On May 14, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and the National Cancer Center Japan (Headquarters: Tokyo, President: Hitoshi Nakagama, "National Cancer Center") reported that both parties have entered into a joint research and development (R&D) agreement concerning "Basic research on the drug discovery and development to accelerate development of anticancer drugs in treatment of patients with rare cancers and refractory cancers", and that research activities have commenced (Press release, Eisai, MAY 14, 2021, View Source [SID1234579977]). This R&D project is to be carried out with funding under the program "Cyclic Innovation for Clinical Empowerment (CiCLE)" established by the Japan Agency for Medical Research and Development (AMED).

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Rare cancer is a disease for which it is difficult for pharmaceutical companies to develop new drugs solo due to the extremely small number of patients, and there are only a limited number of drugs for rare cancers that can be approved for manufacturing and marketing. Also, among certain types of cancer with a large number of patients, refractory cancers, for which standard treatment has not been established, face barriers to creating new drugs due to difficulty of research and development. In order to promptly deliver effective treatments to patients with rare or refractory cancers, it is essential to provide predictability of clinical outcomes with high accuracy and efficiency in non-clinical research that confirms in advance the effectiveness of the drug, to transfer seamlessly non-clinical research to clinical studies, and moreover to elucidate the mechanism of drug resistance, actual therapeutic effects and side effects. Both parties aim to realize these capabilities in this R&D project using Patient-Derived Xenografts (PDX) library, a model in which cancer tissue derived from patients is transplanted into immunodeficient mice with high predictability of clinical outcomes, as well as cancer genome data.

Eisai is advancing the research and development of new anticancer drugs, targeting cancer genomics and the tumor microenvironment, with its experience and knowledge from globally approved in-house discovered compounds: microtubule dynamics inhibitor eribulin mesylate (product name: Halaven) and multiple receptor tyrosine kinase inhibitor lenvatinib mesylate (product names: Lenvima).

The National Cancer Center is a leading institution in basic research, epidemiological research, and clinical studies for all cancer types including rare cancers in Japan. As of May 2020, with a grant from AMED CiCLE, the National Cancer Center has established a large-scale PDX library,"J-PDX", derived from Japanese cancer patients with information on clinical outcomes, and has also completed the development of research infrastructure and framework. More than 410 types of PDX, including rare cancers and refractory cancers, have already been established in J-PDX (as of March 2021).

In research and development under the agreement, Eisai and the National Cancer Center will jointly conduct tumor-agnostic non-clinical research on new drug candidates created by Eisai, using J-PDX with relevant clinical and biological information, and will determine the drugs and the target cancer types to be transferred to clinical studies. After that, investigator-initiated studies will be conducted for rare cancers and refractory cancers in order to confirm clinical benefits of these new drugs, with the aim to apply for approval of them. Further, both parties will consider expanding into new drug discovery research, with establishment of PDX with tumor tissues taken from patients before and after treatment, comparative analyses of drug responsiveness and cancer genome, as well as search for new drug discovery targets and elucidation of drug resistance mechanisms. Through these efforts, both parties aim to establish a drug discovery and development research system that accelerates the development of new anticancer drugs in Japan.

Through research and development based on the agreement, Eisai and the National Cancer Center will work to develop therapeutic drugs for rare cancers and refractory cancers with high unmet medical needs, thereby aiming to make continuous efforts to meet the diversified needs of and increase the benefits provided to patients with cancer, their families, and healthcare professionals.

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.

On May 13, 2021 Helix BioPharma Corp. (TSX:HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that it has closed the first tranche of the previously announced private placement pursuant to the convertible security funding agreement (the "Agreement") with Lind Global Macro Fund, LP, a New York based institutional investment fund managed by The Lind Partners, LLC (together, "Lind") for gross proceeds of CAD$3.5 million (the "First Tranche") (Press release, Helix BioPharma, MAY 13, 2021, View Source [SID1234579904]).

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Pursuant to the First Tranche, the Company has issued a convertible security (the "Convertible Security") with a twoyear term and a face value of $4,112,500 and an aggregate of 1,957,056 common share purchase warrants exercisable into common shares in the capital of the Company ("Common Shares") for a period of 48 months at an exercise price of CAD$1.0283 per Common Share. The Convertible Security accrues a simple interest rate obligation of 8.75% per annum on the amount funded, which interest is prepaid and attributed to the face value of the Convertible Security. The Company has paid Lind a 3% commitment fee on the amount funded under the First Tranche and Alpha Bronze LLC is entitled to a finder’s fee equal to 5% of the amount funded.

As previously disclosed, Lind is entitled to convert the Convertible Security into Common Shares over the two year term, subject to certain limitations, at a conversion price equal to 85% of the five-day trailing volume-weighted average price of the Common Shares prior to the date a notice of conversion is provided to the Company by Lind. The Agreement includes certain restrictions on the maximum face value of each of the Convertible Securities that may be converted in any particular month. In addition, Helix has the option to buy-back 66.7% of the Convertible Security in cash at any time with no penalty, subject to the option of Lind to convert up to 1/3 of the face value of the Convertible Security into Common Shares at the time of such buy-back. If the Convertible Security is repaid by the Company within 180 days of issuance, the face value amount owed will be reduced pursuant to the terms of the Agreement. Lind is also entitled to accelerate its conversion right to the full amount of the face value or demand repayment of the face value in cash upon a default and other designated events as set out in the Agreement. To the extent that the full face value of the Convertible Security has not been converted at the maturity date of the Convertible Security, the outstanding balance of such face value shall be to be repaid to Lind by the Company in cash.

The securities issued in connection with the First Tranche are subject to a hold period pursuant to Canadian securities laws, expiring on September 14, 2021.

The Agreement also contemplates the issuance of a second Convertible Security upon the mutual agreement of the Company and Lind for gross proceeds to the Company of up to CAD$6.5 million.

On May 13, 2021 Bolt Biotherapeutics, Inc. (NASDAQ: BOLT) a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported financial results for the first quarter ended March 31, 2021 and provided an update on recent business highlights (Press release, Bolt Biotherapeutics, MAY 13, 2021, View Source [SID1234579920]).

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"Our successful IPO in the first quarter of 2021 places us in a position of strength to deliver on value-creating milestones in 2021 and 2022. We continue to advance our Phase 1/2 trial for our lead candidate, BDC-1001, for the treatment of patients with HER2-expressing solid tumors. We look forward to completing the monotherapy dose escalation and initiating the monotherapy Phase 2 dose expansion cohorts as well as the evaluation of combining BDC-1001 with an anti-PD-1 antibody later in 2021," said Randall C. Schatzman, Ph.D., Chief Executive Officer of Bolt. "Beyond BDC-1001, we continue to advance our pipeline and are on track to initiate clinical trials for CEA-targeted ISAC BDC-2034 in 2022 and we expect to designate our third clinical candidate later this year."

Recent Business Highlights and Anticipated Milestones

Cash, cash equivalents, and marketable securities were $302.9 million as of March 31, 2021, which is expected to fund operations into 2023 – Bolt is well positioned to continue to drive growth across the company and advance the pipeline through key milestones, with cash to fund operations into 2023.

Completed upsized Initial Public Offering in February 2021 – In February 2021, Bolt completed its Initial Public Offering (IPO) of 13,225,000 shares of common stock, inclusive of the full exercise by the underwriters of their option to purchase 1,725,000 shares, at a public offering price of $20.00 per share. Gross proceeds from the IPO were approximately $264.5 million and net proceeds from the offering, after deducting underwriting discounts, commissions and offering expenses, were approximately $242.0 million.

Presented on the HER2-targeting Boltbody ISAC BDC-1001 in the "New Drugs on the Horizon" symposium and in a trial-in-progress poster in April at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting

At AACR (Free AACR Whitepaper)’s New Drugs on the Horizon symposium, Bolt’s Chief Scientific Officer David Dornan, Ph.D. presented key data-driven decisions made during the development of Bolt’s lead program, BDC-1001, a novel HER2-targeting ISAC. Dr. Dornan’s presentation included a discussion of immunosuppression mediated by various cells in the tumor microenvironment (TME), as well as the tumor-supportive nature of antigen presenting cells (APCs) in the TME in preclinical models. Reawakening these immunosuppressed APCs can result in a productive and durable anti-tumor immune response, as evidenced by BDC-1001 achieving complete tumor regression in preclinical tumor models.
A Trial in Progress poster was also presented at AACR (Free AACR Whitepaper) by Manish R. Sharma, M.D. of START Midwest, a principal investigator in Bolt’s ongoing BDC-1001 Phase 1/2 trial. The poster detailed the design of the four-part study evaluating BDC-1001 administered intravenously with or without an immune checkpoint inhibitor targeting PD-1 in up to 390 patients with HER2-expressing or HER2-amplified advanced or metastatic solid tumors. The dose escalation parts will evaluate sequential doses of BDC-1001 as a monotherapy or in combination with a PD-1 checkpoint inhibitor in a 3+3 design, with the ability to backfill up to a total of 15 patients in each dose cohort. The dose expansion parts will evaluate the recommended Phase 2 dose as monotherapy or in combination with a PD-1 checkpoint inhibitor in four cohorts of patients. Bolt expects to provide a further update on the trial sometime in the second half of 2021.
Upcoming Events

At the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Manish R. Sharma, M.D. of START Midwest, a principal investigator in Bolt’s ongoing BDC-1001 Phase 1/2 trial will present a poster entitled "Preliminary results from a Phase 1/2 study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), in patients (pts) with advanced HER2-expressing solid tumors." This poster will provide more details on the initial 20 patients treated with BDC-1001, as of the initial data cutoff date of January 29, 2021.
First Quarter 2021 Financial Results

Cash Position – Cash, cash equivalents, and marketable securities were $302.9 million as of March 31, 2021, compared to $22.8 million as of December 31, 2020. Bolt expects its cash balance to fund operations into 2023.

Research and Development (R&D) Expenses – R&D expenses were $14.1 million for the quarter ended March 31, 2021, compared to $6.8 million for the same quarter in 2020. The increase in R&D spending in the comparative periods was due primarily to increased manufacturing of BDC-1001 and BDC-2034 (CEA-targeting Boltbody ISAC program), increased personnel-related expenses due to additional hiring and increased facility-related expenses and outside services.

General and Administrative (G&A) Expenses – G&A expenses were $4.3 million for the quarter ended March 31, 2021, compared to $2.1 million for the same quarter in 2020. The increase in G&A spending in the comparative periods was due primarily to increased personnel-related expenses due to additional hiring and increased accounting and legal fees associated with the Company’s Initial Public Offering which was completed in February 2021.

Loss from Operations – Loss from operations was $24.5 million for the quarter ended March 31, 2021 compared to $8.6 million for the same quarter in 2020.

On May 13, 2021 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported first quarter 2021 financial results and recent business updates (Press release, Monopar Therapeutics, MAY 13, 2021, View Source [SID1234579936]).

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Recent Business Updates

Validive

Monopar’s Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer (OPC) dosed its first patient in February 2021 and is actively recruiting patients and initiating additional clinical trial sites. There is no FDA-approved prevention or treatment for CRT-induced SOM.
The U.S. Patent and Trademark Office (USPTO) allowed a new patent with claims for Validive covering "Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy." This patent expands coverage on the potential uses of Validive in cancer patients beyond earlier allowed claims limited specifically to the prevention and/or treatment of oral mucositis in patients receiving CRT.
Camsirubicin and Novel Analogs

Based on the Company’s current inability to gain regulatory approval to initiate the camsirubicin Phase 2 clinical trial in Spain, Monopar is evaluating alternatives to move the dose escalation run-in clinical trial forward outside of Spain. Monopar believes that it will be able to initiate the run-in clinical trial in the second half of 2021 in the U.S. or another country.

The USPTO allowed a new patent with claims covering compositions of matter for a novel family of camsirubicin analogs (2-pyrrilino camsirubicins). This patent expires in 2038, not including any patent term extensions. The patent broadens Monopar’s camsirubicin portfolio and covers a pipeline of compounds designed to retain the potentially favorable non-cardiotoxic chemical backbone of camsirubicin along with the potent broad-spectrum antitumor activity of doxorubicin. Preclinical evidence suggests that this new family of 2-pyrrilino camsirubicin analogs could be active against doxorubicin-resistant tumor cells and thereby may enable use in cancer types beyond those treatable with doxorubicin.
MNPR-101 and Related Compounds

Progress continues in the Monopar/NorthStar Medical Radioisotopes collaboration focused on developing a novel treatment for severe COVID-19 by partnering with (1) IsoTherapeutics Group, LLC to develop, optimize and manufacture humanized urokinase plasminogen activator receptor radioimmunotherapeutics (uPRITs), (2) Aragen Bioscience, Inc. which performed studies to enable the selection of a lead candidate uPRIT along with back-up candidates to potentially advance into IND-enabling development, and (3) The University of Texas Health Science Center at Tyler and its Texas Lung Injury Institute (TLII) to perform in vitro and in vivo studies and to participate in the potential clinical development of uPRITs.
A peer-reviewed preclinical study that reported the potential utility of MNPR-101 conjugates as uPAR imaging agents to improve surgical outcomes in bladder cancer and for surveillance post-resection was published in The European Journal of Cancer. This publication builds on previous studies using conjugates of MNPR-101 and its mouse analog, ATN-658, for the optical imaging of oral and colon cancer.
A peer-reviewed study titled "Engineered Antibody Fragment against the Urokinase Plasminogen Activator for Fast Delineation of Triple-Negative Breast Cancer by Positron Emission Tomography" demonstrated the potential to identify breast cancers with urokinase plasminogen activator (uPA) overexpression, and monitor uPA expression during treatment using positron emission tomography (PET) imaging along with the Company’s uPA antibody fragment radiotracer.
Results for the First Quarter Ended March 31, 2021 Compared to the First Quarter Ended March 31, 2020

Cash and Net Loss

Cash and cash equivalents as of March 31, 2021 were $25.7 million. Monopar anticipates that its current cash and cash equivalents, which includes $10.9 million of net proceeds raised in the first quarter of 2021 under the Company’s Capital on DemandTM Sales Agreement with JonesTrading Institutional Services, at an average gross price per share of $10.20, will fund the Company’s major programs at least through June 2022, including: funding and completing the Phase 2b portion of the VOICE clinical trial and commencing of the Phase 3 portion; funding the camsirubicin run-in clinical trial; continuing advancement of the COVID-19 uPRIT program; and developing other MNPR-101 related compounds and technologies. The Company plans to raise additional funds and/or engage a partner within the next 12 months to complete the VOICE clinical program and continue the camsirubicin clinical development beyond the run-in clinical trial.

Net loss for the first quarter of 2021 was $1.9 million or $0.16 per share compared to net loss of $1.1 million or $0.10 per share for the first quarter of 2020.

Research and Development (R&D) Expenses

R&D expenses for the first quarter of 2021 were $1.2 million compared to $0.3 million for the first quarter of 2020. This increase of $0.9 million was primarily attributed to increases of (1) $0.3 million for the planning of the GEIS-sponsored camsirubicin Phase 2 clinical trial including drug product manufacturing, (2) $0.3 million for R&D personnel expenses, (3) $0.2 million for the VOICE clinical trial and manufacturing-related expenses, and (4) $0.1 million for other R&D operating expenses.

General and Administrative (G&A) Expenses

G&A expenses for the first quarter of 2021 were $0.7 million, a nominal decrease from $0.8 million of G&A expenses for the first quarter of 2020.