Results & Analyst Call Summary

Conference date: May 11, 2020 @ 1:30 PM Pacific Time
for quarter ending: March 11, 2020 (Q1, first quarter)

Forward-looking statements

Overview: Excitement about a COVID-19 vaccine is high, but VGX-3100 for HPV-related precancers data could be a more forceful stock mover.

Basic data (GAAP):

Revenue was $1.3 million, up sequentially from $0.3 million, and down from $2.8 million in the year-earlier quarter. Revenue is from research collaborations.

Net income was negative $32.5 million, up sequentially from negative $37.7 million, and down from negative $29.2 million year-earlier.

EPS (earnings per share, diluted) was negative $0.26, up sequentially from negative $0.38, and down from negative $0.30 year-earlier.

Guidance:

Cash sufficient for multiple years.

Quarter Highlights:

Dr. J. Joseph Kim, Inovio's CEO said, "Inovio had a very productive first quarter, laying the foundation for a transformative year for the company. Our recent and ongoing clinical developments across all of our programs continue to demonstrate the differentiating value and broad applicability of our DNA medicines platform. When the COVID-19 pandemic emerged in early January, Inovio was able to leverage its DNA medicines platform and early funding from CEPI to be one of the first companies to advance a vaccine candidate for COVID-19 into a Phase 1 clinical trial. Inovio's dedicated team of vaccine developers was able to quickly build and expand a global coalition of collaborators, partners, manufacturers, and funders to advance the INO-4800 program. Most importantly, while safely conducting global clinical trials during this COVID pandemic has been a significant challenge, Inovio is on track to deliver key 2020 clinical and regulatory milestones including the planned reporting of REVEAL 1 Phase 3 top-line efficacy data for VGX-3100 in Q4 and the presentation of 12-month overall survival results from the Phase 1/2 clinical trial of INO-5401 immunotherapy in a very hard to treat cancer in glioblastoma multiforme (GBM) at the ASCO20 Virtual Conference later this month." Some clinical trial enrollment rates have been impacted, but not so much as to change current timelines yet.

In January 2020, Inovio was awarded a grant of up to $9 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to develop a vaccine against COVID-19. INO-4800 is the COVID-19 vaccine candidate in the United States. A collaboration agreement with Beijing Advaccine Biotechnology Co. to advance the development of INO-4800 in China was also announced. In March 2020, Inovio received a new $5 million grant from the Bill and Melinda Gates Foundation anticipated to fund accelerated testing and scale up the Cellectra 3PSP for the intradermal delivery of INO-4800, in order to support large scale manufacturing of INO-4800 doses by end of 2020. The Phase 1 trial completed enrollment with preliminary results expected in late June. If FDA approves, the Phase 2/3 trial will start in July or August of 2020. The size of the study will depend on the projected infection rate. Other trials will take place in China and Korea.

Inovio reported positive interim data from its ongoing Phase 2 trial of newly diagnosed GBM (glioblastoma multiforme), which combines Inovio's INO-5401 and INO-9012, in combination with Libtayo, a PD-1 blocking antibody produced by Regeneron Pharmaceuticals in collaboration with Sanofi (but they do not have a license for 5401). 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), substantially exceeding historical standard-of-care data. Inovio will present the 12-month overall survival efficacy data at the American Society of Clinical Oncology (ASCO20) later in May 2020. Abstracts will be available on May 20, 2020.

The Phase 3 study of VGX-3100 in cervical dysplasia caused by HPV continued, with enrollment on track. Enrollment of Reveal 1 completed, data to be reported Q4 2020. Reveal 2 enrolling as of March 2019. Reveal 1 data should be available in Q4 2020 with a BLA submission in 2021. Two phases each will enroll 198 patients. Inovio has a collaboration and license agreement providing ApolloBio Corporation with the exclusive right to develop and commercialize VGX-3100 within Greater China. A Phase 2 study of VGX-3100 for HPV related vulvar neoplasia (VIN) continued. An anal dysplasia [high-grade squamous intraepithelial lesions (HSIL)] Phase 2 continued and is cosponsored by the AIDS malignancy consortium with both HIV positive and negative patients. Positive interim VGX-3100 Phase 2 precancerous anal and vulvar dysplasia was reported at ASCCP in Q2 2020.

In February 2020, INOVIO announced the FDA accepted its Investigational New Drug application to evaluate INO-3107 in a Phase 1/2 trial for treatment of recurrent respiratory papillomatosis (RRP), a rare disease cause by PPV. Expects 63 patients in the trial, post surgery. Endpoint will be doubling time between surgical interventions. Applying for orphan disease designation.

MedImmune MEDI0457 (was INO-3112) combined with durvalumab, a PD-L1 inhibitor, for HPV-associated head and neck squamous cell carcinoma enrollment completed the Phase 2 trial early in Q3 2019. Also expanding to test for other HPV-associated cancers in a separate Phase 2 patient in Q1 2019. One head and neck patient achieved full remission. In December announced a second Phase 2 study of MEDI0457 with with durvalumab targeting a broad array of cancers associated with HPV. MedImmune has also selected MEDI0457 combined with durvalumab to treat a HPV cancer other than head and neck, with a third Phase 2 initiation milestone payment made in Q2 2019. MedImmune is a division of AstraZeneca.

Inovio plans to initiate the next clinical trial of INO-3107 targeting RRP (recurrent respiratory papillomatosis) by mid 2020. Surgery is the current standard of care, and RRP almost always recurs after surgery.

INO-4700 for MERS (Middle East Respirator Syndrome) showed 100% immune response after 3 shots. (Q2 2020) Inovio's vaccines are stable at room temperature, and advantage over most other vaccine types. INO-4800 is based on this vaccine.

INO-5401 with INO-9012 is in a Phase 1/2 trial combined with Regeneron's cemiplimab for newly diagnosed glioblastoma completed enrollment. Phase 2 interim data was reported in Q4 2019. 80% of of biomarked patients were progression free at 6 months, versus 60% for historical control. Will report 12 month OS in June 2020, 18 months in Q4.

INO-5150 interim Phase 1 data showed activity and a dampened rise of PSA in recurrent prostate cancer. Data presentation was made at ESMO showed 86% of patients progression free at week 72. Plans to partner remain on track.

With the Parker institute for cancer immunotherapy, started a trial in Q3 2019 with one arm combining INO-5151 with Celldex Therapeutics FLIT3 ligand (CDX-301) and Bristol-Myers CPI nivolumab (Opdivo) for metastatic castration-resistant prostate cancer. The Phase 1b data showed a slowing in prostate-specific antigen doubling time. Eighty five percent (53 out of 62) of patients remained radiographically progression-free at Week 72 of the study.

Inovio Phase 1 trial for its Zika vaccine, GLS-5700, continues.

Inovio plans to initiate a Phase 2 MERS vaccine field trial in the Middle East with full CEPI funding in 2019. Reported more positive Phase 1 MERS results in April 2020.

Ongoing studies include INO-1400 in HTERT breast, lung and pancreatic cancer has now been extended to more tumor types: head & neck squamous cell, ovarian, colorectal, gastric and esophageal cancers. Enlarging to 5 trial sites with 54 subjects. Believes it will be combined with other vaccines and checkpoint inhibitors.

Inovio also has a variety of other vaccines in clinical or preclinical study. See the Inovio Pipeline for an overview.

Cash and equivalents balance ended at $270 million, up sequentially from $89 million. $64 million in debt in senior notes. In Q1 2020 $208 million was raised under the common stock ATM agreement at an average price of $4.92 per share. Cash sufficient for multiple years. In Q2 2020, so far, the Company sold an additional 12,041,178 shares of common stock for net proceeds of $121.7 million, under an ATM agreement entered into on April 3, 2020, to sell shares of common stock with aggregate gross proceeds of up to $150 million.

R&D expense was $19.1 million. General and administrative expense was $7.4 million. Total operating expenses were $26.6 million. Operating profit negative $25.2 million. Interest and other expense $7.9 million.

Q&A summary:

Funding competition re coronavirus? It is great for Novavax to get funds, as well as J&J and Moderna. Our potential for additional funding is great, there are likely to be 10 to 12 viable vaccines the funders invest in. We do not believe the need to scale up the delivery device will be a limiting factor.

There has never been an emergency authorization for a vaccine. We have been told the vaccine has to show safety and immune responses, particularly with challenge responses. We have multiple animal challenges, so we think we are in a good position. The government should clarify the process in the next couple of months.

INO-5401 abstract v. presentation? Abstract will give OS for 12 months. 52 patients. We will compare our OS 12 to known standard of care data. We hope to be well over the 65% OS rate for standard of care.

Our vaccines generate killer CD8 T cells as well as antibodies, which is an advantage over competitors. Our MERS vaccine gave 100% protection against challenges in animals. We generated robust T cell responses with 4800, and they were rapid, comparing well with competitors. Compared to convalescent patient serum, it is very promising.

Dose to device ratio expected? Our 1 million doses include sufficient devices to deliver the doses. We plan to scale to 100s of million of doses in 2021. We will be adding additional manufacturers for both plasmids and devices.

In GBM, we hope to see further improvement at 18 months.

4800 animal challenge types? Mouse, feret, and primate. Mouse will come out in the next month or so.

The FDA will largely determine how long the Phase 2/3 4800 trial needs to go. It will be placebo controller. Patients will be frontline healthcare workers.

Operating expenses? We expect them to be consistent. We expect most 4800 expenses to be paid by external sources. Our annual cash burn is in the $80 to $85 million range.

Reveal 2 enrollment rate decreased 50% from prior level, during March in April.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: