On May 12, 2020 Frazier Healthcare Partners ("Frazier") reported the launch of Lengo Therapeutics, Inc. ("Lengo"), a biopharmaceutical company focused on the discovery and development of novel treatments targeting driver mutations in oncology (Press release, Frazier Healthcare, MAY 12, 2020, View Source [SID1234557620]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Lengo emerged from discussions at Frazier and among a highly experienced group of oncology researchers, including Frazier Senior Advisors Roger Ulrich, Ph.D., Jim Bristol, Ph.D., Michael Gallatin, Ph.D. and Bruce Roth, Ph.D., who helped identify several mutations in cancers that we felt were not well addressed by existing therapeutics," said Tracy Saxton, Ph.D., CEO of Lengo. "We were fortunate to identify novel chemical matter discovered at Jubilant to address some of these mutations of interest."

Jubilant Life Sciences Ltd ("Jubilant") has granted an exclusive license to Lengo for the worldwide development and commercialization of a portfolio of novel chemistry against undisclosed oncology targets. In connection with the license, Lengo has completed a $15 million Series A financing round from Frazier.

Jubilant and Frazier have been working together on multiple discovery-stage companies since 2016, starting with Mavupharma which was acquired by AbbVie in 2019.

"Company formation is one of our core activities at Frazier, and Jubilant has been a key part of several of our early-stage companies," said Daniel Estes, Ph.D., General Partner on the Frazier Life Sciences team. "We are excited to advance the assets we have licensed at Lengo to the clinic as quickly as possible."

"We are pleased to be strengthening our ties with Frazier Healthcare Partners," said Shyam Bhartia and Hari Bhartia, founders of Jubilant. "We welcome the addition of Lengo to the pipeline of companies we are working on together in drug discovery."

On May 12, 2020 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported certain
differences between its financial forecast on November 6, 2019, for the fiscal year ended March 31, 2020 (April 1, 2019, to March 31, 2020) and the actual results announced today (Press release, Sysmex, MAY 12, 2020, View Source [SID1234557556]). Furthermore, at a meeting of the Managing Board on May 12, 2020, Sysmex resolved to award dividends from surplus as described below, with a record date of March 31, 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

1. Change from Financial Forecasts

(1) Consolidated Financial Results for Fiscal Year from April 1, 2019, to March 31, 2020

(2) Reason

In addition to the impact of the spreading COVID-19 pandemic, major reasons for the change in consolidated net sales were lower-than-expected sales in the hemostasis and urinalysis fields in the United States and sales to distributors in Latin America and the EMEA region, which were lower than forecast. Despite efforts to reduce selling, general and administrative expenses, operating profit, profit before tax and profit attributable to owners of the parent were also below forecast, due to lower sales and a foreign exchange valuation loss.

2. Dividend from Surplus

(2) Reason

In terms of returns to shareholders, we intend to provide a stable dividend on a continuous basis and aim for a consolidated payout ratio of 30% under our basic policy of sharing the successes of our operations in line with business performance. In accordance with this policy, we have set the ordinary year-end dividend for the fiscal year ended March 31, 2020, at ¥36 per share. Accordingly, annual total dividends will be ¥72 and the consolidated payout ratio will be 43.1%. This amounts to an increase of ¥2 in the total dividend for the year, from ¥70 in the fiscal year ended March 31, 2019.

On May 12, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that Fred Schwarzer, Chief Executive Officer, will present at the 2020 RBC Capital Markets Global Healthcare Conference on Tuesday, May 19 at 4:15 p.m. ET (Press release, IGM Biosciences, MAY 12, 2020, View Source [SID1234557589]). The conference will be held in a virtual meeting format.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On May 12, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that a research paper describing the mechanism of action for the Company’s first second-generation Bicycle Toxin Conjugate (BTC), BT5528, has been published in the American Association for Cancer Research (AACR) (Free AACR Whitepaper) journal Molecular Cancer Therapeutics (Press release, Bicycle Therapeutics, MAY 12, 2020, View Source [SID1234557605]). The manuscript, titled "MMAE delivery using the Bicycle toxin conjugate BT5528," discusses the preclinical profile of BT5528, which has physiochemical properties thought to enable more favorable safety and efficacy profiles than antibody drug conjugates (ADCs) with the same tumor antigen target and similar cytotoxic payload. The e-publication can be found here.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Bicycles are a unique therapeutic modality designed to address clinical needs that can’t be met by biologic or small molecule approaches," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "The preclinical data for BT5528 published in Molecular Cancer Therapeutics suggest that the key features of Bicycles, such as their low molecular weight, short systemic half-life and renal route of elimination, can result in a therapeutic candidate with an in vivo pharmacokinetic profile that yields a wider preclinical therapeutic index than that of a comparator ADC."

BT5528 is a second-generation BTC, which uses a valine-citrulline cleavable linker and a cytotoxin MMAE payload, that targets EphA2, a tumor antigen that is overexpressed in a wide range of solid tumor types and is associated with poor outcomes, making it ideal for selective payload targeting using ADCs and other approaches. The manuscript published in Molecular Cancer Therapeutics describes the preclinical development of BT5528, which involved a suite of pharmacokinetic, efficacy and safety studies aimed at derisking the toxicology that limited development of MedImmune’s MEDI-547, an ADC comprised of an EphA2 targeted monoclonal antibody (1C1) conjugated to a cytotoxin MMAF.

Though MEDI-547 showed promising anti-tumor activity in preclinical models, its toxicology profile included bleeding and coagulation events in non-human species, which were later observed in a Phase I study, resulting in the discontinuation of clinical development. Unlike with MEDI-547, Bicycle did not observe coagulopathy, DIC-like syndrome or changes in closely monitored clotting parameters in preclinical toxicology studies of BT5528. Furthermore, BT5528 and a 1C1-mcMMAF ADC designed to approximate MEDI-547 showed broadly equivalent tumor regression in certain standard tumor models, but BT5528 demonstrated improved efficacy over the ADC in large, poorly vascularized tumor models that are more difficult to treat. These results support the hypothesis that low molecular weight peptide conjugates achieve faster and greater tumor penetration and thus greater efficacy than antibody conjugates.

BT5528 is being evaluated in a Phase I/II multi-center, open-label trial, which is currently enrolling patients with advanced solid tumors in indications associated with EphA2 expression into Phase I dose escalations of BT5528 as a monotherapy and in combination with nivolumab. To date, doses of BT5528 continue to appear well-tolerated with manageable adverse events as the dose escalations approach clinically relevant dose levels.

On May 12, 2020 Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, reported its results from operations for the quarter ended March 31, 2020 (Press release, Medicure, MAY 12, 2020, View Source [SID1234557621]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Quarter Ended March 31, 2020 Highlights:

Recorded total net revenue from the sale of products of $3.0 million during the quarter ended March 31, 2020 compared to $4.9 million for the quarter ended March 31, 2019;

Recorded total net revenue from the sale of AGGRASTAT of $2.7 million during the quarter ended March 31, 2020 compared to $4.8 million for the quarter ended March 31, 2019;

Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA1) for the quarter ended March 31, 2020 was negative $1.3 million compared to adjusted EBITDA of negative $1.7 million for the quarter ended March 31, 2019; and

Net loss for the quarter ended March 31, 2020 was $1.5 million compared to net loss of $2.8 million for the quarter ended March 31, 2019.
Financial Results

Net revenues for the three months ended March 31, 2020 were $3.0 million compared to $4.9 million for the three months ended March 31, 2019. Net revenues from AGGRASTAT for the three months ended March 31, 2020 were $2.7 million compared to $4.8 million for the three months ended March 31, 2019. ZYPITAMAGTM and SNP contributed $163,000 and $31,000, respectively during the three months ended March 31, 2020. Additionally, ReDSTM contributed net revenue of $89,000 for the three months ended March 31, 2020 compared to $103,000 for the three months ended March 31, 2019.

The Company continues to show strong patient market share with AGGRASTAT, however, the market share is offset by increased price competition caused by enhanced generic Integrilin competition, which resulted in lower discounted prices for AGGRASTAT into the first quarter of 2020. There was also decreases in the volume of the product sold compared to 2019. The Company is beginning to see an increase in demand for ZYPITAMAGTM and expects growth in ZYPITAMAGTM revenues going forward.

Adjusted EBITDA for the three months ended March 31, 2020 was negative $1.3 million compared to negative $1.7 million for the three months ended March 31, 2019. The change in adjusted EBITDA for the three months ended March 31, 2020 is the result of lower selling, general and administration and research and development expenses, partially offset by lower revenues during the three months ended March 31, 2020 when compared to the same period in 2019.

Net loss for the three months ended March 31, 2020 was $1.5 million or $0.14 per share compared to net loss of $2.8 million or $0.18 per share for the three months ended March 31, 2019. The change in the net loss for the three months ended March 31, 2020 is the result of lower selling, general and administration and research and development expenses and a gain on foreign exchange, partially offset by lower revenues experienced during the three months ended March 31, 2020 when compared to the three months ended March 31, 2019.

At March 31, 2020, the Company had unrestricted cash totaling $12.7 million consistent with the $13.0 million of unrestricted cash held as of December 31, 2019. Cash flows used in operating activities for the three months ended March 31, 2020 totaled $822,000 compared to $1.9 million for the three months ended March 31, 2019.

All amounts referenced herein are in Canadian dollars unless otherwise noted.

Notes

(1) The Company defines EBITDA as "earnings before interest, taxes, depreciation, amortization and other income or expense" and Adjusted EBITDA as "EBITDA adjusted for non‑cash and non-recurring items". The terms "EBITDA" and "Adjusted EBITDA", as it relates to the three months ended March 31, 2020 and 2019 results prepared using IFRS, do not have any standardized meaning according to IFRS. It is therefore unlikely to be comparable to similar measures presented by other companies.

Conference Call Info:

Webcast: This conference call will be webcast live over the internet and can be accessed from the Medicure investor relations page at the following link: View Source

You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company’s website.