On May 10, 2023 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the first quarter of 2023, affirmed 2023 financial guidance and provided business updates (Press release, Jazz Pharmaceuticals, MAY 10, 2023, View Source [SID1234631380]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"This quarter, we once again delivered strong commercial results, advanced our efforts to unlock the tremendous potential of our pipeline and built on our record of driving operational excellence. On the commercial front, key products launched over the past several years are demonstrating impressive and durable performance with Xywav annualizing at more than $1 billion and our oncology therapeutic area approaching $1 billion in annual revenue, driven by Rylaze and Zepzelca. Adoption of low-sodium Xywav continues to grow across both narcolepsy and idiopathic hypersomnia (IH), and we expect Xywav to remain the oxybate of choice in 2023. We remain confident in the blockbuster potential of Epidiolex/Epidyolex and its significant additional growth opportunities, and we look forward to continued strong in-person engagement with customers globally," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "Our strong execution and robust pipeline position us well to achieve Vision 2025 and create meaningful value for our shareholders."

"Our enhanced pipeline is positioned to deliver at least three late-stage data readouts by the end of 2024, including JZP150 in post-traumatic stress disorder (PTSD), suvecaltamide in essential tremor (ET) and zanidatamab in first-line gastroesophageal adenocarcinoma (1L GEA)," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "These late-stage trials are exploring new therapies with the potential to transform the lives of patients affected by diseases where substantial unmet medical need remains."

Key Highlights

•Continued confidence that low-sodium Xywav will remain the oxybate of choice in 2023; already annualizing at more than $1 billion.
•Epidiolex/Epidyolex continues to grow year-over-year with an expanding global prescriber base.
•Strong Rylaze demand drove net product sales of $85.9 million in 1Q23.
•Pipeline positioned to deliver at least three late-stage data readouts by the end of 2024, including JZP150 in PTSD, suvecaltamide in ET and zanidatamab in 1L GEA.
•The Company will host a KOL investor webcast to review the HERIZON-BTC-01 trial data, which will be presented at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting.
•1Q23 total revenues increased 10% to $892.8 million compared to 1Q22.
•On track to achieve full year revenue expectations; full year financial guidance affirmed.

1

Business Updates

Key Commercial Products
Oxybate (Xywav and Xyrem):
•Total revenues for the combined oxybate business, including royalties from a high-sodium oxybate authorized generic (AG) in 1Q23, increased 6% to $458.0 million in 1Q23 compared to the same period in 2022.
•Average active Jazz oxybate patients on therapy was approximately 17,400 in 1Q23, an increase of 5% compared to the same period in 2022.

Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
•Xywav net product sales increased 49% to $277.8 million in 1Q23 compared to the same period in 2022.
•Xywav is the Company’s largest product by net product sales, annualizing at more than $1 billion, as a result of continued adoption in both narcolepsy and IH.
•There were approximately 11,050 active Xywav patients exiting 1Q23.

Xywav for Narcolepsy:
•There were approximately 9,050 narcolepsy patients taking Xywav exiting 1Q23.
•The benefits of reducing sodium intake resonate with patients and prescribers as the large majority of new-to-oxybate narcolepsy patients continue to be prescribed Xywav.
•FDA continues to recognize seven years of Orphan Drug Exclusivity (ODE), through July 2027, for Xywav in narcolepsy. FDA published its summary of clinical superiority findings stating that "Xywav is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem." Further, FDA stated that "the differences in the sodium content of the two products at the recommended doses will be clinically meaningful in reducing cardiovascular morbidity in a substantial proportion of patients for whom the drug is indicated." For clarity, the authorized generics of Xyrem contain the exact same drug product as branded Xyrem.
•FDA has also recognized that the difference in sodium content between Xywav and Lumryz is likely to be clinically meaningful in all patients with narcolepsy and that Xywav is safer than Lumryz in all such patients. Lumryz is a branded, fixed-dose, high-sodium oxybate that has the same sodium content as Xyrem.
•Xywav is the only approved oxybate therapy that does not carry a warning and precaution related to high sodium intake.

Xywav for Idiopathic Hypersomnia (IH):
•There were approximately 2,000 IH patients taking Xywav exiting 1Q23.
•Recent Jazz survey of sleep specialists indicates 70% anticipate increasing their prescribing of Xywav for IH over the next six months.
•Xywav is the first and only treatment approved by FDA to treat the full condition of IH.
•FDA recognized ODE for IH extending regulatory exclusivity to August 2028.

Xyrem (sodium oxybate) oral solution:
•Xyrem net product sales decreased 28% to $178.1 million in 1Q23 compared to the same period in 2022, reflecting the continued adoption of Xywav by patients with narcolepsy and the launch of a high-sodium oxybate AG in January 2023.
•Royalties from high-sodium oxybate AG were $2.1 million in 1Q23. Due to the royalty structures within the AG agreements, we expect the royalties from AG to be significantly higher in the second half of 2023 relative to the first half.

2

Epidiolex/Epidyolex (cannabidiol):
•Epidiolex/Epidyolex net product sales increased 20% to $188.9 million in 1Q23 compared to the same period in 2022.
•A pivotal Phase 3 trial of Epidyolex for Dravet syndrome, Lennox-Gastaut syndrome and tuberous sclerosis complex in Japan is enrolling patients.
•Epidiolex/Epidyolex global prescriber base is increasing with multiple launches expected outside of the U.S. this year.
•Additional Epidiolex growth opportunities underscored by BECOME survey’s caregiver reported outcomes beyond seizure control, and compelling data for use of Epidiolex in combination with clobazam.
•Epidyolex is launched and reimbursed in all five key European markets: United Kingdom, Germany, Italy, Spain and France.

Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
•Rylaze net product sales increased 58% to $85.9 million in 1Q23 compared to the same period in 2022.
•Continued strong demand for Rylaze reflects the significant unmet patient need for a high-quality, reliable supply of Erwinia asparaginase for patients with acute lymphoblastic leukemia.
•In May 2022, the Company completed the Marketing Authorization Application submission to European Medicines Agency for a Monday/Wednesday/Friday dosing schedule and intramuscular and intravenous administration for JZP458 (approved as Rylaze in the U.S.) with potential for approval in 2023.
•The Company is also continuing to evaluate patient need in other geographies.

Zepzelca (lurbinectedin):
•Zepzelca net product sales increased 13% to $67.2 million in 1Q23 compared to the same period in 2022.
•Zepzelca is the treatment of choice in second-line (2L) small cell lung cancer (SCLC) setting.
•Zepzelca development program highlights:
◦The EMERGE-201 Phase 2 basket trial evaluating Zepzelca as monotherapy in select relapsed/refractory solid tumors is ongoing.
◦Phase 3 trial in partnership with F. Hoffmann-La Roche Ltd (Roche) to evaluate 1L use of Zepzelca in combination with Tecentriq (atezolizumab), compared to Tecentriq alone, as maintenance therapy in patients with extensive-stage SCLC after induction chemotherapy is ongoing. The Company expects complete enrollment in the trial by the end of 2023.
◦The Company’s partner, PharmaMar, is conducting the Phase 3 confirmatory trial, LAGOON, in 2L SCLC. If positive, this trial could confirm the benefit of Zepzelca in the treatment of SCLC when patients progress following 1L treatment with a platinum-based regimen.

Key Pipeline Highlights
Zanidatamab:
•Zanidatamab is a bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients.
•Initial focus is in biliary tract cancers (BTC) and GEA with potential to transform the current standard of care in multiple HER2-expressing cancers.
•Positive top-line data from the pivotal HERIZON-BTC-01 clinical trial has the potential to support regulatory submissions for zanidatamab as a monotherapy in patients with previously treated HER2-amplifed and expressing BTC.
•Data from the HERIZON-BTC-01 clinical trial will be presented at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting on Friday, June 2, 2023; the Company will host an investor webcast with Dr. Shubham Pant, M.D.,
3

MBBS, Professor in the Department of Gastrointestinal Medical Oncology with a joint appointment in the Department of the Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, to review the BTC data.
•In January 2023, the Company and Zymeworks announced the first overall survival data of 84% at 18 months from a Phase 2 trial of zanidatamab in combination with chemotherapy in 1L patients with HER2-expressing metastatic GEA.
•The pivotal trial, HERIZON-GEA-01, evaluating zanidatamab in 1L GEA is ongoing and top-line data are expected in 2024.

JZP150:
•JZP150, a selective fatty acid amide hydrolase, or FAAH, inhibitor, is in clinical development for the potential treatment of PTSD.
•Patient enrollment is ongoing in a Phase 2 trial and top-line data readout is anticipated in late 2023.
•The Company received Fast Track Designation for JZP150 development in PTSD from FDA, underscoring the significant unmet medical needs of patients.

Suvecaltamide (JZP385):
•Suvecaltamide, a highly selective and state dependent modulator of T-type calcium channels, is in clinical development for the treatment of ET and Parkinson’s disease tremor.
•Patient enrollment is ongoing in the Phase 2b ET trial and top-line data readout is anticipated in 1H24.
•A Phase 2 trial in patients with Parkinson’s disease tremor is ongoing.

JZP441:
•JZP441, is a potent, highly selective oral orexin-2 receptor agonist designed to activate orexin signaling with the potential to be applicable in the treatment of narcolepsy, IH and other sleep disorders.
•A Phase 1 development program to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of JZP441 in sleep-deprived healthy volunteers is ongoing.
•The Company expects initial proof of concept in healthy volunteers in 2023.

JZP815:
•A Phase 1 trial evaluating JZP815 in patients with advanced or metastatic solid tumors with MAPK pathway alterations is ongoing.
•The pan-RAF inhibitor program is part of a novel class of next-generation precision oncology therapies that has the potential to benefit cancer patients with high unmet needs in multiple different solid tumors.

JZP898:
•JZP898 is an engineered IFNα cytokine pro-drug that is activated specifically within the tumor microenvironment where it can stimulate IFNα receptors on cancer-fighting immune effector cells.
•The Company expects to file an Investigational New Drug (IND) application for JZP898 in the U.S. this year.

4

Financial Highlights
Three Months Ended
March 31,
(In thousands, except per share amounts) 2023 2022
Total revenues $ 892,812 $ 813,721
GAAP net income $ 69,420 $ 1,647
Non-GAAP adjusted net income $ 285,261 $ 261,934
GAAP earnings per share $ 1.04 $ 0.03
Non-GAAP adjusted EPS $ 3.95 $ 3.73

GAAP net income for 1Q23 was $69.4 million, or $1.04 per diluted share, compared to $1.6 million, or $0.03 per diluted share, for 1Q22.
Non-GAAP adjusted net income for 1Q23 was $285.3 million, or $3.95 per diluted share, compared to $261.9 million, or $3.73 per diluted share, for 1Q22.
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

Total Revenues
Three Months Ended
March 31,
(In thousands) 2023 2022
Xywav $ 277,761 $ 186,080
Xyrem 178,130 247,497
Total Oxybate 455,891 433,577
Epidiolex/Epidyolex 188,909 157,893
Sativex 7,098 4,742
Sunosi1
— 15,878
Total Neuroscience 651,898 612,090
Rylaze 85,927 54,220
Zepzelca
67,181 59,338
Defitelio/defibrotide 39,079 49,489
Vyxeos 36,700 33,757
Total Oncology 228,887 196,804
Other 3,434 943
Product sales, net 884,219 809,837
High-sodium oxybate AG royalty revenue 2,096 —
Other royalty and contract revenues 6,497 3,884
Total revenues $ 892,812 $ 813,721

___________________________
(1)Divestiture of Sunosi U.S. was completed in May 2022.

Total revenues increased 10% in 1Q23 compared to the same period in 2022.
•Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was $654.0 million in 1Q23 compared to $612.1 million in 1Q22. Neuroscience net product sales in 1Q23 increased 7% to $651.9 million compared to the same period in 2022 primarily driven by increased Xywav and Epidiolex/Epidyolex net product sales, partially offset by the decline in Xyrem revenues, reflecting the continued strong adoption of Xywav by patients with narcolepsy and the launch of a high-sodium oxybate AG in January 2023. High-sodium oxybate AG royalty
5

revenue relates to royalty revenue received from Hikma Pharmaceuticals plc on net sales of a high-sodium oxybate AG product.
•Oncology net product sales in 1Q23 increased 16% to $228.9 million compared to the same period in 2022 primarily driven by the continued growth in Rylaze product sales, which increased 58% to $86.0 million.

Operating Expenses and Effective Tax Rate
Three Months Ended
March 31,
(In thousands, except percentages) 2023 2022
GAAP:
Cost of product sales $ 128,644 $ 115,284
Gross margin 85.5% 85.8%
Selling, general and administrative $ 297,917 $ 308,813
% of total revenues 33.4% 38.0%
Research and development $ 189,410 $ 129,981
% of total revenues 21.2% 16.0%
Income tax expense (benefit)1
$ (15,324) $ 536
Effective tax rate 1
(27.8)% 8.5%

__________________________
1. The GAAP income tax benefit for 1Q23 increased as a result of the mix of pre-tax income and losses across tax jurisdictions, and increases in our patent box and foreign derived intangible income benefits.

Three Months Ended
March 31,
(In thousands, except percentages) 2023 2022
Non-GAAP adjusted:
Cost of product sales $ 64,728 $ 48,206
Gross margin 92.7% 94.0%
Selling, general and administrative $ 260,515 $ 258,701
% of total revenues 29.2% 31.8%
Research and development $ 173,918 $ 116,459
% of total revenues 19.5% 14.3%
Income tax expense $ 40,197 $ 55,223
Effective tax rate 12.3% 17.2%

Changes in operating expenses in 1Q23 over the prior year period are primarily due to the following:
•Cost of product sales increased in 1Q23 compared to the same period in 2022, on a GAAP and on a non-GAAP adjusted basis, primarily due to changes in product mix.
•Selling, general and administrative (SG&A) expenses, on a GAAP basis, decreased in 1Q23 compared to the same period in 2022 primarily due to transaction and integration expenses related to the acquisition of GW Pharmaceuticals plc (GW) and Sunosi (solriamfetol) related spend incurred in 1Q22, partially offset by increased investment in our priority programs. SG&A expenses, on a non-GAAP adjusted basis, were in line with the same period in 2022.
•Research and development (R&D) expenses increased in 1Q23 compared to the same period in 2022, on a GAAP and on a non-GAAP adjusted basis, primarily due to the inclusion of costs related to clinical programs for zanidatamab, as well as JZP815, JZP898 and JZP441, offset by a decrease in costs related to JZP458.
6

Cash Flow and Balance Sheet
As of March 31, 2023, cash and cash equivalents were $1.2 billion, and the outstanding principal balance of the Company’s long-term debt was $5.8 billion. In addition, the Company had undrawn borrowing capacity under a revolving credit facility of $500 million. For the three months ended March 31, 2023, the Company generated $320.7 million of cash from operations which is an increase of $111.7 million as compared to the same period in 2022, reflecting strong business performance and continued financial discipline.

2023 Financial Guidance
The Company is affirming its full year 2023 financial guidance as follows:

(In millions) Guidance
Revenues $3,675 – $3,875
–Neuroscience (includes royalties from high-sodium oxybate AG)
$2,675 – $2,825
–Oncology $950 – $1,050

(In millions, except per share amounts and percentages) GAAP Non-GAAP
Gross margin % 89%
93%1,6
SG&A expenses $1,197 – $1,277
$1,045 – $1,1052,6
SG&A expenses as % of total revenues 31% – 35% 27% – 30%
R&D expenses $739 – $797
$675 – $7253,6
R&D expenses as % of total revenues 19% – 22% 17% – 20%
Effective tax rate (32)% – (8)%
9% – 11%4,6
Net income $410 – $560
$1,240 – $1,3106
Net income per diluted share5
$5.90 – $7.90
$16.90 – $17.856
Weighted-average ordinary shares used in per share calculations5
75 75

___________________________
1.Excludes $135-$155 million of amortization of acquisition-related inventory fair value step-up and $14-$16 million of share-based compensation expense.
2.Excludes $152-$172 million of share-based compensation expense.
3.Excludes $64-$72 million of share-based compensation expense.
4.Excludes 41%-19% from the GAAP effective tax rate of (32%)-(8%) relating to the income tax effect of adjustments between GAAP net income and non-GAAP adjusted net income, resulting in a non-GAAP adjusted effective tax rate of 9%-11%.
5.Diluted EPS calculations for 2023 include 9 million shares related to the assumed conversion of the Exchangeable Senior Notes and the associated interest expense add-back to net income of $28 million and $25 million, on a GAAP and on a non-GAAP adjusted basis, respectively, under the "if converted" method.
6.See "Non-GAAP Financial Measures" below. Reconciliations of non-GAAP adjusted guidance measures are included above and, in the table titled "Reconciliation of GAAP to non-GAAP Adjusted 2023 Net Income Guidance" at the end of this press release.

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 2023 first quarter results.
Interested parties may register for the call in advance here or via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast.
A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.

On May 10, 2023 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported financial results and operational highlights for the first quarter of 2023 (Press release, Inovio, MAY 10, 2023, View Source [SID1234631379]). INOVIO’s management will host its quarterly conference call and webcast today at 4:30 p.m. EDT. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"In the first quarter of 2023 we made solid progress with several key pipeline candidates, including important headway in our development plans for INO-3107, our DNA medicine candidate for the treatment of RRP," said INOVIO’s President and Chief Executive Officer, Dr. Jacqueline Shea. "From our ongoing discussions, we believe we are in alignment with the FDA on several critical design elements for our planned Phase 3 program for INO-3107, as we continue to work through a number of their questions. Additionally, we were also encouraged to receive a positive opinion from the European Committee for Orphan Medicinal Products on our application for orphan drug designation for INO-3107. The final determination is now with the European Commission, which will decide on our application this month. We believe the committee’s opinion is another step in the right direction for the development of this candidate on a global basis."

Dr. Shea continued: "Since our last quarterly report, INOVIO has presented at several scientific and medical conferences, including presentations by lead investigators from our RRP and Ebola booster studies sharing important new immunological and safety data that shows the immense potential and versatility of our candidates. At the same time, we continued our focus on operational excellence, taking steps to build upon the strong team we have in place by the hiring of Dr. Cheryl Elder as Senior Vice President of Regulatory Affairs. Cheryl’s considerable regulatory expertise and track record of successfully bringing products through licensure will help us implement efficient regulatory strategies as we work to advance our promising candidates through development and the regulatory approval process."

Organizational and Clinical Highlights

INO-3107 – Recurrent Respiratory Papillomatosis (RRP)

During the quarter, INOVIO announced data from the second cohort of its Phase 1/2 clinical trial (NCT:04398433) that was statistically significant and showed 10 of the 11 (91%) patients saw a reduction in surgical interventions in the year following initial treatment, with measurement beginning at Day 0, the start of trial therapy. Of these 10 patients, four did not require surgery. There was a statistically significant median decrease of three surgical interventions when comparing the year following treatment to the year prior. In the year prior to treatment, the number of surgical interventions for these 11 patients ranged between 2 and 8, and the median was 5. INO-3107 was well-tolerated and immunogenic among patients in the second cohort. The safety and efficacy results for the second cohort were consistent with results announced for the first cohort in October 2022.
Following quarter end, data from the entire study, including new combined safety and immunology data not previously announced, were presented by lead investigator Dr. Ted Mau at the scientific program of the American Broncho-Esophagological Association (ABEA) at the Combined Otolaryngology Spring Meetings (COSM) in Boston, Massachusetts. The presentation highlighted the safety profile of INO-3107, which continued to be well-tolerated and elicited mostly low-grade (Grade 1) treatment-emergent adverse effects (TEAEs) such as injection site pain and fatigue. There were no high-grade TEAEs deemed related to treatment and no TEAEs leading to treatment discontinuation. The new data also showed that INO-3107 provoked a strong immune response, inducing activated CD4 T cells and activated CD8 T cells with lytic potential. T-cell responses were also observed at Week 52, indicating a persistent cellular memory response. Additional analyses are ongoing to determine a possible relationship between specific CD4 and CD8 phenotypes and clinical outcomes. The new data also included a marked improvement after treatment in the RRP staging assessment score. We believe these encouraging data indicate that INO-3107 could provide clinical benefit to adults with RRP.
Following quarter end, INOVIO announced that the European Committee for Orphan Medicinal Products issued a positive opinion on INOVIO’s application for orphan drug designation for INO-3107, with the final decision from the European Commission expected in late May.
INO-4201 – Ebola Booster for ERVEBO

During the quarter, INOVIO announced positive results from a Phase 1b trial with INO-4201 as a potential Ebola booster for ERVEBO (NCT04906629) showing INO-4201 was well-tolerated and boosted humoral responses in 36 of 36 (100%) of treated participants.
Following quarter end, lead investigator Dr. Angela Huttner presented new safety and immunology data from the trial at the 33rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in April. The new data showed that a single-dose of INO-4201 followed by electroporation was well-tolerated and immunogenic compared to placebo in a cohort of healthy volunteers primed with ERVEBO up to 5 to 7 years previously. Binding antibody titers rose significantly after boost for each time point measured, peaking at week 2 in all treated participants. Mean neutralizing antibody titers also rose and remained high and constant until the end of the 24-week trial period. There was also a noteworthy engagement of T cells, including increased production of IFNγ, IL2, and/or TNFα from EBOV-specific CD4+ and CD8+ T cells. The additional data indicated that a booster dose of INO-4201 has the potential to restore the levels of antibodies needed to extend protection against Ebola and thus could be an important tool in future Ebola outbreaks.
VGX-3100 – High-Grade Squamous Intraepithelial Lesions (HSIL)

During the quarter, INOVIO shared topline results from REVEAL2, the second Phase 3 trial for VGX-3100 as a treatment for cervical HSIL indicating that the trial results did not meet the primary endpoint in the biomarker-selected population, but the trial did achieve statistical significance in the all-participants population.
INOVIO has continued to analyze the clinical characteristics of the biomarker positive population that may have had an impact on response to treatment, such as stage of disease, infection with other HPV types, clinical site location, age, and smoking status. Additionally, INOVIO is working to better understand why some patients who exhibited a clinical response were not positive for the biomarker. INOVIO expects to share findings from its ongoing biomarker analysis in the third quarter.
In the all-participants population of REVEAL2, VGX-3100 showed an ability to clear HPV infection, with viral clearance of 37.3% in the treated group versus 8.7% in the placebo group. INOVIO continues to evaluate how this data further informs its extensive body of evidence regarding the potential of DNA medicines to treat HPV-related diseases, including anal HSIL, which can be a precursor to anal cancer. INOVIO continues to discuss next steps for developing VGX-3100 for anal HSIL with key opinion leaders and regulators.
Discussions with partner ApolloBio to support continued development of VGX-3100 in China are underway.
Strengthened Product Development Team

Dr. Cheryl Elder joined INOVIO as Senior Vice President of Regulatory Affairs, adding additional leadership and expertise to an already strong product development team. With over 30 years of experience leading cross-functional teams in drug development in multiple therapeutic areas, Dr. Elder has a successful track record of driving regulatory strategies within both small and multinational biotechnology companies, including Hoffman La Roche and, most recently, Novartis Pharmaceuticals. She will be responsible for developing INOVIO’s regulatory strategy and will lead company interaction with regulatory authorities globally.
Data Presentations & Publications

During and following the quarter, INOVIO presented, published, or submitted data from several of its clinical programs:

Glioblastoma Drug Development Summit (March): Dr. Jeffrey Skolnik, INOVIO’s Senior Vice President, Clinical Development, presented data on INO-5401 (glioblastoma therapeutic candidate).
World Vaccines Congress (April): Dr. Michael Sumner, INOVIO’s Chief Medical Officer, presented data on INO-3107 (RRP product candidate) and INO-4201 (Ebola vaccine booster candidate).
33rd European Congress of Clinical Microbiology and Infectious Diseases (April): Dr. Angela Huttner, Infectious Disease Consultant, Geneva University Hospitals, and lead investigator for the trial, presented data on INO-4201 (Ebola vaccine booster candidate).
The Laryngoscope(April): Paper entitled "Interim Results of a Phase 1/2 Open-Label Study of INO-3107 for HPV-6 and/or HPV-11–Associated RRP" accepted for publication in this peer-reviewed journal focused on advances in the diagnosis and treatment of head and neck disorders.
American Broncho-Esophagological Association Meeting (May): Dr. Ted Mau, lead investigator and laryngologist at University of Texas Southwestern Medical Center, presented data on INO-3107 (RRP therapeutic candidate).
INOVIO plans to continue to submit papers and abstracts related to its research for publication and presentation as data becomes available to various journals and medical conferences. Further details will be shared upon acceptance for publication.

First Quarter 2023 Financial Results

INOVIO reported total revenue of $115,000 for the three months ended March 31, 2023, compared to $199,000 for the same period in 2022. Total operating expenses were $44.1 million compared to $71.9 million for the same period in 2022.
INOVIO’s net loss for the quarter ended March 31, 2023 was $40.6 million, or $0.16 per basic and diluted share, compared to net loss of $79.1 million, or $0.36 per basic and diluted share, for the quarter ended March 31, 2022.
Operating Expenses

Research and development (R&D) expenses for the three months ended March 31, 2023, were $30.2 million compared to $56.0 million for the same period in 2022. The decrease in R&D expenses was primarily the result of lower drug manufacturing, clinical trial expenses and outside services related to INO-4800, and lower expensed inventory and outside services related to our CELLECTRA 3PSP device and array automation project, among other variances.
General and administrative (G&A) expenses were $13.9 million for the three months ended March 31, 2023, compared to $16.0 million for the same period in 2022. The decrease in G&A expenses was primarily related to a decrease in non-cash stock-based compensation, insurance and other outside services expenses, offset by higher legal expenses, among other variances.
Capital Resources

As of March 31, 2023, cash and cash equivalents and short-term investments were $223.8 million compared to $253.0 million as of December 31, 2022. As of March 31, 2023, the Company had 262.7 million common shares outstanding and 283.2 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, 2023, which can be accessed at: View Source
Cash Guidance

INOVIO continues to expect its cash runway to extend into the first quarter of 2025. This projection includes a cash burn estimate of approximately $33 million for the second quarter 2023 and its ongoing expectation that cash burn will decrease incrementally from there into the first quarter of 2025. These projections do not include any funds that may be raised through the Company’s existing at-the-market program or other capital-raising activities.
Conference Call / Webcast Information

INOVIO’s management will host its quarterly conference call and webcast at 4:30 p.m. ET today. A replay of the conference call will be available following the conclusion of the call. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

On May 10, 2023 Immunocore Holdings plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious diseases and autoimmune conditions, reported its financial results for the first quarter ended March 31, 2023, and provided a business update (Press release, Immunocore, MAY 10, 2023, View Source [SID1234631378]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"In the first year of launch, we have established KIMMTRAK as the most prescribed medicine for HLA-A*02:01 positive patients with mUM in the US, Germany and France," commented Ralph Torbay, Head of Commercial of Immunocore. "We continue to work with health authorities and healthcare professionals to bring KIMMTRAK to more patients with mUM around the world, with the goal of extending their lives."

First Quarter 2023 Highlights (including post-period)

KIMMTRAK (tebentafusp-tebn) for metastatic uveal melanoma (mUM)

KIMMTRAK is approved in over 30 countries globally and commercial expansion continues as we prepare to make the medicine available to even more patients. Total net product revenue (or "net sales") arising from the sale of KIMMTRAK (tebentafusp) was £42.1 million (or $52.0 million) for the first quarter of 2023, of which £29.5 million (or $36.5 million) was in the United States, £12.3 million (or $15.2 million) in Europe, and £0.2 million (or $0.2 million) in international regions.

During the first quarter of 2023, KIMMTRAK became the most prescribed medicine for HLA*02:01 positive patients with mUM with over half of patients in first line (1L) receiving KIMMTRAK. In addition, the majority of mUM patients in the U.S. were being treated with KIMMTRAK in the community setting.

In France and Germany, an estimated 80% and 70%, respectively, of first line HLA-A*02:01 positive patients with mUM treated in the first quarter received KIMMTRAK. The Company launched KIMMTRAK in Austria and Israel in the first quarter and expects the commercial transition in Italy in the second quarter of this year. The Company expects to launch KIMMTRAK in four additional European countries by the end of 2023.

In April, the Company presented data in HLA-A*02:01+ patients with mUM at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data demonstrated a correlation between early circulating tumor DNA (ctDNA) reduction and longer overall survival (OS) in the Phase 3 trial with KIMMTRAK (tebentafusp). ctDNA reduction by week 9 was observed in 88% of first-line mUM patients (Phase 3 trial) and 71% in previously treated patients (Phase 2 trial). ctDNA clearance was also higher in first-line patients (37%) compared to second-line patients (13%). In both trials, this reduction was associated with longer OS. The Company presented additional data with tebentafusp including a final analysis, at almost 4 years of follow-up, from the Phase 2 trial, tumor response in orbital lesions, and in vitro data assessing direct and indirect mechanisms of tumor control from TCR-CD3 bispecifics in melanoma.

The Company had two abstracts accepted for poster presentation at the upcoming 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2-6, 2023 in Chicago, IL:

Title: Early ctDNA reduction may identify patients with stable disease and long OS on tebentafusp

Presenting author: Dan Feng
Session: Melanoma/Skin cancers
Date & time: 3 June – 1:15-4:15 p.m. CT

Title: A Phase 2/3 trial in progress on tebentafusp as monotherapy and in combination with pembrolizumab in HLA-A*02:01+ patients with previously treated advanced non-uveal melanoma (TEBE-AM)

Presenting author: Diwakar Davar
Session: Melanoma/Skin cancers (Trial in Progress)
Date & time: 3 June – 1:15-4:15 p.m. CT

Tebentafusp Phase 2 / 3 trial in advanced melanoma

The Company has started randomizing in its Phase 2/3 clinical trial of tebentafusp in patients with previously treated advanced melanoma. The trial is randomizing patients with advanced melanoma, excluding uveal melanoma, who have progressed on an anti-PD1, received prior ipilimumab and, if applicable, received a BRAF kinase inhibitor. Patients will be randomized to one of three arms including tebentafusp, as monotherapy or in combination with an anti-PD1, and a control arm. The Phase 2 portion of the trial will include 40 patients per arm and has a dual primary endpoint of overall survival (OS) and ctDNA reduction.

IMC-F106C targeting PRAME-A02 in multiple solid tumors

The Company is continuing to expand the clinical trial footprint for PRAME-A02 trial enrolling patients into the Phase 1/2 monotherapy and combination arms across multiple tumor types, including the four expansion arms for patients with advanced ovarian, non-small cell lung, endometrial, and melanoma cancers. The Company expects to report data from the monotherapy and combination arms by the first half of 2024.

Expansion of PRAME franchise: IMC-T119C (PRAME-A24) & IMC-P115C (PRAME-A02 HLE)

In January 2023, the Company revealed the addition of two new PRAME ImmTAC candidates IMC-T119C (PRAME-A24) and IMC-P115C (PRAME-A02 HLE) for solid tumors to the pipeline. The Company plans to submit investigational new drug applications (INDs) or clinical trial applications (CTAs) for these two ImmTAC candidates in 2024.

First-in-class ImmTAC candidate – IMC-R117C (PIWIL1)

In January 2023, the Company announced the addition of IMC-R117C to the pipeline, an ImmTAC targeting a novel protein for colorectal and other gastrointestinal cancers. The Company believes IMC-R117C is the first PIWIL1 targeted immunotherapy and plans to submit an IND / CTA in the fourth quarter of 2023.

IMC-M113V: aiming for a functional cure for HIV

In February 2023, the Company presented initial safety and pharmacodynamic activity data with IMC-M113V, the first soluble TCR therapy for people living with Human Immunodeficiency Virus (HIV), at the 2023 Conference on Retroviruses and Opportunistic Infections (CROI). Five out of the ten participants who received the 15-mcg dose showed a >4-fold rise in IL6, which had been prespecified as indicative of pharmacodynamic activity based on the Company’s experience in oncology clinical trials with ImmTAC therapies.

The Company has started enrolling people living with HIV in the multiple ascending dose (MAD) part of the trial, to identify a safe and tolerable dosing schedule. This study will also test whether IMC-M113V could lead to reduction in the viral load and, after stopping all therapies (antiretroviral therapies and ImmTAV), delay or prevent HIV rebound (known as functional cure). The MAD trial will enroll up to 28 participants.

Financial Results

Total net product revenue arising from the sale of KIMMTRAK was £42.1 million (or $52.0 million) for the three months ended March 31, 2023 of which £29.5 million ($36.5 million) was in the United States, £12.3 million ($15.2 million) in Europe and £0.2 million ($0.2 million) in international region. For the three months ended March 31, 2022, we recorded revenue from the sale of KIMMTRAK and tebentafusp of £10.5 million in our first quarter of commercial launch.

The KIMMTRAK revenue of £42.1 million ($52.0 million) for the three months ended March 31, 2023 was at a similar level to the three months ended December 31, 2022, where we reported KIMMTRAK and tebentafusp revenue of £42.3 million.

For the three months ended March 31, 2023, our research and development expenses increased to £28.4 million (or $35.2 million) as compared to £18.6 million for the three months ended March 31, 2022 due to increases in expenditure on our PRAME franchise and other programs. For the three months ended March 31, 2023, our selling and administrative expenses increased to £33.3 million (or $41.2 million) from £20.1 million for the three months ended March 31, 2022 due to foreign exchange movements and increases in selling, commercial and employee costs.

Total operating loss for the three months ended March 31, 2023, was £17.4 million (or $21.5 million), compared to an operating loss of £16.5 million for the three months ended March 31, 2022.

Basic and diluted loss per share for the three months ended March 31, 2023, was £0.35 (or $0.43) compared to a basic and diluted loss per share of £0.37 for the three months ended March 31, 2022.

Cash and cash equivalents increased to £337.5 million (or $417.4 million) as of March 31, 2023 compared to £332.5 million as of December 31, 2022.

We maintain our books and records in pounds sterling. For the convenience of the reader, we have translated pound sterling amounts as of and for the period ended March 31, 2023 into U.S. dollars at a rate of £1.00 to $1.2369.

###

About Uveal Melanoma

Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, and up to 50% of people with uveal melanoma will eventually develop metastatic disease. Unresectable or metastatic uveal melanoma typically has a poor prognosis and had no approved treatment until KIMMTRAK.

About KIMMTRAK

KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.

IMPORTANT SAFETY INFORMATION

Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of patients who received KIMMTRAK with 0.8% being grade 3 or 4. Ensure immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS.

Skin Reactions

Skin reactions, including rash, pruritus, and cutaneous edema occurred in 91% of patients treated with KIMMTRAK. Monitor patients for skin reactions. If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions.

Elevated Liver Enzymes

Elevations in liver enzymes occurred in 65% of patients treated with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity.

Embryo-Fetal Toxicity

KIMMTRAK may cause fetal harm. Advise pregnant patients of potential risk to the fetus and patients of reproductive potential to use effective contraception during treatment with KIMMTRAK and 1 week after the last dose.

The most common adverse reactions (≥30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (≥50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.

For more information, please see full Summary of Product Characteristics (SmPC) or full U.S. Prescribing Information (including BOXED WARNING for CRS).

About KIMMTRAKConnect

Immunocore is committed to helping patients who need KIMMTRAK obtain access via our KIMMTRAKConnect program. The program provides services with dedicated nurse case managers who provide personalized support, including educational resources, financial assistance, and site of care coordination. To learn more, visit KIMMTRAKConnect.com or call 844-775-2273.

On May 10, 2023 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a platform-based life science tools and drug discovery company, reported its financial results for the quarter ended March 31, 2023 and provided recent drug discovery business highlights (Press release, HTG Molecular Diagnostics, MAY 10, 2023, View Source [SID1234631377]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

HTG has pioneered a proprietary platform-based approach that is designed to help improve drug discovery, referred to as transcriptome-informed drug discovery and design. At the center of this approach is the application of HTG’s proprietary RNA profiling technologies, functionally married with advanced medicinal chemistry using a novel artificial intelligence ("AI")-driven platform. This unique drug candidate optimization platform is expected to allow for more biologically-relevant insight into drug candidate selection and design much earlier in the discovery process than in traditional drug discovery. HTG believes this approach will result in higher efficiency, improved risk management and cost efficiencies to bring novel drug candidate molecules from very early discovery through entry to development.

HTG achieved three significant drug discovery business milestones in the first quarter of 2023 to advance the compounds for its first target and indication through lead optimization and to further strengthen its AI-driven drug discovery engine.

First, HTG achieved in vitro demonstration of efficacy of its first lead compounds both as a standalone therapy and in combination with the current standard of care.

The Company utilized its proprietary HTG EdgeSeq RNA profiling platform to biologically interrogate the lead molecules. This data, along with other primary and secondary data, was then introduced into the Company’s AI-driven drug discovery engine, resulting in the creation of a second generation of molecules. The second generation of molecules has been subjected to the same in vitro experiments as the first, demonstrating improved efficacy over the first generation of molecules. These results also demonstrate the utility of the AI-driven drug discovery engine in combination with high-quality full transcriptome data.

Finally, the Company’s AI-driven drug discovery engine was used to design compounds using transcriptomic data as the starting point. These system-designed compounds showed highly similar characteristics to HTG’s lead compounds that were designed starting with the target. These results demonstrate the ability of HTG’s engine to design novel compounds based on transcriptomic data alone, which the Company believes will provide other opportunities for expanded platform applications, including drug repurposing.

In addition to further advancing the Company’s drug discovery platform, these first quarter efforts have significantly advanced HTG’s first oncology indication in liquid tumors through lead optimization studies and the Company expects that these efforts will support entry into preclinical development in the next several months. In addition, the Company’s second target for the treatment of solid tumors has been selected and added to HTG’s oncology portfolio, which also includes an early pipeline in neurodegenerative diseases.

"Through the diligent efforts of our strong and knowledgeable team, we have once again achieved extensive progress toward our strategy to establish our transcriptome-informed drug discovery process as the preferred methodology for small molecule drug discovery, complementing and expanding the advanced capabilities that our HTG EdgeSeq technology has provided for many years in profiling. The three major milestones reached by our team during the first quarter of 2023 have not only advanced and strengthened our AI-driven drug discovery engine, but have significantly advanced candidate molecules through lead optimization for our first indication in liquid tumors, with a program in solid tumors expected to follow closely behind," said John Lubniewski, Chief Executive Officer and Director at HTG.

Partnering discussions have been initiated with global biopharmaceutical companies around the Company’s portfolio of drug candidate molecules in oncology and neurodegenerative disease indications. In addition, HTG has initiated partnering conversations regarding the use of HTG’s drug discovery engine within the partners’ portfolios of drug assets.

"While our partnering discussions are in early stages, we are pleased with the level of preliminary interest we have seen in our drug discovery platform from pharmaceutical companies that historically in-license candidates for preclinical development as part of their business model as well as those interested in using our AI-driven drug discovery engine with their own target portfolios," Mr. Lubniewski continued. "We believe this interest is driven by our highly differentiated approach to drug discovery, which uses our proprietary transcriptomic profiling technologies, integrated with a machine learning-based chemical library design platform, to better-inform the design and selection of drug candidate molecules. We believe that this approach will yield drug candidates with lower risk profiles and increased opportunities for development success, providing faster and more cost-efficient outcomes than traditional approaches, and believe that these potential partners are beginning to quickly understand these advantages."

First Quarter 2023 Financial Results:

Product and product-related services revenue for the quarter ended March 31, 2023 was $1.0 million, compared to $1.2 million for the same period in 2022. This revenue continues to primarily reflect sales of the Company’s two whole transcriptome products, the HTG Transcriptome and HTG EdgeSeq miRNA panels, to new and existing customers as consumables and sample processing services. Sales of these products represented 66% of revenue for the quarter ended March 31, 2023.

Net loss from operations for the quarter ended March 31, 2023 was $5.0 million, compared to $6.3 million for the same period in 2022. Net loss per share was $(2.28) for the quarter ended March 31, 2023 compared with $(9.73) for the first quarter of 2022, reflecting approximately 1.3 million additional common shares issued in December 2022. This operating margin improvement also reflects cost reduction measures implemented in the second quarter of 2022 which aligned the Company’s profiling cost structure with expected future revenue to reduce operating cash burn.

Cash, cash equivalents and investments in available-for-sale securities totaled $6.6 million as of March 31, 2023, with current liabilities of approximately $6.6 million and non-current liabilities of $3.8 million.

On May 10, 2023 Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of fibrotic diseases, including non-alcoholic steatohepatitis ("NASH"), hepatocellular carcinoma ("HCC"), and other chronic diseases, reported that it will effect a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-20, effective as of 4:01 p.m. Eastern Time today, May 10, 2023 (Press release, Hepion Pharmaceuticals, MAY 10, 2023, View Source [SID1234631376]). Hepion common stock will begin trading on a split-adjusted basis when the market opens on May 11, 2023 under the existing trading symbol "HEPA."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

As a result of the reverse stock split, the CUSIP number for the Company’s common stock will now be 426897302. The reverse stock split was previously approved by Hepion stockholders at the Special Meeting of Stockholders held on December 15, 2022, with the final ratio determined by the Company’s Board of Directors.

Upon effectiveness of the reverse stock split, every 20 shares of Hepion common stock issued and outstanding as of the effective date will be automatically combined into one share of common stock. Outstanding equity-based awards and other outstanding equity rights will be proportionately adjusted. No fractional shares will be issued as a result of the reverse stock split. Immediately after the reverse stock split becomes effective, the Company will have approximately 3,811,482 shares of common stock issued and outstanding. Stockholders of record otherwise entitled to receive a fractional share as a result of the reverse stock split will automatically be entitled to receive an additional fraction of a share of common stock to round up to the next whole share.

The reverse stock split is primarily intended to bring the Company into compliance with Nasdaq’s minimum bid price requirement.

"The shareholder-approved reverse split comes at an opportune time as we expect to soon be in a position to deliver rencofilstat’s hepatic function and NASH biomarker results from the Phase 2 ALTITUDE-NASH clinical trial. In addition, it may make our stock more attractive to institutional investors and other members of the investing public, thereby providing for a stronger and more diverse investor base," commented Robert Foster, Chief Executive Officer of Hepion.

Additional information concerning the reverse stock split can be found in Hepion’s definitive proxy statement filed with the Securities and Exchange Commission on November 21, 2022.