On November 14, 2018 Cytori Therapeutics (NASDAQ: CYTX) ("Cytori" or the "Company") reported Q3 2018 financial results and provided updates on corporate activities (Press release, Cytori Therapeutics, NOV 14, 2018, View Source [SID1234531481]).

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Q3 2018 net loss was $2.3 million, or $0.27 per share. Operating cash burn for Q3 was approximately $2.6 million. Cytori ended Q3 with approximately $6.8 million of cash and cash equivalents.

Cytori is developing its lead chemotherapy drug, ATI-0918, a generic version of pegylated liposomal doxorubicin hydrochloride, with the goal of submitting a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) next year. We previously completed a bioequivalence study against the European reference drug and are in the process of completing manufacturing-related activities to support the MAA. The Company also continues to evaluate potential commercial partnering opportunities for ATI-0918 with a focus on Europe, which has a current estimated market size of over $120 million.

Cytori is also developing another chemotherapy drug, ATI-1123, a patented, albumin-stabilized pegylated liposomal docetaxel. The Company recently received an orphan drug designation from the U.S. FDA for small cell lung cancer and intends to pursue FDA’s 505(b)(2) new drug application (NDA) pathway in the U.S. which may offer accelerated and lower cost development.

In the first half of 2019, Cytori expects a 1-year data readout from the 45 patient, multi-center, potential pivotal clinical trial in stress urinary incontinence conducted in Japan called ADRESU.

Later in 2018, Cytori expects a 6-month data readout from the 40 patient, French SCLERADEC II clinical trial in scleroderma patients.

Cytori is actively conducting the U.S. Phase I RELIEF trial in thermal burn injury trial sponsored by BARDA. Cytori completed a successful In-Process Review meeting with BARDA this past June.

Commercially, Cytori is focusing its efforts in Japan and continues to see favorable growth trends in the use of its cell therapy products approved under the Regenerative Medicine Law in the aesthetic and orthopedic markets. The Company remains on track to see continued double digit year-over-year growth in Celution System consumable utilization.

Finally, Cytori recently received the first $1.0 million royalty milestone from Bimini Technologies, LLC (Bimini). In 2013, Cytori divested the Puregraft product line that includes periodic royalty payments of up to $10.0 million and certain other economic benefits based on Bimini achieving gross profits milestones.

"A key corporate objective is to complete manufacturing support activities and seek European marketing authorization for ATI-0918, our lead oncology drug product. Furthermore, we have recently expanded development activities for the ATI-1123 phase II oncology program and its potential 505(b)(2) acceptability," said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. "In cell therapy, we are focused on continued revenue growth based on positive quarter-over-quarter and year-over-year consumable utilization trends. In the meantime, we are awaiting pivotal clinical data from our Japanese stress urinary incontinence trial."

Q3 2018 and year-to-date Financial Performance

Q3 2018 and year-to-date operating cash burn was $2.6 million and $9.5 million, compared to $4.0 million and $13.9 million for the same periods in 2017, respectively.
Q3 2018 and year-to-date product revenues were $0.9 million and $2.2 million, compared to $0.5 million and $2.0 million for the same periods in 2017, respectively.
Q3 2018 and year-to-date contract revenues were $0.5 million and $2.3 million, compared to $1.3 million and $2.9 million for the same periods in 2017, respectively.
Q3 2018 and year-to-date consumable utilization in Japan grew by approximate 90% and 70%, when comparing to the same periods in 2017, respectively.
Cash and debt principal balances at September 30, 2018 were approximately $6.8 million and $13.0 million, respectively.
Q3 2018 adjusted net loss was $4.0 million or $0.45 per share, compared to a net loss of $4.8 million or $1.39 per share for the same period in 2017. The adjusted net loss excludes a non-cash beneficial conversion feature (a non gaap measure) related to the issuance of our Series C convertible preferred shares in the third quarter of 2018 of $2.5 million, as well as a credit of $1.7 million related to a change in fair value of warrant liability (a non gaap measure). Q3 2018 net loss allocable to common stockholders was $4.8 million, or $0.55 per share.
Year-to-date 2018 adjusted net loss was $12.1 million or $1.73 per share, compared to $18.4 million or $6.22 per share for the same period in 2017. The adjusted net loss excludes a non-cash beneficial conversion feature (a non gaap measure) related to the issuance of our Series C convertible preferred shares in the third quarter of 2018 of $2.5 million, as well as a credit of $1.7 million related to a change in fair value of warrant liability (a non gaap measure). Year-to-date 2018 net loss allocable to common stockholders was $12.9 million, or $1.85 per share.
Selected Key Anticipated Milestones:

Complete ATI-0918 development and manufacturing required to prepare and file a MAA with the EMA.
Seek FDA 505(b)(2) pathway applicability for ATI-1123 product.
Obtain Japan MHLW Class III approval for Celution System consumables.
Report 1-year Japanese ADRESU pivotal clinical trial data for post-surgical male stress urinary incontinence.
Enrollment update in the BARDA-funded U.S. RELIEF clinical trial.
Report French investigator initiated SCLERADEC II clinical trial data in scleroderma hand dysfunction.
Management Conference Call Webcast

Cytori will host a management conference call at 5:30 p.m. Eastern Time today to further discuss its progress. The webcast will be available live and by replay two hours after the call and may be accessed under "Webcasts" in the Investor Relations section of Cytori’s website. If you are unable to access the webcast, you may dial in to the call at +1.877.402.3914, Conference ID: 9699923.

On November 14, 2018 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported its financial results for the third quarter ended September 30, 2018 (Press release, Sutro Biopharma, NOV 14, 2018, View Source [SID1234531319]).

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"This has been an outstanding third quarter for Sutro. We have completed our initial public offering and achieved multiple milestones in the development of our own clinical programs for treatment of multiple myeloma and ovarian cancer," said Bill Newell, Sutro’s Chief Executive Officer. "We look forward to working with our newest partners and collaborators as the Sutro team continues to execute at a high level to advance our vision of transforming the lives of patients."

Business Highlights and Recent Developments

STRO-001 Clinical Program

STRO-001 granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma.
The Leukemia & Lymphoma Society (LLS) agreed to contribute clinical development funding for STRO-001 through its Therapy Acceleration Program, which forges collaborations with biotechnology companies to help bring innovative therapies to patients faster.
Potential first-in-class antibody-drug conjugate (ADC) directed against CD74 is currently being studied in a Phase 1 clinical trial enrolling separate dose escalation cohorts for myeloma and B-cell lymphoma.
STRO-002 Clinical Program

The FDA has concluded their 30-day review of Sutro’s Investigational New Drug (IND) application for STRO-002, a targeted antibody-drug conjugate directed against folate receptor-alpha. Sutro expects to commence a Phase 1 clinical trial focused on ovarian and endometrial cancers in early 2019.
Corporate Highlights

Collaboration and licensing agreement signed with Merck to discover and develop novel immune-modulating therapies for cancer and autoimmune disorders.
Sutro is primarily responsible for preclinical research and Merck will obtain exclusive worldwide rights to therapeutic candidates derived from the collaboration.
Sutro received from Merck an upfront payment of $60 million, a $20 million investment in its Series E preferred stock, and $10 million investment in a private placement of common stock concurrent with the IPO.
Sutro is eligible for milestone payments totaling up to $1.6 billion, assuming the development and sale of all therapeutic candidates and all possible indications identified under the collaboration, as well as tiered royalties ranging from mid-single digit to low teen percentages on worldwide sales of commercial products that may result from the collaboration.
The initial public offering (IPO) that closed on October 1, 2018, provided Sutro with gross proceeds of $85.0 million, before deducting underwriting discounts and commissions and offering expenses. Additionally, Sutro received proceeds of $10.0 million from Merck in a private placement of common stock concurrent with the IPO.
Appointment of Stephen Worsley as Chief Business Officer and Linda Fitzpatrick as Chief People and Communications Officer.
Third Quarter 2018 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of September 30, 2018, Sutro had cash, cash equivalents and marketable securities of $123.0 million.

In October 2018, Sutro announced the closing of its IPO of 5,667,000 shares of its common stock at a price of $15.00 per share. The gross proceeds to Sutro from the IPO, before deducting underwriting discounts and commissions and offering expenses, were $85.0 million. In addition to the IPO, Sutro concurrently sold in a private placement to Merck Sharp & Dohme Corp. (Merck) additional shares of common stock at the IPO offering price for gross proceeds of $10.0 million. Proceeds from the IPO and the concurrent private placement are not reflected in Sutro’s September 30, 2018 balance sheet.

Revenue

Revenue was $7.8 million for the third quarter of 2018, which included collaboration revenue of $6.9 million recognized primarily from Merck, Celgene and EMD Serono, in addition to other revenue of $0.9 million. During the third quarter of 2018, Sutro began recording revenue from Merck primarily from the $60.0 million upfront payment received by Sutro under the July 2018 collaboration and licensing agreement, for which revenue is being recognized ratably over an approximate four-year period. Future collaboration revenue from Merck, Celgene and EMD Serono, and from any future collaboration partners, will fluctuate as a result of the timing and amount of upfront, milestones and other collaboration agreement payments.

Operating Expenses

Total operating expenses for the third quarter of 2018 were $18.0 million, comprised of research and development expenses of $12.6 million and general and administrative expenses of $5.4 million. Total operating expenses for the quarter included non-cash stock-based compensation expense of $0.3 million and depreciation and amortization expense of $1.1 million. In future quarters, Sutro expects to incur additional general and administrative expenses as it operates as a public company following its IPO that closed on October 1, 2018.

Net Loss Per Share Calculation

The financial statements as of September 30, 2018, including share and per share amounts, do not give effect to the IPO, or the conversion of the redeemable convertible preferred stock, as the IPO and such conversions were completed on October 1, 2018. Relatedly, the weighted-average shares used in calculating net loss per share for the third quarter of 2018 include only common stock outstanding prior to the IPO.

On November 14, 2018 GamaMabs Pharma, a biotechnology company developing optimized therapeutic antibodies targeting the Anti-Müllerian Hormone Receptor II (AMHRII) for the treatment of cancer, reported its presentation of new data regarding its First-In-Class GM102 antibody at two upcoming conferences (Press release, GamaMabs Pharma, NOV 14, 2018, View Source [SID1234531457]).

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Clinical data for 20 Granulosa Cell Tumor patients treated with GM102 in the C101 clinical study, will be presented at the EORTC–NCI–AACR 2018 Symposium, Dublin (Ireland), on November 13-16, 2018. The poster describes safety and hints of activity of GM102 in this orphan disease with high unmet need and no approved therapy.

"Following the first results of the C101 study in gynecological cancers published at ASCO (Free ASCO Whitepaper) this year, we will present additional clinical data for the subset of granulosa ovarian cancer patients who do not have therapeutic alternatives at this stage in their disease," said Dr. Isabelle Tabah-Fisch, Chief Medical Officer at GamaMabs Pharma

Unveiled activation of T-cells by GM102 following macrophage activation and synergy with immune-checkpoint inhibitors targeting T-cells, will be presented at the AACR (Free AACR Whitepaper) 2018 Conference on Tumor Immunology and Immunotherapy, Miami (Florida) on November 27-30.

"We are looking forward to presenting new data on T-cell activation induced by GM102, confirming the potential of our mAb as a single agent and in combination with immune-checkpoint inhibitors," said Jean-François Prost, Chief R&D Officer at GamaMabs.

The presentation details are:

EORTC–NCI–AACR Symposium 2018
Title: ‘GM102, a first-in-class monoclonal glyco-engineered antibody (Ab) targeting Anti-Mullerian-Hormone-Receptor II (AMHRII): safety and hints of activity in Granulosa Cell Tumors (GCT)’, Leary A.
Session: Late Breaking Poster Presentation
Abstract number: 15LBA
Date and time: November 16, 2018, 10am ­– 2pm
Location: Exhibition Hall, The Convention Centre, Dublin (CCD)
AACR Conference on Tumor Immunology and Immunotherapy
Title: ‘GM102, a low fucosylated anti-Müllerian Hormone type II Receptor (AMHRII) antibody, promotes in vitro antitumoral activities of innate (macrophages) and adaptative (CD4+ and CD8+ T cells) immune cells’
Poster number: B77
Date and time: Thursday, November 29, 5pm – 7pm (EST)
Session category/title: Poster Session B
Location: Loews, Miami Beach, rooms Americana 3 and 4
GM102 is a first-in-class glyco-engineered (low-fucose) monoclonal antibody selectively targeting AMHRII-expressing tumors. AMHRII, an embryonic receptor involved in the regression of the Müllerian ducts in the male embryo, is constitutively expressed in ovarian granulosa tumors (GCT) and is re-expressed in a majority of tumor samples in a wide range of gynecological and non-gynecological tumors such as colorectal and lung cancers, hepatocarcinoma or renal cell carcinoma. GM102 is currently being studied in two clinical trials, a phase 1b in recurrent gynecological cancers and a phase 2 in advanced or metastatic colorectal cancers.

GM102 exerts its anti-tumor activity through NK cell and macrophage engagement in the tumor microenvironment, resulting in enhanced tumor phagocytosis and subsequent T cell activation.

Following presentation, the two posters will be available on the publication page of GamaMabs’ website

On November 14, 2018 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported its financial results for the first quarter ended September 30, 2018 (Press release, DelMar Pharmaceuticals, NOV 14, 2018, View Source [SID1234531304]). DelMar executive management will host a business update conference call for investors, analysts and other interested parties on November 20, 2018 at 4:30 p.m. Eastern Time.

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"During the quarter, we continued to focus on advancing our Phase 2 clinical trials for MGMT-unmethylated GBM patients at the MD Anderson Cancer Center in Houston, Texas, and at Sun Yat-sen University Cancer Center in Guangzhou, China where we have seen accelerated enrollment in both studies," commented Saiid Zarrabian, President and Chief Executive Officer of DelMar Pharmaceuticals. "Furthermore, we launched an initiative with Oppenheimer & Co. Inc. to explore and evaluate strategic opportunities to facilitate shareholder value generation."

RECENT HIGHLIGHTS

Continued enrolling patients in Phase 2, open-label, second-line, Avastin-naïve, MGMT-unmethylated, recurrent glioblastoma multiforme ("GBM") study being conducted at the MD Anderson Cancer Center (the "MDACC study").
As of October 31, 2018, forty-four patients have been enrolled in the MDACC study, which continues the accelerated enrollment rates observed since spring, 2018
The dosing levels used in the MDACC study have continued to demonstrate a safety profile well within the existing safety monitoring guidelines described in the present study protocol
Similar to prior clinical experience, myelosuppression has been the most common adverse event observed

Continued enrolling patients in Phase 2, open-label, first-line temozolomide-naïve, MGMT-unmethylated GBM study at Sun Yat-sen University Cancer Center.
As of October 31, 2018, ten patients have been enrolled in this study
Observed increased enrollment rates in the recent quarter

At the annual meeting of the Society for Neuro-Oncology being held from November 15 to 18, 2018, the Company will provide clinical trial updates on both of its Phase 2 studies in MGMT-unmethylated GBM patients. In addition, updated preclinical data on VAL-083 in combination with Avastin, and VAL-083 as a potential treatment of pediatric diffuse intrinsic pontine glioma ("DIPG") will be presented.
Based on overall clinical and corporate development progress achieved to date, we expect to have cash available to fund planned operations into the middle of calendar 2019
For further details on the Company’s operating and financial results, as well as more detail about its updated strategy, refer to DelMar’s Form 10-K filed with the SEC on September 24, 2018, as well as the Company’s Quarterly Report on Form 10-Q for the three month ended September 30, 2018 filed with the SEC on November 13, 2018: View Source

CONFERENCE CALL DETAILS

DelMar will host a conference call to discuss its financial results for quarter ended September 30, 2018 and provide a corporate update on November 20, 2018, at 4:30 p.m. Eastern Time. For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the telephone Dial-in Number is 1-877‑876‑9174 (toll free) with Conference ID DELMAR.

A replay of the conference call will be available on the IR Calendar of the Investors section of the Company’s website at www.delmarpharma.com and will be archived for 30 days.

SUMMARY OF FINANCIAL RESULTS FOR THE QUARTER ENDED SEPTEMBER 30, 2018

At September 30, 2018, the Company had combined cash and cash equivalents and clinical trial deposits on hand of approximately $4.6 million.

For the quarter ended September 30, 2018, the Company reported a net loss of $1,991,804 or $0.09 per share, compared to a net loss of $2,666,406, or $0.18 per share, for the quarter ended September 30, 2017.

The following represents selected financial information as of September 30, 2018. The Company’s financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar’s consolidated financial statements and management’s discussion and analysis, as filed.

On November 14, 2018 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immunotherapies derived from its Immulytic platform, reported financial results for its second fiscal quarter ended September 30, 2018, and provided an update on its business (Press release, Replimune, NOV 14, 2018, View Source [SID1234531348]).

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"All of our programs are progressing to track within the timelines outlined to investors during our July 2018 initial public offering" said Robert Coffin, Ph.D., co-founder and CEO of Replimune. "We were pleased to receive FDA acceptance of our IND for RP1 this past quarter which allows us to expand enrollment of our Phase 1/2 trial beyond the U.K. and into the U.S. by year-end 2018. In addition, we continue to make progress developing both RP2 and RP3 which will expand the potential utility of our platform beyond the current indications and into most solid tumors."

Recent Business Highlights and Upcoming Events
Investigational New Drug (IND) application for RP1 accepted by the U.S. Food and Drug Administration (FDA). RP1 is Replimune’s first Immulytic product candidate to enter the clinic and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency intended to result in highly immunogenic cell death and activation of a systemic anti-tumor immune response. The accepted IND allows Replimune to start enrolling patients in the Company’s ongoing Phase 1/2 clinical trial in the U.S., which is expected to occur by year-end 2018.
Continued progress with the Phase 1/2 study of RP1 in multiple solid tumors. Replimune’s Phase 1/2 clinical trial with RP1 is currently ongoing in the U.K. In the first part of the clinical trial Replimune is initially testing RP1 alone and then in combination with nivolumab for safety and biological activity in patients with advanced, heavily pre-treated solid tumors. The combination phase of the first part of the clinical trial is expected to be underway in the U.S. and the U.K. by the year end. The second part of the Phase 1/2 clinical trial is on track to begin in the first half of 2019, and will study the safety and efficacy of RP1 in combination with nivolumab in approximately 120 patients with metastatic melanoma, metastatic bladder cancer, microsatellite instability high cancer, and non-melanoma skin cancers under Replimune’s collaboration agreement with Bristol-Myers Squibb.
Phase 2 clinical trial of RP1 in combination with cemiplimab remains on track to initiate in the first half of 2019. This Phase 2 trial is intended to be a randomized, controlled clinical trial of RP1 in combination with the anti-PD-1 antibody cemiplimab compared to cemiplimab alone, in approximately 240 patients with cutaneous squamous cell carcinoma (CSCC). CSCC is the highest mortality skin cancer after melanoma and accounts for 4,000 to 9,000 annual deaths in the U.S. The primary objective of the Phase 2

clinical trial is intended to assess the response rate of the combination therapy compared to treatment with anti-PD-1 therapy alone, with key secondary endpoints expected to include the rate of complete response and the duration of response. This clinical trial is the first to be conducted under our collaboration with Regeneron, and has been designed as a potentially registration-directed clinical trial.

Build out of Replimune’s own manufacturing facility to support late-stage development and commercialization is on track and expected to be operational first half of 2020. In July 2018, Replimune signed a lease for a 63,000-square-foot facility in Framingham, MA where the Company intends to establish world-class multi-product manufacturing capabilities for its Immulytic product candidates. The facility is currently being built out and expected to be operational in the first half of 2020.

IND filing for RP2 remains on track for the first half of 2019. The Company expects to file an IND during the first half of 2019 with the FDA in the U.S., and/or a Clinical Trial Authorisation (CTA) with the Medicine and Healthcare Products Regulatory Agency (MHRA) in the U.K., in order to initiate a Phase 1 trial of RP2 and RP2 in combination with anti-PD1 therapy in mixed solid tumors. RP2 is a version of RP1 that, in addition to expressing a fusogenic protein and GM-CSF, also expresses a genetically encoded anti-CTLA-4 antibody intended to block the inhibition of the immune response otherwise caused by CTLA-4.

·RP3 product candidate to be finalized by year-end 2018. RP3 is the Company’s third oncolytic immunotherapy and includes the properties of both RP1 and RP2 while also expressing ligands for the various immune co-stimulatory pathways responsible for T-cell proliferation and/or activation. The precise payload of immune-activating ligands for RP3 is expected to be finalized by the end of 2018, and initiation of the Phase 1 clinical trial with RP3 remains on track for the first half of 2020.

Financial Highlights

Replimune reported a net loss of $6.5 million for the quarter ended September 30, 2018 compared with $4.7 million for same period in the prior year. The increase in net loss for the year was due to increased research and development expenses as well as expenses related to Replimune’s initial public offering (IPO).

Research and development expenses for the quarter ended September 30, 2018 were $5.0 million compared with $3.1 million for same period in the prior year. The increase in research and development expenses was primarily driven by additional costs related to Replimune’s preclinical and clinical development activities for its pipeline, as well as increased salary and related benefits costs due to the increase in employee headcount from 28 on September 30, 2017 to 43 on September 30, 2018.

General and administrative expenses were $2.1 million for the quarter ended September 30, 2018 compared with $1.1 million for same period in the prior year. The increase in general and administrative expenses was primarily due to an increase in legal and accounting fees related to the Company’s IPO, the increase in employee headcount and the impact of stock-based compensation in 2018.

Replimune ended the quarter with $147.9 million in cash, cash equivalents and short-term investments, compared with $61.6 million as of March 31, 2018. The increase reflects net proceeds received of $103.3 million in connection with its IPO.

Based on its current operating plan, Replimune expects that its current cash, cash equivalents and short-term investments will enable it to fund its operating expenses and capital expenditure requirements into the second half of 2021.