following our patients carefully to see how well they do long term. The OVATION 2 investigators remain enthusiastic about the potential of GEN-1 to treat late-stage ovarian cancer, which currently has few treatment options."

Celsion announced earlier this week that GEN-1 had received Fast Track designation from the U.S. Food and Drug Administration (FDA). This designation is intended to facilitate the development and expedite the regulatory review of drugs to treat serious conditions and fill an unmet medical need. According to the FDA, a Fast Track Drug must show some advantage over available therapy, including:

Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
Avoiding serious side effects of an available therapy
Decreasing a clinically significant toxicity of an available therapy that is common and causes discontinuation of treatment
About GEN-1 Immunotherapy

GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy or a combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and recently completed a Phase Ib dose-escalation trial (OVATION 1 Study) of GEN-1 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer.

CohBar to Present at the H.C. Wainwright Global Life Sciences Conference

On February 25, 2021 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported that its Chief Executive Officer, Steven Engle, will present a company overview at the H.C. Wainwright Global Life Sciences Conference, being held virtually March 9 – 10, 2021 (Press release, CohBar, FEB 25, 2021, View Source [SID1234575743]).

H.C. Wainwright Global Life Sciences Conference
Webcast: The presentation may be accessed via webcast on demand using the following link: View Source

Altimmune Announces Financial Results For The Year Ended December 31, 2020 And Provides A Corporate Update

On February 25, 2021 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the year ended December 31, 2020 and provided a corporate update (Press release, Altimmune, FEB 25, 2021, View Source [SID1234575742]).

"The past year has been a transformative time for our Company as we made substantial progress in each of our five portfolio programs," said Vipin K. Garg, Ph.D., President and Chief Executive Officer. "During the year we initiated multiple clinical trials for several of our product candidates (T-COVID, ALT-801 and HepTcell) and completed preparations to begin a Phase 1 clinical trial of AdCOVID, which has begun enrolling volunteers. These achievements have set the stage for a busy and exciting year ahead, as we anticipate multiple data readouts from these programs over the coming months. With two promising technology platforms and five novel product candidates now advancing in clinical development, we believe 2021 has the potential to be a momentous year for Altimmune."

Program Highlights

AdCOVID:

Commenced enrollment in AdCOVID Phase 1 clinical trial evaluating a novel, needle-free intranasal delivery approach for COVID-19 vaccination
Altimmune has commenced enrollment in its Phase 1 clinical trial of AdCOVID, which is designed to evaluate a needle-free intranasal delivery approach for vaccination against COVID-19. Altimmune believes AdCOVID has the potential to become a leading candidate for COVID-19 vaccination based on its ease of administration, and the potential for reduced disease transmission, and cold chain-free vaccine distribution, if the product is demonstrated to have extended stability at room temperature. As demonstrated in the NasoShield and NasoVax clinical trials, the Company believes the expected attributes of AdCOVID make it ideally suited for use in a pediatric setting as the intranasal administration and expected tolerability profile are well suited to meet the needs of children.

The Phase 1 clinical trial will evaluate the safety and immunogenicity of AdCOVID in up to 180 healthy adult volunteers between the ages of 18 and 55. Subjects will receive AdCOVID at one of three dose levels administered as a nasal spray. In addition to the primary study endpoint of safety and tolerability, the immunogenicity of AdCOVID will be evaluated by serum IgG binding and neutralizing antibody titers, mucosal IgA antibody from nasal samples, and T cell responses. Altimmune anticipates having a full data readout from this Phase 1 study in Q2 2021.

Initiated development of additional AdCOVID vectors targeting emerging SARS-CoV-2 variants
The emergence of SARS-CoV-2 variants is raising concerns about the effectiveness of currently authorized vaccines and prompting vaccine developers to engineer new vaccine candidates to combat these viral mutations. Altimmune has initiated the development of vaccine candidates against several variants as one is likely to become dominant in the population in the coming months. Altimmune plans to have these new vaccine candidates ready for use in upcoming later-stage clinical trials.

Established a consortium of manufacturing partners for potential commercial supply of AdCOVID
Altimmune has executed agreements with three commercial manufacturing partners with significant experience in adenoviral vector production. The Company has also established relationships with leading drug product fill/finish partners with sufficient capacity to meet potential commercial demand. Together, the Company believes that this network of strategic manufacturing partners will ensure Altimmune’s commercial readiness to supply vaccine, assuming the clinical data support this advancement.

Furthered AdCOVID preclinical studies in collaboration with the University of Alabama at Birmingham (UAB) and Saint Louis University
Based on the promising preclinical data for AdCOVID published on the BioRxiv server, Altimmune continues preclinical studies of AdCOVID in collaboration with UAB and Saint Louis University to evaluate AdCOVID in additional animal models and to further evaluate heterologous prime boost regimens of AdCOVID in support of future clinical development activities. Data from these ongoing preclinical studies are expected in Q1 and Q2 2021.

ALT-801:

Commenced dosing in a Phase 1 clinical trial of ALT-801, a novel GLP-1/glucagon dual-agonist being evaluated for the treatment of NASH
Altimmune commenced dosing in a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of ALT-801, a GLP-1/glucagon dual-agonist being developed for the treatment of NASH. This trial is being conducted in Australia and is expected to enroll approximately 100 volunteers. The primary pharmacodynamic endpoints in the trial are weight loss and reduction in liver fat, outcomes that have been associated with NASH resolution and fibrosis improvement in advanced clinical studies of other NASH therapeutics. The Company has successfully completed the initial phases of the study and anticipates a data read-out from the 6-week MAD study in Q2 2021, followed by 12-week data in Q3 2021.

Amended clinical trial protocol to extend MAD cohorts to incorporate 12-week Phase 1b study in Australia
Altimmune amended the clinical trial protocol for the ALT-801 Phase 1 clinical development program to incorporate its planned 12-week extension trial in patients with non-alcoholic fatty liver disease or NAFLD within the ongoing Phase 1 SAD/MAD trial in Australia. The Company believes that by incorporating the 12-week extension into this trial, it can avoid any potential impact of COVID-19 and maintain study timelines. Pending the results of this trial, Altimmune plans to transition rapidly to a 52-week, Phase 2, biopsy-trial based on NASH endpoints in early 2022. In parallel with these efforts, Altimmune continues to plan to file an Investigational New Drug (IND) application for ALT-801 in the United States in mid-2021.

Initiated chronic toxicology studies of ALT-801 to enable 52-week Phase 2 clinical study
Altimmune completed 6-week and 13-week GLP toxicology studies of ALT-801 with no significant toxicity or GI adverse events. The Company has initiated 6-month and 9-month GLP toxicology studies to support the planned 52-week biopsy-driven Phase 2 trial planned for early 2022.

T-COVID:

Completed Cohorts 1 and 2 in the Phase 1/2 trial of T-COVID in patients with early COVID-19
Altimmune, working with the Department of Defense, has completed the two safety cohorts in the EPIC (Efficacy and Safety of T-COVID in the Prevention of Clinical Worsening in COVID-19) study, a Phase 1/2 clinical trial of T-COVID, an investigational intranasally-administered therapeutic for the treatment of early COVID-19 infection. The trial is being overseen by an independent Data Safety Monitoring Committee, and no significant safety findings have been observed to date.

Cohort 3 is an efficacy and safety cohort that will include patients at higher-risk for severe COVID-19 infection, such as those 65 years or older, or those with one or more risk factors for severe COVID-19 complications. To ensure that a sufficient number of higher risk patients are enrolled, the study protocol was recently modified to require that a minimum number of patients meet one or more of these criteria in this final cohort. Additional enrichments of the study population are currently being evaluated to increase the event rates in the trial. While these modifications could extend the study timeline, the Company believes they could significantly enhance the probability of a meaningful trial outcome. Based on these changes, data from this trial is now expected in Q2 2021.

HepTcell:

Commenced dosing in a multinational Phase 2 clinical trial of HepTcell
In December, Altimmune began a multinational Phase 2 clinical trial of HepTcell, which is being conducted in the United States, Canada and Europe. The trial is a double-blind, randomized, placebo-controlled trial of 80 adult patients with HBeAg-negative inactive CHB and HBsAg ≤ 100 IU/mL.

HepTcell will be administered in 6 doses at 4-week intervals for 24 weeks, and patients will be followed for one year to evaluate safety and durability of response. The primary efficacy endpoint is virological response, defined as a 1-log reduction in HBsAg levels from baseline. Secondary efficacy endpoints include reactivation of anti-HBV T cell responses, HBsAg clearance, and other assessments of virologic response. Altimmune anticipates a data read-out from this trial in 1H 2022.

Financial Results for the Year Ended December 31, 2020

Altimmune had cash, cash equivalents and short-term investments of $216.0 million at December 31, 2020 compared to $37.3 million at December 31, 2019. The increase of $178.7 million is attributable to $213.5 million of net receipts during the year due primarily to its 2020 public offering, full utilization of the at-the-market offering program, and receipts from warrant exercises, offset by $34.4 million of cash used for operating activities.
Revenue was $8.2 million for the year ended December 31, 2020 compared to $5.8 million in the prior year period, an increase of $2.4 million. The change was primarily due to an increase in revenue under the Company’s U.S. government contracts due to timing of manufacturing and clinical trials for the NasoShield and T-COVID programs.
Research and development expenses were $49.8 million for the year ended December 31, 2020, compared to $17.8 million in the prior year period, representing an increase of $32.0 million. The increase was primarily attributable to increased costs related to development of AdCOVID, T-COVID and ALT-801 and an increase in the contingent liability for stock-based milestone payments associated with the acquisition of ALT-801.
General and administrative expenses were $13.2 million for the year ended December 31, 2020 compared to $8.5 million in the prior year period, an increase of $4.7 million. The increase is attributable to additional employee compensation as Altimmune’s workforce grew in 2020 along with an increase in professional costs.
Income tax benefit was $5.4 million for the year ended December 31, 2020, as compared to $59,000 for the same period in 2019. The increase is attributable to the Coronavirus Aid, Relief, and Economic Security Act (the "CARES Act") passed on March 27, 2020 which made temporary changes regarding the utilization and carry back of net operating losses.
Net loss attributed to common stockholders for the year ended December 31, 2020 was $49.0 million, or $1.91 net loss per share, compared to $21.0 million in the prior year, or $1.60 net loss per share. The difference in net loss is primarily attributable to higher research and development expenses and general and administrative expenses, offset by higher revenue and an increase in income tax benefit.
Conference Call Information

Following the conclusion of the call, the webcast will be available for replay on the Investor Relations page of the Company’s website at www.altimmune.com. The company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

LIDDS Interim report January – December 2020

On February 25, 2021 LIDDS reported that Interim report January – December 2020 (Press release, Lidds, FEB 25, 2021, View Source [SID1234575741])

JANUARY – DECEMBER 2020

Net sales amounted to MSEK 0.3 (0.0)
Operating expenses amounted to MSEK -33.0 (-31.4)
Profit/loss before and after tax amounted to MSEK -32.3 (-31.4)
Earnings per share amounted to SEK -1.20 (-1.34)
Cash flow from operating activities amounted to MSEK -27.4 (-31.2)
Equity amounted to MSEK 42.8 (15.5) and the debt/equity ratio was 79% (72%)
OCTOBER – DECEMBER 2020

Net sales amounted to MSEK 0.3 (0.0)
Operating expenses amounted to MSEK -12.9 (-8.5)
Profit/loss before and after tax amounted to MSEK -12.5 (-8.5)
Earnings per share amounted to SEK -0.42 (-0.36)
Cash flow from operating activities amounted to MSEK -10.1 (-9.8)
Equity amounted to MSEK 42.8 (15.5) and the debt/equity ratio was 79% (72%)
SIGNIFICANT EVENTS DURING THE FORTH QUARTER 2020

Intratumoral injection of NZ-TLR9, NanoZolid formulation of a Toll-Like Receptor 9 (TLR9), results in strong antitumoral efficacy combined with prominent antitumoral immune responses in mouse tumor models. NZ-TLR9 forms an intratumoral depot which releases the TLR9 agonist for least 6 weeks and thus minimizes the need for repeated injections.
The warrants programme was finalized in October 2020 and 0.8 percent of the warrants issued was exercised.
A newly revised guideline from the Chinese National Medical Products Administration (NMPA) has extended the requirements to a full registration dossier for the conditional market approval (CMA). LIDDS licensee Jiangxi Puheng Pharma is therefore aiming to submit the application for CMA for the prostate cancer drug candidate Liproca Depot in China during Q1, 2021.
A review article in OncoTargets and Therapy journal defines LIDDS as a key player in TLR9 agonist research field and being the only provider having a sustained release product in development.
LIDDS announced that the company will apply for a relisting of its shares from Nasdaq First North to Nasdaq Stockholm Main Market in 2021.
Nina Herne will assume the role of CEO for LIDDS as from April 19, 2021. Monica Wallter will continue in LIDDS as Senior Adviser.
SIGNIFICANT EVENTS FOLLOWING THE END OF THE PERIOD

The Phase I study where NanoZolid is combined with docetaxel continues with dose escalation. New patients are in recruitment to receive injection in solid tumors with new dose of docetaxel.
European Urology Focus has accepted a scientific article describing LIDDS Phase IIb study results with Liproca Depot.
LIDDS has filed a patent application for local intracranial treatment of brain tumors. The NanoZolid technology enables controlled and sustained release of oncology drugs. Preclinical study has showed that NanoZolid injected as a depot in brain is tolerable and safe.
LIDDS has signed a manufacturing agreement for NZ-TLR9 with Pharmidea in Latvia.

The interim report is available on the company’s website, go to View Source