On March 31, 2022 Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on oncology and rare diseases, reported financial results for the year ended December 31, 2021 and provided an update on recent corporate highlights (Press release, Mereo BioPharma, MAR 31, 2022, View Source [SID1234611291]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"During 2021, we continued to execute on all fronts and made substantial progress across our pipeline. We further advanced our etigilimab anti-TIGIT program, reporting highly promising interim data from the ongoing ACTIVATE Phase 1b/2 study and expanded our research to include clear-cell ovarian cancer through our partnership with Cancer Focus Fund and MD Anderson," said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "In addition, we reported positive data from multiple studies of alvelestat, which also received orphan drug designation for the treatment of AATD. We ended the year well positioned for further success in 2022, with a strong balance sheet supported by the proceeds of our public offering early last year. Following our accomplishments in 2021, we look forward to our upcoming catalysts in 2022."

Highlights from 2021 and Recent Developments

Etigilimab (MPH-313)

Reported interim data in Q4 2021 from ACTIVATE Phase 1b/2 open label study of etigilimab anti-TIGIT antibody in combination with nivolumab in solid tumors
Based on analysis of 15 patients in the efficacy analysis set with a minimum of one scan to-date or clinical progression, those receiving the etigilimab / nivolumab combination have achieved one complete response in cervical cancer, one partial response in ovarian cancer and four instances of stable disease in ovarian cancer, cervical and uveal melanoma
Well tolerated with a favorable safety profile
Ongoing Phase 1b/2 basket combination study continues to enroll well
Update on additional patients and durability of initial responses expected in Q2 2022
Alvelestat (MPH-966)

Received orphan designation from the FDA for the treatment of AATD
Held an R&D Day update on the alvelestat programs in Q1 2022, including in the ongoing Phase 2 trial which enrolled 99 patients with AATD
Data expected in early Q2 2022
Reported positive bio-marker data from investigator-sponsored Phase 1b/2 study of alvelestat in patients with BOS following hematopoietic stem cell transplantation
Reported positive top-line results from Phase 1b/2 trial in hospitalized patients with COVID-19 respiratory disease; Alvelestat, on top of standard of care, resulted in a more rapid time to improvement in WHO Disease Severity score in the first 5-7 days compared to placebo plus standard of care.
Corporate Updates

Partnerships

Announced partnership with the Cancer Focus Fund supporting a Phase 1b/2 clinical study of etigilimab in combination with nivolumab in clear cell ovarian cancer to be conducted at The University of Texas MD Anderson Cancer Center
Ultragenyx expects to enroll the first patient in the Phase 2/3 study of setrusumab in 5–25 year-olds with osteogenesis imperfecta in 1H 2022
Public Offering of American Depositary Shares

Public offering gross proceeds of $115.1 million in Q1 2021
Strengthened Board of Directors

Pierre Jacquet, M.D., Ph.D. appointed to Board of Directors, September 2021
Anne Hyland appointed to Board of Directors, March 2022
Full Year 2021 Financial Results
Revenue was £36.5 million in 2021, representing the upfront payment under the licensing and collaboration agreement with Ultragenyx in January 2021 for the development and commercialization of setrusumab for OI.

Full year 2021 research and development expenses were £23.6 million, compared to £16.3 million in 2020, an increase of £7.2 million, or 44%. R&D expenses relating to etigilimab increased by £12.5 million. The increase was due to the costs associated with commencement of the open label Phase 1b/2 basket study in combination with nivolumab in a range of tumor types. R&D expenses relating to alvelestat increased £0.6 million, or 13%, primarily related to the ongoing Phase 2 proof-of-concept study. Partially offsetting the increases, R&D expenses relating to setrusumab and navicixizumab decreased by £4.1 million and £1.7 million, respectively. The decrease related to setrusumab was primarily driven by the licensing and collaboration agreement with Ultragenyx, under which Ultragenyx will fund global development of the program, and the decrease related to navicixizumab was driven by the global out-licensing agreement with OncXerna for the development and commercialization of navicixizumab.

Administrative expenses decreased by £5.3 million, or 25%, from £21.2 million in 2020 to £15.9 million in 2021. The decrease was primarily driven by a £4.0 million reduction in legal and professional fees in 2021, reflecting lower activity and related transaction costs in 2021 compared to 2020. Premises-related costs decreased by £1.3 million in 2021 primarily due to one-off transaction costs in 2020 associated with renegotiation of our office lease in Redwood City.

Net profit attributable to equity holders for the year 2021 was a net profit of £12.7 million, compared to a net loss of £163.6 million in 2020, reflecting an operating loss of £20.9 million and a gain of £40.0 million, due to changes in the fair value of financial instruments resulting from an unrealized gain on warrants.

Total ordinary shares outstanding at December 31, 2021 were approximately 585 million. Total ADSs outstanding at December 31, 2021 were approximately 116.5 million, with each ADS representing five ordinary shares of the Company.

Cash and short-term deposits totaled £94.3 million at December 31, 2021.

On March 31, 2022 Idera Pharmaceuticals, Inc. ("Idera," the "Company," "we," "us," or "our") (Nasdaq: IDRA) reported its financial and operational results for the fourth quarter and year ended December 31, 2021 (Press release, Idera Pharmaceuticals, MAR 31, 2022, View Source [SID1234611290]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are actively identifying and evaluating new development or commercial-stage assets for Idera’s portfolio while we continue to preserve cash," stated Vincent Milano, Idera’s Chief Executive Officer. "In addition, we have asked JMP Securities, a Citizens Company, our current partner and advisor on business development activities, to expand their current scope of work beyond acquisition or in-licensing opportunities to include additional strategic alternatives for the Company."

Fourth Quarter Financial Results
Our cash position as of December 31, 2021 was $32.5 million. Based on our current operating plan, we anticipate that our current cash and cash equivalents will fund our operations through the one-year period subsequent to the March 31, 2022 filing date of the Annual Report Form 10-K.

Research and development expenses for the three months ended December 31, 2021 totaled $2.1 million, compared to $5.1 million for the same period in 2020. General and administrative expense for the three months ended December 31, 2021 totaled $2.0 million, compared to $2.9 million for the same period in 2020.

Additionally, during the three months ended December 31, 2020, we recorded $3.2 million and $65.4 million non-cash warrant revaluation loss and non-cash future tranche right revaluation loss, respectively, related to the change in fair value of securities issued in connection with our December 2019 private placement transaction. No such non-cash losses were recognized in the three months ended December 31, 2021, as the warrants and future tranche rights were terminated in the first quarter of 2021.

As a result of the factors above, net loss applicable to common stockholders for the three months ended December 31, 2021 was $4.1 million or $0.08 per basic and diluted share compared to net loss applicable to common stockholders of $76.7 million or $2.11 per basic and diluted share for the same period in 2020. Excluding the non-cash loss of approximately $68.6 million for the three months ended December 31, 2020 related to the change in fair value of securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $8.1 million.

Full Year Results
Research and development expenses for the year ended December 31, 2021 totaled $16.4 million compared to $24.8 million for the same period in 2020. General and administrative expenses for the year ended December 31, 2021 totaled $10.0 million compared to $11.9 million for the same period in 2020. Restructuring costs for the year ended December 30, 2021 totaled approximately $1.3 million and relate to a reduction in force initiated in April 2021 to better align our workforce to our ongoing operational and business development activities. No such restructuring costs were incurred during 2020.

Additionally, during the year ended December 31, 2021 we recorded $7.0 million and $118.8 million non-cash warrant revaluation gain and non-cash future tranche right revaluation gain, respectively, related to the termination of securities issued in connection with our December 2019 private placement transaction in the first quarter of 2021. The losses of non-cash warrant revaluation and non-cash future tranche right revaluation were $3.7 million and $72.4 million, respectively, for the same period in 2020.

As a result of the factors above, net income applicable to common stockholders for the year ended December 31, 2021 was $96.9 million or $1.97 per basic share compared to net loss applicable to common stockholders of $112.7 million or $3.33 per basic share for 2020. On a diluted basis, net loss applicable to common stockholders for the year ended December 31, 2021 was $28.8 million or $0.58 per diluted share compared to net loss applicable to common stockholders of $112.7 million or $3.33 per diluted share for 2020.

Excluding the non-cash gain of approximately $125.8 million related to the termination of securities issued in connection with the December 2019 private placement transaction in the first quarter of 2021, net loss applicable to common stockholders for the year ended December 31, 2021 was $28.8 million. Excluding the non-cash loss of approximately $76.1 million related to the change in fair value of securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders for the year ended December 31, 2020 was $36.6 million.

On March 31, 2022 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that it has commenced an underwritten public offering of shares of its common stock and warrants to purchase shares of its common stock (Press release, Sellas Life Sciences, MAR 31, 2022, View Source [SID1234611289]). All of the securities in the offering will be sold by SELLAS.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

SVB Leerink and Cantor are acting as joint book-running managers for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The public offering will be made pursuant to a shelf registration statement on Form S-3 (File No. 333-255318) that was previously filed with the Securities and Exchange Commission (the "SEC") on April 16, 2021 and declared effective on April 29, 2021. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at View Source The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained, when available, from SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected] or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 4th Floor, New York, NY 10022, or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On March 31, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, and GenFleet Therapeutics (Shanghai), Inc. ("GenFleet"), a clinical-stage biotechnology company developing cutting-edge therapeutics in oncology and immunology, reported that the companies have entered into an exclusive license agreement that grants rights to SELLAS for the development and commercialization of GFH009, a highly selective small molecule cyclin-dependent kinase 9 ("CDK9") inhibitor, across all therapeutic and diagnostic uses worldwide outside of Greater China (mainland China, Hong Kong, Macau and Taiwan) (Press release, Sellas Life Sciences, MAR 31, 2022, View Source [SID1234611288]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

GFH009, currently in Phase 1 clinical trials in the United States and China, is a highly selective next-generation CDK9 inhibitor. CDK9 activity has been shown to negatively correlate with overall survival in a number of cancer types, including hematologic cancers, such as acute myeloid leukemia ("AML") and lymphomas, as well as solid cancers, such as osteosarcoma, pediatric soft tissue sarcomas, and melanoma, and endometrial, lung, prostate, breast and ovarian cancer. As demonstrated in pre-clinical and clinical data, to date, GFH009’s high selectivity has the potential to reduce toxicity as compared to older CDK9 inhibitors and other next-generation CDK9 inhibitors currently in clinical development. The Company believes, based on the initial pharmacokinetic data of the ongoing Phase 1 dose-escalating clinical trial, that the administration of GFH009 leads to lower toxicity and more potent efficacy due to its unique mechanism of action. Thus far in the Phase 1 clinical trial, which is planned to enroll approximately 80 patients, including an expansion part 2 of the study, and which is at the fourth of six doses, stable disease has been observed in three patients and, in one AML patient, a bone marrow blast decrease from 40% to 20% was observed at 9 mg, which is the third of six dose levels.

"SELLAS’ license agreement with GenFleet marks a pivotal milestone for the Company as we expand and diversify our clinical pipeline with GFH009 and progress it toward commercialization," said Angelos Stergiou, M.D., Sc.D. h.c., President and CEO of SELLAS. "There is significant interest in CDK9 inhibitors in the industry, and we are extremely excited to have the opportunity to develop GFH009. Not only has GenFleet advanced the molecule to clinical trials, but the asset also has attributes that can potentially make it best-in-class. Working with GenFleet brings together two companies with complementary skill sets: GenFleet is a leader in cutting-edge drug discovery, and SELLAS’ focus and expertise is in clinical development and commercialization of oncology drugs for a range of indications, particularly hematological malignancies. In early 2023, we plan to initiate a Phase 2 clinical trial with GFH009 in combination with venetoclax in AML, a cancer we know quite well as it is the indication of our registrational study for galinpepimut-S ("GPS"), our lead asset. We also plan to initiate a Phase 1/2 basket study in pediatric soft tissue sarcomas in late 2022 or early 2023 where there is a pressing unmet medical need and where GFH009 could potentially contribute to extending the lives of the afflicted children."

Dr. Stergiou continued, "SELLAS and GenFleet both strive on a daily basis to meet the unmet medical needs of patients all over the world who are suffering from cancer, and this license agreement reflects our joint commitment to developing novel, more tolerable treatment options for these patients and their families/caregivers. Additionally, we believe GenFleet’s track record of success suggests that GFH009 has the potential to bring to SELLAS the ability to address many indications in a cost- and time-effective manner."

"SELLAS’ excellence in execution, as well as its expertise and capabilities in clinical development, especially in AML and other hematological and solid cancers, will help GenFleet to maximize the value of this asset," concluded Qiang Lu, PhD, Chairman of GenFleet Therapeutics. "We are pleased that GFH009, one of the leading assets in our first-in-class portfolio, will now be developed and commercialized on a worldwide basis, with numerous trials planned in 2023, thus potentially benefiting patients not only in China but also those throughout the world."

Following completion of the Phase 1 clinical trial and achievement of a maximum tolerated dose, SELLAS plans to commence a Phase 2 clinical trial of GFH009 in combination with venetoclax and azacitidine in AML patients with active disease. The current standard of care for the vast majority of AML patients, including older patients, is venetoclax in combination with a hypomethylating agent such as azacitidine. GFH009 has shown in preclinical models a strong synergy with venetoclax. The Company believes that GFH009 has the potential to improve response to venetoclax or possibly convert resistance to venetoclax into a response and that the program will not only be a synergistic, but also an integral complement to the Company’s program for GPS in AML patients. The Company also plans to commence a Phase 1/2 basket clinical trial of monotherapy GFH009 in pediatric soft tissue sarcomas, including Ewing’s sarcoma and rhabdomyosarcoma, in late 2022 or early 2023, which it expects to be completed by the end of 2023. Positive results from this program could ultimately provide the basis for a rare pediatric disease priority voucher. GenFleet plans to commence several Phase 2 studies in China for various hematological malignancies.

Under the financial terms of the agreement, SELLAS will pay to GenFleet (i) an initial payment of $10 million as an upfront license and technology transfer fee, a portion of which is payable within 30 days of the execution of the license agreement with the remainder due upon the completion of the technology transfer, (ii) development and regulatory milestone payments for up to three indications totaling up to $48 million in the aggregate, and (iii) milestone payments totaling up to $92 million in the aggregate upon the achievement of certain net sales thresholds of GFH009 in the United States and rest of the world other than Greater China in a given calendar year. SELLAS will also pay GenFleet tiered royalties based on a percentage of annual net sales of GFH009 ranging from the low to high single digits.

SELLAS plans to host a R&D Day for analysts, investors and media in the second quarter of 2022. More information will be provided soon.

On March 31, 2022 AIM ImmunoTech Inc. (NYSE: American AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported its financial results for the full year 2021 and provided a business update (Press release, AIM ImmunoTech, MAR 31, 2022, View Source [SID1234611287]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We believe 2021 was an important, foundational year for AIM. Our oncology pipeline continued to develop and generate important data across our clinical programs. This progress has substantially and positively impacted our growing body of data – data which continues to be consistent with key findings across multiple indications. Importantly, this data provides valuable guidance as we are identifying the clear pathways for next steps with Ampligen, as a monotherapy as well as its utility as a combination therapy, in high-value indications with the potential to fill significant gaps in various treatment paradigms," commented Thomas Equels, Chief Executive Officer of AIM. "So far, in 2022 Ampligen data has been published in peer-reviewed journals and multiple abstracts and posters have been accepted at prestigious scientific congresses, representing noteworthy progress across our pipeline. Over the course of 2022, we expect to achieve a number of additional potentially value-driving clinical, regulatory and operational catalysts. Our team is laser focused on executing on our strategy and propelling AIM toward its next phase of growth."

Recent Highlights

Received notification from the U.S. Food and Drug Administration ("FDA") that the FDA’s Clinical Hold on AIM’s investigational new drug ("IND") application for a Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer (AMP-270) has been lifted and the Company may proceed with the study.
Announced the publication of positive data from a single-center, named-patient program treating advanced and metastatic pancreatic cancer patients.
Announced the strategic sale of its facility located in New Brunswick, New Jersey for a purchase price of $3.9 million.
Appointed Robert Dickey IV as Chief Financial Officer, effective April 4, 2022.
Announced the publication of positive results from Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer.
Clinical Program Update

Ampligen (rintatolimod): dsRNA being developed for globally important cancers, viral diseases and disorders of the immune system

Ampligen has demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors. Additionally, Ampligen has shown success in increasing survival rates and efficacy in the treatment of animal tumors when used in combination with checkpoint blockade therapies. Ampligen is being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the country. Ampligen is also being used as a monotherapy to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center.

Immuno-Therapy Targeting Multiple Cancers with High Unmet Need

Advanced Recurrent Ovarian Cancer – Phase 1 portion was completed. A follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin and pembrolizumab, plus Ampligen; up to 45 patients to be enrolled; numerous patients have commenced treatment. ClinicalTrials.gov: NCT03734692
Stage 4 Colorectal Cancer Metastatic to the Liver – Phase 2a study of Ampligen as a component of a chemokine modulatory regimen on colorectal cancer metastatic to liver has been completed; 15 patients were enrolled and treated. Data was accepted for a late-breaking presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 being held April 8-13, 2022 and are under embargo until then. ClinicalTrials.gov: NCT03403634
Stage 4 Metastatic Triple Negative Breast Cancer – Phase 1/2 study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab. Eight patients were enrolled and treated. Data was accepted for a late-breaking presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 being held April 8-13, 2022 and are under embargo until then. ClinicalTrials.gov: NCT03599453
Early-Stage Prostate Cancer – Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy. Patient enrollment has been initiated in this study designed for up to 45 patients. ClinicalTrials.gov: NCT03899987
Early-Stage Triple Negative Breast Cancer – Phase 1 study of chemokine modulation plus neoadjuvant chemotherapy in patients with early-stage triple negative breast cancer has received FDA authorization. The objective of this study is to evaluate the safety and tolerability of a combination of Ampligen and celecoxib with or without Intron A, when given along with chemotherapy. The goal of this approach is to increase survival. This study is recruiting patients and is designed for up to 24 patients. ClinicalTrials.gov: NCT04081389
Refractory Melanoma – Phase 2 study that will evaluate polarized dendritic cell vaccine, interferon alpha-2, Ampligen and celecoxib for the treatment of HLA-A2+ refractory melanoma at Roswell Park. Up to 24 patients to be enrolled. ClinicalTrials.gov: NCT04093323
Advanced Ovarian Cancer – AIM plans to develop a Phase 2 Cisplatin Resistant Advanced Recurrent Ovarian Cancer Clinical Study utilizing Ampligen at the University of Pittsburgh.
Broad-Spectrum Immune System Response Against SARS-CoV-2 (COVID-19)

Previous animal studies yielded positive results utilizing Ampligen to treat Western Equine Encephalitis Virus, Ebola and SARS-CoV-1. The Company has conducted experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication. The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2. AIM is currently evaluating the safety and effectiveness of intravenous Ampligen to reduce replication of SARS-CoV-2 virus from upper airway in patients in an ongoing Phase 1/2 study for the treatment of COVID-19 cancer patients. The Company plans to conduct an intranasal study of Ampligen to potentially enhance and expand natural immunity.

Immune System Disorders (ISD): Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) / COVID-19 Long Hauler

The Company is currently sponsoring an expanded access program (EAP) for ME/CFS patients in the United States, and in 2021 AIM dosed its first "Long Hauler" patient with Ampligen in its post-COVID-19 "Long Hauler" portion of the active AMP-511 EAP in the United States. Early data from the ongoing AMP-511 EAP and data from an earlier study, AMP-502, has indicated that patients with cognitive function deficiency have reported improvements in cognitive function after Ampligen treatment.

Summary of Recent Ampligen Data Publications

Abstracts accepted for presentation at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, being held April 8-13, 2022:
Negative impact of paclitaxel on human breast tumor microenvironment and its reversal by the combination of interferon-α with TLR3 agonist rintatolimod
Initial results of a phase II study evaluating a chemokine-modulatory (CKM) regimen in patients with colorectal cancer metastatic to the liver
Systemic Rintatolimod and Interferon-α2b selectively reprogram local tumor microenvironment in patients with metastatic triple negative breast cancer for enhanced influx of cytotoxic T-lymphocytes but not regulatory T-cells
Combined loco-regional and systemic, triple agent chemoimmunotherapy increases biomarkers of T cell chemotaxis in ovarian cancer
Positive data from a single-center named patient program was published in March 2022. The manuscript titled, "Rintatolimod (Ampligen) enhances numbers of peripheral B cells and is associated with longer survival in patients with locally advanced and metastasized pancreatic cancer pre-treated with FOLFIRINOX: a single-center named patient program1," was published in the peer-reviewed journal, Cancers Special Issue: Combination and Innovative Therapies for Pancreatic Cancer.
Positive results of a Phase 1/2 study of intraperitoneal chemo- immunotherapy in advanced recurrent ovarian cancer were published in January 2022. The manuscript titled, "Phase I trial combining chemokine-targeting with loco-regional chemo-immunotherapy for recurrent, platinum-sensitive ovarian cancer shows induction of CXCR3 ligands and markers of type 1 immunity2" was published in the American Association for Cancer Research (AACR) (Free AACR Whitepaper) publication, Clinical Cancer Research.
Rintatolimod Induces Antiviral Activities in Human Pancreatic Cancer Cells: Opening for an Anti-COVID-19 Opportunity in Cancer Patients?
Phase II Trial of Adjuvant Dendritic Cell Vaccine in Combination with Celecoxib, Interferon-α, and Rintatolimod in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Metastases
Summary of Financial Highlights for Fiscal Year 2021

As of December 31, 2021, AIM reported cash and cash equivalents of $48.3 million, compared to $54.4 million as of December 31, 2020.
Research and development expenses for the year ended December 31, 2021 were $7.6 million, compared to $5.7 million for the year ended December 30, 2020.
General and administrative expenses for the year ended December 31, 2021 were $8.7 million, compared to $8.7 million for the year ended December 31, 2020.
The net loss from operations for the year December 31, 2021 was $19.1 million, or $0.40 per share, compared to $14.4 million, or $0.45 per share, for the year ended December 31, 2020.