Entry into a Material Definitive Agreement

On September 17, 2020, Checkpoint Therapeutics, Inc., a Delaware corporation (the "Company"), reported that it entered into an underwriting agreement (the "Underwriting Agreement") with H.C. Wainwright & Co., LLC (the "Underwriter") (Filing, Checkpoint Therapeutics, SEP 17, 2020, View Source [SID1234565431]). Pursuant to the Underwriting Agreement, the Company agreed to sell to the Underwriter, and the Underwriter agreed to purchase for resale to the public, in a firm commitment underwritten public offering, 7,142,857 shares (the "Firm Shares") of the Company’s common stock, $0.0001 par value per share (the "Common Stock"), at a price to the public of $2.80 per share, less underwriting discounts and commissions. In addition, pursuant to the Underwriting Agreement, the Company has granted the Underwriter an option, exercisable for 30 days from the closing date of this offering, to purchase up to an additional 1,071,428 shares of Common Stock (the "Additional Shares" and, together with the Shares, the "Offered Shares") at the same offering price to the public, less underwriting discounts and commissions. On September 20, 2020, the Underwriter partially exercised its option purchase 178,572 Additional Shares. The offering of the Offered Shares was registered pursuant to a Registration Statement (No. 333-221493) on Form S-3, which was filed by the Company with the Securities and Exchange Commission on November 9, 2017 and declared effective on December 1, 2017, including a prospectus contained therein, as supplemented by a prospectus supplement, dated September 17, 2020, relating to this offering (the "Registration Statement"). A copy of the Underwriting Agreement is attached hereto as Exhibit 1.1 and is incorporated by reference herein.

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H.C. Wainwright & Co., LLC is acting as sole book-running manager for the offering.

The Company expects to receive net proceeds from the sale of the Offered Shares, after deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company, of approximately $19.0 million, which includes proceeds from the additional shares of Common Stock to be sold pursuant to Underwriter’s partial exercise of its option to purchase additional shares. The offering, including the Additional Shares to be issued and sold pursuant to the partial exercise of the Underwriter’s option to purchase additional shares, is expected to close on September 22, 2020, subject to satisfaction of customary closing conditions.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriter, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions.

Alston & Bird LLP, counsel to the Company, delivered an opinion as to the validity of the Offered Shares, a copy of which is attached hereto as Exhibit 5.1 and is incorporated by reference herein.

This Current Report on Form 8-K is being filed to incorporate the Underwriting Agreement and opinion by reference into such Registration Statement. The foregoing summary description of the offering and the documentation related thereto, including without limitation, the Underwriting Agreement, does not purport to be complete and is qualified in its entirety by reference to such exhibits.

The Underwriting Agreement has been included to provide investors and security holders with information regarding its terms. It is not intended to provide any other factual information about the Company. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosures exchanged between the parties in connection with the execution of the Underwriting Agreement. The representations and warranties may have been made for the purposes of allocating contractual risk between the parties to the agreement instead of establishing these matters as facts and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Investors are not third-party beneficiaries under the Underwriting Agreement and should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company or any of its subsidiaries or affiliates. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Underwriting Agreement, and this subsequent information may or may not be fully reflected in the Company’s public disclosures.

Exact Sciences to participate in Cowen Liquid Biopsy Summit

On September 17, 2020 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will participate in the following event and invited investors to participate by webcast (Press release, Exact Sciences, SEP 17, 2020, View Source [SID1234565274]).

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Cowen Liquid Biopsy Summit
Presentation on Thursday, September 24, 2020, at 10:30 a.m. EDT
The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

Abbott Declares 387th Consecutive Quarterly Dividend

On September 17, 2020 The board of directors of Abbott (NYSE: ABT) reported a quarterly common dividend of 36 cents per share (Press release, Abbott, SEP 17, 2020, View Source [SID1234565292]).

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This marks the 387th consecutive quarterly dividend to be paid by Abbott since 1924. The cash dividend is payable Nov. 16, 2020, to shareholders of record at the close of business on Oct. 15, 2020.

Abbott has increased its dividend payout for 48 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have increased dividends annually for at least 25 consecutive years.

VBI Vaccines Announces Biomarker Data From VBI-1901 Phase 1/2a Study in Recurrent GBM Presented at ESMO Virtual Congress 2020

On September 17, 2020 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported additional biomarker data from its ongoing Phase 1/2a study evaluating VBI-1901, the company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM) patients presented in an e-poster at The European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, VBI Vaccines, SEP 17, 2020, View Source [SID1234565310]).

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Expanding the biomarker analysis of the six tumor responders seen to-date in the study, including a confirmed durable partial response, the e-poster highlighted data that further assessed correlates of tumor response and clinical benefit. Specifically, human leukocyte antigen (HLA) restriction and T cell receptor (TCR) repertoires were evaluated.

"We continue to broaden the analysis around tumor responders in our ongoing Phase 1/2a study of VBI-1901 to enable us to identify GBM patients most likely to benefit from the vaccine immunotherapeutic in the next phase of clinical development," said Dr. David E. Anderson, VBI’s Chief Scientific Officer. "This analysis suggests that VBI-1901 is able to induce a CMV antigen-specific immune response to target a broader set of CMV antigens beyond what is expressed in VBI-1901, evident by HLA analysis and functional T cell assays. As with the previously announced CD4+/CD8+ ratio, a biomarker which may reflect the immunologic fitness of CD4+ T cells in recurrent GBM patients, these biomarkers will continue to be evaluated throughout the study."

In parallel to the ongoing biomarker analysis, enrollment in the Phase 1/2a Part B study arm of VBI-1901 in combination with GSK’s AS01B adjuvant system continues, with initial immunologic and tumor data expected in Q4 2020.

The e-poster is available on the "Events/Presentations" page in the "Investors" section of the VBI Vaccines website.

About the Phase 1/2a Study Design

VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 38 patients with recurrent GBM:

Phase 1 (Part A)
Dose escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients with any number of prior recurrences.
This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0 µg.
Enrollment completed in December 2018.
Phase 2a (Part B)
Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase.
This phase is a two-arm study, enrolling 10 first-recurrent GBM patients in each arm, assessing 10.0 µg of VBI-1901 in combination with either GM-CSF or GSK’s proprietary AS01B adjuvant system as immunomodulatory adjuvants.
Enrollment of the 10 patients in the GM-CSF arm is complete. Enrollment of the 10 patients in the AS01B arm is ongoing.
VBI-1901 is administered intradermally when adjuvanted with GM-CSF and intramuscularly when adjuvanted with the AS01B adjuvant system. Patients in both phases of the study receive the vaccine immunotherapeutic every four weeks until tumor progression.

About VBI-1901 and GBM

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and is exceptionally lethal.

OncoHost to Present Data on Host Response Profiling for NSCLC Patients at ESMO Virtual Congress 2020

On September 17, 2020 OncoHost, a global leader in host response profiling for improved personalized cancer therapy, announced today that its research on the use of its plasma proteomics platform using advanced bioinformatic analysis to improve outcomes of immunotherapy-treated non-small cell lung cancer (NSCLC) patients will be presented at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, OncoHost, SEP 17, 2020, View Source [SID1234565327]). The clinical study was conducted in collaboration with the Technion Institute of Technology, the Chaim Sheba Medical Center Institute of Oncology, Thomas Jefferson University and the University of Connecticut. The study focuses on how through analyzing individual host response profiles (i.e. the patient’s reaction), oncologists may be able to harness said host response to better predict clinical outcomes and suggest optimal combination treatment with immunotherapy.

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"Immunotherapy based on immune checkpoint inhibitors (ICIs) has made a paradigm shift in oncology, unfortunately, not every patient has the same response to this exciting treatment modality," said Professor Adam Dicker, Sr. VP and Chair & Professor of Radiation Oncology, Pharmacology & Experimental Therapeutics at Jefferson University and chief medical officer at OncoHost. "Our study characterizes the host response to ICI, aiding in the discovery of predictive biomarkers for the potential for clinical benefit in NSCLC. This represents an important step for predicting host response in blood-based proteomic biomarkers – precision oncology at its best."

The study, conducted on OncoHost’s machine learning-based Host Response Profiling platform, PROphet, demonstrated that analyzing host response profiles in patients aids in the discovery of predictive biomarkers for patient stratification in NSCLC, and that the mechanisms of resistance to immunotherapy are associated with host response to the drug. The research also revealed that the advanced bioinformatic analysis and host response identification, characterization and analysis based on proteomic data can help predict patient outcomes with high accuracy.

"This research demonstrates the value of our first of-its-kind profiling platform, which provides a new layer of information, enabling early identification of non-responsiveness to cancer treatments and discovery of new targets to overcome treatment resistance," said Dr. Ofer Sharon, CEO of OncoHost. "Using this platform in clinical settings can help physicians better predict response for NSCLC patients and identify previously unanticipated targets for future interventions and clinical trials."

The ESMO (Free ESMO Whitepaper) Virtual Congress 2020 is taking place September 19-21.

Poster Title: Blood-based proteomic biomarkers for predicting response to immunotherapy in non-small cell lung cancer.
Abstract #: 3213
Presentation #: 1314P

The poster will be available on the ESMO (Free ESMO Whitepaper) website.