On May 5, 2022 Arcadia Biosciences, Inc. (Nasdaq: RKDA), a producer and marketer of innovative, plant-based health and wellness products, reported that it will release its financial and business results for the first quarter of 2022 after market close on May 12, 2022 (Press release, Arcadia Biosciences, MAY 5, 2022, View Source [SID1234613733]).

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The company has scheduled a conference call for 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss first-quarter results and key strategic achievements. Interested participants can join the conference call using the following numbers:

A live webcast of the conference call will be available on the Investors section of Arcadia’s website at www.arcadiabio.com. Following completion of the call, a recorded replay will be available on the company’s investor website.

On May 5, 2022 Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon & Changjae Lee) reported its financial results for the first quarter of 2022 (separate basis) (Press release, Daewoong Pharmaceutical, MAY 5, 2022, View Source [SID1234613732]). In the first quarter, the separate sales and operating profit marked KRW 272.2 billion and KRW 26.8 billion, up 12.6% and 32.6% year-over-year, respectively . In the same quarter, the consolidated sales and operating profit marked KRW 298.4 billion and KRW 23 billion, up 10.7% and 2.2% y-o-y, respectively.

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Daewoong achieved record-high annual sales and operating profit in 2021 and again broke its record in the highest quarterly operating profit (separate basis) in the first quarter of this year. The sales growth of highly profitable ethical-the-counter (ETC) drugs and the increase in the export of Nabota were led by improvements in profitability, operating profit, and gross profit margin (GPM).

Sales of ETC drugs recorded KRW 197.6 billion, a 9% increase from KRW 181 billion y-o-y, leading to an increase in earnings. It is characterized by more than 20% growth compared to the same period of the previous year in highly profitable product lines such as an antiulcer drug Nexiad, a dyslipidemia drug Litorvazet, a gastric ulcer drug Axid, a hyperlipidemia drug Crezet, and an antithrombotic drug Cloart.

Sales of Nabota surged by 98% y-o-y, from KRW 15.4 billion to KRW 30.7 billion exports. In particular, its exports increased by 189% y-o-y, from KRW 7.9 billion to KRW 22.8 billion. For example, the exports to its U.S. sales partner Evolus amounted to KRW 18.3 billion, risen by three times y-o-y. Favorable exchange rates also supported the earnings. Nabota is expected to drive sales growth continuously, as Evolus is preparing to officially launch Nabota in Europe in the third quarter, and Nabota shows strong market presence in the countries where it has already been released.

Sales of over-the-counter (OTC) drugs recorded KRW 29.7 billion, a 12% increase from KRW 26.4 billion y-o-y. Due to the spread of COVID-19 and a surge in home treatment, the company’s representative cold medicine EZN6 grew by 77.3% y-o-y, and the quasi-drugs related to physical fatigue Urshot and a wet patch Easyderm also contributed to the growth. Sales of supplements also surged by 169% y-o-y, owing to its strategic reinforcement of the supplement portfolio for the liver, centered on the liver-specialized brand Ener Thistle, blood circulation, intestine, and vitamins, and focus on online sales channels.

"With export expansion of Nabota based on superior product power and quality, the highly profitable ETC product lines continued to grow, leading to another record-breaking highest quarterly operating profit," said Sengho Jeon, Daewoong Pharmaceutical CEO. "For the second quarter and the second half of this year, we are expected to achieve solid growth and increasing profitability, thanks to the expansion of Nabota’s overseas sales channels, the launch of highly profitable new products, such as Fexuclue tablets, a new drug for gastroesophageal reflux disease, and an increase in the gross profit margin."

On May 5, 2022 Insilico Medicine ("Insilico"), a clinical-stage end-to-end artificial intelligence (AI)-driven drug discovery company, reported that the company has nominated a preclinical candidate (PCC) targeting methionine adenosyltransferase 2A (MAT2A) from AI-designed molecules for the treatment of methylthioadenosine phosphorylase (MTAP)-deleted cancers (Press release, Insilico Medicine, MAY 5, 2022, View Source [SID1234613731]). The PCC is part of Insilico’s growing portfolio of synthetic lethality assets in development.

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MTAP deletion is one of the most common gene deletions seen in cancers including lung, bladder, and pancreatic cancer, and is associated with poor prognosis. MAT2A is defined as a synthetic lethality target in MTAP-deleted cancers and plays an essential role in producing S-adenosylmethionine (SAM), a molecule involved in cell function and survival. Inhibitors of MAT2A lead to a selective anti-proliferative effect on MTAP-deleted cancer cells by reducing the level of SAM to affect PRMT5-Dependent mRNA splicing, inducing DNA damage.

Insilico’s PCC is a potent and selective MAT2A inhibitor. It demonstrated excellent drug-likeness with good solubility and permeability, good activity at low doses in animal models, and a favorable safety profile in preclinical studies. Insilico is progressing the PCC in IND-enabling studies and anticipates IND filing in early 2023.

"Powered by AI, the MAT2A program team was able to discover the PCC molecule with high selectivity of MTAP-deleted cancer cells over wide-type cells, which we believe provides key differentiation compared to reported MAT2A inhibitors," said Feng Ren, PhD, Chief Scientific Officer of Insilico Medicine. "This is the second PCC in our growing synthetic lethality pipeline, and we are progressing the molecule in IND-enabling studies towards clinical trials for the treatment of MTAP-deleted cancers."

Insilico has built a strong portfolio of synthetic lethality assets supported by scientists with deep drug discovery expertise and its AI-driven small molecule design and generation engine, Chemistry42. The company announced its first synthetic lethality PCC, which targets USP1 for tumors with homologous recombination deficiency, in mid-April. Continuing this success, Insilico delivered the PCC for the MAT2A program approximately 12 months after its initiation.

"This PCC continues the expansion of our synthetic lethality portfolio, driven by our end-to-end AI drug discovery platform," said Insilico founder and CEO Alex Zhavoronkov, PhD. "With this latest discovery, we continue to utilize the power of AI to treat the most aggressive cancers with the highest unmet needs."

Insilico is developing a growing portfolio in frontier areas. In just over 12 months, it has delivered 7 PCCs, including AI-discovered therapeutics of novel targets with novel structures and AI-designed therapeutics of known targets with desired properties. It also successfully completed a Phase 0 microdose trial and entered a Phase I clinical trial with its first internally developed program for fibrosis.

On May 5, 2022 Anthos Therapeutics, a clinical-stage biopharma company developing innovative therapies for cardiovascular and metabolic diseases, reported that the first patient had been enrolled in a phase 3 clinical trial investigating a Factor XI agent (Press release, Anthos Therapeutics, MAY 5, 2022, View Source [SID1234613730]). The ASTER study is one of two complementary, international, multicenter trials where abelacimab is being studied in patients with Cancer Associated Thrombosis (CAT). In the ASTER trial, Anthos’ novel dual-acting Factor XI monoclonal antibody, abelacimab, is being compared to apixaban, the leading Factor Xa inhibitor, to assess their effects on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE.

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"Encouraged by evidence from a recently completed positive phase 2 study,1 we believe abelacimab could become an important new treatment option for the treatment and prevention of thrombosis in a variety of patients, including those with Cancer Associated Thrombosis. Abelacimab’s novel dual inhibitory activity offers the potential to provide effective antithrombotic activity with a reduced risk of bleeding compared to existing therapies. Additionally, the monthly dosing of abelacimab could reduce the burden of a daily regimen, such as daily injections or pills, for patients already receiving multiple therapies including chemotherapy," said Gary E. Raskob, Ph.D., Interim Senior Vice President, and Provost at the University of Oklahoma Health Sciences Center and the Chair of the Abelacimab CAT Program Steering Committee.

Venous Thromboembolism (VTE), which includes both deep vein thrombosis and pulmonary embolism, is the second most prevalent cause of death in patients with cancer, second only to the disease itself.2 However, treatment of CAT can be challenging because the currently available anticoagulants used to treat VTE can have an increased risk of bleeding.3,4

"An acute episode of thrombosis in patients with cancer adds additional complexity to the treatment of cancer itself and is a grave concern for physicians, patients, and caregivers. Our extensive phase 3 program for abelacimab includes two trials specifically designed for patients with Cancer Associated Thrombosis, including those with a particularly high risk of bleeding. Enrolling the first patients in the ASTER phase 3 trial is an important first step toward making an effective and potentially safer anticoagulant available to patients with cancer. This phase 3 program is in addition to our ongoing phase 2 AZALEA-TIMI 71 trial comparing abelacimab to rivaroxaban in atrial fibrillation (AF), which completed enrollment with 1,287 patients in December 2021. This study, the largest trial to date with a Factor XI inhibitor, will compare bleeding rates in AF patients treated with abelacimab and rivaroxaban," said Dan Bloomfield, M.D., Chief Medical Officer, Anthos Therapeutics.

About Abelacimab
Abelacimab is a novel, highly selective, fully human monoclonal antibody designed to induce effective hemostasis-sparing anticoagulation through Factor XI inhibition. Abelacimab targets the active domain of Factor XI, demonstrating dual inhibitory activity against both Factor XI and its activated form, Factor XIa. Abelacimab can be administered intravenously (IV) to achieve rapid inhibition of Factor XI activity and then used subcutaneously (SC) monthly to maintain nearly complete inhibition in a chronic setting. In a PK/PD study, abelacimab administered IV provided profound suppression of Factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days. 1,5 In a Phase 2 study whose results were published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.1 Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.6 Abelacimab is an investigational agent and has not been approved for any indication.

About the Abelacimab Phase 3 Program in Cancer Associated Thrombosis (CAT)
The abelacimab phase 3 CAT program comprises two complementary studies targeting to enroll approximately 2700 patients across 220 sites in more than 20 countries — the largest program of any anticoagulant performed in Cancer-Associated Thrombosis.

ASTER is an international multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE in whom DOAC treatment is recommended. Abelacimab 150 mg will be administered intravenously (IV) on Day 1 and subcutaneously (SC) monthly thereafter for up to 6 months; Apixaban 10 mg will be administered orally, twice daily (bid) for the first 7 days, followed by 5 mg bid up to 6 months.

MAGNOLIA is an international multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study in patients with gastrointestinal (GI) / genitourinary (GU) cancer in whom DOAC treatment is not recommended. The study will compare the effect of abelacimab relative to dalteparin on VTE recurrence and bleeding in patients with cancer associated VTE who are at a high bleeding risk with non-resectable, locally or regionally invasive GI / GU tumors. Abelacimab 150 mg will be administered intravenously (IV) on Day 1 and subcutaneously (SC) monthly thereafter for up to 6 months; dalteparin administered subcutaneously will be given daily, 200 IU/kg/day for the first month, and then 150 IU/kg/day up to 6 months.

About the AZALEA-TIMI 71 Phase 2 Trial
The AZALEA-TIMI 71 trial is an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study to evaluate the effect of two blinded doses of abelacimab relative to open label rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke. The trial completed enrollment in December 2021, with 1287 patients across 95 global study sites including the U.S., Canada, as well as from parts of Europe, and Asia.

Verhamme P et al. New Engl J Med July 2021 (View Source)
Fernandes CJ et al. Eur. Resp. Rev. 2019 (View Source)
Agnelli G et al. New Engl J Med April 2020 (View Source)
Abdol Razak NB et al. Cancers (Basel) Oct. 2018 (View Source)
Yi BA et al. J Thromb Haemost. Oct. 2021 (View Source)
Hsu et al. J Am Coll Cardiol. Aug. 2021 (https://www.sciencedirect.com/science/article/abs/pii/S0735109721053213?via%3Dihub)

On May 5, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported recent operational highlights and financial results for the first quarter ended March 31, 2022 (Press release, Oncolytics Biotech, MAY 5, 2022, View Source [SID1234613729]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"Recent updates from multiple clinical trials have showcased pelareorep’s wide-ranging therapeutic potential as well as the advantages of our corporate strategy," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Our latest data in HR+/HER2- breast cancer show pelareorep driving changes in the tumor microenvironment that are known to be associated with improved patient outcomes and a decreased risk of recurrence. These results increase our understanding of pelareorep’s mechanism of action and build upon our prior phase 2 data that showed pelareorep delivering a clinically meaningful and statistically significant survival benefit to HR+/HER2- breast cancer patients. They also further de-risk our lead program’s upcoming randomized phase 2 data readout, which is expected to confirm and expand upon these prior findings and move us forward into a registrational study."

Dr. Coffey continued, "Recent clinical and preclinical data also showed pelareorep safely combined with a range of drug classes and demonstrated its potential to enable the success of CAR T cell therapies against solid tumors. We believe our strategy has positioned us for sustained success, as its execution allowed us to generate proof-of-concept data in multiple indications while maintaining a strong balance sheet and a clear focus on our lead breast cancer program."

First Quarter and Subsequent Highlights

Breast Cancer Program

AWARE-1 data demonstrate pelareorep’s ability to improve the prognosis of HR+/HER2- breast cancer patients and decrease their risk of recurrence

New clinical biomarker analyses from AWARE-1’s first two cohorts presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Meeting evaluated changes in the tumor microenvironment (TME) following treatment with pelareorep and letrozole with (cohort 2) or without (cohort 1) the checkpoint inhibitor atezolizumab (link to PR). Gene expression analyses showed 100% of evaluable patients with a Risk of Recurrence Score (ROR-S) classified as "low" 21-days post-treatment vs. 55% with a "low" ROR-S prior to treatment. In both cohorts, the treatment regimen caused tumors to convert from the more aggressive luminal B classification to luminal A classification, which is associated with improved clinical outcomes. Collectively across both cohorts, the percentage of evaluable patients with a luminal A classification increased from 55% before treatment to 85% 21 days after treatment. Statistically significant increases in markers of tumor cell death and T cell activation were also observed with treatment. Altogether, these results reaffirm pelareorep’s ability to improve the prognosis of breast cancer patients and decrease their risk of recurrence by remodeling the TME and stimulating anti-tumor immunity.

Partner Adlai Nortye advanced Chinese bridging trial of pelareorep-paclitaxel combination to final dosing cohort

The ongoing bridging trial is evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer. Initiation of the trial’s final cohort followed the completion of the dose escalation evaluation periods of the first two cohorts, which indicated that the studied combination was well tolerated with no new safety signals observed. The dosing regimen for the trial’s second cohort is equivalent to that administered in IND-213, while the regimen for the third cohort is equivalent to the regimen being administered in BRACELET-1, an ongoing phase 2 trial in HR+/HER2- breast cancer that is evaluating pelareorep plus paclitaxel with and without a checkpoint inhibitor. Completion of the bridging trial is expected to accelerate pelareorep’s development in China, the world’s second largest oncology market.

Gastrointestinal Cancers Program

Successfully completed safety run-ins for the phase 1/2 GOBLET trial

The GOBLET trial is evaluating the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with advanced or metastatic pancreatic, colorectal, and anal cancers. The three-patient safety run-ins for the trial’s pancreatic cancer and third-line metastatic colorectal cancer (mCRC) cohorts have each been successfully completed following an independent review by the study’s Data Safety Monitoring Board (DSMB), which noted no safety concerns. Following the DSMB reviews and authorization from the Paul Ehrlich Institute (PEI; Germany’s medical regulatory body), all of the trial’s four cohorts are now cleared for full enrollment.

In addition to providing data on the safety and efficacy of pelareorep-atezolizumab combinations, the GOBLET trial is designed to evaluate CEACAM6 and T cell clonality as predictive biomarkers of treatment response. Use of a predictive biomarker in future studies may increase their likelihood of success by ensuring selection of the most appropriate patients.

Additional Immunotherapeutic Opportunity

Preclinical data demonstrating the synergistic anti-cancer activity of pelareorep combined with chimeric antigen receptor (CAR) T cell therapy in solid tumors published in Science Translational Medicine

Though CAR T cells have generated long-term cures in patients with hematological malignancies1, they have thus far had limited success against solid tumors due primarily to challenges posed by short-lived perseverance, immunosuppressive TMEs, and antigen escape. A peer-reviewed preclinical study published recently in Science Translational Medicine showed the persistence and anti-cancer activity of CAR T cells improved dramatically when these cells were loaded with pelareorep (link to PR, link to publication). Compared to either treatment alone, treatment with pelareorep-loaded CAR T cells led to statistically significant survival benefits in murine models of skin and brain cancer. In addition, boosting mice treated with pelareorep-loaded CAR T cells with a subsequent intravenous dose of pelareorep led to a further enhancement in efficacy and tumor cures in >80% of mice treated in each model. Mechanistic analyses indicated that the enhanced efficacy of this combination was due to pelareorep’s ability to increase CAR T cell perseverance, reverse immunosuppressive TMEs, and reduce antigen escape. The reduction in antigen escape was linked to the creation of dual-specific CAR T cells that target both the tumor directly and pelareorep proteins within the tumor. Given that solid tumors represent the vast majority of cancer cases, these results demonstrate pelareorep’s potential to significantly expand the commercial opportunity offered by CAR T cell therapies.

Financial Highlights

As of March 31, 2022, the Company reported $39.5 million in cash and cash equivalents.
Operating expense for the first quarter of 2022 was $2.6 million, compared to $3.1 million for the first quarter of 2021.
R&D expense for the first quarter of 2022 was $3.7 million, compared to $2.8 million for the first quarter of 2021.
The net loss for the first quarter of 2022 was $6.8 million, compared to a net loss of $6.4 million in the first quarter of 2021. The basic and diluted loss per share was $0.12 in the first quarter of 2022, compared to a basic and diluted loss per share of $0.13 in the first quarter of 2021.
Net cash used in operating activities for the first quarter of 2022 was $6.3 million, compared to $5.6 million for the first quarter of 2021.
Anticipated Milestones and Catalysts

Completion of enrollment in phase 2 BRACELET-1 metastatic breast cancer study: Q2 2022
GOBLET pancreatic cohort update: Q3 2022
Top-line data from phase 2 BRACELET-1 metastatic breast cancer study: Q4 2022
Oncolytics expects to provide updates on the timing of the following milestones:

Interim safety update from BRACELET-1 metastatic breast cancer study
Webcast and Conference Call

Management will host a conference call for analysts and institutional investors at 5:00 p.m. ET today, May 5, 2022. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 6952-6976. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 526-976#.