On December 2, 2019 ViewRay, Inc. (Nasdaq: VRAY), maker of the MRIdian, which combines MRI and external-beam radiation therapy to simultaneously image and treat cancer patients, reported that it has commenced an underwritten public offering of $75.0 million of shares of its common stock (Press release, ViewRay, DEC 2, 2019, View Source [SID1234551844]). In addition, ViewRay expects to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of shares of common stock at the public offering price, less the underwriting discounts and commissions. All of the shares of common stock to be sold in the offering will be offered by ViewRay. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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ViewRay intends to use the net proceeds from the offering for working capital and general corporate purposes, including capital expenditures, research and development expenses, investments, commercial expenses, clinical data generation costs and infrastructure expenses.

Piper Jaffray & Co. is acting as the sole book-running manager for the offering.

The common stock will be offered and sold pursuant to an effective shelf registration statement on Form S-3 (File No. 333-229145) filed by ViewRay with the Securities and Exchange Commission ("SEC") and only by means of a prospectus supplement and accompanying prospectus included in the registration statement. A preliminary prospectus supplement related to the offering will be filed with the SEC. Prospective investors should read the preliminary prospectus supplement, when available, and the accompanying prospectus and other documents ViewRay has filed with the SEC for more complete information about ViewRay and the offering. These documents are available at no charge by visiting the SEC’s website at View Source Alternatively, copies of the preliminary prospectus supplement, when available, and the accompanying prospectus may be obtained by contacting Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected].

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 of these securities under the securities laws of any such state or jurisdiction.

On December 2, 2019 Oncotelic Inc. ("Oncotelic"), a wholly owned subsidiary of Mateon Therapeutics Inc. (OTCQB:MATN, "Mateon") dedicated to the development of innovative treatments for cancer, reported the publication of two peer-reviewed expert editorials authored by Fatih Uckun MD PhD, the Chief Medical Officer for Mateon, and Vuong Trieu, PhD, the Chief Executive Officer and President for Mateon, at Oncotelic in the oncology journals Cancer Clinics Journal and Annals of Hematology and Oncology Research (Press release, Mateon Therapeutics, DEC 2, 2019, View Source [SID1234551813]). Also published was a peer-reviewed research article in the prestigious oncology journal Cancers.

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The editorial titled "Monotherapy of High-Grade Gliomas with a TGF-beta2 Targeting RNA Therapeutic" provides an overview regarding the development status, mechanism of action, and clinical potential of Mateon’s first-in-class RNA therapeutic OT101 for the treatment of the most aggressive brain tumors in adults.

Citation Reference: Uckun FM, Trieu VN. Monotherapy of High-Grade Gliomas with a TGF-beta2 Targeting RNA Therapeutic. Cancer Clin J. 2019; 1(1): 1007 (View Source)

The editorial titled "Convection-enhanced delivery of an anti-TGFbeta RNA therapeutic as a new therapeutic concept for children with diffuse intrinsic pontine glioma ("DIPG")" explains a new concept for the treatment of pediatric DIPG patients with an RNA therapeutic targeting TGFbeta 2 and the scientific rationale and proof of concept data behind it.

Citation Reference: Uckun FM, Trieu VN. Convection-enhanced delivery of an anti-TGFbeta RNA therapeutic as a new therapeutic concept for children with diffuse intrinsic pontine glioma. Annals of Hematology and Oncology Research 2019; 1(1):1003 (View Source)

"These editorials emphasize our commitment to advance our investigational drug OT101 which shows high clinical impact potential to address unmet needs in neuro-oncology.", stated Dr. Trieu.

The research article "Recurrent or Refractory High-Grade Gliomas Treated by Convection-Enhanced Delivery of a TGFβ2-Targeting RNA Therapeutic: A Post-Hoc Analysis with Long-Term Follow-Up" was published in Cancers as part of the Special Issue Personalized Medicine: Recent Progress in Cancer Therapy and is available online:

Abstract: View Source

HTML Version: View Source/htm

PDF Version: View Source/pdf

Special Issue: View Source

Citation Reference: Uckun, F.M.; Qazi, S.; Hwang, L.; Trieu, V.N. Recurrent or Refractory High-Grade Gliomas Treated by Convection-Enhanced Delivery of a TGFβ2-Targeting RNA Therapeutic: A Post-Hoc Analysis with Long-Term Follow-Up. Cancers 2019, 11, 1892 (View Source/htm)

Dr. Uckun explained: "Our post-hoc analysis of the NCT00431561 Phase II clinical study outcome data demonstrates that the anti-TGFβ2 RNA therapeutic OT101 when intratumorally-administered via convection-enhanced delivery (CED) exhibits promising single-agent activity against recurrent or refractory (R/R) high-grade gliomas (HGG). Most importantly, OT101 induced durable complete response (CR), partial response (PR) and stable disease (SD) in more than one third of the efficacy population. In the objective responders, OT101 displayed a previously not reported pattern of single agent activity, which was characterized by (i) slow but robust tumor size reductions; (ii) very often, an early onset transient increase of tumor edema and/or pseudo-progression which preceded the tumor size reductions; and (iii) late-onset objective responses that were achieved at a median of 287 days. To our knowledge, this is the first demonstration that the intratumoral delivery of an RNA therapeutic via extended CED in the absence of other therapeutic agents or radiation results in >3 year median PFS and >3.5 year OS in greater than one third of the efficacy population in a R/R HGG trial. It will be important to evaluate OT101 in difficult-to-treat IDH-wildtype, MGMT-unmethylated R/R HGG patients who have failed a temozolomide-based first line adjuvant therapy, as they have a dismal prognosis and are in urgent need for new and effective salvage therapies. Intratumorally administered OT101 exhibited a promising safety profile, but some CED procedure and device-related potential complications were also identified. Therefore, risk mitigation strategies, especially preventive methods aimed at reducing the risk of infections, will be employed in future trials to further improve the potential patient benefit of intratumoral OT101 therapy"

OT101, a first-in-class RNA therapeutic designed to abrogate the immunosuppressive actions of TGF-beta 2, is Oncotelic’s lead anti-brain tumor drug candidate. In a completed Phase 2 clinical study, OT-101 exhibited clinically meaningful single-agent activity and induced durable complete and partial responses in recurrent and refractory adult high-grade glioma patients, including adults with GBM. DIPG, an orphan disease with a low survival rate and no established or effective standard of care. Despite numerous clinical trials of chemotherapeutic agents, immuno-oncology drugs and specific targeted therapies, no significant progress has been made in the treatment of DIPG and the prognosis remains dismal, with a mean OS of 9–12 months from the time of diagnosis, a median survival time of approximately 10 months, and a two-year OS rate of less than 10 percent. Five-year survival is less than 3 percent, and many long-term survivors have evidence of moderate or severe cognitive impairment, likely as a consequence of radiation therapy. Chemotherapy does not have an established role in the management of patients with DIPG. Furthermore, there is no standard treatment for progressive DIPG after the failure of radiation therapy and no salvage regimen has been shown to extend survival. Therefore, there is an urgent need for therapeutic innovations for treatment of DIPG, as reflected by multiple treatment modalities being evaluated in early neuro-oncology clinical trials. Further development of OT-101 may offer renewed hope for salvage therapy not only for adult high-grade glioma patients but also for pediatric DIPG patients. Last month, US Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation for OT101/Trabedersen for the treatment of diffuse intrinsic pontine glioma (DIPG) as a drug for a "rare pediatric disease," as defined in section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act.

On December 2, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that the company plans to present at the following conferences in December (Press release, Iovance Biotherapeutics, DEC 2, 2019, View Source [SID1234551829]):

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Piper Jaffray 31st Annual Healthcare Conference in New York, Dec. 3-5, 2019
Location: Lotte New York Palace
Date/Time: Tuesday, Dec. 3, at 11:30 a.m. EST

Evercore ISI 2nd Annual HealthCONx Conferencein Boston, Dec. 3-5, 2019
Location: Four Seasons Hotel Boston
Date/Time: Wednesday, Dec. 4, at 1:35 p.m. EST
Live and archived webcasts of the presentations will be available in the Investors section of the Iovance website at View Source

On December 2, 2019 ViewRay, Inc. (Nasdaq: VRAY) reported that it has signed a non-binding memorandum of understanding for collaboration with Elekta AB (Nasdaq: EKTA-B.ST) ("Elekta") to advance the knowledge and use of MR-guided radiation therapy (Press release, ViewRay, DEC 2, 2019, View Source [SID1234551845]). In connection with the collaboration, Elekta has committed to invest capital for up to a 9.9% minority interest in ViewRay, subject to the terms and conditions set forth in a commitment agreement.

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Additionally, ViewRay has signed a non-binding memorandum of understanding with Medtronic (NYSE: MDT) to enter into a clinical collaboration in an area of mutual interest that includes exploring the clinical benefits of the MRIdian MR-guided radiation therapy system. In connection with the collaboration, Medtronic has committed to invest in a minority interest in ViewRay, subject to the terms and conditions set forth in a commitment agreement.

ViewRay’s largest shareholder, Fosun International Limited ("Fosun"), has also committed capital up to an amount that would enable it to maintain its current beneficial ownership percentage in ViewRay, subject to the terms and conditions set forth in a commitment agreement.

The investments from Elekta and Medtronic are conditioned upon the consummation of an equity capital raise of at least $75 million.

"We are pleased to announce these important collaborations and investments in ViewRay. Our goal is to concurrently prove the value of MR-guided radiation therapy and strengthen our balance sheet," said Scott Drake, President and CEO of ViewRay. "We are well-positioned to drive MRIdian to standard of care. The ability to see clearly during the procedure, track tumors and soft tissues, and auto-gate the beam is integral to delivering highly precise, personalized medicine."

Collaboration with Elekta

The key objective of the collaboration with Elekta is to advance MR-linac technology and its application as the radiation therapy with superior precision, medical outcomes, and operational cost efficiency. The companies intend to facilitate clinical studies exploring the impact of MR-guided therapy in oncology and work jointly to expand the potential role of MR-guided therapy into other areas that could benefit from the technology. The companies are also exploring initiatives such as the formation of a cooperative group and working on healthcare policy. The collaboration is subject to the execution of definitive documentation.

In connection with the collaboration, Elekta has committed to invest capital for up to a 9.9% minority interest in ViewRay. Elekta’s investment in ViewRay is subject to the terms and conditions set forth in a commitment agreement, including the condition of consummation of an equity capital raise of at least $75 million. In addition, Elekta’s investment in ViewRay is subject to an aggregate cap of $36 million.

"We believe that ViewRay and Elekta can work together to drive broad adoption of MR-linacs," said Scott Drake, President and CEO of ViewRay. "We look forward to further promoting this technology to benefit patients worldwide."

"Two companies actively promoting the implementation of the MR-linac technology in the market and collaborating on clinical applications will benefit clinicians and their patients with better and wider treatment options, improved outcomes, and lower costs," said Richard Hausmann, Elekta’s President and CEO.

On December 2, 2019 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that it will host an analyst/investor event and webcast on December 9 at 12:30 PM EST in Salon 2 at the Rosen Centre Hotel in Orlando, Florida, in conjunction with the annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, Constellation Pharmaceuticals, DEC 2, 2019, View Source [SID1234551814]).

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The event will be webcast live and can be accessed on the Investor Relations section of Constellation’s website at View Source Analysts and investors may also access the event and participate in the live question-and-answer session by dialing (877) 473-2077 (domestic) or (661) 378-9662 (international) and referring to conference ID 7892044. A replay of the call will be available at (855) 859-2056, (404) 537-3406 or (800) 585-8367.