On November 10, 2022 Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported financial results and business highlights for the quarter ended September 30, 2022 (Press release, Aptevo Therapeutics, NOV 10, 2022, View Source [SID1234623761]).

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Business Highlights

Presenting new Phase 1b expansion trial data for APVO436 in the treatment of Acute Myeloid Leukemia (AML) at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held December 10-13 in New Orleans, Louisiana
The poster, entitled "Updated Results from a Phase 1 Study of APVO436, a Novel Bispecific Anti-CD123 x Anti-CD3 ADAPTIR Molecule, in Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome"​ will be presented on Sunday, December 11, 2022 from 6:00 PM-8:00 PM Central time
Announced that the US Food and Drug Administration (FDA) issued a "may proceed" notification for the ALG.APV-527 investigational new drug application (IND), allowing the initiation of clinical trials evaluating the compound for the treatment of 5T4-expressing tumors in multiple solid tumor types
Continued dosing patients in the Company’s Phase 1b expansion program evaluating APVO436 for the treatment of acute myeloid leukemia in both combination therapy and monotherapy
"We are very excited to present our APVO436 expansion phase data at the upcoming ASH (Free ASH Whitepaper) meeting, fulfilling a promise we made earlier in the year and further underscoring our enthusiasm for the compound and rationale for its continued advancement in the clinic. We are also working to rapidly progress ALG.APV-527 in the clinic for evaluation in the treatment of solid tumors. Advancing our work across these programs will put us in a strong position to produce meaningful data readouts across our clinical programs in 2023," said Marvin White, President and CEO of Aptevo. Mr. White added "The combination of our existing cash and future expected milestone payments provides us sufficient runway to conduct our business for at least the next twelve months."

Third Quarter 2022 Financial Results Summary

Cash Position: Aptevo had cash, cash equivalents and restricted cash of $22.6 million as of September 30, 2022. This includes $0.4 million of restricted cash that was released in October 2022.

Royalty Revenue: For the three months ended September 30, 2022 and September 30, 2021, royalty revenue was $0 and $3.1 million, respectively. Royalty revenue for the period covered by this report reflects revenue recorded only in the first quarter of 2022 due to our Amendment to Royalty Purchase Agreement with HCR. As a result of the Amendment, we ceased reporting as royalty revenue royalties paid by Pfizer to HCR related to Pfizer’s sales of RUXIENCE (rituximab-pvvr). The last quarter for which we reported this royalty revenue was Q1 2022. The Amendment was effected to address a Nasdaq compliance matter and had the additional effect of eliminating the requirement to report all future Pfizer non-cash royalty revenue and extinguishing the liability that we recorded upon the initial sale of the royalties to HCR.

The Amendment does not affect the potential $22.5 million in milestone payments we may collect in the future based on achievement of RUXIENCE sales thresholds in 2022 and 2023 (up to $12.5 million related to 2022 sales and $10 million related to 2023 sales). RUXIENCE is a registered trademark of Pfizer.

Research and Development Expenses: For the three months ended September 30, 2022, research and development expenses increased by $0.1 million, to $4.5 million from $4.4 million for September 30, 2021. The increase is primarily due to higher spending on our APVO436 clinical trial as we continue to advance that trial in our Phase 1b expansion program.

General and Administrative Expenses: For the three months ended September 30, 2022, general and administrative expenses decreased by $0.2 million, to $3.3 million from $3.5 million for September 30, 2021. The decrease is primarily due to lower employee and consulting costs.

Other Income (Expense), Net: Other income (expense), net consists primarily of gain on extinguishment of liabilities, costs related to debt extinguishment, accrued exit fees on debt, non-cash interest on financing agreements, and interest on debt. Other expense, net was $0.3 million for the three months ended September 30, 2022, as compared to $2.3 million other expense, net for the three months ended September 30, 2021. The decrease is primarily due to no non-cash interest expense recorded during the period due to our Amendment to Royalty Purchase Agreement. Additionally, interest expense on our MidCap Credit Agreement has decreased due to principal payments made in 2022.

Discontinued Operations: For the three months ended September 30, 2022 and 2021, we collected $0.2 and $0.1 million in deferred payments from Medexus related to IXINITY sales, respectively. Pursuant to our LLC Purchase Agreement, the rate for deferred payments increased from 2% to 5% of net sales as of June 30, 2022.

Net Income (Loss): Aptevo’s net loss for the three months ended September 30, 2022, was $7.6 million or $1.50 per share, as compared to a net loss of $6.9 million or $1.43 per share for the corresponding period in 2021.

On November 10, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported the presentation of non-clinical and clinical data supporting the immune activating activity of ST101 at the SITC (Free SITC Whitepaper) 37th Annual Meeting in Boston, MA (Press release, Sapience Therapeutics, NOV 10, 2022, View Source [SID1234623760]). ST101 is a first-in-class antagonist of C/EBPβ, currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279).

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C/EBPβ is a leucine zipper family transcription factor that regulates macrophage differentiation, promoting the expression of M2 myeloid-derived suppressor cells (MDSCs) that contribute to suppression of antitumor immunity and correlate with poor prognosis. ST101 binds to C/EBPβ, preventing its dimerization and enhancing ubiquitin-proteasome dependent C/EBPβ degradation, resulting in repolarizing MDSCs from the immunosuppressive M2 to the pro-inflammatory M1 phenotype. In non-clinical studies, ST101 exposure to human peripheral blood mononuclear cells resulted in dose-dependent reduction in M2 macrophage and corresponding induction of pro-inflammatory M1 macrophage. At the highest ST101 concentration, a 40-fold increase in the M1/M2 ratio was observed. Validating these findings, subtherapeutic doses of ST101 significantly enhanced the anti-tumor activity of anti-PD1 antibodies in an orthotopic breast cancer tumor model. Sapience believes that reprogramming MDSCs from the M2 to the M1 phenotype represents a potential strategy to enhance antitumor immunity.

"These data validate the potential of ST101 to reprogram the tumor microenvironment to promote a more active immune system, which supports a novel, macrophage-driven mechanism of action for ST101," said Sapience CEO and President, Dr. Barry Kappel. "We are eager to broaden the development strategy of ST101 and explore combinations with immune-oncology molecules, such as checkpoint inhibitors, to treat solid tumor cancers with high unmet need."

"We are thrilled to present these data at SITC (Free SITC Whitepaper) 2022, the premier scientific meeting that showcases novel immunotherapy approaches for cancer," added Jim Rotolo, Ph.D., Sapience’s VP, Translational Pharmacology and Head of Research. "These data further elucidate the unique mechanism of action for ST101 and build upon our recent publication in Molecular Cancer Therapeutics, highlighting the therapeutic promise of disrupting C/EBPβ-driven oncogenic activity. We look forward to exploring the activity of ST101 in immune-oncology therapeutic strategies."

Further details of the ST101 mechanism of action can be found on the company’s website: ST101: Sapience Therapeutics, Inc.

SITC Poster Presentation Details:
Title: "ST101, a peptide antagonist of novel I/O target CEBPβ, reprograms MDSC polarization and decreases tumor-associated Tregs, suggesting an immune component to observed clinical responses"
Abstract Number: 1173
Location: Poster Hall C
Date/Time: Thursday, November 10, 2022 – Friday, November 11, 2022, 9am-9pm

The Sapience SITC (Free SITC Whitepaper) poster has been published as a supplement in the Journal for ImmunoTherapy of Cancer (JITC), the society’s global, open access, peer-reviewed journal, and is available on the Presentations section of the company’s website: Presentations :: Sapience Therapeutics, Inc.

About ST101
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: Phase 1 dose escalation/regimen exploration and Phase 2 dose expansion. In the ongoing Phase 2 dose expansion, Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, castration-resistant prostate cancer and locally advanced or metastatic hormone-receptor positive breast cancer. In the ongoing dose escalation part of the study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM and evidence of long-lasting stable disease in several additional patients.

ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.

On November 10, 2022 Theriva Biologics (NYSE American: TOVX), ("Theriva" or the "Company"), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported that it plans to host a conference call on Friday, November 11, 2022, at 8:30 a.m. ET to discuss its financial results for the quarter ended September 30, 2022 and provide a corporate update (Press release, Theriva Biologics, NOV 10, 2022, View Source [SID1234623759]). The call was originally scheduled for Thursday, November 10, 2022, at 8:30 a.m. ET.

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Individuals may participate in the live call via telephone by dialing 1-888-254-3590 (domestic) or 1-929-477-0402 (international) and using the conference ID: 5687287. Participants are asked to dial in 15 minutes before the start of the call to register. Investors and the public can access the live and archived webcast of this call via the "Investors" section of the company’s website, View Source, under "Events" or by clicking here, for 90 days after the call.

On November 10, 2022 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the three and nine months ended September 30, 2022, and provided a business update (Press release, Altimmune, NOV 10, 2022, View Source [SID1234623758]).

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"We continue on course in our advancement of pemvidutide for two important clinical indications, obesity and non-alcoholic steatohepatitis (NASH), and look forward to data readouts from our NAFLD trial extension in mid-December 2022 and from our interim 24-week readout on approximately 160 subjects from our MOMENTUM Phase 2 obesity trial in Q1 2023," said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune.

"We believe that the promising reductions in liver fat content and alanine aminotransferase (ALT) levels observed in our recently completed 12-week Phase 1b NAFLD trial should translate into success on the approvable NASH endpoints, including NASH resolution and fibrosis improvement, in late-phase biopsy trials. The magnitude of the effects on the liver combined with meaningful reductions in body weight could represent important points of differentiation from other drugs in development for NASH."

Dr. Garg added, "Turning to our MOMENTUM obesity trial, we believe that the level of weight loss we expect to see at 48 weeks will be similar to the leading drugs in the class. The trial is being conducted in a typical obesity population at established obesity trial sites and employs lifestyle interventions that are standard in obesity trials. We believe the absence of dose titration, together with the favorable tolerability profile, reductions in serum lipids and reductions in liver fat content observed in clinical trials to date, could translate into greater ease of administration, improved adherence to therapy and greater potential for cardiovascular benefit in this patient population."

Recent Highlights and Anticipated Milestones:

Pemvidutide

Topline data readout from 12-week Phase 1b NAFLD trial in September 2022
This trial was conducted in the U.S., with Dr. Stephen A. Harrison, Director, Pinnacle Research and University of Oxford, serving as Principal Investigator.
A total of 94 subjects were randomized and dosed, with approximately 80% being of Hispanic ethnicity, and with a median liver fat content of approximately 22%.
A 68.5% relative reduction in liver fat content was achieved at the 1.8 mg dose at Week 12, with 94.4% of subjects achieving a 30% reduction of liver fat and 55.6% achieving normalization of liver fat, defined as 5% or less on MRI-PDFF, at Week 12.
As announced in a late-breaking abstract presented on November 7, 2022, at the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Washington, DC, greater than 83% of subjects who received pemvidutide and who participated in a corrected T1 (cT1) imaging sub-study achieved an 80 millisecond (ms) or more reduction in cT1 relaxation times at Week 12 at each pemvidutide dose. Elevated cT1 scores have been correlated with hepatic and cardiovascular events in clinical studies. An 80 ms reduction has been shown to correlate with a 2-point improvement in NAFLD Activity Score on liver biopsies.

Topline 24-week data from NAFLD trial (12-week extension) expected mid-December 2022
This extension trial provides 12 weeks of additional treatment to subjects with NAFLD who completed the 12-week Phase 1b trial, allowing subjects to receive a total of 24 weeks of treatment.
Although the extension trial was initiated several months after the start of the original 12-week Phase 1b NAFLD trial, a total of 66 of 94 subjects (70%) rolled over into this trial.
Randomization and first dosing of all subjects is complete in 48-week Phase 2 MOMENTUM obesity trial – 24-week interim analysis of approximately 160 subjects expected in Q1 2023
This Phase 2 trial is being conducted at 30 sites across the U.S., with Dr. Lou Aronne, Professor of Clinical Medicine, Weill Cornell Medical College, a leading authority in obesity and obesity clinical trials, serving as the Principal Investigator.
The trial was designed to enroll approximately 320 non-diabetic subjects with obesity, or overweight with at least one co-morbidity. Subjects were randomized 1:1:1:1 to 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise. Baseline characteristics of the study population include median body weight and body mass index (BMI) of approximately 101 kg and 36 kg/m2, respectively, and median liver fat content of approximately 5%, as measured in approximately 100 subjects participating in a body composition sub-study. The study population is approximately 75% female, and approximately 20% of subjects are of Hispanic ethnicity.
The primary endpoint is the relative (percent) change in body weight at 48 weeks compared to baseline. Additional readouts include metabolic and lipid profiles, cardiovascular measures and glucose homeostasis.
A 24-week interim analysis on approximately 160 subjects is planned in Q1 2023.
Enrollment complete in Phase 1b trial of subjects with type 2 diabetes
This 12-week safety trial will evaluate the effects of pemvidutide in approximately 48 subjects with type 2 diabetes and obesity or overweight.
Data readout is expected in Q1 2023.
HepTcell

Enrollment continuing in the Phase 2 clinical trial in chronic hepatitis B
Endpoints include virological markers of hepatitis B infection and functional cure.
Data readout is expected in H2 2023.
Financial Results for the Three Months Ended September 30, 2022

Altimmune had cash, cash equivalents and short-term investments totaling $201.9 million at September 30, 2022.
Revenue was minimal for the three months ended September 30, 2022 compared to $0.2 million in the same period in 2021. The change in revenue quarter over quarter was primarily due to the discontinuation of development activities for the T-COVID and NasoShield programs in 2021.
Research and development expenses were $20.3 million for the three months ended September 30, 2022, compared to $29.2 million in the same period in 2021. The expenses for the quarter ended September 30, 2022 included $14.0 million in direct costs related to development activities for pemvidutide and $1.8 million in direct costs related to development activities for HepTcell.
General and administrative expenses were $4.5 million for the three months ended September 30, 2022, compared to $4.2 million in the same period in 2021. The change was primarily attributable to increased stock compensation expense.
Net loss for the three months ended September 30, 2022 was $23.5 million, or $0.48 net loss per share, compared to a net loss of $33.5 million, or $0.81 net loss per share, in the same period in 2021.

Conference Call Information:

Date: Thursday, November 10, 2022
Time: 8:30 am Eastern Time
Webcast: The conference call will be webcast live on Altimmune’s Investor Relations website at View Source
Dial-in: Participants who would like to join the call may register here to receive the dial-in numbers and unique PIN to access the call.

Following the conclusion of the call, the webcast will be available for replay on the Investor Relations page of the Company’s website at www.altimmune.com. The Company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

About Pemvidutide

Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and NASH. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Pemvidutide incorporates the EuPortTM domain, a proprietary technology that increases its serum half-life for weekly dosing while slowing the entry of pemvidutide into the bloodstream, which may improve its tolerability. In a 12-week Phase 1b clinical trial, NAFLD subjects treated with pemvidutide demonstrated promising reductions in liver fat content, serum ALT levels and body weight.

About HepTcell

HepTcell is a novel, investigational, immunotherapeutic comprised of nine synthetic peptides representing conserved hepatitis B (HBV) sequences formulated with IC31, a TLR9-based adjuvant from Valneva SE. The HBV-directed peptides are designed to drive T cell responses against all HBV genotypes towards a functional cure for chronic HBV in patients of diverse genetic backgrounds.

On November 10, 2022 Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, reported its financial results and operational highlights for the third quarter ended September 30, 2022 (Press release, Novavax, NOV 10, 2022, View Source,sales%20to%20our%20license%20partners. [SID1234623754]).

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"Our progress in the third quarter continued as we successfully expanded our COVID-19 vaccine’s label, achieved policy recommendations globally and expanded our body of clinical evidence supporting the differentiated benefit of our vaccine technology," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "New data that we announced today reaffirms the broad immune responses of NVX-CoV2373 against circulating variants. Additionally, based on our most recent Phase 1/2 trial results for our COVID-19-Influenza Combination (CIC) vaccine candidate, we look forward to initiating our Phase 2 clinical trial by the end of this year."

Third Quarter 2022 and Recent Highlights

Expanded COVID-19 Vaccine in Adult Population Aged 18 and Older

Nuvaxovid booster authorized for emergency use in the U.S., European Union (EU), Switzerland, United Arab Emirates (UAE) and New Zealand, with submissions completed to World Health Organization (WHO), as well as in Great Britain and South Korea
Recommendations provided by U.S. Centers for Disease Control and Prevention (CDC), E.U.’s Committee for Medicinal Products for Human Use and Switzerland’s Federal Office of Public Health

Nuvaxovid granted import and use permit in Israel for primary series and as a booster

Covovax granted full product registration in South Africa for primary series
Expanded COVID-19 Vaccine in Adolescent Population Aged 12 Through 17

Nuvaxovid primary series authorized for emergency use in the U.S., EU, Japan, Great Britain, Australia, South Korea, Taiwan, Switzerland, Thailand, UAE and New Zealand, with submissions completed to WHO and in Singapore
Recommendation provided by U.S. CDC

Nuvaxovid granted import and use permit in Israel for primary series and as a booster
COVID-19 Vaccine Manufacturing and Supply

Delivered over 94 million doses of NVX-CoV2373 globally to date

Completed submission to add Novavax Czech Republic as an EU manufacturing site

Solidified manufacturing and supply network ensuring capacity to support ongoing global demand
COVID-19 Clinical Development Program

Announced topline results from Phase 3 Boosting Trial for Omicron BA.1 vaccine candidate (NVX-CoV2515), meeting the primary strain-change endpoint and reaffirming that prototype vaccine induces broadly cross-reactive responses, suggesting utility against current and future variants

PREVENT-19 Phase 3 NVX-CoV2373 homologous booster data support benefits against variants
Following a single homologous booster dose, adult participants demonstrated increased anti-spike IgG levels and increased functional antibody levels measured by hACE2 receptor inhibition against Omicron BA.1, BA.2 and BA.5 variants, approximating levels observed in our Phase 3 efficacy studies
Robust booster responses were consistent between younger (less than 65 years of age) and older (greater than 65 years of age) adults, and independent of whether the booster dose was administered eight or 11 months after the primary series, offering further evidence of broad utility and duration of response with NVX-CoV2373
Adolescent participants following a single booster dose demonstrated neutralizing titers were 2.7-fold higher than those seen with primary vaccination and a broad antibody response against Omicron BA.1, BA.2 and BA.5 variants

Demonstrated NVX-CoV2373 induced consistent immune responses when boosted on top of mRNA or AD26 vaccines, and achieved primary endpoint of Lot Consistency study for adults aged 18 through 49, demonstrating a consistent manufacturing process
When used as a heterologous boost (after either 2 or 3 doses of mRNA OR 1 or 2 doses of AD26) NVX-CoV2373 generated antibody levels previously found to be related to efficacy in the PREVENT-19 Phase 3 trial

Initiated Phase 2b/3 Hummingbird global clinical trial for NVX-CoV2373 in younger children aged six months through 11 years, enrolling the sentinel cohort in the first group aged six through 11 years in the U.S.
Based on initial supportive safety and tolerability data analyzed by an independent Safety and Monitoring Committee, progressed to recruiting the full age cohort
COVID-19-Influenza Combination (CIC) Vaccine Candidate Clinical Development

Announced positive cellular immunity results of CIC Phase 1/2 trial following initial results announced in April, demonstrating ability to generate immune responses, including both antibody and polyfunctional CD4+ T-cell responses, against SARS-CoV-2 and homologous and heterologous influenza strains
Generated robust antibody responses against both prototype and Omicron BA.1 strains of SARS-CoV-2 and influenza antigens
Safety and tolerability profile was consistent with standalone NVX-CoV2373 prototype vaccine and quadrivalent influenza vaccine candidate
Phase 2 trial expected to begin by the end of 2022
Corporate Highlights

Strengthened corporate leadership with appointment of a new board member and executive promotions
Rick Rodgers appointed to Board of Directors
Silvia Taylor promoted to Executive Vice President, Chief Communications Officer
Henrietta Ukwu, M.D. promoted to Executive Vice President, Chief Regulatory Officer
Financial Results for the Three Months Ended September 30, 2022

Total revenue for the third quarter of 2022 was $735 million, compared to $179 million for the comparable period in 2021. Third quarter of 2022 total revenue includes $628 million of revenue comprised of $626 million of product sales from NVX-CoV2373 based on the sale of 35 million doses sold by Novavax and $2 million of royalties, milestone and adjuvant sales to our license partners. Grant revenue of $106 million in the third quarter of 2022 compared to $135 million in the prior year resulted from a decrease in activity under our agreements with the Coalition for Epidemic Preparedness Innovations.

Cost of sales for the third quarter of 2022 were $435 million. This includes $249 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments under our third-party supply agreements. During 2021 and prior to receipt of regulatory authorizations for NVX-CoV2373, certain manufacturing costs were expensed to research and development that would otherwise have been capitalized to inventory. Cost of sales valued at expected standard costs, including expenses related to excess and obsolete inventory, would have been approximately $444 million.

Research and development expenses for the third quarter of 2022 were $304 million compared to $408 million for the comparable period in 2021. The decrease was primarily the result of a $98 million benefit from the settlement of a manufacturing agreement.

Selling, general and administrative expenses for the third quarter of 2022 were $123 million compared to $78 million for the comparable period in 2021. The increase in the period was the result of activities in support of the commercialization of NVX-CoV2373.

Net loss for the third quarter of 2022 was $169 million compared to a net loss of $322 million for the comparable period in 2021.

Cash, cash equivalents, and restricted cash were $1.3 billion as of September 30, 2022, compared to $1.5 billion as of December 31, 2021.
Financial Guidance

Refining full year 2022 total revenue guidance, to approximately $2.0 billion, the low end of the previous guidance of $2.0 to $2.3 billion. Total revenue reflects all sources, including product sales of Nuvaxovid by Novavax, grants revenue, royalties and other revenue.

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 (833) 974-2381 (Domestic) or (412) 317-5774 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 7:30 p.m. ET on November 8, 2022 until 11:59 p.m. ET on November 15, 2022. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 3408655.

A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until February 8, 2023.

Trade Name in the U.S.

The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein and is formulated with Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

The vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.

Novavax has established partnerships for the manufacture, commercialization, and distribution of the vaccine worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax’ global supply chain.

About Matrix-M Adjuvant

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.

About Novavax’ Influenza Program

Novavax’ influenza vaccine, previously known as NanoFlu, is a quadrivalent recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. The influenza vaccine uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences, and contains Novavax’ patented saponin-based Matrix-M adjuvant. This investigational candidate was evaluated during a controlled phase 3 trial conducted during the 2019-2020 influenza season.