On April 3, 2023 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, reported its financial results for the fourth quarter and full year 2022 and provided a business update (Press release, AIM ImmunoTech, APR 3, 2023, View Source [SID1234629729]). As previously announced, the Company will host its inaugural conference call and audio webcast, today, Monday, April 3, 2023, at 8:30 AM ET (details below).

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"2022 was a year marked by continued successful operational, clinical and regulatory execution across our development pipeline. We made significant progress building upon our solid foundation of pre-clinical and clinical work to advance Ampligen. Our team is committed to the development of Ampligen for unmet medical needs in cancers, immune disorders and viral diseases. Further, we have launched a new corporate website to better communicate our plans and progress. AIM’s goal is to generate near- and long-term value for all stockholders," commented Thomas K. Equels, Chief Executive Officer of AIM.

Recent Highlights

Launched new corporate website to align with the Company’s mission and vision going forward: advancing immunology solutions for a better future.
Nancy K. Bryan, pharmaceutical industry veteran, appointed to Board of Directors.
Announced the publication of a new analysis of the ability of Ampligen (rintatolimod) to inhibit the spread and replication of Ebola virus disease, which adds to the body of evidence supporting Ampligen’s potential as an early-onset prophylactic therapy against human Ebola outbreak. Additionally, the data from the analysis was presented in a late-breaking presentation at the 36th International Conference on Antiviral Research (ICAR).
Commenced its Phase 2 study of Ampligen for the treatment of pancreatic cancer and began recruiting patients.
Entered into an external sponsored collaborative clinical research agreement with Erasmus MC and AstraZeneca to evaluate the potential of AIM’s Ampligen in combination with AstraZeneca’s Imfinzi (durvalumab) for the treatment of pancreatic cancer.
Broadened patent portfolio with new Netherlands utility patent covering Ampligen and other AIM-developed dsRNA products to include rugged dsRNA for use in COVID-19 treatment or prevention.
Appointed Christopher McAleer, Ph.D. as Scientific Officer.
Presented positive safety, tolerability and biological activity data for intranasal Ampligen in healthy subjects at the British Society for Immunology Congress 2022.
Expected Upcoming Pipeline Milestones

Q2 2023

Locally Advanced Pancreatic Cancer: Enroll first patient in Phase 2 study
Locally Advanced Pancreatic Cancer: Dose first patient in Phase 2 study
Post-COVID Conditions: IRB approval to commence Phase 2 study
Post-COVID Conditions: Enroll and dose first patient in Phase 2 study
Q3 2023

Advanced Recurrent Ovarian Cancer: Announce formal interim results
Q4 2023

Metastatic Pancreatic Cancer: Begin clinical trial
Post-COVID Conditions: Enroll last patient in Phase 2 study
Summary of Financial Highlights for Fiscal Year 2022

As of December 31, 2022, AIM reported cash and cash equivalents of $34.2 million, compared to $48.3 million as of December 31, 2021.
Research and development expenses for the year ended December 31, 2022 were $7.0 million, compared to $7.7 million for the year ended December 31, 2021.
General and administrative expenses were $13.1 million for the year ended December 31, 2022 compared to $8.7 million for the year ended December 31, 2021.
Please refer to the full 10-K for complete details.

Conference Call and Webcast Details

As previously announced, the Company will host its inaugural quarterly conference call and live audio webcast to discuss the operational and financial results on today, April 3, 2023, at 8:30 AM ET.

The call will be hosted by members of AIM’s leadership team, Thomas K. Equels, Chief Executive Officer and Christopher McAleer, PhD, Scientific Officer. Interested participants and investors may access the conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The live webcast will be accessible on the Events and Presentations page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.

On April 3, 2023 Addex Therapeutics Ltd (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported that it has entered into a definitive agreement with a leading institutional healthcare investor (the "Investor") to sell 7,999,998 shares in the form of 1,333,333 American Depositary Shares ("ADSs") at a gross purchase price of $0.95 per ADS (Press release, Addex Therapeutics, APR 3, 2023, View Source [SID1234629728]). Each ADS represents six shares. Additionally, Addex has agreed to issue unregistered pre-funded warrants to purchase 3,929,825 ADSs (the "Unregistered Pre-Funded Warrants") at a funded amount of $0.94 with $0.01 payable on exercise as well as unregistered warrants to purchase up 5,263,158 ADSs (the "Unregistered Warrants" and together with the "Unregistered Pre-Funded Warrants", the "Warrants") in a concurrent private placement. The Unregistered Warrants have an exercise price of $1 per ADS, will become exercisable in 90 days after their date of issuance and will expire five years from their date of issuance. Each ADS represents 6 ordinary shares.

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The gross proceeds to Addex, before deducting offering expenses, will be $5.0 million. Addex intends to use the net proceeds from this offering to advance its portfolio of drug candidates and for general corporate purposes.

The closing of the offering is expected to occur on or about April 5, 2023, subject to the satisfaction of customary closing conditions.

Addex also entered into warrant repricing transactions with the Investor to amend previously issued warrants to reduce the exercise price of such warrants, as well as to amend certain other terms. The warrants to be amended were originally issued in private placements that closed on December 21, 2021 ("Original 2021 Warrants") and July 26, 2022 ("Original 2022 Warrants"). The Original 2021 Warrants are currently exercisable at $6.50 per ADS to purchase an aggregate of up to 1,538,462 ADSs. The Original 2022 Warrants are currently exercisable at $1.90 per ADS to purchase an aggregate of up to 2,500,000 ADSs.

By letter agreement, dated April 3, 2023, Addex and the Investor agreed to amend the Original 2021 Warrants and Original 2022 Warrants to reduce their exercise price to $1 per ADS ("Reduced Exercise Price") and certain other amendments (the "Amended Warrants"). The Amended Warrants will not be exercisable until July 5, 2023.

The ADSs (but not the Warrants or the shares underlying the Warrants) are being offered by Addex pursuant to a "shelf" registration statement on Form F-3 that was originally filed on April 7, 2021 and declared effective by the Securities and Exchange Commission ("SEC") on April 13, 2021 and the base prospectus contained therein (File No. 333-255089). The offering of the shares is being made only by means of a prospectus supplement that forms a part of the registration statement. Electronic copies of the prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at View Source

The Warrants, the shares underlying the Warrants and the Amended Warrants are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares underlying the Warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the Warrants, the Amended Warrants and underlying shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such 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 April 3, 2023 Jounce Therapeutics, Inc. ("Jounce" or the "Company") and Redx Pharma plc ("Redx") reported to have agreed to terminate their proposed business combination following the decision by Jounce’s Board of Directors to withdraw the recommendation for the all-share merger transaction with Redx (the "Redx Business Combination") (Press release, Jounce Therapeutics, APR 3, 2023, View Source [SID1234629726]).

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Jounce’s decision was based upon the receipt of an unsolicited proposal from Concentra Biosciences, LLC ("Concentra"), which led to Jounce entering into a merger agreement whereby Concentra will acquire Jounce through a cash tender offer for all of Jounce’s outstanding shares for $1.85 in cash per share plus a non-tradeable contingent value right (the "CVR"). The $1.85 per share upfront consideration represents a premium of approximately 75% to Jounce’s closing share price immediately prior to the March 14, 2023, public disclosure of Concentra’s acquisition proposal.

Jounce conducted a thorough review of both the proposed transaction with Concentra and the proposed Redx Business Combination, with the assistance of its legal and financial advisers, and Jounce’s Board of Directors ultimately concluded that the proposed transaction with Concentra is in the best interest of Jounce stockholders, and therefore, unanimously approved the merger agreement with Concentra and withdrew its recommendation of the Redx Business Combination. On March 27, 2023, Jounce notified Redx of the withdrawal of its recommendation in favor of the Redx Business Combination and termination of the co-operation agreement dated February 23, 2023 between Jounce and Redx.

Given that Jounce’s Board of Directors has withdrawn its recommendation to proceed with the Redx Business Combination, Jounce believes it is unlikely that Jounce stockholders would support the Redx Business Combination, which is a condition to closing the transaction. Accordingly, Jounce and Redx have agreed not to proceed with the proposed scheme of arrangement. In addition, Jounce has confirmed that it does not wish to switch to a contractual takeover offer. As a result, the U.K. Takeover Panel has confirmed that upon Redx announcing:

its withdrawal of its recommendation;
that it will not proceed with the scheme of arrangement; and
it has agreed to the release of Jounce from its obligation to proceed with the offer,
the offer period in respect of the Redx Business Combination will end with effect from the publication of Redx’s announcement, and the transaction will lapse.

As a result, Jounce will not be convening a Jounce meeting of stockholders to consider the Redx Business Combination. Under the U.K. Takeover Code, except with consent of the U.K. Takeover Panel, Jounce must not, among other things, announce a further offer for Redx within 12 months from the date of this announcement.

On April 3, 2023 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has entered into an agreement with the National Cancer Center to collaborate on investigator-initiated clinical research for the EZH2 inhibitor tazemetostat hydrobromide (generic name, product name "Tazverik Tablets 200 mg", "tazemetostat") based on "Patient-Proposed Healthcare Services" system (Press release, Eisai, APR 2, 2023, View Source [SID1234629724]). This clinical research will be conducted by the National Cancer Center Hospital.

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The "Patient-Proposed Healthcare Services" system is a system under which medical treatment using unapproved drugs not covered by insurance is applied for to the government based on the patient’s request, and is conducted as a clinical trial to confirm safety and efficacy. Under the terms of the agreement, Eisai will provide tazemetostat free of charge to the National Cancer Center Hospital as the drug to be used in "A clinical trial of Tazemetostat for pediatric and AYA* patients with malignant tumors which have no standard of care or and which is refractory to standard of care: Patients-Proposed Healthcare Service" to be conducted by the hospital under this program.

Researched and developed by Eisai and Epizyme, Inc.,** an Ipsen (Headquarters: France) company, tazemetostat is a first-in-class, oral small molecule inhibitor of the epigenetic enzyme EZH2. It is one of the histone methyltransferases in the epigenetics-related protein group, and is thought to regulate the expression of cancer-related genes and suppress the growth of cancer cells by specifically targeting EZH2, which contributes to the cancer growth process.1 Eisai holds the rights for development and commercialization of tazemetostat in Japan, where it was approved for the indication of "relapsed or refractory EZH2 gene mutation-positive follicular lymphoma (only when standard treatment is not applicable)" in 2021, and manufactures and distributes the product.

Eisai positions oncology as a key franchise area and aims to create innovative drugs that act towards curing cancer. Eisai is committed to expanding the potential clinical benefits of tazemetostat for cancer treatment, as it seeks to contribute to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families and healthcare professionals.

On March 31, 2023 Genor Biopharma (Stock code: 6998.HK) reported its 2022 annual financial results, business progress and other highlights in the past year (Press release, Genor Biopharma, MAR 31, 2023, View Source [SID1234629910]).

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Dr. GUO Feng, Chairman of the Board and Chief Executive Officer, Genor Biopharma, said: "2022 was a year full of changes and challenges. It was also a year for the positive development of Genor Biopharma and the firm implementation of the strategy of ‘Focus, Optimization, Acceleration and Enrich’. The company has achieved a number of important milestones at a speed better than the industry average, and lays a solid foundation for steady growth in 2023."

Focus and Optimization, Acceleration 2022

GB491 (Lerociclib) – a CDK4/6 inhibitor was developed for breast cancer patients with better safety and excellent efficacy

GB491 (Lerociclib) is a novel, potent, selective oral bioavailable CDK4/6 inhibitor co-developed by the Group and G1 Therapeutics, a US-based company, for use in combination with endocrine therapy in advanced breast cancer. Patient enrollment in Phase III trials for both the first line and the second line was completed quickly via adaptive and seamless experiment design, scientific reference and data bridging, a seamless registration strategy, and excellent execution.

At present, NMPA has officially accepted the new drug application for GB491 (Lerociclib) in combination with Fluvestran as the treatment of HR+/HER2- locally advanced or metastatic breast cancer patients with disease progression following previous endocrine therapy. And GB491 (Lerociclib) has completed patient enrolment for the first line Phase III clinical trial.

Based on data from the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2020 Conference, GB491 (Lerociclib) has demonstrated excellent safety and tolerability profile, enabling uninterrupted daily dosing and better long-term benefits, and could potentially be a BIC CDK4/6 drug candidate.

GB261 (CD20/CD3, BsAb) – potential best-in-class (BIC) CD20/CD3

GB261 (CD20/CD3, BsAb) is the first T-cell engager with ultra-low affinity to bind CD3 and has Fc-enabled functions (ADCC and CDC). GB261 (CD20/CD3, BsAb) significantly inhibits rituximab-resistant cancer cell proliferation in both in vitro assays and in vivo models; meanwhile with T-cell activation, GB261 (CD20/CD3, BsAb) induces less cytokine release compared with compounds in the same class. Thus, GB261 (CD20/CD3, BsAb) is a highly potent bi-specific therapeutic antibody for B-cell malignancies. It has potential to be a better and safer T-cell engager with competitive advantages over other CD3/CD20 agents.

GB261 (CD20/CD3, BsAb) has opened more than a dozen clinical centres in Australia and China. Efficacy has been observed in the first-in-human (FIH) clinical trial in Australia in the dose-climbing low-dose group with preliminary clinical Proof of Concept (POC) data, which was consistent with the molecular design mechanism of GB261 (CD20/CD3, BsAb), indicating a good safety, pharmacokinetic profile and clinical antitumor activities. The high-dose group currently is in dose escalation.

In China, GB261 (CD20/CD3, BsAb) obtained an implied license for Phase I/II clinical trials from the NMPA on May 23, 2023 for the treatment of patients with recurrent or refractory B-cell non-Hodgkin lymphoma (B-NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). On September 8, 2022, GB261 (CD20/CD3, BsAb) Phase I/II clinical trials achieved the first patient dosing in China.

GB263T (EGFR/cMET/cMETT, TsAb) – the world’s first EGFR/cMET/cMET tri-specific antibody

GB263T (EGFR/cMET/cMET, TsAb) is targeting EGFR and two different epitopes of cMET, and has been designed with the goal of improving safety and efficacy. Thus, GB263T is a highly differentiated tri-specific antibody that exhibits multiple mechanisms of action to inhibit primary and secondary EGFR mutations and cMET signaling pathway simultaneously.

Preclinical studies showed that GB263T (EGFR/cMET/cMET, TsAb) potently blocked ligand-induced phosphorylation of EGFR and cMET, and demonstrated better dual inhibition of EGFR and cMET signaling pathways compared to the JNJ-372 analogue. GB263T (EGFR/cMET/cMET, TsAb) effectively induced enhanced internalization of EGFR and cMET, and downregulated the expression levels of both EGFR and cMet proteins. The in vivo anti-cancer efficacy of GB263T (EGFR/cMET/cMET, TsAb) was demonstrated in several different tumor models, such as those with EGFR exon 20 insertion, EGFR exon 19 deletion, including C797S mutation, and various cMET alteration models. In all models studied, GB263T (EGFR/cMET/cMET, TsAb) demonstrated significant and dose-dependent tumor inhibition. In addition, GB263T (EGFR/cMET/cMET, TsAb) did not show any major toxicities in monkeys, even at a high dose given for four weeks in a GLP tox study.

Bellberry HREC approval for the FIH clinical trial of GB263T (EGFR/cMET/cMET, TsAb) was obtained in Australia on March 28, 2022 for the treatment of patients with advanced non-small cell lung cancer (NSCLC), with the first patient dosed on May 18.

In China, the Phase I/II clinical trials application for GB263T (EGFR/cMET/cMET, TsAb) was approved by the National Medical Products Administration (NMPA) on June 2, 2022, with the first patient dosed on October 14, 2022 in China for the treatment of patients with advanced NSCLC. The high-dose group currently is in dose escalation.

GB492 (IMSA101) – potential best-in-class STING agonist

GB492 (IMSA101) is the major mediator of innate immune sensing of cancerous cells, which the Group 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 patients. Multiple studies have shown that STING agonists can activate cGAS-STING signaling and significantly enhance the efficacy of the cancer immunity cycle when used in combination with other immune checkpoint inhibitors (ICI). It may become a potential FIC therapy.

In Phase I/II clinical trials of GB492 (IMSA101) as a monotherapy or in combination with GB226 (Aibining艾比寧, Geptanolimab) in patients with advanced/treatment-refractory malignancies, monotherapy clinical trials were finished and a dose escalation up to 400ug was completed in January 2022

In January 2022, approval was obtained from the CDE to directly conduct a dose-escalating study of GB492 (IMSA101) in combination with PD-1 in patients with advanced malignancy, based on the available data on the 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 (IMSA101) was administered alone and when it was administered with GB226 (Aibining艾比寧, Geptanolimab). It is the first STING agonist combination therapy that has obtained clinical trial approval in China.

Deep cultivation and cooperation, value enrichment

Focusing on the potential global first-in-class (FIC)/best-in-class (BIC) innovation pipeline, Genor Biopharma has developed and is executing a comprehensive strategy to optimize and enrich the existing product portfolio and conduct molecular research with the greatest potential to produce clinical and commercially viable drugs. It aims to address unmet medical needs in China and around the world. As of December 31, 2022, five FIC/BIC bi-specific/multi-specific antibody projects were carried out and nearly 10 differentiated innovation projects involving different molecular forms were in the early stage of research and development.

Independent innovation and strategic cooperation have developed simultaneously. In May 2022, Genor Biopharma entered into a cooperative development agreement with Abogen Biosciences Co., Ltd. ("Abogen") to jointly develop globally innovative mRNA products and related pharmaceuticals. GH Biopharma’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. It is progressing smoothly. One of the collaborative projects is in the pre-pcc stage. Currently, the Group is exploring opportunities to conduct cooperative development projects with various innovative technology platforms. It is actively expanding external cooperation in early research and development, commercialization and other levels, in order to continuously expand global innovation.

On February 23, 2022, the NMPA granted marketing approval for Jiayoujian 佳佑健 (GB242, Infliximab) which is used for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriasis, adult ulcerative colitis, adult and pediatric (aged above 6 years old) Crohn’s disease and fistulizing Crohn’s disease. Genor Biopharma commercialized its first product. Up to now, Jiayoujian 佳佑健 (GB242, Infliximab) is available for online procurement in 22 provinces and cities across the country, and has achieved sales of approximately RMB 11.9 million.

Efficient operation, win in 2023

In the face of the complex international situation and uncertainties brought about by the COVID-19 pandemic, Genor Biopharma has clarified its development priorities and adopted a variety of effective measures to continuously optimize its organizational structure, operation management and daily business. In 2023, it will promote key projects with higher operational efficiency to achieve its strategic goals.

Specifically, Genor Biopharma will continue to focus on promoting key projects and exploration of FIC potential in multi-dimensions to achieve an effective balance between efficiency and cost based on the in-depth understanding of target molecular biology, cell biology and immunological mechanisms. Cooperative R&D and open innovation, Genor Biopharma is actively exploring cooperation projects between its platform for early discovery of highly differential T-cell Engager / bi-specific/multi-specific antibodies in immune-oncology / BsADC and different innovative technology platforms to further promote global innovation through cooperation.

In terms of clinical pipeline advancement, Genor Biopharma expects to achieve the approval of the new drug application for GB491 (Lerociclib cyclin-dependent kinase 4/6 inhibitor) in combination with Fluvestran as the treatment of HR+/HER2- locally advanced or metastatic breast cancer patients with disease progression following previous endocrine therapy; and to submit an NDA application to the NMPA depending on the results of the Phase III clinical trials of GB491 (Lerociclib) in 1L HR+/HER2- breast cancer. It remains committed to addressing the large group of breast cancer patients in China and around the world with a safe, effective and well-tolerated novel therapy in the next 18 months.

As for bi-specific and tri-specific antibody drug candidates, Genor Biopharma will continue to accelerate the development of clinical trials in Australia and China. GB261 (CD20/CD3, BsAb) is scheduled to complete its phase I/II clinical trials within the next 12 to 18 months and proceed to the pivotal registration trial. The clinical trial of GB263T (EGFR/cMET/cMET, TsAb) will continue to progress rapidly, with preliminary clinical data to validate POC planned within the next 12 months. Meanwhile, Genor Biopharma will actively expand external partnerships in its clinical programs.

FINANCIAL HIGHLIGHTS

Total revenue was RMB15.9 million for the Reporting Period, primarily generated by (i) drug sales of Jiayoujian 佳佑健 (GB242, Infliximab Biosimilar), and (ii) providing research and manufacturing services to our customers under fee-for-service contracts.
Research and development expenses were RMB583.9 million for the Reporting Period, as compared with RMB612.7 million for the year ended 31 December 2021. The spending was mainly attributable to (i) our new drugs development fee and ongoing clinical trials expenses and (ii) our employee salary and related benefit costs. The decrease was mainly due to the decrease in employee benefits expenses.
Total comprehensive loss was RMB731.8 million for the Reporting Period, as compared with RMB865.8 million for the year ended 31 December 2021. The decrease was primarily due to (i) decrease in expenses and (ii) total revenue generated for the Reporting Period.
By the end of December 2022, the cash balance was RMB1.59 billion. Enough to support the company’s stable operation in the next 4-5 years.