8-K
INOVIO PHARMACEUTICALS, INC. (INO)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 9, 2022
Inovio Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-14888 | 33-0969592 |
|---|---|---|
| (State or other jurisdiction<br>of incorporation) | (Commission<br>File Number) | (IRS Employer<br> <br>Identification No.) |
| 660 W. Germantown Pike, Suite 110 | ||
| --- | ||
| Plymouth Meeting, PA 19462 | ||
| (Address of principal executive offices, including zip code) |
(267) 440-4200
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br>Symbol(s) | Name of each exchange<br>on which registered |
|---|---|---|
| Common Stock, $0.001 par value | INO | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02 | Results of Operations and Financial Condition. |
|---|
On May 10, 2022, Inovio Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the three months ended March 31, 2022. A copy of this press release is furnished as Exhibit 99.1 hereto and is incorporated by reference herein.
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 2.02 and Exhibit 99.1 hereto are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing by the Company under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.
| Item 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
|---|
(b) Resignation of J. Joseph Kim as President, Chief Executive Officer and Director
On May 9, 2022, J. Joseph Kim, President and Chief Executive Officer of the Company, resigned from those positions and also resigned as a member of the Company’s Board of Directors (the “Board”), in each case effective upon the filing of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, which is expected to occur on May 10, 2022 (such filing date, the “Separation Date”). Dr. Kim will no longer stand for re-election at the Company’s 2022 annual meeting of stockholders to be held on May 16, 2022.
(c)(e) Appointment of Jacqueline E. Shea as President and Chief Executive Officer
On May 10, 2022, the Board appointed Dr. Jacqueline Shea, currently the Company’s Chief Operating Officer, to serve as the Company’s President and Chief Executive Officer, effective upon the effectiveness of Dr. Kim’s resignation from those roles. Biographical information about Dr. Shea is contained in the Company’s definitive proxy statement for its 2022 annual meeting of stockholders filed with the Securities and Exchange Commission on March 25, 2022 and is incorporated herein by reference.
There are no related party transactions between Dr. Shea and the Company that would require disclosure under Item 404(a) of Regulation S-K, and there is no family relationship between Dr. Shea and any of the Company’s directors or other executive officers.
In connection with Dr. Shea’s appointment as President and Chief Executive Officer, on May 10, 2022, the Board approved, at the recommendation of the Compensation Committee of the Board, an increase in her base salary from $495,000 to $700,000, a one-time promotion bonus of $100,000 and an increase in her target bonus opportunity from 50% of her current annual base salary to 60% of her increased base salary.
In addition, on May 10, 2022, the Board approved the grant to Dr. Shea of equity awards as follows: (a) a stock option to purchase 309,400 shares, which will vest in four equal installments, with 25% vesting immediately on the grant date and 25% vesting on each anniversary of the grant date thereafter, and (b) a restricted stock unit for 198,000 shares, which will vest over three years in three equal installments beginning on the first anniversary of the grant date, subject in each case to Dr. Shea’s continued service through the applicable vesting date. The stock option grant will have an exercise price equal to the closing price of the Company’s common stock on the grant date.
Each award described above is subject to the terms and conditions of the award agreements pursuant to which they are granted. Dr. Shea will remain eligible for additional future equity awards as may be determined by the Board, or a committee thereof, in accordance with the Company’s equity incentive plans.
(e) Separation Agreement with J. Joseph Kim
On May 10, 2022, Dr. Kim and the Company entered into a Separation Agreement (the “Separation Agreement”) that is materially consistent with, but supersedes, Dr. Kim’s employment agreement with the Company, which was filed as Exhibit 10.19 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 and filed with the Securities and Exchange Commission on March 1, 2022. The Separation Agreement provides that Dr. Kim will receive, subject to him executing a general release of claims in favor of the Company and not revoking the agreement within the period provided by law to do so (the end of such period, the “Effective Date”), the following separation payments and benefits: (i) cash severance of $1,491,074, representing 24 months of his base salary in effect as of the Separation Date, subject to standard deductions and withholdings, payable in a lump sum within 10 days after November 11, 2022; (ii) additional cash severance of $939,074, subject to standard deductions and withholdings, payable in a lump sum within 10 days after November 11, 2022; (iii) a COBRA subsidy payment of $93,913.70, paid in installments over the 24-month period following the Separation Date, provided that the first payment will be made within 10 days after November 11, 2022, which will be inclusive of installments otherwise payable prior to that date. The COBRA subsidy payment equals the gross amount of 24 months of payments for premiums under Company’s health plans for Dr. Kim and his dependents, grossed up by 45% to offset the payroll taxes and withholdings to be deducted.
Under the terms of the equity award agreements for Dr. Kim’s outstanding RSUs, as of the Separation Date, the RSUs will become fully vested. As soon as practicable, but no later than June 9, 2022, one-half of the RSUs will be settled in shares of Company’s common stock, and one-half will be settled in cash, based on the fair market value of the Company’s common stock on the date of settlement.
Under the terms of the Separation Agreement, the Company has agreed to retain Dr. Kim as a non-employee advisor to the Company through May 10, 2025 (the “Advisory Period”). Dr. Kim has agreed to provide services for up to five hours per week for the first six months of the Advisory Period, with a de minimis time commitment thereafter. In exchange for the advisory services, the Company has agreed to pay Dr. Kim a $15,000 monthly retainer for the first six months of the Advisory Period, then a $5,000 monthly retainer for the second six months of the Advisory Period and a $25,000 annual retainer for the last two years of the Advisory Period. Dr. Kim’s outstanding stock options will continue to vest during the Advisory Period, and the Company has agreed to extend the exercise period of Dr. Kim’s vested stock options so that they remain exercisable until five years after the Separation Date or, if earlier, the original expiration date of the vested options.
In addition to the foregoing benefits, for one year from the Separation Date, Dr. Kim will have continued access to an executive coach at the Company’s expense. The Company will also reimburse Dr. Kim for up to $15,000 in legal expenses incurred in connection with the negotiation of the Separation Agreement.
The foregoing description of the Separation Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Separation Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2022.
| Item 7.01. | Regulation FD Disclosure. |
|---|
On May 10, 2022, the Company issued a press release announcing the management transition. A copy of this press release is furnished herewith as Exhibit 99.2 to this Current Report. The information contained in this Item 7.01 and in the press release furnished as Exhibit 99.2 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act and is not incorporated by reference into any of the Company’s filings under the Securities Act or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.
| Item 9.01 | Financial Statements and Exhibits. |
|---|
(d) Exhibits
| Exhibit<br>Number | |
|---|---|
| 99.1 | Press Release, dated May 10, 2022, “INOVIO Reports First Quarter 2022 Financial Results and Program Developments.” |
| 99.2 | Press Release, dated May 10, 2022, “INOVIO Announces the Appointment of Jacqueline Shea, Ph.D., as Chief Executive Officer.” |
| 104 | Cover Page Interactive Data File (formatted as inline XBRL). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| INOVIO PHARMACEUTICALS, INC. | ||
|---|---|---|
| Date: May 10, 2022 | By: | /s/ Peter Kies |
| Peter Kies | ||
| Chief Financial Officer |
EX-99.1
Exhibit 99.1
INOVIO Reports First Quarter 2022 Financial Results
and Program Developments
| • | Announces prioritization of heterologous booster strategy for COVID-19<br>vaccine candidate INO-4800 and discontinuation of Phase 3 INNOVATE trial to optimize potential impact on global public health |
|---|---|
| • | Reports, with partner Advaccine, positive T cell immune response data with<br>INO-4800 as a heterologous booster to an inactivated COVID-19 vaccine |
| --- | --- |
| • | Announces change in plans for VGX-3100 following input from FDA on need<br>for additional trials for a marketing application for the treatment of HPV-associated cervical high-grade squamous intraepithelial lesions |
| --- | --- |
| • | Announces appointment of Jacqueline Shea, Ph.D. as CEO |
| --- | --- |
| • | Will hold investor call today at 4:30 PM EDT |
| --- | --- |
PLYMOUTH MEETING, PA – 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, today reported financial results for the quarter ended March 31, 2022 and announced recent program and corporate developments. 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 http://ir.inovio.com/events-and-presentations/default.aspx.
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 cases^1^, 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-associatedCervical 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: NewlyDiagnosed 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) 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 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: http://ir.inovio.com/financials/default.aspx.
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 http://ir.inovio.com/events-and-presentations/default.aspx.
About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help protect people from infectious diseases and help treat people with cancer and HPV-associated diseases. Our DNA medicines are delivered using our proprietary smart device to produce a robust and tolerable immune response against targeted pathogens and cancers.
Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations, Defense Advanced Research Projects Agency/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense/Department of Defense, HIV Vaccines Trial Network, International Vaccine Institute, Kaneka Eurogentec, Medical CBRN Defense Consortium, National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Thermo Fisher Scientific, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. For more information, visit www.inovio.com.
CONTACTS:
Media: Jeff Richardson, 267-440-4211, jeff.richardson@inovio.com
Investors: Ben Matone, 484-362-0076, ben.matone@inovio.com
References:
- Institute for Health Metrics Evaluation. Used with permission. All rights reserved.
* * * *
This press release contains certainforward-looking statements relating to our business, including our plans to develop DNA medicines, our expectations regarding our research and development programs, including the planned initiation and conduct of preclinical studies and clinicaltrials and the availability and timing of data from those studies and trials, our planned heterologous booster strategy, our ability to obtain regulatory approval for our product candidates, and our plans to expand our collaboration with Advaccine..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 developmentprograms and commercialization activities and outcomes, our ability to secure sufficient manufacturing capacity to mass produce our product candidates, the availability of funding to support continuing research and studies in an effort to provesafety 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 milestonesfor 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 conditionstargeted by us or our 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 andwhether 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 canwithstand 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 orother 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 31,2021, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that anyproduct candidate in our pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-lookinginformation 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.
INOVIO Pharmaceuticals, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
| March 31,2022 | December 31,2021 | |||||
|---|---|---|---|---|---|---|
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 59,009,491 | $ | 71,143,778 | ||
| Short-term investments | 301,384,357 | 330,170,940 | ||||
| Accounts receivable | 4,003,680 | 5,466,850 | ||||
| Accounts receivable from affiliated entities | 3,487,116 | 2,565,194 | ||||
| Prepaid expenses and other current assets | 31,946,477 | 38,836,991 | ||||
| Prepaid expenses and other current assets from affiliated entities | 75,772 | 261,192 | ||||
| Total current assets | 399,906,893 | 448,444,945 | ||||
| Fixed assets, net | 16,696,936 | 17,453,206 | ||||
| Investment in affiliated entity | 3,369,068 | 3,906,796 | ||||
| Intangible assets, net | 2,499,585 | 2,626,355 | ||||
| Goodwill | 10,513,371 | 10,513,371 | ||||
| Operating lease<br>right-of-use assets | 11,251,440 | 11,571,026 | ||||
| Other assets | 1,273,795 | 1,425,794 | ||||
| Total assets | $ | 445,511,088 | $ | 495,941,493 | ||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable and accrued expenses | $ | 38,115,396 | $ | 47,644,530 | ||
| Accounts payable and accrued expenses due to affiliated entities | 1,407,386 | 548,032 | ||||
| Accrued clinical trial expenses | 11,827,755 | 10,326,266 | ||||
| Deferred revenue | 15,378 | 21,628 | ||||
| Operating lease liability | 2,672,974 | 2,603,956 | ||||
| Grant funding liability | 5,283,271 | 4,559,721 | ||||
| Grant funding liability from affiliated entity | 37,500 | 37,500 | ||||
| Total current liabilities | 59,359,660 | 65,741,633 | ||||
| Deferred revenue, net of current portion | 60,648 | 64,361 | ||||
| Convertible senior notes | 16,207,864 | 14,959,647 | ||||
| Operating lease liability, net of current portion | 14,765,868 | 15,459,559 | ||||
| Deferred tax liabilities | 32,046 | 32,046 | ||||
| Other liabilities | — | 14,826 | ||||
| Total liabilities | 90,426,086 | 96,272,072 | ||||
| Stockholders’ equity: | ||||||
| Preferred stock | — | — | ||||
| Common stock | 226,509 | 217,382 | ||||
| Additional paid-in capital | 1,642,419,819 | 1,609,589,797 | ||||
| Accumulated deficit | (1,287,103,438 | ) | (1,209,855,522 | ) | ||
| Accumulated other comprehensive loss | (457,888 | ) | (282,236 | ) | ||
| Total Inovio Pharmaceuticals, Inc. stockholders’ equity | 355,085,002 | 399,669,421 | ||||
| Total liabilities and stockholders’ equity | $ | 445,511,088 | $ | 495,941,493 |
INOVIO Pharmaceuticals, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| Three Months Ended March 31, | ||||||
|---|---|---|---|---|---|---|
| 2022 | 2021 | |||||
| Revenues: | ||||||
| Revenue under collaborative research and development arrangements | $ | 65,895 | $ | 39,615 | ||
| Revenue under collaborative research and development arrangements with affiliated<br>entities | 8,842 | 49,949 | ||||
| Other revenue | 124,337 | 281,556 | ||||
| Total revenues | 199,074 | 371,120 | ||||
| Operating expenses: | ||||||
| Research and development | 55,978,611 | 39,044,418 | ||||
| General and administrative | 15,953,458 | 13,881,194 | ||||
| Total operating expenses | 71,932,069 | 52,925,612 | ||||
| Loss from operations | (71,732,995 | ) | (52,554,492 | ) | ||
| Other income (expense): | ||||||
| Interest income | 669,814 | 769,237 | ||||
| Interest expense | (313,488 | ) | (513,034 | ) | ||
| Loss on investment in affiliated entities | (537,728 | ) | (830,475 | ) | ||
| Net unrealized loss on<br>available-for-sale equity securities | (4,840,641 | ) | (847,958 | ) | ||
| Other income (expense), net | (153,468 | ) | 8,978 | |||
| Net loss | (76,908,506 | ) | (53,967,744 | ) | ||
| Share in net loss of Geneos | (2,165,213 | ) | (434,387 | ) | ||
| Net loss | $ | (79,073,719 | ) | $ | (54,402,131 | ) |
| Net loss per share attributable to Inovio Pharmaceuticals, Inc. stockholders | ||||||
| Basic and diluted | $ | (0.36 | ) | $ | (0.27 | ) |
| Weighted average number of common shares outstanding | ||||||
| Basic and diluted | 218,940,693 | 202,414,445 |
EX-99.2
Exhibit 99.2
INOVIO Announces the Appointment of Jacqueline Shea, Ph.D., as Chief Executive Officer
Dr. Shea brings more than 25 years of leadership and industry expertise in life sciences and biotech
PLYMOUTH MEETING, PA – 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, today announced the appointment of Jacqueline Shea, Ph.D., as President and Chief Executive Officer (CEO) of INOVIO, effective immediately. 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.
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.
About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to potentially treat and protect people from infectious diseases, cancer, and diseases associated with HPV. Our DNA medicines are delivered using our proprietary smart device to produce a robust and tolerable immune response against targeted pathogens and cancers.
Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations, Defense Advanced Research Projects Agency/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense/Department of Defense, HIV Vaccines Trial Network, International Vaccine Institute, Kaneka Eurogentec, Medical CBRN Defense Consortium, National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Thermo Fisher Scientific, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. For more information, visit www.inovio.com.
CONTACTS:
Investors: Ben Matone, 484-362-0076, ben.matone@inovio.com
Media: Jeff Richardson, 267-440-4211, jrichardson@inovio.com