View all news

Inovio Pharmaceuticals Reports 2019 Third Quarter Financial Results

November 12, 2019

PLYMOUTH MEETING, Pa., Nov. 12, 2019 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NASDAQ: INO), an innovative biotechnology company focused on the discovery, development, and commercialization of synthetic DNA products for treating cancers and infectious diseases, today reported financial results for the third quarter ended September 30, 2019. 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.

Inovio Highlights

  • VGX-3100/MEDI0457/INO-3107/HPV-Related Diseases

REVEAL 1 Phase 3 trial of VGX-3100 for HPV-related high-grade cervical dysplasia, which completed enrollment of 198 patients in the second quarter of 2019, is on schedule to read out top-line efficacy data by the fourth quarter of 2020. Enrollment for the second Phase 3 trial for this program, REVEAL 2, remains on track, with expanded sites both within the United States and globally, including new sites recently opened in Argentina, Lithuania, and Spain.

Inovio completed enrollment of 33 patients for its Phase 2 trial of VGX-3100 for HPV-related high-grade vulvar dysplasia (vulvar HSIL).

In addition, the company completed enrollment in its open-label, 24 patient, Phase 2 trial of VGX-3100 in patients with HPV-related high-grade anal dysplasia (anal HSIL).

Inovio plans to present interim results for both vulvar HSIL and anal HSIL clinical trials at a medical conference in the first quarter of 2020.

In a global partnership with AstraZeneca, MEDI0457 (formerly INO-3112) in combination with durvalumab, an anti-PD-L1 checkpoint inhibitor, continues to be evaluated in multiple Phase 2 studies in patients with HPV-related head and neck, cervical, anal, penile, and vulvar cancers. Inovio is eligible to receive future milestone payments and double-digit tiered royalties on MEDI0457 product sales.

Inovio continues to prepare to initiate a pivotal clinical trial of INO-3107 for HPV-caused recurrent respiratory papillomatosis (RRP), which the company plans to advance as a rare, orphan product, within the first half of 2020.

  • INO-5401/Glioblastoma Multiforme (GBM) Phase 2 Trial

Inovio reported positive interim data from its ongoing Phase 2 trial of newly diagnosed glioblastoma multiforme (GBM), which combines Inovio's INO-5401, a T cell-activating immunotherapy encoding for three tumor-specific antigens (hTERT, WT1, and PSMA), and INO-9012, an immune activator encoding IL-12, in combination with Libtayo®, a PD-1 blocking antibody produced by Regeneron Pharmaceuticals in collaboration with Sanofi.

Key interim data from the 52-patient clinical trial showed that 80% (16 of 20) of MGMT gene promoter methylated patients and 75% (24 of 32) of unmethylated patients were progression-free at six months (PFS6) measured from the time of their first dose, substantially exceeding historical standard-of-care data (approximately 60% of MGMT promoter methylated patients and 40% of unmethylated patients historically were progression-free at six months). The data was presented at the Society for Immunotherapy of Cancer (SITC) 2019 Annual Meeting. Inovio will report 12- and 18-month overall survival data next year.

  • INO-5151/Prostate Cancer Combination Trial

INO-5151 was featured in a trial-in-progress poster at SITC 2019. INO-5151, which is a combined formulation of INO-5150 (with SynCon® antigens encoding for PSA and PSMA) and INO-9012, is being tested in one arm (Cohort C) of this exploratory platform study along with nivolumab, a PD-1 inhibitor (Bristol-Myers Squibb), and CDX-301 (Celldex). This study is being conducted and funded by the Parker Institute for Cancer Immunotherapy (PICI) and the Cancer Research Institute (CRI), as part of Inovio's previously established clinical collaboration agreement (ClinicalTrials.gov Identifier: NCT03835533).

  • DNA-encoded monoclonal antibodies (dMAb®)/DNA-encoded Bi-specific T Cell Engagers (dBTE)

Inovio and its collaborator, The Wistar Institute, received a $4.6 million grant from the National Institutes of Health (NIH) in support of innovative research of antimicrobial resistance (AMR) and continued development of Inovio's DNA-encoded monoclonal antibodies (dMAb®) platform.

Using direct local delivery into the body by the CELLECTRA® platform, the synthetic genetic codes provided by the dMAbs instruct the body's cells to become a customized patient-specific factory that manufactures its own therapeutic antibody products, enabling a major leap in antibody technology. Traditional monoclonal antibodies represent the largest segment of pharmaceutical markets today, accounting for more than $100 billion in pharmaceutical sales each year, with treatments spanning cancer, infectious diseases, inflammation, and cardiovascular diseases. With its synthetic design and in-patient production, dMAb products represent a disruptive and innovative entrant to this important class of pharmaceuticals. Collectively, dMAb and dBTE offer the opportunity to provide improved yet cost-effective therapeutic options across cancer and infectious diseases.

Earlier this year, Inovio advanced its first dMAb candidate INO-A002 (for preventing or treating Zika virus infection) to a Phase 1 dose-escalation trial to assess safety and tolerability and expression of dMAb-produced antibodies with full funding from the Bill & Melinda Gates Foundation.

  • Cash Position

As of September 30, 2019, cash and cash equivalents and short-term investments were $93.8 million compared to $81.2 million as of December 31, 2018.

In August, Inovio closed a private placement of 1.0% convertible bonds due 2024 with an aggregate principal amount of 18 billion Korean Won (KRW) (approximately USD $15.0 million based on the exchange rate on the date of issuance) issued to a group of institutional investors led by Korea Investment Partners (KIP), a global venture capital and private equity firm. These bonds are convertible into Inovio's Korean Depositary Receipts (KDRs) assuming Inovio has completed a secondary listing of its securities on the KOSDAQ Market of the Korea Exchange in the form of KDRs, or otherwise shares of common stock if KDRs are not listed at the time of conversion. Net proceeds from the offering were approximately $14.5 million after deducting offering expenses payable by Inovio.

In July, Inovio implemented a strategic cost-reduction plan (including a 28% staff reduction and cessation of several R&D and clinical programs), which resulted in an approximately 25% reduction in annual burn. The reallocation of resources focuses the company's commercialization efforts for its lead asset, VGX-3100, while also developing high-value, fast-to-market product candidates, such as INO-3107 to treat RRP and INO-5401 for GBM.

Dr. J. Joseph Kim, Inovio's President & CEO, said, "Our recently presented INO-5401 data demonstrated promising efficacy results, in terms of progression-free survival rates, against a very difficult to treat cancer in GBM and highlighted the potential of our immunotherapies utilizing tumor-associated antigens in cancer treatments. Looking ahead, the next 12 months should be a transformational period for Inovio, as we expect to have data readouts from multiple Phase 3 and Phase 2 programs. With our sharpened focus on advancing and commercializing products for HPV-related diseases and fast-to-market opportunities, the company is uniquely positioned to bring multiple products to the market."

Dr. Kim further stated, "We continue to advance our HPV treatment capabilities, where we will have efficacy results from our Phase 3 VGX-3100 REVEAL 1 trial and Phase 2 VIN/AIN programs next year. Additionally, we plan to initiate a pivotal clinical trial of INO-3107 for HPV-caused RRP, which we expect to move forward rapidly as a rare, orphan product. In cancer, you can expect overall survival data from our INO-5401 cancer combination trial with Regeneron for GBM, building upon the promising PFS6 data. Finally, the fully enrolled head and neck cancer Phase 2 trial sponsored by our partner AstraZeneca, combining MEDI0457 with AstraZeneca's checkpoint inhibitor should be completed by the third quarter. Collectively, these anticipated data readouts in 2020 all point to great promise for Inovio's product pipeline, and further solidify Inovio as the leader in synthetic DNA immunotherapy."

Third Quarter 2019 Financial Results

Inovio's total revenue was $867,000 for the three months ended September 30, 2019, compared to $2.0 million for the same period in 2018. Inovio's total operating expenses were $24.8 million for the three months ended September 30, 2019, compared to $28.6 million for the same period in 2018.

Inovio's net loss for the quarter ended September 30, 2019 was $23.1 million, or $0.23 per basic and $0.25 per diluted share, compared to $25.0 million, or $0.27 per basic and diluted share, for the same period in 2018.

Revenue

The year-over-year decrease in revenue under collaborative research and development arrangements was primarily due to a decrease in reimbursed drug manufacturing activities related to our partnership with AstraZeneca.

Operating Expenses

R&D expenses were $19.1 million for the three months ended September 30, 2019, as compared to $21.9 million for the same period in 2018. The decrease in R&D expenses was primarily related to decreases in employee compensation expense, drug manufacturing expense related to our partnership with AstraZeneca and engineering and lab supplies, among other variances. These decreases were offset by a personnel-related restructuring charge in connection with the one-time employee termination costs incurred during the third quarter of 2019.

Contributions received from current grant agreements and recorded as contra-R&D expense were $2.8 million for the three months ended September 30, 2019, compared to $2.6 million for the same period in 2018.

General and administrative (G&A) expenses were $5.7 million for the three months ended September 30, 2019, versus $6.8 million for the same period in 2018. The decrease in G&A expenses was primarily related to decreases in employee compensation, allocated depreciation expense, and legal expenses, among other variances.

Capital Resources

As of September 30, 2019, cash and cash equivalents and short-term investments were $93.8 million compared to $81.2 million as of December 31, 2018. As of September 30, 2019, Inovio had 99.0 million common shares outstanding and 129.5 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 condensed consolidated 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 September 30, 2019, which can be accessed at: http://ir.inovio.com/investors/financial-reports/default.aspx.

Conference Call / Webcast Information

Inovio's management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss Inovio's financial results and provide a general business update.

The live webcast and a replay may be accessed by visiting Inovio's website at http://ir.inovio.com/investors/events/default.aspx. Telephone replay will be available approximately one hour after the call at 877-344-7529 (US toll-free) or 412-317-0088 (international toll) using replay access code 10136605.

About Inovio Pharmaceuticals, Inc.

Inovio is an innovative biotechnology company focused on the discovery, development, and commercialization of its synthetic DNA technology targeted against cancers and infectious diseases. Inovio's proprietary technology platform applies antigen sequencing and delivery to enable in vivo protein expression, which can activate potent immune responses to targeted diseases. The technology has been demonstrated to consistently activate robust and fully functional T cell and antibody responses against targeted cancers and pathogens. Inovio's most advanced clinical program, VGX-3100, is in Phase 3 development for the treatment of HPV-related cervical pre-cancer. Also in development are Phase 2 immuno-oncology programs targeting HPV-related cancers and GBM, as well as externally funded platform development programs in Zika, MERS, Lassa, and HIV. Partners and collaborators include ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency, GeneOne Life Science, HIV Vaccines Trial Network, Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Regeneron, Roche/Genentech, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. For more information, visit www.inovio.com.

* * * *

This press release contains certain forward-looking statements relating to our business, including our plans to develop DNA-based immunotherapies, our expectations regarding our research and development programs, including the planned initiation and conduct of clinical trials and the availability and timing of data from those trials. 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 and product development programs, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, our ability to support our pipeline of SynCon® active immunotherapy and vaccine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or 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 and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2018, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

 

Inovio Pharmaceuticals, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS



September 30,
 2019


December 31,
 2018


(Unaudited)



ASSETS




Current assets:




Cash and cash equivalents

$

15,853,236



$

23,693,633


Short-term investments

77,945,753



57,538,852


Accounts receivable

776,295



3,316,361


Accounts receivable from affiliated entities

978,544



738,583


Prepaid expenses and other current assets

1,677,602



1,406,590


Prepaid expenses and other current assets from affiliated entities

1,581,111



1,120,805


Total current assets

98,812,541



87,814,824


Fixed assets, net

13,516,389



15,949,014


Investment in affiliated entity - GeneOne

5,707,256



6,381,926


Investment in affiliated entity - PLS

2,289,501



3,023,987


Intangible assets, net

3,960,457



4,760,145


Goodwill

10,513,371



10,513,371


Operating lease right-of-use assets

14,002,860




Other assets

2,731,055



2,669,998


Total assets

$

151,533,430



$

131,113,265


LIABILITIES AND STOCKHOLDERS' EQUITY




Current liabilities:




Accounts payable and accrued expenses

$

9,783,964



$

23,134,733


Accounts payable and accrued expenses due to affiliated entities

462,596



977,792


Accrued clinical trial expenses

4,500,898



5,671,764


Deferred revenue

106,111



223,577


Deferred revenue from affiliated entities

64,825



33,575


Deferred rent



1,065,387


Operating lease liability

2,011,008




Deferred grant funding

1,896,526



4,165,848


Deferred grant funding from affiliated entities

720,925



27,083


Total current liabilities

19,546,853



35,299,759


Deferred revenue, net of current portion

124,105



150,793


Convertible senior notes

62,119,671




Convertible bonds

7,954,851




Derivative liability

4,503,918




Deferred rent, net of current portion



8,518,207


Operating lease liability, net of current portion

20,953,308




Deferred tax liabilities

26,649



24,766


Deferred grant funding from affiliated entities

135,000




Other liabilities

50,343



87,333


Total liabilities

115,414,698



44,080,858


Stockholders' equity:




Preferred stock




Common stock

99,046



97,226


Additional paid-in capital

735,017,743



707,794,215


Accumulated deficit

(702,123,617)



(620,426,436)


Accumulated other comprehensive income (loss)

700,398



(528,867)


Total Inovio Pharmaceuticals, Inc. stockholders' equity

33,693,570



86,936,138


Non-controlling interest

2,425,162



96,269


Total stockholders' equity

36,118,732



87,032,407


Total liabilities and stockholders' equity

$

151,533,430



$

131,113,265


 

Inovio Pharmaceuticals, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)



Three Months Ended
September 30,


Nine Months Ended
September 30,


2019


2018


2019


2018

Revenues:








Revenue under collaborative research and development arrangements

$

617,427



$

1,813,287



$

3,452,422



$

27,488,185


Revenue under collaborative research and development arrangements with affiliated entities

53,014



184,990



179,984



393,317


Miscellaneous revenue

196,422



2,591



200,036



97,771


Total revenues

866,863



2,000,868



3,832,442



27,979,273


Operating expenses:








Research and development

19,137,209



21,851,858



66,013,364



68,892,229


General and administrative

5,681,441



6,791,693



18,506,570



23,679,018


Total operating expenses

24,818,650



28,643,551



84,519,934



92,571,247


Loss from operations

(23,951,787)



(26,642,683)



(80,687,492)



(64,591,974)


Other income (expense):








Interest income

637,438



565,039



2,018,302



1,648,987


Interest expense

(2,428,671)





(5,279,702)




Change in fair value of common stock warrants



228,665





360,795


Change in fair value of derivative liability

2,551,453





2,551,453




Gain (loss) on investment in affiliated entities

(485,841)



1,017,359



(1,409,156)



1,305,174


Other income (expense), net

140,956



(184,052)



232,629



(558,796)


Net loss before income tax benefit/(provision for income tax)

(23,536,452)



(25,015,672)



(82,573,966)



(61,835,814)


Income tax benefit/(provision for income taxes)





169,571



(2,169,811)


Net loss

(23,536,452)



(25,015,672)



(82,404,395)



(64,005,625)


Net loss attributable to non-controlling interest

445,759





707,214




Net loss attributable to Inovio Pharmaceuticals, Inc.

$

(23,090,693)



$

(25,015,672)



$

(81,697,181)



$

(64,005,625)


Net loss per share attributable to Inovio Pharmaceuticals, Inc. stockholders








          Basic

$

(0.23)



$

(0.27)



$

(0.83)



$

(0.70)


          Diluted

$

(0.25)



$

(0.27)



$

(0.83)



$

(0.70)


Weighted average number of common shares outstanding








          Basic

99,007,985



92,423,122



98,204,375



91,350,117


          Diluted

102,807,056



92,423,122



98,204,375



91,350,117


 

 

CONTACTS:

Investors:

Ben Matone, 484-362-0076, ben.matone@inovio.com

Media:

Jeff Richardson, 267-440-4211, jrichardson@inovio.com

 

Cision View original content:http://www.prnewswire.com/news-releases/inovio-pharmaceuticals-reports-2019-third-quarter-financial-results-300956823.html

SOURCE Inovio Pharmaceuticals, Inc.

Categories: Press Releases
View all news