On May 11, 2021 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will present at the 2021 RBC Capital Markets Healthcare Conference at 10:55 a.m. Eastern Time on Tuesday May 18, 2021 (Press release, Neurocrine Biosciences, MAY 11, 2021, View Source [SID1234579667]). Matt Abernethy, Chief Financial Officer, and Eiry Roberts, Chief Medical Officer, will present at the conference.

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The live presentation will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

On May 11, 2021 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported financial results for the quarter ended March 31, 2021, and provided an update on the company (Press release, Schrodinger, MAY 11, 2021, View Source [SID1234579682]).

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"We had strong execution across multiple facets of our business during the quarter," stated Ramy Farid, Ph.D., chief executive officer at Schrödinger. "We are continuing to advance our internal drug discovery pipeline and recently selected a development candidate for our MALT1 inhibitor program. Progress on our internal programs, coupled with our collaborators’ successes with molecules we’ve helped discover, are powerful examples that our platform and approach generates high-quality development candidates. We look forward to seeing the full impact of our technology as pharmaceutical, biotechnology and materials companies adopt our platform on a larger scale."

Today the company announced an expanded collaboration with AstraZeneca to deploy Schrödinger’s computational platform to help accelerate drug discovery. The collaboration is an expansion of the agreement announced in September 2019, which was a pilot project across an initial small number of programs. Under the expanded agreement, AstraZeneca will fully deploy Schrödinger’s platform across all its structurally-enabled small molecule discovery programs.

First Quarter 2021 Financial Results

Revenue was $32.1 million for the first quarter of 2021, a 23 percent increase compared to the first quarter of 2020.
Software revenue was $26.3 million for the first quarter of 2021, an 11 percent increase compared to the first quarter of 2020.
Drug discovery revenue was $5.8 million for the first quarter of 2021, compared to $2.4 million in the first quarter of 2020.
Gross profit was $16.2 million in the first quarter of 2021, up three percent over the first quarter in 2020. Software gross margin was 78 percent in the first quarter of 2021, compared to 83 percent for the same period in the prior year.
Operating expenses for the first quarter of 2021 were $40.1 million, compared to $27.4 million in the first quarter of 2020.
Other income, which included losses on equity investments, changes in fair value of such investments and interest income, was $23.5 million in the first quarter of 2021 compared to a loss of $2.4 million for the first quarter of 2020. Other income for the first quarter of 2021 included a $24.8 million non-cash gain from the change in fair value of Schrödinger’s equity stake in Morphic Therapeutic. Additionally, in the first quarter of 2021, Schrödinger sold its equity stake in Relay Therapeutics, Inc. for cash proceeds of $15.7 million, which resulted in a non-cash loss of $1.8 million as a result of the fair value based on the share price of the Relay Therapeutics common stock at the sales date.
Net loss, after adjusting for non-controlling interests, was $0.0 million for the first quarter of 2021, compared to a net loss of $13.8 million in the first quarter of 2020.
Recent Business Highlights

Continued revenue growth and strategic execution

Reported 23 percent total revenue growth in the first quarter of 2021, driven by significant increase in drug discovery revenue in addition to continued uptake of Schrödinger’s core technologies including FEP+ and its enterprise solution, LiveDesign, as well as growth in new customers.
Ended the first quarter of 2021 with cash, cash equivalents, restricted cash and marketable securities of $649.0 million, compared to $643.2 million as of December 31, 2020.
Progressed internal pipeline

Selected a development candidate for the company’s MALT1 inhibitor program. Targeting MALT1 is emerging as a potential therapeutic strategy to treat certain relapsed or resistant B-cell lymphomas and chronic lymphocytic leukemia.
Continued to advance multiple programs toward IND-enabling studies; subject to completion of the preclinical data packages, the company expects to submit up to three IND applications in 2022, with the first submission to the FDA expected in the first half of next year.
Presented preclinical data on the company’s CDC7 inhibitor program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Virtual Meeting. The data showed that Schrödinger’s picomolar CDC7 inhibitors were highly selective and inhibited tumor cell growth alone and in combination with several approved and investigational cancer treatments.
Advanced discovery efforts to allow addition of new programs to the company’s internal pipeline in 2021.
Continued investment in Schrödinger’s computational platform

Formed a strategic partnership with NVIDIA to further optimize Schrödinger’s software platform for the NVIDIA DGX SuperPODTM, an enterprise system that can be scaled to enable any organization to reach supercomputing speed and power. Optimizing Schrödinger’s platform for the NVIDIA GPU framework is designed to give customers access to an all-in-one supercomputing solution for in silico drug and materials discovery.
Further expanded the domain of applicability for Schrödinger’s software platform. Recently published research provided rationale for applying Schrödinger’s free energy calculation technology, FEP+, to ion channels using structures generated by cryo-electron microscopy (cryo-EM). The company’s scientists also published research describing a highly accurate method to predict the binding modes of small molecule inhibitors binding to protein targets with flexible binding sites, which have historically been challenging targets for structure-based drug design. Additionally, Schrödinger scientists co-authored a white paper describing how recent advances in protein production and cryo-EM can rapidly facilitate the structural enablement of drug targets.
Full-Year 2021 Financial Outlook

As of May 11, 2021, Schrödinger continues to expect total revenue to range from $124 million to $142 million, with software revenue expected to range from $102 million to $110 million and drug discovery revenue expected to range from $22 million to $32 million for the fiscal year ending December 31, 2021. Additional details are as follows:

Software revenue growth is expected to be higher in the second half of the year with the majority of second half growth in the fourth quarter of 2021.
Drug discovery revenue is expected to be highly variable quarter to quarter based on the timing of potential milestones related to collaborative agreements.
Schrödinger continues to aggressively fund R&D to advance its technology and drug discovery pipeline. The company expects operating expense growth to be higher than the 42% annual growth rate reported in 2020 and expects software gross margin to be lower than the 81% reported in 2020.
Webcast and Conference Call Information

Schrödinger will host a conference call to discuss its first quarter financial results on Tuesday, May 11, 2021, at 8:30 a.m. ET. The conference call can be accessed live by dialing (833) 727-9520 (domestic) or +1 (830) 213-7697 (international) and referring to conference ID 3297222. The webcast can also be accessed under "News & Events" in the investors section of Schrödinger’s website, View Source The archived webcast will be available on Schrödinger’s website following the event.

On May 11, 2021 Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that Bill Lundberg, M.D., Chief Executive Officer of Merus, will participate in a fireside chat at the 2021 RBC Capital Markets Global Healthcare Conference on Tuesday, May 18 at 8:00 a.m. ET (Press release, Merus, MAY 11, 2021, View Source [SID1234579698]).

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The live webcast of the presentation will be available on the Investors page of the Company’s website. An archived presentation will be available on the Merus website for a limited time.

On May 11, 2021 Molecular Targeting Technologies, Inc. (MTTI) and University of Antwerp reported the approval of a Clinical Trial Application by the European Federal Agency for Medicines and Health Products (FAMHP) (equivalent to a US IND) (Press release, Molecular Targeting Technologies, MAY 11, 2021, View Source [SID1234579714]). The clinical study will evaluate the safety, dosimetry and treatment response of TDURA (99mTc-Duramycin), in patients with advanced colorectal cancer (CRC)* .

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Colorectal cancer is the third most commonly diagnosed malignancy in the world and the second leading cause of cancer death in the United States. While a range of novel active agents has improved the prognosis of patients with colorectal cancer, 50% of advanced colorectal cancer patients die from metastatic disease.

Monitoring treatment efficacy early, within days, can significantly improve patient outcomes. Current diagnostic techniques can take weeks to months to gauge tumor killing drug efficacy. In some cases, treatment may only be effective in 40% of patients, leading to rapidly advancing cancer and higher costs while regrouping to change therapies.

Duramycin, a naturally occurring peptide that binds to phosphatidylethanolamine (PE), has been radiolabeled and used for early imaging of tumor death in animal models.

Professor Sigrid Stroobants, MD, Chair of Nuclear Medicine, U of Antwerp commented "Objective and accurate evaluation of tumor response to therapy is one of the biggest challenges in oncology. Early assessment of therapeutic ineffectiveness can avoid treatment related toxicity and could lead to improved survival through earlier treatment intensification, stopping the ineffective therapy, or starting second-line therapy."

Chris Pak, MTTI President & CEO said, "The most commonly used methods to evaluate the effectiveness of a treatment are morphological and volumetric which cannot see the effects of therapy early. If TDURA optimizes patient treatment, the benefits to the patients and savings to health care systems will be substantial."

On May 11, 2021 Insmed Incorporated (Nasdaq: INSM) reported that it priced a registered underwritten public offering of 10,000,000 shares of its common stock (the "Shares") at a price to the public of $25.00 per share before deducting underwriting discounts and commissions, and a registered underwritten public offering of $500 million aggregate principal amount of its 0.75% convertible senior notes due 2028 (the "Notes") (Press release, Insmed, MAY 11, 2021, View Source [SID1234579732]). A portion of the net proceeds from the offering of the Notes will be used to repurchase $225 million in aggregate principal amount of Insmed’s existing outstanding 1.75% Convertible Senior Notes due 2025 (the "2025 Notes"). The gross proceeds to Insmed from the offerings, before deducting underwriting discounts and commissions and other offering expenses payable by Insmed, are expected to be $250 million and $500 million, respectively. In addition, Insmed has granted the underwriters of the offering of Shares (the "Equity Offering") a 30-day option to purchase up to an additional 1,500,000 Shares and to the underwriters of the offering of the Notes (the "Notes Offering") a 30-day option, solely to cover over-allotments, to purchase up to an additional $75 million in aggregate principal amount of the Notes. All of the Shares and Notes to be sold in the offerings are to be sold by Insmed.

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The offerings are expected to close on or about May 13, 2021, subject to satisfaction of customary closing conditions. The closing of each offering is not contingent on the closing of the other offering.

The Notes will be senior unsecured obligations of Insmed and will rank senior in right of payment to any of Insmed’s future indebtedness that is expressly subordinated in right of payment to the Notes and will rank equally in right of payment with all of Insmed’s existing and future liabilities that are not so subordinated, including the existing 2025 Notes. The Notes will accrue interest payable semiannually in arrears on June 1 and December 1 of each year at the rate of 0.75% per year, beginning on December 1, 2021. The Notes will mature on June 1, 2028, unless earlier repurchased, redeemed or converted in accordance with their terms prior to such date. Prior to June 6, 2025, Insmed will not have the right to redeem the Notes. Subject to certain conditions, on or after June 6, 2025, Insmed may redeem for cash all or a part of the Notes. Prior to March 1, 2028, the Notes will be convertible at the option of holders of the Notes only upon satisfaction of certain conditions and during certain periods, and thereafter, will be convertible at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. Upon conversion, holders of the Notes will receive shares of Insmed common stock, cash or a combination thereof, at Insmed’s election. The conversion rate for the Notes will initially be 30.7692 shares of Insmed common stock per $1,000 principal amount of Notes, which is equivalent to an initial conversion price of approximately $32.50 per share, and is subject to adjustment under the terms of the Notes. Insmed may be obligated to increase the conversion rate for any conversion that occurs in connection with certain corporate events or a redemption of the Notes by Insmed. The initial conversion price represents a premium of approximately 30% over the public offering price per share of the Shares in the Equity Offering.

Concurrently with the offerings, Insmed plans to enter into separate and privately negotiated repurchase transactions with certain holders of a portion of the 2025 Notes. In these transactions, Insmed plans to repurchase 2025 Notes with an aggregate principal amount of $225 million for an aggregate repurchase price of approximately $237 million plus accrued interest, using a portion of the net proceeds from the Notes Offering. Insmed intends to use the remaining net proceeds from the Notes Offering and the net proceeds from the Equity Offering to fund activities related to the commercialization and development of ARIKAYCE, further research and development of brensocatib, TPIP or any of its product candidates, and for other general corporate purposes, including business expansion activities.

J.P. Morgan Securities LLC and SVB Leerink LLC are acting as book-running managers for the offerings. Morgan Stanley & Co. LLC is also acting as a book-running manager for the offerings. Credit Suisse Securities (USA) LLC and Stifel, Nicolaus & Company, Incorporated are acting as co-lead managers for the Equity Offering. Cantor Fitzgerald & Co. and H.C. Wainwright & Co., LLC are acting as co-managers for the Equity Offering.

The Equity Offering and the Notes Offering are being made pursuant to Insmed’s shelf registration statement on Form S-3 (File No. 333-238560) including the base prospectus contained therein, a preliminary prospectus supplement related to the Equity Offering (together with such base prospectus, the "Equity Prospectus") and a preliminary prospectus supplement related to the Notes Offering (together with such base prospectus, the "Notes Prospectus"), all of which Insmed filed with the Securities and Exchange Commission ("SEC"). Before investing in the Shares or the Notes, investors should read the Equity Prospectus and the Notes Prospectus, respectively, in each case, including the documents incorporated by reference therein, and any free writing prospectus related to the Equity Offering and the Notes Offering, as the case may be. These documents may be freely obtained by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies may be obtained, when available, from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.