On May 10, 2022 Lyell Immunopharma, Inc., (Lyell) (Nasdaq: LYEL), a T-cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, reported financial results for the first quarter of 2022 (Press release, Lyell Immunopharma, MAY 10, 2022, View Source [SID1234614077]).

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"We continue to progress our mission to develop T-cell therapies that can outlast and eradicate solid tumors," said Liz Homans, CEO of Lyell Immunopharma. "Our multi-modal pipeline has advanced two products into Phase 1 clinical development, and we remain on track to submit an IND in the second half of this year for LYL845, our wholly owned TIL product candidate, and with our collaborators at GSK we remain on track to submit an IND for LYL331, a next-generation NY-ESO-1 T-cell receptor product candidate in late 2022 – early 2023. We remain focused on executing towards clinical data, and our strong financial position enables us to see our current pipeline through key milestones in evaluating T-cell exhaustion and lack of durable stemness as key barriers to successful cell therapy in patients with solid tumor cancers."

Recent Business Highlights

Announced two upcoming abstract presentations at the 25th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper), scheduled for May 16 – 19, 2022, in Washington, DC. The presentations will highlight preclinical data characterizing two investigational products in Phase 1 clinical development, LYL797 and LYL132, that incorporate Lyell reprogramming technologies designed to address major barriers to successful adoptive cell therapy.
Presented preclinical data characterizing LYL797 at the Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting. LYL797 is a receptor tyrosine kinase-like orphan receptor 1 (ROR1)-targeted CAR T-cell therapy that incorporates Lyell’s genetic and epigenetic reprogramming technologies, Gen-R and Epi-R, designed to overcome T-cell exhaustion and promote durable stemness.
Initiated screening for the Phase 1 clinical trial for LYL797. The trial is designed to be an open label dose escalation and expansion trial that initially enrolls patients with relapsed/refractory triple‑negative breast cancer or non-small cell lung cancer who have failed at least two lines of therapy. Initial data is expected in 2023.
Announced FDA clearance of the IND for LYL132, a next-generation T-cell receptor (TCR) therapy for patients with solid tumors expressing New York esophageal squamous cell carcinoma 1 (NY-ESO-1) that incorporates Epi-R.
Expanded executive management team with the appointment of veteran biotech leader Gary Lee, Ph.D. as Chief Scientific Officer. With more than a decade of experience heading translational cell and gene therapy programs, Dr. Lee sets and oversees the company’s research strategy and pipeline.
First Quarter 2022 Financial Results

GAAP and Non-GAAP Operating Results

Lyell reported a net loss of $68.1 million for the first quarter ended March 31, 2022, compared to a net loss of $55.0 million for the same period in 2021. Non-GAAP net loss, which excludes non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities, was $50.0 million for the first quarter ended March 31, 2022 compared to $32.3 million for the same period in 2021.
Research and development (R&D) expenses were $35.8 million for the first quarter ended March 31, 2022, compared to $41.5 million for the same period in 2021. The decrease in R&D expense was primarily driven by a reduction in the success payment liability balance, which offset increases in infrastructure and personnel costs to support the expansion of our R&D and manufacturing capabilities. Non‑GAAP R&D expenses, which exclude non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities for the first quarter ended March 31, 2022, were $35.9 million, compared to $26.7 million for the same period in 2021.
General and administrative (G&A) expenses were $34.4 million for the first quarter ended March 31, 2022, compared to $16.8 million for the same period in 2021. The increase in G&A expense was primarily due to a $10.4 million increase in stock-based compensation expense, primarily related to award modifications and new awards granted. Non‑GAAP G&A expenses, which exclude non-cash stock-based compensation, for the first quarter ended March 31, 2022 were $16.2 million, compared to $9.0 million for the same period in 2021. The increase in non-GAAP G&A expenses was driven by litigation-related expenses and public company operating costs.
A discussion of these non-GAAP financial measures, including reconciliations of the most comparable GAAP measures to non-GAAP financial measures, is presented below under "Non-GAAP Financial Measures."

Cash, cash equivalents and marketable securities

Cash, cash equivalents and marketable securities as of March 31, 2022 were $838.0 million, compared to $898.3 million as of December 31, 2021. Lyell believes that its cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into 2025.

On May 10, 2022 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the first quarter 2022 (Press release, Sana Biotechnology, MAY 10, 2022, View Source [SID1234614076]).

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"In the first quarter, we made significant progress in moving toward clinical trials for programs across our multiple platforms including the ex vivo hypoimmune allogeneic CAR T (SC291) and in vivo fusogen CAR T (SG295) programs, and we remain on track to file INDs for both of these programs this year," said Steve Harr, Sana’s President and Chief Executive Officer. "In addition to advancing these programs, we continue to make progress across our earlier pipeline, including SC451, our hypoimmune stem-cell derived pancreatic islet cell therapy for patients with type 1 diabetes, and multiple product candidates in our CAR T portfolio. Our people, broad set of technologies, and strong balance sheet enable us to pursue this ambitious pipeline."

Continued progress in building Sana’s hypoimmune ex vivo platform and in vivo fusogen platform with presentations at multiple conferences

Hypoimmune ex vivo platform: Presented preclinical data demonstrating that hypoimmune CAR T cells were able to evade both the innate and adaptive arms of the immune system in animal models while retaining their antitumor activity at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

In vivo fusogen platform: Scheduled to present preclinical data regarding hypoimmune pancreatic islet cells, generation of hypoimmune allogeneic regulatory T cells, retargeted fusosomes for in vivo delivery to T cells, fusosome-targeted gene transfer to human hepatocytes, and a novel vector copy number assay at the 2022 American Society of Gene & Cell Therapy meeting later in May.
Expanded Sana’s CAR T capability to potentially develop best-in-class, broadly accessible CAR T cell therapies

Entered into an exclusive agreement with the National Institutes of Health (NIH) for worldwide commercial rights to the NIH’s CD22 chimeric antigen receptor with a fully-human binder. This CAR construct has shown efficacy in several clinical studies, including in CD19 CAR T cell therapy failures. Targeting both CD19 and CD22 with an "off-the-shelf" product, whether in combination with Sana’s hypoimmune platform or fusogen platform, offers the potential of higher and more durable complete response rates in earlier-stage patients as well as in patients that have previously failed an autologous CD19 CAR T cell therapy.

Entered into a non-exclusive agreement with IASO Biotherapeutics and Innovent Biologics for commercial rights to a clinically validated fully-human B cell maturation antigen (BCMA) CAR construct, which Sana intends to incorporate into both the company’s ex vivo hypoimmune allogeneic and in vivo fusogen platforms for the treatment of multiple myeloma.
First Quarter 2022 Financial Results

GAAP Results

Cash Position: Cash, cash equivalents, and marketable securities as of March 31, 2022 were $657.4 million compared to $746.9 million as of December 31, 2021. The decrease of $89.5 million was primarily driven by cash used in operations of $77.7 million and cash used for the purchase of property and equipment of $7.5 million. Cash used in operations includes $6.2 million of upfront license payments related to licensing CD22 and BCMA as well as multiple cash payments that will not recur this year.

Research and Development Expenses: For the three months ended March 31, 2022, research and development expenses, inclusive of non-cash expenses, was $72.7 million compared to $41.9 million for the same period in 2021. The increase of $30.8 million was due to an increase in personnel expenses related to increased headcount to expand Sana’s research and development capabilities, increased costs for third-party manufacturing, laboratory supplies, facility and other allocated costs, and costs to acquire technology complementary to our own. Research and development expenses include non-cash stock-based compensation of $5.7 million and $2.7 million for the three months ended March 31, 2022 and 2021, respectively.

Research and Development Related Success Payments and Contingent Consideration: For the three months ended March 31, 2022, we recognized a non-cash gain of $55.4 million in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate, compared to expenses of $127.1 million for the same period in 2021. The value of these potential liabilities can fluctuate significantly with changes in our market capitalization and stock price.

General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2022, inclusive of non-cash expenses, were $14.4 million compared to $11.8 million for the same period in 2021. The increase of $2.6 million was primarily due to increased personnel-related expenses attributable to an increase in headcount to support our continued research and development activities. General and administrative expenses include stock-based compensation of $2.0 million and $1.5 million for the three months ended March 31, 2022 and 2021, respectively.

Net Loss: Net loss for the three months ended March 31, 2022 was $31.4 million, or $0.17 per share, compared to $180.6 million, or $1.52 per share, for the same period in 2021.
Non-GAAP Measures

Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the three months ended March 31, 2022 was $82.0 million compared to $48.9 million for the same period in 2021. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities, excluding cash inflows from financing activities, cash outflows from business development activities, and the purchase of property and equipment.

Non-GAAP Net Loss: Non-GAAP net loss for the three months ended March 31, 2022 was $86.9 million, or $0.47 per share, compared to $53.6 million, or $0.45 per share, for the same period in 2021. Non-GAAP net loss excludes certain one-time costs to acquire technology and non-cash expenses related to the change in the estimated fair value of contingent consideration and success payment liabilities.
A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under "Non-GAAP Financial Measures."

On May 10, 2022 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, reported its financial results for the first quarter ended March 31, 2022 (Press release, Calithera Biosciences, MAY 10, 2022, View Source [SID1234614075]).

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"We made significant headway in the transfer of mivavotinib and sapanisertib materials to Calithera during the first quarter and are well into site start-up activities. We are on track to begin enrolling patients in both mivavotinib and sapanisertib trials in the second quarter of 2022 and expect to share data from these studies by the first quarter of 2023," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "We are also excited about our preclinical synthetic lethality program, having presented the first data from our internally-discovered, first-of-their-kind VPS4A inhibitors at the AACR (Free AACR Whitepaper) Annual Meeting. This year has shaped up to be an exciting one for Calithera, given the potential we see in both our clinical and preclinical programs."

First Quarter 2022 and Recent Highlights

Mivavotinib (SYK inhibitor): Based on clinical data showing enhanced activity of mivavotinib in activated B-cell-like (ABC) diffuse large B-cell lymphoma (DLBCL) and preclinical data demonstrating enhanced SYK activity and inhibition in DLBCL with MyD88/CD79 mutations, Calithera designed a phase 2 trial of mivavotinib in relapsed or refractory non-GCB (ABC) DLBCL with enrichment of MYD88/CD79b-mutated tumors using liquid next-generation sequencing (NGS) testing. The phase 2a portion of the study will confirm activity in the biomarker-defined subsets and further refine dose and schedule. The trial will enroll non-GCB (ABC) DLBCL patients based on Hans algorithm, and researchers will collect MyD88 and CD79 mutation status using ctDNA-based liquid NGS to accrue a pre-specified number of patients harboring MyD88 or CD79b mutations. Approximately 50% of all ABC DLBCL tumors have one or both of these mutations. Calithera anticipates the first patient enrolled in the second quarter of 2022. Data generated from this study could position the company to initiate a study with registrational intent in biomarker-specific populations in DLBCL.

Sapanisertib (Dual mTORC 1/2 inhibitor): In a recent investigator-led study, sapanisertib demonstrated durable single-agent activity in patients with heavily pretreated NRF2 (NFE2L2)-mutated squamous non-small cell lung cancer (NSCLC). These mutations occur in approximately 15% of patients with squamous NSCLC. Calithera is initiating a phase 2 study intended to strengthen the existing data in patients with NRF2-mutated squamous NSCLC and evaluate its activity in NRF2 wildtype (WT) squamous NSCLC. Sapanisertib has the potential to be a first-in-class treatment for individuals with NRF2-mutated squamous NSCLC, a patient population with poorer prognosis, unmet clinical need, and no targeted therapies. Sapanisertib could also be a possible treatment for other NRF2-mutated cancers beyond NSCLC. Calithera anticipates the first patient enrolled in this study in the second quarter of 2022.

Presented data on its novel series of VPS4A inhibitors. Calithera presented the first data from its preclinical synthetic lethality pipeline at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting. The presented poster detailed Calithera’s discovery of a novel series of VPS4A (vacuolar protein sorting-associated protein 4A) inhibitors that are currently advancing through lead optimization. These data validate the synthetic lethal interaction between the gene paralogs VPS4A and VPS4B, and we believe, provide the first preclinical evidence supporting a newly discovered series of compounds designed to target these proteins for cancer treatment. To our knowledge, these are the first active, on-target VPS4 inhibitors described to date.
Closed a $10.0 Million Underwritten Public Offering of Common Stock and Warrants to Purchase Common Stock. On April 1, 2022, Calithera closed an underwritten public offering of 18,518,519 shares of its common stock at a combined price to the public of $0.54 per share and accompanying warrants. Each share of common stock is accompanied by a warrant to purchase one share of common stock at an exercise price of $0.54 per share, which is immediately exercisable and will expire 18 months from the date of issuance, or a short-term warrant, and a warrant to purchase one share of common stock at an exercise price of $0.54 per share, which is immediately exercisable and will expire 5 years from the date of issuance, or a long-term warrant. Calithera received gross proceeds of $10.0 million, resulting in $8.5 million of net proceeds after deducting underwriting discounts and commissions and offering expenses.
Selected First Quarter 2022 Financial Results

Cash and cash equivalents totaled $44.7 million at March 31, 2022, which Calithera expects, together with proceeds from its public offering, will be sufficient to meet its operating plan through the second quarter of 2023.

Research and development expenses for the first quarter 2022 were $9.6 million, compared to $15.3 million in the same period prior year. The decrease of $5.8 million was primarily due to a decrease in the telaglenastat program, partially offset by increases in the sapanisertib and mivavotinib programs.

General and administrative expenses for the first quarter 2022 were $4.3 million, compared to $5.4 million in the same period prior year. The decrease of $1.2 million was primarily due to decreases in personnel-related costs.

Net loss for the three months ended March 31, 2022 was $13.8 million.

Conference Call Information

Calithera will host an update conference call today, Tuesday, May 10, at 2:00 p.m. Pacific Time/5:00 p.m. Eastern Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and referring to conference ID 4979639. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On May 10, 2022 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help protect people from infectious diseases and treat people with cancer and HPV-associated diseases, reported financial results for the quarter ended March 31, 2022 and announced recent program and corporate developments (Press release, Inovio, MAY 10, 2022, View Source [SID1234614074]). INOVIO’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

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In a separate press release, the Company announced the appointment of Jacqueline Shea, Ph.D., as President and Chief Executive Officer (CEO). Dr. Shea, INOVIO’s former Chief Operating Officer, succeeds Dr. J. Joseph Kim in these roles.

"We believe in the potential of our DNA medicines and vaccines to combat infectious diseases, cancer and HPV-associated diseases," said Dr. Jacqueline Shea, President and CEO of INOVIO. "To achieve these goals, INOVIO must strategically prioritize our resources to capitalize on its demonstrated ability to generate functional T-cell and antibody immune responses, lack of anti-vector response, tolerability for re-administration and favorable temperature stability for transport, storage and distribution."

First Quarter Program Updates

COVID-19: INNOVATE

INOVIO has decided to prioritize its COVID-19 efforts to advance its heterologous booster strategy. In so doing, the company will discontinue its Phase 3 INNOVATE trial. This decision reflects emerging global data that indicate a lower incidence of severe COVID-19 cases1, which would necessitate an increase in trial size and costs for INNOVATE. In contrast, the heterologous booster market offers greater opportunities as the world prepares to enter the endemic phase of COVID-19.

COVID-19: Heterologous Booster – Preliminary Data

With its partner, Advaccine, INOVIO reported positive T cell immune response data with INO-4800 as a heterologous booster to an inactivated COVID-19 vaccine. This data came from a heterologous booster clinical trial conducted by Advaccine that assessed the immune responses following a primary series of two doses of an inactivated COVID-19 vaccine followed by a booster with INO-4800 after 3 or 6 months. Interim immunogenicity data showed that using INO-4800 as a booster after 6 months resulted in a 6.3-fold increase in T cell immune response. In a separate Advaccine study where a third dose of an inactivated COVID-19 vaccine was assessed, the cellular response increased by 1.7-fold. The highest booster effect of INO-4800 was observed with a 2 mg dose of INO-4800 delivered 6 months after a primary series with an inactivated vaccine.

Following INO-4800 vaccination, the preservation of cross-reactive T cell responses remains a consistent observation against multiple SARS-CoV-2 variants of concern, including Omicron, without a significant loss in response magnitude. T cells that can recognize SARS-CoV-2 may play a role in reducing disease severity. Therefore, INO-4800 has the potential to play an important role in reducing incidence of severe COVID-19 cases, which could reduce hospitalizations as the virus continues to mutate and new variants arise.

INOVIO is continuing discussions with regulators in select countries regarding potential regulatory pathways for licensure. The Company believes the increased global awareness about the importance of T cell immune responses and durability of protection for effective booster vaccines correspond well with INO-4800’s key strength – its ability to generate CD8+ T cell responses against SARS-CoV-2.

INOVIO is planning to expand its partnership with Advaccine beyond INO-4800 to include heterologous boosters and vaccine candidates covering future variants. The expanded partnership will allow both companies to share data, leverage Advaccine’s multiple manufacturing sites in China, and access opportunities globally.

VGX-3100: HPV-associated Cervical High-Grade Squamous Intraepithelial Lesions (HSIL)

Based on feedback from the U.S. Food and Drug Administration (FDA), INOVIO has changed its development plans for VGX-3100 for HPV-16/18-associated cervical HSIL to a biomarker-selected population. In a recent preliminary letter, the FDA advised INOVIO that the REVEAL2 Phase 3 study would not be sufficient to support approval of a potential marketing application for VGX-3100 in that population. The FDA recommended that using REVEAL2 as an exploratory study to evaluate a biomarker-selected population and then conducting one or two additional well-controlled trials in the biomarker-positive population would be more likely to provide sufficient evidence to support approval of a marketing application.

To better assess potential efficacy in a biomarker-selected population, the Company plans to amend the fully enrolled REVEAL2 trial to revise the primary analysis population from the all-comers population to the biomarker-positive population. Both the biomarker-positive population and the all-comers population will be analyzed.

INOVIO will continue its REVEAL2 trial to completion and assess the path forward for the VGX-3100 program following analysis of the REVEAL2 results. Given the likelihood for at least one additional trial, INOVIO no longer expects to submit a BLA in 2023 for VGX-3100.

INO-3107: Recurrent Respiratory Papillomatosis (RRP)

INOVIO completed enrollment of 32 participants in the open-label, multicenter Phase 1/2 trial to evaluate the efficacy, safety, tolerability, and immunogenicity of INO-3107 in participants with HPV-6/11-associated RRP who have required at least two interventions in the past year for the removal of associated papilloma(s). For this study, adult participants will first undergo removal of their papilloma(s) and will subsequently receive four doses of INO-3107, one every three weeks. The efficacy endpoint will be a reduction in the frequency of therapeutic interventions following the first dose of INO-3107 relative to the frequency prior to study therapy.

INOVIO expects preliminary efficacy, safety and immunogenicity data from a portion of participants from this Phase 1/2 trial in the second half of this year. The Company will share additional clinical development plans after analysis of the data.

INO-5401: Newly Diagnosed Glioblastoma Multiforme (GBM)

INOVIO’s abstract providing follow-up Phase 1/2 overall survival, safety and immunogenicity data from the Company’s novel combination trial of DNA medicines INO-5401 and INO-9012 in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in the treatment of newly diagnosed GBM has been selected for oral presentation as part of an Oral Abstract Session at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting under the title "Intramuscular (IM) INO-5401 + INO-9012 with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma".

The complete text of the abstract will be posted on the website, meetings.asco.org, on May 26, 2022 at 5:00 PM EDT. The 2022 ASCO (Free ASCO Whitepaper) Annual Meeting will take place on June 3-7, 2022 at the McCormick Place Convention Center in Chicago, Illinois.

First Quarter 2022 Financial Results

INOVIO reported total revenue was $199,000 for the three months ended March 31, 2022, compared to $371,000 for the same period in 2021. Total operating expenses were $71.9 million compared to $52.9 million for the same period in 2021.

INOVIO’s net loss for the quarter ended March 31, 2022, was $79.1 million, or $0.36 per basic and diluted share, compared to net loss of $54.4 million, or $0.27 per basic and diluted share, for the quarter ended March 31, 2021.

Operating Expenses

Research and development (R&D) expenses for the three months ended March 31, 2022, were $56.0 million compared to $39.0 million for the same period in 2021. The increase in R&D expenses was primarily related to higher drug manufacturing and clinical trial expenses related to INO-4800 and higher employee compensation. The increase was also due to $6.3 million lower contra-research and development expense recorded from grant agreements. These increases were offset by lower engineering services and expensed equipment related to our CELLECTRA 3PSP device array automation project, among other variances.

General and administrative (G&A) expenses were $16.0 million for the three months ended March 31, 2022, versus $13.9 million for the same period in 2021. The increase in G&A expenses was primarily related to an increase in employee compensation and insurance expenses, among other variances.

Capital Resources

As of March 31, 2022, cash and cash equivalents and short-term investments were $360.4 million compared to $401.3 million as of December 31, 2021. As of March 31, 2022, the Company had 226.5 million common shares outstanding and 247.8 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 March 31, 2022, which can be accessed at: View Source

Conference Call / Webcast Information

INOVIO’s management will host a live conference call and webcast at 4:30 p.m. Eastern Daylight Time today to discuss INOVIO’s financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

On May 10, 2022 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help protect people from infectious diseases and treat people with cancer and HPV-associated diseases, reported the appointment of Jacqueline Shea, Ph.D., as President and Chief Executive Officer (CEO) of INOVIO, effective immediately (Press release, Inovio, MAY 10, 2022, View Source [SID1234614073]). Dr. Shea succeeds Dr. J. Joseph Kim in these roles. Dr. Kim has also resigned as a member of the INOVIO board of directors, and the board intends to appoint Dr. Shea as a director following INOVIO’s annual meeting of the stockholders on May 16, 2022.

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Mr. Simon X. Benito, Chairman of the Board of INOVIO, said, "On behalf of the entire Board, I am pleased to announce Dr. Shea’s appointment as President and CEO of INOVIO. Dr. Shea brings more than 25 years of experience in the life sciences and biotech industries. Since joining as Chief Operating Officer in March 2019, Dr. Shea has shown exceptional leadership and technical expertise overseeing INOVIO’s manufacturing, commercial, business development, project and alliance management operations as well as serving as a key member of the executive team. We look forward to Dr. Shea taking the helm during a particularly challenging period in INOVIO’s history. Her tenured leadership, deep knowledge of our business, and broad expertise makes her an excellent choice for the role."

Mr. Benito added, "On behalf of the Board, I would like to thank Dr. Kim for his commitment to INOVIO and his founding vision of a world free from disease through DNA medicines. As a co-founder of the Company, Joseph has been a true entrepreneur and pioneer in the field of vaccines and immunotherapies since its inception. I am pleased that he has agreed to act in an advisory capacity to Dr. Shea during the transition."

Dr. Shea said, "I am honored to take on the role of CEO and grateful for the support of the Board in entrusting me to lead INOVIO for its next chapter. While we have many challenges to face, I believe strongly in the potential of our DNA medicines technology and continue to be inspired by INOVIO’s talented and dedicated team. I look forward to reshaping the future of INOVIO and advancing our efforts across multiple therapeutic areas with the potential to improve the lives of patients globally."

Prior to joining INOVIO in March 2019, Dr. Shea served as the Chief Operating Officer and later the Chief Executive Officer of Aeras, a not-for-profit organization dedicated to developing new vaccines against tuberculosis (TB). During her tenure she oversaw two major clinical trial breakthroughs in the development of TB vaccines. Previously, she held executive roles at Emergent BioSolutions and was also the General Manager and Vice President of The Oxford-Emergent Tuberculosis Consortium. A molecular biologist and cell cycle geneticist, Dr. Shea received a BSc Hons in Applied Biology from the University of Bath and holds a Ph.D. from the National Institute for Medical Research in the United Kingdom. She has been named as an inventor on more than 20 patents, has authored numerous publications, served on multiple advisory boards and currently serves on the board of Trustees for the Sabin Vaccine Institute.