Entry into a Material Definitive Agreement

On October 14, 2020, X4 Pharmaceuticals, Inc. (the "Company"), reported that it entered into a common stock purchase agreement (the "Purchase Agreement") with Aspire Capital Fund, LLC, an Illinois limited liability company ("Aspire Capital"), which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $50.0 million of shares of the Company’s common stock at the Company’s request from time to time during the 36-month term of the Purchase Agreement (Filing, 8-K, X4 Pharmaceuticals, OCT 14, 2020, View Source [SID1234568572]). Concurrently with entry into the Purchase Agreement, the Company also entered into a registration rights agreement with Aspire Capital (the "Registration Rights Agreement"), pursuant to which the Company filed with the Securities and Exchange Commission ("SEC") a prospectus supplement to the Company’s effective shelf registration statement on Form S-3 (File No. 333-242372), which registers the issuance and sale of the shares of common stock that the Company may offer to Aspire Capital from time to time under the Purchase Agreement.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the Purchase Agreement, on any trading day selected by the Company, the Company has the right, in its sole discretion, to present Aspire Capital with a purchase notice (each, a "Regular Purchase Notice") directing Aspire Capital (as principal) to purchase up to 30,000 shares of the Company’s common stock (not to exceed $1,000,000 worth of shares unless the Company and Aspire Capital agree otherwise) per business day, up to an aggregate of $50.0 million of the Company’s common stock at a per share price (the "Purchase Price") equal to the lesser of:


the lowest sale price of the Company’s common stock on the Nasdaq Stock Market LLC ("Nasdaq") on the date of sale; or


the arithmetic average of the three (3) lowest closing sale prices for the Company’s common stock on Nasdaq during the ten (10) consecutive trading days ending on the trading day immediately preceding the purchase date.

In addition, on any date on which the Company submits a Regular Purchase Notice to Aspire Capital in an amount equal to 30,000 shares, the Company also has the right, in its sole discretion, to present Aspire Capital with a volume-weighted average price purchase notice (each, a "VWAP Purchase Notice") directing Aspire Capital to purchase an amount of the Company’s common stock equal to up to 30% of the aggregate shares of the Company’s common stock traded on Nasdaq on the next trading day (the "VWAP Purchase Date"), subject to a maximum number of shares the Company may determine. The purchase price per share pursuant to such VWAP Purchase Notice is generally 97% of the volume-weighted average price for the Company’s common stock traded on Nasdaq on the VWAP Purchase Date.

The Purchase Agreement provides that the Company and Aspire Capital shall not effect any sales under the Purchase Agreement on any purchase date where the closing price of the Company’s common stock on Nasdaq is less than $0.25. In addition, the Company may not sell more than an aggregate of 3,255,700 shares of its common stock under the Purchase Agreement unless it obtains stockholder approval of the sale of additional shares or if after giving effect to a sale of additional shares, the average price paid for all shares then-issued under the Purchase Agreement would be equal to or greater than $6.76. There are no trading volume requirements or restrictions under the Purchase Agreement, and the Company will control the timing and amount of sales of the Company’s common stock to Aspire Capital. Aspire Capital has no right to require any sales by the Company but is obligated to make purchases from the Company as directed by the Company in accordance with the Purchase Agreement. There are no limitations on use of proceeds, financial or business covenants, restrictions on future financing transactions, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. The Purchase Agreement may be terminated by the Company at any time, at its discretion, without any cost to the Company. Aspire

Capital has agreed that neither it nor any of its agents, representatives and affiliates shall engage in any direct or indirect short-selling or hedging of the Company’s common stock during any time prior to the termination of the Purchase Agreement. Management currently expects to use any proceeds received by the Company under the Purchase Agreement to develop the Company’s product pipeline, for working capital and for general corporate purposes.

The foregoing description is not complete and is qualified in its entirety by reference to the full texts of the Purchase Agreement and the Registration Rights Agreement, copies of which are filed with as Exhibits 99.1 and 4.1, respectively, to this Current Report on Form 8-K and are incorporated herein by reference. The Company is filing the opinion of its counsel, Cooley LLP, relating to the legality of the shares of Common Stock offered and sold pursuant to the Purchase Agreement, as Exhibit 5.1 to this Current Report on Form 8-K.

This Current Report on Form 8-K contains forward-looking statements within the meaning of Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by the words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" or other similar terms or expressions that concern the Company’s expectations, strategy, plans or intentions. Forward-looking statements include, without limitation, statements related to the potential future sale of shares of the Company’s common stock, the price for such sales under the Purchase Agreement, and the Company’s expected use of proceeds from such sales. Any forward-looking statements in this Current Report on Form 8-K are based on management’s current expectations and beliefs. Actual events or results may differ materially from those expressed or implied by any forward-looking statements contained herein, including, without limitation, the risks and uncertainties described in the section entitled "Risk Factors" in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on August 4, 2020, and in subsequent filings the Company makes with the SEC from time to time. The Company undertakes no obligation to update the information contained in this Current Report on Form 8-K to reflect new events or circumstances, except as required by law.

Flagship Pioneering Announces Appointment of Tuyen Ong as CEO-Partner

On October 14, 2020 Flagship Pioneering, a unique life sciences innovation enterprise, reported that expanded and strengthened its executive leadership team with the appointment of Tuyen Ong, M.D. as CEO-Partner (Press release, Flagship Ventures, OCT 14, 2020, View Source [SID1234568547]). Dr. Ong will also serve as Chief Executive Officer at Ring Therapeutics, a Flagship Labs-founded company that promises to revolutionize gene therapy with its commensal virus platform.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Ong is an accomplished biotechnology and pharmaceutical executive with a wealth of experience in research and development. He most recently served as Senior Vice President, Head of the Ophthalmology Franchise at Biogen.

"We are very excited to add Tuyen to our team of talented and experienced executives at Flagship, and to be able to further expand our group of CEO-Partners, a hybrid role unique to Flagship that assures maximum alignment and value creation for our breakthrough ventures," says Noubar Afeyan, Ph.D., founder and CEO of Flagship Pioneering and founding Chairman of Ring Therapeutics. "Tuyen’s extensive track record of building value for pharma and biotech, combined with his expertise in the development of gene therapies, will be tremendously beneficial to Ring and our other nucleic acid platform companies."

In his role as CEO-Partner of Flagship Pioneering, Dr. Ong joins the Flagship senior leadership team and will provide his knowledge and insights across the Flagship enterprise. He will also serve on the boards of directors of certain Flagship companies. Dr. Ong will also work as part of Flagship’s team to plan, drive, and achieve the highest possible value creation for Flagship and its companies.

As CEO of Ring Therapeutics, Dr. Ong will lead the development of the company’s groundbreaking nucleic acid therapy platform based on its large portfolio of commensal Anellovirus-based vectors.

"I’m delighted to join Flagship Pioneering’s outstanding executive leadership team and look forward to co-creating the next generation of innovative life sciences companies founded by Flagship," says Dr. Ong. "I am also thrilled to be joining Ring Therapeutics’ talented team of executives and scientists in its ambitious effort to develop transformational therapies using its multi-product platform by unlocking its unique knowledge of the human commensal virome and revolutionizing the nucleic acid medicine paradigm."

"I look forward to working closely with Tuyen to help realize the full potential of Ring," said Avak Kahvejian, Ph.D., Flagship Pioneering General Partner and Founding CEO of Ring Therapeutics. "Over the last two years, Ring has uncovered the largest collection of commensal, human viruses, and is leveraging these discoveries to develop the first potentially redosable and targetable gene therapy platform. We are very excited by the prospect of creating multiple breakthrough medicines from this platform."

About Tuyen Ong

Tuyen Ong is an experienced biotechnology and pharmaceutical executive with a passion for driving progress in medical sciences and bringing innovation to patients. Dr. Ong has deep expertise in R&D and gene therapy, having led the development of breakthrough treatments for retinopathies and rare diseases.

In his most recent role, Dr. Ong served as Senior Vice President, Head of the Ophthalmology Franchise at Biogen. Prior to the acquisition of Nightstar by Biogen in 2019, he served as Nightstar’s Chief Development Officer, where he defined the clinical and regulatory strategy for the company’s lead gene therapy programs. During his career, Dr. Ong has also held numerous senior leadership positions at PTC Therapeutics, Bausch and Lomb, and Pfizer, leading clinical development across multiple therapeutic disease areas of high-unmet need.

Dr. Ong holds an M.D. from University College London and an MBA from New York University Stern School of Business. He is a member of the Royal College of Ophthalmologists.

Rain Therapeutics Announces Late-Breaker Oral Presentation at the 32nd EORTC-NCI-AACR Virtual Symposium

On October 14, 2020 Rain Therapeutics Inc., a privately-held, clinical stage biotechnology company focused on targeted therapies for patients with cancer, reported a late-breaking presentation at the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Virtual Symposium being held October 24-25, 2020 (Press release, Rain Therapeutics, OCT 14, 2020, View Source [SID1234568516]). The oral presentation will provide an update on data from the Phase 1 clinical trial of RAIN-32 (Milademetan), an oral MDM2 inhibitor.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Additional presentation details can be found below:
Oral Presentation
Title: Milademetan, an oral MDM2 inhibitor, in well-differentiated/dedifferentiated liposarcoma: results from a phase 1 study in patients with solid tumors or lymphomas

Session Title: New Drugs on the Horizon

Presenter: Mrinal M. Gounder, M.D., Memorial Sloan Kettering Cancer Center
Session Date: Sunday, October 25
Session Time: 9:00 p.m. – 10:45 p.m. CET/4:00 p.m.-5:45 p.m. EDT
Presentation Time: 10:00 p.m. CET/5:00 p.m. EDT

The session will be followed by a Q&A from 10:10 p.m.to 10:30 p.m. CET/5:10 p.m. to 5:30 p.m. EDT. Additional details can be found on the conference website.

About RAIN-32
RAIN-32 has been evaluated in patients with various solid tumors, acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), and has received Orphan Drug Designation for the treatment of liposarcoma. RAIN-32 also has been evaluated in continuous and intermittent dose schedules that may offer a differentiated tolerability profile as compared to other MDM2 programs.

A separate clinical study for RAIN-32 is ongoing to evaluate safety and efficacy in patients with FLT3-ITD AML in combination with the FLT3 inhibitor, quizartinib. In addition, multiple investigator sponsored studies are being conducted by MD Anderson Cancer Center (MDACC) as well as National Cancer Center Hospital (NCCH) in Tokyo, Japan.

Oncopeptides signs € 40 million loan agreement with the EIB

On October 14, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) reported that the company has entered into a loan agreement with the European Investment Bank (EIB), granting the company access to an unsecured loan facility of up to €40 M (Press release, Oncopeptides, OCT 14, 2020, View Source [SID1234568501]). The loan may be used to further support the clinical development of melflufen, and the company’s transition from a R&D company into a fully integrated global biopharmaceutical company.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The loan facility is divided into three tranches, each with a maturity of up to five years, which will become available provided that the company reaches certain milestones related to the commercialization of melflufen in the U.S. and the EU, respectively.

If the company utilizes the facility, the EIB will be entitled to a predetermined number of warrants in Oncopeptides, in excess of interest on the loan amount. The warrants are divided into three tranches and assuming full drawdown under the loan facility, the EIB will be entitled to warrants corresponding to 0.7 percent of the total number of shares in the company on a fully diluted basis. The total number of warrants will be issued by Oncopeptides’ board of directors pursuant to the authorization granted by the AGM 2020, and each relevant tranche will be delivered to the EIB upon the company’s potential decision to draw the relevant tranche of the loan.

"This is the kind of project that the Investment Plan for Europe was set up to support. There is still a market gap when it comes to what is called "non-dilutive growth capital", allowing innovative, fast growing EU-based SMEs to grow without giving up ownership of their ideas or company", says Thomas Östros, Vice-President of EIB. "We are very happy to get behind yet another innovative Swedish company that has ground-breaking plans for the future."

"As the company is approaching a potential commercialization of its lead product melflufen, several new financing options become available. The EIB facility is a flexible solution that can be drawn upon with limited dilution for the shareholders, which is highly valuable to the company in this transition phase. We are grateful for the support from the EIB and look forward to working together through the continued expansion of Oncopeptides", says Anders Martin-Löf, CFO of Oncopeptides.

Melflufen in clinical development
On August 29th the U.S. Food and Drug Administration FDA granted priority review for Oncopeptides´ New Drug Application of melflufen (INN melphalan flufenamide). The FDA has set a target date for their review to February 28, 2021.

The submission is based on the results from the pivotal phase 2 HORIZON study, which demonstrates that melflufen in combination with dexamethasone has a potential to provide a therapeutic option for patients with RRMM that are hard to treat and have a poor prognosis, including patients with triple-class refractory myeloma and patients with extramedullary disease (EMD). Oncopeptides has a comprehensive clinical development program and is currently conducting one randomized phase 3 study and six clinical phase 2 studies.

The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons above, on October 14, 2020 at 18:00 (CET).

About melflufen
Melflufen (INN melphalan flufenamide) is a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately hydrolyzed by peptidases to release an entrapped hydrophilic alkylator payload. Aminopeptidases are overexpressed in tumor cells and are even more pronounced in advanced cancers and tumors with a high mutational burden. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies. In the pivotal phase 2 HORIZON study melflufen plus dexamethasone demonstrated encouraging efficacy and a clinically manageable safety profile in heavily pretreated patients with relapsed refractory multiple myeloma, with primarily hematologic Adverse Events (AE) and a low incidence of non-hematologic AEs.

Louis Stokes Cleveland VA Medical Center Purchases ViewRay’s MRIdian Linac for MRI-Guided Radiation Therapy

On October 14, 2020 ViewRay, Inc. (Nasdaq: VRAY) reported that the Louis Stokes Cleveland VA Medical Center in Cleveland, Ohio has purchased the MRIdian Linac MRI-Guided Therapy System, a cutting-edge radiation therapy device that combines the latest innovations in precision radiation delivery and ground-breaking MR-guidance (Press release, ViewRay, OCT 14, 2020, View Source [SID1234568498]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

MRIdian offers advantages for the delivery of safe and effective radiotherapy, including the ability to see the tumor and surrounding tissue during treatment, adapt the therapy in response to changes in patient anatomy and tumor size during treatment, continuous tracking of the tumor during treatment, and automatic pausing of the radiation if the tumor moves outside of the boundary. As a result, the system delivers ablative, high-dose radiation to the tumor while protecting the surrounding healthy tissue from damage.

The ability to deliver high-dose radiation treatments, referred to as stereotactic body radiation therapy (SBRT), means patients can receive their treatment in fewer sessions than conventional radiation therapy. Instead of 25 to 40 treatment sessions, patients receiving SBRT may complete treatment in as few as one to five treatment sessions. This is particularly beneficial for patients who may have to travel a long distance for treatment.

The Louis Stokes Cleveland VA Medical Center is part of the VA Northeast Ohio Healthcare System, which provides comprehensive, seamless health care and social services for 112,589 Veterans across Northeast Ohio. The VA Northeast Ohio Healthcare System focuses on treating the whole Veteran through health promotion and disease prevention. VA Northeast Ohio Healthcare System contributes to the future of medicine through education, training, and research programs.

"We’re proud to support the Louis Stokes Cleveland VA Medical Center in their mission to offer the most advanced technologies to Veterans," said Paul Ziegler, Senior Vice President of Sales and Marketing at ViewRay. "Their investment in a MRIdian program furthers their commitment to delivering the highest quality health care to our nation’s heroes."

Currently 39 MRIdian systems are installed at hospitals around the world, where they are used to treat a wide variety of solid tumors and are the focus of numerous ongoing research efforts. MRIdian has been the subject of hundreds of peer-reviewed publications, scientific meeting abstracts and presentations. More than 10,000 patients have been treated with MRIdian. For a list of treatment centers, please visit: View Source