On May 16, 2022 Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences," HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported that the China National Medical Products Administration (NMPA) has approved the supplemental new drug application (sNDA) for toripalimab in combination with paclitaxel and cisplatin in the first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC). The sNDA was accepted by the NMPA in July 2021. This is the fifth indication approved for toripalimab in China and will benefit Chinese patients with advanced ESCC.

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!

The approval of the sNDA is based on results from the JUPITER-06 study (NCT03829969), a randomized, double-blind, placebo-controlled, multi-center Phase III clinical study. JUPITER-06 compared the efficacy and safety of toripalimab in combination with TP chemotherapy (paclitaxel + cisplatin) and placebo in combination with TP chemotherapy in the first-line treatment of patients with advanced or metastatic ESCC. The study results showed that, compared with chemotherapy alone, toripalimab in combination with TP chemotherapy demonstrated a statistically significant increase in survival benefits, with median overall survival (mOS) significantly extended to 17 months, progression-free survival (PFS) to 5.7 months, disease progression or mortality risk reduced by 42% (HR=0.58, P<0.0001), and patients benefiting regardless of their PD-L1 expression. In terms of safety, no new safety signal was found when adding toripalimab to the chemotherapy treatment. The results of JUPITER-06 were published in Cancer Cell.

"China is one of the countries with the highest incidence of esophageal cancer," said Professor Ruihua Xu from Sun Yat-sen University Cancer Center, the principal investigator of JUPITER-06. "However, due to the differences between Eastern and Western patients in terms of cause of the disease and pathological characteristics, clinical evidence for innovative treatments specifically targeting the main subtypes of ESCC in China is relatively lacking. JUPITER-06 has demonstrated that a PD-1 inhibitor independently developed in China, combined with a TP chemotherapy regime, is more suitable for Chinese clinical practice. The results, to our surprise, were overwhelmingly positive. PFS and OS improved so significantly that patients broke the record in the survival of advanced ESCC in first-line treatment. This ‘China Protocol’ is a major contribution to the international field of immunotherapy."

"The symptoms of early esophageal cancer patients are insidious and difficult to be detected. Many patients are already at advanced stages when they are diagnosed initially. However, chemotherapy, the standard first-line treatment for advanced ESCC, has a poor prognosis," said Dr. Jianjun Zou, Global Research and Development President at Junshi Biosciences. "Through our combined efforts with JUPITER-06 investigators and participating patients, the study confirmed that toripalimab combined with chemotherapy significantly increases treatment efficacy. We look forward to bringing the better treatment option to these patients in China and will also actively communicate with regulatory agencies in other countries to make this innovative therapy beneficial to patients all over the world."

"We are excited that the approval of the new indication of first-line treatment of advanced ESCC for toripalimab allows us to bring our immuno-oncology therapy to more patients, including those with low PD-L1 expressing tumors for whom available checkpoint inhibitors appear to be less effective," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "We will continue to focus on exploring the potential of I-O drugs in treating tumors with unmet medical needs."

About Esophageal Cancer
Esophageal cancer is one of the most common malignant tumors in alimentary tract. According to data released by GLOBOCAN 2020, in 2020, 320,000 new esophageal cancer cases and 300,000 deaths due to esophageal cancer occurred in China, both accounting for more than half of the global total. The incidence and death rates of esophageal cancer ranked fifth and fourth among all domestic malignant tumors respectively. ESCC and esophageal adenocarcinoma are the two main histological subtypes of esophageal cancer. ESCC is the main subtype in China, accounting for approximately 90% of all esophageal cancer cases. For patients with advanced ESCC, the current standard first-line treatment is often the platinum-based chemotherapy, but the clinical benefit is limited, and the 5-year overall survival rate remains less than 20%. Therefore, there is an urgent unmet need for new drugs and treatments to extend the survival of patients.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.

More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). Currently, there are five approved indications for toripalimab in China:

unresectable or metastatic melanoma after failure of standard systemic therapy;
recurrent or metastatic nasopharyngeal carcinoma NPC after failure of at least two lines of prior systemic therapy;
locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;
in combination with paclitaxel and cisplatin as the first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic ESCC.
The first three indications have been included in the National Reimbursement Drug List ("NRDL") (2021 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for melanoma and NPC.

In addition, a sNDA Application for toripalimab is currently under review by the NMPA in China:

in combination with chemotherapy as the first-line treatment of patients with advanced or metastatic NSCLC without EGFR or ALK mutations.
In the United States, the FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. Junshi Biosciences and Coherus plan to resubmit a Biologics License Application (BLA) for toripalimab for advanced NPC by mid-summer 2022. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug Designation for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and SCLC. In 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Junshi Biosciences and Coherus plan to file additional toripalimab BLAs with the FDA over the next several years for multiple other cancer types.

(Press release, Shanghai Junshi Bioscience, MAY 16, 2022, View Source [SID1234663443])

On May 16, 2022 Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences," HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported that the China National Medical Products Administration (NMPA) has approved the supplemental new drug application (sNDA) for toripalimab in combination with paclitaxel and cisplatin in the first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC). The sNDA was accepted by the NMPA in July 2021. This is the fifth indication approved for toripalimab in China and will benefit Chinese patients with advanced ESCC.

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!

The approval of the sNDA is based on results from the JUPITER-06 study (NCT03829969), a randomized, double-blind, placebo-controlled, multi-center Phase III clinical study. JUPITER-06 compared the efficacy and safety of toripalimab in combination with TP chemotherapy (paclitaxel + cisplatin) and placebo in combination with TP chemotherapy in the first-line treatment of patients with advanced or metastatic ESCC. The study results showed that, compared with chemotherapy alone, toripalimab in combination with TP chemotherapy demonstrated a statistically significant increase in survival benefits, with median overall survival (mOS) significantly extended to 17 months, progression-free survival (PFS) to 5.7 months, disease progression or mortality risk reduced by 42% (HR=0.58, P<0.0001), and patients benefiting regardless of their PD-L1 expression. In terms of safety, no new safety signal was found when adding toripalimab to the chemotherapy treatment. The results of JUPITER-06 were published in Cancer Cell.

"China is one of the countries with the highest incidence of esophageal cancer," said Professor Ruihua Xu from Sun Yat-sen University Cancer Center, the principal investigator of JUPITER-06. "However, due to the differences between Eastern and Western patients in terms of cause of the disease and pathological characteristics, clinical evidence for innovative treatments specifically targeting the main subtypes of ESCC in China is relatively lacking. JUPITER-06 has demonstrated that a PD-1 inhibitor independently developed in China, combined with a TP chemotherapy regime, is more suitable for Chinese clinical practice. The results, to our surprise, were overwhelmingly positive. PFS and OS improved so significantly that patients broke the record in the survival of advanced ESCC in first-line treatment. This ‘China Protocol’ is a major contribution to the international field of immunotherapy."

"The symptoms of early esophageal cancer patients are insidious and difficult to be detected. Many patients are already at advanced stages when they are diagnosed initially. However, chemotherapy, the standard first-line treatment for advanced ESCC, has a poor prognosis," said Dr. Jianjun Zou, Global Research and Development President at Junshi Biosciences. "Through our combined efforts with JUPITER-06 investigators and participating patients, the study confirmed that toripalimab combined with chemotherapy significantly increases treatment efficacy. We look forward to bringing the better treatment option to these patients in China and will also actively communicate with regulatory agencies in other countries to make this innovative therapy beneficial to patients all over the world."

"We are excited that the approval of the new indication of first-line treatment of advanced ESCC for toripalimab allows us to bring our immuno-oncology therapy to more patients, including those with low PD-L1 expressing tumors for whom available checkpoint inhibitors appear to be less effective," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "We will continue to focus on exploring the potential of I-O drugs in treating tumors with unmet medical needs."

About Esophageal Cancer
Esophageal cancer is one of the most common malignant tumors in alimentary tract. According to data released by GLOBOCAN 2020, in 2020, 320,000 new esophageal cancer cases and 300,000 deaths due to esophageal cancer occurred in China, both accounting for more than half of the global total. The incidence and death rates of esophageal cancer ranked fifth and fourth among all domestic malignant tumors respectively. ESCC and esophageal adenocarcinoma are the two main histological subtypes of esophageal cancer. ESCC is the main subtype in China, accounting for approximately 90% of all esophageal cancer cases. For patients with advanced ESCC, the current standard first-line treatment is often the platinum-based chemotherapy, but the clinical benefit is limited, and the 5-year overall survival rate remains less than 20%. Therefore, there is an urgent unmet need for new drugs and treatments to extend the survival of patients.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.

More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). Currently, there are five approved indications for toripalimab in China:

unresectable or metastatic melanoma after failure of standard systemic therapy;
recurrent or metastatic nasopharyngeal carcinoma NPC after failure of at least two lines of prior systemic therapy;
locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;
in combination with paclitaxel and cisplatin as the first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic ESCC.
The first three indications have been included in the National Reimbursement Drug List ("NRDL") (2021 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for melanoma and NPC.

In addition, a sNDA Application for toripalimab is currently under review by the NMPA in China:

in combination with chemotherapy as the first-line treatment of patients with advanced or metastatic NSCLC without EGFR or ALK mutations.
In the United States, the FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. Junshi Biosciences and Coherus plan to resubmit a Biologics License Application (BLA) for toripalimab for advanced NPC by mid-summer 2022. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug Designation for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and SCLC. In 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Junshi Biosciences and Coherus plan to file additional toripalimab BLAs with the FDA over the next several years for multiple other cancer types.

(Press release, Shanghai Junshi Bioscience, MAY 16, 2022, View Source [SID1234663441])

On May 16, 2022 Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing small molecule immunotherapies in oncology, reported the appointment of Johan Baeck, MD, as Executive Vice President and Chief Medical Officer (Press release, Promontory Therapeutics, MAY 16, 2022, View Source [SID1234615802]). Dr. Baeck joins Promontory Therapeutics from Jounce Therapeutics where he served as Senior Vice President, Clinical Development and Medical Affairs.

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!

Joseph F. O’Donnell, MD, who previously served as Chief Medical Officer, will remain with Promontory Therapeutics and assume the role of Senior Medical Director focusing on patient eligibility, enrollment and clinical case management.

"We are especially pleased to welcome Dr. Baeck to the Promontory team. His extensive clinical development and medical affairs experience with both large pharmaceutical and smaller biotech companies complements our growth strategy," said Promontory President and Chief Executive Officer Robert Fallon. "In addition, Dr. Baeck’s strong background in immuno-oncology fits well with our focus on small molecule immunotherapy as we advance our lead agent, PT-112, in clinical trials for treating multiple cancer types, including prostate and lung cancers, and the rare disease of thymoma."

"I am excited to be part of a great group of dedicated, smart and driven people at Promontory," said Dr. Baeck. "The company is operating within the heart of the immuno-oncology field and new approaches will favor modalities with novel I-O mechanisms and single agent anti-cancer activity such as Promontory’s immunogenic cell death inducer, PT-112. The company is poised to make a major impact in the field."

Dr. Baeck completed his Medical Degree in Leuven, Belgium and was a practicing physician in Belgium before transitioning to the pharmaceutical industry. After many years with Abbott Laboratories and Novartis in key commercial, clinical development and medical affairs roles, as well as with smaller biotechs, he joined Immunocore as VP and Global Head of Medical Affairs and later Jounce Therapeutics. He has published in the immuno-oncology field and frequently speaks on recent I-O developments at key medical meetings.

On May 16, 2022 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company focused on advanced therapies for autoimmune and inflammatory diseases, reported financial results for the full year ended December 31, 2021, as well as recent pipeline progress (Press release, Akari Therapeutics, MAY 16, 2022, View Source [SID1234614778]).

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 the last twelve months, Akari has advanced nomacopan pre-clinical and clinical development programs, including three focus areas of autoimmune skin diseases, thrombotic microangiopathies, and progressive retinal diseases," said Rachelle Jacques, President and CEO of Akari Therapeutics. "Broad and deep research and development work is producing compelling science in diseases with complex pathologies and is providing the foundation for next steps in the development of bispecific recombinant nomacopan. Late-stage programs in pediatric HSCT-TMA and BP are active and advancing in Part A clinical studies, which will inform the pivotal Part B studies that will be the basis for potential regulatory submissions in the U.S. and Europe."

Full Year 2021 and Recent Clinical Highlights

Late-Stage Program Studying Investigational Nomacopan in Pediatric HSCT-TMA

Phase III Part A clinical trial sites are open and recruiting in the U.S. and Europe for investigation of nomacopan in pediatric HSCT-TMA.
Urgent unmet need exists in pediatric HSCT-TMA with no approved treatment options in the U.S. or Europe; currently the subset of patients Akari is studying are facing a mortality rate of ~80%
Nomacopan was granted Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) for pediatric HSCT-TMA
Patient dosing is underway in the Part A study that has a recruitment goal of approximately seven patients, with a minimum of two patients in each of three age cohorts
Late-Stage Program Studying Investigational Nomacopan in Bullous Pemphigoid (BP)

FDA and European Medicines Agency (EMA) registration-directed Phase III Part A study of nomacopan in moderate and severe BP patients is open for enrollment following resolution of third-party supply chain partner issues that resulted in delays. Data from the Part A study will inform the pivotal Part B study that will be the basis for potential regulatory submissions in the U.S. and Europe
There are no approved therapies; superpotent topical steroid and high dose oral corticosteroid (OCS) are the current standards of care
The mortality rate in BP is approximately three-fold higher than the general population due to the disease itself, and infections and cardiovascular conditions that are more common in older patients and are exacerbated by treatment with high dose OCS.1
There is significant unmet need for an effective steroid-sparing therapy.
Nomacopan was granted Orphan Drug and Fast Track designations by the FDA and Orphan Drug designation from the EMA for the treatment of BP
Results from the completed Phase II study of subcutaneous nomacopan in patients with mild to moderate BP were published online in JAMA Dermatology in May 2022
The Phase II study advanced understanding of the nomacopan safety profile and informed duration of treatment in the ARREST-BP Phase III Part A clinical trial, which is currently open for enrollment
The multi-center, single arm nonrandomized controlled Phase II study included nine patients newly diagnosed or recurrent patients with mild to moderate active BP
Patients received subcutaneous nomacopan (30 mg once daily) with lesional mometasone from Day 1 to 21 of treatment and nomacopan only from Day 21 to Day 42
Seven of nine patients responded to nomacopan with three, regarded as complete responders, showing >80% reduction in BPDAI (BP disease activity index) activity and four patients showing >70% reduction in pruritis by Day 42; two of nine patients were non-responders
None of the nine patients reported Common Terminology Criteria for Adverse Events (CTCAE) grade three, four or five treatment-related adverse events
A poster outlining the design of the Phase III study of nomacopan in patients with moderate to severe BP was presented at the 2021 International Pemphigus & Pemphigoid Foundation (IPPF) Scientific Symposium
Pre-Clinical Program Studying Investigational Long-Acting PAS-Nomacopan for Geographic Atrophy/Dry Age-Related Macular Degeneration (GA/dAMD)

Akari has conducted pre-clinical studies that explore the importance of the leukotriene B4 (LTB4)-VEGF axis and the potential role of nomacopan’s bispecific inhibition of both C5 and LTB4 in treating GA/dAMD
Studies have indicated that while certain complement inhibitors slow the progression of GA, they may also promote choroidal neovascularization (CNV), which can harm the macula, damage vision,2,3 and require VEGF rescue therapy
LTB4 is a potent leukotactic agent that can increase retinal vascular endothelial growth factor (VEGF) a key driver of CNV. Inhibition of LTB4 may decrease the risk of CNV.4
Akari has conducted pre-clinical studies that explore the importance of the LTB4-VEGF axis and the potential role of nomacopan’s bispecific inhibition of both C5 and LTB4 in treating GA/dAMD
In a non-infectious allergic uveitis animal model, PAS-nomacopan reduced VEGF by more than 50% compared to saline control, equivalent to the inhibition caused by an anti-VEGF antibody. In addition, PAS-nomacopan was significantly more effective in reducing retinal inflammation than the anti-VEGF antibody.
A pre-clinical study presented at ARVO 2022 used an industry standard model of laser induced CNV. Intravitreal (IVT) PAS-nomacopan injected once during a 16-day treatment period was compared to an FDA-approved VEGF inhibitor for impact on neovascularization. The IVT single dose of PAS-nomacopan significantly reduced CNV (p=0.022) as compared to saline and was as effective as multiple IVT injections of the VEGF inhibitor (p=0.019.) Single IVT injection of PAS-nomacopan showed a trend towards reduced leakage on Day 14 (p = 0.097).
Currently approved therapies for retinal diseases injected directly into the vitreous cavity are typically administered monthly. Studies have shown that due to adverse effects (such as an increase in intraocular pressure [IOP]), discomfort and anxiety, IVT injection presents a heavy burden on patients
PASylation of nomacopan has the potential to make it long-lasting in the back of the eye and may provide a dosing interval that is more attractive to patients
Akari is continuing pharmacokinetic (PK) and pharmacodynamic (PD) work to optimize PAS-nomacopan with the aim of achieving safety and efficacy in GA, and meeting patient preferences for less frequent injections
Studies of Investigational Nomacopan in Inflammation-Implicated Lung Conditions

Advanced the study of investigational nomacopan in the treatment of inflammation-implicated lung conditions
The CORONET study evaluated compassionate use of investigational nomacopan in the treatment of hospitalized COVID-19 pneumonia patients in the U.S.
The CASCADE study in the U.K. explored correlations between biomarkers and risk stratification categories to help predict the subsets of COVID-19 pneumonia patients who have a higher propensity to deteriorate clinically to more severe disease
Nomacopan Manufacturing

Significantly increased the total yield of nomacopan (more than five-fold) with a new manufacturing process
References:

Tedbirt B, et al., JAMA Dermatol. 2021 Apr 1;157(4)
Liao DS, et al. Ophthalmology. 2020 Feb;127(2)
Jaffe GJ et al. Ophthalmology. 2021 Apr;128(4)
Sasaki F et al. JCI Insight. 2018 Sep 20;3(18)
Full Year 2021 Financial Results

At December 31, 2021, the Company had cash of approximately $9.4 million, compared to cash of approximately $14.1 million at December 31, 2020.
In March 2022, Akari entered into an agreement with Paulson Investment Company, LLC to serve as placement agent in connection with a registered direct offering and sold approximately 7.4 million of the Company’s ADSs for gross proceeds of approximately $8.9 million.
In December 2021, Akari entered into an agreement with Paulson Investment Company, LLC to serve as placement agent in connection with a registered direct offering and sold approximately 4.3 million of the Company’s ADSs for gross proceeds of approximately $6.0 million.
In July 2021, Akari closed a private placement of approximately $12.3 million in gross proceeds by issuing approximately 7.9 million of the Company’s ADSs.
Research and development (R&D) expenses for full year 2021 were approximately $9.1 million, as compared to approximately $8.8 million for full year 2020.
General and administrative expenses for full year 2021 were approximately $8.1 million, as compared to approximately $9.2 million for full year 2020. This decrease was primarily due to a one-time non-cash financing expense of approximately $900,000 in 2020 related to the 2020 Purchase Agreement with Aspire Capital.
For full year 2021, total other loss was approximately $210,000 as compared to total other income of approximately $899,000 for full year 2020. This change was primarily due to the accounting reclassification of warrant liabilities to shareholders’ equity as of December 2020.
Net loss for the full year 2021 was approximately $17.4 million, as compared to net loss of approximately $17.1 million for full year 2020.
A copy of the Company’s Annual Report on Form 20-F for the year ended December 31, 2021 will be filed with the Securities and Exchange Commission and posted on the Company’s website at View Source

On May 16,2022 Allarity Therapeutics, Inc. ("Allarity" or the "Company"), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, reported financial results for the fourth quarter and year ended December 31, 2021, and provided a corporate update (Press release, Allarity Therapeutics, MAY 16, 2022, View Source [SID1234614753]).

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!

"2021 was a momentous year for Allarity Therapeutics," said Steve Carchedi, President and Chief Executive Officer. "We advanced our clinical-stage assets, raised a record amount of new investment for the Company, and completed our listing on the U.S. Nasdaq stock exchange. We are grateful for the collective support of our internal team, shareholders, and advisors, who are enabling the further development of our prioritized programs to address significant unmet needs within difficult-to-treat cancers. As we await further feedback from the United States Food and Drug Administration (FDA) regarding our NDA application for dovitinib, we remain steadfast in our mission to pair promising cancer therapeutics with our proprietary companion diagnostic technology to help significantly improve treatment outcomes for patients suffering from cancer. We look forward to sharing further updates on dovitinib and our other two priority clinical programs throughout the year."

A delay in filing the Company’s Form 10-K triggered a notification of non-compliance by Nasdaq concerning Listing Rule 5250(c)(1), as announced on April 22, 2022. Issuing a promissory note to Novartis to replace an unenforceable note issued by one of the Company’s Danish subsidiaries in 2018 and an error in the calculation of a tax Net Operating Loss allowance led to a restatement of the Company’s Form 10-Q dated September 30, 2021, and financial statements for the twelve months ended December 31, 2020, were the primary cause of the delay. The Company has filed the restated Form 10-Q for September 30, 2021, and its Form 10-K for 2021 today with the U.S. Securities and Exchange Commission (SEC). With these filings completed, the Company expects to regain compliance with Nasdaq Listing Rule 5250(c)(1) in the near future. The restatement of our financial statements for the year ended December 31, 2020, also resulted in a "Triggering Event" under our Certificate of Designations for our Series A Preferred Stock (the "Preferred Stock") because of the requirement to file a post-effective amendment to the Company’s Form S-1 registration statement that registers shares of our common stock issuable upon conversion of the Preferred Stock. As previously disclosed, the Investor that holds all of our Preferred Stock and the Company entered into a Forbearance Agreement and Waiver, dated April 27, 2022, providing the Company a forbearance period until June 4, 2022, in order to have the post-effective amendment declared effective by the SEC.

Full Year 2021 and Recent Highlights

In March 2022, entered into two agreements amending the LiPlaCis program. As a result of this amendment, Allarity will be exempt from any future financial obligation associated with the further development of LiPlaCis, including the cancellation of outstanding liability of $971million. Allarity will also maintain its ability to receive possible future milestone payments of up to $3.5 million
Scheduled a Type C meeting with the FDA, to be held in Q2 2022, to discuss potential paths to approval for dovitinib. This action followed the FDA’s issuance of Refusal to File (RTF) letters in February 2022 in response to the Company’s New Drug Application (NDA) and related Pre-Market Approval (PMA) application for dovitinib
Announced licensing agreements with Oncoheroes Biosciences, which will fund and advance the clinical development of both dovitinib and stenoparib in pediatric cancers utilizing Allarity’s DRP companion diagnostics
Completed listing on the U.S. Nasdaq Stock Market under the trading symbol "ALLR"
Received a $20 million PIPE investment from an institutional investor in conjunction with U.S. Nasdaq listing
Entered into an agreement with Lonza Group for the manufacturing of dovitinib to meet anticipated future commercial production needs
Entered, in July 2021, into an agreement for the sale of our irofulven program and assets to Lantern Pharma, Inc., under which Allarity received a $1 million upfront payment; the Company is eligible to receive an additional $1 million in payments plus up to U.S. $16 million in milestone payments from Lantern over the life of the program, in addition to royalties on future commercial net sales of the product. In Q1 2022, the Company received a fee payment from Lantern Pharma under the this agreement
Completed an oversubscribed rights issue, raising SEK 102.8 million ($12.1 million) before issue costs to further finance the development of Allarity’s three priority pipeline programs
Announced positive preclinical data in osteosarcoma in which dovitinib increased the median survival time in animals by 50% compared to the control group
Initiated a Phase 2 trial of IXEMPRA in Europe for the second-line treatment of metastatic breast cancer (mBC), with trial sites opened in a number of European countries
Expanded enrollment in an ongoing Phase 2 trial of stenoparib for the treatment of ovarian cancer (OC), with new trial sites opened or planned in the U.S. and Europe.

Anticipated Milestones in 2022

Announcing results of the Type C meeting with the FDA and outlining future development plans for dovitinib and its DRP-Dovitinib companion diagnostic
Initiation of prospective clinical study of dovitinib in metastatic Renal Cell Carcinoma together with its DRP-Dovitinib companion diagnostic
Interim data readout of Phase 2 clinical trial for IXEMPRA in mBC anticipated in Q4 2022
Interim data readout of Phase 2 clinical trial for stenoparib in OC anticipated in Q4 2022
Fourth Quarter and Full Year 2021 Financial Results

Balance Sheet: As of December 31, 2021, Allarity’s cash was $19.6 million, as compared to $298 thousand as of December 31 2020. This includes net proceeds from the Company’s December 2021 initial public offering in the U.S. The Company’s current cash, are expected to fund operations through 2022.

R&D Expenses: Research and Development (R&D) expenses were $9.5 million for the three months ended December 31, 2021, and $14.2 million for the full year 2021, compared to $1.7 million and $4.2 million for comparable periods in 2020, respectively.

G&A Expenses: General and Administrative (G&A) expenses were $6.2 million for the three months ended December 31, 2021, and $12.4 million for the full year 2021, compared to $856 thousand and $4.1 million for comparable periods in 2020, respectively.

Net Loss: Net loss was $16.8 million for the three months ended December 31, 2021, and $26.6 million for the full year 2021, compared to $1.7 million and $6.6 million for comparable periods in 2020, respectively.