On September 30, 2022 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on the discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, reported financial results for the first six months of 2022 and provided an update on clinical and corporate progress (Press release, Vivoryon Therapeutics, SEP 30, 2022, View Source [SID1234621574]). The report is available on the Company’s website at View Source

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"The first half of 2022 was marked by decisive progress in the development of our lead candidate varoglutamstat in AD, which cumulated in several data presentations at the prestigious AAIC 2022 in San Diego in July and August," said Dr. Ulrich Dauer, CEO of Vivoryon. "Firstly, we have been able to further de-risk clinical development of varoglutamstat with extremely encouraging safety results from our VIVIAD Phase 2b study. At the same time, adding to the preclinical data package by characterizing the additive effect of varoglutamstat in combination with anti-Abeta antibodies, we continue to explore the full potential for its application in a variety of therapeutic settings. These data, which have sparked excitement within the medical community and beyond, substantiate our commitment to making a difference to all those affected by Alzheimer’s disease. Having secured a significant private placement will enable us to continue to follow our carefully crafted development strategy. We warmly welcome our new investor KKR Dawn Aggregator L.P. and are very grateful to them and to our longstanding investor Claus Christiansen for their support through the upcoming clinical milestones."

Portfolio Highlights (H1 2022 and post-period)

VIVIAD

VIVIAD (NCT04498650) is a state-of-the-art Phase 2b study conducted in Europe and designed to evaluate the safety, tolerability and efficacy of varoglutamstat in 250 subjects with mild cognitive impairment (MCI) and mild Alzheimer’s disease (AD).
On June 23, 2022, Vivoryon announced that it has completed the parallel group, dose-finding part of its VIVIAD study and that the independent Data Safety Monitoring Board (DSMB) has selected the highest dose investigated, 600 mg twice daily (BID), as the final dose to be administered in the second part of the study. The DSMB decision is based on safety data from 181 patients, 90 of which had completed the week 24 treatment visit at the May 17 cut-off date. All subjects randomized to the treatment arm will be treated at the selected dose of 600 mg BID moving forward and will continue treatment for up to 48-96 weeks dependent on study entry date.
Vivoryon presented detailed safety data from the VIVIAD study at the Alzheimer’s Association International Conference (AAIC) in San Diego (July 31 to August 4, 2022). The safety data showed that varoglutamstat was well tolerated with only 14% of overall reported adverse events (AEs) considered to be potentially related to study treatment. All of the AEs were gastrointestinal, general, or related to the nervous system or skin. Only four patients (2.2%) experienced serious AEs (SAEs) and only two patients (1.1%) discontinued the study. Both the total number of SAEs and the discontinuation rate were considerably lower than the respective numbers at the 800 mg BID varoglutamstat dose in Vivoryon’s completed Phase 2a SAPHIR study (NCT02389413; 15% SAEs, 33% discontinuation), while retaining a similar level of target inhibition.
VIVIAD is actively enrolling patients at 22 study centers in five European countries and will continue to evaluate its primary and secondary outcome measures, which include multiple cognitive, safety and biomarker endpoints. Vivoryon remains on track for final data readout for the study in the second half of 2023.
VIVA-MIND

VIVA-MIND (NCT03919162) is a combined Phase 2a/b study for varoglutamstat conducted in the U.S. which seeks to enroll 180 patients with early AD into the Phase 2a adaptive dose finding part. If predefined criteria are fulfilled, the trial will pass a stage-gate into the Phase 2b part, enrolling an additional 234 patients treated at the selected dose for at least 72 weeks. Thus, taken together a total of 414 patients will be treated on stable doses of varoglutamstat for 18 months in the course of the study. The primary endpoint for this study is CDR-SB (clinical dementia rating scale – sum of boxes), an established approvable endpoint measuring a combination of cognitive abilities and activities of daily living. The study is coordinated by the Alzheimer’s Disease Cooperative Study (ADCS), and supported by a USD15 million grant from the National Institute on Aging (NIA award number R01AG061146).
VIVA-MIND is actively enrolling patients, with currently 14 sites open and on track for an interim futility analysis planned for the first half of 2023.
Preclinical Programs

Also at AAIC 2022, Vivoryon presented preclinical data on the Company’s N3pE amyloid-targeting molecules. The results underscore the unique potential of Vivoryon’s N3pE amyloid-targeting therapeutic strategy in both mono- and combination therapy settings in AD. The data show, that a combination treatment of aducanumab and varoglutamstat achieves additive effect on Abeta pathology, indicating feasibility of dose reduction to improve safety of Abeta antibody-based AD treatments. This demonstrates the potential benefit of a combination therapy designed to simultaneously make use of two different and independent molecular N3pE-related mode of actions – small molecule based QPCT/L inhibition and anti-N3pE-immunotherapy. Additional data from murine analog of PBD-C06 highlight the differentiated safety profile vs. other anti-Abeta antibodies at N3pE amyloid-lowering concentrations.
Partnered Programs

On February 28, 2022, Vivoryon and its partner Simcere announced that China’s Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) has approved the Clinical Trial Application for varoglutamstat for the development in Greater China by Simcere. Simcere has communicated that the company is currently preparing for initiation of clinical studies in China.
Corporate Development Highlights (H1 2022 and post-period)

On September 30, 2022, the Company entered into a private placement of 2,054,796 registered shares at an offering price of EUR 7.30 per share. The new shares from the capital increase represent 9.3% of Vivoryon’s existing share capital and will be issued from the Company’s authorized capital under exclusion of the existing shareholders’ pre-emptive rights. Consequently, the Company’s issued share capital will increase to EUR 24,105,278.00 on completion of the private placement. In addition, the investors will have the option to purchase, in aggregate, up to another 2,054,796 registered shares at a price of EUR 7.30 during a period ending twelve months after the date of the approval of a EU Recovery prospectus (in accordance with Section 14a Prospectus Regulation) or three months after the achievement date of a defined clinical milestone, whichever is later. The gross proceeds of the private placement amount to EUR 15.0 million, and up to an additional EUR 15.0 million will be raised if the option to purchase the additional shares is exercised in full. Vivoryon intends to use the net proceeds from the offering to support the ongoing clinical development of its lead candidate varoglutamstat, currently in Phase 2 in Europe and the United States for the treatment of patients with Alzheimer’s disease, as well as for general corporate purposes. The private placement was supported by Vivoryon’s longstanding investor Claus Christiansen and KKR Dawn Aggregator L.P. ("Dawn Biopharma"), a platform controlled by affiliates of Kohlberg Kravis Roberts & Co. L.P. ("KKR"), a leading global investment firm, as new investor to the Company. Completion of the private placement is expected to occur on October 6, 2022.
In an in-person and webcasted breakfast and networking event at AAIC 2022, held on August 2, 2022, Vivoryon met with researchers, clinicians and the investment community to discuss the future of AD treatments and provided updates on its VIVA-MIND and VIVIAD studies for varoglutamstat. The event also featured spotlight presentations by Prof. Howard Feldman, MD, Professor of Neurosciences and Director of the ADCS at UC San Diego and VIVA-MIND study director, Cynthia Lemere, PhD, Associate Professor of Neurology, Ann Romney Center for Neurologic Diseases, Brigham and Women’s Hospital, Harvard Medical School, Boston and Dr. Frank Weber, CMO of Vivoryon.
On June 22, 2022, Vivoryon held its Annual General Meeting where all voting items were approved with a large majority. Voting items included the re-appointment of Charlotte Lohmann, Dr. Erich Platzer, Dr. Dinnies von der Osten and Dr. Jörg Neermann as members of the Company’s Non-Executive Board, as well as the appointment of Dr. Claudia Riedl and Samir Shah, MD, to its Non-Executive Board of Directors.
On April 1, 2022 Vivoryon announced the successful completion of a private placement, raising gross proceeds of EUR 21 million, with net proceeds from the offering intended to be used to support the ongoing clinical development of varoglutamstat, as well as for general corporate purposes. The capital raise was supported by a number of high-quality institutional investors from Europe and the U.S. as well as members of Vivoryon’s Executive and Non-Executive Boards.
Financial Results for the First Half Year 2022

The Company generated no license revenues or smaller revenue in half year 2022 or 2021.

Research and development expenses increased in 2022 by EUR 1.6 million compared to the six months ended June 30, 2021. This increase is primarily attributable to EUR 1.7 million higher expenses related to our clinical trial VIVIAD, which has advanced significantly compared to the six months ended June 30, 2021.

General and administrative expenses for the six months ended June 30, 2022 are about the same level as for the six months ended June 30, 2021. Higher expenses for share based payments with EUR 0.3 million were compensated by EUR 0.3 million lower expenses for legal and consulting services.

Net loss for the six months ended June 30, 2022 was EUR 12.6 million, compared to EUR 11.7 million for the six months ended June 30, 2021. The Company held EUR 24.4 million in cash and cash equivalents as of June 30, 2022, compared to EUR 14.7 million as of December 31, 2021.

Cash flows provided from financing activities were EUR 19.6 million for the six months ended June 30, 2022 compared to cash used in financing activities of EUR 0.5 million in the six months ended June 30, 2021. The change mainly relates to a private placement on April 1, 2022 by way of accelerated book building, placing 2,000,000 registered shares at an offering price of EUR 10.50 per share. The Company’s issued share capital has increased to EUR 22,050,482. The gross proceeds of the offering amounted to EUR 21.0 million.

Financial Guidance

Including the proceeds from the private placement entered into on September 30, 2022, according to current planning and estimates, Vivoryon expects that its existing cash and cash equivalents will be sufficient to fund its research and development expenses as well the general and administrative expenses and cash flows from investing and financing activities at least through December 2023. This does not include the exercise of the option to acquire up to an additional 2.054.796 shares for a period ending the later of twelve months after the date of the approval of a EU Recovery prospectus (in accordance with Section 14a Prospectus Regulation) or the achievement date of a defined clinical milestone.

Vivoryon Therapeutics N.V. Financial Statements

Condensed Statements of Profit or Loss and Other Comprehensive Income for the six months ended June 30, 2022 and 2021

The accompanying notes are an integral part of these condensed interim financial statements.

The accompanying notes are an integral part of these condensed interim financial statements.

The accompanying notes are an integral part of these condensed interim financial statements.

Half Year Financial Report 2022

The condensed interim financial statements of Vivoryon have been prepared in accordance with IAS 34 Interim Financial Reporting and International Financial Reporting Standards (IFRS) of the International Accounting Standards Board, as adopted by the European Union (EU-IFRS). The half-year financial statements were not audited or reviewed. The reports are available on the Company’s website www.vivoryon.com.

Conference Call and Webcast

Vivoryon will host a conference call and webcast today, September 30, 2022, at 3:00 pm CEST (9:00 am EDT). A Q&A session will follow the presentation of the full year results.

Please dial in ten minutes prior to commencement.

A live webcast and slides will be made available at: www.vivoryon.com/investors-news/news-and-events/presentations-webcasts/

Approximately one day after the call, a slide-synchronized audio replay of the conference will be available on: www.vivoryon.com/investors-news/news-and-events/presentations-webcasts/

On September 29, 2022 LEPU BIOPHARMA reported that its first innovative biological drug, anti-PD-1 antibody – Puyouheng (generic name: pucotenlimab injection) has been approved for marketing by the National Medical Products Administration (NMPA) for the indication of unresectable or metastatic melanomas after the failure of previous systemic therapy (Press release, Lepu Biopharma, SEP 29, 2022, View Source [SID1234633515]). It is another approved indication for Puyouheng (pucotenlimab injection) following the approval of the indication of MSI-H/dMMR solid tumor in July this year and will bring a new immunotherapy treatment option for patients with melanoma in China. The Company is also pleased to announce that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People’s Republic of China (PRC) has granted MRG003 breakthrough therapy designation for the treatment of recurrent or metastatic nasopharyngeal cancer (R/M NPC).

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Bringing a new option to tumor immunotherapy for patients.

This approval was mainly based on a single-arm, open-label, pivotal phase II clinical study with a primary endpoint of the objective response rate (ORR) assessed by the Independent Review Committee (IRC) according to the RECIST 1.1. A total of 119 patients were enrolled in this trial. As of July 30, 2021, the ORR assessed by the IRC was 20.2% (95% CI: 13.4-28.5, 1 case of complete response, 23 cases of partial response). The results of the study show that Puyouheng brings significant benefits to patients in the treatment of unresectable or metastatic melanomas after the failure of previous systemic therapy, and meets the preset primary endpoint with excellent safety. The results of the clinical study were first published at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

Melanoma is a malignant tumor of melanocytes. Although melanoma only accounts for less than 5% of skin cancers, it is the deadliest form which takes up more than 75% of all deaths caused by skin cancers. Surgical treatment is the main option for malignant melanomas in the early stage with a better prognosis, while the treatment of advanced melanomas is limited with a poor prognosis. As an innovative anti-PD-1 humanized monoclonal antibody drug, Puyouheng innovatively prolongs its half-life through triple mutations and can bind to PD- 1 with high affinity to restore the ability of immune cells to kill cancer cells by blocking the binding of PD-1 to its ligands PD-L1 and PD-L2.

With a strong affinity to PD-1 and outstanding binding stability, Puyouheng has demonstrated excellent anti-tumor efficacy in both in vitro and clinical trials.

Actively conducting studies on the combination therapy within our pipelines under the support of a clinical layout covering multiple solid tumors.

Puyouheng has been approved for marketing with indications of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors and advanced melanomas. In addition to the two approved indications, focusing on Puyouheng, LEPU BIOPHARMA is accelerating its development in the treatment of multiple solid tumors and actively investigating combined tumor immune immunotherapies, including the treatment of gastric cancer, liver cancer, lung cancer, and other cancer types with high incidence. In terms of international development, LEPU BIOPHARMA is also speeding up its efforts to expand the international market, promoting joint development, cooperation and authorization of new drugs globally. In January 2022, it obtained IND approval from the US FDA for pucotenlimab in the treatment of advanced solid tumors.

Breakthrough therapy designation granted by the CDE to MRG003 for the treatment of R/M NPC Breakthrough therapy designation is for innovative or modified new drugs that treat a condition that is seriously life-threatening or has serious quality-of- life impairment, and such condition has no effective therapies or compared with current available therapies, sufficient evidence demonstrates an obvious advantage in clinic treatment of the new drugs.

Previously, MRG003 has been granted the Orphan-drug Designation by the Food and Drug Administration of the United States (the "FDA") for the treatment of R/M NPC. MRG003 is the most advanced EGFR-targeted ADC in clinical-stage development in China and has the potential to seize market opportunities. The breakthrough therapy designation, which helps to expedite the development and review of the drug by the CDE, represent an encouraging signal to the promotion of MRG003 as well as the strategy of developing market-differentiating pipeline of the Company.

About Puyouheng (pucotenlimab injection)
Puyouheng (pucotenlimab injection) is a humanized IgG4 monoclonal antibody against human PD-1 independently developed in China. It can bind to PD-1 with high affinity to restore the ability of immune cells to kill cancer cells by blocking the binding of PD-1 to its ligands PD-L1 and PD-L2. Puyouheng (pucotenlimab injection) adopts an innovative molecular design to prolong its half-life, showing strong clinical anti-tumor activity and good safety. The innovative use of antibody engineering technology to introduce triple mutations in the Fc region improves the binding affinity of FcRn, thereby prolonging the drug’s half-life significantly, showing its promising clinical efficacy and drug compliance in patients. Compared with all rival anti-PD-1 antibodies that have been marketed or entered phase III clinical trials, the mean half-life of Puyouheng (pucotenlimab injection) is 21.8 days (single dosing) and 38.2 days (steady-state). In addition, the prolonged half-life does not cause additional adverse events, indicating the excellent clinical efficacy of the drug.

About MRG003
MRG003 is an ADC comprised of an EGFR-targeted monoclonal antibody ("mAb") conjugated with the potent microtublin inhibiting payload monomethyl auristatin E ("MMAE") via a valinecitrulline linker. It binds specifically with high affinity to EGFR on the surface of tumor cells, releases the potent payload upon internalization and lysosomal protease cleavage of the linker and results in tumor cell death. EGFR is highly expressed in colorectal cancer, lung cancer, head and neck cancer and other malignant solid tumors, and is expressed in 89% advanced NPC. Therefore, EGFR is an important target for cancer treatment. In China, the Company is conducting exploring research of MRG003 in several indications and amongst others, patient enrollment was completed in March 2022 for exploratory Phase II clinical study of MRG003 in advanced NPC. It has entered the follow-up period and clinical data is outstanding.

On September 29, 2022 ConcertAI, LLC (ConcertAI) reported the launch of its new Digital Trial Software-as-a-Service solution (Press release, Bristol-Myers Squibb, SEP 29, 2022, View Source [SID1234621760]). Powered by ConcertAI’s deep and broad real-world data, IT infrastructure, digital technology and a broad network of leading research sites, Digital Trial Solution integrates clinical research and clinical practice seeking to simplify patient identification, consent, IRB approval and contract negotiations . This offering seeks to ultimately reduce or eliminate duplicative data entry and constant data monitoring so clinical research staff can focus their resources on patient care.

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"As an industry leader in discovering, developing and delivering medicines to help patients prevail over serious diseases, we are employing digital innovation to redesign and redefine how pre- and post-approval studies are conducted and, together with ConcertAI, we are fundamentally changing the way we do clinical research from study design, through enrollment and execution," said Venkat Sethuraman, senior vice president, Global Biometrics and Data Sciences, Bristol Myers Squibb. "The Digital Trial Solution will allow us to accelerate access to innovative, lifesaving cancer medicines to patients. And we anticipate this approach will become BMS’ gold standard for oncology studies in the future."

The Digital Trial Solution helps researchers rethink the who, what, where and how to design trials, recruitment criteria and data collection standards needed to launch trials that take less time to execute, cost less and are more diverse across patients and sites. The Digital Trial Solution is advancing us towards the industry goal of digital-only trials and clinical studies that are more directly generalizable to the community settings where most patients receive their care.

"Traditional methods are failing trial sponsors, cancer patients and their providers, and the lack of adequate technologies to implement more effective and efficient digital clinical development solutions has been painfully exposed during the COVID-19 pandemic," said Jeff Elton, PhD, chief executive officer, ConcertAI. "Our mission is to build the most advanced technologies and AI solutions for the future of digital oncology clinical development to meet and exceed the regulatory appetite for diversity and digital enablement."

ConcertAI is developing the first digital research solutions and clinical trials network that will make it easier for providers to screen patients for trials and gather the necessary clinical data to execute a study once the patient has enrolled. This modular set of technology re-envisions how clinical research can be entirely integral to healthcare provider workflows, while enabling an end-to-end digital solution for the biopharma sponsor that delivers enormous benefits in accuracy, reliability, time and cost when executing a clinical trial. SaaS tools and real-world data provide the differential performance benefit for study sponsors, research clinics and, most importantly, community-based patients.

"We are extremely proud to have worked with ConcertAI for the past two years to help them shape this highly innovative digital solution," said Marisa Co, vice president, R&D Business Insights & Analytics, Bristol Myers Squibb. "Achieving our first participant enrolled through the Digitally Accelerated Clinical Trial (DACT) model has been a tremendous cross-functional effort and demonstrates BMS’ commitment to use data and technology to simplify and accelerate the clinical research process."

The Digital Trial Solutions use digitalization technologies that reduce the time, complexity and burden of finding participants and conducting trials. The solution is designed for healthcare practices by integrating directly into the practices’ clinical workflows including electronic medical records, imaging and lab systems, assisting them with more efficient ways to identify patients that may be candidates for clinical trials, which research sites benefit from through a set of integrated applications that makes patient screening easier. The solution can also help reduce errors-over manual entry of trial data. This benefits the healthcare community through broader clinical trial access to patients. ConcertAI’s first deployments are underway with a schedule of network expansions over the coming months creating the largest digitally enabled oncology, hematology and urology research capacity in the industry.

On September 29, 2022 Provectus (OTCQB: PVCT) reported that the Company has initiated a new sponsored research program with Amina El Ayadi, PhD, Assistant Professor, Surgical Sciences Division and Jayson Jay, PhD, Postdoctoral Research Fellow and Jeane B. Kempner Scholar of the Burn, Trauma, and Critical Care Research Laboratory in the Department of Surgery at the University of Texas Medical Branch at Galveston (UTMB) to characterize the effects of Provectus’ proprietary pharmaceutical-grade rose bengal sodium (RBS) on full-thickness cutaneous wounds and during the subsequent phases of wound healing (Press release, Provectus Biopharmaceuticals, SEP 29, 2022, View Source [SID1234621586]). RBS is the lead member of a class of small molecules called halogenated xanthenes that is entirely owned by Provectus.

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Starting from the Texas City Disaster of 1947, the deadliest industrial accident in U.S. history and one of history’s largest non-nuclear explosions, UTMB clinicians and researchers in the Department of Surgery have developed treatments that improve the survival chances of patients with massive burns, reduce scar formation, and accelerate patient recovery. Many novel treatments discovered by UTMB researchers have been adopted by specialist burn centers around the world. The Department of Surgery’s Burn, Trauma, and Critical Care Research Laboratory is equipped with an array of cutting-edge equipment and technologies that support its research activities, including a dedicated cell culture suite, confocal microscope, flow cytometer, Comprehensive Lab Animal Monitoring System (CLAMS), and bioprinter for 3D cell culture.

Drs. El Ayadi and Jay plan to examine the safety of topically-applied, multi-dosed RBS over the wound healing periods of inflammation and cellular proliferation, determine the efficacy of RBS in a pre-clinical model of wound healing, and elucidate a spatiotemporal immune activation signature over wound healing time in a large animal model of burn and full-thickness cutaneous trauma.

On September 29, 2022 YishengBio Co., Ltd. (to be renamed as YS Biopharma Co., Ltd., and herein referred to as "YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer, and Summit Healthcare Acquisition Corp. (Nasdaq: SMIH) ("Summit"), a publicly traded special purpose acquisition company, reported that they have entered into a definitive agreement for a business combination of Summit and the Company (the "Transaction") (Press release, Yisheng Biopharma, SEP 29, 2022, View Source [SID1234621582]). Upon closing of the Transaction, the combined company will be renamed as YS Biopharma Co., Ltd. and become a publicly traded company on the Nasdaq.

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YS Biopharma’s YSJATM rabies vaccine is one of the leading products in the human use rabies vaccine market in China with a total product sales of approximately RMB503 million in the fiscal year ended March 31, 2022. Supported by strong sales & marketing infrastructure, over 90 million doses of YSJATM rabies vaccine have been administered with excellent protection efficacy and safety for post-exposure protection against rabies.

YS Biopharma has also developed a broad pipeline powered by its proprietary PIKA immunomodulating technology platform, including four clinical stage candidates, targeting a wide range of clinical indications with significant market potential, such as rabies, COVID-19, hepatitis B, cancer, shingles and influenza.

Over the years, YS Biopharma has made significant advancements in commercialization expertise and manufacturing infrastructure. It has completed the construction of three state-of-art manufacturing plants for YSJATM rabies vaccine, PIKA adjuvanted rabies vaccine and PIKA adjuvanted recombinant COVID-19 vaccine.

Upon closing of the Transaction, YS Biopharma will continue to be led by Mr. Yi Zhang, its founder and chairman, Dr. Hui Shao, its president and chief executive officer, and the current management team. YS Biopharma has over 800 employees with business operations in China, Singapore, the United States, the United Arab Emirates and the Philippines.

Mr. Yi Zhang, the founder and chairman of YS Biopharma, commented, "YS Biopharma has always been the trailblazer and at the forefront in developing new technology and products for vaccine and immunological therapeutics. This transaction will fuel our strategy for future business expansion and execution and allow shareholders to participate in significant upside potential created by the partnership with Summit."

Dr. Hui Shao, the president and the chief executive officer of YS Biopharma, stated, "Today’s announcement on strategic combination between YS Biopharma and Summit represents a major milestone in our journey to become a global leader in transformative vaccine and therapeutic biologics arena. We anticipate the closing of the business and financial transactions will further accelerate the commercialization endeavor of our promising pipeline in many countries and create shareholder values for both YS Biopharma and Summit."

Mr. Bo Tan, the chief executive officer, co-chief investment officer and director of Summit, stated, "Summit is missioned to identify high-quality growth companies in global healthcare industry. YS Biopharma is clearly a differentiated vaccine platform with growing revenue and robust pipelines. With sponsor’s firm commitment, support from our shareholders and Forward Purchase Investors and further enhanced by a bonus share structure in the transaction, we believe YS Biopharma will be well positioned to achieve the next series of milestones and the business combination will create meaningful value for our shareholders."

YS Biopharma Investment Highlights

A global commercialization-stage biopharmaceutical company focusing on innovative vaccines and therapeutic biologics with over 800 employees and business operations in China, Singapore, the United States, the United Arab Emirates and the Philippines
A leading human use rabies vaccine manufacturing company in China, with approximately RMB503 million product sales in the fiscal year ended March 31, 2022, over 1,700 local Centers for Disease Control and Prevention sales coverage, as well as over 90 million doses administered with excellent safety and efficacy profile for post-exposure protection against rabies
An in-house developed and proprietary PIKA immunomodulating technology platform in immunological and therapeutic innovation, having established strong intellectual franchise evidenced by over 70 patents granted by over 30 jurisdictions covering both technology and product innovations
PIKA adjuvanted rabies vaccine candidate is expected to enter into a multi-center Phase III clinical trials in Singapore, the Philippines, Vietnam and Pakistan in the fourth quarter of 2022, with the potential to become "best in class," and cited as a novel vaccine with dose reduction and accelerated regimen by the Background Paper of World Health Organization (WHO)
PIKA recombinant COVID-19 vaccine in Phase II/III clinical development in the United Arab Emirates, the Philippines and Pakistan with potentially differentiated immunological profile as compared to mRNA-based vaccines, including two-year sustainable immune response, cellular immuno response, broad neutralization against all the prevalent COVID-19 virus mutants such as Omicron variants, and additional therapeutic treatment benefits
Established track record, technical expertise and infrastructure in mass production of vaccine and biologics, providing strong execution support in clinical development and commercialization objectives
Transaction Overview

The pre-money equity value of YS Biopharma in the proposed Transaction is approximately $834 million. YS Biopharma shareholders will become the majority owners immediately after the closing of the Transaction. The business combination is expected to provide up to approximately $230 million in gross proceeds to YS Biopharma, including $30 million from Forward Purchase Investors and up to approximately $200 million currently held in Summit’s trust account, assuming no redemption from Summit’s existing public shareholders. Proceeds from the Transaction will allow YS Biopharma to fund its ongoing and planned clinical trials, future commercial launch of PIKA adjuvanted rabies vaccine, the construction of new GMP-compliant manufacturing plants as well as developing other product candidates.

Each of the board of directors of YS Biopharma and Summit has unanimously approved the proposed Transaction. The shareholders of YS Biopharma have also approved the proposed Transaction at its extraordinary general shareholders meeting. Completion of the proposed Transaction is still subject to the approval of Summit’s shareholders and certain other customary closing conditions, including, among others, a registration statement on Form F-4 (the "Registration Statement"), of which the proxy statement/prospectus forms a part, being declared effective by the U.S. Securities and Exchange Commission (the "SEC"), and the approval by the Nasdaq Stock Market LLC on the listing application of the combined company. The Transaction is targeted to be completed in the first quarter of 2023.

Additional information about the proposed Transaction, including copies of the business combination agreement and related agreements, will be provided in a Current Report on Form 8-K to be filed by Summit with the SEC and available at www.sec.gov. YS Biopharma intends to file the Registration Statement, which will contain a proxy statement and a prospectus, with the SEC in connection with the Transaction.

Advisors

Wilson Sonsini Goodrich & Rosati, Jingtian & Gongcheng and Maples and Calder (Hong Kong) LLP are serving as legal advisors to YS Biopharma in connection with the Transaction.

Cooley LLP and Ogier are serving as legal advisors to Summit in connection with the Transaction.

Investor Presentation

An investor presentation with more detailed information regarding the proposed Transaction will be filed by Summit as an exhibit to a Current Report on Form 8-K, which can be viewed on the SEC’s website at www.sec.gov.