On July 14, 2020, Cytokinetics, Incorporated ("Cytokinetics") reported that it entered into a License and Collaboration Agreement (the "License Agreement") with Ji Xing Pharmaceuticals Limited ("Ji Xing"), an entity sponsored by investment funds managed or advised by RTW Investments, LP, pursuant to which Cytokinetics granted to Ji Xing an exclusive license to develop and commercialize Cytokinetics’ proprietary small molecule cardiac myosin inhibitor product referred to as CK-274 (the "Product") in the greater China region, including mainland China, Hong Kong, Macau, and Taiwan (Filing, 8-K, Cytokinetics, JUL 14, 2020, View Source [SID1234561846]).

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Under the terms of the License Agreement, Cytokinetics will receive from Ji Xing an upfront payment of $25 million. Cytokinetics may be eligible to receive from Ji Xing milestone payments totaling up to $200 million for the achievement of certain development and commercial milestone events in connection to the Product in the field of obstructive hypertrophic cardiomyopathy ("oHCM") and/or non-obstructive hypertrophic cardiomyopathy ("nHCM") and other indications. In addition, Ji Xing will pay to Cytokinetics tiered royalties in the low-to-high teens range on the net sales of the Product in the greater China region, subject to certain reductions for generic competition, patent expiration and payments for licenses to third party patents.

Ji Xing will be responsible for the development and commercialization of the Product at its own cost and is required to use diligent efforts to develop and commercialize the Product in the greater China region. The development of the Product will be initially focused on hypertrophic cardiomyopathy, and Ji Xing will have the opportunity to participate in Cytokinetics’ global pivotal clinical trials of the Product. Cytokinetics will supply the Product to Ji Xing either as a finished product or as an active pharmaceutical ingredient.

The License Agreement, unless terminated earlier, will continue on a market-by-market basis until expiration of the relevant royalty term. Ji Xing has the right to terminate the License Agreement for convenience. Each party may terminate the License Agreement for the other party’s uncured material breach, insolvency, or failure to perform due to extended force majeure events. Cytokinetics may also terminate the License Agreement if Ji Xing challenges Cytokinetics’ patents or undergoes certain change of control transactions. Product rights will revert to Cytokinetics upon termination, and, under certain circumstances, subject to a low single digit royalty payment on the net sales of the Product in the greater China region.

The foregoing description of the material terms of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the License Agreement, a copy of which Cytokinetics intends to file, with confidential terms redacted, with the United States Securities and Exchange Commission (the "SEC") as an exhibit to Cytokinetics’ Quarterly Report on Form 10-Q for the quarterly period ending September 30, 2020.

Funding Agreement

On July 14, 2020, Cytokinetics entered into a Funding Agreement (the "Funding Agreement") with Dolya Holdco 19 Designated Activity Company ("RTW"), an affiliate of RTW Investments, LP. Pursuant to the Funding Agreement, RTW has committed to provide up to $90 million ("Funding Commitment") to fund Cytokinetics’ development and commercialization of the Product in nHCM and oHCM. $45 million of the Funding Commitment will be available, at Cytokinetics’ option, if certain clinical trial milestones of the Product for oHCM are achieved by January 14, 2023, and $45 million of the Funding Commitment will be available, at Cytokinetics’ option, if certain clinical trial milestones of the Product for nHCM are achieved by January 14, 2024. If Cytokinetics develops the Product in another indication, RTW and Cytokinetics will negotiate an additional funding commitment from RTW to fund Cytokinetics’ development and commercialization of the Product in such other indication (other than oHCM or nHCM).

In exchange for the Funding Commitment and upon receipt of such funding from RTW, Cytokinetics has agreed to make payments to RTW ("Product Royalty Payment") equal to 2%, if RTW funds $45 million of the Funding Commitment, or 4%, if RTW funds the full $90 million of the Funding Commitment, in each case in respect of net sales of the Product by Cytokinetics and any of its licensees in the United States, the European Union, Switzerland, the United Kingdom and certain other countries in Europe (the "Territory"). The Product Royalty Payment with respect to the Product in a country in the Territory will be terminated upon the later of (i) the last patent expiration of patents related to the Product in such country and (ii) the expiration of regulatory exclusivities for the Product in such country.

The Funding Agreement contains customary representations and warranties of Cytokinetics and RTW, including with respect to organization, authorization and tax matters, and certain covenants with respect to payment, reports, intellectual property, out-licenses, and certain other actions with respect to the Product. After Cytokinetics receives funding from RTW

and until such time that RTW receives Product Royalty Payments above a certain agreed threshold, (i) RTW will be granted a security interest in the intellectual property located in the United States and accounts receivable related to the Product and (ii) Cytokinetics will be subject to a negative pledge in respect of certain assets related to the Product.

The Funding Agreement contains customary conditions to disbursement, which may include the consent of Cytokinetics’ senior secured lenders at the time of disbursement.

The foregoing description of the material terms of the Funding Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Funding Agreement, a copy of which Cytokinetics intends to file, with confidential terms redacted, with the SEC as an exhibit to Cytokinetics’ Quarterly Report on Form 10-Q for the quarterly period ending September 30, 2020.

Royalty Purchase Agreement.

On July 14, 2020, Cytokinetics entered into a Royalty Purchase Agreement (the "Royalty Purchase Agreement") with RTW, pursuant to which Cytokinetics will sell its right to receive certain payments on the net sales of products containing the compound mavacamten, a cardiac myosin inhibitor ("Mavacamten Royalty") under the Research Collaboration Agreement, dated August 24, 2012, between Cytokinetics and MyoKardia, Inc. (as amended, the "Collaboration Agreement") to RTW for an one-time payment of $85 million. Such purchase price will be paid to Cytokinetics at a closing, which is expected to occur on or before October 12, 2020 or such later date as may be agreed by the parties. The closing of the transactions contemplated by the Royalty Purchase Agreement are subject to customary closing conditions, as well as the parties obtaining the consent of MyoKardia to the sale of the Mavacamten Royalty to RTW, as well as obtaining the consent of its senior secured lenders, Oxford Finance LLC and Silicon Valley Bank.

The Royalty Purchase Agreement contains customary representations and warranties of Cytokinetics and RTW, including with respect to organization, authorization and tax matters, and certain covenants with respect to royalty payments, and certain other actions with respect to the Collaboration Agreement.

The foregoing description of the material terms of the Royalty Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Royalty Purchase Agreement, a copy of which Cytokinetics intends to file, with confidential terms redacted, with the SEC as an exhibit to Cytokinetics’ Quarterly Report on Form 10-Q for the quarterly period ending September 30, 2020.

Common Stock Purchase Agreements

On July 14, 2020, Cytokinetics entered into Common Stock Purchase Agreements (each, a "CSPA") with each of RTW Master Fund, Ltd., RTW Innovation Master Fund, Ltd. and RTW Venture Fund Limited (collectively, the "RTW Investors").

The CSPAs provide for the sale and issuance of an aggregate of 2,000,000 shares of common stock of Cytokinetics (the "Shares") at a price per share of $25.00 and an aggregate purchase price of $50 million, and the closing is to occur on July 14, 2020. The RTW Investors have agreed to certain trading and other restrictions with respect to the Shares, including a restriction on sales or other transfers of the Shares, subject to certain exceptions, for a period of two years from the closing date, which period will be extended if Cytokinetics initiates a pivotal clinical trial of CK-274 in oHCM or nHCM prior to the end of such two year period.

The foregoing description of the material terms of the CSPAs does not purport to be complete and is qualified in its entirety by reference to the complete text of the form of CSPA, a copy of which Cytokinetics intends to file, with confidential terms redacted, with the SEC as an exhibit to Cytokinetics’ Quarterly Report on Form 10-Q for the quarterly period ending September 30, 2020.

On July 14, 2020 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to development of next-generation medicines to improve the lives of patients with immune-mediated diseases, reported block sales of an aggregate of 4,580,361 shares of common stock to Perceptive Advisors, LLC and Avidity Partners Management LP, two leading healthcare-focused investment funds, under Aldeyra’s previously announced at-the-market offering program (Press release, Aldeyra Therapeutics, JUL 14, 2020, View Source [SID1234561844]). The shares were sold for a price of $4.25 per share. Aggregate gross proceeds, before deducting commissions, were approximately $19.5 million. The sales completed Aldeyra’s previously disclosed at-the-market offering program and no further sales will be made under this program. Jefferies, LLC served as sales agent under the at-the-market offering program.

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Aldeyra anticipates using the net proceeds from the sales for the continued development of the company’s lead compound reproxalap and other product candidates, as well as for debt maintenance, working capital, and other general corporate purposes. Based on current operating plans, cash, cash equivalents, and marketable securities are sufficient to fund operations through the end of 2022, including potential NDA approvals for reproxalap, a first-in-class topical ocular reactive aldehyde species (RASP) inhibitor, in dry eye disease and allergic conjunctivitis, assuming positive clinical trial results, and planned NDA submissions, acceptances, and approvals. Use of proceeds are also expected to include the continuation of Part 1 of the Phase 3 GUARD Trial for proliferative vitreoretinopathy, a rare retinal disease with no approved therapy, and Phase 2 clinical testing of ADX-629, an orally administered RASP inhibitor, in inflammatory diseases.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the company’s common stock nor shall there be any sale of such common stock in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 14, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that its investigational CD20xCD3 T-cell engaging bispecific mosunetuzumab has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma who have received at least two prior systemic therapies (Press release, Hoffmann-La Roche, JUL 14, 2020, View Source [SID1234561840]).

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"We are pleased that the FDA has granted Breakthrough Therapy Designation to mosunetuzumab, recognising the promising early efficacy data for this molecule and the remaining unmet need in follicular lymphoma," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Indeed, we are excited by the potential of both our CD20xCD3 bispecific antibodies – mosunetuzumab and glofitamab – in development for difficult-to-treat lymphomas, and remain committed to developing innovative therapies to improve outcomes for patients."

This designation was granted based on encouraging efficacy results observed in the phase I/Ib GO29781 study [NCT02500407] investigating mosunetuzumab in R/R non-Hodgkin lymphoma (NHL). The safety profile of this T-cell engaging bispecific was consistent with its mechanism of action. Results from this study were previously presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2019 Annual Meeting.

BTD is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions with preliminary evidence that indicates they may demonstrate a substantial improvement over existing therapies. This is the 34th BTD for Roche’s portfolio of medicines, and the 10th designation for its haematology portfolio.

A robust clinical development programme for mosunetuzumab is ongoing across a number of lymphoma indications and earlier lines of treatment, investigating the molecule alone and in combination to identify where mosunetuzumab may be able to provide benefit over current treatment options. This includes further investigation of mosunetuzumab in combination with Roche’s Polivy (polatuzumab vedotin) and Tecentriq (atezolizumab) as well as with chemotherapy regimens and non-Roche molecules.

About mosunetuzumab
Mosunetuzumab is an investigational CD20xCD3 T-cell engaging bispecific designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. This dual targeting activates and redirects a patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. Mosunetuzumab has a structure similar to that of a natural human antibody in that it has two ‘Fab’ regions, but is different from naturally-occurring antibodies in that one ‘Fab’ region targets CD20 and the other ‘Fab’ region targets CD3. A robust clinical development programme for mosunetuzumab is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with CD20-positive B-cell non-Hodgkin lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, and other blood cancers.

About the GO29781 study
The GO29781 study [NCT02500407] is a phase I/Ib, multicentre, open-label, dose-escalation study evaluating the safety and pharmacokinetics of mosunetuzumab in people with relapsed or refractory B-cell non-Hodgkin lymphoma. Outcome measures include best objective response rate by revised International Working Group criteria, maximum tolerated dose, and tolerability.

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Polivy (polatuzumab vedotin), Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes idasanutlin, a small molecule which inhibits the interaction of MDM2 with p53; T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, targeting both CD20 and CD3; Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1; and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

On July 14, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) and Blueprint Medicines Corporation (NASDAQ:BPMC), reported the signing of a licensing and collaboration agreement providing exclusive rights to Roche for global co-development and commercialisation outside the United States (US), excluding Greater China* (Press release, Hoffmann-La Roche, JUL 14, 2020, View Source [SID1234561839]). In the US, Genentech, a member of the Roche Group, will obtain co-commercialisation rights to pralsetinib, Blueprint Medicine’s investigational, once-daily oral precision therapy for the treatment of people with RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other types of thyroid cancer, as well as other solid tumours. In addition, pralsetinib has demonstrated tumour-agnostic potential. The companies also plan to expand development of pralsetinib in multiple treatment settings and explore development of a next-generation RET inhibitor under the collaboration.

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RET-activating fusions and mutations are key disease drivers in many cancer types, including NSCLC and MTC, and treatment options that selectively target these genetic alterations are limited. With the ongoing need for more targeted therapies that may offer clinical benefit to people with these types of cancers, this collaboration reflects Roche’s strategy of providing treatments tailored specifically to a patient’s individual tumour profile and delivering truly personalised healthcare.

In lung cancer, pralsetinib will complement Roche’s broad portfolio of already approved medicines, alongside Alecensa, Rozlytrek, Tecentriq, Avastin and Tarceva and will further support our focus on understanding driver mutations in lung cancer through personalised treatment approaches. Beyond lung cancer, pralsetinib’s tumour-agnostic potential further expands Roche’s ongoing commitment to finding new approaches to treat cancer in a more personalised way based on the genetic mutation of the disease, irrespective of the tumour site of origin.

* Greater China encompasses Mainland China, Hong Kong, Macau and Taiwan.

"We are very excited to enter into this collaboration with Blueprint Medicines, a partner we have already been working with for four years, with the goal of bringing a potentially transformative treatment option to patients with rare RET-altered cancers as quickly as possible," said James Sabry, Head of Roche Pharma Partnering. "In bringing pralsetinib to patients, we will leverage our global reach and expertise in oncology, as well as our capabilities in diagnostics and the use of real-world data toward our aim of providing personalised treatments for patients."

"With Roche’s global reach and unparalleled expertise in personalised healthcare, this collaboration will accelerate our ability to bring pralsetinib to patients with significant medical needs around the world and expand development of pralsetinib across multiple treatment settings where there is potential to benefit even broader patient populations," said Jeff Albers, Chief Executive Officer of Blueprint Medicines.

Blueprint Medicines has submitted a new drug application (NDA) for pralsetinib to the US Food and Drug Administration (FDA) and a marketing authorisation application to the European Medicines Agency (EMA) for the treatment of RET fusion-positive NSCLC. The FDA granted priority review with an expected decision date of 23 November 2020. Blueprint Medicines has also submitted an NDA to the US FDA for RET mutation-positive MTC and RET fusion-positive thyroid cancer. The FDA has accepted the MTC application for its Real-Time Oncology Review (RTOR) pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

Under the terms of the agreement, Blueprint Medicines will receive an upfront cash payment of $675 million and a $100 million equity investment in Blueprint Medicines’ common stock. In addition, Blueprint Medicines is eligible to receive up to $927 million in contingent development, regulatory and sales-based milestones, and royalties on net product sales outside the US. Roche and Blueprint Medicines will share global development expenses based on pre-specified cost-sharing percentages and equally share profits and losses in the US.

The closing of a minority portion of the equity investment is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and other customary closing conditions.

About RET-Altered Solid Tumours
RET activating fusions and mutations are key disease drivers in many cancer types, including NSCLC and multiple types of thyroid cancer. RET fusions are implicated in approximately 1 to 2 percent of patients with NSCLC and approximately 10 to 20 percent of patients with papillary thyroid cancer, while RET mutations are implicated in approximately 90 percent of patients with advanced MTC. In addition, oncogenic RET alterations are observed at low frequencies in colorectal, breast, pancreatic and other cancers, and RET fusions have been observed in patients with treatment-resistant EGFR-mutant NSCLC.

About Pralsetinib
Pralsetinib is an investigational, once-daily oral precision therapy designed to selectively target RET alterations, including fusions and mutations, regardless of the tissue of origin. Preclinical data have shown that pralsetinib potently inhibits primary RET fusions and mutations that cause cancer in subsets of patients, as well as secondary RET mutations predicted to drive resistance to treatment. Blueprint Medicines is developing pralsetinib for the treatment of patients with RET-altered NSCLC, various types of thyroid cancer and other solid tumours.

About Roche in Oncology
Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anti-cancer chemotherapy drug, fluorouracil, to patients in 1962. Roche’s commitment to developing innovative medicines and diagnostics for cancers remains steadfast.

The Roche Group’s portfolio of innovative cancer medicines includes: Alecensa (alectinib); Avastin (bevacizumab); Cotellic (cobimetinib); Erivedge (vismodegib); Gazyva/Gazyvaro (obinutuzumab); Herceptin (trastuzumab); Kadcyla (trastuzumab emtansine); MabThera/Rituxan (rituximab); Perjeta (pertuzumab); Polivy (polatuzumab vedotin-piiq); Tarceva (erlotinib); Rozlytrek (entrectinib); Tecentriq (atezolizumab); Venclexta/Venclyxto (venetoclax); Xeloda (capecitabine); Zelboraf (vemurafenib). Furthermore, the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies. For more information on Roche’s approach to cancer, visit www.roche.com.

About Roche in Personalised Healthcare
For more than 20 years, Roche has helped lay the scientific groundwork for personalised healthcare with treatments that target the underlying biology of cancer and other diseases. Now, with profound changes in data and technology transforming how medicines are discovered, developed and delivered to patients, we are uniquely positioned to extend this approach across all of healthcare. With our ability to integrate research and development, personalised diagnosis, disease monitoring and treatment access, we are advancing personalised healthcare for every aspect of the patient experience.

Our strategy is rooted in groundbreaking science that can accelerate drug discovery and development. We are also leveraging technologies such as real-world datasets, artificial intelligence, genomic profiling and digital health across our therapeutic portfolio, with an initial emphasis on oncology, neurology, ophthalmology and diagnostics. Through collaborations with academic institutions, industry partners, patients, physicians and regulatory agencies, our goal is to dramatically improve the performance of the entire healthcare ecosystem and the lives of every patient.

On July 13, 2020 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will report second quarter financial results after the Nasdaq market closes on Monday, August 3, 2020 (Press release, Neurocrine Biosciences, JUL 13, 2020, View Source [SID1234563735]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

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Participants can access the live conference call by dialing 877-876-9173 (US) or 785-424-1667 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.