On August 31, 2022 Flagship Biosciences, Inc., a leader in spatial biology and biomarker analytics services, reported the acquisition of Interpace Pharma Solutions ("IPS"), a division of Interpace Biosciences and provider of cytogenetic, molecular pathology, and genomic profiling solutions (Press release, Flagship Biosciences, AUG 31, 2022, View Source [SID1234619246]). This acquisition follows a growth equity investment in Flagship from Ampersand Capital Partners, BroadOak Capital Partners, and Research Corporation Technologies. The strategic combination of Flagship and IPS creates a full repertoire of biomarker lab and analytic services to advance precision therapeutic development and adds a state-of-the-art laboratory in Research Triangle Park, NC.

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Flagship Biosciences offers cutting-edge spatial biology services, powered by its patented AI image analysis technology that improves the accuracy of tissue-based pathology by delivering thousands of measurements on every cell and enabling the discovery of biomarkers that might be missed using traditional histology methods. Experts in pathology and regulatory strategy, the team at Flagship offers advanced end-to-end biomarker and analytics services to support drug trials, biomarker discovery, and clinical diagnostics. They also offer guidance in the development of companion diagnostics.

Flagship Biosciences offers cutting-edge spatial biology services, powered by its patented AI image analysis technology.

To better serve their biopharma and diagnostics clients, Flagship Biosciences will integrate the technologies and services of IPS to support all phases of clinical trials and diagnostic development in immuno-oncology, hematology, solid tumors, and various non-oncology sectors. Flagship Biosciences’ expanded services menu will now include advanced molecular biomarker solutions, flow cytometry, cytogenetics, genomics, and bioinformatics solutions. New genomic profiling capabilities will enhance biomarker characterization and improve patient stratification for clinical trials and treatment selection.

"By combining these organizations, we create a single-source provider offering a larger range of biomarker and analytics services while maintaining and expanding the proven expertise of each laboratory," said Trevor Johnson, CEO at Flagship Biosciences. "This will allow our customers to gain deeper insights into their clinical projects through multiple biomarker testing paradigms with cohesive data and analytical capabilities, managed in a simplified project workflow."

On August 31, 2022 Aesther Healthcare Acquisition Corp (NASDAQ: AEHA) ("Aesther"), a special purpose acquisition company (SPAC) formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, or similar business combination with one or more businesses, reported that it has entered into an Agreement and Plan of Merger with Ocean Biomedical, Inc. ("Ocean Biomedical"), a next-generation biopharma company, (the "Merger Agreement") (Press release, Ocean Biomedical, AUG 31, 2022, View Source [SID1234619008]). The combined company will work to accelerate the development of Ocean Biomedical’s core assets in oncology, fibrosis, and infectious diseases, all based on new target discoveries enabling first-in-class drug and vaccine candidates – developed through past and ongoing grants totaling $123.9 million.

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Upon closing of the merger transaction (the "Transaction"), Ocean Biomedical will be a wholly owned subsidiary of Aesther and Aesther will change its name to Ocean Biomedical, Inc. and its common stock and warrants are expected to be listed on Nasdaq, under the symbols "OCEA" and "OCEAW," respectively.

Ocean Biomedical was co-founded by Dr. Chirinjeev Kathuria MD, an investor, physician, and entrepreneur who is a graduate of Brown University’s Alpert School of Medicine, and Stanford University’s Graduate School of Business.

Dr. Jack A. Elias MD and Dr. Jake Kurtis MD/PhD are the scientific co-founders of Ocean Biomedical. Dr. Elias is an internationally renowned lung specialist who has made seminal discoveries in lung cancer, pulmonary fibrosis, asthma and COPD. He has served as Chief of Pulmonary and Critical Care Medicine and Chairman of the Department of Internal Medicine at Yale School of Medicine and Yale New Haven Hospital. He subsequently served as Dean of Biology and Medicine at the Warren Alpert Medical School of Brown University and Senior Vice President for Health Affairs at Brown University between 2017 and 2022 and is presently the Warren Alpert Professor of Translational Sciences in Internal Medicine and Molecular Microbiology and Immunology at Brown University. Dr. Kurtis is a groundbreaking global health and infectious disease expert who serves as the Chair of Pathology and Laboratory Medicine at Brown, and Executive Director of Brown’s MD-PhD program.

Ocean Biomedical’s Chief Executive Officer is Elizabeth Ng, a graduate of the Massachusetts Institute of Technology, and Stanford University’s Graduate School of Business. She has held strategy/portfolio management leadership roles at Gilead Sciences, Merck and Co, and BioMarin Pharmaceutical.

Around its core scientists and CEO, Ocean Biomedical has gathered a world-class biopharma management team to guide discoveries through clinical testing, and continue building its diverse portfolio into adjacent diseases with similar biological pathways.

• Oncology. Ocean Biomedical is developing several cancer drugs based on discoveries of targets that regulate multiple cancer-inducing pathways including a recently discovered master regulator of antitumor immune responses. They are being used to target non-small cell lung cancer and glioblastoma multiforme, a devastating form of brain cancer.
• Fibrosis. Ocean Biomedical has identified and is developing a small molecule which has demonstrated efficacy and favorable safety signals in animal models. It is being used to target multiple fibrotic diseases, including Idiopathic Pulmonary Fibrosis (IPF), and Hermansky-Pudlak Syndrome, a rare ‘orphan disease’ with no known treatment.
• Infectious Diseases. Ocean Biomedical is accelerating development of a uniquely powerful malaria vaccine and several malaria therapeutics that target newly discovered pathways.
• Discovery Platform. Ocean Biomedical plans to deploy the proprietary discovery platform that led to its malaria breakthroughs to target similarly intransigent disease challenges.

Innovative Targets for Global Unmet Needs

Oncology

Ocean Biomedical’s novel target in oncology is Chitinase 3-Like1 (CHI3L1), a key regulator of many visceral tumors regardless of the genetic mutations that drive them. Ocean’s proprietary mono-specific and bispecific antibodies are the first to target CHI3L1. The efficacy proof of concept is an 85-95% reduction in primary and metastatic tumor burden in multiple animal models in the absence of adverse effects. Monoclonal antibodies (mAbs), such as CHI3L1, are generally well-tolerated in humans given their inherent target specificity. CHI3L1 is also an excellent biomarker: with serum and tissue levels which predict severity and prognosis in multiple tumor types. Ocean Biomedical seeks to address major unmet needs in its initial indications with the mAb for lung cancer and the bispecific antibody for brain cancer. These antibodies also synergize with existing therapeutics to enhance their potency and the duration of their beneficial effect. There is potential for expansion beyond lung and brain cancer to other visceral cancers such as to breast, liver, colon, and others.

Needs Addressed

Non-small cell lung cancer (NSCLC) is the leading cause of cancer death and second most diagnosed cancer in the US. NSCLC affects approximately 460,000 people in the U.S. and accounts for about 85% of new lung cancers. NSCLC continues to rank among the cancers with the lowest 5-year survival rates. Early diagnosis is essential, as 40%-50% of patients are diagnosed with Stage IV disease. Currently, NSCLC is primarily being treated by surgical resection with curative intent, although radiation and chemotherapy have also been employed. Drugs that target components of the antitumor immune response such as the PD-1/PD-L1/PD-L2 axis have improved therapeutic responses. However, only a minority of patients that get these drugs respond to them and the responses that are seen are often not durable. As a result, it is clear that new treatments are urgently needed.

Glioblastoma multiforme (GBM) is a lethal type of brain tumor that affects approximately 28,000 people in the U.S. The median survival time is about 15 months, and 5-year survival is just 8% for those aged 45-54 and 5% for those aged 55-64. About 25% of GBM patients are not actively treated due to rapid disease progression. Treatment usually involves surgery, followed by chemotherapy and radiation. No curative therapies exist for the disease and there have been multiple pipeline failures. It represents a massive unmet medical need.

Fibrosis

Ocean Biomedical’s small molecule candidate in fibrosis addresses a novel target, Chitanse 1 (Chit1), a key regulator of tissue damage and remodeling, and has the potential to be disease-modifying. The small molecule candidate has demonstrated an 85-90% reduction in collagen accumulation in 4 animal models of pulmonary fibrosis. It has also shown good safety signals and was well-tolerated in other companies’ prior clinical studies.

Needs Addressed

Idiopathic Pulmonary Fibrosis (IPF) is a progressive disease that results in irreversible loss of lung function, with high morbidity and mortality rates. IPF prevalence in the US has been reported to range from 10 to 60 cases per 100,000 while in Europe it ranges from 1.3 to 32.5 cases per 100,000 people. Prevalence is much higher in patients over 50 and is also higher in males. There are two drugs approved for use in treating IPF, but they only slow decline in lung function. In addition, they have significant side-effects, and a high proportion of patients choose not to take the drug therapy.

Hermanksy-Pudlak Syndrome (HPS) is a rare, genetic disease. Symptoms are severe including highly penetrable pulmonary fibrosis, oculocutaneous albinism, and bleeding due to platelet dysfunction, and colitis. HPS-related pulmonary fibrosis occurs early in life (30’s-40’s) and patients have a 10-12 year mean survival rate. There are currently no approved therapeutics for HPS-related pulmonary fibrosis. Patients often resort to off-label use of IPF therapeutics which have not shown efficacy in HPS and which have severe side-effects.

Infectious Diseases

Ocean Biomedical’s vaccine and therapeutic candidates use a groundbreaking approach to target Malaria, one of the world’s most intractable diseases. Malaria is caused by parasites and transmitted through the bites of infected mosquitoes. The deadliest of these parasites is Plasmodium falciparum, and Ocean Biomedical’s vaccine and therapeutic candidates target PfGARP and PfSEA-1 –novel targets discovered by Scientific Co-Founder Dr. Jake Kurtis – that are critical for this parasite’s survival. The proof of concept has been established with 100% killing of malaria parasites in in-vitro assays, and greater than 90% killing of malaria parasites in mRNA-based immunization of non-human primates. The targets have no homology to any human protein and Ocean Biomedical’s vaccine and therapeutic candidates are projected to be safe and well tolerated. Ocean Biomedical’s Malaria vaccine is based on the mRNA vaccine delivery platform which is the same one used by Pfizer/BioNTech for COVID-19 vaccines. Ocean Biomedical’s therapeutic candidate is a humanized mAb.

Ocean Biomedical’s vaccine target discovery platform which was used to identify the malaria targets also is believed to have exciting potential for use in discovering targets against other infectious diseases such as tuberculosis or other emerging global viruses.

Needs Addressed

Malaria is a deadly disease with significant unmet therapeutic needs, with 2-3 billion people at risk of infection annually worldwide and 200-300 million infected annually worldwide. It remains the leading single-agent killer of children with more than 500,000 children under age 5 killed annually. There is high unmet public health need with no effective prophylactic vaccine and current Standard of Care therapeutics have potential risk from drug resistant strains.

Suren Ajjarapu, Chairman and CEO of Aesther, commented on the potential of the business combination saying, "The world is on the cusp of a new era in biomedicine, and we are excited to be teaming up with a biopharma company that has both cutting-edge science and an innovative business model. We think that combination will result in positive valuations and long term growth, as we continually focus on identifying and accelerating promising discoveries."

Ocean Biomedical’s Executive Chairman, Dr. Chirinjeev Kathuria commented, "Our executive team and our scientists are excited to partner with Aesther Healthcare to advance our cancer, fibrosis, and malaria discoveries into their Phase 1 trials and beyond, and to extend our unique model to other research and discovery partners."

Dr. Jack A. Elias, Ocean Biomedical’s scientific co-founder, described the potential impact of his lab’s discoveries saying, "We believe we have discovered a master pathway that regulates multiple key cancer inducing moieties including critical immune checkpoint inhibitors in the lung. In turn, interventions based on this master pathway control the ability of tumor cells to develop, spread to the lung and grow once they’re in the lung." He notes that "these are very novel observations that give us a completely new vision for the processes that regulate anti-cancer immune responses in the lung via immune checkpoint inhibition." Dr. Elias also notes that based on these findings his team believes they have developed "anti-CHI3L1 monoclonal antibodies and bi-specific antibodies that are extremely exciting potential therapeutics. The combination with Aesther will allow us to further expand our development activities in this area."

"Malaria is one of the most significant killers of children on earth," said scientific co-founder Dr. Jonathan Kurtis. "We believe our team’s discovery of PfGARP is a major advance toward developing a vaccine for this devastating disease. Ocean Biomedical is committed to developing and delivering this vaccine to people who need it, around the world and the combination with Aesther will help accelerate those efforts."

Ocean Biomedical’s CEO, Elizabeth Ng commented, "I have reviewed hundreds of interesting research programs/assets but the ones that are part of our initial portfolio – in cancer, fibrotic diseases, and infectious disease – are some of the most scientifically compelling and potentially life-impacting ones that I have ever seen. I am honored to be leading a company that can potentially improve the lives of millions of patients worldwide."

Leadership Team
Following the closing of the proposed Transaction, Dr. Chirinjeev Kathuria will serve as the Chairman of the Board of Directors. The Board will consist of nine members, including Dr. Kathuria, Suren Ajjarapu, Chairman and CEO of Aesther and Michael Peterson, a current member of the Aesther Board of Directors.

The executive team will be led by Elizabeth Ng (Chief Executive Officer) and will include Dr. Jack A. Elias (Co-founder and Chair of Scientific Advisory Board), Dr. Jake Kurtis (Co-founder, Scientific Advisory Board), Gurinder Kalra (Chief Financial Officer), Dr. Inderjote Kathuria (Chief Strategy Officer), Daniel Behr (EVP of Academic Partnerships), and Robert Sweeney (Chief Accounting Officer). Executive team bios are available at www.oceanbiomedical.com.

Transaction Overview
The proposed Transaction was unanimously approved by the boards of directors of all parties, at an expected combined pro forma enterprise value of approximately $345 million, assuming no redemptions of current Aesther public stockholders. In connection with the proposed Transaction, Aesther signed a Confirmation Agreement for an up to $40 million committed backstop by Vellar Opportunity Fund SPV LLC – Series 3. Additionally, the proposed Transaction includes a contingent earnout payable to the Ocean Biomedical stockholders and the sponsor. The proposed Transaction is expected to be completed in Q4 2022, subject to, among other things, the approval by Aesther stockholders, governmental, regulatory and third party approvals, satisfaction of minimum closing net tangible asset and cash requirements and the satisfaction or waiver of other customary closing conditions.

Advisors
EF Hutton, division of Benchmark Investments, LLC, serves as capital markets advisor to Aesther Healthcare Acquisition Corp. Nelson Mullins Riley & Scarborough LLP serves as legal counsel to Aesther Healthcare Acquisition Corp. and Malone Bailey, LLP serves as auditors to Aesther Healthcare Acquisition Corp. Dykema Gossett PLLC serves as legal counsel to Ocean Biomedical, Inc. and Deloitte & Touche LLP serves as auditors to Ocean Biomedical, Inc.

On August 31, 2022 Genor Biopharma reported its interim results for 2022, sharing the company’s business progress, financial data, and highlights during the period (Press release, Genor Biopharma, AUG 31, 2022, View Source [SID1234618964]).

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Dr. GUO Feng, Chairman of the Board and Chief Executive Officer, Genor Biopharma, said: "Despite the pandemic challenges and the continuing impact of the international situation, Genor Biopharma relied on its passion and power to face difficulties with its profound professional capability in the first half of 2022. It firmly adhered to the "Acceleration, Expansion, Focus and Consolidation" strategy. Turning crises into opportunities, the company achieved a number of important goals much faster than the industry overall. Seven of nine plans for 2022 were completed at a high level of quality. With close cross-departmental cooperation and excellent execution ability, Genor Biopharma will further leverage its results, expand its advantages, successfully reach its annual target, and create steady growth."

With the successful approval of Jiayujian (GB242, infliximab) in February 2022, Genor Biopharma commercialized its first product. In the first half of 2022, the company accelerated multiple key clinical trials and improved its competitive advantage in the industry. It also strengthened its platform for early discovery of global FIC/differential bi-specific/multi-specific antibodies in immune-oncology, expanded business development and cooperation, and continuously built up momentum for sustained and strong development.

The group directed its efforts towards the strategy of global innovation and the research and development of FIC/BIC potential innovative medicine. Fueled by the Company’s strong antibody discovery platform. Currently:

GB261(CD20/CD3) has obtained the preliminary clinical Proof of Concept (POC) data.
GB263T(EGFR/cMET/cMET) has achieved patient dosing in the FIH clinical trial in Australia.
Both GB261(CD20/CD3) and GB263T(EGFR/cMET/cMET) have been approved by the National Medical Products Administration (NMPA) for phase I/II clinical trials.
Nearly 10 tumor therapy projects with global differentiation are in early discovery stage.
The company entered into a cooperative development agreement with Abogen to jointly develop globally innovative mRNA products and related pharmaceuticals.

The regularity applications for clinical trial of the Company’s innovative medicine in its product pipelines have been accelerated to promote the clinical progress, driven by its highly specialized departments and the close collaboration between different departments.

GB491(Lerociclib, a differentiated oral CDK4/6 inhibitor), whose phase III clinical trial for the first line/second line breast cancer indication is progressing rapidly as planned.
GB492(IMSA101, STING agonist), whose clinical trials for monotherapy and in combination with Aibining (GB226, Geptanolimab) have achieved first-patient dosing and are progressing rapidly.

Acceleration – Achieved rapid advancement far beyond the industry overall for a number of key clinical trials

GB491(Lerociclib) – developed for breast cancer patients with better safety and efficacy

GB491(Lerociclib), is a novel, potent, selective oral bioavailable CDK4/6 inhibitor co-developed by Genor Biopharma and G1 Therapeutics, a US based company, for use in combination with endocrine therapy in advanced breast cancer. Based on the data published at European Society for Medical Oncology 2020 conference, GB491(Lerociclib) has demonstrated a better safety and tolerability profile, enabling uninterrupted daily dosing and better long-term benefits, and could potentially be a BIC CDK4/6 drug candidate.

The phase III trials for both first and second line could be continuously accelerating via adaptive and seamless study design, scientific reference and data bridging, seamless registration strategy, and excellent execution. In January 2022, the first patient of phase III clinical trials of GB491(Lerociclib) in combination with Letrozole in first line HR+/HER2- advanced breast cancer was dosed.

GB261(CD20/CD3，BsAb)

GB261(CD20/CD3) is a highly differentiated CD20/CD3 bi-specific antibody developed in-house. GB261(CD20/CD3) is the first T-cell engager with ultra-low affinity to bind CD3 and has Fc functions (ADCC and CDC).

With similar binding affinity to CD20 as rituximab, GB261(CD20/CD3) significantly inhibits rituximab-resistant cancer cell proliferation by in vitro assays and in vivo models. More importantly, GB261(CD20/CD3) induced low levels of cytokine production by Human Peripheral Blood Mononuclear Cell (hPBMC) in monkeys, indicating low occurrences of cytokine release syndrome (CRS). Thus, GB261(CD20/CD3) is a highly promising bi-specific therapeutic antibody for B cell malignancies. It may ultimately provide a concept shift to better and safer T-cell engager antibody drugs for various cancers.

On 18 March 2022, the NMPA accepted GB261(CD20/CD3)’s IND application, and gave an implied permission for its phase I/II clinical trial on 23 May.

Currently, we are in process of the dose escalation up to 10mg in the clinical trial of GB261(CD20/CD3) for the treatment of B-cell non-Hodgkin Lymphoma (B-NHL) in Australia. We have obtained the preliminary clinical Proof of Concept (POC) data and observed objective responses, which were consistent with the molecular design mechanism of GB261(CD20/CD3), indicating a good safety and pharmacokinetic profile.

GB263T(EGFR/cMET/cMET, TsAb)

GB263T(EGFR/cMET/cMET) was the first tri-specific antibody of EGFR/cMET/cMET in the world, targeting EGFR and two different cMET epitopes to enhance its safety and efficacy. Such design has two Fabs to bine EGFR. Its Fc fragment has been mutated to enhance Fc functions.

GB263T(EGFR/cMET/cMET) with highly differentiated sign, exhibits multiple mechanisms of action to inhibit primary and secondary EGFR mutations and cMET signaling pathway simultaneously. The significant anti-tumor activities have been demonstrated by in vitro studies and in vivo animal models.

The EC approval for the FIH clinical trial of GB263T(EGFR/cMET/cMET) was obtained in Australia on 28 March 2022, with the first patient dosed on 18 May.

The research and development of GB263T(EGFR/cMET/cMET) fully demonstrated the advantages of cross-team collaboration and enhanced the Company’s globalization capabilities and innovation practices. By closely working with the globally renowned Key-Opinion-Leaders (KOLs), the clinical trial protocol was finished on the date of obtaining the toxicology data, substantially speeding up the submission to the EC.

The new drug clinical trial application of GB263T(EGFR/cMET/cMET) in China was formally accepted by the NMPA on 28 March 2022, the phase I/II clinical trial of which was approved by the NMPA on 2 June 2022.

GB492(IMSA101)-Potentially Best-In-Class Sting Agonist

GB492(IMSA101) is the major mediator of innate sensing of cancerous cells, which Genor Biopharma exclusively licensed from ImmuneSensor Therapeutic in June 2020. STING agonist, as an immune stimulatory therapy, may further increase the response of immune checkpoint inhibitors for patient. Multiple studies have shown that STING agonists can activate the cGAS-STING signaling and significantly enhance the efficacy of cancer immunity cycle when using in combination with other immune checkpoint inhibitors(ICI), which may become a potential FIC therapy.

In phase I/II clinical trial of GB492(IMSA101) as a monotherapy or in combination with GB226(Aibining, Geptanolimab) in patients with advanced /treatment-refractory malignancies:

In January 2022, monotherapy clinical trials finished.
In January 2022, dose escalation up to 400ug completed.
In January 2022, approval from CDE was obtained to directly conduct a dose-escalating study of GB492 in combination with PD-1 in subjects with advanced malignancy, based on the available data on 400ug dose group in the monotherapy study in China and all data of the monotherapy dose-escalation study in the United States. In this clinical trial, an innovative FIH trial design was employed to combine the dose escalations when GB492 is administered alone and when it is administered with GB226. It is the first STING agonist combination therapy that has obtained clinical trial approval in China.

Expansion – Carried out multi-level strategic cooperation to enhance value creation

In June 2022, the company entered into a cooperative development agreement with Abogen to jointly develop globally innovative mRNA products and related pharmaceuticals. The Company’s antibody development platform will be integrated with Abogen’s mRNA technology platform to enable them to jointly research and develop mRNA drugs for tumor treatment.

Currently, Genor Biopharma is exploring opportunities to conduct cooperative development projects with various innovative technology platforms.

On 23 February 2022, the NMPA has granted marketing approval for Jiayujian(GB242, infliximab) which is used for the treatment of Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriasis, Adult Ulcerative Colitis, Adult and Pediatric Crohn’s Disease and Fistulising Crohn’s Disease. Up to now, Jiayujian(GB242, infliximab) has been obtained for online procurement in more than 20 provinces including Yunnan, Shandong, Hainan, Guangdong Guangzhou, Hubei, Anhui, Shanghai and Tianjin.

Jiayujian(GB242, infliximab) will be commercialized through cooperation with a focus on the development of gastrointestinal indications, such as ulcerative colitis. By doing so, we are able to create a differentiation advantage from other competing products in the market and maximize the value of Inflixib biosimilar.

Focus – Highlighted differentiation and improved operation efficiency

Through paralleled efforts in original innovation and strategic cooperation, Genor Biopharma has successfully established the research and development platform for early discovering global FIC/differential bi-specific/multi-specific antibodies in immune-oncology and therapeutic areas with large unmet medical needs. The R&D team focused on developing targeted antibodies and projects with first-in class (FIC) potential, ad continued to promote the research and development platform for discovering FIC/best in class (BIC) potential bi-specific / multi-specific antibodies in immune-oncology. The company will maximize its existing product portfolio by developing and executing a comprehensive strategy to conduct research on molecular with the best potential to become clinically beneficial and commercially viable drugs, and to address unmet medical needs in China and globally.

As of June 2022, nearly 10 innovative early research projects involving different drug molecular forms have been carried out, focusing on the field of tumor therapy. Genor Biopharma will continue to accelerate the development of clinical trials for several kinds of bi-specific and multi-specific antibody drug candidates in Australia and China, advancing the clinical POC of GB261 and GB263T in the clinical phase I.

At the same time, all departments of the company are unified and clear development priorities, adopt a variety of effective measures, constantly optimize and improve operational efficiency, and do everything possible to reduce unnecessary expenses. In the first half of 2022, "focus" is not only reflected in the optimization of R&D pipeline projects, but also in the organizational structure, operations management, and every aspect of daily business.

Consolidation – Strengthened response to risks and turned crises into opportunities

In the first half of 2022, the Covid-19 situation was severe. As one of the key biomedical enterprises in Zhangjiang area, Genor Biopharma actively proceeded with communication and application, and thus was included in the list of the second batch of enterprises resuming work released in Shanghai on 28 April 2022. Subsequently, Dr. GUO Feng, Chairman of the Board and Chief Executive Officer, immediately served as the leader to set up a project group in person to prepare for the resumption of work, with the active participation by company’s government affairs department, administration department, human resources department, procurement department as well as the EHS (Health, Safety and Environment) team of CMC department. Besides, there were 26 employees stationed at the park on Zhangjiang Road in Pudong, Shanghai during the epidemic, so as to ensure the steady progress of the core projects.

From March to May, Genor Biopharma completed the enrollment of patients with breast cancer in the clinical trial in an efficient manner, while achieving rapid clinical progress beyond the industry level in terms of GB491(Lerociclib).

Financial Highlights

Total revenue was approximately RMB 3.0 million during the reporting period, primarily generated by providing research and manufacturing services to our customers under fee-for-service contracts.
Research and development expenses were approximately RMB 295.1 million for the reporting period, as compared with approximately RMB 271.5 million for the six months ended 30 June 2021. The spending was mainly attributed to our new drugs development fee and ongoing clinical trials expenses.
Total comprehensive loss was approximately RMB 407.5 million for the reporting period, as compared with approximately RMB 402.9 million for the six months ended 30 June 2021.

On On August 31, 2022, ImmunityBio, Inc. (the "company" or "we") reported that entered into a series of transactions including, in part, a new debt financing resulting in $125.0 million of gross proceeds, along with the amendment and restatement of the company’s nearest term debt maturity to extend the maturity from December 17, 2022 to December 31, 2023 and an adjustment to the interest rate to match the new debt issuance, and the amendment and restatement of the company’s fixed-rate debt maturing September 30, 2025 to add an equity conversion feature, in each case as further described below (Filing, 8-K, ImmunityBio, AUG 31, 2022, View Source [SID1234618946]).

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New $125.0 million Variable-Rate Promissory Note
On August 31, 2022, we executed a $125.0 million promissory note with Nant Capital, LLC ("Nant Capital"), an entity affiliated with Dr. Patrick Soon-Shiong, our Executive Chairman and Global Chief Scientific and Medical Officer. This note bears interest at Term Secured Overnight Financing Rate ("Term SOFR") plus 8.0% per annum. The accrued interest shall be payable quarterly on the last business day of March, June, September and December, commencing on September 30, 2022. The outstanding principal amount and any accrued and unpaid interest are due on December 31, 2023. We may prepay the outstanding principal amount, together with any accrued interest at any time, in whole or in part, without premium or penalty.
We received net proceeds of $124.4 million from this financing, net of a $0.6 million origination fee paid to the lender, which we intend to use for commercialization efforts, clinical trials, working capital and general corporate purposes.
Amendment and Restatement of Variable-Rate Promissory Note due December 17, 2022
As of June 30, 2022, we had a $300.0 million variable-rate promissory note with Nant Capital. This note bore interest at Term SOFR plus 5.4% per annum, which was paid quarterly. We may prepay the outstanding principal amount, together with any accrued interest at any time, in whole or in part, without premium or penalty. In the event of a default on the loan (as defined in the promissory note), including if we do not repay the loan at maturity, the company has the right, at its sole option, to convert the outstanding principal amount and accrued and unpaid interest due under this note into shares of the company’s common stock at price of $5.67 per share.
On August 31, 2022, the terms of the variable-rate promissory note were amended and restated to extend the maturity date of the loan from December 17, 2022 to December 31, 2023, increase the spread on the loan from 5.4% to 8.0% per annum, and reset the quarterly interest payment date from the 17th to the last business day of March, June, September and December, commencing on September 30, 2022. No other material terms or conditions of this variable-rate promissory note were modified as part of this amendment and restatement.
Amendment and Restatement of Fixed-Rate Promissory Notes due September 30, 2025
We had six outstanding fixed-rate promissory notes with Nant Capital, NantWorks, LLC, NantCancerStemCell, LLC, and NantMobile, LLC (all entities affiliated with Dr. Soon-Shiong) in an aggregate amount of $312.5 million, including accrued interest, as of June 30, 2022. These notes bear interest at a rate ranging from 3.0% to 6.0% per annum, provide that the outstanding principal is due and payable on September 30, 2025, and accrued and unpaid interest is payable either upon maturity or, with respect to one of the notes, on a quarterly basis. We may prepay the outstanding principal amount of any advance under such notes, together with accrued and unpaid interest, at any time, in whole or in part, without premium or penalty, subject to an advance notice period of at least five business days, during which the lender can convert the amount requested to be prepaid by the company into shares of company common stock, as part of the amendment and restatement described below.
On August 31, 2022, the terms of each fixed-rate promissory note were amended and restated to include a conversion feature that gives each lender the right at any time, at its sole option, to convert the entire outstanding principal amount and accrued and unpaid interest due under each note at the time of conversion into shares of the company’s common stock at a price of $5.67 per share. No other material terms or conditions of these fixed-rate promissory notes were modified as part of these amendments.
The foregoing description of the related-party promissory notes does not purport to be complete and is qualified in its entirety by reference to the full text of the notes, copies of which will be filed with the company’s Quarterly Report on Form 10-Q for the period ended September 30, 2022 and are incorporated herein by reference.

On August 31, 2022 Molecular Templates, Inc., (Nasdaq: MTEM, "Molecular Templates" or "MTEM") a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported that it will participate in the following September 2022 conferences (Press release, Molecular Templates, AUG 31, 2022, View Source [SID1234618897]). Presentation links can be found in the "News and Media" section of the corporate website. One-on-one meetings may be scheduled via conference representatives or directly with Molecular Templates.

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Citi 17th Annual BioPharma Conference, September 7 – 8, 2022

Location: Boston, MA
H.C. Wainwright 24th Annual Global Investment Conference, September 12 – 14, 2022

Location: New York, NY

Webcast Presentation: September 12, 2022, available starting 7am ET here
Morgan Stanley 20th Annual Global Healthcare Conference, September 12 – 14, 2022

Location: New York, NY
Cantor Oncology, Hematology, and HemeOnc Conference, September 28, 2022

Location: New York, NY

Live Panel Presentation: "Innovation is the Name of the Game: Novel Modalities for Oncology", September 28, 9:50am – 10:30am ET