Kaleido Biosciences Reports First Quarter 2021 Financial Results

On May 4, 2021 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health, reported financial results for the first quarter ended March 31, 2021 (Press release, Kaleido Biosciences, MAY 4, 2021, View Source [SID1234579102]).

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"Kaleido is off to a strong start in 2021 marked by positive results from our 350-patient clinical study with KB109 in outpatients with mild-to-moderate COVID-19 and a recently completed financing, which will support the continued expansion of our novel, targeted Microbiome Metabolic TherapyTM (MMT) candidates," said Dan Menichella, President and Chief Executive Officer of Kaleido. "Consistent with the interim findings we reported earlier this year, results from the full dataset demonstrated that KB109 has a favorable safety and tolerability profile and reduced COVID-19 related healthcare utilization and recovery time in patients with one or more comorbidity. Based on these results, we are investing in the manufacturing of KB109 and are initiating an IND application with the FDA."

Continued Mr. Menichella: "Beyond our COVID-19 program, we have a robust pipeline of MMT-based candidates that holds immense potential. We continue to make progress enrolling patients in our non-IND study evaluating KB295 in individuals with mild-to-moderate ulcerative colitis with topline data anticipated mid-year. We believe these data are critical as patients and clinicians express interest in novel, oral therapeutic options with a strong safety and tolerability profile."

Recent Program and Corporate Highlights

An analysis from the full dataset (n=350) of the K031 controlled non-IND study of KB109 in patients with mild-to-moderate COVID-19 demonstrated a reduction in overall COVID-19 related healthcare utilization—comprised of hospitalizations, emergency room visits, and urgent care visits. The study also demonstrated a significant reduction in recovery time for patients age 45 and older or with one or more comorbidity who received KB109 plus self-supportive care as compared to patients receiving self-supportive care alone.
In February, Kaleido closed a public offering with gross proceeds of approximately $69.4 million, before deducting underwriting discounts and commissions and other offering expenses.
In April, Kaleido announced a research collaboration with researcher Robert Jenq, M.D. Professor of Genomic Medicine, at The University of Texas MD Anderson Cancer Center, to explore the potential of Kaleido’s novel MMT in preventing febrile neutropenia—a serious complication associated with hematopoietic stem cell transplantations (HSCT).
First Quarter Financial Results

Kaleido reported a net loss of $23.0 million, or $0.58 per common share, for the first quarter of 2021 compared to $19.6 million, or $0.64 per common share, for the same period in 2020. The first quarter net loss includes non-cash stock-based compensation expenses of $4.2 million, as compared to $2.7 million in the first quarter of 2020.

Research and development (R&D) expenses were $17.2 million and $13.1 million for the three months ended March 31, 2021 and 2020, respectively. The increase was primarily due to increased spend relating to our two COVID-19 studies and the modification of the vesting provision of stock options and restricted stock units related to the resignation of our former CMO.

General and administrative (G&A) expenses were $5.5 million and $5.9 million for the three months ended March 31, 2021 and 2010, respectively. The decrease was primarily due to reduced headcount and lower utilization of outside contractors.

As of March 31, 2021, the Company reported cash and cash equivalents of $92.4 million. The Company continues to manage its operating expenses and, as a result, has cash runway into the first quarter of 2022.

About Microbiome Metabolic Therapies (MMT)

Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted, synthetic glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its discovery and development platform to study MMTs in microbiome samples to rapidly advance MMT candidates rapidly into clinical studies in healthy subjects and patients. These human clinical studies are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., and in Phase 2 or later development.

Jazz Pharmaceuticals Announces First Quarter 2021 Financial Results

On May 4, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the first quarter of 2021 and affirmed financial guidance for 2021 (Press release, Jazz Pharmaceuticals, MAY 4, 2021, View Source [SID1234579101]).

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"Demand for Xywav is strong, as both patients and physicians embrace the health benefits associated with reducing daily sodium intake. We also continue to see robust uptake of Zepzelca among both platinum-resistant and platinum-sensitive small cell lung cancer patients, consistent with the positive feedback we’ve received on its profile," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "We are on track to deliver significant revenue growth and diversification in 2022, are poised for two additional product launches this year and look forward to completing the acquisition of GW Pharmaceuticals this month, all key milestones in our transformation to an innovative biopharmaceutical company and neuroscience leader."

Robert Iannone, M.D., M.S.C.E., executive vice president, research and development and chief medical officer, added, "Across our R&D organization, we’ve continued our track record of strong execution. We presented positive Xywav data in idiopathic hypersomnia (IH) at the American Academy of Neurology Annual Meeting. We are also pleased to have announced that FDA granted priority review of Xywav in IH with a PDUFA goal date set for August 12, 2021, bringing us another step closer to delivering this important treatment to patients with IH, for whom there is currently no FDA-approved therapy. Further, our JZP458 program remains on track with a potential approval in mid-2021. I’m proud that our continued execution enables us to bring life-changing medicines to often overlooked patient groups with significant unmet need."

Business Updates

Corporate Development

On February 3, 2021, the Company announced that it had entered into a definitive agreement to acquire GW Pharmaceuticals plc (GW) for $220.00 per American Depositary Share, in the form of $200 in cash and $20 in Jazz ordinary shares, based on the volume weighted average price of Jazz ordinary shares on Nasdaq for the 15 consecutive trading day period beginning on the 18th trading day immediately preceding the closing date of the transaction, for a total value of approximately $7.2 billion, or $6.7 billion net of GW cash. The Company has secured $5.35 billion of financing to support the GW transaction; $1.5 billion as senior secured notes and a $3.85 billion term loan. This financing structure supports the Company’s rapid deleveraging to its stated targets.

All shareholder and regulatory approvals required for the acquisition have now been obtained. Completion of the acquisition remains subject to the sanction by the High Court of Justice of England and Wales (Court) and other customary closing conditions. The Court hearing to sanction the acquisition is currently scheduled for May 5, 2021, and the completion of the acquisition is expected to occur shortly thereafter. Upon close of the transaction, the combined company will be a leader in neuroscience with a global commercial and operational footprint, well positioned to maximize the value of its diversified portfolio.

Neuroscience

Oxybate (Xyrem and XywavTM):

Net product sales for the combined oxybate business increased 1% to $411.0 million in the first quarter of 2021 compared to the same period in 2020.
Average active oxybate patients on therapy were approximately 15,700 in the first quarter of 2021, an increase of approximately 4% compared to the same period in 2020.
Strong Xywav uptake, coupled with utilization of our patient access programs, resulted in a 3% decrease in revenue bottle volume in the first quarter of 2021 compared to the same period in 2020.
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:

Xywav net product sales were $75.4 million in the first quarter of 2021.
There were approximately 3,900 active patients on Xywav exiting the first quarter of 2021, following the U.S. launch in November 2020.
The Company has achieved its goal of obtaining broad payer coverage, having entered into agreements with all three of the largest pharmacy benefit managers and coverage now at 80% of commercial lives. The Company continues to work with other payers to further expand coverage.
Xyrem (sodium oxybate) oral solution:

Xyrem net product sales decreased 18% to $335.6 million in the first quarter of 2021 compared to the same period in 2020.
Xywav in Idiopathic Hypersomnia

The U.S. Food and Drug Administration (FDA) has granted Priority Review Designation and confirmed the supplemental New Drug Application (sNDA) seeking approval for Xywav in adult patients with idiopathic hypersomnia (IH). The Prescription Drug Fee User Act (PDUFA) target action date for an FDA decision has been set for August 12, 2021, which is in line with the objective of launching in the fourth quarter of 2021.
Positive Phase 3 trial results were presented at the American Academy of Neurology annual meeting in April 2021. The efficacy and safety results demonstrate the potential Xywav has for helping people living with IH, an often debilitating neurologic sleep disorder for which there are currently no approved treatments in the U.S.
Sunosi (solriamfetol):

Sunosi net product sales were $11.6 million in the first quarter of 2021, compared to $1.9 million in the same period of 2020 following the U.S. launch in July 2019.
In the first quarter of 2021, U.S. prescriptions increased 10% compared to the fourth quarter of 2020.
JZP385:

JZP385, a highly selective modulator of T-type calcium channels, is in clinical development for the potential treatment of essential tremor.
The Company expects to initiate a Phase 2b trial in mid-2021.
JZP150:

JZP150, a fatty acid amide hydrolase (FAAH) inhibitor, is in clinical development for the potential treatment of post-traumatic stress disorder.
The Company expects to initiate a Phase 2 trial in late 2021.
Oncology

Zepzelca (lurbinectedin):

Zepzelca net product sales were $54.3 million in the first quarter of 2021, with continued growth across both platinum-resistant and platinum-sensitive patients in second-line small cell lung cancer (SCLC). Zepzelca was launched in the U.S. in July 2020.
The Company anticipates initiating a Phase 3 trial evaluating immunotherapy plus lurbinectedin maintenance therapy, compared to immunotherapy alone, in patients with extensive-stage SCLC after induction chemotherapy in 2021.
The Company and Pharma Mar, S.A. (PharmaMar) continue to engage with FDA regarding the confirmatory data package.
JZP458 (recombinant Erwinia asparaginase):

In December 2020, the Company initiated the submission of a Biologics License Application (BLA) to FDA for JZP458 for intramuscular use as a component of a multi-agent chemotherapeutic regimen for the treatment of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL) in adult and pediatric patients who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.
The BLA will be reviewed under the Real Time Oncology Review program (RTOR) an initiative of FDA’s Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients.
The Company is targeting a mid-2021 launch in the U.S., subject to FDA approval.
The Company continues to prioritize global development of JZP458 with the objective of ensuring that ALL/LBL patients have access to a reliably-produced, high-quality recombinant asparaginase.
Enrollment in the pivotal Phase 2/3 trial continues beyond the current RTOR submission, with the recent initiation of the intravenous cohort.
Vyxeos (daunorubicin and cytarabine) liposome for injection:

Vyxeos net product sales increased 1% to $33.2 million in the first quarter of 2021 compared to the same period in 2020.
FDA approved a revised label for Vyxeos to include a new indication for newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients aged one year and older.
Defitelio (defibrotide sodium) / defibrotide:

Defitelio/defibrotide net product sales increased 5% to $49.6 million in the first quarter of 2021 compared to the same period in 2020.
Erwinaze / Erwinase (asparaginase Erwinia chrysanthemi):

Erwinaze/Erwinase net product sales increased 9% to $41.1 million in the first quarter of 2021 compared to $37.7 million for the same period in 2020.
The Company’s agreement with Porton Biopharma Limited terminated on December 31, 2020. The Company has the right to sell certain Erwinaze inventory post-termination and expects to distribute this Erwinaze inventory during the first half of 2021. Once sales of available inventory are complete, the Company will cease recording net sales of Erwinaze.
Financial Highlights

GAAP net income for the first quarter of 2021 was $121.8 million, or $2.09 per diluted share, compared to a GAAP net loss of $157.8 million, or $2.82 per diluted share, for the first quarter of 2020. Non-GAAP adjusted net income for the first quarter of 2021 was $228.8 million, or $3.92 per diluted share, compared to $25.8 million, or $0.45 per diluted share, for the first quarter of 2020.

The GAAP net loss and non-GAAP adjusted net income for the first quarter of 2020 included the post-tax impact of a $200.0 million upfront payment made to PharmaMar for the exclusive U.S. commercialization and development rights to Zepzelca. The GAAP net loss for the first quarter of 2020 also included the post-tax impact of an impairment charge of $136.1 million following the Company’s decision to stop enrollment in its Phase 3 clinical trial of defibrotide for the prevention of veno-occlusive disease (VOD).

Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

Total revenues increased 14% in the first quarter of 2021 compared to the same period in 2020.

Products launched since 2019 accounted for 23% of total net product sales in the first quarter of 2021.
Neuroscience net product sales in the first quarter of 2021 increased 3% to $422.6 million compared to the same period in 2020 and oxybate net product sales increased to $411.0 million led by strong Xywav net product sales of $75.4 million partially offset by a decrease in Xyrem net product sales driven by the strong adoption of Xywav by existing Xyrem patients. Oxybate revenue bottle volumes were impacted by our patient access programs. Sunosi net product sales increased by $9.7 million compared to the first quarter of 2020.
Oncology net product sales in the first quarter of 2021 increased 51% to $178.2 million compared to the same period in 2020 driven primarily by robust Zepzelca net product sales of $54.3 million. Zepzelca launched in the U.S. in July 2020.
Operating expenses changed over the prior year periods primarily due to the following:

Selling, general and administrative (SG&A) expenses increased in the first quarter of 2021 compared to the same period in 2020 on a GAAP and on a non-GAAP adjusted basis primarily due to increased investment in sales, marketing and launch activities with the commencement of the Sunosi direct-to-consumer television marketing campaign and the continuation of the launches of Xywav and Zepzelca in the U.S., as well as an increase in other expenses primarily related to the expansion of the commercial operations. SG&A expenses in the first quarter of 2021 on a GAAP basis also included transaction expenses related to the proposed GW acquisition.
Research and development expenses decreased in the first quarter of 2021 compared to the same period in 2020, on a GAAP and on a non-GAAP adjusted basis, primarily due to a decrease in expenses related to the Company’s clinical programs.
Acquired in-process research and development (IPR&D) expense in the first quarter of 2020 on a GAAP and on a non-GAAP adjusted basis primarily related to a $200.0 million upfront payment to PharmaMar for the exclusive U.S. commercialization and development rights to Zepzelca.
In the first quarter of 2020, the Company recorded an impairment charge of $136.1 million on a GAAP basis following the Company’s decision to stop enrollment in its Phase 3 clinical trial of defibrotide for the prevention of VOD.
The effective tax rate for the first quarter of 2021 compared to the same period in 2020 decreased on a GAAP basis primarily due to the impact of the defibrotide IPR&D asset impairment charge, the acquired IPR&D expense primarily relating to the $200.0 million upfront payment to PharmaMar, and changes in income mix among the various jurisdictions in which we operate.
Cash Flow and Balance Sheet

As of March 31, 2021, cash, cash equivalents and investments were $2.4 billion, and the outstanding principal balance of the Company’s long-term debt was $2.4 billion. In the first quarter of 2021, the Company generated $285.0 million of cash from operations.

2021 Financial Guidance1

The Company is affirming its full year 2021 financial guidance as follows:

Conference Call Details

Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. ET (9:30 p.m. IST) to provide a business and financial update and discuss its 2021 first quarter results. The live webcast may be accessed from the Investors section of the Company’s website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing +1 855 353 7924 in the U.S., or +1 503 343 6056 outside the U.S., and entering passcode 8765706.

A replay of the conference call will be available through May 11, 2021 by dialing +1 855 859 2056 in the U.S., or +1 404 537 3406 outside the U.S., and entering passcode 8765706. An archived version of the webcast will be available for at least one week in the Investors section of the Company’s website at www.jazzpharmaceuticals.com.

Entry into a Material Definitive Agreement

On May 4, 2021, Invitae Corporation (the "Company") reported that entered into a Sales Agreement (the "Agreement") with Cowen and Company, LLC (the "Sales Agent") (Filing, 8-K, Invitae, MAY 4, 2021, View Source [SID1234579100]). The Agreement provides for the issuance and sale by the Company of common stock having an aggregate offering price of up to $400,000,000. Pursuant to the Agreement, the Company may offer and sell the shares in transactions deemed to be an "at-the-market" offering as defined in Rule 415(a)(4) of the Securities Act of 1933, which shares can be sold by the Company from time to time, depending upon market demand, with the Sales Agent acting as an agent for sales.

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The Company will pay the Sales Agent a commission of up to 3.0% of the gross proceeds from the sale of shares of common stock by it as agent under the Agreement. The Agreement provides that the Company will provide customary indemnification rights to the Sales Agent. The Company has no obligation to sell any shares of common stock pursuant to the Agreement and may at any time suspend sales pursuant to the Agreement. Either party may terminate the Agreement pursuant to the terms of the Agreement without liability of any party.

The shares of common stock will be sold pursuant to the Company’s automatic shelf registration statement on Form S-3 (File No. 333-230053), that was filed with the Securities and Exchange Commission and became automatically effective on March 4, 2019, including the related prospectus, dated March 4, 2019, as supplemented by the prospectus supplement dated May 4, 2021. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state.

Under the Agreement, the Company may also sell shares of common stock to the Sales Agent as principal for its own account, at a price to be agreed upon at the time of sale. If the Company sells shares to the Sales Agent as principal, the Company will enter into a separate terms agreement with the Sales Agent, and the Company will describe the agreement in a separate prospectus supplement or pricing supplement.

The foregoing description of the Agreement does not purport to be complete and is subject to and qualified in its entirety by reference to the Agreement, a copy of which is attached hereto as Exhibit 1.1 and is incorporated herein by reference.

Invitae Reports $103.6 Million in Revenue Driven by 259,000 in Billable Volume in First Quarter of 2021

On May 4, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported financial and operating results for the first quarter ended March 31, 2021 signaling continued momentum into 2021 (Press release, Invitae, MAY 4, 2021, View Source [SID1234579099]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"We had a very strong start to the year, experiencing record daily volumes, and we expect that momentum to continue into the coming years," said Sean George, co-founder and chief executive officer of Invitae. "Genetic information is the foundation for personalized medicine, and we believe Invitae is uniquely positioned to deliver that information from a single platform across all stages of life, ushering personalized medicine into the mainstream to improve healthcare for all."

First Quarter 2021 Financial Results

Generated revenue of $103.6 million in the quarter, a 61% increase compared to $64.2 million in the same period in 2020
Reported billable volume of 259,000 in the quarter, a 72% increase compared to 151,000 in the same period in 2020
Reported average cost per billable unit of $290 in the quarter compared to $268 average cost per billable unit in the same period in 2020. Non-GAAP average cost per unit was $242 in the quarter
Achieved gross profit for the first quarter of 2021 of $28.1 million, compared to $23.8 million in the same period in 2020. Non-GAAP gross profit was $40.5 million in the first quarter
Total operating expense, which excludes cost of revenue, for the first quarter of 2021 was $140.5 million compared to $121.6 million in the same period in 2020. Non-GAAP operating expenses, which excludes cost of revenue, for the quarter was $155.4 million.

Net loss for the first quarter of 2021 was $109.5 million, or a $0.56 net loss per share, compared to a net loss of $98.5 million in the first quarter of 2020, or a $0.99 net loss per share. Non-GAAP net loss for the quarter was $122.2 million, or a $0.63 non-GAAP net loss per share.

At March 31, 2021, cash, cash equivalents, restricted cash and marketable securities totaled $681.9 million as compared with $360.7 million as of December 31, 2020. Net increase in cash, cash equivalents and restricted cash for the quarter was $73.0 million. Non-GAAP cash burn was $112.3 million for the quarter. Cash burn for the quarter would have been $94.6 million excluding the cash paid for acquisitions, primarily related to the cash paid to acquire One Codex.

In January, the company announced the sale of approximately 8.9 million shares of its common stock at a price of $51.50 per share, resulting in net proceeds, after underwriting discounts and commissions and offering expenses, of $434.3 million. Subsequent to the close of the first quarter, on April 1, 2021, the company announced that a small group of investors, led by SB Management, a subsidiary of Softbank Group Corp., made an investment of $1.2 billion in convertible senior notes to support the company’s future growth initiatives.

Corporate and Scientific Highlights

In April, the company announced plans to open a new laboratory and production facility near Research Triangle Park in North Carolina to further expand its capacity to strengthen our operations and help us offer industry-leading turnaround times – including for customers across the Atlantic and in South America.
Made two additions to our platform:
Acquired genomics company Genosity to support the speed, efficiency and flexibility needed for mainstream global adoption of personalized cancer care and monitoring to help transform how cancer is diagnosed, treated and monitored; and
Added One Codex’s microbiome and infectious disease testing capabilities to offer a high-quality, low-cost, end-to-end metagenomics product (sequencing and results) and enable the development of future offerings in infectious disease, preterm birth and wellness.
Joined The eMERGE Network, a nationwide effort organized and funded by the National Human Genome Research Institute, connecting genetic data and electronic medical record (EMR) systems to advance the use of genetics in healthcare. Invitae is providing genetic testing for a study of up to 25,000 people to evaluate the impact of population screening, especially on underserved populations.
Issued Invitae’s inaugural Environmental, Social and Governance (ESG) report, highlighting the company’s commitment and increased focus on sustainability issues and in recognition of their impact on the business and patient health.
Presented additional results at the 2021 American College of Medical Genetics and Genetics (ACMG) Annual Clinical Genetics Meeting from a landmark study conducted in collaboration with Mayo Clinic. The study evaluating colorectal cancer patients found one in six people harbor genetic changes that are known to substantially increase the risk for cancer, especially in patients who were younger when diagnosed.
Added digital health AI company Medneon’s risk assessment tools to our education and clinical support offerings to further support cancer patients by making it easier for clinicians to determine who should get testing and how to use genetic information to individualize treatment.
Launched a project with Bristol Myers Squibb, Janssen Research & Development, LLC (Janssen), Novartis and Genentech, a member of the Roche Group, to develop a standardized panel for Molecular Residual Disease (MRD) detection in patients with Acute Myeloid Leukemia (AML) to support clinical trial testing across multiple drug development programs in order to better establish the clinical utility of MRD as a biomarker in AML.
Expanded the capabilities of Invitae’s advanced clinical chatbot Gia to enable clinician use of Gia to guide their patients in an intuitive, enjoyable and telemedicine-friendly conversation through receiving and understanding genetic test results and possible next steps, including scheduling a call with a genetic counselor.
Signed 25 biopharma partnership deals in the quarter, including the introduction of a new sponsored testing program to provide no-charge genetic testing to individuals at risk for or suspected of having the most common adult Neurodegenerative conditions, including Parkinson’s disease, amyotrophic lateral sclerosis and early-onset Alzheimer’s disease, in the United States, Canada, Australia and Brazil.
Webcast and Conference Call Details
Management will host a conference call and webcast today at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss financial results and recent developments. To access the conference call and webcast, please register at the link below:

View Source

Upon registering, each participant will be provided with call details and a registrant ID. Reminders will also be sent to registered participants via email.

The live webcast of the call and slide deck, may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.

INOVIO to Present at Upcoming Investor Conferences in May

On May 4, 2021 INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, reported that INOVIO management will present at the following virtual investor conferences in May (Press release, Inovio, MAY 4, 2021, View Source [SID1234579098]):

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Bank of America Merrill Lynch Health Care Conference
Date: Wednesday, May 12, 2021
Time: 9:30 AM ET
Presentation Format: Fireside Chat

RBC Global Healthcare Conference
Date: Tuesday, May 18, 2021
Time: 9:45 AM ET
Presentation Format: Fireside Chat

Live and archived versions of the virtual presentations will be available through the INOVIO Investor Relations Events page and may be accessed by visiting INOVIO’s website at View Source All presentation times are subject to change.