On August 15, 2022 Celsion Corporation (NASDAQ: CLSN), a clinical-stage drug-development company focused on DNA-mediated immunotherapy and next-generation vaccines, reported financial results for the three and six months ended June 30, 2022, and provided an update on its clinical development program of GEN-1, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase II clinical development for the treatment of advanced-stage ovarian cancer, and its preclinical studies of PLACCINE, a proprietary, multivalent DNA plasmid technology utilizing synthetic, non-viral delivery vectors, being evaluated in proof of concept studies for superiority over current mRNA vaccines (Press release, Celsion, AUG 15, 2022, View Source [SID1234618319]).

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"As we approach the second half of the year, I am pleased to report that Celsion is in a strong financial position, making important progress with our innovative development platforms in oncology and infectious disease. Our OVATION 2 Phase II study of GEN-1 in advanced ovarian cancer continues to advance, with complete enrollment anticipated in the third quarter. Our PLACCINE platform, which was highlighted at the recent World Vaccine Forum, continues to show promise for the potential to address a range of infection diseases as we evaluate its capability in a head to head comparison with commercial covid-19 vaccines," said Dr. Corinne Le Goff, Celsion’s president and chief executive officer. "Moreover, given the uncertainty of the capital markets, it’s clear that the steps that we have taken over the past 18 months to ensure a cash balance that provides a runway into 2025 was a smart strategy. We expect to report several value creating developments during this time frame."

Recent Developments

GEN-1 Immunotherapy

Data Safety Monitoring Board Unanimously Recommends Continued Dosing Patients in the OVATION 2 Study. In June 2022, the Company announced that following a pre-planned interim safety review of 87 as treated patients (46 patients in the experimental arm and 41 patients in the control arm) randomized in the Phase I/II OVATION 2 Study with GEN-1 in advanced (Stage III/IV) ovarian cancer, the Data Safety Monitoring Board (DSMB) unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2. The DSMB also determined that safety was satisfactory with an acceptable risk/benefit, and that weekly doses of GEN-1 were well tolerated during a course of treatment that is given over six months in combination with standard neoadjuvant chemotherapy. No dose-limiting toxicities were reported.

The Company also announced that more than 87% of the projected 110 patients have been enrolled in the OVATION 2 Study. Interim clinical data from patients who have undergone interval debulking surgery showed that the GEN-1 treatment arm is showing improvement in R0 surgical resection rates and CRS 3 chemotherapy response scores over the control arm. A complete tumor resection (R0) is a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. The chemotherapy response score is a three-tier standardized scoring system for histological tumor regression into complete/near complete (CRS 3), partial (CRS 2) and no/minimal (CRS 1) response based on omental examination.

In February 2021, the Company announced that GEN-1 received FDA Fast Track Designation in advanced ovarian cancer. Celsion plans to request FDA Breakthrough Therapy Designation for GEN-1 based on the encouraging clinical data.

Findings from the Use of a Synthetic Control Arm to Estimate Treatment Effect in Phase Ib dose-escalating OVATION I Study presented at 2022 AACR (Free AACR Whitepaper) Annual Meeting. In April 2022, Celsion demonstrated its commitment to innovation in clinical research. The Company and the premier global data management CRO, Medidata, announced findings on the use of a Synthetic Control ArmⓇ (SCA) in a completed Phase Ib dose-escalating study of GEN-1 in the neoadjuvant treatment of patients with Stage III/IV ovarian cancer at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). In a poster presentation entitled "Phase IB trial efficacy estimates via a clinical trial synthetic control arm," which took place on Monday April 11, 2022, the research team’s findings demonstrated how comparing patients from a single-arm trial can help enhance understanding of treatment effects in advance of randomized trials, inform drug development and trial design, and increase the scientific value of early phase trials.

A Synthetic Control Arm is a type of external control and is formed by carefully matching patients treated with a new investigational therapy to anonymized clinical trial patients from Medidata’s extensive repository of historical clinical trials using baseline demographic and disease characteristics. Using this advanced statistical methodology, Celsion and Medidata found that progression-free survival was prolonged for the patients treated with the investigational therapy GEN-1 along with standard of care chemotherapy in the OVATION 1 Study compared to well-balanced historic control patients treated with the same standard of care chemotherapy alone (Hazard Ratio=0.53, 95% Confidence Interval (0.16, 1.73). This larger than expected effect size led to a decrease in the number of planned patients for Celsion’s subsequent Phase II trial and was used in support of Fast Track Designation from the U.S. Food and Drug Administration (FDA) received in February 2021.

Vaccine Initiative

PLACCINE Vaccine Platform Technology Highlighted During Oral Presentation at the World Vaccine Congress. In April 2022, the Company presented its PLACCINE platform technology at the World Vaccine Congress which took place in Washington D.C. In an oral presentation during a Session on Cancer and Immunotherapy, Dr. Khursheed Anwer, Celsion’s Chief Science Officer, highlighted the Company’s technology platform in his presentation entitled: "Novel DNA Approaches for Cancer Immunotherapies and Multivalent Infectious Disease Vaccines." PLACCINE is one of three platform technologies Celsion has for a range of therapeutics in oncology and immunotherapy. A copy of Dr. Anwer’s presentation is available on the investor portion of the Celsion website under Scientific Presentations.

PLACCINE is demonstrating the potential to be a platform for a range of infectious disease that provides for rapid design capability for targeting two or more different variants of a single virus in one vaccine. There is a clear public health need for vaccines today that address more than one strain of viruses, like COVID-19, which have fast evolving variant capability. Murine model data has thus far been encouraging and suggests that the Company’s approach provides not only flexibility, but also the potential for efficacy comparable to benchmark COVID-19 commercial vaccines with durability to protect expected to be greater than 6 months.

In the murine model, our multivalent PLACCINE vaccine targeted against two different variants showed to be immunogenic as determined by the levels of IgG, neutralizing antibodies, and T-cell responses. Additionally, our multivalent vaccine was equally effective against two different variants of the COVID-19 virus while the commercial mRNA vaccine appeared to have lost some activity against the newer variant. The Company continues to evaluate our technology and look forward to the results from our ongoing proof-of-concept non-human primate study evaluating our PLACCINE vaccine against the challenge from live SARS-CoV-2 virus in the second quarter, with durability results available in the second half of this year.

Corporate Developments

Dr. Corinne Le Goff Appointed as President and Chief Executive Officer; Michael H. Tardugno Appointed Executive Chairman of the Board. In July 2022, the Company announced that the Company’s Board of Directors appointed biopharmaceutical leader Corinne Le Goff, Pharm D, MBA, as President and Chief Executive Officer and Director, effective July 18, 2022. Michael H. Tardugno will continue to serve as Executive Chairman of Celsion’s Board of Directors.

Dr. Le Goff brings decades of global healthcare leadership experience to the Company across a range of therapeutic areas including oncology, vaccines, immunology, CNS and cardio-metabolism. She brings a wealth of experience in developing and launching successful drugs from her tenure at both large pharmaceutical companies and small, innovative biotech companies.

Prior to her Celsion appointment, Dr. Le Goff most recently served as the Chief Commercial Officer of Moderna, responsible for developing the global presence and capabilities necessary to ensure the global distribution of Moderna’s COVID-19 vaccine. She also led the development of the Moderna’s mRNA platform long-term commercial strategy. Dr. Le Goff joined Moderna from Amgen, where she served as President of the U.S. Business, driving the growth strategy with increased contributions from Repatha and Aimovig. During her 6-year tenure at Amgen, she also served as Senior Vice President of Global Product Strategy & Commercial Innovation and as President of the Europe Region overseeing 48 markets. Dr. Le Goff was actively engaged with the policy community and advocates for innovative, high-quality, and affordable healthcare. She represented Amgen as a member of the Healthcare Leadership Council. Prior to joining Amgen, Dr. Le Goff held a number of senior international roles at Roche, including President of Roche France, a major affiliate of the Roche Group, and Global Product Strategy Head of Neuroscience & Rare Diseases. Early in her career, Dr. Le Goff spent 11 years in various leadership roles at Sanofi and Pfizer in the United States.

Dr. Le Goff earned a PhD in pharmaceutical sciences from Rene Descartes University in Paris and an MBA from Sorbonne University and INSEAD. She also holds qualifications from Northwestern University and the Hong Kong University of Science and Technology. She received the distinction of being named a Chevalier de la Légion d’Honneur in 2014. She holds a U.S. patent and was recently recognized by Forbes Magazine as one of the women over the age of 50 who are changing the world.

Strengthened Balance Sheet Through Registered Direct Offering of Common Shares totaling $7.0 Million in Gross Proceeds Priced At-The-Market under NASDAQ Rules. On April 8, 2022, the Company announced the closing of a registered direct offering of 1,328,274 shares of common stock at a purchase price of $5.27 per share, resulting in gross proceeds of $7.0 million, before deducting placement agents’ fees and expenses. Celsion intends to use the net proceeds for general corporate purposes, including research and development activities, capital expenditures and working capital.

Second Quarter Financial Results

Celsion reported a net loss for the second quarter of 2022 of $6.0 million ($0.87 per share) compared with a net loss of $5.4 million ($0.95 per share) in 2021. Operating expenses were $6.1 million for the second quarter in 2022, which represented a $0.9 million (17%) increase from $5.2 million for the second quarter of 2021.

The Company ended the second quarter of 2022 with $48.1 million in cash, investments, restricted cash, and accrued interest receivable. Coupled with future planned sales of the Company’s State of New Jersey net operating losses, the Company believes it has sufficient capital resources to fund its operations into 2025.

Research and development expenses were $3.2 million for the second quarter of 2022, an increase of $0.6 million or 23% from $2.6 million for the comparable period in 2021. R&D costs associated with the development of GEN-1 to support the OVATION 2 Study as well as development of the PLACCINE DNA vaccine technology platform increased to $1.7 million in the second quarter of 2022 compared to $1.4 million in the same three-month period of 2021. Costs associated with the OPTIMA Study were $0.5 million in the second quarter of 2022 which represented expenses associated with closing out this Phase III study which was discontinued in the first quarter of 2021. In July 2020, the Company unblinded the OPTIMA Study at the recommendation of the DMC to halt the study due to futility. Other clinical, CMC and regulatory costs were $1.0 million in the second quarter of 2022 and 2021.

General and administrative expenses were $2.9 million in the second quarter of 2022, compared with $2.6 million in the same period of 2021. This $0.3 million increase was primarily attributable to higher professional fees (largely legal fees to defend various suits filed after the announcement in July 2020 of the OPTIMA Phase III clinical results) and higher premiums for directors’ and officers’ insurance offset by lower non-cash stock compensation expense.

Other non-operating expenses were $65 thousand in the second quarter of 2022 compared to $0.4 million in the comparable prior year. This decrease was attributable to the payment of early termination fees to Horizon Technology Finance Corporation in June 2021. The Company entered into a $10 million loan facility with Silicon Valley Bank (SVB). The Company immediately used $6 million from the SVB facility to retire all outstanding indebtedness with Horizon Technology Finance Corporation. In connection with the termination of the Horizon Technology Financing Facility in the second quarter of 2021, the Company paid early termination and end of term charges to Horizon and recognized $0.2 million as a loss on early debt extinguishment.

Financial Results for the Six Months Ended June 30, 2022

For the six months ended June 30, 2022, the Company reported a net loss of $16.5 million ($2.59 per share), compared with a net loss of $11.1 million ($2.19 per share) in the same period of 2021. Operating expenses were $12.1 million during the first six months of 2022, which represented a $1.4 million (13%) increase from $10.7 million in the same six-month period of 2021.

Net cash used for operating activities was $13.4 million in the first six months of 2022, compared with $7.3 million in the same period in 2021. This increase was primarily due to the one-time payment of $4.6 million in interest expense resulting from the sale and subsequent redemption of $30 million of Series A & B convertible redeemable preferred stock in the first quarter of 2022. The Company’s projected cash utilization for the balance of 2022 is approximately $5 million per quarter. Cash provided by financing activities of $6.3 million during the first six months of 2022 was derived from an at-the-market equity offering in April 2022. The Company also received net proceeds of $1.4 million from the sale of its unused New Jersey NOLs in February 2022.

Research and development expenses increased $1.1 million to $6.3 million in the first six months of 2022 from $5.2 million in the comparable prior-year period. R&D costs associated with the development of GEN-1 to support the OVATION 2 Study as well as development of the PLACCINE DNA technology platform increased to $3.7 million in the first six months of 2022, compared with $2.8 million in the comparable 2021 period. Costs for the Phase III OPTIMA Study increased $0.1 million to $0.5 million in the first six months of 2022, compared with $0.4 million in the first six months of 2021, due to closing out this Phase III study which was discontinued in the first quarter of 2021. Other costs related to clinical supplies and regulatory support for the Company’s clinical development programs increased $0.1 million in the first six months of 2022, compared with the same prior year period.

General and administrative expenses were $5.7 million in the first six months of 2022, compared with $5.5 million in the same period of 2021. The $0.2 million increase was primarily attributable to higher legal and professional fees offset by lower non-cash stock compensation expense.

Other non-operating expenses were $4.7 million in the first six months of 2022 compared to $0.7 million in the comparable prior year period. This increase was attributable to the one-time payment of $4.6 million in interest expense resulting from the sale and subsequent redemption of $30 million of Series A & B convertible redeemable preferred stock in the first quarter of 2022.

Conference Call

The Company is hosting a conference call to provide a business update, discuss second quarter 2022 financial results and answer questions at 11:00 a.m. EDT today. To participate in the call, interested parties may dial 1-888-220-8451 (Toll-Free/North America) or +1-323-794-2588 (International/Toll) and ask for the Celsion Corporation Second Quarter 2022 Earnings Call (Conference Code: 5801156) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at www.celsion.com. The call will be archived for replay on Monday, August 15, 2022, and will remain available until August 29, 2022. The replay can be accessed at +1-719-457-0820 or 1-888-203-1112 using Conference ID: 5801156. An audio replay of the call will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. EDT Monday, August 15, 2022.

On August 15, 2022 Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the three months ended June 30, 2022 (Press release, Galectin Therapeutics, AUG 15, 2022, View Source [SID1234618318]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Joel Lewis, Chief Executive Officer and President, stated: "Our team made significant progress on a number of fronts this quarter. The most consequential action for the Company undoubtedly was finalizing a $60 million line of credit facility from Richard Uihlein. Proceeds from this very favorable financing arrangement are expected to cover all our currently projected costs for the Phase 2b portion of our NAVIGATE trial. Once again, I want to express my gratitude to Mr. Uihlein for his dedication to and belief in the Company. His unwavering commitment clearly has provided the resources necessary for the successful completion of our global pivotal clinical trial.

"Additionally, our team is making substantial progress in completing an Investigational New Drug (IND) package, including the development of a phase 2 trial protocol. The Company’s objective is to file an IND with the Food and Drug Administration (FDA) Office of Oncologic Diseases (OOD) for the treatment of recurrent or metastatic head and neck cancer for belapectin in combination with Keytruda, an immune checkpoint inhibitor. We will have more updates as they become available. Finally, we are looking forward to completion of enrollment of the phase 2b portion of our NAVIGATE clinical trial."

Dr. Pol Boudes, Chief Medical Officer, stated: "The COVID-19 pandemic impacted enrollment timelines for many clinical trials over the past couple of years and we, as well as other NASH study sponsors, are no exception. In response to continuing challenges, particularly in Europe and Australasia, we initiated multiple new sites in Mexico and South America. We have been pleased, thanks to assistance from local partners, to see a rapid acceptance of our program by Health Authorities and Ethics Committees. Our investigators meeting in Mexico gathered 15 new sites and gave us a unique opportunity to judge the gravity of the NASH epidemy in this country. As a result of these actions, we now have multiple sites that started to screen patients. I have also personally visited multiple sites and investigators over the past few months, in addition to meeting with several more at the International Liver Conference, this June in London, UK. We continue to receive consistent and supportive feedback from our investigators regarding the importance and uniqueness of NAVIGATE and the potential to bring to patients with cirrhosis and portal hypertension a therapy for this large unmet medical need. We have now randomized 230 patients with an additional 70 patients currently in screening. We expect enrollment to be completed in the fourth quarter of this year."

Financial Results

For the three months ended June 30, 2022, the Company reported a net loss applicable to common stockholders of $9.7 million, or ($0.16) per share, compared to a net loss applicable to common stockholders of $8.5 million, or ($0.15) per share for the three months ended June 30, 2021. The increase is largely due to an increase in 2022 research and development expenses related to the Company’s NAVIGATE trial.

Research and development expenses for the three months ended June 30, 2022, was $8.1 million compared with $6.5 million for the three months ended June 30, 2021. The increase was primarily due to costs related to the NAVIGATE clinical trial and other supportive activities. General and administrative expenses for the three months ended June 30, 2022, were $1.6 million, compared to $1.7 million for the three months ended June 30, 2021. The decrease was primarily due to a decrease in investor relations/business development expenses.

As of June 30, 2022, the Company had $24.2 million of cash and cash equivalents. The Company believes it has sufficient cash, including availability under its new $60 million line of credit, to fund currently planned operations and research and development activities through at least December 31, 2024.

About Belapectin

Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs, including fibrotic disorders of the liver, lung, kidney, heart and vascular system. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis, and these results provide the basis for the conduct of the NAVIGATE trial. The NAVIGATE trial (www.NAVIGATEnash.com), titled "A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis," began enrolling patients in June 2020, and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 has a significant role in cancer, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and KEYTRUDA in advanced melanoma and in head and neck cancer. This trial provided a strong rationale for moving forward into a Company-sponsored Phase 2 development program, which the company is exploring.

About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis

Non-alcoholic steatohepatitis (NASH) has become a common disease of the liver with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in the U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocyte damage (ballooning) in people who consume little or no alcohol. Over time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. It is estimated that as many as 1 to 2 million individuals in the U.S. will develop cirrhosis as a result of NASH, for which liver transplantation is the only curative treatment available. Approximately 9,000 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.

On August 15, 2022 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company"), a leader in converting IV biologics to subcutaneous delivery and autoinjector devices, reported that it intends to offer, subject to market conditions and other factors, $500 million aggregate principal amount of convertible senior notes due 2028 (the "Convertible Notes") (Press release, Halozyme, AUG 15, 2022, View Source [SID1234618317]). The Convertible Notes are to be offered and sold to "qualified institutional buyers" pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The Company also expects to grant a 13-day option to the initial purchasers to purchase up to an additional $75 million aggregate principal amount of Convertible Notes.

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The Convertible Notes will be senior, unsecured obligations of the Company and will accrue interest payable semi-annually in arrears. The Convertible Notes will mature on August 15, 2028, unless earlier redeemed, repurchased or converted in accordance with their terms prior to such date. Prior to the close of business on the business day immediately preceding February 15, 2028, the Convertible Notes will be convertible only upon the satisfaction of certain conditions and during certain periods, and on and after February 15, 2028, at any time prior to the close of business on the second scheduled trading day immediately preceding the maturity date, the Convertible Notes will be convertible regardless of these conditions. The Company will settle conversions in cash and, if applicable, shares of the Company’s common stock. The initial conversion rate, interest rate and other terms of the Convertible Notes will be determined at the time of pricing in negotiations with the initial purchasers of the Convertible Notes.

In connection with the offering, the Company intends to enter into privately negotiated capped call transactions with option counterparties that may include one or more of the initial purchasers and/or their affiliates and/or other financial institutions. If the initial purchasers exercise their option to purchase additional notes, the Company may enter into additional capped call transactions with the option counterparties. The capped call transactions are generally expected to reduce potential dilution to the Company’s common stock upon conversion of the convertible notes and/or offset any cash payments the Company is required to make in excess of the principal amount of converted notes, as the case may be.

The Company has been advised that, in connection with establishing their initial hedges of the capped call transactions, the option counterparties and/or their affiliates (i) expect to purchase shares of the Company’s common stock and/or enter into derivative transactions with respect to the Company’s common stock concurrently with, or shortly after, the pricing of the Convertible Notes and (ii) may modify their hedge positions by entering into or unwinding derivative transactions with respect to the Company’s common stock and/or purchasing or selling the Company’s common stock or other securities of the Company in secondary market transactions following the pricing of the Convertible Notes and prior to the maturity of the Convertible Notes. These activities could have the effect of increasing, or preventing a decline in, the market price of the Company’s common stock concurrently with, or shortly following, the pricing of the Convertible Notes. The effect, if any, of these activities, including the direction or magnitude, on the market price of the Company’s common stock will depend on a variety of factors, including market conditions, and cannot be ascertained at this time. Any of these activities could, however, adversely affect the market price of the Company’s common stock.

The Company expects to use a portion of net proceeds of the offering to fund the cost of entering into the capped call transactions. The Company also expects to use a portion of the net proceeds of the offering to enter into privately negotiated agreements with certain holders of its outstanding 1.25% convertible senior notes due 2024 (the "Existing Convertible Notes") to exchange their Existing Convertible Notes for a combination of cash and shares of its common stock through privately negotiated transactions entered into concurrently with or shortly after the pricing of the proposed offering (the "Note Repurchases").

In parallel to this transaction, the Company expects to use a portion of the net proceeds of the offering for the repurchase of shares of its common stock (the "Share Repurchases") up to $200 million, concurrently with, or shortly after, the pricing of the offering in privately negotiated transactions or otherwise, which may be effected through one or more of the initial purchasers or any affiliate thereof.

The Share Repurchases, if consummated in full, would represent an increase of $100 million of the previously planned share repurchases to be made in 2022 under the Company’s ongoing three-year $750 million share repurchase program, which was commenced and previously announced in 2021.

Further, the Company expects to use a portion of the net proceeds of the offering to repay all of its outstanding $250 million term loan facility due 2026. The Company intends to use the remainder of the net proceeds from the offering for general corporate purposes, including other repurchases of the Company’s common stock from time to time under the existing stock repurchase program, working capital, capital expenditures, potential acquisitions and strategic transactions. If the initial purchasers exercise their option to purchase additional notes, the Company intends to use a portion of the net proceeds from the sale of additional notes to fund the cost of entering into additional capped call transactions.

The Note Repurchases and Share Repurchases could increase (or reduce the size of any decrease in) the market price of Halozyme common stock or the Convertible Notes. We also expect that some existing noteholders may purchase or sell shares of the Company’s common stock in the market to hedge their exposure in connection with these transactions. The Note Repurchases, Share Repurchases and any associated hedging by holders could affect the market price of the Company’s common stock prior to, concurrently with or shortly after the pricing of the Convertible Notes and could also result in a higher effective conversion price for the Convertible Notes.

This press release is neither an offer to sell nor a solicitation of an offer to buy the Convertible Notes or the shares of the Company’s common stock issuable upon conversion of the Convertible Notes, if any, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. Any offer of these securities will be made only by means of a private offering memorandum.

The offer and sale of the Convertible Notes and the shares of the Company’s common stock issuable upon conversion of the Convertible Notes, if any, have not been registered under the Securities Act, or the securities laws of any other jurisdiction, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

On August 15, 2022 Roivant Sciences Ltd. (Nasdaq: ROIV), a next-generation biopharmaceutical company dedicated to improving the delivery of healthcare to patients, reported its financial results for the first quarter ended June 30, 2022 and provided an update on the Company’s operations (Press release, Roivant Sciences, AUG 15, 2022, View Source [SID1234618316]).

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Roivant’s Chief Executive Officer, Matt Gline, noted: "I’m excited by the strong early signals we’re seeing from the ongoing VTAMA launch in psoriasis, including approximately 14,000 prescriptions in the first eleven weeks. The recent positive topline results from Torii Pharmaceutical and Japan Tobacco’s study of tapinarof in atopic dermatitis underscore our conviction in VTAMA’s potential in AD as our own Phase 3 trials progress. We are also pleased with recent execution across the rest of our pipeline, including the continued progress in our pivotal trials at Immunovant and Priovant. We are proud to advance the development of these important medicines for patients."

Roivant also announced today that Amy Mahery will be joining the company as Chief Commercial Officer and will serve as a member of the leadership team. Amy has more than twenty years of industry experience and has been involved in the commercialization and launch of therapies across oncology, neurology and immunology. Most recently, she was the Senior Vice President and Head of the Global Business Franchise, Neurology and Immunology (N&I) at EMD Serono, where she led commercial strategy for the N&I portfolio from clinical development to launch and late lifecycle.

On September 28, Roivant will host an investor day, at which the Company will provide updates on the ongoing VTAMA launch in psoriasis, clinical development at the Vants and continued progress in drug discovery. The webcast for this virtual event will begin at 11 a.m. EDT, and participants can register to attend at View Source

Recent Developments

Dermavant: Since its launch in late May, VTAMA has had approximately 14,000 prescriptions written by more than 3,000 unique prescribers based on the latest available IQVIA data through August 5 for prescriptions and July 29 for prescribers. VTAMA became the most prescribed branded topical for the treatment of psoriasis in the U.S. within eight weeks of launch. In July, Torii Pharmaceutical and Japan Tobacco announced positive topline results from their Phase 3 study of tapinarof in atopic dermatitis. In this trial, tapinarof showed statistical superiority to vehicle on the primary endpoint of efficacy, IGA response at week 8. In addition, tapinarof showed statistical superiority to vehicle for EASI achievement rate at week 8, a key secondary endpoint of efficacy. There were no new observed safety or tolerability findings reported.
Priovant: Priovant expects to complete enrollment for its ongoing potentially registrational global trial evaluating oral brepocitinib for the treatment of SLE in August 2022. Oral brepocitinib is a potential first-in-class dual, selective inhibitor of TYK2 and JAK1 licensed from Pfizer that has been evaluated in 14 completed Phase 1 and Phase 2 trials, including 5 placebo-controlled Phase 2 trials in psoriatic arthritis, plaque psoriasis, ulcerative colitis, alopecia areata and hidradenitis suppurativa that generated statistically significant and clinically meaningful efficacy results. Priovant is also developing oral brepocitinib for the treatment of dermatomyositis, for which it recently initiated a single registrational Phase 3 trial.
Major Upcoming Milestones

Dermavant: Dermavant expects to provide updates on the commercial launch of VTAMA for psoriasis on a periodic basis and to report topline data from the Phase 3 trials of VTAMA for the treatment of atopic dermatitis in the first half of calendar year 2023.
Priovant: Priovant plans to announce topline results from the potentially registrational trial evaluating brepocitinib for the treatment of patients with SLE in the second half of calendar year 2023.
Immunovant: Immunovant plans to initiate two pivotal trials to evaluate batoclimab for the treatment of thyroid eye disease in the second half of calendar year 2022, with topline results expected in the first half of calendar year 2025. Immunovant plans to announce two new indications for batoclimab and the third indication (in addition to MG and TED) it will initiate as a pivotal trial in calendar year 2022 on an investor call scheduled for September 7, 2022.
Hemavant: Hemavant plans to announce data from the ongoing open-label Phase 1/2 trial evaluating RVT-2001 for the treatment of transfusion-dependent anemia in lower-risk MDS patients in the second half of calendar year 2023.
Kinevant: Kinevant plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the first half of calendar year 2024.
First Quarter Ended June 30, 2022 Financial Summary

Cash Position

As of June 30, 2022, we had cash, cash equivalents and restricted cash of approximately $2.0 billion.

Research and Development Expenses

Research and development (R&D) expenses were $135.8 million for the three months ended June 30, 2022 compared to $78.5 million for the three months ended June 30, 2021. The quarter-over-quarter increase was primarily due to increases in program-specific costs and personnel-related expenses, reflecting the progression of our programs and drug discovery. Additionally, share-based compensation expense increased largely as a result of the ongoing vesting of certain equity instruments for which the liquidity event vesting condition was met upon the closing of the business combination with MAAC in September 2021. We did not recognize share-based compensation expense related to these equity instruments during the three months ended June 30, 2021 as the liquidity event requirement had not been met and was not deemed probable of being met. Non-GAAP R&D expenses were $122.5 million for the three months ended June 30, 2022 compared to $76.2 million for the three months ended June 30, 2021.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $149.1 million for the three months ended June 30, 2022 compared to $82.8 million for the three months ended June 30, 2021. The quarter-over-quarter increase was primarily due to increases in share-based compensation expense largely as a result of the ongoing vesting of certain equity instruments for which the liquidity event vesting condition was met upon the closing of the business combination with MAAC in September 2021. We did not recognize share-based compensation expense related to these equity instruments during the three months ended June 30, 2021 as the liquidity event requirement had not been met and was not deemed probable of being met. Additionally, SG&A expenses for Dermavant have increased as a result of the commercial launch of VTAMA in May 2022. Non-GAAP SG&A expenses were $87.7 million for the three months ended June 30, 2022 compared to $64.4 million for the three months ended June 30, 2021.

Net Loss

Net loss was $353.8 million for the three months ended June 30, 2022 compared to $101.1 million for the three months ended June 30, 2021. On a per common share basis, net loss was $0.48 for the three months ended June 30, 2022 and $0.13 for the three months ended June 30, 2021. Non-GAAP net loss was $210.7 million for the three months ended June 30, 2022 compared to $133.4 million for the three months ended June 30, 2021.

(1) Represents non-cash amortization of intangible assets associated with milestone payments made in connection with regulatory approvals.

(2) Represents non-cash share-based compensation expense.

(3) Represents non-cash depreciation and amortization expense, other than amortization of intangible assets associated with milestone payments made in connection with regulatory approvals.

(4) Represents the unrealized loss (gain) on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings.

(5) Represents the change in fair value of debt and liability instruments, which is non-cash and primarily includes the unrealized loss (gain) relating to the measurement and recognition of fair value on a recurring basis of certain liabilities.

(6) Represents the one-time gain on termination of the options held by Sumitomo Pharma Co., Ltd. to purchase Roivant’s ownership interest in certain Vants (the "Sumitomo Options").

(7) Represents the estimated tax effect of the adjustments.

Beginning in the fourth quarter of the fiscal year ended March 31, 2022, the Company no longer excludes from its non-GAAP financial measures acquired IPR&D expenses, which include consideration for the purchase of IPR&D through asset acquisitions and license agreements as well as payments made in connection with asset acquisitions and license agreements upon the achievement of development milestones. Previously, these items were excluded from the Company’s non-GAAP financial measures. In conjunction with this change, acquired IPR&D expenses are now reported as a separate line item in its consolidated statements of operations. Prior period amounts have been revised to conform to the current presentation.

There was no acquired IPR&D expense for the three months ended June 30, 2022. For the three months ended June 30, 2021, acquired IPR&D expense was $0.1 million.

Investor Conference Call Information

Roivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, August 15, 2022 to report its financial results for the fiscal quarter ended June 30, 2022 and provide a corporate update.

To access the conference call by phone, please register online using this registration link. A webcast of the call will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.

On August 15, 2022 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the second quarter ended June 30, 2022 and provided a business update on recent corporate and regulatory developments (Press release, Protalix, AUG 15, 2022, View Source [SID1234618315]).

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"Positive topline results from our phase III BALANCE clinical trial of PRX-102 for the treatment of adult patients with Fabry disease were announced last April. The clinical study report (CSR) for the trial is now complete," said Dror Bashan, Protalix’s President and Chief Executive Officer. "The final analysis of the BALANCE study, which was designed to evaluate the efficacy and safety of 1 mg/kg of PRX–102 administered every other week compared to agalsidase beta in patients previously treated with agalsidase beta, confirms the positive topline results and favorable tolerability profile. The results from the BALANCE study highlight our confidence that PRX–102 has the potential to become an important treatment option for patients with Fabry disease. We are excited to move closer to potential approval of PRX–102 and commercial launch, and thank our team members and external partners for their continued support."

2022 Second Quarter and Recent Business Highlights

Corporate Developments

On June 30, 2022, the Company announced the appointment of Shmuel "Muli" Ben Zvi, Ph.D. to the Board of Directors. Dr. Ben Zvi is serving as the new Chairman of the Audit Committee and as a member of the Compensation Committee.
Second Quarter 2022 Financial Highlights

The Company recorded revenues from selling goods of $3.4 million for the three months ended June 30, 2022, an increase of $0.2 million, or 6%, compared to revenues of $3.2 million for the same period of 2021.
Revenue from licenses and R&D services for the three months ended June 30, 2022 were $5.4 million, an increase of $2.2 million, or 69%, compared to $3.2 million for the same period in 2021. Revenues from license and R&D services are comprised primarily of revenues recognized in connection with the Chiesi Agreements.
Cost of goods sold for the three months ended June 30, 2022 was $4.1 million, a decrease of $0.6 million, or 13%, compared to cost of goods sold of $4.7 million for the same period in 2021. The decrease in cost of goods sold was primarily the result of decreased manufacturing costs due to higher yields and lower wastage.
Research and development expenses for the three months ended June 30, 2022 were $7.6 million, a decrease of $0.1 million, or 1%, compared to $7.7 million for the same period in 2021.
Selling, general and administrative expenses were $2.6 million for the three months ended June 30, 2022, a decrease of $0.6 million, or 19%, compared to $3.2 million for the same period in 2021. The decrease resulted primarily from a decrease in salary related and selling costs.
Financial income, net were $0.2 million for the three months ended June 30, 2022, compared to financial expenses, net of $2.1 million for the same period in 2021. The decrease resulted primarily from lower interest and debt amortization costs due to a decrease in the Company’s outstanding notes from an aggregate principal amount of $57.92 million of 2021 Notes to an aggregate principal amount of $28.75 million of 2024 Notes, and an increase in the exchange rate of New Israeli Shekels for U.S. Dollars over the period.
Cash, cash equivalents and short-term bank deposits were approximately $28.6 million at June 30, 2022.
Net loss for the three months ended June 30, 2022 was approximately $5.3 million, or $0.11 per share, basic and diluted, compared to a net loss of $11.2 million, or $0.25 per share, basic and diluted, for the same period in 2021.
Conference Call and Webcast Information

The Company will host a conference call today, August 15, 2022, at 8:30 a.m. Eastern Daylight Time, to review the corporate and clinical developments, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:

Conference Call Details:

The conference will be webcast live from the Company’s website and will be available via the following links:

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.