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.

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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.

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"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]).

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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.

On May 12, 2020 Skyhawk Therapeutics, Inc. ("Skyhawk") reported that it has expanded its strategic collaboration with Merck, known as MSD outside the United States and Canada, to discover, develop and commercialize small molecules that modulate RNA splicing (Press release, Skyhawk Therapeutics, MAY 12, 2020, View Source [SID1234626566]). Skyhawk’s proprietary SkySTARTM technology platform will be employed to discover and develop innovative RNA-binding small molecules designed to selectively modify RNA splicing, as a new modality for the potential treatment of certain autoimmune and metabolic diseases. The collaboration now spans four disease areas: neurodegeneration, oncology, autoimmunity, and metabolic diseases.

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Under the collaboration agreement, Skyhawk will grant Merck, through a subsidiary, the option to exclusively license worldwide intellectual property rights to candidates discovered and developed under the collaboration that are directed to program targets. Following Merck’s exercise of its option, Merck will be responsible for further development and commercialization. Skyhawk will receive an upfront cash payment and, to the extent Merck exercises its option, potential milestone payments and royalties on sales of approved products resulting from the collaboration.

"Merck has been a wonderful partner in discovering novel drug candidates for neurological diseases and cancer," said Bill Haney, co-founder and CEO of Skyhawk Therapeutics. "Our expanded collaboration into autoimmune and metabolic diseases reflects the success to date in the SkySTARTM platform’s ability to advance small molecules that can address the unmet medical needs of patients. Skyhawk’s team is delighted to be working with a partner with such a long history of commitment to challenging diseases, and relentless pursuit of developing new treatment options for patients."

"RNA splicing modification offers a new approach to modulating targets previously considered undruggable," said Dr. Dean Y. Li, senior vice president, Discovery Sciences and Translational Medicine, Merck Research Laboratories. "We look forward to expanding our collaborative efforts to explore the potential of this new modality in additional disease areas."

On May 12, 2020 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, reported that Michael Kauffman, MD, PhD, Chief Executive Officer, will participate in a fireside chat at the 2020 RBC Capital Markets Global Healthcare Virtual Conference on Tuesday, May 19, 2020 at 8:35 a.m. ET (Press release, Karyopharm, MAY 12, 2020, View Source [SID1234557560]).

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A live webcast of the fireside chat can be accessed on the "Events & Presentations" in the Investor section of the Company’s website, View Source A replay of the webcast will be archived on the Company’s website for 90 days following the fireside chat.