On June 3, 2020 Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported new interim data presented from the Phase 2 part of its Phase 1/2 clinical trial of RP1 in combination with Opdivo that continues to provide strong support for its lead indications of cutaneous squamous cell carcinoma (CSCC) and anti-PD-1 refractory melanoma (Press release, Replimune, JUN 3, 2020, View Source [SID1234560794]).

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"CSCC is a significant commercial opportunity that we believe has the potential to drive substantial value for the company. The number of complete responses (CRs) observed is highly suggestive that our combination approach with RP1 can provide better patient outcomes compared to anti-PD-1 therapy alone, where CRs are infrequent," said Philip Astley-Sparke, CEO of Replimune. "In anti-PD-1 refractory melanoma, we believe we also have a strong efficacy signal and are optimistic that our currently-enrolling 125 patient cohort could generate data to support regulatory approval, pending feedback from the U.S. Food and Drug Administration (FDA) and other regulatory agencies. We are also excited to be moving to evaluate RP1 in anti-PD-1 refractory non-small cell lung cancer (NSCLC), given the large unmet need in this tumor type. We believe we have established clinical proof of principle with RP1 in immune-responsive tumor types and in anti-PD-1 refractory cancers, and now have a solid foundation upon which to establish our product candidates more broadly as the second cornerstone of immuno-oncology."

New interim clinical data in CSCC from the enrolling 30 patient non-melanoma skin cancer cohort evaluating RP1 in combination with Opdivo continues to strongly support the Company’s registration-directed clinical trial of RP1 in combination with Libtayo

Overall, four of seven evaluable patients have ongoing CRs and six of seven have an ongoing CR or partial response (PR) (compared to one out of five patients and two out of five, respectively, as presented at the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting in November 2019). The data continues to demonstrate that RP1 in combination with Opdivo is well-tolerated, demonstrates immune activation and continues to drive deep and durable responses in patients with CSCC. Furthermore, the number of CRs observed to date in advanced CSCC patients with aggressive disease treated with RP1 in combination with anti-PD-1 provides clear differentiation versus anti-PD-1 therapy alone, which we believe provides the Company strong validation of its clinical development plan.

"The data in patients with CSCC treated with RP1 in combination with Opdivo has continued to strengthen since it was last presented at the SITC (Free SITC Whitepaper) conference in November 2019, with PRs converting to CRs, providing patients with the potential for cure, and with further responses observed, including CRs," said Professor Kevin Harrington, PhD, Professor in Biological Cancer Therapies at The Institute of Cancer Research, London, and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust​ in the UK. "RP1 in combination with anti-PD-1 therapy therefore appears to be highly active for the treatment of CSCC, both in patients with advanced loco-regional disease, which is the main cause of death in patients with CSCC, and in patients with distant metastatic disease, with the potential to provide a highly effective new therapeutic option for these patients."

The Company’s registration-directed Phase 2 clinical trial (CERPASS) in CSCC is a multi-center, randomized, controlled clinical trial intended to enroll approximately 240 patients. The primary objective is to compare the response rate following treatment with RP1 in combination with Libtayo versus Libtayo alone. Libtayo is an anti-PD-1 therapy developed by Regeneron and Sanofi and was approved by the FDA last year for the treatment of patients with metastatic or locally advanced CSCC who are not candidates for curative surgery or radiation. This clinical trial is being conducted under the Company’s collaboration agreement with Regeneron. Multiple clinical trial sites in the United States and Australia are open for enrollment. Additional clinical trial sites in these and other countries will be added, with recruitment expected to take approximately 18 to 24 months.

A clinical trial of single-agent RP1 in organ transplant recipients with CSCC is also open for enrollment. This clinical trial is intended to enroll approximately 30 patients and assess the safety and efficacy of RP1 in liver and kidney transplant recipients with recurrent CSCC. Anti-PD-1 therapy is not indicated for solid organ transplant recipients due to the risk of rejection of the transplanted organ.

New interim clinical data in anti-PD-1 refractory melanoma from the fully accrued 30 patient melanoma cohort testing RP1 in combination with Opdivo continues to strongly support the Company’s registrational approach

Overall, 36 melanoma patients have been treated in the Phase 1/2 clinical trial of RP1 in combination with Opdivo, of which there were 6 patients in the Phase 1 expansion cohort and 30 patients in the Phase 2 cohort. Sixteen anti-PD-1 refractory cutaneous melanoma patients have been treated. An additional eight patients with anti-PD-1 naïve cutaneous melanoma and 12 patients with uveal or mucosal melanoma (both anti-PD-1 naïve and refractory) have also been enrolled. Initial results from this immature data set (the final patient was enrolled in January 2020) in the anti-PD-1 refractory cutaneous melanoma patients showed:

Five patients so far have met the formal criteria for response; four of which had previously failed both anti-PD-1 and anti-CTLA-4 therapies
Two further patients remain on treatment with the opportunity for response
The minimum final objective response rate (ORR) for these patients will therefore be 31%
The majority of melanoma patients treated with anti-PD-1 therapy have primary resistance, or acquire resistance to checkpoint blockade drugs following initial response. The clear activity of RP1 in anti-PD-1 refractory patients, including in patients with extensive visceral disease, represents a new potential therapeutic option for these patients. Based on the initial efficacy data with RP1 in melanoma, the Company initiated a registration-directed 125-patient cohort of anti-PD-1 refractory melanoma in the Phase 2 clinical trial of RP1 in combination with Opdivo in the first quarter of 2020. The additional cohort is being enrolled under an expansion of the clinical trial collaboration and Opdivo supply agreement with Bristol Myers Squibb (BMS).

Clinical data from the additional patients with anti-PD-1 naïve cutaneous melanoma, mucosal melanoma and uveal melanoma are also supportive of the clinical activity of RP1 in combination with Opdivo. This includes eight patients with anti-PD-1 naïve cutaneous melanoma, six patients with mucosal melanoma and six patients with uveal melanoma.

Anti-PD-1 naïve cutaneous melanoma (N=8): Four patients so far have met the formal definition of response with two further patients remaining on treatment with the opportunity for response
Mucosal melanoma (N=6): Two patients (one anti-PD1 naive, one having had prior anti-PD-1) have met the formal definition of response
Uveal melanoma (N=6): Two patients with extensive liver disease are responding to treatment, both refractory to combined Opdivo and Yervoy, one so far having a 27.3% reduction by RECIST criteria uni-dimensional measurement and 61% reduction by WHO criteria bi-dimensional measurement
"Responses to RP1 in combination with Opdivo in patients with difficult to treat melanomas who have failed both anti-PD-1 and anti-CTLA-4 would not have been expected for those receiving a second line of anti-PD1 alone," said Mark Middleton, Professor of Experimental Cancer Medicine in the Department of Oncology, consultant Medical Oncologist at the Oxford Cancer and Haematology Centre and Head of the Department of Oncology at the University of Oxford. "The clinical activity of RP1 in combination with Opdivo in these patients appears robust, with the overall safety profile suggesting no additional toxicities compared to anti-PD1 therapy alone."

The data from this clinical update can be found in the presentation linked here.

Based on the emerging data indicating that RP1 can be safely administered to tumors in the lung and that evidence of activity, including in anti-PD1 refractory disease, has been observed in patients with lung metastases of other tumor types, the Company announced its intention to enroll a thirty patient cohort of patients with anti-PD1 refractory NSCLC in the Phase 2 clinical trial of RP1 in combination with Opdivo, subject to approval of a protocol amendment by the regulatory authorities. The Company also announced that it plans to terminate the enrollment of the cohort of patients with metastatic bladder cancer in light of changes to the competitive landscape.

Investor event and webcast information
Replimune will host a virtual investor event today, Wednesday, June 3, 2020 at 8:00 a.m. ET. The webcast and accompanying slides will be available under "Events and Presentations" in the Investors and Media section of the company’s website at www.replimune.com. Alternatively, audience members may listen to the call by dialing (833) 651-0806 from locations in the United States and (918) 922-6072 from outside the United States. The conference ID number is 4268503. An archived webcast recording of the event will be available on the website for approximately 30 days.

About CSCC
CSCC is the second most common form of skin cancer and is estimated to be responsible for at least 7,000 deaths each year in the United States. It currently accounts for approximately 20% of all skin cancers in the United States, with the number of newly diagnosed cases expected to rise annually. When CSCC invades deeper layers of the skin or adjacent tissues, it is categorized as locally advanced. Once it spreads to other distant parts of the body, it is considered metastatic. Libtayo is the only approved therapy in the United States and Brazil, and conditionally approved therapy in the European Union and Canada, for the treatment of locally advanced or metastatic CSCC.

About Melanoma
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic melanoma is the deadliest form of the disease and occurs when cancer spreads beyond the surface of the skin to other organs. The incidence of melanoma has been increasing steadily for the last 30 years. In the United States, 91,270 new diagnoses of melanoma and more than 9,320 related deaths are estimated for 2018. Globally, the World Health Organization estimates that by 2035, melanoma incidence will reach 424,102, with 94,308 related deaths. Melanoma is mostly curable when treated in its very early stages; however, survival rates are roughly halved if regional lymph nodes are involved.

About RP1
RP1 is Replimune’s lead Immulytic product candidate and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.

On June 3, 2020 Specialised Therapeutics Asia reported that NOVEL marine-derived drug to treat Small Cell Lung Cancer (SCLC) has been granted a provisional designation by the Therapeutic Goods Administration (TGA), based on encouraging results from an international trial evaluating its safety and efficacy in several solid tumours, including SCLC (Press release, Specialised Therapeutics Asia, JUN 3, 2020, View Source [SID1234560810]).

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Data from a key Phase 2 study of the drug Lurbinectedin demonstrated a 35% overall response rate in second-line patients, with a median overall survival of 9.3 months (95% CI 6.3-11.8), which is a clinically meaningful advantage over current standard of care in patients in second-line SCLC therapy.[1]

These results also underpin a decision by the US Food and Drug Administration (FDA) granting Lurbinectedin a priority and accelerated review. Lurbinectedin will now be reviewed concurrently by the FDA and other international regulators, including the TGA, under the ‘Project Orbis’ initiative.

This multi-country collaboration between international regulators is designed to streamline approvals where there is a strong unmet medical need, predominantly in oncology and haematology. This project may enable cancer patients to receive expedited access to new therapies.

In tandem with the provisional designation, Lurbinectedin is now being investigated in patients at five cancer centres in Sydney, Melbourne and Queensland. All study subjects are SCLC patients who have relapsed after being treated with standard platinum-based chemotherapy, with or without immunotherapy.

A principal investigator on the new Australian study, Associate Professor Tom John at the Peter MacCallum Cancer Centre, said patients had few treatment options after failure of first-line therapy.

Associate Professor John commented: "The initial Lurbinectedin data are encouraging, and we will be collecting local data to see if it matches that seen in the international study. There is still a significant medical unmet need in Small Cell Lung Cancer. We welcome new treatment options for this difficult to treat patient population."

Lurbinectedin is being made available in Australia and Singapore by independent pharmaceutical company Specialised Therapeutics Asia (STA) under exclusive license from Spanish biopharmaceutical company PharmaMar.

STA Chief Executive Officer Mr Carlo Montagner described the TGA’s provisional designation for Lurbinectedin and review under the Project Orbis collaboration as "extremely encouraging".

"We welcome the provisional designation that acknowledges the encouraging data demonstrated to date and the high unmet medical need in patients with refractory SCLC," he said.

"We look forward to progressing Lurbinectedin through relevant regulatory channels in South East Asia and Australia / New Zealand as expeditiously as possible."

In the interim, STA will continue to make this compound available to eligible patients under a named co-pay Patient Access Program in our region."

Up to 1900 Australians[2] and 1100 Singapore residents are diagnosed with SCLC every year, representing approximately 15% of all lung cancers.[3]

On June 3, 2020 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, reported that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to 67Cu-SARTATE, a therapy for the clinical management of neuroblastoma (Press release, Clarity Pharmaceuticals, JUN 3, 2020, View Source [SID1234560761]).

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The FDA defines a "rare pediatric disease" (RPD) as a serious or life-threatening disease primarily affecting individuals aged 18 years or younger that impacts fewer than 200,000 people in the United States. The program is intended to facilitate development of new drugs and biologics for the prevention and treatment of RPDs.

Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality.1 High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.2

Upon FDA marketing approval of 67Cu-SARTATE for neuroblastoma with RPD designation, Clarity may be eligible to receive a Priority Review Voucher (PRV), which can be used to obtain FDA review of a New Drug Application for another product in an expedited period of six months. The Voucher may also be sold or transferred and to date PRVs have been sold for between US$67.5 million to US$350 million.

Dr Alan Taylor, Clarity’s Executive Chairman, commented, "The FDA decision to grant RPDD to 67Cu-SARTATE for the treatment of neuroblastoma, following an earlier decision to grant it an Orphan Drug Designation, emphasises the critical need for better treatments for this devastating disease, and is testament to the significant level of work we have completed to date on this therapy.

"The current neuroblastoma treatment strategies are limited, especially in late-stage disease, and the prognosis of high-risk neuroblastoma patients remains unfavourable. Our team at Clarity and our collaborators around the world are committed to improving these outcomes.

"We are very excited about the development of SARTATE in neuroblastoma and are looking forward to the results from our US-based Phase 1/2 trial3. We are hoping that the grant of RPDD will get us one step closer to our ultimate goal of developing better treatments for children and adults with cancer."

On June 3, 2020 Replimune Group, Inc. (NASDAQ: REPL), a biotechnology company developing a series of oncolytic immuno-gene therapies derived from its Immulytic platform, reported financial results for the fiscal fourth quarter and year ended March 31, 2020 and provided a business update (Press release, Replimune, JUN 3, 2020, View Source [SID1234560795]).

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"I am very pleased with our continued progress developing our pipeline of oncolytic immuno-gene therapies. Today we released additional data with RP1 in our lead indications of cutaneous squamous cell carcinoma (CSCC) and anti-PD1 refractory cutaneous melanoma that we believe point to a high probability of success in our registration-directed clinical trial in CSCC and our potentially registrational cohort of patients currently being enrolled with anti-PD1 refractory melanoma. We also reported plans to initiate clinical development of RP1 in anti-PD1 refractory patients with non-small cell lung cancer (NSCLC)," said Philip Astley-Sparke, CEO of Replimune. "We look forward to presenting further clinical updates from our skin cancer programs later in the year, together with single agent safety and efficacy data and initial data in combination with Opdivo from our ongoing Phase 1 clinical trial with our second product candidate, RP2. We believe we have established clinical proof of principle with RP1 in immune-responsive tumor types and that we now have a solid foundation to further establish our product candidates more universally as the second cornerstone of immune-oncology."

Recent Events and Corporate Highlights

Presented new interim clinical data from the Phase 2 portion of the Phase 1/2 clinical trial of RP1 in combination with Opdivo in non-melanoma and melanoma skin cancers that continue to support clinical programs in both CSCC and anti-PD1 refractory melanoma. A link to the data presented can be found here.

New interim data for patients with CSCC treated with RP1 continued to strengthen since the last update provided at the 2019 Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). Overall four of seven evaluable patients have ongoing complete responses (CRs) and six of seven have an ongoing CR or partial response (PR) as compared to the data presented at SITC (Free SITC Whitepaper) in November 2019, where one out of five patients had a CR and two out of five had a PR. Importantly, we believe that the number of CRs seen to date in advanced CSCC patients with aggressive disease treated with RP1 in combination with anti-PD1 provides clear differentiation for RP1 versus anti-PD1 therapy alone. Overall, the data continues to demonstrate that RP1 in combination with Opdivo is well tolerated, demonstrates immune activation, continues to drive deep and durable responses in patients with CSCC, and provides what we believe to be strong validation of the Company’s clinical development plan.

Early interim data of RP1 in combination with Opdivo in 16 patients with anti-PD1 refractory cutaneous melanoma demonstrated clear activity, including in patients with extensive visceral disease. Five of 16 patients have so far met the formal criteria of a response, including four of whom had previously failed both anti-PD1 and anti-CTLA4 therapies, providing for a minimum final response rate from this cohort of 31%. With a majority of melanoma patients having primary or acquired resistance to checkpoint blockade, we believe that the initial efficacy seen represents a potential new therapeutic option for these patients.

Additional promising data with RP1 combined with Opdivo in patients with anti-PD1 naïve cutaneous melanoma, mucosal melanoma and uveal melanoma were presented. Uveal and mucosal represent difficult to treat melanoma sub-types and the patients enrolled include responding patients who have already failed both anti-PD1 and anti-CTLA4 therapies.

Announced plans to enroll a new 30 patient cohort in anti-PD1 refractory NSCLC into the Phase 2 portion of the clinical trial of RP1 combined with Opdivo and terminate further enrollment of the 30 patient cohort in metastatic bladder cancer. Anti-PD1 refractory NSCLC represents an area of considerable unmet need. RP1 in combination with Opdivo has demonstrated the ability to shrink lung metastases of other tumor types, including in patients with anti-PD1 refractory disease, where administration of RP1 via imaging guidance has been demonstrated to be both feasible and generally well tolerated in the patients treated so far. Additionally, as a result of a new emerging standard of care in metastatic bladder cancer, the Company has elected to terminate enrollment of this cohort.

Manufacturing. The Company has completed construction of and equipped its 63,000 square feet state of the art commercial capacity manufacturing facility in Framingham MA and successfully completed technology transfer activities. The facility has been designed to allow us to produce enough material to cover full global commercialization of all our current product candidates.

Intellectual Property. The Company has made significant progress in developing its intellectual property portfolio during the year, including through the grant of US patents covering its core technology. These include US patent number 10,612,005, which protects the use of an oncolytic virus expressing an inserted gene encoding a fusogenic glycoprotein (thereby intended to increase the extent and immunogenicity of tumor cell death) together with a gene encoding an immune stimulating protein, and US 10,570,377 which protects the use of the Company’s novel strains of herpes simplex virus (HSV) which were identified through an extensive screen of clinical isolates of HSV to identify strains with the greatest ability to kill human tumor cells.

Announced new appointments to the Board. In April the Company announced the appointment of Dieter Weinand as Chairman of the Board of Directors and the appointment of Paolo Pucci as a new member of the Board of Directors. Mr. Weinand succeeds Philip Astley-Sparke who in January transitioned from part time Executive Chairman to full time Chief Executive Officer. The appointments bring international experience within commercial, operational, and strategic functions in the pharmaceutical industry along with extensive experience in the field of oncology.

Amendment of debt facility. On June 1st the Company closed an expansion of its debt facility with Hercules Growth Capital from $30m to $40m and extension of the interest only period. Combined with various cost containment measures, this should allow the Company to fund operations through 2022.
Program Highlights

Replimune is currently developing three oncolytic immuno-gene therapies derived from its Immulytic platform. RP1 is Replimune’s first clinical product candidate and is based on a proprietary new strain of herpes simplex virus armed with a gene encoding a potent fusogenic protein (GALV-GP-R), intended to enhance tumor killing potency, immunogenic cell death and the activation of systemic anti-tumor immune responses, and with a gene encoding the cytokine GM-CSF. RP2 is a version of RP1 that in addition to expressing GALV-GP-R and GM-CSF also expresses a genetically encoded anti-CTLA-4 antibody-like molecule intended to block the inhibition of the initiation of immune response caused by CTLA-4. RP3 is a further armed oncolytic immuno-gene therapy which additionally expresses two immune co-stimulatory activating ligands – CD40L and 4-1BBL – together with anti-CTLA-4 and GALV-GP-R. CD40L activates CD40, with the goal of achieving broad activation of both innate and adaptive immunity, and 4-1BBL activates 4-1BB (CD137), intended to promote the expansion of cellular and memory immune responses.

RP1 in combination with Libtayo in CSCC: Enrollment in the 240-patient registration-directed Phase 2, randomized, controlled clinical trial is ongoing and is expected to take approximately 18 to 24 months with enrollment intended in the US, Australia, Canada, and European countries including the United Kingdom.

RP1 in combination with Opdivo in melanoma, non-melanoma skin cancers, and MSI-H/dMMR tumors: The melanoma cohort has completed accrual and preliminary results were presented on June 3, together with updated data from the enrolling non-melanoma skin cancer (NMSC) cohort. The NMSC cohort is expected to be fully accrued by the end of 2020, representing a delay partially relating to COVID-19 disruptions. Similarly, it is likely that accumulating sufficient data to inform a decision as to whether to pursue MSI-H/dMMR tumors into registration-directed development will be delayed into 2021.

RP1 in combination with Opdivo in anti-PD-1 refractory melanoma patients: In February 2020, the Company initiated recruitment into a new registration-directed 125-patient cohort in the Phase 2 clinical trial of RP1 in combination with Opdivo.

RP1 as monotherapy in solid organ transplant recipients with CSCC: In May 2020, the Company initiated enrollment into a 30 patient Phase 1/2 clinical trial to assess the safety and efficacy of RP1 in liver and kidney transplant recipients with recurrent CSCC.

RP2 alone and in combination with Opdivo: The ongoing Phase 1 clinical trial evaluating the safety, tolerability, and optimal dose for further development of RP2 alone and in combination with Opdivo remains on track, with initial safety and efficacy data from the single agent RP2 part of the clinical trial together with initial data in combination with Opdivo expected to be presented by the end of 2020.

RP3 alone and in combination with anti-PD-1 therapy: The Phase 1 clinical trial of RP3 alone and in combination with anti-PD-1 therapy remains on track to initiate in 2020.
Financial Highlights

Cash Position: As of March 31, 2020, cash, cash equivalents and short-term investments were $168.6 million, as compared to $134.8 million as of March 31, 2019. This increase was primarily related to $99.7 million in net proceeds from financing activities offset by an increase in cash utilized for capital investments associated with our new manufacturing facility and advancing our expanded clinical development plan.

Based on our current operating plan, we believe that our existing cash and cash equivalents and short-term investments along with our debt commitments will enable us to fund our operating expenses and capital expenditure requirements through 2022.
R&D Expenses: Research and development expenses were $11.2 million for the fourth quarter and $38.8 million for the fiscal year ended March 31, 2020, as compared to $5.4 million for the fourth quarter and $22.2 million for the fiscal year ended March 31, 2019. This increase was primarily due to increased clinical and manufacturing expenses driven by the Company’s lead programs and increased personnel expenses. Research and development expenses included $0.7 million in stock-based compensation expenses for the fourth quarter and $3.7 million in stock-based compensation expenses for the fiscal year ended March 31, 2020.

G&A Expenses: General and administrative expenses were $5.2 million for the fourth quarter and $17.4 million for the fiscal year ended March 31, 2020, as compared to $2.4 million for the fourth quarter and $8.8 million for the year ended March 31, 2019. The increase was primarily driven by personnel related costs, professional fees, and facility expansion. General and administrative expenses included $1.0 million in stock-based compensation expenses for the fourth quarter and $4.1 million in stock-based compensation expenses for the fiscal year ended March 31, 2020.

Net Loss: Net loss was $15.8 million for the fourth quarter and $52.6 million for the fiscal year ended March 31, 2020, as compared to a net loss of $6.7 million for the fourth quarter and $30.8 million for the fiscal year ended March 31, 2019.
About CSCC
CSCC is the second most common form of skin cancer and is estimated to be responsible for at least 7,000 deaths each year in the U.S. It currently accounts for approximately 20% of all skin cancers in the U.S., with the number of newly diagnosed cases expected to rise annually. When CSCC invades deeper layers of the skin or adjacent tissues, it is categorized as locally advanced. Once it spreads to other distant parts of the body, it is considered metastatic. Libtayoâ is the only approved therapy in the United States and Brazil, and conditionally approved therapy in the European Union and Canada, for the treatment of locally advanced or metastatic CSCC.

About Melanoma
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic melanoma is the deadliest form of the disease and occurs when cancer spreads beyond the surface of the skin to other organs. The incidence of melanoma has been increasing steadily for the last 30 years. In the United States, 91,270 new diagnoses of melanoma and more than 9,320 related deaths are estimated for 2018. Globally, the World Health Organization estimates that by 2035, melanoma incidence will reach 424,102, with 94,308 related deaths. Melanoma is mostly curable when treated in its very early stages; however, survival rates are roughly halved if regional lymph nodes are involved.

About RP1
RP1 is Replimune’s lead Immulytic product candidate and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.

On June 3, 2020 Shorla Pharma Limited (‘Shorla’), an Irish specialty pharmaceutical company, reported the completion of a Series A investment of $8.3 million (Press release, Shorla Pharma, JUN 3, 2020, View Source [SID1234560811]). The financing was led by Seroba Life Sciences (‘Seroba’), a European Venture Capital firm headquartered in Dublin, Ireland with additional investment from Irish and Canadian based family offices and participation from Enterprise Ireland.

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Shorla has developed innovative oncology drugs with a focus on rare, orphan and pediatric cancers, delivering more effective products in indications where existing treatments are sub-optimal for the target patients.

The company was founded by Sharon Cunningham and Orlaith Ryan (‘Shorla’ is a combination of both first names), both formerly with EirGen Pharma (‘EirGen’) in Waterford, Ireland. Shorla is based in Questum, a Clonmel, Ireland based acceleration center.

Together with a strong team of scientists, clinicians and an extensive industry network, the company has an advanced pipeline of innovative drug products to treat a number of unmet patient needs. The funding will support the advancement of the product pipeline, along with expansion of technical and commercial operations in both Ireland and the US.

Alan O’Connell, a Partner at Seroba who has joined the Shorla board, said, "We’re delighted to support an Irish company with such a promising pipeline of products designed to improve treatment options for cancer patients. Shorla is led by experienced founders with a track record of success in the sector and we look forward to working with them to grow the company and bring their products to market."

Speaking about the investment, Orlaith Ryan of Shorla said, "This significant investment will provide the necessary resource to further advance the product pipeline through health authority registration and commercialization which will ultimately create valuable and clinically impactful treatments that improve patient outcomes."

Commenting about the support from Seroba, Sharon Cunningham added, "Seroba is a leading venture capital firm in the global life sciences industry and they, along with other participants in the investment syndicate bring invaluable experience to Shorla and have a proven track record in the pharmaceutical sector. We’re confident that we have the right partners to support us in executing our vision."

Julie Sinnamon, CEO, Enterprise Ireland, said, "We are delighted to support Shorla and to be part of this investment round. Ireland is widely recognised as a center for the global life sciences industry as well as a leader in medtech and pharmaceutical manufacturing. Helping to maintain that reputation, Shorla, led by two female founders, is a highly innovative company developing new solutions to critical issues in the oncology area. It is also particularly heartening to see this company starting in a regional location. Earlier this year, the Enterprise Ireland ‘Action Plan for Women in Business’ cited that less than 10 percent of VC funding is going to companies with women founders. This investment is consistent with that action plan in terms of developing a larger number of companies of scale led by female founders. It is fantastic to have a role model like Shorla to demonstrate what’s possible. I wish the team luck with the project and congratulate the company on its success to date."