Market Newsdesk

Commences Voluntary Chapter 11 Process


to Implement Financial Restructuring

Obtains Commitment for $105


 Million


in New Money 


Debtor-In-Possession Financing to Support Continued Ordinary Course Operations, Including Payments for Wages and Benefits, Vendors and Suppliers

OKLAHOMA CITY, Nov. 14, 2020 (GLOBE NEWSWIRE) —   Gulfport Energy Corporation (NASDAQ: GPOR) (the “Company” and together with its wholly owned subsidiaries, “Gulfport”) today announced that it has entered into a Restructuring Support Agreement (the “RSA”) with over 95% of its revolving credit facility lenders and certain noteholders holding over two-thirds of the outstanding aggregate principal amount of its senior unsecured notes.  Attached to the RSA is a “pre-negotiated” restructuring plan (the “Plan”) that will strengthen Gulfport’s balance sheet, significantly reduce its funded debt, and lower ongoing operational costs.  Pursuant to the RSA and the Plan, Gulfport expects to eliminate approximately $1.25 billion in funded debt and significantly reduce annual cash interest expense going forward.  Gulfport will also issue $550 million of new senior unsecured notes under the Plan to existing unsecured creditors of certain Gulfport subsidiaries.  Certain of Gulfport’s noteholders have committed to backstop a minimum new money investment of $50 million in the form of convertible preferred stock. The RSA is designed to allow Gulfport to move through the restructuring process as expeditiously as possible.

To implement the restructuring contemplated by the RSA and the Plan, Gulfport has filed petitions for voluntary relief under chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the Southern District of Texas (“the Court”). Gulfport intends to use the proceedings to strengthen its balance sheet, restructure certain debt obligations, significantly reduce its midstream cost structure, and achieve a more sustainable capital structure. Gulfport intends to continue to operate in the ordinary course of business during the restructuring process.

Gulfport also announced that it has secured $262.5 million in debtor-in-possession (“DIP”) financing from Gulfport’s existing lenders under its revolving credit facility, including $105 million in new money that will be available upon Court approval. The financing is structured to fund Gulfport’s ordinary course operations during the chapter 11 proceedings, including employee wages and benefits and payments to suppliers and vendors. Gulfport has also received a commitment from its existing lenders to provide $580 million in exit financing upon emergence from chapter 11.

David M. Wood, President and Chief Executive Officer of Gulfport Energy, stated, “Since Gulfport’s leadership team was reconstituted in 2019, we have taken decisive actions to streamline our business, strengthen our balance sheet, focus on cash flow generation, exercise capital discipline, and drive operational efficiencies and cost reductions across the Company. Despite these efforts, our large legacy debt burden in addition to significant legacy firm transportation commitments created a balance sheet and cost structure that was unsustainable in the current market environment. After working diligently to explore all strategic and financial options available, Gulfport’s Board of Directors determined that commencing a chapter 11 process is in the best interest of the Company and its stakeholders.”

Mr. Wood continued, “We expect to exit the chapter 11 process with leverage below two times and rapidly delever thereafter due to a much-improved cost structure driven by reduced legacy firm transport commitments and costs. These improvements will significantly improve our ability to generate cash flow and value for our stakeholders going forward.”

Mr. Wood continued, “I want to thank our creditors, financing partners and other stakeholders for their support. We also deeply appreciate the hard work of our dedicated employees and their commitment to each other and to our valued business partners. We hope to move through the restructuring process quickly and efficiently and emerge as a stronger company positioned for future success.”

To ensure its ability to continue operating in the ordinary course of business, Gulfport has filed customary “first day” motions with the Court seeking a variety of relief, including authority to maintain operations in accordance with pre-petition practices and to pay certain pre-petition claims for, among other things, employee wages and benefits, royalties, and certain vendor and suppliers obligations.

Additional information regarding Gulfport’s chapter 11 filing will be available at www.gulfportenergy.com/restructuring. Court filings and information about the claims process are available at https://dm.epiq11.com/Gulfport. Questions should be directed to the Company’s claims agent by email to [email protected] or by phone at (888) 905-0409 (toll free) or +1 (503) 597-7687 (international).

Kirkland & Ellis LLP and Jackson Walker L.L.P. are serving as legal co-counsel, Perella Weinberg Partners and its affiliate, Tudor Pickering Holt & Co. are serving as financial advisors, and Alvarez & Marsal is serving as restructuring advisor to the Company.

About
Gulfport

Gulfport Energy is an independent returns-oriented, gas-weighted, exploration and development company and is one of the largest producers of natural gas in the contiguous United States. Headquartered in Oklahoma City, Gulfport holds significant acreage positions in the Utica Shale of Eastern Ohio and the SCOOP Woodford and SCOOP Springer plays in Oklahoma. Gulfport has 259 employees.

Forward-Looking Statements

This press release includes “forward-looking statements” for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than statements of historical fact. They include statements regarding: (i) the effect of the Chapter 11 reorganization and sufficiency of the financing package; (ii) Gulfport’s ability to continue implementing operating efficiencies and technical developments; and (iii) Gulfport’s ability to capitalize on the reorganization and emerge as a stronger and more competitive enterprise. Although Gulfport believes the expectations and forecasts reflected in the forward-looking statements are reasonable, Gulfport can give no assurance they will prove to have been correct. They can be affected by inaccurate or changed assumptions or by known or unknown risks and uncertainties. Important risks, assumptions and other important factors that could cause future results to differ materially from those expressed in the forward-looking statements are described under “Risk Factors” in Item 1A of Gulfport’s annual report on Form 10-K for the year ended December 31, 2019 and any updates to those factors set forth in Gulfport’s subsequent quarterly reports on Form 10-Q or current reports on Form 8-K (available at http://www.ir.gulfportenergy.com/all-sec-filings). Gulfport undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.

Investor
Contact

Jessica Antle – Director, Investor Relations
[email protected]
405-252-4550

Media
Contact

Reevemark
Hugh Burns / Paul Caminiti / Nicholas Leasure
212-433-4600

—
Maintained
efficacy
and
greatly reduced anti-VEGF treatment burden after 
a single IVT injection of ADVM-022
—

—
R
obust
preliminary
aqueous
a
nti-VEGF protein expression
observed
at
18 months
in Cohort 1
–

— Well tolerated with ocular cell grades and steroid eye drop use
decreasing
over time —

—
First p
ivotal trial planned for mid-2021
following regulatory agency discussions
—

— Company to host webcast with Key Opinion Leaders to discuss
new
OPTIC data
today, Saturday,
November 14, 2020 at 7:30 am PT / 10:30 am ET —

REDWOOD CITY, Calif., Nov. 14, 2020 (GLOBE NEWSWIRE) — Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced positive new interim data from Cohorts 1-4 of the OPTIC Phase 1 clinical trial of ADVM-022 intravitreal (IVT) injection gene therapy in patients requiring frequent anti-VEGF injections for their wet age-related macular degeneration (AMD).

“With these impressive OPTIC data and the removal of the partial clinical hold on ADVM-022 by the FDA, our goal is to continue to advance into pivotal trials to demonstrate the transformative potential of our gene therapy,” said Laurent Fischer, M.D., chief executive officer of Adverum. “We are excited that ADVM-022 has the potential to be a “one and done” IVT injection that may dramatically reduce the treatment burden for the millions of patients with wet AMD and DME worldwide. Particularly during COVID-19, we are reminded of the benefits that ADVM-022, a novel gene therapy that has demonstrated long-term treatment benefit after one in-office IVT injection, could deliver to patients. Our Adverum team is laser-focused on accelerating the development and future commercial launch plans for ADVM-022. I am humbled by the dedication of the retina specialists and their staff, and our employees, to help progress our clinical trials which generate the data necessary to drive our mission of helping patients with severe ocular diseases.”

Adverum reported new interim data from the OPTIC trial (October 15, 2020 cutoff date) that further demonstrate the transformative potential of ADVM-022 to greatly reduce the anti-VEGF injection burden for patients with wet AMD:

• ADVM-022 continues to maintain efficacy at both high and low doses (n=30)
  • Mean BCVA¹ maintained
  • Mean CRT² maintained to improved
• Durability out to 92 weeks from a single IVT injection with zero supplemental injections in Cohort 1 (high dose)
• Robust preliminary aqueous anti-VEGF protein expression observed at 18 months in Cohort 1 (high dose)
  • Mean aqueous anti-VEGF protein level 1840 ng/mL
• Substantial reduction in annualized anti-VEGF injection frequency³ following ADVM-022 in patients who previously required frequent injections:
  • High dose: 99% reduction
  • Low dose: 85% reduction
• Most patients are supplemental anti-VEGF injection free in OPTIC:
  • High dose: 14/15⁴ patients injection free
  • Low dose: 10/15⁵ patients injection free
• ADVM-022 continues to be well tolerated with a favorable safety profile at both high and low doses
  • All ADVM-022-related ocular adverse events (AE) were mild (78%) to moderate (22%)
  • Ocular inflammation, when observed, has been responsive to steroid eye drops and overall is decreasing over time
  • No clinical or fluorescein evidence of posterior inflammation
    • No vasculitis, retinitis, choroiditis, vascular occlusions, or endophthalmitis

OPTIC Phase 1 Clinical Trial Data:

Results Following a Single ADVM-022 Dose:	Cohort 1	Cohort 2		Cohort 3		Cohort 4
Patients	n=6	n=6		n=9		n=9
M edian (Range) F ollow-up V isit ( W eeks)	8 6 (64 to 92)	64 (64 to 68)		4 8 (32 to 48)		1 6 (12 to 24)
ADVM-022 Dose	High dose 6 x 10^11 vg/eye	Low dose 2 x 10^11 vg/eye		Low dose 2 x 10^11 vg/eye		High dose 6 x 10^11 vg/eye
Prophylactic S teroid R egimen	13-day oral	13-day oral		6-week eye drops		6-week eye drops
Supplemental Anti-VEGF Injection Use :
Number of patients supplemental injection free	6/6 patients	3/6 patients		7/9 patients		8/9 patients
Total supplemental anti-VEGF injections	0 injections	17 injections in 3 patients		8 injections in 2 patients		1 injection in 1 patient
Follow-up BCVA 1 and CRT 2 :
	All Patients	All Patients	Supp. IVT-free Patients 50% (3/6)	All Patients	Supp. IVT-free Patients 78% (7/9)	N/A
BCVA mean change from baseline (letters)	-2.5	+0.2	+1.0	-0.9	+4.1	N/A
CRT mean change from baseline (μm)	-19.7 μm	-1.0 μm	-23.7 μm	-113.4 μm	-132.7 μm	N/A
Ocular Inflammation and Management:
% patients with any cellular inflammation at most recent visit	33%	0%		11%		22%
Average # of daily steroid eye drops6	1.2	0.5		0.8		1.9

1 Best corrected visual acuity (BCVA)
2 Central retinal thickness (CRT)
3 Annualized rate (Before) = (number of IVTs in 12 months prior to ADVM-022) / (days from the first IVT in the past 12 months to ADVM-022 / 365.25)
Annualized rate (After) = (number of aflibercept IVTs since ADVM-022) / (days from ADVM-022 to the last study follow-up / 365.25)
4 All patients from Cohort 1 (n=6) and Cohort 4 (n=9)
5 All patients from Cohort 2 (n=6) and Cohort 3 (n=9)
6 Average calculated across entire cohort at their last follow up visit

Carl D. Regillo, M.D., F.A.C.S, director of the Wills Eye Hospital Retina Service said, “The sustained anatomical response observed in OPTIC in my experience is unprecedented, extending out beyond 18 months following a single intravitreal injection of ADVM-022. In addition, ADVM-022 has been well tolerated, and ocular inflammation, when observed, is responsive to steroid eye drops and decreases over time. ADVM-022 is a novel gene therapy that has demonstrated the potential to transform the treatment of patients living with wet AMD.”

Aaron Osborne, MBBS, chief medical officer of Adverum, added, “In OPTIC, we have enrolled the wet AMD patients requiring frequent injections to manage their condition, so we are very pleased with the significant reduction in anti-VEGF treatment burden demonstrated in both the high and low dose of ADVM-022. Additionally, the robust ocular anti-VEGF levels are a clear indication of ADVM-022’s stable, continuous therapeutic protein expression out to 18 months. We will continue to monitor our 30 patients and plan to present longer-term data, including additional anti-VEGF protein expression data from patients who consent to aqueous taps, in the first half of 2021. We are planning for our end-of-Phase 1 meeting with the U.S. FDA on our development program, including the initiation of our first pivotal clinical trial in wet AMD in mid-2021. With these continued impressive data, we believe that both doses warrant further investigation.”

Future
Plans

ADVM-022 in wet AMD

• Present longer-term data from OPTIC Phase 1 trial, including additional anti-VEGF protein expression data, in the first half of 2021
• Initiate a pivotal trial mid-2021

ADVM-022 in D
ME

• Present clinical data from INFINITY Phase 2 trial in the second half of 2021

Adverum Webcast:

Date: November 14, 2020
Time: 7:30 – 9:00 am PT (10:30 am – 12:00 pm ET)
Presenters:

• Carl D. Regillo, M.D., F.A.C.S, director of the Wills Eye Hospital Retina Service and investigator in the OPTIC Phase 1 trial
• Steven Yeh, M.D., associate professor, director, section of uveitis and ocular immunology, Emory Eye Center
• David S. Boyer, M.D., senior partner, Retina-Vitreous Associates Medical Group and adjunct clinical professor of ophthalmology, University of Southern California/ Keck School of Medicine, Los Angeles, investigator in the OPTIC Phase 1 trial

The live video webcast will be accessible under Events and Presentations in the Investors section of the company’s website. To participate in the conference call, dial 1-877-705-6003 (domestic) or 1-201-493-6725 (international) and refer to the “Adverum Biotechnologies’ OPTIC Clinical Data Discussion Conference Call.” It is recommended call participants dial in 15 minutes in advance. The archived audio webcast will be available on the Adverum website following the call and will be available for 30 days.

About the OPTIC Phase 1 Trial of ADVM-022 in Wet AMD

This multi-center, open-label, Phase 1, dose-ranging trial is designed to assess the safety and tolerability of a single intravitreal (IVT) administration of ADVM-022 in patients with wet AMD who are responsive to anti-vascular endothelial growth factor (VEGF) treatment. Patients received high dose (6 x 10^11 vg/eye) of ADVM-022 in Cohort 1 (n=6) and Cohort 4 (n=9) and patients received low dose (2 x 10^11 vg/eye) of ADVM-022 in Cohort 2 (n=6) and Cohort 3 (n=9). Patients in Cohorts 3 and 4 received six weeks of prophylactic steroid eye drops rather than 13 days of prophylactic oral steroids which were used in Cohorts 1 and 2. The primary endpoint of the trial is the safety and tolerability of ADVM-022 after a single IVT administration. Secondary endpoints include changes in best-corrected visual acuity (BCVA), measurement of central retinal thickness (CRT), as well as the need for supplemental anti-VEGF injections. Each patient enrolled will be followed for a total of two years.

Eleven leading retinal centers across the United States are participating in the OPTIC Phase 1 trial for ADVM-022. For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03748784.

About ADVM-022 Gene Therapy

ADVM-022 utilizes a propriety vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. ADVM-022 is administered as a one-time intravitreal injection (IVT), designed to deliver long-term efficacy and reduce the burden of frequent anti-VEGF injections, optimize patient compliance and improve vision outcomes for patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).

In recognition of the need for new treatment options for wet AMD, the U.S. Food and Drug Administration granted Fast Track designation for ADVM-022 for the treatment of wet AMD.

Adverum is currently evaluating ADVM-022 in the OPTIC Phase 1 clinical trial in patients with wet AMD and the INFINITY Phase 2 trial in patients with DME.

About
W
et AMD

Age-related macular degeneration (AMD) is a progressive disease affecting the macula, the region of the retina at the back of the eye responsible for central vision. In patients with wet AMD, an aggressive form of AMD, abnormal blood vessels grow underneath and into the retina. These abnormal blood vessels leak fluid and blood into and beneath the retina, causing vision loss.

Wet AMD is a leading cause of vision loss in patients over 60 years of age, with a prevalence of approximately 1.2 million individuals in the U.S. and 3 million worldwide¹. The incidence of new cases of wet AMD in the U.S. is approximately 150,000 to 200,000 annually, and this number is expected to grow significantly as the country’s population ages^2,3.

The current standard-of-care therapies for wet AMD are anti-VEGF proteins. These therapies can be burdensome, as patients generally require chronic intravitreal (IVT) injection of anti-VEGF protein every 4-12 weeks. Compliance with this regimen can be difficult for patients and their caregivers, leading to compliance deficiencies and loss of vision from underdosing. It is estimated that these standard-of-care branded anti-VEGF therapies used for the treatment of wet AMD, DR, retinal vein occlusion, and other ocular diseases generated in excess of $11 billion in sales worldwide in 2019⁴.

¹ Arch Ophthalmol. 2004;122(4):564-572. doi:10.1001/archopht.122.4.564.
² Brown GC, Brown MM, Sharma S, et al. The Burden of Age-Related Macular Degeneration: A Value-Based Medicine Analysis. Transactions of the American Ophthalmological Society. 2005.
³ California Retina Consultants. Advances in Wet AMD. Available at: https://www.californiaretina.com/advances-in-wet-amd/
⁴ Year-end 2019 financial statements from Regeneron, Roche, and Novartis.

About Adverum Biotechnologies

Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration and diabetic macular edema. For more information, please visit www.adverum.com.

Forward-looking Statements

Statements contained in this press release regarding events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding: the potential for ADVM-022 in treating patients with wet AMD and DME; the expected growth of the incidence of new cases of wet AMD in the U.S. as its population ages; Adverum’s expectations that it will present longer-term data from the OPTIC Phase 1 trial for ADVM-022 in wet AMD in the first half of 2021 and data from the INFINITY Phase 2 trial for ADVM-022 in DME in the second half of 2021; Adverum’s plans to accelerate the development and future commercial launch plans for ADVM-022; and Adverum’s expectations as to its plans to advance ADVM-022 in wet AMD by initiating a pivotal trial mid-2021. All of these statements are based on certain assumptions made by Adverum on current conditions, expected future developments and other factors Adverum believes are appropriate in the circumstances. Adverum may not achieve any of these in a timely manner, or at all, or otherwise carry out the intentions or meet the expectations disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include risks inherent to, without limitation: Adverum’s novel technology, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; the results of early clinical trials not always being predictive of future results; the potential for preliminary or interim results of clinical trials to change as the clinical trial continues or in connection with the preparation and analysis of final results; the potential for future complications or side effects in connection with use of ADVM-022; obtaining regulatory approval for gene therapy product candidates; enrolling patients in clinical trials; reliance on third parties for conducting the OPTIC and INFINITY trials and vector production; the effects of the COVID-19 pandemic on the company’s operations and on the company’s ongoing clinical trials; and ability to fund operations through completion of the OPTIC and INFINITY trials and thereafter. Risks and uncertainties facing Adverum are described more fully in Adverum’s Form 10-Q filed with the SEC on November 5, 2020 under the heading “Risk Factors.” All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Investor and Media Inquiries:
Myesha Lacy
Adverum Biotechnologies, Inc.
[email protected]
1-650-649-1257