Cytokinetics Announces Pricing of Public Offering of Convertible Senior Notes

On November 8, 2019 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that it has agreed to sell an aggregate of $120.0 million principal amount of its 4.00% convertible senior notes due 2026, or the notes, in an underwritten public offering (Press release, Cytokinetics, NOV 8, 2019, View Source [SID1234550801]). Cytokinetics has granted the underwriters a 30-day option to purchase up to an additional $18.0 million aggregate principal amount of the notes in connection with the offering, solely to cover over-allotments. The aggregate principal amount of the offering was increased from the previously announced offering size of $100.0 million. The offering is expected to close on November 13, 2019, subject to customary closing conditions.

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!

Cytokinetics intends to use the net proceeds from the proposed offering to fund (i) the continued development of and commercial readiness activities associated with omecamtiv mecarbil, (ii) the continued clinical development of CK-274 and related compounds in indications associated with hypertrophic cardiomyopathies and related diseases associated with diastolic dysfunction and cardiac fibrosis, including heart failure with preserved ejection fraction, (iii) the continued clinical development of reldesemtiv in patients with amyotrophic lateral sclerosis and spinal muscular atrophy, including potential Phase 3 clinical trials and other commercial readiness activities, and (iv) working capital and other general corporate purposes, including tenant improvement of the new facility Cytokinetics plans to move into in 2021, capital expenditures, debt service or retirement of debt, including existing debt outstanding under Cytokinetics’ loan and security agreement. Cytokinetics also intends to use a portion of the net proceeds from the proposed offering to pay the cost of the capped call transaction described below.

The notes will be senior unsecured obligations of Cytokinetics and will bear interest at a fixed rate of 4.00% per year, payable semi-annually in arrears on May 15 and November 15 of each year, commencing on May 15, 2020. The notes will mature on November 15, 2026, unless earlier converted, redeemed or repurchased. Prior to the close of business on the business day immediately preceding July 15, 2026, the notes will be convertible at the option of the holders only upon the satisfaction of certain conditions. Thereafter, the notes will be convertible at the option of the holders at any time until the close of business on the scheduled trading day immediately before the maturity date. Upon conversion, Cytokinetics will pay or deliver, as the case may be, cash, shares of its common stock or a combination of cash and shares of its common stock, at its election. The initial conversion rate will be 94.7811 shares per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $10.55 per share), subject to adjustment upon the occurrence of specified events.

Cytokinetics may not redeem the notes prior to November 20, 2023. Cytokinetics has the right, at its election, to redeem all, or any portion, of the notes, at any time and from time to time, on a redemption date occurring on or after November 20, 2023 and, in the case of any partial redemption, on or before the 60th scheduled trading day before the maturity date, for cash, but only if the last reported sale price per share of Cytokinetics’ common stock exceeds 130% of the conversion price then in effect for a specified period of time ending on the trading day immediately before the date the notice of redemption is sent, at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

Morgan Stanley & Co. LLC and Mizuho Securities are acting as joint book-runners for the offering. JMP Securities is acting as lead manager, and H.C. Wainwright & Co. is acting as co-manager for the offering.

In connection with the pricing of the notes, Cytokinetics has entered into a privately negotiated capped call transaction (together with any additional capped call transactions entered into in connection with the exercise by the underwriters of their over-allotment option as described below, the capped call transactions), with one of the underwriters in the offering or its affiliate, or the capped call counterparty. The capped call transactions will cover, subject to customary adjustments, the number of shares of Cytokinetics’ common stock that will initially underlie the notes. The capped call transactions are generally expected to reduce the potential dilution of Cytokinetics’s common stock and/or offset any cash payments Cytokinetics is required to make in excess of the principal amount of converted notes, as the case may be, as a result of any conversion of the notes, with such reduction and/or offset subject to a cap based on the cap price. The cap price of the capped call transactions will initially be approximately $14.07 per share, which represents a premium of approximately 70% over the per share closing price of Cytokinetics’s common stock of $8.275 per share on November 7, 2019, and is subject to certain adjustments under the terms of the capped call transactions. If the underwriters in this offering exercise their over-allotment option, Cytokinetics expects to use a portion of the net proceeds from the sale of the additional notes to enter into an additional capped call transaction with the capped call counterparty.

In connection with establishing its initial hedge of the capped call transactions, the capped call counterparty or its affiliates have advised Cytokinetics that it or its affiliates expect to purchase Cytokinetics’ common stock and/or enter into various derivative transactions with respect to Cytokinetics’ common stock concurrently with, or shortly after, the pricing of the notes, including with certain investors in the notes. This activity could increase (or reduce the size of any decrease in) the market price of Cytokinetics’ common stock or the notes at that time.

In addition, the capped call counterparty or its affiliates may modify its hedge positions by entering into or unwinding various derivatives with respect to Cytokinetics’ common stock and/or purchasing or selling Cytokinetics’ common stock or other securities of Cytokinetics in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so on each exercise date of the capped call transaction, which are expected to occur during the 60 trading day period beginning on the 61st scheduled trading day prior to the maturity date of the notes, or following any termination of any portion of the capped call transaction in connection with any repurchase, redemption or early conversion of the notes). This activity could also cause or avoid an increase or decrease in the market price of Cytokinetics’ common stock or the notes, which could affect noteholders’ ability to convert the notes and, to the extent the activity occurs during any observation period related to a conversion of the notes, affect the amount and value of the consideration that noteholders will receive upon conversion of the notes.

An automatic shelf registration statement relating to the notes was previously filed with the Securities and Exchange Commission, or SEC, and became immediately effective on November 6, 2019. The offering will be conducted by means of a prospectus supplement and accompanying prospectus. The final prospectus supplement and the accompanying prospectus relating to and describing the terms of the proposed offering will be filed with the SEC and, when filed, will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus related to the offering may also be obtained by contacting: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; or Mizuho Securities USA LLC, Attn: Equity Capital Markets, 320 Park Avenue, 12th Floor, New York, NY 10022-6815, by telephone (212) 205-7600, or by email: [email protected].

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

Oncolytics Biotech® Announces AWARE-1 Data Presented at the 34th Annual Meeting of the Society for Immunotherapy of Cancer

On November 8, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), highlighting data from the AWARE-1 study in early breast cancer (Press release, Oncolytics Biotech, NOV 8, 2019, View Source [SID1234550800]). The 34th Annual SITC (Free SITC Whitepaper) Meeting is being held November 6-10, 2019 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.

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!

"This is the first-time our biomarker data from AWARE-1 has been presented at a major academic conference," said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "The primary objective of this study is to evaluate changes in the immune environment of patients diagnosed with early stage breast cancer using our biomarker of T cell clonality measured by CelTIL score. This measures a change or expansion of infiltrating immune cells and importantly, an increase in CelTIL is known to correlate with a positive patient outcome. This initial data shows replication of pelareorep occurs exclusively in tumor tissue and there is an increase in CelTIL through the expansion of existing T cells, and most importantly, through the creation of new T cell clones. We continue to show that pelareorep changes the immunogenetic environment within the tumor, and the results of this early stage breast cancer study support our use of this biomarker and its value in predicting tumor response in our upcoming BRACELET-1 study in hormone receptor positive metastatic breast cancer."

The next patient cohort to report from AWARE-1 focuses on patients receiving pelareorep and the standard of care, without Tecentriq. This cohort will allow for the comparison of patients treated with standard of care plus pelareorep, to patients receiving the standard of care, plus pelareorep, plus Tecentriq. This will be the first data from AWARE-1 to confirm the impact pelareorep has on enhancing the anti-tumor T cell response both on its own, and in combination with a checkpoint inhibitor.

The poster, "A window-of-opportunity Study of pelareorep in Early Breast Cancer (AWARE-1)", was authored by AWARE-1 principal investigator, Aleix Prat, et al, and presented by Dr. Patricia Villagrasa, Scientific Director at SOLTI Innovative Breast Cancer Research. The AWARE-1 study continues to screen and enroll patients and we expect to provide interim data before the end of the year and final results in the first half of 2020.

SITC Presentation Details

Title: A window-of-opportunity Study of pelareorep in Early Breast Cancer (AWARE-1)
Abstract ID: P373
Poster Presentation – Friday, Nov. 8, 7:00 am – 8:00 pm
Location: Poster Hall (Prince George AB)
About AWARE-1

AWARE-1 is an open label window-of-opportunity study in early stage breast cancer that will enroll 38 patients into five cohorts:

Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)
The study combines the standard of care by breast cancer subtype with pelareorep and atezolizumab. Patients are biopsied on day one followed immediately by treatment, then again on day three, and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer sub-type. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers.

The study is being coordinated by Dr. Aleix Prat, Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS) and member of Oncolytics’ Scientific Advisory Board.

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

Iovance Biotherapeutics Announces Updated Phase 2 Clinical Data from the Lifileucel Metastatic Melanoma Trial at the Society for Immunotherapy of Cancer 34th Annual Meeting

On November 8, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that new data from Cohort 2 of the ongoing Phase 2 lifileucel metastatic melanoma study (C-144-01) were presented Friday, Nov. 8, 2019, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting in National Harbor, Maryland (Abstract P865) (Press release, Iovance Biotherapeutics, NOV 8, 2019, View Source [SID1234550799]).

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!

Highlights from the poster presentation include:

An objective response rate (ORR) of 35 percent as assessed by IRC as compared to 36 percent as assessed by investigator
Median DOR was not reached as assessed by either IRC (range: 1.6+ to 21.2+ months) or investigator (range: 2.2 to 21.2+ months) at 11.3 months median follow up. In addition, based on the most recent data cut from the study, median DOR was not reached as assessed by investigator at 12.8 months of median study follow-up.
An overall concordance rate of 89.4 percent between investigator assessment and IRC assessment (n=66)
"We are pleased to see continued evidence of durability with lifileucel therapy as patients are evaluated with longer term follow-up," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "In addition, concordance between IRC assessment and investigator reported results is highly favorable in this metastatic disease setting as compared with the published literature. These results continue to show that lifileucel offers a potential therapeutic option for the metastatic melanoma patients enrolled in this study. We continue to enroll patients in the pivotal cohort of the study, Cohort 4, which is expected to serve as the basis for an expected Biologics License Application (BLA) submission for lifileucel in late 2020."

Cohort 2 in the ongoing C-144-01 study includes consecutively dosed post-PD-1 patients with Stage IIIC/IV unresectable melanoma who also have received BRAF/MEK therapy if clinically indicated. In this study, patients had experienced a mean of 3.3 lines of prior therapy including anti-PD1 blocking antibody, and the patients had a high baseline tumor burden. The adverse event profile of lifileucel treatment in the C-144-01 study continued to be consistent with the underlying advanced disease and the profile of the lymphodepletion and IL-2 regimens.

Affimed Announces Pricing of Public Offering of Common Shares

On November 8, 2019 Affimed N.V. ("Affimed" or the "Company") (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported the pricing of its previously announced public offering of 12,000,000 of its common shares at a public offering price of $2.50 per common share (Press release, Affimed, NOV 8, 2019, View Source [SID1234550798]). In addition, Affimed has granted the underwriters a 30-day option to purchase up to an additional 1,800,000 common shares at the public offering price less underwriting discounts. After deducting the underwriting discounts, the net proceeds of the public offering are expected to be approximately $28.2 million. The offering is expected to close on or about November 13, 2019, subject to customary closing conditions.

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!

Jefferies LLC and SVB Leerink LLC are acting as joint book-running managers and SunTrust Robinson Humphrey, Inc. and Laidlaw & Company (UK) Ltd. as co-managers of the offering. A shelf registration statement relating to these securities filed with the Securities and Exchange Commission (the "SEC") was declared effective by the SEC on November 7, 2018. The offering will be made only by means of a prospectus and prospectus supplement. A preliminary prospectus supplement and accompanying prospectus related to the offering have been filed with the SEC and are available at the SEC’s website located at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. Copies of the final prospectus supplement and accompanying prospectus related to the offering may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, 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. 6132, 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 state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

BioInvent to Present BI-1206 Preclinical Data in Mantle Cell lymphoma at ASH 2019

On November 8, 2019 BioInvent International AB (publ) (OMXS: BINV) reported it will make a poster presentation with preclinical data on BI-1206 at the annual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in Orlando, Florida held December 7-10 (Press release, BioInvent, NOV 8, 2019, View Source [SID1234550797]).

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!

The abstract, published here, highlights a preclinical study of BI-1206 in an ibrutinib-venetoclax dual resistant PDX model derived from a doubly-resistant mantle cell lymphoma (MCL) patient. Single agent BI-1206 had potent anti-MCL activity in the FcγRIIb-expressing MCL PDX model to overcome ibrutinib-venetoclax dual resistance.

FcγRIIb was further shown to be highly expressed in 27/27 primary patient MCL samples examined. Along with previously published data demonstrating an important role for FcγRIIB in resistance to rituximab-based cancer immunotherapy, and BI-1206 in boosting rituximab efficacy and overcoming rituximab-resistance, these data indicate the significant potential of BI-1206 to address a significant unmet need in MCL and hematologic malignancy.

BioInvent CEO Martin Welschof said: "These pre-clinical data indicate a broad and clinically important role of FcγRIIb in mantle cell lymphoma, and highlight the potential of BI-1206 to help overcome resistance in this indication. This further reinforces our belief that FcγRIIb will become a key element for treating hematological and solid malignancies, and the potential of BI-1206 to play an important role in combating these diseases."

BI-1206, one of BioInvent’s proprietary anti-FcyRIIB antibodies and its lead compound, is currently being investigated in clinical trials in non-Hodgkin lymphoma, chronic lymphocytic leukemia and solid tumors.

Details of the poster:

Title: BI-1206, a Monoclonal Antibody Against FcyRIIIb, Showed Superior Anti-Tumor Activity in an Ibrutinib-Venetoclax Dual Resistant PDX Model in Mantle Cell Lymphoma

Session Name: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic Agents: Poster II

Time: Sunday, December 8, 2019, 6:00 – 8:00 PM

Location: Orange County Convention Center, Hall B