On November 12, 2021 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended September 30, 2021 (Press release, Soligenix, NOV 12, 2021, View Source [SID1234595487]).

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Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "There continues to be a great deal of activity across our Specialized BioTherapeutics and Public Health Solutions business segments. We continue to work diligently to prepare the new drug application (NDA) for HyBryte (SGX301 or synthetic hypericin) following the positive pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in cutaneous T-cell lymphoma (CTCL). The Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) granted orphan drug designation to the active ingredient hypericin for the treatment of T-cell lymphoma, expanding the treatment population beyond CTCL. Additionally, we announced expansion of synthetic hypericin development into psoriasis, under the research name SGX302, where we plan to initiate a Phase 2a clinical study in the second half of 2022. This decision follows validation of synthetic hypericin’s biologic activity in the FLASH study, as well as positive proof-of-concept (PoC) demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients, a large and underserved market with a significant unmet medical need. Under our Public Health Solutions business segment, we remain focused on developing heat-stable vaccines for global use. Most notably, we announced publication of compelling pre-clinical immunogenicity studies for CiVax (heat stable COVID-19 vaccine program) demonstrating durable broad-spectrum neutralizing antibody responses in non-human primates (NHPs), including against the Beta, Gamma and Delta variants."

Dr. Schaber continued, "With approximately $29 million in cash, not including our non-dilutive government funding, we anticipate having the necessary capital to achieve our upcoming milestones, including NDA filing and expansion into psoriasis with the conduct of the Phase 2a clinical trial. We are also continuing to actively assess various strategic options, including but not limited to, partnership and merger and acquisition opportunities."

Soligenix Recent Accomplishments

On November 8, 2021, the Company announced it had been granted a Pediatric Investigation Plan (PIP) product-specific waiver in the United Kingdom from the Medicines and Healthcare products Regulatory Agency for HyBryte in the treatment of CTCL. To view this press release, please click here.
On November 4, 2021, the Company announced the publication of pre-clinical immunogenicity studies for RiVax (heat stable ricin toxin vaccine) demonstrating enduring protection for at least 12 months post-vaccination. The article titled "Durable Immunity to Ricin Toxin Elicited by a Thermostable, Lyophilized Subunit Vaccine" has been accepted for publication in the journal mSphere. To read the publication, please click here. To view this press release, please click here.
On September 28, 2021, the Company announced the publication of pre-clinical immunogenicity studies for CiVax demonstrating durable broad-spectrum neutralizing antibody responses, including against the Beta, Gamma and Delta variants of concern. The article, titled "Protein Vaccine Induces a Durable, More Broadly Neutralizing Antibody Response in Macaques than Natural Infection with SARS-CoV-2 P.1", has been posted as an accelerated preprint on bioRxiv. To view the publication, please click here. To view this press release, please click here.
On September 16, 2021, the Company announced that following the validation of synthetic hypericin’s biologic activity in the positive pivotal Phase 3 FLASH study in CTCL, as well as PoC demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients, the Company will be expanding this novel therapy under the research name SGX302 into psoriasis, a large and underserved market affecting between 60-125 million people worldwide. To view this press release, please click here.
On September 9, 2021, the Company announced that the Office of Orphan Products Development of the U.S. FDA had granted orphan drug designation to the active ingredient hypericin for the treatment of T-cell lymphoma, extending the target population beyond CTCL as previously granted. To view this press release, please click here.
On August 23, 2021, the Company announced a publication describing the formulation of single-vial platform presentations of monovalent (single antigen), bivalent (two antigens) and trivalent (three antigens) combinations of filovirus vaccine candidates. In collaboration with University of Hawaiʻi at Mānoa (UHM) and University of Colorado co-authors, the manuscript titled "Single-Vial Filovirus Glycoprotein Vaccines: Biophysical Characteristics and Immunogenicity after Co-lyophilization with Adjuvant", has been published in Vaccine. To read the publication, please click here. To view this press release, please click here.
On August 18, 2021, the Company announced positive data demonstrating the efficacy of multiple filovirus vaccine candidates in NHPs, including thermostabilized multivalent vaccines in a single vial platform presentation. Collaborators at UHM describe the potent efficacy of vaccine candidates protecting against three life-threatening filoviruses, Zaire ebolavirus, Sudan ebolavirus and Marburg Marburgvirus in an article titled "Recombinant Protein Filovirus Vaccines Protect Cynomolgus Macaques from Ebola, Sudan, and Marburg Viruses", published in Frontiers in Immunology. To read the article, please click here. To view this press release, please click here.
Financial Results – Quarter Ended September 30, 2021

Soligenix’s revenues for the quarter ended September 30, 2021 were $0.2 million as compared to $0.6 million for the quarter ended September 30, 2020. Revenues primarily included payments on grants received to support the development of: SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax, our thermostabilization platform technology; and CiVax, our vaccine candidate for the prevention of COVID-19.

Soligenix’s basic net loss was $3.6 million, or ($0.09) per share, for the quarter ended September 30, 2021, as compared to $1.8 million, or ($0.06) per share, for the quarter ended September 30, 2020. This increased net loss was primarily due to a reduction in revenue from the expiration of government contracts, an increase in research and development expenses associated with the continued development of HyBryte and additional interest expense on convertible debt.

Research and development expenses were $2.5 million as compared to $1.3 million for the quarters ended September 30, 2021 and 2020, respectively. The increase in research and development spending for the quarter ended September 30, 2021 was primarily attributable to the increased expenses associated with the continued development of HyBryte.

General and administrative expenses were $0.9 million and $0.8 million for the three months ended September 30, 2021 and 2020, respectively.

As of September 30, 2021, the Company’s cash position was approximately $29 million.

On November 12, 2021 Vaccitech plc (NASDAQ: VACC) reported its financial results for the third quarter, ended September 30, 2021, and provided an overview of the Company’s recent corporate developments (Press release, Vaccitech, NOV 12, 2021, View Source [SID1234595510]). Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer.

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"We continue to advance our promising pipeline with the recent publication of data on our MERS vaccine program. We also anticipate that initial clinical data on two of our chronic infectious disease therapeutic programs will be presented at scientific conferences next week," commented Bill Enright, Vaccitech’s CEO. "As we continue to expand and advance our programs, we will need additional lab and office space for our talented staff so we have planned a move mid next year into a new, state of the art facility."

Third Quarter and Recent Corporate Developments

Signed a clinical trial collaboration agreement with Arbutus Biopharma Corporation to evaluate an innovative therapeutic combination for the treatment of subjects with chronic hepatitis B virus infection (CHB) who are already receiving standard-of-care nucleoside or nucleotide analog (NA) therapy. The Phase 2a clinical trial will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of Arbutus’s RNAi therapeutic, AB-729, followed by the Company’s immunotherapy candidate, VTP-300, in NA-suppressed subjects with CHB.
Preclinical research demonstrated that VTP-600, a ChAdOx1/MVA prime-boost immunotherapeutic, demonstrated potential as an anti-cancer therapeutic. The research was conducted by scientists at the University of Oxford and the Ludwig Institute for Cancer Research.
Signed a lease for 31,000 square feet within the Zeus development at Harwell Science and Innovation Campus. The site will house the Company’s headquarters, state-of-the-art wet laboratory and offices. Vaccitech anticipates completing the relocation by mid-2022.
Announced online publication in The Lancet Microbe of the results of a Phase 1 clinical trial of VTP-500, a vaccine candidate in development to prevent Middle East Respiratory Syndrome (MERS). The study, conducted by researchers at The King Abdullah International Medical Research Centre and Oxford University, showed that the vaccine candidate was generally well tolerated and induced both humoral and cellular immune responses.
Upcoming Milestones

At the virtual AASLD’s The Liver Meeting in November, two posters will present safety and immunogenicity data from the Phase 1 and Phase 1b/2a trials of VTP-300: HBV001, in healthy volunteers and patients with chronic hepatitis B (CHB) infection and HBV002 in patients with CHB infection. The posters become available for viewing by attendees at 8 a.m. EST on November 12.
At the virtual 34th International Papillomavirus Conference in November, the Company expects to present safety and immunogenicity data from the lead-in portion of the Phase 1/2a clinical trial of VTP-200.
In the fourth quarter, the Company expects to initiate dosing in a Phase 1/2a trial of VTP-600 in patients with non-small cell lung cancer in combination with a checkpoint inhibitor and chemotherapy. The trial is currently open for enrollment.
In the first quarter of 2022, the Company intends to conduct an interim efficacy review of HBV002, the Phase 1b/2a clinical trial of VTP-300 in patients with chronic HBV infection.
In the second quarter of 2022, the Company expects to initiate dosing in a Phase 1/2a clinical trial of VTP-800/850, in combination with a checkpoint inhibitor, in patients with prostate cancer.
In the third quarter of 2022, the Company intends to conduct an interim efficacy review of HPV001, a Phase 1/2a clinical trial of VTP-200, a potential non-invasive treatment for persistent high-risk HPV infection.
Third Quarter 2021 Financial Highlights:

Cash position: As of September 30, 2021, cash and cash equivalents were $233.9 million, compared to $43.3 million as of December 31, 2021. The increase was primarily due to completion of the Series B financing in the first quarter of 2021, which raised $168 million including the conversion of our previously issued convertible loan notes, and to the initial public offering in the second quarter, which raised gross proceeds of $110.5 million. The Company believes its cash and cash equivalents are sufficient to fund operations into the first half of 2024.
Research and development (R&D) expenses: Research and development expenses were $4.4 million for the third quarter of 2021 compared to $3.7 million for the comparable period of the prior year. The increase in R&D expenses was primarily due to increased spending on progressing the development of VTP-300 and VTP-850.
General and administrative expenses: General and administrative expenses were $1.2 million for the third quarter of 2021 compared to $1.0 million for the comparable period of the prior year. The third quarter of 2021 expense includes a $5.8 million unrealized foreign exchange gain on revaluation of Company’s cash balances. Net of this gain, the increase in general and administrative expenses between the periods was attributable to higher personnel costs, reflecting an increase in the Company’s headcount over the prior period and higher insurance costs associated with operating as a public company.
Net loss: The Company generated a net loss attributable to its shareholders of $4.6 million, or ($0.13) per share on both basic and fully diluted bases, for the third quarter of 2021 compared to a net income of $0.2 million, or $0.02 per share a basic basis and $0.01 on a fully diluted basis, for the same period of the prior year.

On November 12, 2021 Senti Bio, a leading gene circuit company, reported results from SENTI-401, one of its preclinical stage oncology programs, that aims to more precisely target tumors while sparing healthy cells (Press release, Senti Biosciences, NOV 12, 2021, View Source [SID1234596740]). The poster presentation, which is on display starting today at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), describes preclinical data from SENTI-401, a Logic Gated allogeneic, chimeric antigen receptor natural killer (CAR-NK) cell therapy development program for the treatment of colorectal cancer (CRC). The results support the Company’s vision of using gene circuits to create next-generation, "smart" cell and gene therapies with computer-like logic in human cells.

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Targeting of tumor-associated antigens, such as carcinoembryonic antigen (CEA), can result in severe clinical toxicities due to the killing of healthy epithelial cells whose cell surfaces also express CEA. This includes toxicity risk to cells in the colon and gastrointestinal tract as well as the lungs. SENTI-401 is designed to incorporate logic gating to target and kill CEA-expressing tumor cells, while preventing the killing of CEA-expressing healthy epithelial cells. The SENTI-401 NOT GATE pairs a CEA-targeting activating-CAR (aCAR) with an inhibitory-CAR (iCAR) that recognizes a safety antigen (SA) uniquely expressed in certain healthy gastrointestinal and lung epithelial cells. The SA was identified and validated through Senti Bio’s proprietary Bioinformatics-Driven Antigen Pairing (B-DAP) discovery platform. The poster highlights the SENTI-401 development program’s NOT GATE gene circuit technology as follows:

Killing of colorectal cancer cells:

Generated, tested and optimized anti-CEA CAR constructs for optimal performance in NK cells using Senti Bio’s Design-Build-Test-and-Learn (DBTL) platform.
Evaluated CAR-NK cells for anti-tumor activity, and demonstrated potent killing of CEA-expressing CRC target cells in vitro. A single dose of these CAR-NK cells also demonstrated anti-tumor activity in a human CRC xenograft model, reducing tumor burden in >33% of the treated mice.

Preservation of healthy cells:

iCAR suppressed aCAR mediated killing (p<0.05) in a SA-dependent manner without diminishing aCAR-mediated anti-tumor activity.
V-set and Immunoglobulin Domain Containing 2 (VSIG2), a membrane protein, was identified as the SA via Senti Bio’s B-DAP discovery platform and validated in healthy tissue samples. VSIG2 is uniquely expressed in CEA-positive healthy cells but not in tumor cells.
Used Senti Bio’s DBTL platform to evaluate multiple iCAR designs that utilize inhibitory domains that can selectively prevent CAR-mediated killing in an SA-dependent manner.

"Existing cancer therapies generally target only a single tumor-associated antigen, which means that they can only be used safely and effectively where that antigen is expressed primarily on tumor cells," said Alba Gonzalez, PhD, presenter of the abstract and Associate Director, Research at Senti Bio. "What is so exciting about our Logic Gating platform is the potential to advance a highly novel approach to CAR-NK based therapy that may more precisely treat colon cancer, and other solid tumors, with a reduced risk for on-target, off-tumor toxicities, thereby offering the potential to increase the therapeutic window and provide meaningful benefit to patients."

The abstract (Poster #116) is available on the SITC (Free SITC Whitepaper) website. The poster is available on the Senti Bio website.

About Logic Gating and NOT GATE Gene Circuits
Logic Gating gene circuits are designed to enable cell and gene therapies to control their therapeutic activity in response to the presence or absence of multiple disease biomarkers. NOT GATE gene circuits are one type of Logic Gates that are designed to widen the therapeutic window by enabling killing of cancer cells while preserving healthy cells. The NOT GATE functions by recognizing Safety Antigens on the cell surface, or antigens that are selectively expressed on healthy cells and not on cancer cells, thus limiting on-target, off-tumor killing. By protecting healthy cells, the NOT GATE has the potential to enable more effective on-target, on-tumor killing of tumor cells that express tumor-associated antigens.

On November 12, 2021 Candel Therapeutics, Inc. ("Candel" or "the Company") (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, Candel Therapeutics, NOV 12, 2021, View Source [SID1234595385]).

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"With the completion of our IPO in August 2021 and multiple data readouts across our product candidates expected over the next 12 months, we are well-capitalized and in a strong position to advance on the Company’s goal to bring novel oncolytic viral immunotherapies to patients with cancer," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel Therapeutics. "In the quarter and recent weeks, we expanded visibility of our technology and clinical programs with six presentations at medical conferences, highlighting clinical observations for our lead product candidate from our adenoviral platform, CAN-2409, in prostate cancer and our lead product candidate from our HSV platform, CAN-3110, in high-grade glioma, two areas of significant unmet need."

Third Quarter 2021 & Recent Highlights

In September, Scott E. Eggener, MD, principal investigator, presented data at the AdMeTech Foundation’s Fifth Global Summit on Precision Diagnosis and Treatment of Prostate Cancer, highlighting safety observations from the Company’s phase 2 clinical trial of CAN-2409 in patients with localized, low to intermediate risk prostate cancer undergoing active surveillance.
Also in September, E. Antonio Chiocca, MD, PhD, FAANS, principal investigator, presented clinical and immunological biomarker data from the phase 1 clinical trial of CAN-3110 in patients with recurrent high-grade glioma at the 16th Meeting of the European Association of Neuro-Oncology.
In October, Dr. Tak provided a technology overview at the Cambridge Healthtech Institute’s 9th Annual Immuno-Oncology Summit in a session titled Novel Oncolytic Viral Immunotherapies for Solid Tumors.
Separately, at the Hanson Wade 6th Annual Oncolytic Virotherapy Summit held in October, Dr. Tak highlighted Candel’s approach with its novel oncolytic viral immunotherapies, CAN-2409 and CAN-3110, to immunize against a patient’s own tumor neo-antigens. Also at this conference, Dr. Chiocca presented on the Company’s CAN-3110 program in glioblastoma.
In October, the Company announced the appointment of Mace L. Rothenberg, MD, as a senior advisor to Dr. Tak. Dr. Rothenberg, an industry veteran with more than 30 years of experience across government, academia and industry, will help support the Company’s continued growth and acceleration.
Also in October, the Company’s Chief Medical Officer, Laura K. Aguilar, MD, PhD, presented data on patient-reported tolerability of intraprostatic injections at the 28th Annual Prostate Cancer Foundation Scientific Retreat. These data further support patient receptiveness to intra-prostatic injection of CAN-2409 and its comparability, in terms of tolerance, to routine intra-prostatic biopsies.
In early November, the Company had two presentations at the 13th International Oncolytic Virus Conference Meeting. Dr. Chiocca provided details on the first-in-human clinical trial of CAN-3110 in glioblastoma. Dr. Tak gave a talk in a Special Session, titled Leveraging Viral Oncolytic Immunotherapy Platform to Tip the Balance in Favor of the Immune System that highlighted recent advancements of CAN-2409 and CAN-3110 development, including the enrollment completion and patient tolerability data from the phase 3 trial in prostate cancer, and the blinded safety data from the phase 2 clinical trial in patients with prostate cancer undergoing active surveillance.
Also in November, the Company’s Vice President, Head of Research, Francesca Barone, MD, PhD, presented novel biomarker data from the ongoing phase 1 open-label, dose-escalation clinical trial of CAN-3110 in patients with recurrent high-grade glioma at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting. The presentation focused on the biological findings of this study, showed the ability of CAN-3110 to induce immune activation both locally, in the tumor microenvironment, and systemically in peripheral blood of treated patients.
Key Upcoming Milestones

Patrick Y. Wen, MD, principal investigator, will present initial safety data on CAN-2409 in combination with nivolumab from a phase 1 clinical trial in high-grade glioma at the 26th Annual Meeting of the Society for Neuro-Oncology (SNO) in November.
Financial Results for the Third Quarter Ended September 30, 2021

Cash Position: Cash and cash equivalents as of September 30, 2021 were $88.4 million, as compared to $35.1 million as of December 31, 2020. The increase was due to successful completion of the Company’s initial public offering in August 2021, which provided net proceeds of $71.3 million, after deducting underwriting discounts and commissions and offering expenses and the use of $18.3 million to fund operating activities and capital expenditures for the nine months ended September 30, 2021. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund its operations into the second quarter of 2023.

Research & Development Expenses: Research and development expenses were $5.3 million and $11.3 million for the three and nine months ended September 30, 2021, respectively, as compared to $1.8 million and $5.2 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount to support the ongoing clinical trials for Candel’s product candidates as well as increased clinical development costs. Excluding stock-based compensation expense of $1.5 million for the three months ended September 30, 2021, and $2.0 million for the nine months ended September 30, 2021, research and development expenses for the three and nine months ended September 30, 2021, were $3.8 million and $9.3 million, respectively.

General and Administrative Expenses: General and administrative expenses were $2.8 million and $6.8 million for the three and nine months ended September 30, 2021, respectively, as compared to $1.0 million and $2.6 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount required to support the growth of the Company and the transition to a public company, an increase in professional fees associated with Candel’s preparation for the IPO completed in August 2021 and costs associated with operating as a public company. Excluding stock-based compensation expense of $0.4 million for the three months ended September 30, 2021, and $1.4 million for the nine months ended September 30, 2021, general and administrative expenses for the three and nine months ended September 30, 2021, were $2.4 million and $5.4 million, respectively.

Total Operating Expenses: Total operating expenses were $8.1 million and $18.1 million for the three and nine months ended September 30, 2021, respectively, as compared to $2.8 million and $7.8 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount required to support the growth of the Company and the transition to a public company, an increase in professional fees associated with Candel’s preparation for the IPO completed in August 2021, an increase in costs associated with operating as a public company and increased clinical development costs. Excluding stock-based compensation expense of $1.9 million for the three months ended September 30, 2021, and $3.4 million for the nine months ended September 30, 2021, total operating expenses for the three and nine months ended September 30, 2021, were $6.2 million and $14.7 million, respectively.

Net Loss: Net loss was $16.2 million and $37.7 million for the three and nine months ended September 30, 2021, respectively, as compared to $2.6 million and $7.2 million for the comparable periods of 2020. The net loss for the three and nine months ended September 30, 2021, includes a noncash charge of $8.3 million and $20.6 million for the change in the fair value of the Company’s warrant liability and stock-based compensation of $1.9 million and $3.4 million, respectively. Excluding the noncash charges for the change in the warrant liability and excluding the stock-based compensation, the net loss for the three and nine months ended September 30, 2021, was $6.0 million and $13.7 million, respectively.

On November 12, 2021 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported its financial results for the third quarter of 2021 (Press release, NexImmune, NOV 12, 2021, View Source [SID1234595401]).

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"We had another strong quarter as characterized by our continued progress developing the AIM technology platform," said Scott Carmer, Chief Executive Officer. "Our primary focus remains on completing enrollment in our Phase I/II clinical trials for NEXI-001 and NEXI-002. We plan to provide clinical updates for the NEXI-001 trial in AML during the first half of 2022 and will update the NEXI-002 trial in relapsed / refractory multiple myeloma at the upcoming ASH (Free ASH Whitepaper) conference. Additionally, we are presenting the antigen peptide targets to be included in our first solid tumor IND application for HPV-associated malignancies at the SITC (Free SITC Whitepaper) Annual Meeting. Finally, we’re very excited with the progress of our research collaboration with the lab of Professor Kevan Herold at Yale University, which explores the effects of our AIM injectable nanoparticle as a therapeutic for Type 1 Diabetes. Our team looks forward to providing future updates on these and other important projects as we continue to progress the development of our AIM technology across a range of therapy areas and with multiple modalities."

Select 3Q 2021 Clinical and Business Highlights

Clinical and Preclinical Updates

NEXI-001

Robust immune responses across all dose levels with signs of increased clinical activity associated with higher doses
NEXI-001 continues to be well tolerated across all dose levels administered to date, with no Grade ≥3 treatment-related adverse events, including infusion reactions, GVHD, CRS or neurotoxicity (ICANS), reported
Due to the favorable emerging clinical profile, plans are underway to expand the addressable population with an additional study arm to include patients with haplo-identical donors
Ongoing enrollment in the Phase I/II trial has been affected by higher than anticipated patient replacements between the enrollment and 28-day DLT clearance period due to non-treatment-related events; updated clinical results expected to be announced in the first half of 2022
NEXI-002

Safety cohort completed and expansion phase continues to enroll and dose
NEXI-002 continues to be well tolerated with no Grade ≥3 treatment-related adverse events, including infusion reactions, GVHD, CRS or neurotoxicity (ICANS), reported
Further clinical data from the Phase I/II trial is expected to be announced at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021
NEXI-003

Preclinical data supporting the selection of multiple immunogenic antigen peptides commonly expressed on HPV-associated tumors is being presented during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting (SITC 2021) in November 2021
Investigational New Drug (IND) submission planned for mid-year 2022
Other R&D

First collaboration in autoimmune diseases announced with Yale University Professor Kevan Herold to evaluate AIM INJ nanoparticles as a therapeutic in Type 1 diabetes
Business Updates

Announced the appointments of Dr. Jack Ragheb as SVP, Translational Medicine, and Matthew Schiller as Head of Business Development
Select 3Q 2021 Financial Highlights

Cash, cash equivalents and marketable securities for the company as of September 30, 2021 were $93.2M compared to $102.8M for quarter ending June 30, 2021. Based upon current operating plans, NexImmune expects that its existing cash, cash equivalents and marketable securities will enable the company to fund its operating and capital expenditure requirements through 4Q22.

Research and development expenses were $11.3M in the third quarter of 2021, compared to $4.9M for the same period in the prior year. The increase in R&D expenses was mainly attributable to costs for the two clinical trials, as well as personnel-related expenses driven by increased headcount.

General and administrative expenses were $4.2M, compared to $2.8M for the same period the prior year. The increase was due primarily to increases in headcount and fees related to professional and consulting services.

Net loss, according to generally accepted accounting principles in the U.S. (GAAP), was $14.6M for the quarter, or a basic and diluted GAAP loss per share of $0.65. This compared to a net loss of $8.6M, or a basic and diluted GAAP loss per share of $7.52, for the same period the prior year.