On June 8, 2020 Cytokinetics, Incorporated (Nasdaq:CYTK) reported that Robert I. Blum, President and Chief Executive Officer, is scheduled to participate in a virtual fireside chat at the Goldman Sachs 41st Annual Global Healthcare Conference on Wednesday, June 10 at 4:40 PM EDT, and to participate in the Raymond James Human Health Innovation Conference on June 18, 2020 (Press release, Cytokinetics, JUN 8, 2020, View Source [SID1234560935]).

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Interested parties may access the live webcast of the presentation at the Goldman Sachs 41st Annual Global Healthcare Conference by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay of the presentation will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event.

On June 8, 2020 Oncology Venture A/S (Nasdaq First North Stockholm: OV.ST) ("OV" or the "Company") reported that it has acquired the remaining 37% ownership in its priority Dovitinib program from investor Sass & Larsen ApS (Press release, Oncology Venture, JUN 8, 2020, View Source(8%20June%202020,from%20investor%20Sass%20%26%20Larsen%20ApS. [SID1234560934]). As a result of the transaction, the Company now has full control of its most advanced pipeline program.

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The price of the remaining 37 % of OV-SPV2 ApS is agreed to SEK 36 million and a potential royalty payment of 10 % for the first 24 months following the signature of the agreement. The royalty payment, if any, will be of net sales revenues. The payment of the SEK 36 million is made by conversion of the payment into Oncology Venture A/S shares. The conversion price is SEK 1.388 per nominal DKK 0.05 share corresponding to today’s closing price of OV’s share. In total Sass & Larsen will receive 25,936,599 OV shares.

The new shares hold no special rights and will rank pari passus with all other shares in OV. Following the conversion, the Company’s share capital will be nominal DKK 7,974,053.90 divided into 25,936,599 shares of nominal DKK 0.05 each.

In March 2020, the Company announced details of its pre-NDA meeting with the U.S. Food and Drug Administration (FDA) to discuss a potential path to approval for Dovitinib used to treat Renal Cell Carcinoma (RCC) (kidney cancer), the current lead indication for the drug. The Company’s proposal is to seek approval based on "non-inferiority" against the already approved compound Sorafenib (Bayer), based on prior Phase 3 trial results (by Novartis). At that time, the Company also announced its plan to file a New Drug Application (NDA) for the approval of Dovitinib for the treatment of RCC late in the second half of 2020.

Dovitinib, a pan-tyrosine kinase inhibitor (TKI) originally developed by Novartis, addresses a significant unmet need for improved therapies for the treatment of Renal Cell Carcinoma. Annual sales of Sorafenib, under the trade name Nexavar, were approximately USD $715 million in 2018. The global RCC market is projected to grow to USD $6.3 billion by 2022. In addition to the RCC market, Dovitinib has promising potential as a monotherapy in a number of other indications, including metastatic breast cancer, hepatocellular cancer, endometrial cancer and gastrointestinal stromal tumors, as well as in combination therapy with other approved drugs, including immune checkpoint inhibitors.

Steve Carchedi, CEO of Oncology Venture, stated "We are excited to gain full ownership of our priority Dovitinib program, as we advance towards U.S. submission of our first NDA and towards approval, marketing and sale of this key asset. Our acquisition of the remaining investor interest in this program now provides our Company and our shareholders with the full potential upside of this promising drug, as we bring it towards the market and to cancer patients."

On June 8, 2020 Helsinn, a Swiss pharmaceutical group focused on building quality cancer care and rare diseases products, reported that on April 1, 2020 the U.S. Food and Drug Administration (FDA) completed the review of the Investigational New Drug (IND) application for TAS0953/HM06 and released a "Study May Proceed" letter for the Phase 1/2 Study of TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities (Press release, Helsinn, JUN 8, 2020, View Source [SID1234560919]).

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The study is intended to be conducted globally and is due to commence in the third quarter of 2020.

TAS0953/HM06 is being developed together with its partner Taiho Pharmaceutical Co., Ltd. In 2017, Helsinn and Taiho signed a global co-development and commercialization agreement for TAS0953/HM06.

TAS0953/HM06 is an investigational oral treatment which inhibits several RET abnormalities identified as oncogenic driver alterations in NSCLC, papillary and medullary thyroid cancers, and several other tumor types. This innovative drug candidate offers several differentiating features as compared to other RET inhibitors.

Sergio Cantoreggi, Group Chief Scientific Officer and Head of R&D at Helsinn, commented: "Helsinn and Taiho have been working closely together as part of a global development partnership and we’re delighted to have reached this latest milestone that will allow us to start treating patients with TAS0953/HM06 in a Phase 1/2 clinical trial starting in the next quarter. We are excited by the potential of TAS0953/HM06 to treat NSCLC and other tumors which harbor RET abnormalities and look forward to working with Taiho to progress the treatment through the clinic."

TAS0953/HM06 is an investigational agent and is not approved for commercial use in any country.

About TAS0953/HM06

TAS0953/HM06 is an oral RET inhibitor in development for advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) and other tumors which express RET gene abnormalities. Preclinical data showed several differentiating features in comparison to other targeted therapies acting on RET abnormalities.

Taiho and Helsinn signed a co-development and commercialization agreement for TAS0953/HM06 in 2017 and will continue to pursue together all preclinical, clinical and CMC developments. This alliance also includes efforts to reach as many patients as possible around the world through their own commercial infrastructures or through valued partners.

About RET abnormalities in NSCLC and other cancers1

RET kinase abnormalities have been identified as targetable oncogenic drivers in NSCLC, papillary and medullary thyroid cancers, and several other tumor types. In NSCLC, RET fusions are more common in younger patients with no prior history of smoking and in those with adenocarcinomas, however the underlying mechanisms remain unknown.

1Helsinn and Taiho research and analysis of ASCO (Free ASCO Whitepaper) 2018; ASCO (Free ASCO Whitepaper) 2019; Cancer Biol Ther 2015; Cell Rep 2017; JCO 2018; Johns Hopkins 2019; Nat Med 2012; Nat Rev Clin Oncol 2018; OMIM; Onco Targets Ther 2019

On June 8, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a novel bioelectric medicine company, reported preliminary results of its rights offering, which expired at 5:00 p.m. Eastern Time on June 8, 2020 (the "Expiration Date") (Press release, Pulse Biosciences, JUN 8, 2020, View Source [SID1234560918]).

In accordance with the pricing structure described in the prospectus relating to the rights offering, the final subscription price for the units offered (the "Units") is $7.01 per Unit, which is the initial price established at commencement of the rights offering. Each Unit consisted of one share of the Company’s common stock, par value $0.001 per share, and 0.15 warrants to purchase shares of common stock. Each warrant will be exercisable for one share of the Company’s common stock at an exercise price that shall be equal to $7.01, the subscription price for the Units. Warrants are exercisable immediately and expire on the fifth anniversary of the completion of this rights offering.

Based on a preliminary tabulation by Broadridge Corporate Issuer Solutions, Inc. (the "Subscription Agent"), as of the Expiration Date, the Company received basic subscriptions and over-subscriptions exceeding the maximum number of up to 4,279,600 Units offered in the rights offering. Available Units will be allocated proportionately among rights holders who exercised their over-subscription right based on the number of Units each rights holder subscribed for under their basic subscription rights, in accordance with the procedures described in the prospectus relating to the rights offering. The common stock and warrants comprising the Units will separate upon the closing of the rights offering and will be issued individually. The Company expects the Subscription Agent to distribute such shares and warrants, as well as the sale proceeds, on or about June 11, 2020.

The Company will receive aggregate gross proceeds from the rights offering of $30 million, excluding proceeds of up to $4.5 million from the exercise of warrants issued in the rights offering (if any such exercises occur). The results of the rights offering are preliminary and subject to change pending finalization of subscription procedures by the Subscription Agent.

A registration statement, as amended, relating to the Units was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on May 8, 2020. A prospectus relating to the offering was filed with the SEC on May 14, 2020 and is available on the SEC’s website. Subscription rights that were not exercised by 5:00 p.m. Eastern Time on June 8, 2020 have expired.

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On June 8, 2020 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics, reported that it has selected development candidate, IDE397, for its Methionine adenosyltransferase 2a (MAT2A) Synthetic Lethality program (Press release, Ideaya Biosciences, JUN 8, 2020, View Source [SID1234560913]). The MAT2A program targets patients with tumors having methylthioadenosine phosphorylase (MTAP) deletions. With the nomination of IDE397 as a development candidate for the MAT2A program, IDEAYA has initiated IND-enabling studies and is targeting filing the Investigational New Drug (IND) application in the fourth quarter 2020.

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"With IDE397, we have achieved our preclinical target product profile of a differentiated compound, including potency, safety assessment, and physicochemical property characteristics. Based on the preclinical in vivo efficacy data we have generated, we believe IDE397 has the potential for evaluation in both monotherapy and combination studies in select solid tumor types with the genetic alteration of MTAP-deletion," said Michael Dillon, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.

IDE397 Product Profile and MAT2A Program Summary:

Monotherapy activity with robust tumor growth inhibition and pharmacodynamic (PD) modulation in multiple endogenous MTAP-/- in vivo models
Monotherapy activity and tumor regression in HCT116 MTAP-/- xenograft model
No changes in liver enzymes or increased unconjugated bilirubin levels observed in preclinical studies
Favorable physicochemical properties and pharmacokinetics observed across multiple species
MAT2A program enabled by structure-based drug design; over 17 high resolution co-crystal structures have been resolved to enable lead optimization
About MAT2A and MTAP-Deletion:
MTAP-null cells lack the ability to metabolize 5-methylthioadenosine, or MTA, which is an essential step in a biochemical pathway involved in salvaging metabolite S-adenosyl methionine, or SAM. Increased levels of MTA partially inhibit the methyltransferase PRMT5 for which SAM is the substrate. This partial inhibition renders MTAP-null cells more dependent on the activity of methionine adenosyltransferase II alpha or MAT2A, an enzyme that is responsible for the synthesis of SAM. Because of this dependence, loss of MTAP results in synthetic lethality when MAT2A is pharmacologically inhibited.

MTAP deletions are prevalent in approximately 15% of all human tumors across various tumor types. Genetic profiling tests for the deletion of MTAP or for the commonly co-deleted gene CDKN2A are commercially available.