On May 6, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Lipocine, MAY 6, 2021, View Source [SID1234579415]).

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First Quarter Recent Corporate Highlights

Announced positive topline results from the Phase 2 LiFT ("Liver Fat intervention with oral Testosterone") clinical study, investigating LPCN 1144 in biopsy-confirmed NASH male subjects
Both LPCN 1144 treatment arms met the primary endpoint, change in hepatic fat fraction via magnetic resonance imaging proton density fat fraction ("MRI-PDFF"), with statistical significance
36-week biopsy data from the LiFT study are expected in August 2021
Continued enrolling patients into an open label extension to the LiFT clinical study in which all patients will have access to LPCN 1144
Announced the publication of results supporting the therapeutic potential of LPCN 1144 in the treatment of non-alcoholic steatohepatitis ("NASH") and hepatic fibrosis
The results were featured in a paper entitled "Treatment Potential of LPCN 1144 on Liver Health and Metabolic Regulation in a Non–Genomic, High Fat Diet Induced NASH Rabbit Model" (Comeglio et al), published in the Journal of Endocrinological Investigation
Continued to evaluate commercial options for TLANDO, our oral testosterone product for testosterone replacement therapy ("TRT") in adult males with hypogonadism
Posters featuring clinical data on TLANDO were presented at the ENDO 2021 Conference
Raised gross proceeds of approximately $28.7 million in a public offering of approximately 16.4 million shares of common stock
First Quarter Ended March 31, 2021 Financial Results
Lipocine reported a net loss of $3.4million, or ($0.04) per diluted share, for the first quarter ended March 31, 2021, compared with a net loss of $5.8 million, or ($0.14) per diluted share, for the first quarter ended March 31, 2020.

Research and development expenses were $1.6 million for the first quarter ended March 31, 2021, compared with $2.5 million for the first quarter ended March 31, 2020. The decrease in research and development expenses during the three months ended March 31, 2021 was primarily due to a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects and a decrease in raw material costs of TLANDO XR offset by increases in personnel expense and other R&D expenses.

General and administrative expenses were $1.5 million for the first quarter ended March 31, 2021, compared with $2.1 million for the first quarter ended March 31, 2020. The decrease in general and administrative expenses during the three months ended March 31, 2021 was primarily due to a decrease in legal costs due to less activity in 2021 as compared to 2020 in the following activities: lawsuit filed against Clarus Therapeutics Inc. for patent infringement in April 2019 and the on-going class action lawsuit defense. Additionally, personnel costs decreased in 2021. These decreases were offset by an increase in corporate insurance expenses.

As of March 31, 2021, the Company had $50.0 million of unrestricted cash, cash equivalents, and marketable investments, compared to $19.7 million of unrestricted cash, cash equivalents and marketable investment securities as of December 31, 2020.

On May 6, 2021 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported it will host a conference call on Wednesday May 12, at 8:00 a.m. Eastern time to discuss its financial and operating results for the first quarter of 2021, in addition to providing a business update (Press release, VolitionRX, MAY 6, 2021, View Source [SID1234579414]).

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Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with Terig Hughes, Chief Financial Officer and Scott Powell, Executive Vice President, Investor Relations. The call will provide an update on recent developments and Volition’s activities, including details of new and ongoing clinical trials, important events which have taken place in the first quarter of 2021, and milestones for 2021 and beyond.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until May 26, 2021. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13719633.

On May 6, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that it has entered into a clinical trial collaboration with a subsidiary of Merck (known as MSD outside the U.S. and Canada) to evaluate Fusion’s lead candidate, [225Ac]-FPI-1434 (FPI-1434), in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with solid tumors expressing insulin-like growth factor 1 receptor (IGF-1R) (Press release, Fusion Pharmaceuticals, MAY 6, 2021, View Source [SID1234579413]).

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"With our strong preclinical data demonstrating promising activity with FPI-1434 and immuno-oncology agents, we believe we have an opportunity to improve efficacy in tumor indications where KEYTRUDA is approved, and to potentially expand into new tumor indications," said Chief Executive Officer John Valliant, Ph.D. "This collaboration with Merck builds off our research on the mechanism of action of alpha radiation and aligns with our goal to expand the utility of radiopharmaceutical therapies, including advancing into earlier lines of cancer therapy."

The planned Phase 1/2 combination trial will evaluate safety, tolerability and pharmacokinetics of FPI-1434 in combination with pembrolizumab and is expected to initiate approximately six to nine months after achieving the recommended Phase 2 dose in the ongoing Phase 1 study of FPI-1434 monotherapy. Under the terms of the agreement, Fusion will sponsor the study and Merck will supply KEYTRUDA.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About FPI-1434
FPI-1434 is a radioimmunoconjugate designed to target and deliver alpha emitting medical isotopes to cancer cells expressing IGF-1R, a receptor that is overexpressed on many tumor types. FPI-1434 utilizes Fusion’s Fast-Clear linker to connect a human monoclonal antibody that targets IGF-1R with actinium-225, a powerful alpha-emitting isotope with desirable half-life and decay chain properties.

On May 6, 2021 Asieris Pharmaceuticals ("Asieris") and BeiGene, Ltd. ("BeiGene") reported that they have entered into a clinical collaboration agreement to evaluate the safety and efficacy of oral APL-1202 in combination with tislelizumab as neoadjuvant therapy in patients with muscle invasive bladder cancer (MIBC) (Press release, Asieris Pharmaceuticals, MAY 6, 2021, View Source [SID1234579412]). Asieris plans to submit INDs in China and United States for an open-label, multi-center Phase I/II clinical study with primary objectives including: to evaluate the safety in MIBC patients; determine the RP2D (recommended phase 2 dose), and efficacy as neoadjuvant therapy for MIBC.

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APL-1202 is an orally available reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment. It is currently in phase III/pivotal clinical trials in China as single agent for the first-line treatment of non-muscle invasive for the second-line treatment of NMIBC. Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. It has been approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with high expression of PD-L1 who have failed to receive platinum-based chemotherapy, including neoadjuvant or adjuvant chemotherapy that has progressed within 12 months.

"We are excited to collaborate with BeiGene to further explore the potential of APL-1202," said Dr. Xue Yong, MD, PhD, Chief Medical Officer at Asieris. "We found that synergistic effects of APL-1202 and immunotherapies have been shown in orthotopic prostate cancer and MIBC efficacy animal models. Based on these preclinical data, we hope that this clinical trial will prove the concept of APL-1202’s activity in modulating tumor microenvironment, and believe that APL-1202 in combination with tislelizumab could be an effective neoadjuvant therapy for patients with MIBC."

On May 6, 2021 HanAll Biopharma (KRX: 009420) (HanAll) reported that it achieved 27.8 billion won in sales, 5.4 billion won in operating profit and 4.5 billion won in net profit in the first quarter of this year (Press release, HanAll Biopharma, MAY 6, 2021, View Source [SID1234579411]).

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Sales and operating profit rose 26% and 80%, respectively, compared to the same period last year thanks to increased R&D revenue and increased product revenue. Operating margin increased to 19% from 14%, and net income for the period was estimated at 4.5 billion won, up 13 percent year-on-year.

The growth of R&D revenue including milestone payments from HL161 and HL036 licensed to Immunovant and Harbour BioMed was a main performance driver while domestic drug sales slightly increased year-on-year. HanAll remain committed to delivering innovative medicines for patients with its improved financial performance.

The company plans to start the second Phase 3 clinical trial in dry eye disease (DED) in the 2H of 2021, which is being co-developed with Daewoong Pharmaceutical.

Meanwhile, HanAll has recently appointed David Hernandez, former Head of Clinical Operations Japan at Merck Biopharma, as Vice President of Clinical Operations at HPI, a U.S. subsidiary of HanAll, to accelerate clinical trials of its current and future pipeline compounds.