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G1 Therapeutics Provides Third Quarter 2020 Corporate and Financial Update

On November 4, 2020 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported a corporate and financial update for the third quarter ended September 30, 2020 (Press release, G1 Therapeutics, NOV 4, 2020, View Source [SID1234569991]).

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"Since I joined G1 in 2014, the company has made tremendous progress in advancing trilaciclib from the lab to receiving Priority Review for our NDA and a PDUFA action date of February 15, 2021. We have built exceptional commercial and medical teams that are prepared for the potential approval of trilaciclib in the first quarter of next year. In addition, we have developed a comprehensive clinical and regulatory strategy to evaluate the use of trilaciclib in other solid tumors, including a registrational trial in metastatic colorectal cancer that is on track to start this quarter," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "It has been a privilege to work with the talented team at G1 to accomplish these goals, and I am equally fortunate to be handing the reins to Jack Bailey, our board member and incoming CEO. Jack is a superb leader with extensive experience launching novel therapeutics and managing product development to maximize benefit to patients."

Regulatory, Clinical and Corporate Highlights

NDA for trilaciclib in small cell lung cancer (SCLC) accepted by FDA and assigned Priority Review in August 2020. The application was supported by positive data from three randomized clinical trials showing the myelopreservation benefits of trilaciclib in patients with SCLC being treated with chemotherapy. The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of February 15, 2021 (press release here). Trilaciclib has also received Breakthrough Therapy Designation by the FDA.
Additional analyses of trilaciclib SCLC trial results presented at North America Conference on Lung Cancer (NACLC). A mini-oral session highlighted analysis of three randomized trials in patients with small cell lung cancer that showed trilaciclib significantly reduced hospitalizations caused by chemotherapy-induced myelosuppression or sepsis.
Completed enrollment in rintodestrant/palbociclib combination trial in October 2020. The company expects preliminary safety, tolerability and efficacy data from 40 patients enrolled in this Phase 2 trial to be presented in the second quarter of 2021. The trial is comparing a treatment regimen of rintodestrant plus palbociclib (known commercially as Ibrance) to fulvestrant plus palbociclib in patients with ER+, HER2- breast cancer.
CEO succession plan announced in September 2020. Effective January 1, 2021, Mark Velleca, M.D., Ph.D., will transition to the role of senior advisor and continue to serve as a member of the G1 Board of Directors. John ("Jack") Bailey, a member of the company’s board, has been named as CEO (press release here).
"I’m excited to have the opportunity to lead G1 through its next chapter as a commercial company," said Jack Bailey, incoming CEO. "Our top priorities remain the successful execution of our launch strategy for trilaciclib in small cell lung cancer and advancing the clinical development of trilaciclib in other tumor types. I’ve gotten to know the team at G1 since joining the board earlier this year, and have been struck by their desire to help patients. It’s a privilege to join this group that shares a common passion for delivering better treatment options to people living with cancer."

Third Quarter 2020 Financial Highlights and 2020 Guidance

Cash Position: Cash and cash equivalents totaled $238.3 million as of September 30, 2020, compared to $269.2 million as of December 31, 2019.
License Revenue: License revenues were $26.6 million for the third quarter of 2020, mostly related to the upfront cash payments from license agreements of $20.0 million and $6.0 million from EQRx, Inc. and Genor Biopharma, Inc., respectively.
Operating Expenses: Operating expenses were $36.3 million for the third quarter of 2020, compared to $34.0 million for the third quarter of 2019. GAAP operating expenses include stock-based compensation expense of $4.9 million for the third quarter of 2020, compared to $4.4 million for the third quarter of 2019.
Research and Development Expenses: Research and development (R&D) expenses for the third quarter of 2020 were $17.9 million, compared to $22.9 million for the third quarter of 2019. The decrease in R&D expenses was primarily due to a decrease of $4.6 million in costs for manufacturing active pharmaceutical ingredients, as well as a decrease of $1.6 million in external costs related to discovery and pre-clinical costs development. The decrease is partially offset by an increase of $1.2 million in spend for clinical trials.
General and Administrative Expenses: General and administrative (G&A) expenses for the third quarter of 2020 were $18.4 million, compared to $11.1 million for the third quarter of 2019. The increase in G&A expenses was largely due to an increase in compensation due to additional headcount, increase in pre-commercialization activities, and an increase in professional fees and other administrative costs necessary to support our commercial operations.
Net Loss: G1 reported a net loss of $11.7 million for the third quarter of 2020, compared to $32.4 million for the third quarter of 2019.
2020 Guidance: The company has updated its cash and cash equivalents guidance provided in the second quarter, and now expects to end 2020 with cash and cash equivalents of $200-$205 million (previous guidance of $185-$200 million). This guidance does not include consideration of potential additional proceeds from partnerships, collaboration activities and/or other sources of capital.
Key Anticipated 2020/2021 Milestones

Initiation of Phase 3 trilaciclib metastatic colorectal cancer clinical trial in November/December 2020.
Presentation of additional Phase 2 data of trilaciclib in triple-negative breast cancer at the San Antonio Breast Cancer Summit (SABCS) in December 2020.
Presentation of additional rintodestrant monotherapy data at SABCS in December 2020.
Pending FDA approval, commercial launch of trilaciclib in SCLC in 1Q21.
Presentation of rintodestrant/palbociclib Phase 2 data in 2Q21.
Webcast and Conference Call
The management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the third quarter 2020 ended September 30, 2020. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 6634419. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

AnaptysBio Announces Third Quarter 2020 Financial Results and Provides Pipeline Updates

On November 4, 2020 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, reported operating results for the third quarter ended September 30, 2020 and provided pipeline updates (Press release, AnaptysBio, NOV 4, 2020, View Source [SID1234569972]).

"We are excited with the recent interim results from our GALLOP trial and look forward to engaging with regulatory authorities to progress imsidolimab into registration trials for the treatment of GPP," said Hamza Suria, president and chief executive officer of AnaptysBio. "Under our amended immuno-oncology collaboration with GSK, we look forward to the anticipated first FDA approval of dostarlimab and its advancement for patients suffering with various oncological disorders."

Imsidolimab (Anti-IL-36 Receptor) Program

In July, we announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for imsidolimab, our proprietary anti-interleukin-36 receptor (IL-36R) antibody, for the treatment of patients with GPP. Treatment of GPP by imsidolimab is being evaluated in the GALLOP Phase 2 trial.

Patients demonstrated rapid onset, overall safety and promising efficacy upon imsidolimab monotherapy in a Day 29 interim analysis of our GALLOP Phase 2 GPP trial. Six of 8 patients achieved the primary endpoint of disease improvement upon Day 29, while erythema with skin pustules, which clinically defines GPP, decreased by 94% on Day 29 relative to baseline.
An end-of-Phase 2 meeting, based upon data available from the 8 patients enrolled in the GALLOP trial, is anticipated in Q4 2020.

We are also conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in approximately 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, which is now fully enrolled with topline data anticipated in Q1 2021.

We anticipate expanding the imsidolimab program in two new indications, EGFR-mediated skin toxicities and ichthyosis, based upon human translational data that suggests each of these conditions are mediated by dysregulated signaling through the IL-36 pathway. Initiation of Phase 2 trials for each of these indications is anticipated in Q4 2020.

Worldwide registry of GPP and PPP patients, named RADIANCE, to be initiated in Q1 2021, to improve understanding of the patient journey and support enrollment of future trials.
ANB030 (Anti-PD-1 Agonist) Program

We anticipate topline data from our ongoing Phase 1 healthy volunteer clinical trial of ANB030, our wholly-owned PD-1 agonist antibody, designed to assess the safety, pharmacokinetics and pharmacodynamics of ANB030 in single and multiple ascending dose cohorts in mid-2021. Preclinical translational data using ANB030 was presented in March 2020 at the Festival of Biologics Meeting.
ANB032 (Anti-BTLA Modulator) Program

We anticipate filing an investigational new drug application (IND) for ANB032, our wholly-owned BTLA modulator antibody, in Q4 2020. We presented preclinical data regarding ANB032 at the 2020 Federation of Clinical Immunology Societies (FOCIS) Virtual Annual Meeting in October 2020.
Etokimab (ANB020 Anti-IL-33) Program

In an interim analysis at week 8 of the ongoing ECLIPSE Phase 2 trial of etokimab in chronic rhinosinusitis with nasal polyps, patients dosed with etokimab every four (q4w) or eight weeks (q8w) failed to achieve statistically significant improvement in their bilateral nasal polyps score (NPS), an endoscopic measure of nasal occlusion, and their sino-nasal outcome test (SNOT-22), a patient reported quality-of-life assessment, versus placebo at the week 8 timepoint. Both endpoints demonstrated statistically significant improvement over baseline levels of NPS and SNOT-22. Blood eosinophil levels, which are a biomarker of etokimab’s mechanism, demonstrated statistically significant reduction relative to baseline in both etokimab treatment arms. We intend to decide on a path forward for the etokimab program after reviewing week 16 primary endpoint data by year-end 2020.
Dostarlimab (Anti-PD-1 Antagonist) Program Partnered with GSK

In October 2020, we amended our immuno-oncology collaboration with GSK resulting in increased financial consideration to AnaptysBio. Royalties due to AnaptysBio for dostarlimab were increased to 8-25% of global net sales, where AnaptysBio will receive 8% of annual global net sales below $1 billion, and 12-25% of net sales above $1 billion. The $1.1 billion in cash milestone payments due under the collaboration agreement remain unchanged, and AnaptysBio anticipates receiving $75 million in such cash milestones over the next 18 months as dostarlimab obtains FDA and EMA regulatory approval for the first two indications. An additional $165 million in sales milestones is anticipated by AnaptysBio upon achievement of certain dostarlimab annual sales revenues. GSK has also agreed, starting January 1, 2021, to pay AnaptysBio a 1% royalty on all of GSK’s global net sales of Zejula. In addition, GSK has agreed to pay AnaptysBio a one-time cash payment of $60 million within 30 days. In exchange, AnaptysBio has provided GSK with freedom to conduct development and commercialization of Zejula in combination with third-party molecules and settled the ongoing legal dispute between AnaptysBio and GSK.
Third Quarter Financial Results

Cash, cash equivalents and investments totaled $374.5 million as of September 30, 2020 compared to $428.5 million as of December 31, 2019, for a decrease of $54.0 million. The decrease relates primarily to cash used for operating activities.

Collaboration revenue was zero and $15.0 million for the three and nine months ended September,30 2020, which related to milestone payments for successful BLA and MAA filings for dostarlimab by GSK, compared to zero and $5 million for the three and nine months ended September 30, 2019.

Research and development expenses were $19.5 million and $58.5 million for the three and nine months ended September 30, 2020, compared to $29.9 million and $77.9 million for the three and nine months ended September 30, 2019. The decrease was due primarily to reduced outside services for manufacturing and clinical expenses based on the timing of projects.

General and administrative expenses were $4.8 million and $13.8 million for the three and nine months ended September 30, 2020, compared to $3.8 million and $12.3 million for the three and nine months ended September 30, 2019. The increase was due primarily to increased legal and insurance expenses.

Net loss was $23.8 million and $53.6 million for the three and nine months ended September 30, 2020, or a net loss per share of $0.87 and $1.96, compared to a net loss of $31.0 million and $77.1 million for the three and nine months ended September 30, 2019, or a net loss per share of $1.15 and $2.85.

Financial Guidance
AnaptysBio expects its net cash burn in 2020 will be close to breakeven assuming the $20 million milestone payment upon first FDA approval of dostarlimab is received by year-end. We anticipate that our cash, cash equivalents and anticipated revenues will fund our current operating plan at least into 2023.

SHINE announces first sales of n.c.a. Lu-177

On November 4, 2020 SHINE Medical Technologies reported that its Therapeutics division has made its first commercial sales of lutetium-177 to multiple customers (Press release, Shine Medical Technologies, NOV 4, 2020, View Source;pk_kwd=shine-announces-first-sales-of-n-c-a-lu-177 [SID1234569969]). Lutetium-177, or Lu-177, is a therapeutic isotope in demand by clinical trial sponsors because of its potential to revolutionize the treatment of cancer patients. There are dozens of clinical trials studying Lu-177’s potential to treat a range of cancers.

"SHINE’s recent sales of Lu-177 are a significant milestone for the company and important validation of our production and commercial processes," said Katrina Pitas, vice president and general manager of SHINE Therapeutics. "We look forward to serving customers in both the clinical trial and cancer therapy markets. We expect demand for Lu-177 to grow rapidly as its efficacy and impact on the field of cancer therapy continue to be demonstrated."

SHINE’s Lu-177 production process enables the company to produce the high specific activity, non-carrier-added Lu-177 that is required by today’s clinical trials. SHINE’s technology also has unique advantages that allow the company to scale production of the isotope quickly and more efficiently. The technology was developed with the help of SHINE’s scientific partners in the Czech Republic, the Institute of Organic Chemistry and Biochemistry (IOCB Prague) and the Nuclear Physics Institute (NPI) of the Czech Academy of Sciences.

Building One, the first building on SHINE’s isotope production campus, will serve as the company’s bridge production facility. SHINE will produce Lu-177 under GMP conditions at Building One in the short term, while the company builds a larger facility exclusively for the production of Lu-177. Groundbreaking for the larger facility is expected in November. SHINE’s new therapeutic isotope production facility will be able to scale to support the company’s anticipated Lu-177 demand for the next five years. It will be capable of producing more than 300,000 doses of Lu-177 per year.

"This milestone is really exciting, as Lu-177 is effectively a smart bomb for certain types of cancer," said Greg Piefer, CEO of SHINE. "The ability to target metastatic cancer with very high precision can give hope of survival to patients who previously have had no real options. We’re enthusiastic about bringing our core competencies to this market, and believe we’ll play a major role in ensuring patients worldwide will have access to this very important isotope."

Lu-177 is a low-energy beta-particle emitter that works by directly irradiating cancer cells after being delivered to the cancer site by a targeting molecule. Lu-177 is used to treat neuroendocrine cancers. It also shows promise for the treatment of metastatic prostate and other cancers.

Cytokinetics Reports Third Quarter 2020 Financial Results

On November 4, 2020 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2020 (Press release, Cytokinetics, NOV 4, 2020, View Source [SID1234569931]). Net loss for the third quarter was $3.2 million, or $0.05 per share, compared to net loss for the third quarter of 2019 of $29.6 million, or $0.50 per share. Cash, cash equivalents and investments totaled $451.2 million at September 30, 2020 and does not include $85 million expected upon the closing of RTW Investments’ purchase of Cytokinetics’ royalty rights on the future sales of mavacamten.

"We were pleased to recently announce positive topline results in GALACTIC-HF which demonstrated a reduction in the primary efficacy outcome endpoint with omecamtiv mecarbil." said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "We look forward to the presentation of the primary results at the AHA Scientific Sessions, including pre-specified subgroup analyses which will elaborate on patients that had differential effects with our cardiac myosin activator. During the third quarter, we continued to make progress on our pipeline, highlighted by the advancement of CK-274 in REDWOOD-HCM and our advancing a second cardiac myosin inhibitor into clinical development. With a strong balance sheet, fortified by business development and financing deals completed in July, we are well positioned to continue funding the progression of our muscle-directed drug candidates in clinical trials."

Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Completed conduct of closeout activities for GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil. Topline results from the trial were recently announced showing that treatment with omecamtiv mecarbil achieved the primary composite efficacy endpoint and demonstrated a statistically significant effect to reduce in cardiovascular (CV) death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure), compared to placebo in patients treated with standard of care (HR: 0.92; 95% CI: 0.86, 0.99, p=0.0252). No reduction in the secondary endpoint of CV death was observed. Adverse events, including major ischemic cardiac events, were balanced between treatment arms.

Primary results from GALACTIC-HF will be presented at the American Heart Association (AHA) Scientific Sessions 2020, as part of a virtual Late Breaking Clinical Trial session on Friday, November 13, 2020 from 10:35-10.45 a.m. CDT.

Reviewing prespecified analyses and supplemental analyses of results of GALACTIC-HF in collaboration with Amgen. Discussions ongoing with Amgen on potential next steps.

Continued conduct of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil. We expect enrollment to be completed in 1H 2021. METEORIC-HF is being conducted by Cytokinetics in collaboration with Amgen.
AMG 594 (cardiac troponin activator)

Convened advisory board of consultants to discuss potential indications to inform Phase 2 trial planning. Continued discussions of potential next steps in the development program with Amgen.
CK-3773274 (CK-274, cardiac myosin inhibitor)

Continued conduct of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial designed to determine the safety and tolerability of CK-274 in patients with obstructive hypertrophic cardiomyopathy (HCM). Recently completed enrollment of first cohort of patients in REDWOOD-HCM, summary data from which will inform progression to the second cohort of the trial, expected by the end of 2020.

Presented preclinical data at the American Association of Pharmaceutical Scientists (AAPS) 2020 PharmSci 360 showing that CK-274 demonstrated desirable pharmacokinetics in vivo, supporting the intended pharmacokinetic profile of once-daily oral dosing in humans and steady state plasma concentrations achieved within two weeks of initiation of dosing.
CK-271 (CK-271, second cardiac myosin inhibitor)

Initiated a Phase 1 study of CK-271, our second cardiac myosin inhibitor. We expect to complete the study by the end of 2020.
Skeletal Muscle Program

reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))

Convened meetings with ALS community stakeholders to obtain feedback on endpoints and other matters relating to the design of a potential Phase 3 trial of reldesemtiv in patients with ALS.

Conducted readiness activities in preparation for the start of a potential Phase 3 clinical trial of reldesemtiv in patients with ALS.
Pre-Clinical Development and Ongoing Research

Continued pre-clinical development of CK-3762601 (CK-601), a next-generation FSTA. We expect to continue conduct of IND-enabling studies of CK-601 in 2020.

Published a manuscript on pre-clinical data in the Journal of Cachexia, Sarcopenia and Muscle, showing the fast skeletal muscle troponin activator CK-2066260 (CK-260) increases submaximal force in conditions with muscle weakness in vitro.

Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators.

Continued independent research activities directed to our other muscle biology research programs.
Corporate

Executed a series of transactions with affiliates of RTW Investments, LP, and Ji Xing Pharmaceuticals Limited related to CK-274 whereby Cytokinetics will receive a combination of committed capital, funding and sale proceeds of up to $250 million and is eligible to receive up to $200 million in milestone payments plus royalties on future sales of CK-274 in certain Asian countries

Raised $189 million in net proceeds, after deducting underwriting discounts and commissions, from an underwritten public offering in July of 8,385,417 shares of common stock including the underwriter’s exercise of their overallotment option.

Convened a virtual investor & analyst day to provide updates on the company’s advancing cardiovascular pipeline and strategies to build a commercial franchise.

Participated in the launch of Kainomyx, Inc., a new biopharmaceutical company focused on the discovery and development of small molecule therapeutics for the treatment of parasitic diseases.

Provided $1 million grant and entered four-year partnership with the HCM Registry (HCMR), a global registry of patients with hypertrophic cardiomyopathy focused on improving predictive measures of risk for complications and identifying biomarkers associated with adverse clinical outcomes.

Renewed our partnership with Cure SMA to increase education, awareness, public policy and fundraising for spinal muscular atrophy (SMA).

Announced a call for proposals for the third annual Cytokinetics Communications Fellowship Grant program. The program provides $100,000 in grants to five selected patient advocacy organizations serving the ALS, heart failure, HCM, or SMA communities, and is intended to support increased capacity in communications, awareness building and community engagement.
Financials

Revenues for the three and nine months ended September 30, 2020 were $41.7 million and $49.1 million, respectively, compared to $6.1 million and $21.7 million for the corresponding periods in 2019. The increase in revenues for the three and nine month ended September 30, 2020 was primarily due to $36.5 million of license revenue recognized in the third quarter 2020 for the RTW transactions.

Research and development expenses for the three and nine months ended September 30, 2020 increased to $24.2 million and $67.7 million, respectively, compared to $20.2 million and $67.8 million for the same periods in 2019, respectively, due to increased spending on readiness for reldesemtiv and an increase in spending for our cardiac myosin inhibitor programs.

General and administrative expenses for the three and nine months ended September 30, 2020 increased to $12.3 million and $38.9 million from $9.8 million and $29.0 million in 2019 due primarily to an increase in personnel related costs including stock-based compensation and higher outside spending for commercial readiness.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s third quarter 2020 results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or +1 (706) 679-3078 (international) and typing in the passcode 3979672.

An archived replay of the webcast will be available via Cytokinetics’ website until November 18, 2020. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or +1 (404) 537-3406 (international) and typing in the passcode 3979672 from November 4, 2020 at 7:30 PM Eastern Time until November 18, 2020.

Jubilant Therapeutics to Participate in Upcoming Investor Conferences

On November 4, 2020 Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule modulators to address unmet medical needs in oncology and autoimmune diseases, reported that Company management will participate in three upcoming investor conferences (Press release, Jubilant Therapeutics, NOV 4, 2020, View Source [SID1234569912]).

– The Credit Suisse 29th Annual Healthcare Conference taking place November 9-12. Jubilant Therapeutics will present virtually on Wednesday, November 11 at 8:00 a.m. Eastern Time (ET). Click Here to register and attend.

– The LSX Investival Showcase taking place November 11-16. Jubilant Therapeutics will share a company presentation virtually during this event that would be available on the event portal. Click Here to register and attend.

– The Jefferies 2020 Virtual London Healthcare Conference taking place November 17-19. Jubilant Therapeutics will virtually attend this conference and will be available for meetings. Click Here to register and attend.