On August 5, 2021 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported financial results for the second quarter of 2021 (Press release, Oncternal Therapeutics, AUG 5, 2021, View Source [SID1234585850]). Oncternal management will host a webcast today at 5:00 p.m. ET to provide a business update and discuss its second quarter of 2021 financial results.

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"We presented very encouraging data from our clinical programs, expanded our ongoing study of cirmtuzumab for patients with MCL, we continue to progress towards initiating a first-in-human trial of our ROR1 targeted CAR-T, and started evaluating an intensified dosing regimen for TK216, an ETS inhibitor which has generated encouraging results in Ewing sarcoma. Furthermore, we strengthened our management team, and we continue to have a strong balance sheet and look forward to multiple potential catalysts in the coming months," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO.

Recent Highlights

Cirmtuzumab (ROR1 antibody):

In June 2021, we presented encouraging interim clinical data for cirmtuzumab in combination with ibrutinib in patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) in a poster session at ASCO (Free ASCO Whitepaper) 2021 (NCT0308887). The data remain consistent and confirm and extend previous results. An objective response rate (ORR) of 83% (15 of 18 evaluable patients) was observed for heavily pre-treated patients with MCL treated with cirmtuzumab plus ibrutinib, which compares favorably to the historical ORR of 66% for ibrutinib monotherapy (Rule, 2017). The complete response (CR) rate of 39% for MCL patients treated with cirmtuzumab plus ibrutinib (7 of 18 evaluable patients) also compares favorably to the historical CR rate of 20% for ibrutinib monotherapy, with CRs remaining durable for 8-30+ months. The median progression-free survival (PFS) and overall survival (OS) were not reached for MCL patients with a median follow-up of 18.9 months. The median PFS and OS were also not reached for CLL patients, with a median follow-up of 22.1 months. The combination of cirmtuzumab and ibrutinib continues to be well tolerated, with a safety profile consistent with or slightly improved compared to historical data for ibrutinib monotherapy. For example, in patients with MCL, Grade 3-4 neutrophil decrease was documented in 11.5% of patients with cirmtuzumab plus ibrutinib, compared to 29% for ibrutinib alone from its registration study.
In July 2021, we opened a new treatment cohort of the ongoing Phase 1/2 study to evaluate cirmtuzumab plus ibrutinib in up to 34 patients with MCL who are refractory to prior BTK inhibitor treatment (ibrutinib, acalabrutinib or zanubrutinib), or who are at high risk for progression, having had an inadequate response to ibrutinib (stable disease or partial response).
The investigator-sponsored study of cirmtuzumab and paclitaxel for metastatic or locally advanced, unresectable breast cancer at UC San Diego (NCT02776917) has completed enrollment and the results are expected to be presented at a scientific conference or publication.
The investigator-sponsored study of cirmtuzumab consolidation for treatment of patients with detectable CLL on venetoclax at UC San Diego (NCT04501939) remains active and enrolling patients.
TK216 (ETS inhibitor):

In June 2021, we presented encouraging interim clinical data for TK216 in patients with relapsed or refractory Ewing sarcoma in an oral session at ASCO (Free ASCO Whitepaper) 2021 (NCT02657005). The data remain consistent and confirm and extend previous results. Two patients who achieved a CR remain with no evidence of disease, one for over 24 months and the other for over 14 months on study. The treatments continued to be well tolerated, with reversible myelosuppression as the most common side effect.
In July 2021, we added a new Phase 2 expansion cohort targeting up to 21 Ewing sarcoma patients to evaluate clinical responses to single agent TK216 using an optimized dosing regimen, treating for 28 days per cycle, to intensify the amount of TK216 administered over time.
Corporate:

In Q2 2021, we appointed Salim Yazji, M.D., as Chief Medical Officer and Pablo Urbaneja as Senior Vice President of Corporate Development.
Expected Upcoming Milestones

Cirmtuzumab (ROR1 antibody) programs
Clinical data update for patients with MCL and CLL treated with cirmtuzumab plus ibrutinib in the ongoing Phase 1/2 study in the fourth quarter of 2021
FDA interaction regarding potential registration trial of cirmtuzumab in patients with MCL
Preclinical data in additional ROR1-expressing tumors in the fourth quarter of 2021
ROR1 CAR-T program
First-in-human dosing in the first half of 2022
TK216 (ETS inhibitor) programs
Clinical data update for patients with Ewing sarcoma treated in the ongoing Phase 1/2 study in the fourth quarter of 2021
Preclinical data in additional ETS-driven tumors in the fourth quarter of 2021
Second Quarter 2021 Financial Results

Our grant revenue was $0.9 million for the second quarter ended June 30, 2021. Our grant revenue is derived from a sub-award under a grant from the California Institute for Regenerative Medicine (CIRM) to UC San Diego, which was awarded to advance our Phase 1/2 clinical trial evaluating cirmtuzumab in combination with ibrutinib for the treatment of patients with MCL or CLL.

Our total operating expenses for the second quarter ended June 30, 2021 were $8.6 million, including $1.8 million in non-cash stock based compensation. Research and development expenses for the quarter totaled $5.2 million, and general and administrative expenses for the quarter totaled $3.4 million. Net loss for the second quarter was $7.7 million, or a loss of $0.16 per share, basic and diluted.

As of June 30, 2021, we had $103.7 million in cash and cash equivalents. We believe these funds will be sufficient to fund our operations into 2023. As of June 30, 2021, we had approximately 49.4 million shares of common stock outstanding.

Management Webcast

As previously announced, Oncternal will host a webcast today, August 5, 2021, at 5:00 p.m. ET (2:00 p.m. PT). The live webcast will be available online and may be accessed from the "Investors" page of the company website at View Source A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.

On August 5, 2021 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the second quarter of 2021. Net loss for the second quarter was $61.6 million, or $0.86 per share, compared to net loss for the second quarter of 2020 of $40.8 million, or $0.68 per share (Press release, Cytokinetics, AUG 5, 2021, View Source [SID1234585849]). Cash, cash equivalents and investments totaled $424.0 million at June 30, 2021. After the quarter, Cytokinetics raised approximately $297.3 million in net proceeds after deducting the applicable underwriting discounts and commissions through a public offering of common stock. Cytokinetics expects to end 2021 with more than $600 million in cash.

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"During the second quarter, we made progress in advancing our late-stage muscle biology-directed pipeline and are now preparing for our first NDA submission while two other programs are expected to proceed in pivotal Phase 3 trials this year," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "Results from REDWOOD-HCM and GALACTIC-HF demonstrate the potential of modulating cardiac myosin to improve outcomes in patients with HCM and heart failure for which there are no medical treatments that address underlying impaired contractility. Following our recent financing, we are also taking steps to build our commercial organization in anticipation of our first potential product launch next year in parallel with our continued clinical progress."

Q2 and Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Engaged with the U.S. Food and Drug Administration (FDA) in both a Type C meeting and a pre-NDA meeting to inform our plans to submit a New Drug Application (NDA) for omecamtiv mecarbil in 2H 2021. The submission will be based on GALACTIC-HF which demonstrated a positive effect on the primary composite endpoint of cardiovascular death or heart failure events in patients with heart failure and reduced ejection fraction who were receiving standard of care plus omecamtiv mecarbil.

Results from a secondary analysis of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) were presented at the American College of Cardiology 70th Annual Scientific Session & Expo (ACC.21) showing that the treatment effect of omecamtiv mecarbil increased progressively as baseline ejection fraction decreased. The results were also published in the Journal of the American College of Cardiology.

Additional results from GALACTIC-HF were presented at Heart Failure 2021, an International Congress of the European Society of Cardiology demonstrating that the patients who derived greater treatment benefit from omecamtiv mecarbil included patients without atrial fibrillation or flutter, patients with higher baseline NT-proBNP and patients with severe heart failure based on modified criteria from the Heart Failure Association of the European Society of Cardiology (ESC-HFA) advanced heart failure position statement.

Completed enrollment in 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 to complete conduct of METEORIC-HF by year end and report results in early 2022.

Expanded Medical Affairs team and activities. Hired medical directors and deployed Medical Science Liaisons in key U.S. locations. Organized framework for the Investigator Sponsored Study Program.

Established Go-to-Market-strategy and conducted commercial readiness activities, including organizational design, market research, forecasting, market access preparations and supply chain and logistics planning.
aficamten (CK-3773274, cardiac myosin inhibitor)

Received approval from the World Health Organization and the United States Adopted Name Council for aficamten to be used as the International Nonproprietary Name for CK-3773274.

Announced positive topline results from Cohorts 1 and 2 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM) demonstrating that treatment with aficamten for 10 weeks resulted in statistically significant reductions from baseline compared to placebo in the average resting left ventricular outflow tract pressure gradient (LVOT-G) (p=0.0003, p=0.0004, Cohort 1 and Cohort 2, respectively) and the average post-Valsalva LVOT-G (p=0.001, p<0.0001, Cohort 1 and Cohort 2, respectively). The majority of patients treated with aficamten (78.6% in Cohort 1 and 92.9% in Cohort 2) achieved the target goal of treatment, defined as resting gradient <30 mmHg and post-Valsalva gradient <50 mmHg at Week 10 compared to placebo (7.7%). Treatment with aficamten in REDWOOD-HCM was generally well tolerated. The incidence of adverse events was similar between treatment arms. No serious adverse events were attributed to aficamten and no treatment interruptions occurred on aficamten, and no new cases of atrial fibrillation in patients treated with aficamten were reported.

Opened enrollment in Cohort 3 of REDWOOD-HCM for patients whose background therapy includes disopyramide. Activated the first site for enrollment in REDWOOD-HCM OLE, the open label extension clinical study designed to assess the long-term safety and tolerability of aficamten in patients with symptomatic obstructive HCM who have participated previously in REDWOOD-HCM.

Engaged FDA in a Type C meeting and subsequent end-of Phase 2 interaction to review the design of the planned Phase 3 clinical trial of aficamten in patients with obstructive HCM as well as the intended dosing strategy. Feedback was supportive of our objectives and progression.

Conducted preparations for a pivotal Phase 3 clinical trial of aficamten in patients with obstructive HCM, expected to begin in Q4 2021.

Ji Xing Pharmaceuticals continued enrolling patients in a Phase 1 study of aficamten in China and is preparing to participate in the planned Phase 3 clinical trial of aficamten in patients with obstructive HCM.

Presented scientific data related to the optimization of aficamten, including the first disclosure of its chemical structure, at the American Chemical Society Spring 2021 Virtual Meeting.
Skeletal Muscle Program

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

Recently started COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), the planned pivotal Phase 3 clinical trial of reldesemtiv in patients with ALS.
Pre-Clinical Development and Ongoing Research

Continued to advance new chemical entities and to conduct IND-enabling studies with expectation of our potentially advancing 1-2 potential drug candidates into clinical development over the next year.

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

Raised approximately $297.3 million in net proceeds, after deducting underwriting discounts and commissions from an underwritten public offering of 11,500,000 shares of common stock including the underwriter’s exercise of their overallotment option.

Executed agreements related to the termination of our Collaboration Agreement with Amgen and the transition to Cytokinetics of the development and commercialization rights for omecamtiv mecarbil and CK-136.

Announced the continuation of our partnership with The ALS Association in the fight against ALS.
Financials

Revenues for the three and six months ended June 30, 2021 were $2.8 million and $9.4 million, respectively, compared to $3.6 million and $7.4 million for the corresponding periods in 2020. The changes in revenues are due to changes in reimbursable collaborative activities with Amgen and Astellas.

Research and development expenses for the three and six months ended June 30, 2021 increased to $36.4 and $68.0 million, respectively, compared to $21.8 million and $43.5 million for the same periods in 2020. The changes were primarily due to increases in spending for COURAGE-ALS and our clinical development activities for our cardiac muscle inhibitor programs. In addition, this quarter, we incurred transition costs related to the termination of our collaboration with Amgen and the purchase from Amgen of approximately $7.3 million of materials including manufactured quantities of the active pharmaceutical ingredient for omecamtiv mecarbil.

General and administrative expenses for the three and six months ended June 30, 2021 increased to $21.2 million and $36.8 million from $14.2 million and $26.6 million in 2020 due primarily to an increase in personnel related costs including stock-based compensation and higher outside spending for commercial readiness.

Financial Guidance and Cash Runway

The company recently updated its financial guidance for 2021. We expect our revenues for 2021 will be in the range of $23 million to $28 million, our operating expenses will be in the range of $230 million to $250 million, and our net cash utilization will be in the range of $195 million to $215 million. This new guidance includes non-recurring new building construction costs of approximately $35 million and assumes receipt of $45 million under our funding agreement with RTW Investments, LP.

The company ended the second quarter with $424 million cash. With the common stock offering in July and our having raised approximately $297 million in net proceeds, we believe that we have more than three years of cash runway based on our revised 2021 cash utilization guidance.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s second quarter 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 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 (706) 679-3078 (international) and typing in the passcode 7387377.

An archived replay of the webcast will be available via Cytokinetics’ website until August 19, 2021. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 7387377 from August 5, 2021 at 7:30 PM Eastern Time until August 19, 2021.

On August 5, 2021 Bayer AG reported the acquisition of Vividion Therapeutics, Inc. (Vividion), a US-headquartered biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics (Press release, Bayer, AUG 5, 2021, View Source [SID1234585848]). Vividion’s platform is able to produce a variety of small molecule therapies across indications, with initial focus on targets relevant to oncology and immunology. Vividion’s lead programs include multiple precision oncology targets and precision immunology targets, with ongoing efforts on a transcription factor NRF2 antagonist for the potential treatment of NRF2 mutant cancers, as well as NRF2 activators for various inflammatory diseases such as irritable bowel disease – among other pre-clinical programs.

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Following closing of the acquisition, Bayer will own full rights to Vividion’s proprietary discovery platform, which comprises three integrated, synergistic components: a novel chemoproteomic screening technology, an integrated data portal, and a proprietary chemistry library. The acquisition of Vividion strengthens Bayer’s small molecule capabilities and expands Bayer’s reach into new modalities. Under the terms of the agreement, Bayer will pay an upfront consideration of USD 1.5 billion and potential success-based milestone payments of up to USD 500 million.

"This acquisition is a cornerstone of our strategy to fuel our pipeline with breakthrough innovation," said Stefan Oelrich, Member of the Board of Management, Bayer AG and President of the Bayer’s Pharmaceuticals Division. "Vividion’s technology is the most advanced in the industry, and it has demonstrated its ability to identify drug candidates that can target challenging proteins. Together with Bayer’s existing know-how, we will be able to develop first-in-class drug candidates, increasing the value of our pipeline. We want to provide innovative therapies for patients whose medical needs are not yet met by today’s treatment options."

Identification of drug candidates for proteins that are considered undruggable is a great challenge in drug discovery. Vividion’s chemoproteomic screening platform is able to identify previously unknown binding pockets on well-validated protein targets by screening chemical probes against the entire human proteome to assess selectivity. This yields highly potent and selective compounds that provide a wide therapeutic window for a variety of areas of high-unmet medical need. Vividion’s technology has already proven its applicability pre-clinically in oncology and immune-related diseases, and has the potential to expand into additional indications.

"Despite advances in genomics, structural biology and high-throughput screening, about 90% of disease-causing proteins cannot be targeted by current therapies due to the lack of a known addressable binding site. Our proprietary chemoproteomic platform technology addresses the key limitations of conventional screening techniques and allows us to discover previously unknown, or cryptic, functional pockets on the surface of proteins and identify small molecules that selectively bind to those targets," said Jeff Hatfield, Chief Executive Officer at Vividion. "When combined with Bayer’s expertise in the development of small molecules to market and patient, an unparalleled position comes into existence to unlock undruggable targets and generate first-in-class novel compounds for the benefit of patients."

To preserve its entrepreneurial culture as an essential pillar for nurturing successful innovation, Vividion will continue to operate as an independent organization on an arm’s length basis. Vividion will remain accountable to advance its technology and portfolio while benefiting from the experience, infrastructure and reach of Bayer as a global pharmaceutical company.

Closing of the transaction is contingent on customary closing conditions, including receipt of the required regulatory approvals, and is expected to take place in Q3 2021.

Credit Suisse is serving as financial advisor to Bayer, while Baker McKenzie is serving as legal counsel. Centerview Partners is serving as financial advisor to Vividion, while Cooley LLP is serving as legal counsel

On August 5, 2021 Kureha Corporation reported that it FY2021 1Q Results (Press release, Kureha Corporation, AUG 5, 2021, View Source [SID1234585847])

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Revenue recovered in Advanced Materials after the pandemic-related slump
• Higher core operating profit supported by Advanced Materials, Specialty Plastics and Other Operations
• Operating profit improved as a result of higher core operating profit
• Profit attributable to the Company increased as a result of higher profit before taxes

Advanced plastics Operating profit improved on higher sales volumes of PVDF, PPS and PGA: continued strong demand for PVDF binder in the automobile LiB market; enhanced production for PPS at a new facility; and PGA frac plugs sales steadily recovering in the post-pandemic shale oil and gas market Carbon products Operating profit remained flat despite higher sales volumes of carbon fiber insulation products for industrial high-heat furnacesAgrochemicals & Pharmaceuticals Sales volume growth of Kremezin, a therapeutic agent for chronic kidney failures, more than offset by a volume decline in agrochemical fungicides, together yielding lower operating profit Industrial chemicals Operating profit improved on higher sales volumes of organic chemicals

Home products / Fiber products Operating profit growth driven by higher ‘NEW Krewrap’ home products and ‘Seaguar’ fishing lines volumes Packaging materials Profit decreased due to higher raw materials cost despite improved revenue from heatshrink multilayer film, etc.

• The shale oil and gas market is gradually recovering as economic activity returns with rising oil prices
• Expanded the adaptation of PGA frac plugs in entire horizontal wells (full-bore use) at major customers by offering flexible volume price discounts since fall 2020
• Continues to promote the full-bore use and expand Kureha’s market share in high-/mid-temperature oilfields via flexible pricing and product design improvements, while developing improved PGA frac plugs for very low-temperature wells
• Aims to generate profit in the PGA business in FY2023 0 25 50 75 LiB binder application Other applications
• Robust PVDF sales continues on strong demand in the automobile LiB market since 3Q FY2020, driven by nations’ environment initiatives and subsidy policies promoting electric vehicles • Price negotiations underway to reflect rising raw materials cost
• Plans to increase the production of PVDF binder for automobile LiB applications at the Iwaki Factory, starting from February 2022
• Announces the decision to build a new PVDF plant (10,000tps) in Changshu, China on July 20, 2021

On August 5, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)- based DNA manufacturing and nucleic acid-based technologies, reported that it will report fiscal 2021 third quarter financial results after market close on Thursday, August 12, 2021 (Press release, Applied DNA Sciences, AUG 5, 2021, View Source [SID1234585846]). The Company’s management will discuss the results during a conference call and simultaneous webcast at 4:30 p.m. EDT that same day. Presentation slides will also be posted to the ‘IR Calendar and Corporate Presentations’ sub-page of the Company’s corporate website and embedded into the live webcast.

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Conference Call and Webcast Information – Live
Date: Thursday, August 12, 2021, at 4:30 p.m. Eastern Daylight Time
Dial in: 844-887-9402, 412-317-6798 (international)
Hosts: Dr. James A. Hayward, chairman, president, and CEO, Beth Jantzen, chief financial officer
Webcast: View Source

Conference Call and Webcast Information – Replay
A telephonic replay of the conference call will be available for one week beginning one hour after the end of the live conference call.

Dial in: 877-344-7529, 412-317-0088 (international), Access Code: 10158254
Webcast: View Source
Availability: Telephonic replay: until Thursday, August 19, 2021; webcast replay: 1 year

The webcast and accompanying PowerPoint presentation will also be archived on the ‘IR Calendar and Corporate Presentations’ page listed under the Investor Relations drop-down menu on the Company’s website.