On August 11, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported a positive outcome of an interim futility review for the HopES Sarcoma Phase II clinical trial that is evaluating TYME’s lead cancer metabolism-based candidate, SM-88, as a potential oral treatment for patients with Ewing’s Sarcoma and other high-risk sarcomas (Press release, TYME, AUG 11, 2020, View Source [SID1234563447]).

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"It is evident that the salvage cohort will pass the futility test and meet the criteria for expansion," said Sant Chawla, M.D., founder of the Sarcoma Oncology Center, Santa Monica, CA and principal investigator for the HopES Sarcoma trial.

The interim futility review was completed in late July and, based on the analysis of the data and recommendations of Dr. Sant Chawla, the study will proceed with the current trial design as planned. The next major milestone in the HopES Sarcoma trial is expected in calendar year 2021. Sarcomas represents a great unmet medical need and significant opportunity for all stakeholders. There are more than 12,000 patients diagnosed each year without meaningful treatment options.

"We are pleased to have reached this important point in the HopES Sarcoma trial and now await the final results of the trial to determine the potential of oral SM-88 in high-risk sarcomas in an effort to improve the lives of these patients with, what we believe could be, a better safer approach," said Giuseppe Del Priore, M.D., M.P.H., Chief Medical Officer at TYME. "To date, SM-88 has demonstrated encouraging tumor responses in 15 different cancers across four separate studies with minimal serious grade 3 or higher adverse events."

The HopES Sarcoma trial is a prospective open-label Phase II trial evaluating the efficacy and safety of SM-88, with the conditioning agents methoxsalen, phenytoin and sirolimus, in two cohorts of patients. Up to 24 evaluable patients (12 per cohort) will be enrolled. The first cohort will evaluate oral SM-88 as maintenance monotherapy following standard primary or palliative treatments for Ewing’s sarcoma patients with a high risk of relapse or disease progression. The second cohort will determine the clinical benefits of SM-88 as salvage monotherapy for patients with clinically advanced sarcomas. Patient dosing began in January 2020. The Joseph Ahmed Foundation is providing funding and patient support for this investigator-initiated Phase II (HopES) trial of SM-88 in patients with previously treated metastatic sarcoma, sponsored by the Sarcoma Oncology Research Center. The primary objectives are to measure efficacy events, including overall response, stable disease and progression free survival. Secondary objectives include duration of response, overall survival, clinical benefit rate using response evaluation criteria in solid tumors (RECIST 1.1), and incidence of treatment-emergent adverse events. Learn more at TYMETRIALS.com.

About Sarcomas and Ewing’s Sarcoma

Sarcomas are rare cancers in adults but are more common in children. There are approximately 12,0001 new sarcoma cases annually in the U.S. alone. There are many "subtypes" of sarcoma, as it can arise in many tissue structures throughout the body (nerves, muscles, joints, bone, fat, blood vessels – collectively referred to as the body’s "connective tissues"). Sarcomas are most frequently found in the limbs, as this is where the majority of the body’s connective tissues are found but can also present within the sites of more "common" cancers (e.g., breast sarcoma, stomach sarcoma, lung sarcoma, ovarian sarcoma, etc.). Sarcoma cancers often grow hidden deep in the body and are often diagnosed when the tumor size limits effective treatment options.

Ewing’s sarcoma is a primary bone cancer within a group of cancers known collectively as the Ewing’s sarcoma family of tumors. Ewing’s sarcoma is a type of tumor that forms in the bone or soft tissue. It is a rare type of cancer that is often overlooked and receives minimal recognition and research funding. Although Ewing’s sarcoma is typically a pediatric cancer, (it accounts for 30% of bone cancers in children), it can also be found in adults. The most commonly affected areas include the pelvis, thigh, lower leg, upper arm, and chest wall.

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. SM-88 is an investigational therapy that is not approved for any indication in any disease. Learn more.

About the Joseph Ahmed Foundation

The Joseph Ahmed Foundation (JAF) is a 501(c)(3) non-profit organization that was founded in 2016 by the family of Joseph Ahmed, who lost his courageous battle with Ewing’s Sarcoma eight months after his diagnosis on September 1, 2014, at the age of 16. Through their tragic loss and grief, Joseph’s loved ones established the Joseph Ahmed Foundation which is dedicated to raising public awareness for the importance of early detection of the disease, and the urgent need of funding for research and development of innovative treatment and therapies to treat Ewing’s Sarcoma and other forms of pediatric cancer. JAF’s mission is to provide resources for research programs and support services through fundraising, philanthropic donations, corporate sponsorship and grants. JAF is comprised of passionate board members and volunteers who all share the same vision, finding a cure. The foundation can be reached at 212-867-8667. The global website is www.thejosephahmedfoundation.org

On August 11, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported the appointment of Dominic Smethurst, MA, MBChB, MRCP, MFPM as Chief Medical Officer (Press release, Bicycle Therapeutics, AUG 11, 2020, View Source [SID1234563446]). Dr. Smethurst brings to Bicycle extensive expertise in developing bispecific immuno-oncology agents, as well as toxin conjugate therapeutics for cancer and other serious diseases.

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"Given his in-depth knowledge of conventional and disruptive therapeutic modalities, we believe Dominic is uniquely qualified to guide development of Bicycles as potential solutions to many of the limitations faced by small molecule and antibody-based medicines," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "Dominic will be responsible for designing and driving execution of the clinical development plans for our pipeline candidates, all of which currently represent possible first-in-class or best-in-class therapies. Dominic adds a critical capability to our senior leadership team, and we are pleased to welcome him to Bicycle."

"Bicycles are an innovative technology that could lead to potentially game-changing new treatments for diseases where existing medicines are inadequate," said Dominic Smethurst, MA, MBChB, MRCP, MFPM, Chief Medical Officer of Bicycle Therapeutics. "Joining the company presents me with an unparalleled opportunity to advance therapeutic candidates that could potentially shift the treatment paradigm for patients suffering from a wide range of severe medical conditions. I look forward to working closely with Kevin and the rest of the Bicycle team to deliver on the promise of such a potentially impactful new modality."

Dr. Dominic Smethurst has over twenty years of experience working with leading pharmaceutical and biotechnology companies, clinical research institutions, and the UK’s National Health Service (NHS). He was most recently a medical consultant, advising biopharma companies on clinical development strategies and licensing projects. Prior to that, he served as Chief Medical Officer of Tusk Therapeutics, an immuno-oncology company acquired by Roche, where he oversaw development of antibodies targeting CD25 and CD137, among others. Previously, as Vice President Oncology and Global Therapeutic Area Lead at Icon, a global contract research organization, he executed clinical trials involving numerous novel cancer treatments, including CAR-T therapies. Prior to that, Dr. Smethurst held physician leadership roles at AstraZeneca, Amgen and Adaptimmune. Dr. Smethurst is a Member of both the Royal College of Physicians and the Faculty of Pharmaceutical Medicine. He earned an MBChB with Distinction from Addenbrooke’s Clinical School Cambridge, as well as an MA from Christ’s College Cambridge.

On August 11, 2020 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported financial results for the second quarter 2020 and provided an update on clinical and corporate progress (Press release, Affimed, AUG 11, 2020, View Source [SID1234563445]).

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"Affimed’s first half performance demonstrates the strength of the new management team and our ability to stay focused on executing our business strategy despite the continuing challenge of the COVID-19 environment. Always with the patient in mind, we are committed to advancing our pipeline as well as continuing to deepen our research to unlock the full potential of the innate immune system to fight cancer," said Dr. Adi Hoess, CEO of Affimed. "We have multiple Innate Cell Engager (ICE) programs in clinical development, both partnered and wholly-owned, which are the basis for providing a cadence of a continuous data output in 2020 and 2021."

Development Program Updates
AFM13 (CD30/CD16A)

Affimed has now successfully activated 54 clinical study sites in 10 countries in the on-going Phase 2 registration-directed study of AFM13 as monotherapy in relapsed or refractory patients with CD30-positive peripheral T-cell lymphoma (pTCL). The study follows a two-stage Simon design with a preplanned interim analysis after 40 patients. At the current recruitment rate the company expects the readout of the interim analysis to happen in mid-2021.
The investigator-sponsored Phase 1 study with the University of Texas, MD Anderson Cancer Center (MDACC), which investigates the combination of AFM13 with allogeneic NK cells in CD30+ Lymphomas, has completed the required validation work in order to administer a stable complex of AFM13 pre-mixed with cord blood-derived allogeneic NK cells. MDACC has recently posted this study as enrolling on its website and it is expected to recruit patients as soon as the COVID-19 conditions in Texas permit.
AFM24 (EGFR/CD16A)

AFM24-101, a first-in-human Phase 1/2a clinical trial of AFM24, the EGFR/CD16A targeted innate cell engager for relapsed/ refractory patients with advanced EGFR-expressing solid tumors continues to recruit according to plan in cohort 2.
AFM24-101 is an open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study to evaluate AFM24 as monotherapy in adult patients with advanced solid malignancies known to be EGFR-positive.
No dose limiting toxicity was observed in dose cohort 1.
A preclinical poster presentation was shown at the virtual AACR (Free AACR Whitepaper) II conference in June on AFM24, demonstrating that it is differentiated from all other EGFR targeting entities: (i) it appears safe – no skin toxicity or other dose limiting toxicities (DLTs) in cynomolgus monkeys, (ii) it addresses a broad patient population – AFM24 targets EGFR independent of its mutational status, and (iii) in contrast to monoclonal antibodies, AFM24 strongly activates NK cells and macrophages.
Genentech Collaboration Update

The Genentech-partnered, novel BCMA-targeted innate cell engager for the treatment of multiple myeloma has now entered a first-in-human Phase I, open-label, multicenter, global dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of RO7297089. The milestone was achieved in the third quarter and triggers a payment in an undisclosed amount to Affimed, which is expected to be recognized in the Company’s third quarter 2020 financial statements.
At the June virtual AACR (Free AACR Whitepaper) II conference, a preclinical poster presentation on RO7297089 showed potent cell killing in tumor cell lines employing NK cells as effector cells with minimal increase in cytokines. A 4-week safety study in cynomolgus monkeys showed a favorable safety profile with no cytokine release or adverse findings at the 15 and 50 mg/kg tested dose levels. Furthermore, time- and dose-dependent reductions in serum IgG levels and plasma cell markers were observed suggesting selective killing of BCMA positive cells by engaging CD16a positive immune cells.
Preclinical Pipeline Update

Progress continues on AFM28 and AFM32 towards late stage preclinical development.
Management Appointments
Angus Smith joined the company as Chief Financial Officer on July 13. Mr. Smith brings broad biopharmaceutical experience to the company including financial strategy and planning, capital markets, business development and operations. Mr. Smith’s appointment completes the planned additions to the management team which now includes Dr. Andreas Harstrick, Chief Medical Officer and Dr. Arndt Schottelius, Chief Scientific Officer.
Additions to the Supervisory Board
Dr. Annalisa Jenkins and Harry Welten were appointed to the Supervisory Board during the recent Annual General Meeting of Shareholders. Dr. Jenkins brings a wealth of expertise in advancing clinical programs through development and regulatory approval. Mr. Welten is an accomplished financial executive who is well suited to help drive value-creating strategies for the company. These additions to the Supervisory Board are expected to further strengthen the company’s industry know-how, experience and diversity.
Second Quarter 2020 Financial Highlights
(Figures for the second quarter ended June 30, 2020 and 2019 are unaudited.)

As of June 30, 2020, cash, cash equivalents and current financial assets totaled €92.6 million compared to €104.1 million on December 31, 2019. During the quarter, the company received net proceeds of approximately €20.8 million under its at-the-market ("ATM") program.

Based on its current operating plan and assumptions, Affimed anticipates that its cash, cash equivalents and current financial assets will support operations into the first half of 2022.

Net cash used in operating activities for the quarter ended June 30, 2020 was €15.0 million compared to €5.6 million in the second quarter of 2019. The second quarter 2019 net cash used in operating activities included a milestone payment to the company from the Genentech collaboration.

Total revenue for the second quarter of 2020 was €2.9 million compared with €4.0 million in the second quarter of 2019. Revenue in 2020 and 2019 predominantly relate to the Genentech collaboration (2020: €2.7 million, 2019: €3.7 million). Revenue from the Genentech collaboration in the second quarter 2020 was comprised of revenue recognized for collaborative research services performed during the quarter.

R&D expenses for the second quarter of 2020 were €11.7 million compared to €11.5 million in the second quarter of 2019. Expenses in 2020 relate predominantly to our AFM13 and AFM24 clinical programs as well as to our early stage development and discovery activities.

G&A expenses for the second quarter of 2020 were €2.6 million compared to €2.3 million in the second quarter of 2019. The increase is primarily related to higher Sarbanes-Oxley compliance costs, as well as an increase in legal, consulting and audit costs.

Net loss for the second quarter of 2020 was €12.2 million or €0.16 per common share. For the second quarter of 2019, the company’s net loss was €10.3 million or €0.17 per common share.

Weighted number of common shares outstanding for the quarter ended June 30, 2020 were 79.2 million.

Affimed encourages shareholders to also review its 6-K filing for the quarter ended June 30, 2020, as filed with the United States Securities and Exchange Commission.

Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information
Affimed will host a conference call and webcast today, Tuesday, August 11, 2020 at 8:30 a.m. EDT to discuss second quarter 2020 financial results and recent corporate developments. The conference call will be available via phone and webcast.
To access the call, please dial +1 (646) 741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference passcode 8855368 approximately 15 minutes prior to the call.
A live audio webcast of the conference call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source A replay of the webcast will be accessible at the same link for 30 days following the call.

On August 11, 2020 4SC AG (4SC, FSE Prime Standard: VSC) reported its Half-Year Report 2020, presenting all material developments up to 30 June 2020 and the Company’s current outlook (Press release, 4SC, AUG 11, 2020, View Source [SID1234563444]). The full communication is available for download on 4SC’s website.

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Jason Loveridge, Ph.D., CEO of 4SC, commented: "4SC made good progress on both its development programs in early 2020, but reflecting the broader sector, was almost totally focused on coping with the impact of the global coronavirus crisis for the majority of the first half of the year. 4SC was forced to impose a temporary suspension on new recruitment in all of its active clinical studies and our clinical team worked overtime to ensure the safety of patients, the quality of data in our ongoing studies, the rapid reopening of the majority of our key studies, and progressing studies in preparation for patient recruitment. We are hoping for a more normal second half of 2020 and remain committed to progressing our drug candidates as quickly and safely as conditions allow".

Key highlight in Q2 2020

FDA accepted Investigational New Drug (IND) application for domatinostat in combination with avelumab (Bavencio) in the MERKLIN 2 study.

2020 Business outlook

Domatinostat

Publish updated data from the SENSITIZE study in melanoma patients refractory to checkpoint blockade
Complete the Phase IIa part of EMERGE study in micro-satellite stable gastrointestinal cancers
Initiate (first patient enrolled) the Phase IIb part of the EMERGE study
Initiate (first patient enrolled) the MERKLIN 2 study in Merkel cell carcinoma patients who are refractory to checkpoint blockade
Complete recruitment of the DONIMI study of domatinostat in the neoadjuvant setting in melanoma
Resminostat

Advance recruitment in the pivotal RESMAIN study so as to see the 125 events required to unblind the study in 2021

Development of cash balance in H1 2020 and financial forecast

At the end of the first half year of 2020, 4SC holds cash balance/funds of €35.165 million as compared to €45.765 million as of 31 December 2019. The monthly use of cash from operations amounted to €1.593 million on average in the first half year of 2020 (H1 2019: €1.185 million) and was below the former range of €2.2 million and €2.6 million forecast for 2020. Based on current financial and operating activities, the Management Board is expecting a lower average monthly cash burn from operations of between €2.0 million and €2.4 million for 2020 as compared to the earlier assumptions of €2.2 million to €2.6 million.

The increase in the monthly use of cash as compared to H1 2019, and the decrease in cash balance/funds in the first half year of 2020 as compared to the end of 2019, were both predominantly due to costs for the ongoing clinical studies RESMAIN and SENSITIZE and mainly a result of the expansion of clinical programs for domatinostat, especially for the preparation of the clinical activities for the MERKLIN 2 study.

The Management Board of 4SC assumes that the funds should be sufficient to finance 4SC into the second half of 2021.

On August 11, 2020 Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, reported its financial results and operational highlights for the second quarter ended June 30, 2020 (Press release, Novavax, AUG 11, 2020, View Source [SID1234563443]).

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"Novavax’ unprecedented development activities for NVX-CoV2373 and progress continued through the second quarter," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "Since identifying a candidate vaccine to address the COVID-19 pandemic in March, we’ve secured significant funding, implemented global manufacturing capacity and completed and reported our successful Phase 1 trial. We’ve also expanded our senior leadership team to advance our efforts to bring NVX-CoV2373 to market as rapidly as possible and grow our infrastructure to support commercial stage operations."

Second Quarter 2020 and Recent Highlights

COVID-19 Program

Announced Phase 1 data from its Phase 1/2 randomized, observer-blinded, placebo-controlled clinical trial of NVX-CoV2373 in healthy adults 18-59 years of age
— Neutralization levels numerically superior to convalescent serum
— Significantly higher immune response with 2-dose, Matrix-MTM adjuvanted vaccine
— Strong T cell responses
— Reassuringly safe and tolerable vaccine profile
— Presentation included on Novavax website here
— Data submitted for peer-review publication and posted to online preprint server at medRxiv.org

Demonstrated protection and high immunogenicity in animal models
— Presented data from non-human primate models that demonstrate protection in challenge studies, enhancement of multifunctional T cells, and production of anti-S IgG and neutralizing antibodies
— Data submitted for peer-review publication and posted to online preprint server at medRxiv.org

Secured $2 billion in funding for development and commercialization of NVX-CoV2373
— Coalition for Epidemic Preparedness Innovations (CEPI) funding up to $388 million
— U.S. Department of Defense (DoD) funding up to $60 million
— U.S. Government funding through Operation Warp Speed (OWS) up to $1.6 billion

Completed collaborations for global development and commercialization of NVX-CoV2373
— Partnered with Takeda Pharmaceutical Company Limited for development, manufacture and commercialization in Japan
— Novavax to receive payments based on achievement of certain development and commercial milestones
— Novavax shares in proceeds from vaccine sales
— Partnered with Serum Institute of India for development and commercialization in India and low- and middle-income countries (LMIC)
— Novavax and Serum Institute will split revenue from sale of product, net of agreed costs

Secured global manufacturing capacity for NVX-CoV2373
— Acquired Praha Vaccines in a cash transaction of approximately $167 million
— Includes biologics manufacturing facility and related assets in Czech Republic
— Facility expected to provide annual capacity approaching 1 billion antigen doses starting in 2021
— Entered into agreements with FUJIFILM Diosynth Biotechnologies’ (FDB) to manufacture bulk drug substance at facilities in North Carolina and Texas
— Large scale manufacturing initiated at FDB North Carolina site
— Entered into manufacturing arrangements with AGC Biologics and PolyPeptide Group for large-scale production of Novavax’ Matrix-M adjuvant in both U.S. and Europe
NanoFlu Program

Successful pivotal NanoFlu Phase 3 clinical trial announced in March 2020
— Added important immunogenicity data regarding development of robust T cell mediated responses
— All results expected to support future BLA submission using U.S. FDA accelerated approval pathway
— Company exploring pathways to manufacture for required lot consistency clinical trial

Phase 2 and Phase 3 data submitted for peer-review publications and posted to online preprint server at medRxiv.org
Corporate

Strengthened leadership with numerous executive management promotions and hiring
Appointed David M. Mott to Novavax’ Board of Directors
— Brings more than three decades of global management, board and investment experience across multiple private and public biopharmaceutical companies
Financial Results for the Three and Six Months Ended June 30, 2020

Novavax reported a net loss of $17.5 million, or $0.30 per share, for the second quarter of 2020, compared to a net loss of $39.6 million, or $1.69 per share, for the second quarter of 2019. For the six months ended June 30, 2020, the net loss was $43.4 million, or $0.84 per share, compared to a net loss of $82.8 million, or $3.77 per share, for the same period in 2019.

Novavax revenue in the second quarter of 2020 was $35.5 million, compared to $3.4 million in the same period in 2019. This significant increase was due to increased development activities relating to NVX-CoV2373 under the CEPI agreement.

Research and development expenses increased 15% to $34.8 million in the second quarter of 2020, compared to $30.4 million in the same period in 2019. The increase was primarily due to increased development activities relating to NVX-CoV2373 under the CEPI agreement, partially offset by decreased employee-related and other costs and development activities of ResVax as compared to the same period in 2019.

General and administrative expenses increased 84% to $17.7 million in the second quarter of 2020, compared to $9.6 million for the same period in 2019. This increase was primarily due to increased professional fees relating to the Novavax CZ acquisition and supporting our NVX-CoV2373 program and increased employee-related expenses.

As of June 30, 2020, Novavax had $609.5 million in cash, cash equivalents, marketable securities and restricted cash, compared to $82.2 million as of December 31, 2019. Net cash provided by operating activities for the first six months of 2020 was $92.5 million, compared to net cash used in operating activities was $80.6 million for same period in 2019.

Novavax has continued to strengthen its balance sheet. Recent activities include:

In June, Novavax entered into an agreement to sell Series A Convertible preferred stock, convertible into 4,388,850 shares of common stock, to an investment fund affiliated with RA Capital Management (RA Capital) in a private placement. Novavax received gross proceeds of $200 million.

Through utilization of at-the-market (ATM) offerings during the second quarter of 2020, Novavax raised net proceeds of $206.3 million and a total of $392.3 million since the beginning of the year.
Conference Call

Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (866) 923-9367 (Domestic) or (707) 287-9331 (International), passcode 3048947. A replay of the conference call will be available starting at 7:30 p.m. ET on August 10, 2020 until 7:30 p.m. ET on August 17, 2020. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 3048947.

A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "For Investors"/"Events" tab on the Novavax website. A replay of the webcast will be available on the Novavax website until November 10, 2020.

About NVX-CoV2373

NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 portion of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Novavax was awarded $1.6 billion by the federal government as part of Operation Warp Speed (OWS), a U.S. government program to deliver millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373 beginning as early as late 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is also investing up to $388 million, and Department of Defense (DoD) is investing up to $60 million of funding to advance clinical development of NVX‑CoV2373.

About NanoFlu

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix‑M adjuvant.

About Matrix-M

Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.