On August 6, 2020 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported financial results for the second quarter of 2020 (Press release, Dynavax Technologies, AUG 6, 2020, View Source [SID1234563039]).

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"Vaccines play a crucial role in protecting people, particularly those at high risk, from infectious diseases," commented Ryan Spencer, Chief Executive Officer of Dynavax. "The current global pandemic highlights the need for continued development of new and improved vaccines. Our first product, HEPLISAV-B, provides adults protection from hepatitis B, a highly infectious deadly virus which, thankfully, can be prevented with effective vaccination. With a demonstrated profile that provides adults higher levels of protection from hepatitis B in one month, compared to other hepatitis B vaccines that require six months, we believe that HEPLISAV-B has the potential to become the standard of care for adult hepatitis B vaccination in the U.S."

Mr. Spencer added, "As expected from the pandemic driven disruption to non-COVID medical care, the adult hepatitis B vaccine market experienced a significant decline early in the second quarter. Despite the short-term impact, we continue to be optimistic about HEPLISAV-B’s long-term value, particularly with the global focus on vaccination efforts as a result of the pandemic. Additionally, we see tremendous opportunity for CpG 1018, our advanced vaccine adjuvant. We have entered into numerous collaborations to develop adjuvanted vaccines across multiple indications, including COVID-19, pertussis, and universal flu. Adjuvanted coronavirus vaccines may play a critical role in providing protection to older adults and people with other chronic conditions, who are at greater risk for COVID-19 and have historically been less responsive to vaccinations."

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

Net product revenue for second quarter 2020 of $2.4 million declined from $8.3 million for the second quarter of 2019, due to the COVID-19 pandemic. Overall adult hepatitis B vaccine utilization declined significantly beginning in late March, reached a low in the middle of the second quarter, and improved in the later part of the quarter.
Interim data were reported from the ongoing study of HEPLISAV-B in patients on hemodialysis showing HEPLISAV-B was well tolerated with a seroprotection rate of 86.4% in 44 patients.
CpG 1018 proprietary toll-like receptor 9 (TLR9) agonist adjuvant
·Announced collaborations with Sinovac Biotech, Valneva SE, Medicago, Medigen Vaccine Biologics and Mount Sinai to further advance CpG 1018 in adjuvanted vaccines. A summary of CpG 1018 collaborations is provided below:

Indication Collaborator Status
COVID-19 Clover Biopharmaceuticals Phase 1
Medicago Phase 1
Medigen Vaccine Biologics Preclinical
Sinovac Biotech Preclinical
Valneva SE Preclinical
Pertussis Serum Institute of India Preclinical
Universal Influenza Mount Sinai Preclinical

Additional Corporate Updates

Completed an $80.5 million public offering of common stock
Appointed Ms. Julie Eastland and Mr. Brent MacGregor to Board of Directors
Entered into a purchase agreement with TriSalus Lifesciences for SD-101 and related assets for $9 million in cash payments, up to an additional $250 million in development and commercial milestone payments and low double-digit royalties on potential future sales
2020 Milestones

Final immunogenicity data from the ongoing study of HEPLISAV-B in patients on hemodialysis anticipated in the fourth quarter with publication planned in the first quarter of 2021.
Completion of safety follow-up for HEPLISAV-B post-marketing studies in the fourth quarter.
Completion of Phase 1-enabling animal studies and toxicology for an improved pertussis vaccine with CpG 1018 is planned for the fourth quarter.
Preliminary safety and immunogenicity results from Phase 1 COVID-19 studies with Clover Biopharmaceuticals and Medicago expected by September and October, respectively.
Financial Results

Product Revenue, Net. Product revenue, net decreased to $2.4 million in the second quarter of 2020 compared to $8.3 million in the same period in 2019, due to lower sales volume caused by the COVID-19 global pandemic. For much of the second quarter, medical centers and physician practices restricted activities at their facilities. This led to a significant decline in adult hepatitis B vaccine utilization, which fell as much as approximately 70% in April. For HEPLISAV-B, product sales to distributors were lower than end user demand as distributors elected to reduce inventory levels during the quarter. With states beginning to reopen, medical centers have gradually expanded their services under strict social distancing rules. Adult hepatitis B vaccine utilization began to increase in mid-June, reached approximately 60% of pre-COVID levels in July and is expected to continue growing as the U.S. returns to more normal conditions.

Cost of Sales – Product. Cost of sales – product for the second quarter 2020 decreased to $1.0 million, compared to $2.1 million for the second quarter of 2019, primarily due to lower sales volume and lower overhead following the May 2019 restructuring, partially offset by higher unit costs as we produce and then sell inventory that reflects the full cost of manufacturing.

Research and Development Expenses. Research and development (R&D) expenses for the second quarter of 2020 decreased to $5.9 million, compared to $16.2 million for the second quarter of 2019 as personnel costs, facilities overhead cost allocations and non-cash stock-based compensation decreased due to lower R&D headcount because of our restructuring in May 2019 and outside services costs decreased with the winding down of our immuno-oncology programs.

SG&A Expenses. Selling, general and administrative (SG&A) expenses for the second quarter of 2020 were $19.0 million, compared to $17.9 million for the second quarter of 2019 as compensation and related personnel costs decreased due to lower headcount and business travel decreased due to COVID-19 travel restrictions, offset by increased administrative expense, expenses related to the post-marketing studies and facility costs due to higher overhead allocation to SG&A.

Loss from Operations and Net Loss. Loss from operations for the second quarter of 2020 decreased to $23.3 million from $39.0 million in the second quarter of 2019. Net loss for the second quarter of 2020 was $51.6 million, or $0.53 per basic and diluted share, compared to a net loss of $42.7 million, or $0.66 per basic and diluted share, for the second quarter of 2019. The net loss in the quarter ended June 30, 2020 includes expense of $25.7 million due to an increase in the estimated fair value of outstanding warrants.

Cash Position. Cash, cash equivalents and marketable securities totaled $200.7 million at June 30, 2020.

Conference Call and Webcast Information
Dynavax will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at www.dynavax.com. Alternatively, participants may dial 800-939-4079 or 212-231-2911 and refer to conference ID 21967375. A replay of the webcast will be available for 30 days following the live event.

Please see Important Safety Information below.

For more information about HEPLISAV-B, visit View Source

About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,I and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.II Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician’s discretion.III Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.IV

About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

Indication and Use
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

Important Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

For full Prescribing Information for HEPLISAV-B, click here.

About CpG 1018
CpG 1018 is the adjuvant used in HEPLISAV-B, an adult hepatitis B vaccine approved by the U.S. Food and Drug Administration (FDA). Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. In pre-clinical and clinical studies, results demonstrated that the addition of CpG 1018 increases antibody concentrations, stimulates helper (CD4+) and cytotoxic (CD8+) T cell populations and generates robust T and B cell memory responses. Additionally, CpG 1018 strongly favors development of the Th1 subset of helper T cells, the type of helper T cell that is essential for protection from infections with viruses and intracellular bacteria. CpG 1018 targets a single, well defined receptor (TLR9) expressed on only a few key cell types and the mechanisms of action as an adjuvant are quite well understood. CpG 1018 provides a well- developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine. Upon completion of on-going scale up activities, the existing equipment capacity for CpG 1018 will be 600 million to 1.2 billion adjuvant doses annually, depending on final dose selected.

On August 6, 2020 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the second quarter ended June 30, 2020 (Press release, Celldex Therapeutics, AUG 6, 2020, View Source [SID1234563038]). The Company will host a conference call at 4:30 p.m. ET today to provide an update on its pipeline and upcoming milestones.

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"In the second quarter of 2020, we presented data from our KIT inhibitor, CDX-0159, in a late breaking session at the EAACI Annual Congress that suggested significant potential to dramatically impact mast cell driven disorders," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "These data provided important proof of concept for the CDX-0159 program and helped support a $150 million public offering driven by high quality health care investors to fully fund the Company’s planned operations through 2023. We are on track to initiate two studies in chronic urticaria later this year and are vetting additional mast cell driven indications to support expanded development in 2021."

"We continue to focus our resources on the programs we believe hold the most promise for patients and shareholders and have prioritized the development of CDX-0159, CDX-1140, and the first candidate from our bi-specific program, CDX-527. We are discontinuing development of CDX-3379, which is in an exploratory study with cetuximab to assess the utility of biomarkers in head and neck cancer. The side effect profile of the combination remains challenging even with prophylactic treatment and, when considered with the emerging clinical activity, we believe our resources are best utilized to expand the development of CDX-0159 and our other pipeline programs. To this end, we intend to start the two planned studies of CDX-0159 this fall and to initiate a combination cohort of CDX-1140 with chemotherapy in treatment naïve metastatic pancreatic cancer and a Phase 1 study of CDX-527 in refractory, advanced cancers later this year. These programs will support data read outs later this year and in 2021," concluded Marucci.

Recent Pipeline Highlights

CDX-0159—a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells.

Results from the Phase 1a dose escalation study of CDX-0159 were featured in a late breaking presentation in June at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2020. CDX-0159 demonstrated a favorable safety profile as well as profound and durable reductions of plasma tryptase, indicative of systemic mast cell ablation. Tryptase suppression below the level of detection was observed after a single 1.0 mg/kg dose and was maintained for more than 2 months at single doses of both 3.0 and 9.0 mg/kg of CDX-0159.

— As indicated in the EAACI presentation, a subset of subjects from the 3mg/kg and 9 mg/kg cohorts agreed to continued follow up for tryptase suppression. This follow up and analysis was completed in July and tryptase levels remained below the level of detection for over 3 months (14 weeks) in 50% of subjects in the 3 mg/kg cohort and over 4 months (18 weeks) in all subjects in the 9 mg/kg cohort.
Celldex plans to initiate Phase 1b studies of CDX-0159 in chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), both mast cell driven diseases, this fall. Celldex is exploring cold-induced and symptomatic dermographism (scratch-induced) urticarias. Celldex is also exploring additional mast cell driven diseases for potential future development, including mast cell activation syndromes, asthma, allergic conditions and mast cell driven gastrointestinal disorders.

Data from the Phase 1b studies in CIndU and CSU are anticipated in the first quarter and second half of 2021, respectively.
CDX-1140—a potent CD40 human agonist antibody developed by Celldex that the Company believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile.

In the Phase 1 dose-escalation study of CDX-1140 in patients with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas, both the monotherapy and combination with CDX-301 dose escalation portions of the trial are complete with an identified maximum tolerated dose (MTD) and recommended Phase 2 dose of CDX-1140 at 1.5 mg/kg—one of the highest systemic dose levels in the CD40 agonist class. Expansion cohorts are actively recruiting including:

— CDX-1140 with KEYTRUDA (pembrolizumab) in patients who have progressed on checkpoint therapy; and,
— CDX-1140 with CDX-301 in patients with head and neck squamous cell carcinoma (HNSCC); and,
— A combination of CDX-1140 with standard of care chemotherapy in first line metastatic pancreatic cancer is expected to initiate later this year.

A data update from the ongoing Phase 1 study is planned for presentation in the fall of 2020.
CDX-527—the first candidate developed by Celldex from its bispecific platform which utilizes the Company’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway.

Celldex anticipates initiating a Phase 1 dose-escalation study in up to ~90 patients with advanced or metastatic solid tumors that have progressed during or after standard of care therapy later this year to be followed by tumor-specific expansion cohorts. The study is designed to determine the MTD during a dose-escalation phase and to recommend a dose level for further study in the subsequent expansion phase. The expansion is designed to further evaluate the tolerability, biologic and anti-tumor effects of selected dose level(s) of CDX-527 in specific tumor types.

Initial data from the Phase 1 study are anticipated in the first half of 2021.
Recent Business Highlights

On June 18, 2020, Celldex announced the closing of an underwritten public offering raising total gross proceeds of approximately $150.0 million.
Second Quarter 2020 Financial Highlights and 2020 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2020 were $206.9 million compared to $53.7 million as of March 31, 2020. The increase was primarily driven by net proceeds of $141.4 million from our June 2020 underwritten public offering and net proceeds of $23.7 million from sales of common stock under our Controlled Equity OfferingSM agreement with Cantor completed in the second quarter prior to the offering in June. These increases were offset by second quarter cash used in operating activities of $11.2 million.

Revenues: Total revenue was $0.2 million in the second quarter of 2020 and $3.0 million for the six months ended June 30, 2020, compared to $0.7 million and $2.1 million for the comparable periods in 2019. The increase in revenue for the six months ended June 30, 2020 compared to the six months ended June 30, 2019 was primarily due to the $1.8 million milestone payment from Rockefeller University related to our manufacturing and development services agreement, partially offset by a decrease in services performed under our manufacturing and research and development agreement with Duke University.

R&D Expenses: Research and development (R&D) expenses were $9.7 million in the second quarter of 2020 and $21.4 million for the six months ended June 30, 2020, compared to $10.1 million and $21.2 million for the comparable periods in 2019. The increase in R&D expense for the six months ended June 30, 2020 compared to the six months ended June 30, 2019 was primarily due to an increase in clinical trial and contract manufacturing expenses, partially offset by lower stock-based compensation expense.

G&A Expenses: General and administrative (G&A) expenses were $3.5 million in the second quarter of 2020 and $7.2 million for the six months ended June 30, 2020, compared to $3.9 million and $8.8 million for the comparable periods in 2019. The decrease in G&A expenses was primarily due to lower stock-based compensation expense.

Changes in Fair Value Remeasurement of Contingent Consideration: The gain on fair value remeasurement of contingent consideration was $5.1 million during the second quarter of 2020 and $4.9 million during the six months ended June 30, 2020, primarily due to updated assumptions for CDX-3379 related milestones due to the discontinuation of the CDX-3379 program and the passage of time.

Intangible Asset Impairment: The Company recorded a non-cash impairment charge of $3.5 million during the second quarter of 2020 due to the discontinuation of the CDX-3379 program.

Net Loss: Net loss was $11.0 million, or ($0.50) per share, for the second quarter of 2020, and $23.7 million, or ($1.20) per share, for the six months ended June 30, 2020, compared to a net loss of $11.8 million, or ($0.84) per share, for the second quarter of 2019 and $29.0 million, or ($2.21) per share, for the six months ended June 30, 2019.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at June 30, 2020 are sufficient to meet estimated working capital requirements and fund planned operations through 2023.

Webcast and Conference Call
Celldex executives will host a conference call at 4:30 p.m. ET today to discuss financial and business results and to provide an update on key 2020 objectives. The conference call and presentation will be webcast live over the internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (800) 446-2782 (within the United States) or (847) 413-3235 (outside the United States). The passcode is 49870841.

A replay of the call will be archived on the Company’s website.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA.

On August 6, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported financial results for the second quarter ended June 30, 2020 (Press release, Personalis, AUG 6, 2020, View Source [SID1234563037]).

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Second Quarter Highlights

Reported record revenues of $19.5 million in the second quarter of 2020 versus $15.8 million in the second quarter of 2019, an increase of 23%

A total of 32 customers have placed orders for NeXT as of June 30, 2020, with 6 of those customers placing their first orders in the second quarter of 2020

Announced a collaboration with Sarepta Therapeutics, Inc. (Nasdaq: SRPT), a leader in precision genetic medicine for rare disease

Announced expansion plans into China along with a partnership with Berry Genomics, who will provide services and support to Personalis

Achieved milestone of completing the 75,000th whole human genome sequenced under the contract with the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP)

"I’m proud to say that we were able to report record revenues once again this quarter, with our team delivering strong execution across both our population sequencing and biopharma businesses, despite the impact from the COVID-19 pandemic, and we continued to see strong ordering levels from both our existing and new customers," said John West, Chief Executive Officer. "In addition, our recently announced liquid biopsy product will be available to order immediately."

Second Quarter 2020 Financial Results

Revenues were $19.5 million in the three months ended June 30, 2020, up 23.2% from $15.8 million in the same period of the prior year. In the second quarter, the VA MVP accounted for $14.8 million of our total revenues, and the remaining $4.7 million was from biopharmaceutical and all other customers.

Gross margin was 24.0% for the three months ended June 30, 2020, compared with 37.3% in the same period of the prior year.

Operating expenses were $14.2 million for the three months ended June 30, 2020, compared with $10.0 million in the same period of the prior year.

Net loss was $9.3 million for the three months ended June 30, 2020 and net loss per share was $0.29 based on a weighted-average basic and diluted share count of 31.7 million, compared with a net loss of $5.9 million and a net loss per share of $0.89 based on a weighted-average basic and diluted share count of 6.6 million in the same period of the prior year.

Cash, cash equivalents, and short-term investments were $105.2 million as of June 30, 2020.

Outlook and COVID-19

Due to continued uncertainty surrounding the COVID-19 pandemic, Personalis will not provide an outlook for fiscal 2020 at this time and will plan to give an update during its third quarter earnings announcement and press release, to the extent practicable, based on available information at that time.

Webcast and Conference Call Information

Personalis will host a conference call to discuss the second quarter financial results after market close on Thursday, August 6, 2020 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using conference ID: 4682918. The live webinar can be accessed at View Source

On August 6, 2020 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the second quarter of 2020 (Press release, Cytokinetics, AUG 6, 2020, View Source [SID1234563036]). Net loss for the second quarter was $40.8 million, or $0.68 per share, compared to net loss for the second quarter of 2019 of $32.1 million, or $0.56 per share. Cash, cash equivalents and investments totaled $213.1 million at June 30, 2020.

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After the quarter, Cytokinetics executed a series of transactions which contribute up to $250 million in cash plus committed cash, as well as up to $200 million in potential milestone payments plus royalties. Also, after the quarter, the company raised $189 million through a public offering of common stock. Cytokinetics expects to end 2020 with more than $500 million in cash plus committed cash, subject to closing conditions.

"Despite challenges related to the COVID-19 pandemic, Cytokinetics achieved significant progress against our key objectives during the second quarter," said Robert I. Blum, Cytokinetics’ President and Chief Executive Office. "After suspending enrollment in METEORIC-HF and REDWOOD-HCM earlier in the quarter, we resumed screening and enrollment in both trials during June. In addition, GALACTIC-HF continued toward conclusion on schedule with top-line results expected in the fourth quarter. Moreover, our recent licensing collaboration, royalty monetization deals and follow-on offering position the company operationally and financially to expand development activities and execute our Vision 2025."

Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Received Fast Track designation for omecamtiv mecarbil for the potential treatment of chronic heart failure with reduced ejection fraction (HFrEF).
Continued conduct of and initiated 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. We expect top-line results in Q4 2020. GALACTIC-HF is being conducted by Amgen in collaboration with Cytokinetics.
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. After suspending enrollment in METEORIC-HF due to the COVID-19 pandemic earlier this year, we resumed enrollment in June. We expect enrollment to be completed in early 2021. METEORIC-HF is being conducted by Cytokinetics in collaboration with Amgen.
Collaborated with Amgen and Servier on preparations for a potential Marketing Application dossier for omecamtiv mecarbil and prepared for possible meetings with regulatory authorities as may be requested to discuss Phase 3 trial results and potential Marketing Applications.
Continued to conduct commercial readiness activities in collaboration with Amgen, in preparation for the commercialization of omecamtiv mecarbil, including market research related to product branding elements, potential positioning, physician preferences and potential customer accounts.
Continued joint disease state education with Amgen to educate the heart failure community on the unmet needs of heart failure patients and the role of cardiac contractility related to cardiac performance in HFrEF.
Collaborated with providers and healthcare systems to generate health economics and outcomes research related to the healthcare costs associated with the treatment of heart failure patients.
Conducted analyses related to the United States heart failure institutional care market segment, including potential target account assessment and prioritization for planned commercialization.
AMG 594 (cardiac troponin activator)

The Phase 1 study of AMG 594 is now complete with data analyses ongoing. Amgen and Cytokinetics are discussing potential next steps in the development program.
Conducted market research relating to potential indications to inform Phase 2 trial planning.
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). After suspending enrollment in REDWOOD-HCM due to the COVID-19 pandemic earlier this year, we resumed enrollment in June. We expect data from the first cohort of patients in REDWOOD-HCM, which will inform progression of the trial to the second cohort, to be available by the end of 2020.
CK-271 (CK-271, second cardiac myosin inhibitor)

Prepared for the start of a Phase 1 study of CK-271 which is expected to begin in Q3 2020.
Skeletal Muscle Program

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

Obtained advice from the European Medicines Agency (EMA) through Protocol Assistance related to the design of a potential Phase 3 clinical trial of reldesemtiv in patients with ALS.
Convened meetings with clinical experts, ALS patient advocates and health technology assessment organizations to obtain feedback on endpoints and other matters relating to the design of the trial.
Pre-Clinical Development and Ongoing Research

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

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.
Executed a series of transactions in July with 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.
Amended our agreement with Astellas, whereby Cytokinetics obtained exclusive rights for the development and commercialization of reldesemtiv, CK-601 and other fast skeletal regulatory activator (FSRA) compounds. Astellas agreed to pay for certain costs associated with the conduct of a potential Phase 3 clinical trial of reldesemtiv in ALS in exchange for a low- to mid-single digit royalty on sales of reldesemtiv in ALS. Astellas and Cytokinetics also extended the joint research program through 2020.
Announced the continuation of our partnership with The ALS Association in the fight against ALS.
Supported the Patient Focused Drug Development Meeting hosted by the HCMA to shed light on the burden of disease and challenges faced by patients with HCM.
Financials

Revenues for the three and six months ended June 30, 2020 were $3.6 million and $7.4 million, respectively, compared to $7.1 million and $15.6 million for the corresponding periods in 2019. The decrease in revenues for the three and six month ended June 30, 2020 was due primarily to the completion of FORTITUDE-ALS in 2019.

Research and development expenses for the three and six months ended June 30, 2020 decreased to $21.8 million and $43.5 million, respectively, compared to $24.0 million and $47.6 million for the same periods in 2019, respectively, due to decreased spending primarily related to the completion of FORTITUDE-ALS in 2019 offset by an increase in spending for REDWOOD-HCM.

General and administrative expenses for the three and six months ended June 30, 2020 increased to $14.2 million and $26.6 million from $9.8 million and $19.3 million in 2019 due primarily to an increase in personnel related costs including stock-based compensation and higher outside spending for commercial readiness.

Financial Guidance

The company also updated financial guidance for 2020. The company still anticipates cash revenue will be in the range of $18 to $22 million and operating expenses will be in the range of $120 to $130 million. Guidance for net cash utilization has been narrowed to the range of $110 to $115 million for 2020.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s second 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 5588711.

An archived replay of the webcast will be available via Cytokinetics’ website until August 20, 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 5588711 from August 6, 2020 at 7:30 PM Eastern Time until August 20, 2020.

On August 6, 2020 Notable, which is redefining cancer treatment by taking a functional approach to precision oncology in hematological cancers, reported a new precision oncology study with Washington University School of Medicine in St. Louis, exploring the feasibility of ex vivo drug screening to predict sensitivity and resistance to chemotherapy, and to identify novel synergies across a broad panel of anti-cancer therapies (Press release, Notable Labs, AUG 6, 2020, View Source [SID1234563035]).

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The study will help determine to what extent Notable’s technology platform has the ability to predict clinical responses in patients treated with standard of care therapies in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). In addition, the study explores how a patient’s disease changes in response to specific therapies, and whether Notable can potentially combat resistance to therapy by finding new effective combinations on its platform.

The study will be conducted at Washington University School of Medicine’s Siteman Cancer Center. Notable is performing the ex vivo drug sensitivity tests in its laboratory in Foster City, CA.

"This is a very important validation study for Notable," said Hiroomi Tada MD PhD, Chief Medical Officer at Notable. "It will provide a large dataset that will enable us to compare our ex vivo test results with patient outcomes, which we need to understand how well our assays work, and determine whether we need to improve the assays for certain classes of drugs to make the tests better. In addition, the study will provide us with insight into how AML and MDS changes in response to treatment, identify potential new combination therapies, and identify if patients are failing a therapy much earlier, allowing us to intervene sooner as resistance is emerging."

Medical oncologist John Welch, MD, PhD, Associate Professor in the Division of Oncology at Washington University School of Medicine, said, "It can be difficult to predict patients’ responses to chemotherapy, and we look forward to evaluating whether Notable’s platform has the potential to change the way clinicians approach cancer therapy for individual patients. This trial is intended to help determine the platform’s accuracy and its value as a clinical care tool."

This is expected to be a five-year study, though data from the first cohort could be available within 12-18 months.