On December 20, 2021 Cytokinetics, Incorporated (Nasdaq: CYTK) and Ji Xing Pharmaceuticals Limited (JI XING), a biopharmaceutical company based in Shanghai and backed by RTW Investments, LP (RTW), reported an expansion of their collaboration by entering into an exclusive license and collaboration agreement to develop and commercialize omecamtiv mecarbil for the proposed treatment of heart failure with reduced ejection fraction (HFrEF) in Greater China (Press release, Cytokinetics, DEC 20, 2021, View Source [SID1234597480]). In addition to the license and collaboration agreement with JI XING, Cytokinetics has also entered into Common Stock Purchase Agreements that provide for the sale and issuance to entities affiliated with RTW of 511,182 of shares of Cytokinetics common stock at a price per share of $39.125.

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Pursuant to these transactions, Cytokinetics will receive committed capital of $70 million, comprised of $50 million from JI XING of upfront and near-term payments under the collaboration agreement and $20 million from RTW as proceeds for the sale of common stock. In addition, Cytokinetics will be eligible to receive up to $330 million from JI XING in additional milestone payments plus tiered royalties on the net sales of omecamtiv mecarbil in Greater China, subject to certain reductions.

"We are pleased to expand our current relationship with JI XING to now include omecamtiv mecarbil, and believe that their expertise in drug development and commercialization in China can help bring omecamtiv mecarbil to substantially more patients in an important cardiovascular market," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "JI XING shares our strategic vision of building a business franchise by leveraging investments in science, people and infrastructure as can benefit the potential commercialization of both omecamtiv mecarbil as well as aficamten which was the subject of our initial collaboration. Together, we believe more patients in China may benefit from both drug candidates."

"We have been impressed by our productive partnership to date focused on aficamten and are pleased to expand our collaboration to now include omecamtiv mecarbil," said Joseph Romanelli, CEO of JI XING. "Despite the advancement of heart failure treatments in China, patients continue to need novel therapies to reduce the risk of disease. With the addition of omecamtiv mecarbil to our growing cardiovascular pipeline, we have the opportunity to potentially bring a much needed, novel heart failure medicine to patients in Greater China."

"The expansion of this collaboration further brings together the expertise from both companies to support the global commercialization of omecamtiv mecarbil and represents a tremendous opportunity to create a larger footprint to impact more people with heart failure," said Roderick Wong, M.D., Chairman of JI XING and Managing Partner, RTW Investments, LP. "The two companies have demonstrated how well they work together, and we are pleased to lend further support in the interests of better cardiovascular health."

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will host a conference call and webcast today, December 20, at 8:30 AM 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 (706) 679-3078 (international) and typing in the passcode 8997061.

An archived replay of the webcast will be available via Cytokinetics’ website until January 3, 2022. 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 8997061 from December 20, 2021 at 11:30 AM Eastern Time until January 3, 2022.

About Omecamtiv Mecarbil

Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator, the first of a novel class of myotropes1 designed to directly target the contractile mechanisms of the heart, binding to and recruiting more cardiac myosin heads to interact with actin during systole. Omecamtiv mecarbil is designed to increase the number of active actin-myosin cross bridges during each cardiac cycle and consequently augment the impaired contractility that is associated with heart failure with reduced ejection fraction (HFrEF). Preclinical research has shown that omecamtiv mecarbil increases cardiac contractility without increasing intracellular myocyte calcium concentrations or myocardial oxygen consumption.2-4

The development program for omecamtiv mecarbil is assessing its potential for the treatment of HFrEF and includes GALACTIC-HF and METEORIC-HF, a Phase 3 clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity.

About Heart Failure

Heart failure is a grievous condition that affects more than 64 million people worldwide5 (and well over 10 million in China6) about half of whom have reduced left ventricular function.7,8 It is the leading cause of hospitalization and readmission in people age 65 and older.9, 10 Despite broad use of standard treatments and advances in care, the prognosis for patients with heart failure is poor.11 An estimated one in five people over the age of 40 are at risk of developing heart failure, and approximately 50 percent of people diagnosed with heart failure die within five years of initial hospitalization.12,13 More than 2 million people in the U.S. are estimated to have an ejection fraction <30%, indicating they may have severe heart failure.14

On December 20, 2021 Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported that patient dosing was initiated in the anti-PD-1 refractory cutaneous squamous cell carcinoma (CSCC) arm of a Phase 2 multi-indication study evaluating the efficacy and safety of vidutolimod in combination with cemiplimab for the treatment of patients with anti-PD-1 refractory CSCC (Press release, Checkmate Pharmaceuticals, DEC 20, 2021, View Source [SID1234597478]). Vidutolimod is an advanced generation Toll-like receptor 9 (TLR9) agonist, delivered as a biologic virus-like particle utilizing a CpG-A oligodeoxynucleotide as a key component.

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"Initiation of dosing in this trial marks a significant step forward in our pursuit of a potential new treatment option for patients affected by CSCC, a life-threatening non-melanoma skin cancer," said Alan Fuhrman, interim President and Chief Executive Officer of Checkmate. "This multi-indication trial is an important element of our plan to expand on the indications that can be potentially treated using vidutolimod."

On December 20, 2021 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported the closing of its previously announced underwritten public offering of 3,802,144 shares of its common stock, which includes the exercise in full of the underwriters’ option to purchase 645,000 additional shares, and to certain investors, pre-funded warrants to purchase 1,142,856 shares of its common stock at an exercise price of $0.0001 (Press release, Syndax, DEC 20, 2021, View Source [SID1234597475]). The public offering price of each share of common stock was $17.50 and the public offering price of each pre-funded warrant was $17.4999 per underlying share, which represents the per share public offering price for the common stock less the $0.0001 per share exercise price for each such pre-funded warrant. The gross proceeds to Syndax from this offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $86.5 million.

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Goldman Sachs & Co. LLC and Cowen acted as joint book-running managers for the offering. BTIG acted as lead manager for the offering. B. Riley Securities acted as co-manager for the offering.

The shares were offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the website of the SEC at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Goldman Sachs and Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by email at [email protected], or by phone at (833) 297-2926.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities 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. Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus, which are a part of the effective registration statement.

On December 20, 2021 Race Oncology Limited ("Race") reported that its Share Purchase Plan (SPP) has closed heavily oversubscribed with $43.9m received in applications from 2,340 shareholders (Press release, Race Oncology, DEC 20, 2021, View Source [SID1234597473]). In line with the terms of the SPP, $29.7m will be accepted, with funds to be applied to Race’s "full case" funding scenario, as set out in Race’s 2021 Annual General Meeting (ASX announcement: 23 November 2021).

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"The Race team has been humbled by the extraordinary show of shareholder support for our Share Purchase Plan and we sincerely thank all those who participated. The number of applications reflects enthusiasm for the significant potential of our lead drug Zantrene, and this enables us to implement our planned clinical and drug development plans across the three-pillar program. We move into 2022 in an exceptional position, with many critical, reportable milestones ahead of us."

Race’s Managing Director and CEO, Mr Phil Lynch
"I would like to personally thank all our shareholders for their generous support of our plans for Zantrene. It is extremely humbling to have so many of our shareholders willing to join and support us on the exciting journey to bring Zantrene back to patients in need."

Race’s Chief Scientific Officer and Executive Director, Dr Daniel Tillett
Use of funds
Funds raised under the SPP will be used as follows: Phase 1b/2 FTO solid tumour clinical trial ($8.0 million); cardio-protection Phase 2b clinical trial in breast cancer patients ($7.5 million); Phase 2 EMD AML/MDS clinical trial in Europe ($9.2 million); improved formulations of Zantrene ($3.2 million); preclinical cardio-protection studies ($1.0 million); and the development of new molecules ($0.8 million).

About the SPP
Race offered a non-underwritten SPP to eligible existing shareholders (in Australia and New Zealand) at the $3.00 issue price. The SPP closed on Friday 17 December 2021 with subscriptions received for $43,953,272.63.

After scale-back, the amount raised under the SPP was $29,700,000, comprising the issue of 9.9 million new ordinary fully paid shares at $3.00 per share, representing approximately 6.6% of the Company’s issued capital as at 21 December 2021.

New shares issued under the SPP will be allocated today and holding statements despatched, with trading expected to begin on the Australian Securities Exchange on the 22 December 2021.

Allocation policy
When determining the amount by which to scale back an Application, Race has taken into account a number of factors, including the size of an applicant’s shareholding, the extent to which Eligible Shareholders have sold or bought additional Shares after the Record Date and the date an application was made. Scale back for Shares held by Custodians was applied at the level of the underlying beneficiary.

Where shareholders were scaled back, they will receive the number of Shares determined by the Company in its absolute discretion, rounded up to the nearest whole Share. If Race rejects or scales-back an application or purported application, the Company will promptly return to the Eligible Shareholder any relevant application monies, without interest.

Eligible Directors, Mr Phillip Lynch, Ms Mary Harney and Dr Daniel Tillett all applied for their full entitlements. Dr John Cullity was ineligible due to being resident in the USA.

On December 20, 2021 Filtricine reported that the preclinical research results of its proprietary medical food technology, Targeted Nutrients Deprivation (TND), have been published in Nutrition and Cancer.
"Broad Anti-Cancer Activity Produced by Targeted Nutrients Deprivation (TND) of Multiple Non-Essential Amino Acids" (Press release, Filtricine, DEC 20, 2021, View Source [SID1234597472])

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Filtricine’s core medical food technology is the deprivation of non-essential amino acids (NEAAs) to manage cancer. Cancer cells, but not normal cells, require those NEAAs due to their heightened and rewired metabolism. Mice fed TND medical food diet with implanted human-derived tumors showed marked reduction in tumor growth. In combination with chemotherapy and immunotherapy, TND diet enhanced the efficacy of tumor suppression. TND diet was entirely safe in mice.

Filtricine is developing a human version of the TND diet, Tality, as a medical food to manage cancer. Filtricine is sponsoring a clinical study at Stanford University School of Medicine for the use of Tality in the management of prostate cancer. Tality is available to prostate cancer patients through this trial. If you are interested in joining the trial, please contact the trial coordinator. Deirdre Crommie at 650-387-7797 or [email protected]

Tality is also available to all cancer patients for free through a volunteer study. Please contact [email protected] if you would like to know more.