Cytokinetics Announces Proposed Public Offering of Convertible Senior Notes

On November 6, 2019 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that it expects to sell, subject to market and other conditions, an aggregate of $100.0 million principal amount of its convertible senior notes due 2026, or the notes, in an underwritten public offering (Press release, Cytokinetics, NOV 6, 2019, View Source [SID1234550641]). Cytokinetics expects to grant the underwriters a 30-day option to purchase up to an additional $15.0 million aggregate principal amount of the notes in connection with the offering, solely to cover over-allotments. All of the notes will be sold by Cytokinetics.

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 notes will be senior unsecured obligations of Cytokinetics and will accrue interest payable semiannually in arrears. The notes will be convertible in certain circumstances into cash, shares of Cytokinetics’ common stock, or a combination of cash and shares of Cytokinetics’ common stock, at Cytokinetics’ election. The interest rate, initial conversion rate and other terms of the notes will be determined at the time of the pricing of the offering.

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.

In connection with the pricing of the notes, Cytokinetics expects to enter 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’ 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. If the underwriters in the 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 expect to purchase shares of 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.

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

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 prospectus supplement and accompanying prospectus. The preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the proposed offering is expected to be filed with the SEC and, if and when filed, will be available on the SEC’s website at www.sec.gov. Copies of the preliminary 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.

Ryvu Therapeutics Announces Presentations on CDK8 Inhibitor SEL120 at the 61st ASH Annual Meeting

On November 6, 2019 Ryvu Therapeutics (WSE: RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, reported that two abstracts have been accepted for presentation at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, FL, taking place from December 7-10, 2019 (Press release, Ryvu Therapeutics, NOV 6, 2019, View Source [SID1234550690]).

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!

Details of the poster presentations are as follows:

Poster Presentation: SEL120 – a First-in-Class CDK8/19 Inhibitor As a Novel Option for the Treatment of Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome – Data from Preclinical Studies and Introduction to a Phase Ib Clinical Trial

Abstract Number: 2651

Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II

Date: Sunday, December 8, 2019

Time: 6:00 p.m. – 8:00 p.m. PST

Location: Orange County Convention Center, Hall B

Poster Presentation: CDK8 Inhibitors Induce Transcriptional Reprogramming of AML Cells Associated with Differentiation

Abstract Number: 3774

Session: 602. Disordered Gene Expression in Hematologic Malignancy, including Disordered Epigenetic Regulation: Poster III

Date: Monday, December 9, 2019

Time: 6:00 p.m. – 8:00 p.m. PST

Location: Orange County Convention Center, Hall B

To view these abstracts, please visit the American Society of Hematology (ASH) (Free ASH Whitepaper) website located at View Source

Abbisko Therapeutics Enters into Licensing Agreement with AstraZeneca for Development and Commercialization of AZD4547

On November 6, 2019 Abbisko Therapeutics, a company dedicated to the discovery and development of innovative cancer therapies reported that it has entered into a licensing agreement with AstraZeneca PLC (LSE/STO/NYSE: AZN) for the development and commercialization of AZD4547, a novel small molecule inhibitor of fibroblast growth factor receptors (FGFRs) (Press release, Abbisko Therapeutics, NOV 6, 2019, View Source;article_id=132 [SID1234556280]).

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!

Under the agreement, Abbisko has acquired an exclusive license for global rights to develop, manufacture and commercialize AZD4547 in all therapeutic, prophylactic, palliative and diagnostic uses in humans and animals including but not limited to FGFR-driven oncology indications. According to the terms of the agreement, AstraZeneca will receive an upfront payment as well as development and sales milestones upon achieving certain regulatory and commercial goals. In addition, AstraZeneca will be eligible to receive tiered royalty fees on net annual sales in the territory.
AZD4547 is a potent, highly selective, orally available clinical stage small molecule inhibitor of FGFR-1, 2 and 3. In preclinical studies, AZD4547 demonstrated strong single agent efficacy in molecularly defined tumor models with a safety profile representative that of the class of agents. In clinical studies, AZD4547 was well tolerated and demonstrated promising response in patients whose tumors harboring FGFR alterations.

Dr. Yao-chang Xu, Chief Executive Officer of Abbisko Therapeutics said "Aberrant activation of FGFR signaling has been implicated in multiple types of cancers. AZD4547 has demonstrated a favorable safety profile in clinical trials and positive signals in cancer patients with FGFR alterations. We believe AZD4547 is a highly competitive drug candidate with potential in a broad range of tumor indications and we look forward to further exploring and realizing AZD4547’s potential in treating patients with FGFR-dependent tumors."

"Susan Galbraith, Senior Vice President and Head of Research and Early Development, Oncology R&D, AstraZeneca said: "This collaboration will leverage Abbisko’s scientific expertise related to FGFR biology and sophisticated development capabilities to further explore AZD4547’s potential benefits to meet unmet medical needs."

Acceleron Reports Third Quarter 2019 Operating and Financial Results

On November 6, 2019 Acceleron Pharma Inc. (Nasdaq:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, reported financial results for the third quarter ended September 30, 2019 (Press release, Acceleron Pharma, NOV 6, 2019, View Source [SID1234550412]).

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!

"With the FDA’s decision on the luspatercept regulatory submission for the treatment of beta-thalassemia expected in less than one month, we are close to achieving a major company milestone-the potential approval for the first Acceleron-discovered medicine," said Habib Dable, President and Chief Executive Officer of Acceleron. "Alongside our global collaboration partner, Celgene, we are preparing for luspatercept’s potential commercial launch in the U.S. We also await the FDA’s decision on our BLA for the MDS indication in April 2020 and the European Medicines Agency’s decision on the MAA for both indications, which is expected in the second half of 2020. We continue to advance our ongoing clinical trials in first-line lower-risk MDS-, non-transfusion-dependent beta-thalassemia- and myelofibrosis-associated anemia. In addition, we are looking forward to presenting luspatercept updates on our Phase 3 MEDALIST and BELIEVE trials, as well as interim results from the ongoing Phase 2 myelofibrosis trial at the upcoming ASH (Free ASH Whitepaper) meeting in December."

Added Mr. Dable: "While our hematology program continues to grow, we are also advancing our two Acceleron-led clinical programs in pulmonary and neuromuscular disease. We anticipate reporting results in the first quarter of 2020 for both our PULSAR Phase 2 sotatercept trial in patients with PAH, and our ACE-083 trial in patients with CMT."

Development Program Highlights

Hematology

Luspatercept: Myelodysplastic Syndromes (MDS), Beta-Thalassemia, and Myelofibrosis (MF)
Luspatercept is an investigational first-in-class erythroid maturation agent designed to address a late-stage erythroid maturation defect that results in chronic anemia and the need for regular red blood cell transfusions in adults with serious hematologic diseases. Luspatercept is part of the global collaboration between Acceleron and Celgene.

The U.S. Food and Drug Administration’s (FDA) review of the Biologics License Application (BLA) for luspatercept is ongoing for the treatment of anemia in adult patients with very low- to intermediate-risk MDS, who have ring sideroblasts and require red blood cell (RBC) transfusions, and for the treatment of anemia in adult patients with beta-thalassemia, who require regular RBC transfusions.

The FDA’s target action date for the beta-thalassemia indication is December 4, 2019, and April 4, 2020 for the MDS indication.

The European Medicines Agency’s (EMA) review of the Marketing Authorization Application (MAA) for luspatercept for the treatment of anemia in adult patients with MDS or beta-thalassemia is ongoing. The EMA decision on the MAA is expected in the second half of 2020.

Six clinical abstracts of luspatercept have been accepted for presentation at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Orlando on December 7-10, 2019, including

Five clinical abstracts highlighting new and updated analyses from the MEDALIST and BELIEVE Phase 3 trials;

One clinical abstract including interim results from the ongoing Phase 2 trial in MF.

xlrnlogoa31.gif

Enrollment is ongoing in the COMMANDS Phase 3 trial in patients with treatment-naïve, lower-risk MDS.

The BEYOND Phase 2 trial in adult patients with non-transfusion-dependent beta-thalassemia is ongoing, with topline results expected by year-end 2020.

Pulmonary Disease

Sotatercept: Pulmonary Arterial Hypertension (PAH)
Sotatercept is an investigational agent designed to be a selective ligand trap for members of the TGF-beta superfamily to rebalance BMPR2 signaling, which is a key molecular driver of PAH. In preclinical studies of PAH, sotatercept (RAP-011) reversed pulmonary vessel muscularization and improved indicators of right heart failure.

The FDA granted Orphan Drug Designation to sotatercept for the treatment of patients with PAH.

Topline results from the PULSAR Phase 2 trial in patients with PAH are expected in the first quarter of 2020.

Enrollment is ongoing in the exploratory SPECTRA trial in patients with PAH, with preliminary results expected in 2020.

Neuromuscular Disease

ACE-083: Charcot-Marie-Tooth Disease (CMT) and Facioscapulohumeral Muscular Dystrophy (FSHD)
ACE-083 is an investigational locally-acting therapeutic designed to have a concentrated effect on muscle mass and strength in target muscles for diseases that cause focal muscle weakness. ACE-083 utilizes the "Myostatin+" approach to inhibit multiple TGF-beta superfamily ligands involved in muscle formation.

Topline results from Part 2 of the Phase 2 trial in patients with CMT are expected in the first quarter of 2020.

Clinical development of ACE-083 in patients with FSHD has been discontinued following the Phase 2 topline results.
Financial Results

Cash Position – Cash, cash equivalents and investments as of September 30, 2019 were $468.3 million, as compared to $291.3 million as of December 31, 2018.
Based on the Company’s current operating plan and projections, it believes that current cash, cash equivalents and investments will be sufficient to fund projected operating requirements until such time as it expects to receive significant royalty revenue from luspatercept sales.

Revenue – Revenue for the third quarter of 2019 was $4.2 million. This revenue was derived from the Company’s collaboration partnership with Celgene and is largely related to expenses incurred by the Company in support of luspatercept.

Costs and Expenses – Total costs and expenses for the third quarter of 2019 were $53.1 million. This includes R&D expenses of $37.6 million and G&A expenses of $15.5 million.

Net Loss – The Company’s net loss for the third quarter of 2019 was $45.4 million.

Conference Call and Webcast

2xlrnlogoa31.gif

The Company will host a webcast and conference call to discuss its third quarter 2019 financial results and provide an update on recent corporate activities on November 6, 2019, at 10:00 a.m. EST.

The webcast will be accessible under "Events & Presentations" in the Investors/Media page of the Company’s website at acceleronpharma.com. Individuals can participate in the conference call by dialing 877-312-5848 (domestic) or 253-237-1155 (international) and referring to the "Acceleron Third Quarter 2019 Earnings Call."

The archived webcast will be available for replay on the Acceleron website approximately two hours after the event.

Bellicum Pharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Operational Update

On November 6, 2019 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the third quarter 2019 and provided an operational update (Press release, Bellicum Pharmaceuticals, NOV 6, 2019, View Source [SID1234550444]).

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!

"Bellicum made significant strides in the third quarter repositioning the company to focus exclusively on our GoCAR programs, as we seek to clinically demonstrate how our technology may extend the impact of CAR-T therapies to more patients," said Rick Fair, President and Chief Executive Officer of Bellicum Pharmaceuticals. "By streamlining the organization and other cost-saving initiatives and executing a financing in August, we believe we have positioned the company to generate meaningful clinical data on our ongoing GoCAR programs and to advance a third GoCAR program toward the clinic."

PROGRAM HIGHLIGHTS AND CURRENT UPDATES

BPX-601 GoCAR-T

Bellicum anticipates presenting new translational data from cohort 5B in the BPX-601 Phase 1/2 trial in early 2020. These data are expected to provide additional evidence on the proposed mechanisms of action of iMC activation in BPX-601, including cell expansion and persistence, cytokine production, tumor infiltration, and CAR-T activity in the tumor microenvironment. Bellicum is currently enrolling cohort 5C. Data from this cohort will be used to evaluate the safety of repeat rimiducid dosing to re-activate iMC over time, which is intended to deepen and extend the treatment effect. Patient enrollment has proceeded more slowly than anticipated primarily as the result of the amended protocol limiting enrollment to second line patients. Initial results from Cohort 5C are expected to be presented in the second half of 2020.
BPX-603 GoCAR-T

In response to Bellicum’s IND application for BPX-603, the FDA has responded with a request for additional preclinical data to better characterize the potential risk of off-tumor / on-target toxicity before IND clearance. Bellicum is engaged in discussions with the FDA to align on a plan to address the request.
Research Programs

An abstract for a preclinical investigation from Bellicum’s natural killer cell GoCAR program has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on November 8, 2019.
Rivo-cel

Bellicum is actively pursuing a strategic partner for rivo-cel to lead future development and commercialization for this product candidate. Bellicum has reduced and expects to continue to reduce its rivo-cel related activities.
Corporate Highlights

In August, Bellicum announced receipt of aggregate gross proceeds of $69.6 million, including gross proceeds of $57.5 million from an underwritten public offering and a $12.1 million private placement option fee related to its private placement of up to $70 million in additional potential gross proceeds.
Bellicum is actively pursuing a partner to purchase its manufacturing facility and establish a preferred supply agreement with the goal of reducing operating costs while maintaining viral vector and cell therapy development capabilities and dedicated manufacturing capacity for its programs.
Third Quarter 2019 Financial Results and Outlook

R&D Expenses: Research and development (R&D) expenses were $14.3 million for the third quarter of 2019, compared to $16.4 million for the third quarter of 2018. The reduction in expenses in the third quarter of 2019 resulted primarily from reduced expenses related to rivo-cel and reduced general R&D expenses, partially offset by higher expenditures related to the GoCAR-T platform. R&D expenses for the nine months ended September 30, 2019 were $51.0 million compared to $51.4 million for the comparable period in the prior year.

G&A Expenses: General and administrative (G&A) expenses were $9.2 million for the third quarter of 2019 compared to $7.0 million during the comparable period in 2018. The higher expenses in the third quarter 2019 relative to the comparable period in 2018 were primarily due to an accrual of severance costs arising from reductions in rivo-cel related activities. G&A expenses for the nine months ended September 30, 2019 were $24.3 million compared to $18.0 million for the first nine months of 2018.

Net Loss: Bellicum reported a net loss of $32.0 million for the third quarter of 2019 compared to a net loss of $23.8 million for the third quarter of 2018. The results included non-cash, share-based compensation charges of $1.6 million and $3.7 million for the third quarter of 2019 and 2018, respectively. Net loss for the nine months ended September 30, 2019 was $83.5 million compared to a loss of $70.8 million for the nine months ended September 30, 2018.

Shares Outstanding: At October 31, 2019, Bellicum had 49,616,316 shares of common stock outstanding and 541,500 shares of preferred stock outstanding. Each preferred share can be converted into 100 shares of common stock.

Cash Position and Guidance: Bellicum reported cash, restricted cash and investments totaling $106.9 million as of September 30, 2019, compared to $98.0 million at December 31, 2018. Based on current operating plans, Bellicum expects that current cash resources will be sufficient to meet operating requirements into 2021.

Conference Call and Webcast

Bellicum’s management will host a webcast and conference call today at 5 p.m. ET / 2 p.m. PT, November 6, 2019, to discuss the financial results for the third quarter 2019 and provide a corporate update. The live call may be accessed by dialing (877) 407-3103 for domestic callers and (201) 493-6791 for international callers. A live webcast of the call will be available from the Investors and Media section of the company’s website at www.bellicum.com and a replay will be available shortly after the live event.

About BPX-601

BPX-601, the company’s first GoCAR-T product candidate, incorporates iMC, Bellicum’s inducible co-activation domain. iMC (inducible MyD88/CD40) is designed to provide a powerful boost to T cell proliferation and persistence and enable the CAR-T to override key immune inhibitory mechanisms, including PD-1 and TGF-beta. BPX-601 is being evaluated as a treatment for solid tumors expressing prostate stem cell antigen (PSCA), including pancreatic, gastric, and prostate cancers.