On May 13, 2021 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported its participation in the Cowen 2nd Annual Virtual Oncology Innovation Summit. Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to present in a virtual fireside chat on Thursday, May 20, 2021 at 10:20 a.m. PT / 1:20 p.m. ET (Press release, Kura Oncology, MAY 13, 2021, View Source [SID1234579951]).

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A live audio webcast of the presentation will be available in the Investors section of Kura’s website at www.kuraoncology.com, with a replay available shortly after the live event.

On May 13, 2021 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY,NYSE: RDY, NSEIFSC: DRREDDY) and Shenzhen Pregene Biopharma Co., Ltd. reported an agreement whereby Dr Reddy’s will acquire an exclusive license in the Republic of India for PRG1801, Pregene’s single domain antibody-based anti-BCMA chimeric antigen receptor T (CAR-T) cell therapy injection (Press release, PreGene, MAY 13, 2021, View Source [SID1234580007]).

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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

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Dr. Reddy’s acquires the exclusive rights to commercialize PRG1801 in India, and will be responsible for future development including clinical trials, in India. Pregene will be the exclusive supplier of the core material – lentiviral vectors for manufacturing PRG1801. Under the terms of the license agreement, Pregene will receive an upfront payment and future milestone payments of USD 5 million for first indication and up to USD 7.5 million of milestone payments for subsequent indications, and is eligible to receive a double-digit royalty, up to USD 150 million, on future sales of PRG1801 in the licensed territory.

PRG1801 is an autologous anti-BCMA CAR-T therapy in development for the treatment of relapsed/refractory multiple myeloma, and has already demonstrated strong signs of efficacy and an excellent safety profile in 34 patients in an investigator initiated trial in China. In 2020, PRG1801 was granted NMPA IND clearance, and a Phase I clinical trial of the product candidate is ongoing in China.

This license agreement provides Pregene with a strong, experienced partner in the large Indian market, and expands Dr. Reddy’s capacity in the field of immune cell therapy for cancers.

About PRG1801

PRG1801 is an autologous anti-BCMA CAR-T therapy that utilizes a humanized single-domain antibody as the antigen binding domain and lentivirus as a vector. The lentivirus vectors are produced by Pregene using a proprietary serum free suspension production system with gene-therapy-grade quality and a high transduction unit yield. This CAR-T therapy has already demonstrated strong signs of efficacy and an excellent safety profile in 34 patients in an investigator initiated trial in China.

Clinical trials of PRG1801 include:

Phase I trial to evaluate the safety and tolerance of patients with relapsed/ refractory multiple myeloma after anti-BCMA CAR-T infusion, and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of anti-BCMA CAR-T for relapsed/refractory multiple myeloma.
Investigator initiated trial in China to evaluate the safety and efficacy of PRG1801 (NCT03661554). Among 34 patients treated, 30 (88.2%) patients achieved best objective response and 19 (55.8%) patients achieved complete response. No neurotoxicity was observed among treated patients. Grade 3 CRS occurred in only one patient (2.9%), and all the other patients had lower grade or no CRS.

On May 13, 2021 SOM Biotech reported its participation in the BIO-Equity Europe 2021 event on May 17th – 19th, which will take place digitally (Press release, SOM Biotech, MAY 13, 2021, View Source;utm_medium=rss&utm_campaign=som-biotech-at-bio-equity-2021 [SID1234580023]).

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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

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Organized by Biocentury and the EBD Group, the BIO-Equity 2021 event attracts leading innovative pharma and biotech companies as well as specialized investors in life sciences. The event enables the exchange of the latest advances in biotechnology and offers a strong partnering platform to foster value-creating collaborations.

Raúl Insa, CEO of SOM Biotech highlights: "We look forward to attending the BIO-Equity 2021 event, to continue building a strong network of business partners and investors. Both are essential pillars of our growth strategy. This event is a great opportunity to give an update on our latest pipeline developments and to showcase the great potential of our proprietary AI-based drug discovery platform. SOMAIPRO is a pioneering approach that has enabled us to build a robust drug development pipeline for orphan/CNS drug candidates with strong blockbuster potential. It is a powerful tool, a drug discovery engine that will continue to help us and our business partners to foster drug development and provide new treatments to tackle acute medical needs safely and with efficacy".

On May 13, 2021 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology company accelerating the genetic revolution using a new class of precision genetic medicines, reported its financial results for the three- and six-month periods ended March 31, 2021 (Press release, NeuBase Therapeutics, MAY 13, 2021, View Source [SID1234580039]).

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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

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"We continue to expand and scale our unique precision genetic medicine platform that we believe can turn genes on, off, or edit them in vivo, and thus address most mechanisms that cause diseases in a single industry-unifying solution," said Dietrich A. Stephan, Ph.D., Founder, CEO and Chairman of NeuBase. "Our recent financing led by top-tier healthcare investors enables us to advance our lead program into the clinic next year and expand our pipeline to address historically undruggable oncogenic driver mutations. We look forward to hosting our R&D day on June 8th, during which we will present an update on our current pipeline programs, as well as introduce an oncology program targeting a genetic driver mutation in a high value indication."

Second Quarter of Fiscal Year 2021 and Recent Operating Highlights

Strengthened the balance sheet with a public equity offering generating $42.6 million in net proceeds, which will enable the Company to advance its lead program into the clinic and expand the pipeline of therapies for rare and common diseases
Expanded platform capabilities and consolidated PNA intellectual property through the acquisition of new scaffold technologies from Vera Therapeutics, formerly known as TruCode Gene Repair, Inc., in late April 2021
Presented positive in vitro and in vivo preclinical data for the Company’s lead drug candidate for the treatment of DM1 at the 2021 Muscular Dystrophy Association (MDA) Virtual Clinical & Scientific Conference
Moved into a newly built state-of-the-art laboratory and office space in Pittsburgh, providing the infrastructure to support accelerating R&D activities
Appointed Gerald McDougall, industry veteran, to the Board of Directors, bringing large-scale partnership and strategy expertise to the Company
Financial Results for the Second Fiscal Quarter Ended March 31, 2021

As of March 31, 2021, the Company had cash and cash equivalents of approximately $24.2 million, compared with cash and cash equivalents of approximately $32.0 million as of September 30, 2020
Subsequent to the end of the fiscal quarter ended March 31, 2021, the Company completed a public equity offering generating net proceeds of approximately $42.6 million
NeuBase estimates its current cash and cash equivalents are sufficient to fund currently planned operating and capital expenditures into the first quarter of CY2023
For the three-month period ended March 31, 2021, the Company reported a net loss of approximately $5.5 million, or a net loss of $0.24 per share, compared with a net loss of approximately $4.4 million, or a net loss of $0.26 per share, for the three-month period ended March 31, 2020
For the three-month period ended March 31, 2021, total operating expenses were approximately $5.9 million, consisting of approximately $2.7 million in general and administrative expenses and $3.2 million of research and development expenses; compared with total operating expenses of $4.4 million for the three-month period ended March 31, 2020, which was comprised of approximately $2.7 million in general and administrative expenses and $1.6 million in research and development expenses
Financial Results for the Six-Month Period Ended March 31, 2021

For the six-month period ended March 31, 2021, the Company reported a net loss of approximately $9.6 million, or a net loss of $0.41 per share, compared with a net loss of approximately $8.9 million, or a net loss of $0.52 per share, for the same period last year
For the six-month period ended March 31, 2021, total operating expenses were approximately $10.6 million, consisting of approximately $5.4 million in general and administrative expenses and $5.2 million of research and development expenses. This compares with total operating expenses of $8.1 million for the same period last year, which was comprised of approximately $5.3 million in general and administrative expenses and $2.8 million in research and development expenses

On May 13, 2021 Insmed Incorporated (Nasdaq: INSM) reported that it intends to offer and sell $250 million of its common stock (the "Shares") and $500 million aggregate principal amount of its convertible senior notes due 2028 (the "Notes") in separate concurrent underwritten public offerings, a portion of which will be used to repurchase Insmed’s existing outstanding convertible senior notes due 2025 (Press release, Insmed, MAY 13, 2021, View Source [SID1234579853]). In addition, Insmed intends to grant the underwriters of the offering of the Shares (the "Equity Offering") a 30-day option to purchase up to an additional 15% of the 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 15% 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. The offerings are subject to market and other conditions, and there can be no assurance as to whether or when the offerings may be completed, or as to the actual size or terms of the offerings. The closing of each offering is not contingent on the closing of the other offering.

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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 its existing 1.75% Convertible Senior Notes due 2025 (the "2025 Notes"). The Notes will accrue interest payable semi-annually in arrears and will mature on June 1, 2028, unless earlier repurchased, redeemed or converted. The Notes will be convertible into shares of Insmed’s common stock, cash or a combination thereof, at Insmed’s election. The interest rate, conversion rate and other terms of the Notes will be determined at the time of pricing of the offering of the Notes.

Insmed intends to use a portion of the net proceeds from the Notes Offering to repurchase a portion of the 2025 Notes in privately negotiated transactions. Insmed intends to use the remainder of the 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 Insmed’s product candidates, and for other general corporate purposes, including business expansion activities.

J.P. Morgan Securities LLC and SVB Leerink LLC are acting as joint book-running managers for the offerings.
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 or will file 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.