AIDS-Related Lymphoma

Distributing real-world data to researchers in hours instead of days SAN FRANCISCO and PHILADELPHIA – December 12, 2023 – The AIDS and Cancer Specimen Resource (ACSR), a biorepository of specimens collected from persons living with HIV (PLWH) established in 1994 and funded by the National Institutes of Health, National Cancer Institute, is using software from Proscia®, a leading provider of digital and computational pathology solutions, to encourage scientific exploration and discovery in cancer in PLWH. Concentriq® for Research has enabled the ACSR to provide near real-time access to pathology data to investigators around the world. The ACSR’s mission is to acquire, store, and equitably distribute biospecimens, including tissue-based pathology data, and associated clinical data from PLWH to the scientific community-at-large. Investigators have leveraged its data to drive the development of new diagnostic and treatment approaches for HIV-associated malignancies. As digital pathology shifts the standard from microscope to high-resolution images, the ACSR recognized an opportunity to improve access to its data and drive further breakthroughs by adopting the technology. “We are fortunate to have a growing library of rare and valuable biospecimens that have contributed to the fight against cancer in PLWH,” said Dr. Paige Bracci, UCSF Professor of Epidemiology and Biostatistics, and Director of the ACSR’s Informatics program. “Concentriq for Research has enabled us to quickly realize the benefits of digital pathology and get this real-world data in the hands of more researchers faster. Proscia’s platform is not only making a difference for the scientific community but also for the patients impacted by its work.” Since selecting Concentriq for Research, the ACSR has reduced the time it takes to provide investigators with pathology data from days to hours. As the enterprise pathology platform facilitates the sharing of images instead of glass slides, the ACSR can transcend geographical barriers and simultaneously share the same datasets so that more research teams can drive scientific advancements. In addition, this approach allows for conservation and increased sustainability of rare and exhaustible tissue specimens to a large number of individual researchers. Concentriq for Research also offers robust annotation and analysis tools to empower investigators in their work. “We are proud to count the ACSR among the members of the Concentriq community,” said David West, Proscia’s CEO. “It enables breakthrough research with its pathology data and has meaningfully improved access to this critical source of insight with our platform. We look forward to seeing the impact that the ACSR continues to make with enterprise digital pathology.” Along with today’s news, the ACSR has announced the availability of a rare melanoma tissue repository on Concentriq for Research. A corresponding tissue microarray of these tumor tissues will be available in early 2024. About The AIDS and Cancer Specimen Resource The AIDS and Cancer Specimen Resource (ACSR) biorepository includes specimens collected from PLWH who have been diagnosed with a wide spectrum of conditions and diseases, particularly cancers, pre and post-HAART. The ACSR’s mission is to acquire, store, and equitably distribute these tissues and biological fluids along with associated clinical data to investigators conducting HIV related research. For more information, visit acsr1.com. About Proscia Proscia is a software company accelerating the transformation to digital pathology to change the way we understand diseases like cancer. Its Concentriq enterprise pathology platform and powerful AI applications are advancing the 150-year-old standard of research and diagnosis towards a data-driven discipline, unlocking new insights that accelerate R&D, improve patient outcomes, and fulfill the promise of precision care. Leading diagnostic laboratories and 14 of the top 20 pharmaceutical companies rely on Proscia’s software each day. For more information, visit proscia.com. Disclaimer: NIH does not endorse or recommend any commercial products, processes, or services. The views and opinions do not necessarily state or reflect those of the U.S. Government.

Achieved efficacy threshold to advance Epstein-Barr virus-positive (EBV+) peripheral T-cell lymphoma into Stage 2 becoming the leading indication in pivotal NAVAL-1 study of Nana-val Prioritized EBV+ diffuse large B-cell lymphoma and EBV+ post-transplant lymphoproliferative disease as key follow-on indications in NAVAL-1 trial Published Phase 1b/2 clinical trial data reporting promising durable signal of efficacy for Nana-val in patients with relapsed or refractory EBV+ lymphoma in Blood Advances, a Journal of the American Society of Hematology Completed enrollment into the fifth dose escalation level of the Phase 1b/2 study of Nana-val in advanced EBV+ solid tumors without any dose-limiting toxicities Strengthened leadership with the appointment of Darrel P. Cohen, M.D., Ph.D. as Chief Medical Officer SAN DIEGO, Aug. 14, 2023 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today provided a business update and reported financial results for the second quarter of 2023. “In the second quarter of 2023, we achieved key milestones in the pivotal NAVAL-1 study of Nana-val by enabling the advancement of this global clinical trial into Stage 2 and establishing EBV-positive PTCL as Nana-val’s leading indication. This milestone was based on a strong signal of efficacy with a favorable safety profile, consistent with our promising Phase 1b/2 clinical trial data,” said Mark Rothera, President and Chief Executive Officer of Viracta. “Given the high unmet medical need in patients with EBV-positive PTCL and our positioning of Nana-val as a potential important treatment option for these patients, our goal is to move forward rapidly towards registration in the U.S. We intend to complete Stage 2 enrollment and meet with the U.S. Food and Drug Administration in 2024 to discuss additional requirements for regulatory approval.” Darrel P. Cohen, M.D., Ph.D., Chief Medical Officer of Viracta commented, “We are thrilled to have our Phase 1b/2 study results published in a high-quality peer-reviewed journal, such as Blood Advances, which underscores the potential of Nana-val to treat patients with EBV-positive lymphoma and elevates the importance of the NAVAL-1 trial. Following the advancement of the PTCL cohort and to optimize our resources behind this trial, we have strategically prioritized key subtypes of EBV-positive lymphoma where we can address high unmet medical needs, increase the probability of success, and focus on the largest EBV-positive lymphoma patient populations.” Clinical Trial Updates and Anticipated Milestones Pivotal NAVAL-1 study of Nana-val in patients with relapsed or refractory (R/R) EBV+ lymphoma The EBV+ peripheral T-cell lymphoma (PTCL) cohort of the pivotal NAVAL-1 clinical trial met the efficacy threshold for expansion into Stage 2 of the study, which was based upon a pre-specified minimum number of objective responses achieved; initial data are consistent with results from the Phase 1b/2 study and establish EBV+ PTCL as Nana-val’s leading indication. Strategically prioritized three lymphoma subtypes: (1) EBV+ PTCL, a T-cell lymphoma with high unmet medical need; (2) EBV+ diffuse large B-cell lymphoma (DLBCL), an aggressive and distinct B-cell lymphoma subtype characterized by adverse clinical outcomes, and (3) EBV+ PTLD, a potentially fatal complication after transplantation, which is highly associated with EBV. Prioritization also enables the allocation of resources to those indications with the greatest probability of success and market opportunity in key geographies. Enrollment into HIV-lymphoma and Hodgkin lymphoma cohorts will be discontinued. Patients with extranodal NK/T-cell lymphoma (ENKTL) and other ultra-rare subtypes of EBV+ lymphoma will continue to be enrolled. Completion of enrollment into Stage 2 of the R/R EBV+ PTCL cohort and engagement with FDA on additional requirements for regulatory approval is anticipated in 2024. Phase 1b/2 clinical trial of Nana-val in patients with R/R EBV+ lymphoma In August 2023, Viracta announced the publication in Blood Advances featuring results from an open-label, multicenter, Phase 1b/2 study of Nana-val in patients with R/R EBV+ lymphoma titled, “Targeted therapy with nanatinostat and valganciclovir in recurrent Epstein-Barr virus-positive lymphoid malignancies: a Phase 1b/2 study.” The publication included a more recent data cut reflecting multiple patients with an ongoing durable response exceeding 30 months across multiple EBV+ lymphoma subtypes, including EBV+ PTCL and EBV+ DLBCL, and two patients with an ongoing response of approximately 36 months. Nana-val was generally well tolerated with reversible low-grade toxicities. The most commonly observed treatment emergent adverse events were reversible cytopenias, low-grade creatinine elevations, and gastrointestinal symptoms. Phase 1b/2 study of Nana-val in patients with recurrent or metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors Enrollment completed through the fifth dose level of the Phase 1b dose escalation portion of the trial without any dose-limiting toxicities reported. The Company remains on track to report complete Phase 1b dose escalation data and select a Recommended Phase 2 Dose (RP2D) of Nana-val in the second half of 2023. Initiation of the trial’s randomized Phase 2 expansion cohort designed to evaluate Nana-val at the RP2D with or without pembrolizumab in patients with R/M EBV+ NPC is expected in the second half of 2023. Initiation of the trial’s exploratory Phase 1b expansion cohort designed to evaluate Nana-val at the RP2D in patients with other advanced EBV+ solid tumors, including gastric carcinoma, leiomyosarcoma, and lymphoepithelioma, is expected in the second half of 2023. Business Updates Strengthened the leadership team with the appointment of Darrel P. Cohen, M.D., Ph.D. as Chief Medical Officer (CMO) In August 2023, Dr. Cohen was appointed as CMO to oversee the clinical development and regulatory advancement of Viracta’s pipeline. Dr. Cohen is a highly accomplished physician and biopharmaceutical executive with more than 25 years of oncology clinical research and drug development experience in both solid tumors and hematologic malignancies. Dr. Cohen was involved in multiple successful regulatory submissions of new targeted cancer drugs such as SUTENT® (sunitinib), XALKORI® (crizotinib), and IBRANCE® (palbociclib) while at Pfizer Oncology. Strengthened intellectual property estate In July 2023, Viracta received a Notice of Allowance from the US Patent and Trademark Office on Viracta’s patent claims directed to a next-generation formulation of nanatinostat. This Notice of Allowance supports Viracta’s life-cycle management strategy, and upon issuance, the claims will expire in October 2041. Second Quarter 2023 Financial Results Cash position – Cash, cash equivalents, and short-term investments totaled approximately $72.9 million as of June 30, 2023, which Viracta expects will be sufficient to fund its operations into late 2024 excluding any additional borrowing under a $50.0 million credit facility, of which $25.0 million remains available, at the Company’s request and subject to the discretion of the lenders. Research and development expenses – Research and development (R&D) expenses were approximately $8.2 million and $15.8 million for the three and six months ended June 30, 2023, respectively, compared to approximately $6.3 million and $12.4 million for the same periods in 2022. This increase in R&D expenses was primarily driven by increases in costs incurred to support the advancement and expansion of our clinical development programs, including incremental costs to support NAVAL-1, our pivotal study of Nana-val in patients with R/R EBV+ lymphoma, and the initiation of our Phase 1b/2 study of Nana-val for the treatment of patients with EBV+ solid tumors, as well as an increase in personnel-related costs. General and administrative expenses – General and administrative (G&A) expenses were approximately $4.3 million and $8.9 million for the three and six months ended June 30, 2023, respectively, compared to $4.2 million and $8.5 million for the same periods in 2022. The increase in G&A expenses can be primarily attributed to an increase in personnel-related costs. Net loss – Net loss was approximately $12.5 million, or $0.32 per share, (basic and diluted) for the quarter ended June 30, 2023, compared to a net loss of $10.6 million, or $0.28 per share, (basic and diluted) for the same period in 2022. Net loss was approximately $24.7 million, or $0.64 per share, (basic and diluted) for the six months ended June 30, 2023, compared to a net loss of $21.1 million, or $0.56 per share, (basic and diluted) for the same period in 2022. About NAVAL-1 NAVAL-1 (NCT05011058) is a global, multicenter, clinical trial of Nana-val in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma. This trial employs a Simon two-stage design where, in Stage 1, participants are enrolled into one of six indication cohorts based on EBV+ lymphoma subtype. If a pre-specified antitumor activity threshold is reached within a lymphoma subtype in Stage 1 (n=10), then additional patients will be enrolled in Stage 2 for a total of 21 patients. EBV+ lymphoma subtypes demonstrating promising antitumor activity in Stage 2 may be further expanded following discussion with regulators to potentially support registration. About the Phase 1b/2 Study of Nana-val in R/M EBV+ NPC and Other EBV+ Solid Tumors This Phase 1b/2 trial (NCT05166577) is an open-label, multinational clinical trial evaluating Nana-val alone and in combination with pembrolizumab. The Phase 1b dose escalation part is designed to evaluate safety and to determine the Recommended Phase 2 Dose (RP2D) of Nana-val in patients with recurrent or metastatic (R/M) Epstein-Barr virus-positive (EBV+) nasopharyngeal carcinoma (NPC). In Phase 2, up to 60 patients with R/M EBV+ NPC will be randomized to receive Nana-val at the RP2D with or without pembrolizumab to further evaluate antitumor activity, safety and tolerability, pharmacokinetics, and potential pharmacodynamic biomarkers. Additionally, patients with other advanced EBV+ solid tumors will be enrolled to receive Nana-val at the RP2D in a Phase 1b dose expansion cohort. About Nana-val (Nanatinostat and Valganciclovir) Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed or refractory (R/R) EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 clinical trial in patients with recurrent or metastatic (R/M) EBV+ NPC and other EBV+ solid tumors. About EBV-Associated Cancers Approximately 90% of the world's adult population is infected with EBV. Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of cells for the duration of the patient's life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV-positive (EBV+) lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma (NPC), and gastric cancer. About Viracta Therapeutics, Inc. Viracta is a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide. Viracta’s lead product candidate is an all-oral combination therapy of its proprietary investigational drug, nanatinostat, and the antiviral agent valganciclovir (collectively referred to as Nana-val). Nana-val is currently being evaluated in multiple ongoing clinical trials, including a pivotal, global, multicenter, open-label Phase 2 basket trial for the treatment of multiple subtypes of relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma (NAVAL-1), as well as a multinational, open-label Phase 1b/2 clinical trial for the treatment of patients with recurrent or metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors. Viracta is also pursuing the application of its “Kick and Kill” approach in other virus-related cancers. For additional information, please visit . Forward-Looking Statements This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the details, timeline and expected progress for Viracta's ongoing and anticipated clinical trials and updates regarding the same, the Company’s expectations related to the FDA submission process and timelines, expectations regarding our target patient populations, and expectations regarding our cash runway. Risks and uncertainties related to Viracta that may cause actual results to differ materially from those expressed or implied in any forward-looking statement include, but are not limited to: Viracta's ability to successfully enroll patients in and complete its ongoing and planned clinical trials; Viracta's plans to develop and commercialize its product candidates, including all oral combinations of nanatinostat and valganciclovir; the timing of initiation of Viracta's planned clinical trials; the timing of the availability of data from Viracta's clinical trials; previous preclinical and clinical results may not be predictive of future clinical results; the timing of any planned investigational new drug application or new drug application; Viracta's plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits, and market acceptance of Viracta's product candidates; Viracta's ability to manufacture or supply nanatinostat, valganciclovir, and pembrolizumab for clinical testing; Viracta's ability to identify additional products or product candidates with significant commercial potential; developments and projections relating to Viracta's competitors and its industry; the impact of government laws and regulations; Viracta's ability to protect its intellectual property position; and Viracta's estimates regarding future expenses, capital requirements, and need for additional financing in the future. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Viracta's reports and other documents that Viracta has or will file, with the SEC from time to time and available at . The forward-looking statements included in this communication are made only as of the date hereof. Viracta assumes no obligation and does not intend to update these forward-looking statements, except as required by law or applicable regulation. Investor Relations Contact: Ashleigh Barreto Head of Investor Relations & Corporate Communications Viracta Therapeutics, Inc. abarreto@viracta.com SOURCE Viracta Therapeutics, Inc. -- Financial tables attached – Viracta Therapeutics, Inc. Selected Balance Sheet Highlights (in thousands) June 30, December 31, 2023 2022 (Unaudited) Cash, cash equivalents and short-term investments $ 72,867 $ 91,043 Total assets $ 76,859 $ 95,991 Total liabilities $ 36,077 $ 34,888 Stockholders' equity $ 40,782 $ 61,103 Viracta Therapeutics, Inc. Condensed Consolidated Statement of Operations and Comprehensive Loss (in thousands except share and per share data) (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Operating expenses: Research and development $ 8,197 $ 6,324 $ 15,804 $ 12,420 General and administrative 4,253 4,181 8,853 8,517 Total operating expenses 12,450 10,505 24,657 20,937 Loss from operations (12,450 ) (10,505 ) (24,657 ) (20,937 ) Total other expense (34 ) (77 ) (36 ) (191 ) Net loss (12,484 ) (10,582 ) (24,693 ) (21,128 ) Unrealized (loss) gain on short-term investments (28 ) — 63 — Comprehensive loss (12,512 ) (10,582 ) (24,630 ) (21,128 ) Net loss per share, basic and diluted $ (0.32 ) $ (0.28 ) $ (0.64 ) $ (0.56 ) Weighted-average common shares outstanding, basic and diluted 38,560,376 37,599,244 38,509,887 37,567,734

Preparing to initiate pivotal Phase 3 trial of INO-3107 in adult RRP patients in first quarter of 2024; INO-3107 received Orphan Drug Designation from European Commission in second quarter Scaling resources and headcount to align with strategic focus on INO-3107 and late-stage clinical candidates closest to market and with greatest opportunity to deliver on the promise of DNA medicines for patients Following biomarker analysis from REVEAL2, INOVIO is stopping investment in VGX-3100 for cervical HSIL for U.S. market; Remains committed to supporting partner ApolloBio's non-biomarker strategy for Chinese market $194.9 million in cash, cash equivalents and short-term investments at quarter end; Headcount reduction and reallocation of resources expected to lower future cash burn and extend cash runway into third quarter of 2025 Investor call today at 4:30 PM EDT PLYMOUTH MEETING, Pa., Aug. 9, 2023 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced its financial results for the second quarter ended June 30, 2023 and provided a strategic update. "We continue to make progress with INO-3107, our candidate for the treatment of recurrent respiratory papillomatosis (RRP). Following positive results from our Phase 1/2 trial earlier this year, we are pleased to announce that we are targeting to have the first patient dosed in a Phase 3 trial in adults in the first quarter of 2024, moving us one step closer to delivering on the promise of DNA medicines for patients suffering from this debilitating disease," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "Based on our interactions with the U.S. Food and Drug Administration (FDA) we believe that we have an acceptable trial design. We are addressing what we believe to be their final questions before we commence our pivotal Phase 3 trial for patients with RRP." "As we move forward with our pipeline, we are focused on making sure our company is scaled for success in light of the challenging funding environment, particularly for pre-commercial biotech companies like INOVIO," Dr. Shea continued. "With that in mind, we made the difficult decision to further reduce our headcount and operational spending to better align with our strategic priorities. We believe that with the pipeline reprioritization announced today, we are well-positioned to execute on our development plans for INO-3107 while also advancing other promising candidates, such as INO-3112, INO-5401, VGX-3100 for anal HSIL and INO-4201. We expect that our existing cash resources will allow us to achieve important catalysts for these programs. I would like to extend my deepest gratitude to all of our employees – past and present – for their efforts on behalf of the company and contributions to the important progress we're making." Pipeline Reprioritization and Corporate Reorganization INO-3107 – Recurrent Respiratory Papillomatosis (RRP) INOVIO has announced today that it is further reprioritizing its pipeline to focus on its highest potential, closest to market programs, specifically its late-stage clinical program for INO-3107 as a treatment for RRP. In a Phase 1/2 trial involving RRP patients, treatment with INO-3107 resulted in a statistically significant reduction in the number of surgical interventions required to manage the disease. INOVIO is targeting to commence its pivotal Phase 3 trial in adult patients with RRP, subject to clearance by regulators, in the first quarter of 2024. On May 5, 2023, data from the Phase 1/2 trial of INO-3107 were presented by lead investigator Dr. Ted Mau at the scientific program of the American Broncho-Esophagological Association (ABEA) at the Combined Otolaryngology Spring Meetings (COSM) in Boston, Massachusetts. The presentation highlighted the safety profile of INO-3107, which was well tolerated by participants in the trial and resulted in mostly low-grade (Grade 1) treatment-emergent adverse effects (TEAEs) such as injection site pain and fatigue. There were no high-grade TEAEs deemed related to treatment and no TEAEs leading to treatment discontinuation. Treatment with INO-3107 induced cellular immune responses against both HPV-6 and HPV-11, with activated CD4 and CD8 T cells, including cytotoxic CD8 T cells thought to be important for clearance of virally infected cells. Preliminary analysis indicates a potential correlation between T-cell responses and reduction of surgeries. T-cell responses were also observed at Week 52, indicating a persistent cellular memory response. Also in May 2023, INO-3107 was granted orphan drug designation by the European Commission (EU) as a potential treatment for RRP. INO-3107 was granted orphan drug designation from the FDA in July 2020, making it the first RRP product candidate to receive designations from both U.S. and EU regulatory bodies. VGX-3100 – Cervical High-Grade Squamous Intraepithelial Lesions (HSIL) INOVIO has decided to cease all further development of VGX-3100 as a potential treatment for cervical HSIL in the United States. This decision is driven by a number of factors, including the recent analysis of biomarker data from REVEAL2 indicating that substantial work would be needed to refine this novel biomarker before it could be used in any further Phase 3 trials. Previously, the U.S. FDA indicated that at least one or more additional well-controlled trials would need to be conducted in the biomarker-positive population before being considered for registration. Given these factors, INOVIO has determined that its resources are best invested in other pipeline candidates with a faster potential path to market. INOVIO remains encouraged by the data collected in both of its completed Phase 3 trials for VGX-3100 in cervical HSIL (REVEAL1 and REVEAL2). In these trials, the data showed that VGX-3100 could clear both virus and lesions, which INOVIO believes could be supportive evidence for pursuing regulatory approval in other global markets. For non-U.S. markets, where the access to and options for treatment differs, INOVIO believes that VGX-3100 could be a valuable treatment option for cervical HSIL should current and future trials continue to show potential efficacy and achieve regulatory approvals. For the Chinese market, INOVIO's partner ApolloBio continues to advance the development of VGX-3100 for cervical HSIL in a Phase 3 trial. This trial is designed to use a similar protocol to that of REVEAL1 and does not utilize the novel biomarker used in INOVIO's REVEAL2 trial. INOVIO also continues to discuss the clinical development of VGX-3100 with potential partners in other global markets. Other VGX-3100 Indications and Clinical Pipeline Candidates Pending discussions with regulators, INOVIO plans to investigate opportunities to advance VGX-3100 as a potential treatment for anal HSIL, an indication that continues to have significant unmet need. Results published in the New England Journal of Medicine in June 2022 from a multi-year study sponsored by the National Cancer Institute, called the ANCHOR study, showed "for the first time that treating anal HSIL is effective at reducing the incidence of anal cancer in a very high-risk group of people – people living with HIV" (NCI press release, June 15, 2022). INOVIO has observed that this study produced results that are moving the medical community away from the historical practice of actively monitoring anal HSIL and toward a more proactive approach in treating lesions that can progress to cancer. The challenge for patients and their healthcare providers in taking a more proactive approach is that there are few effective options available to treat anal HSIL. VGX-3100 has the ability to clear HPV-16/18 lesions and virus, which was not only observed in the cervical HSIL Phase 3 trials, but also in an open-label Phase 2 anal HSIL trial in HIV negative people. VGX-3100 is currently being investigated in an ongoing Phase 2 trial in HIV-positive anal HSIL patients being conducted by the AIDS Malignancy Consortium. INOVIO is also working to advance its oncology product candidates, specifically INO-5401 and INO-3112, which target glioblastoma (GBM) and HPV-related cancers, respectively, as well as other candidates in its early-stage clinical pipeline targeting infectious diseases, in particular the company's Ebola vaccine candidate, INO-4201. Progress for these candidates has continued in the areas of manufacturing, regulatory submissions, and partnership discussions. The next stage of clinical development will most likely require additional funding or partnerships. Corporate Restructuring As a result of the decision to focus its resources on its late-stage candidates with the greatest likelihood of success, including stopping the development of VGX-3100 in cervical HSIL for the U.S. market, INOVIO has taken steps to further conserve its capital resources. The company recently announced plans to further reduce its workforce by 58 employees, or 30%. The company estimates the cost savings from the headcount reduction will provide annual savings of approximately $9.9 million, which alongside other reductions in spending would allow the company to extend its cash runway into the third quarter of 2025. Second Quarter 2023 Financial Results Cash, Cash Equivalents and Short-term Investments: As of June 30, 2023, cash, cash equivalents and short-term investments were $194.9 million compared to $253.0 million as of December 31, 2022. Revenues: Total revenues for the three months ended June 30, 2023 were $226,000, compared to $784,000 for the same period in 2022. Research and Development (R&D) Expenses: R&D expenses for the three months ended June 30, 2023 were $23.7 million compared to $56.5 million for the same period in 2022. The decrease in R&D expenses was primarily the result of lower drug manufacturing, clinical trial expenses and outside services related to INO-4800 and other COVID-19 studies and lower employee and consultant compensation, including stock-based compensation, among other variances. General and Administrative (G&A) Expenses: G&A expenses for the 2023 second quarter were $13.5 million compared to $48.5 million for the same period in 2022. The decrease in G&A expenses was primarily related to significant one-time costs in the second quarter of 2022 related to the settlement of the class action litigation and related legal expenses, as well as severance expenses incurred in 2022 in connection with the separation of the company's former president and chief executive officer, among other variances. Total Operating Expenses: Total operating expenses were $37.3 million compared to $104.9 million for the same period in 2022. Net Loss: INOVIO's net loss for the quarter ended June 30, 2023 was $35.5 million, or $0.13 per basic and diluted share, compared to net loss of $108.5 million, or $0.46 per basic and diluted share, for the second quarter of 2022. Shares Outstanding: As of June 30, 2023, INOVIO had 268.1 million common shares outstanding and 290.0 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting and conversion, as applicable, of its outstanding options, restricted stock units, convertible preferred stock, and convertible debt. INOVIO's balance sheet and statement of operations are provided below. Additional information is included in INOVIO's quarterly report on Form 10-Q for the quarter ended June 30, 2023, which can be accessed at: . Cash Guidance INOVIO estimates that the cost savings announced today will enable it to fund its operations into the third quarter of 2025. This projection includes a cash burn estimate of approximately $34.0 million for the third quarter of 2023 and the expectation that cash burn will decrease incrementally throughout the remainder of 2023 and 2024. These cash projections do not include any funds that may be raised through the Company's existing at-the-market program or other capital-raising activities. Conference Call / Webcast Information INOVIO's management will host its quarterly conference call and webcast at 4:30 p.m. ET today. A replay of the conference call will be available following the conclusion of the call. The live webcast and replay may be accessed by visiting INOVIO's website at . About INOVIO INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's DNA medicines in development are delivered using its investigational proprietary smart device, CELLECTRA®, to produce immune responses against targeted pathogens and cancers. For more information, visit . Contacts Media: Jennie Willson (267) 429-8567 [email protected] Investors: Thomas Hong (267) 440-4298 thomas.hong@inovio.com Forward-Looking Statements This press release contains certain forward-looking statements relating to our business, including our plans to develop and commercialize DNA medicines and our expectations regarding our research and development programs, including the planned initiation and conduct of pre-clinical studies and clinical trials and the availability and timing of data from those studies and trials, the need for third-party funding to continue certain development programs, expectations with respect to annual savings from corporate restructuring activities, projected cash burn for the third quarter of 2023 and reductions in spending through 2024, and the sufficiency of our cash resources to fund operations into the third quarter of 2025. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2022, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that the results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law. SOURCE INOVIO Pharmaceuticals, Inc.