On April 16, 2020 MedX Health Corp. ("MedX" or the "Company") (TSX-V: MDX) reported that, subject to acceptance by the TSX-V the ultimate Closing Date for the non-brokered Private Placement of up to $2.5 million, which was previously announced on March 6, 2020, will be extended by up to 30 days (Press release, MedX Health, APR 16, 2020, View Source [SID1234556386]). The Company has already received Conditional Acceptance for the placement from the TSX-V, but closings have been delayed primarily as a result of Government-imposed restrictions in response to the COVID-19 Pandemic. The proposed placement, to accredited investors, is for the placement of up to 20,833,333 units at $0.12 per unit ("Unit"). Each Unit will be comprised of One (1) fully paid common share and One (1) Share Purchase Warrant, exercisable to purchase One (1) further Common Share at the price of $0.20, exercisable for a period of two years from the date of issue. Closing of the Placement, which will take place in tranches, will be subject to receipt of subscriptions and a number of other conditions, including without limitation the receipt of all relevant regulatory and Stock Exchange approvals or acceptances. Qualified Agents may receive commissions in respect of subscriptions introduced by them by way of cash equal to 8% of funds so introduced, and issuance of agent’s warrants ("Agent’s Warrant(s)") equal in number to 8% of the number of units so subscribed for. Each Agent’s Warrant, which is non-transferable, will be exercisable to acquire one Unit at $0.12 per Unit, at any time during the period of two years following the Closing.

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On April 16, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported the publication of preclinical data and patient case studies from the Phase 1 portion of its TRIDENT-1 clinical study for its lead investigational drug, repotrectinib (Press release, Turning Point Therapeutics, APR 16, 2020, View Source [SID1234564376]).

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Among the findings published in the American Association of Cancer Research peer-reviewed journal, Clinical Cancer Research, repotrectinib demonstrated potent in vitro and in vivo activity in patient-derived preclinical models compared with proxy chemical compounds for other tyrosine kinase inhibitors (TKIs) against ROS1 and the ROS1 G2032R solvent-front mutation. The central nervous system (CNS) activity of repotrectinib was studied in an in vivo model and demonstrated significant reduction of metastatic brain lesions with longer survival compared to a proxy chemical compound for entrectinib.

"Our findings provide encouraging support for repotrectinib as a potential first-line treatment in ROS1-positive non-small cell lung cancer, and later-line use after progression from a prior ROS1 TKI," said Dr. Byoung Chul Cho, Division of Medical Oncology, Yonsei Cancer Center at Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea and corresponding author of the paper. "In addition, these preclinical data as presented initially at the annual AACR (Free AACR Whitepaper) conference in 2019 and now expanded upon in the publication suggest repotrectinib may prevent or delay the emergence of the G2032R solvent-front mutation and subsequent compound mutations, potentially improving clinical outcomes."

In preclinical studies, repotrectinib potently inhibited in vitro and in vivo tumor growth and ROS1-downstream signaling in treatment-naïve models compared with proxy chemical compounds for crizotinib, ceritinib, and entrectinib. Compared to a lorlatinib proxy chemical compound in a xenograft model, repotrectinib markedly delayed the onset of tumor recurrence following drug withdrawal. In addition, repotrectinib induced anti-tumor activity in the CNS. Repotrectinib also showed selective and potent in vitro and in vivo activity against the ROS1 G2032R solvent-front mutation.

Patient case studies (from the previously reported July 22, 2019 data cut-off) included in the manuscript highlighted the potential for repotrectinib to prevent or delay ROS1 kinase domain resistance mutations.

"The emergence of resistance mutations and disease progression in the CNS are characteristics of ROS1-positive non-small cell lung cancer and represent a high unmet medical need given the lack of approved therapies," said Dr. Mohammad Hirmand, chief medical officer of Turning Point Therapeutics. "These findings highlighted in Clinical Cancer Research build on prior preclinical studies of repotrectinib and data we have shown from the Phase 1 portion of TRIDENT-1, and are encouraging for repotrectinib as a potential treatment for both TKI-naïve and -pretreated ROS1-positive non-small cell lung cancer patients."

Approximately 50 to 60 percent of crizotinib-resistant mutations are found within the ROS1 kinase, of which the ROS1 G2032R solvent-front mutation is the most common. In addition, it is estimated that approximately 50 percent of patients treated with ROS1-TKIs experience disease progression due to CNS metastases.

The Clinical Cancer Research article may be found online at View Source

More information about the ongoing TRIDENT-1 study of repotrectinib may be found by searching clinical trial identifier NCT03093116 at View Source

On April 16, 2020 Synthon Biopharmaceuticals B.V., a biopharmaceutical research and development company creating innovative precision medicines for patients with relentless cancers and autoimmune diseases, reported that it is relaunching as relaunch as Byondis (Press release, Synthon, APR 16, 2020, View Source [SID1234556387]).

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Byondis is creating safe and effective precision medicines based on its proprietary technologies, targeting intractable cancers and auto-immune diseases, which aim to improve the standard of care for patients.

The Company has a broad development pipeline, including advanced clinical programs, such as anti-HER2 ADC [vic-]trastuzumab duocarmazine (SYD985) for breast cancer. In the second half of 2020, Byondis is expecting results from its pivotal TULIP Phase III trial comparing SYD985 to physician’s choice treatment in patients with HER2-positive unresectable locally advanced or metastatic breast cancer. Submission of a Biological License Application is scheduled before the end of 2020.

The Company anticipates entering the clinic with four additional programs in the course of 2020/2021. After progressing to clinical proof of concept, Byondis intends to enter into partnerships for late-stage development and commercialization.

Synthon Biopharmaceuticals was established in 2007 as part of Synthon B.V., and became a separate biopharmaceutical subsidiary in 2012, quickly building a promising pipeline of innovative R&D programs. In November last year, following the acquisition of Synthon International Holding B.V. by BC Partners, the founder, Dr Jacques Lemmens, decided to continue as an independent biopharmaceutical company, with its own management team and state-of-the-art facilities. This company relaunches today as Byondis.

"Our relaunch as Byondis is an exciting moment for the Company," said Dr Jacques Lemmens, Founder. "Building on our heritage, while preserving our company culture, we are further progressing in innovation, quality and scientific excellence."

"Now is the time to step up as an independent biopharmaceutical company, with our exceptional people, unique technologies and a well-established development pipeline, including our lead ADC, [vic-]trastuzumab duocarmazine. I am very proud of how the Company has grown and evolved. The new name, Byondis, represents the next chapter and embodies our entrepreneurial spirit and ambition to create innovative precision medicines to outsmart cancers and auto-immune diseases."

The Byondis management team has a wealth of scientific, clinical and operational experience, and is well networked within the pharmaceutical industry. Dr Marco Timmers, CEO, and others in the senior team have collaborated for many years as part of Synthon. During this time, they have created a company driven by science and innovation, with unique technologies and significant validation deals. These include the out-licensing of a biosimilar version of the monoclonal antibody trastuzumab (marketed as KANJINTI) in a global partnership agreement with Amgen in 2012.

"As Byondis, we can now showcase our strong business and scientific proposition," added Dr Marco Timmers, CEO. "We have generated a portfolio of preclinical and clinical programs with the potential to deliver completely novel treatments for cancer and auto-immune diseases. We have unique technologies with differentiating potential, state-of-the-art facilities including our own GMP manufacturing, and broad licensing expertise that makes us an attractive partner for out-licensing. This is a really exciting time for Byondis and our team."

Byondis operates from its headquarters in Nijmegen in the Netherlands, with over 350 highly qualified employees working in state-of-the art research and development and GMP manufacturing facilities. The Company has strong links to academic institutions, global medical communities and the international pharma industry.

On April 16, 2020 Accuray Incorporated (NASDAQ: ARAY) reported that it will report results for its third quarter ended March 31, 2020 on Tuesday, April 28, 2020 after the market close (Press release, Accuray, APR 16, 2020, View Source [SID1234556388]). Management will host a conference call to review the results at 1:30 p.m. PT/4:30 p.m. ET on the same day.

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The conference call dial-in numbers are 877-270-2148 (USA) or 412-902-6510 (International). In addition, a dial up replay of the conference call will be available approximately one hour after the call’s conclusion for one week. The replay number is 877-344-7529 (USA), or 412-317-0088 (International), Conference ID: 10142781.

A live webcast of the call will also be available from the Investor Relations section of the Company’s website at investors.accuray.com. A webcast replay can be accessed on the website and will remain available until Accuray announces its results for the fourth quarter of fiscal 2020.

On April 16, 2020, INmune Bio Inc. (the "Company") reported that it entered into an At-The-Market Sales Agreement (the "Sales Agreement") with BTIG, LLC ("BTIG"), pursuant to which the Company may offer and sell, from time to time, through BTIG, as sales agent, shares of its common stock, par value $0.001 per share (the "Common Stock"), having an aggregate offering price of up to $10,000,000, subject to certain limitations on the amount of Common Stock that may be offered and sold by the Company set forth in the Sales Agreement (Filing, 8-K, INmune Bio, APR 16, 2020, View Source [SID1234556409]). The Company is not obligated to make any sales of Common Stock under the Sales Agreement and any determination by the Company to do so will be dependent, among other things, on market conditions and the Company’s capital raising needs.

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Offers and sales of Common Stock by the Company under the Sales Agreement, if any, will be made through a prospectus supplement to the prospectus forming a part of the Company’s shelf registration statement on Form S-3 (File No. 333-237638) declared effective by the Securities and Exchange Commission (the "SEC") on April 2, 2020 (the "Registration Statement"). The Company filed with the SEC a prospectus supplement dated April 16, 2020 specifically relating to offers and sales of Common Stock under the Sales Agreement (the "ATM Prospectus Supplement"), together with the prospectus forming a part of the effective registration statement. Due to the offering limitations currently applicable to the Company under General Instruction I.B.6. of Form S-3 and the Company’s public float as of as of April 16, 2020, and in accordance with the terms of the Sales Agreement, the Company may offer and sell shares of Common Stock having an aggregate gross sales price of up to $6,678,000 (the "Shares") under the ATM Prospectus Supplement through BTIG, as sales agent, pursuant to the Sales Agreement. If the Company’s public float increases after the date of the ATM Prospectus Supplement such that the Company may sell additional amounts of Common Stock under the Sales Agreement and the Registration Statement, the Company will file with the SEC another prospectus supplement to the prospectus forming a part of the Registration Statement that will include such additional amount of shares of Common Stock that the Company may sell under the Sales Agreement before any such additional shares are sold under the Sales Agreement.

Shares may be sold through the ATM Prospectus Supplement by any method deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended. including sales made through The Nasdaq Capital Market or any other trading market for the common stock, sales made to or through a market maker other than on an exchange or through an electronic communications network, or in negotiated transactions pursuant to terms set forth in a placement notice delivered by the Company to BTIG under the Sales Agreement. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, BTIG will use commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations, and the rules of The Nasdaq Capital Market, to sell the Shares from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. BTIG is not obligated to purchase any shares of Common Stock on a principal basis pursuant to the Sales Agreement.

The Company will pay BTIG commissions for its services in acting as agent in the sale of shares of Common Stock pursuant to the Sales Agreement. BTIG will be entitled to compensation at a fixed commission rate of 3.0% of the gross proceeds from the sale of shares of Common Stock pursuant to the Sales Agreement. The Company has agreed to provide BTIG with customary indemnification and contribution rights, including for liabilities under the Securities Act. The Company also will reimburse BTIG for certain specified expenses in connection with entering into the Sales Agreement. The Sales Agreement contains customary representations and warranties and conditions to the placements of the Shares pursuant thereto. The Sales Agreement will terminate upon the earlier of (i) the sale of all shares of Common Stock subject to the Sales Agreement and (ii) termination of the Sales Agreement as permitted therein. The Company may terminate the Sales Agreement in its sole discretion at any time by giving 10 days’ prior notice to BTIG. BTIG may terminate the Sales Agreement under the circumstances specified in the Sales Agreement and in its sole discretion at any time by giving 10 days’ prior notice to the Company.