On April 18, 2024Bio-Path Holdings, Inc., (Nasdaq: BPTH) (the "Company" or "BioPath"), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that it has entered into a definitive agreement with certain institutional investors for the issuance and sale of 375,000 shares of its common stock at a purchase price per share of $3.225 in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Bio-Path Holdings, APR 18, 2024, View Source [SID1234642149]). Additionally, in a concurrent private placement, Bio-Path has also agreed to issue to such investors unregistered warrants to purchase up to 375,000 shares of common stock at an exercise price of $3.10 per share. The unregistered warrants to be issued in the private placement will become immediately exercisable upon issuance and will expire five years from the date of issuance. The offering is expected to close on or about April 19, 2024, subject to the satisfaction of customary closing conditions.

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Immediately prior to the registered direct offering and the concurrent private placement, the number of outstanding shares of common stock of the Company was 1,190,306. Immediately following the closing of the registered direct offering and the concurrent private placement, the number of outstanding shares of common stock of the Company will be 1,565,306.

H.C. Wainwright & Co., LLC is acting as the exclusive placement agent for the offering.

The gross proceeds to Bio-Path from the offering are expected to be approximately $1.2 million, before deducting the placement agent’s fees and other offering expenses payable by Bio-Path. BioPath currently intends to use the net proceeds from the offering for working capital and general corporate purposes.

The shares of common stock (or common stock equivalents) offered in the registered direct offering (but excluding the unregistered warrants or the shares of common stock underlying such unregistered warrants) described above are being offered and sold by Bio-Path pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-265282), including a base prospectus, previously filed with the Securities and Exchange Commission ("SEC") on May 27, 2022, and declared effective by the SEC on June 14, 2022. The offering of the shares of common stock (or common stock equivalents) are being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and an accompanying base prospectus relating to, and describing the terms of, the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and accompanying base prospectus relating to the registered direct offering, when available, may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at [email protected].

The offer and sale of the unregistered warrants are being made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the unregistered warrants and the underlying shares of common stock may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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

On April 18, 2024 Bio-Path Holdings, Inc., (NASDAQ: BPTH) a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported completion of the second dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1002 evaluating the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia (AML) patients, including venetoclax-resistant patients (Press release, Bio-Path Holdings, APR 18, 2024, View Source [SID1234642148]).

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"We are delighted to safely progress through the second, higher dose cohort to reach an important study milestone for the United States Food and Drug Administration (FDA) to review patient study data," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Enrollment rates have been good, and we look forward to advancing this study in even higher doses with the hope that we can sooner reach the combination therapy segment of our Phase 1/1b study with increased levels of BP1002 for the treatment of these vulnerable patients with few, if any, treatment options."

BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. The current standard of care for patients with AML not eligible for intensive chemotherapy is venetoclax, an oral Bcl-2 inhibitor that targets the BH3 domain of the Bcl-2 protein, in combination with a hypomethylating agent or with low-dose cytarabine. However, many patients become resistant to venetoclax treatment. A published study found that AML patients who had relapsed from frontline venetoclax-based treatment were refractory to salvage therapy and had a median survival of less than 3 months. By targeting Bcl-2 at the mRNA level rather than the protein, BP1002 may overcome and prevent some of the mechanisms of resistance that affect venetoclax treatment. Published preclinical Bio-Path studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target, and we believe that its benign safety profile should enable effective BP1002 combination therapy with approved agents, such as decitabine.

The Phase 1/1b clinical trial is being conducted at several leading cancer centers in the United States, including the Weill Medical College of Cornell University, The University of Texas MD Anderson Cancer Center, Scripps Health, and The University of California at Los Angeles Cancer Center. Initially, the dose escalation portion of the clinical plan calls for a total of six evaluable patients to be treated with BP1002 monotherapy over two dose levels in a standard 3+3 design, with a starting dose of 20 mg/m2 and the second dose of 40 mg/m2. The testing of these two dose levels is now complete and the clinical trial will pause for a brief data review by the FDA, and then we expect that dose testing will continue at the next planned higher dose of 60 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study is expected to commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients.

Gail J. Roboz, M.D., is the National Principal Investigator for the Phase 1/1b trial. Dr. Roboz is a professor of medicine and director of the Clinical and Translational Leukemia Program at the Weill Medical College of Cornell University and the New York-Presbyterian Hospital in New York City. Gary Schiller, M.D., The University of California at Los Angeles Cancer Center, Maro Ohanian, D.O., Department of Leukemia, University of Texas MD Anderson Cancer Center, and David Hermel, M.D., Scripps Health, are each serving as principal investigators.

On April 18, 2024 Outrun Therapeutics ("Outrun"), the E3 ligase inhibitor and protein stabilisation specialist, reported the company exits from stealth following a $10m seed financing round (Press release, Outrun Therapeutics, APR 18, 2024, View Source [SID1234642144]). Outrun’s platform has enabled it to rapidly build a pipeline of highly selective, small molecule, first-in-class E3 ligase inhibitors, as well as identify novel E3 ligase targets across multiple disease areas. Outrun’s lead programme is focused on hard-to-treat solid tumours.

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E3 ligase inhibition in protein stabilisation is of very high interest as a therapeutic approach to treating many diseases. Cells have evolved highly sophisticated ways of keeping disease at bay, and empowering the body to take care of itself is potentially the most effective way of suppressing disease. Inhibiting targeted E3 ligases enables protein stabilisation "at source", being directly part of the tagging mechanism involved in healthy cellular processing of destabilised, unwanted, or mis-formed proteins. This restores the body’s sophisticated natural disease suppression processes and could be applicable to a wide range of indications, including oncology and neurology.

Selective protein stabilisation by inhibiting specific E3 ligases will expand the disease indications that can be addressed with protein stabilisation and minimise side effects. There are ~700 E3 ligases representing the vast number of discrete cellular processes they control, providing potential targets for Outrun to develop effective precision medicines against.

Outrun has developed a proprietary, high throughput platform which allows robust, highly accurate, quantitative assessment of the specificity and selectivity of E3 ligase targets, thereby dramatically reducing the discovery time for E3 ligase inhibitors, improving specificity and target binding. Furthermore, the platform uses engineered protein sensors (EPS) to uncover the detailed biochemistry of E3 ligases, enabling discovery of drugs with potentially superior binding, specificity, and activity. Outrun’s approach is a scalable and modular strategy for developing next-generation small molecule drugs targeting E3 ligases, particularly inhibitors that stabilise proteins.

Dr Carolyn Porter, Chief Executive Officer of Outrun Therapeutics, said: "Protein stabilisation is the mirror image of protein degradation and seeks to maintain the levels of critical proteins that are otherwise unbalanced in certain diseases, disrupting the body’s highly sophisticated natural disease suppression processes. We are bringing our world class knowledge of E3 ligase biology and protein-to-protein interactions, combined with our proprietary discovery platform, to unlock the potential of this exciting new therapeutic area."

Dr Jeffrey Moore, President at MP Healthcare Venture Management, commented: "We believe protein stabilisation via E3 ligase inhibition is a potentially powerful new therapeutic modality. With world leading research under the guidance of a talented management team, we are confident that Outrun has the potential to transform a variety of disease areas, such as oncology and neurology."

Dr Bauke Anninga, Investment Director at M Ventures, added: "We are delighted to be one of the founding investors of Outrun. The Company’s novel platform enabling rapid assessment of the specificity and selectivity of E3 ligase inhibitors, provides a highly competitive edge to reduce discovery timelines and build a first in class pipeline."

Led by a seasoned management team and a strong Board, Outrun was spun out of founder Prof. Satpal Virdee’s world-renowned MRC Protein Phosphorylation and Ubiquitylation Unit at the University of Dundee. Outrun’s Scientific Advisory Board consists of highly relevant, world-leading experts in ubiquitylation and oncology. Outrun is backed by leading venture capital investors M Ventures and MP Healthcare Venture Management.

On April 17, 2024, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (referred to as " ImmuneOnco "), HKEX stock code: 01541.HK) reported that the Phase III clinical study protocol of Timdarpacept (R&D number: IMM01) combined with Tirellizumab for PD-1/PD-L1 inhibitor failed Classic Hodgkin lymphoma (cHL) was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (Press release, ImmuneOnco Biopharma, APR 17, 2024, View Source [SID1234655699]).

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IMM01 is the first SIRP-α-FC fusion protein to enter the clinical stage in China and is being developed to use in combination with other drugs to treat a variety of blood and solid tumors. Recently, the results of two Phase II clinical innovation studies in IMM01 were included in the oral report of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting in 2024 (respectively, IMM01 combined with Tirellizumab in the treatment of cHL indications after previous PD-1 antibody treatment failed, and IMM01 combined with azacitide in the treatment of high-risk MDS indications for initial treatment).

In December 2023, the results of three Phase II clinical innovation studies on IMM01 were selected for oral presentation and poster presentation at the 2023 annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), among which two studies were selected for oral presentation in 2023 ASH (Free ASH Whitepaper) (cHL indication and 1-line MDS indication after PD-(L)1 antibody treatment failure). The results of another 1-line CMML indication study were presented in poster form. This is the clinical research progress of IMM01 project selected for ASH (Free ASH Whitepaper) annual meeting for two consecutive years.

Updated data were reported at the ASH (Free ASH Whitepaper) meeting in 2023: The ORR, CR, and DCR of cHL patients treated with IMM01 combined with Tirelizumab after previous PD-(L)1 antibody treatment failure reached 65.2%, 17.4%, and 100%, which shown to benefit from the combination therapy in each subgroup analysis. In addition, IMM01 combined with tirellizumab was well tolerated, and no patients had permanent discontinuation due to drug-related adverse reactions. The Phase II update results received an oral presentation at ASCO (Free ASCO Whitepaper) 2024 and will be presented in Chicago on June 2.

Founder and chairman of ImmuneOnco Dr. Tian, Wenzhi said: "We are very pleased to have received CDE approval for our Phase III registered clinical study protocol for Timdarpacept (IMM01) in combination with Tirellizumab for PD-1/PD-L1 inhibitor failed Classical Hodgkin lymphoma (cHL). Clinical treatment for PD-1/PD-L1 inhibitor treatment failed cHL is an unmet clinical need especially for those patients whose onset age is relatively young. We believe that Timdarpacept through activating macrophages can turn "cold tumors" into "hot tumors", and can induce more tumor-specific T cell responses by presenting tumor antigens to T lymphocytes, thereby restoring and expanding the sensitivity and therapeutic response of patients to tirellizumab. Our scientific judgment is well supported by the obtained clinical data. In contrast, PD-1 antibody combined with another T cell-associated immune checkpoint antibody is difficult to achieve such clinical manifestations. We firmly believe that the development of Timdarpacept in combination with Tirellizumab against PD-1/PD-L1 monoclonal antibody refractory cHL will have great market competitiveness. We will quickly advance the Phase III registered clinical trial study, and strive to bring benefits to cHL patients as soon as possible."

Chief Medical Officer/Senior Vice President, ImmuneOnco Dr. Lu, Qiying said: "Today’s CDE approval of IMM01 in combination with Tirellizumab for a refractory cHL indication is an extremely important milestone for our company. The results of two clinical phase II studies on IMM01 products were all recognized and affirmed by ASCO (Free ASCO Whitepaper) in 2024, and two were accepted as oral reports. In terms of clinical development layout of IMM01 products, we have carried out a differentiated layout. Aiming at the unmet medical demand of cHL after the failure of previous PD-1/PD-L1 antibody treatment, our combined treatment mode can overcome the drug resistance of previous PD-1/PD-L1 antibody treatment, and reflects the advantages of chemotherapy treatment. It can avoid the long-term toxicity caused by chemotherapy drugs and bring long-term quality of life advantages to patients. In addition, the current efficacy data has been further improved compared to the ASH (Free ASH Whitepaper) abstract submitted in July last year, with better efficacy response (ORR/CR) for the cHL indication. Today, the phase III clinical registration study was approved by CDE indicating that the clinical development of IMM01 has fully entered the registration study stage, and this is the world’s first macromolecule drug to develop cHL registration indications against CD47 targets. At present, our team is well prepared to start the trial. We look forward to rapidly advancing the clinical development of IMM01 products, bringing new therapeutic options to the treatment of cancer patients and addressing unmet clinical needs."

On April 17, 2024 Asieris Pharmaceuticals reported its 2023 Annual Report, revealing impressive outcomes achieved through its specialty pharma strategy, which has facilitated rapid progress in clinical development, early research, and commercialization (Press release, Asieris Pharmaceuticals, APR 17, 2024, https://www.prnewswire.com/news-releases/asieris-pharmaceuticals-unveils-2023-annual-report-core-product-apl-1702-succeeds-in-global-phase-iii-clinical-trials-apl-1706-obtains-nda-acceptance-domestically-specialty-commercial-team-generates-sustained-revenue-streams-302119669.html [SID1234642143]). Asieris boasts a robust pipeline now consisting of 13 products and 16 ongoing research projects. By the end of 2023, cash and cash equivalents along with financial assets held for trading totaled approximately RMB 2.333 billion, ensuring ample capital reserves for sustainable growth.

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Multiple Assets Achieved Clinical Milestones, Paving Way for New Products Launch

In September 2023, APL-1702, a combination of drug and medical device designed for photodynamic non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), met its primary endpoint in the international multi-center phase III clinical trial. Results showed that the APL-1702 treatment group had a significantly higher response rate on the primary efficacy endpoint, with a response rate 89.4% higher than the placebo group (41.1% vs. 21.7%, p = 0.0001). Additionally, APL-1702 demonstrated a 103.9% improvement in the clearance rate of high-risk HPV16 and/or HPV18 compared to controls (31.4% vs. 15.4%). APL-1702 also showed low incidence of treatment-emergent adverse events. These findings were featured in oral presentations at the 2024 European Research Organization on Genital Infection and Neoplasia (EUROGIN) Congress and the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting.

APL-1702 is a first-in-class, non-surgical treatment for cervical HSIL with its efficacy proven in an international phase III trial. It heralds a potential paradigm shift in the treatment of precancerous cervical lesions, with the clinical focus moving from excision to long-term disease management. Emphasis lies in optimizing the delicate balance between treatment risks and benefits, striving to minimize or delay invasive procedures while effectively reversing the progression of the disease.

The company is gearing up to submit a market approval application for APL-1702 to China’s National Medical Products Administration (NMPA), with acceptance anticipated in the second quarter of 2024.

Looking ahead, the company plans to facilitate localized production and initiate development of a second-generation product for APL-1702. It also intends to submit a pre-NDA communication application to the European Medicines Agency (EMA) in the third quarter of 2024. Additionally, the company expects to be in discussions with the US FDA in second half of 2024 to align with the agency on the registration requirements in the US. It is also actively exploring opportunities for overseas development partnership for APL-1702.

In August 2023, the multi-center phase III clinical trial of APL-1706, an imaging drug used for the diagnosis or surgery of bladder cancer, met its primary endpoint. The study confirmed that, in Chinese patients, APL-1706, in combination with blue light cystoscopy (BLC), outperformed white light cystoscopy (WLC) in the detection of bladder cancer, particularly in cases of carcinoma in situ (CIS), and exhibited good tolerability. The company presented the phase III clinical data and real-world research findings at several international conferences, including the 2023 Congress of the Société Internationale d’Urologie (SIU) and the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO-GU).

APL-1706 is the only imaging agent approved worldwide for the diagnosis and surgical treatment of bladder cancer. APL-1706, in combination with BLC for managing non-muscle invasive bladder cancer (NMIBC), has been endorsed in the global expert consensus as well as in the Chinese guidelines for urological and andrological diseases. While not yet available in China, a market approval application for APL-1706 was accepted by the NMPA in November 2023. The company is progressing through the review process and anticipates an NMPA approval by June 2025.

Although a pivotal trial of APL-1202 plus intravesical chemotherapy for the treatment of NMIBC failed to meet the primary endpoint on efficacy in early 2024, the combination of APL-1202 and tislelizumab, an immune checkpoint inhibitor, as neoadjuvant therapy for muscle-invasive bladder cancer (MIBC) demonstrated positive results in the interim analysis of the phase II trial in September 2023. The study showed a significant improvement in pathologic complete response rate among patients who received APL-1202 plus tislelizumab compared with those who received tislelizumab alone (39% vs. 21%). The safety profile in the combination arm was deemed acceptable. These results were selected for a rapid oral abstract presentation at the 2024 ASCO (Free ASCO Whitepaper) GU.

The interim analysis results indicate that APL-1202 significantly enhances the histological response rate of tislelizumab. Based on this, the company plans to conduct clinical studies of APL-1202 in combination with immune checkpoint inhibitors in the population of Chinese patients who have failed platinum-based chemotherapy for bladder cancer. The company intends to promptly communicate with the National Medical Products Administration’s Center for Drug Evaluation (CDE) and submit an application for clinical trials. Furthermore, the company plans to initiate clinical studies of its second-generation compound, APL-1501, in combination with immune checkpoint inhibitors for the treatment of non-muscle invasive bladder cancer with BCG-unresponsive carcinoma in situ (CIS), either with or without papillary tumors, in the United States. The company also aims to engage in communication and regulatory discussions with the FDA regarding the registration clinical development plan in 2024.

Additionally, it is actively pursuing overseas development and collaboration opportunities for APL-1202 and APL-1501, aiming to lower overseas development costs and boost cash flow through out-licensing.

Enhancing Early Research Technology Platforms in Areas of Focus, Generating a Steady Flow of Drug Candidates

Along with advances in clinical development, the company’s early research platform has undergone a process strengthening three core pillars: Targeted Immunomodulator Normalization (TIMN), Targeted & AI-driven Drug Discovery (TAIDD), and Drug Device Combination (DDC). Concurrently, it is actively exploring innovative technologies such as antibody drug conjugate (ADC) and in situ orthotopic bladder cancer (IOBC) model, while consistently generating new drug candidates.

Utilizing the TAIDD platform, APL-2302 (for ovarian and breast cancer), AT-014 (for urinary system tumors), AT-017 (for breast cancer), and AT-018 (for ovarian and breast cancer) have been successfully discovered. Utilizing the DDC platform, APLD-2304 (for NMIBC diagnosis and surgery) has been developed, along with preclinical products such as AT-020 (for various solid tumors) and AT-021 (for breast cancer and other solid tumors) that are based on ADC technology.

In 2023, the company invested approximately RMB 365 million in R&D, representing a 49.49% increase from the previous year. It employeed 198 R&D staff members, marking a 12.50% year-over-year increase.

Specialty Commercial Team Bolstered Capabilities to Drive Revenue Growth

Asieris also continued to strengthen the capabilities of its commercial team for generating sustained revenue streams. During the reporting period, the company achieved an operating revenue of RMB 13.7533 million, which represents an increase of RMB 13.7272 million compared to the same period last year. This revenue primarily stemmed from product sales and fees generated from data out-licensing.

The company has established dedicated business units for oncology and for women’s health to drive commercialization in the targeted areas. The oncology unit has obtained licenses of Neratinib tablets (Ouyoubi) for intensive adjuvant treatment of early breast cancer and Pazopanib tablets (Dipeptid) for the treatment of advanced renal cell carcinoma. The company also promptly assembled a robust commercial team following the introduction of these two products, Dipeptid and Ouyoubi were commercially launched in October and December 2023, respectively, achieving sales revenue of RMB 9.2892 million by the end of 2023.

As of now, the oncology unit has established a sound framework and is well positioned for substantial sales growth of Dipeptid and Ouyoubi in 2024. It targets sales revenue exceeding RMB 100 million and is set to achieve internal breakeven for the entire business unit, aiming to position the company as an industry leader in commercialization capabilities and operational efficiency.

Simultaneously, a women’s health business unit was swiftly established following the success of the international phase III trial for APL-1702 in treating HSIL. This unit will focus on commercializing APL-1702 in the Chinese market and expanding the company’s pipeline in women’s health, with the goal of addressing the unmet clinical needs of female patients.

Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals, said, "The company has maintained a steadfast focus on addressing underserved needs in genitourinary tumors and related diseases, particularly in the specialized areas of early-stage bladder cancer and precancerous cervical lesions. Through our specialty R&D strategy and leveraging our three major technology platforms alongside unique innovations, we’ve generated a suite of highly differentiated drug candidates in 2023. While the clinical trial of APL-1202 in combination with chemotherapy didn’t meet expectations, our overall portfolio has achieved significant milestones in clinical development. Notably, the successful phase III trial of APL-1702 signifies the potential to revolutionize the landscape with the non-surgical treatment for precancerous cervical lesions. We’ve also built up a robust specialty commercial team to generate sustainable revenue streams. Looking ahead, we will step up efforts to strengthen our specialty pipeline and commercial capabilities in diagnosis and treatment realms. We’ll actively pursue international development and collaboration opportunities and aim to create substantial value for both communities and shareholders."