On May 9, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, reported financial results for the first quarter ended March 31, 2019 and provided an overview of the Company’s recent developments (Press release, UroGen Pharma, MAY 9, 2019, View Source [SID1234536075]).

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"The accomplishments and performance of UroGen during the first quarter have set the stage for a pivotal and exciting year ahead as we prepare for the potential approval and commercialization of UGN-101, our first investigational candidate. Our top priority remains completion of our rolling New Drug Application (NDA) for UGN-101 for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC) and, with our commercial preparations well underway, we are confident in our readiness to deliver on a strong launch in the first half of 2020," said Liz Barrett, President and Chief Executive Officer of UroGen. "Our company sees great possibilities for the RTGel platform within uro-oncology, especially around new therapeutic modalities. Our goal is to leverage that and continue to build a company with sustainable growth via a robust pipeline as well as assessing opportunities via external partnerships."

Recent Highlights

UGN-101 Clinical Development:

At the 114th American Urological Association (AUA) Annual Meeting in Chicago, Seth Lerner, M.D. delivered a presentation during the plenary session that highlighted the unmet need and potential for UGN-101 to change the treatment paradigm for patients with LG UTUC.

The updated analysis demonstrated that in the OLYMPUS intent-to-treat population, 71 patients had undergone primary disease evaluation (PDE) at the time of the analysis and 42 of the 71 patients (59 percent) achieved a complete response (CR). Forty-one patients entered follow-up. At the time of the analysis, 27 patients underwent a six-month evaluation, and 24 out of 27 patients (89 percent) have remained disease free at six months. The most common adverse events observed were urinary tract infection, ureteral narrowing and stricture formation. The majority of ureteral events were reported as mild to moderate and have resolved. Full Phase 3 data from the OLYMPUS trial is anticipated for 2H 2019.

The Company remains on track to complete its rolling NDA for UGN-101 in 2H 2019 and is planning for approval in 1H 2020. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC. Full data is planned for 2H 2019.

Pipeline Advancement:

UGN-102:

The Company continues to enroll patients in its Phase 2b OPTIMA II clinical trial of UGN-102 (mitomycin gel) for intravesical instillation as a first-line chemoablation agent in the treatment of patients with intermediate risk low-grade non-muscle invasive bladder cancer (LG NMIBC), a form of disease associated with a high risk of recurrence.

Initial data from the OPTIMA II trial of UGN-102 is expected in 2H 2019.

There are currently no drugs approved by the FDA as first-line treatment for LG NMIBC. UGN-102 represents a substantial opportunity in UroGen’s pipeline and has the potential to be a treatment option for up to approximately 80,000 patients for whom repetitive surgical resection via Transurethral Resection of Bladder Tumor (TURBT) remains the standard of care.

UGN-201:

UroGen is currently evaluating the optimal pathway to advance UGN-201, a TLR7/8 immunomodulatory agent for the treatment of high-grade bladder disease.

Commercial Preparations:

The Company continues to accelerate its pre-commercial activities and infrastructure build-out to support the anticipated U.S. approval and launch of UGN-101 targeted for 1H 2020. The focus is on building awareness of our RTGel technology and unmet needs in UTUC to support rapid adoption and seamless integration of UGN-101 into the urologist practice following regulatory approval.

A strong team of seven medical science liaisons (MSLs) have been strategically deployed across the U.S. to engage in scientific exchange and clinical support.

The Company launched www.UTUC.com, the first resource designed to address a void in the urology space by educating patients about UTUC and available treatment options.

Business Development:

UroGen recently entered into an agreement with Janssen Research & Development, LLC (Janssen) to conduct an early-stage feasibility evaluation in a therapeutic area of mutual interest. UroGen and Janssen will each conduct certain activities under the terms of the agreement.

First Quarter 2019 Financial Results; 2019 Guidance

As of March 31, 2019, cash and cash equivalents totaled $246.7 million. This includes net proceeds of approximately $161.4 million from a public offering of ordinary shares in January 2019.

Research and development expenses for the three months ended March 31, 2019 were $9.7 million, including non-cash share-based compensation expense of $2.3 million.

General and administrative expenses for the three months ended March 31, 2019 were $12.7 million, including non-cash share-based compensation expense of $5.1 million.

The Company reported a net loss of $21.4 million, or basic and diluted net loss per ordinary share of $1.11, for the three months ended March 31, 2019.

The 2019 financial guidance set forth during the Company’s year-end earnings call on February 28th remains the same based on current business goals and anticipated activities.

Conference Call & Webcast Information

Members of UroGen’s management team will host a live conference call and webcast today at 8:30 am Eastern Time to review the Company’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (888) 771-4371 (U.S.) or (847) 585-4405 (International) to listen to the live conference call. The conference ID number for the live call will be 48486174. An archive of the webcast will be available for two weeks on the Company’s website.

On May 9, 2019 Verastem, Inc. (Nasdaq: VSTM), operating as Verastem Oncology, (or "the Company"), focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported financial results for the three months ended March 31, 2019 (Press release, Verastem, MAY 9, 2019, View Source [SID1234536092]).

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"We are now into the second full quarter of the COPIKTRA launch and sales were up approximately 38% compared to the prior quarter," said Robert Forrester, President and Chief Executive Officer of Verastem Oncology. "We have also made substantial progress securing broader reimbursement for our product, with over 92% of targeted health plans now listing and providing reimbursement for COPIKTRA. We continue to receive positive feedback from physicians using COPIKTRA for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies or follicular lymphoma (FL) after at least two prior systemic therapies."

"The commercial team has been diligently working to enhance physician and advocacy group awareness of COPIKTRA, and to overcome certain historical misperceptions concerning the PI3K class. We believe the groundwork we have laid over the past several months will have an increasingly positive impact through 2019 and into next year. In parallel, we continue to advance duvelisib in additional lines of therapy, both as a monotherapy and in combination, as well as in additional indications like peripheral T-cell lymphoma (PTCL) for which preliminary data are expected by the end of this year," concluded Mr. Forrester.

Key First Quarter 2019 and Recent Accomplishments:

COPIKTRA (duvelisib)

Launched COPIKTRA in FL – In mid-March 2019, upon completion of the required 120-day waiting period following receipt of accelerated approval from the FDA, the Company launched its physician education and marketing campaign for COPIKTRA for the treatment of patients with FL after at least two prior systemic therapies. Accelerated approval in FL was based on overall response rate and continued approval may be contingent upon confirmatory trials, the first of which is expected to start in 2019.
Presented COPIKTRA Data at the 23rd Annual International Congress on Hematologic Malignancies (ICHM) – The Company presented four COPIKTRA abstracts at ICHM 2019, including an abstract highlighting Phase 3 DUO data in patients with relapsed or refractory CLL/SLL who have progressed following two prior lines of the therapy. This is the same indication for which COPIKTRA received approval from the FDA in September 2018. In this analysis, COPIKTRA demonstrated progression-free survival (PFS) of 16.4 months and an ORR of 78%, with a manageable safety profile. The remaining three abstracts featured data from a long-term (>2 years) efficacy and safety analysis, the Phase 3 DUO crossover extension study, and prognostic and immune-related factors associated with response to duvelisib from the Phase 2 DYNAMO study in indolent non-Hodgkin’s lymphoma (iNHL). Collectively, the data presented at ICHM 2019 continue to support the use of COPIKTRA in its approved indications of relapsed or refractory CLL/SLL after at least two prior therapies and FL after at least two prior systemic therapies. PDF copies of all of the ICHM 2019 poster presentations are available here.
Phase 2 DYNAMO Study Results Published in the Journal of Clinical Oncology – In February 2019, results of the Phase 2 DYNAMO study, which evaluated COPIKTRA in patients with indolent non-Hodgkin lymphoma (iNHL) who were refractory to both rituximab and chemotherapy or radioimmunotherapy, was published online in the peer-reviewed Journal of Clinical Oncology. The full manuscript, titled "DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients with Refractory Indolent Non-Hodgkin Lymphoma," (Flinn, et al. DOI: 10.1200/JCO.18.00915) can be accessed at www.ascopubs.org.
Continued Commercialization of COPIKTRA in the United States – Verastem Oncology launched COPIKTRA, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, in the United States following FDA approval for the treatment of adult patients with relapsed or refractory CLL/SLL after at least two prior therapies. COPIKTRA also received accelerated approval for the treatment of adult patients with relapsed or refractory FL after at least two prior systemic therapies.

COPIKTRA contains a BOXED WARNING for fatal and/or serious toxicities including infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. Verastem Oncology has implemented a Risk Evaluation and Mitigation Strategy to provide appropriate dosing and safety information to better support physicians in managing their patients on COPIKTRA.

Additionally, use of COPIKTRA is associated with other adverse reactions which may also require dose reduction, treatment delay or discontinuation of COPIKTRA.

Please see www.COPIKTRAHCP.com/prescribinginformation for full Prescribing Information including BOXED WARNING and Select Important Safety Information provided below.
Corporate and Financial

Chief Commercial Officer Joseph Lobacki to Step Down in 2019 – Joseph Lobacki, Chief Commercial Officer of Verastem Oncology will be stepping down from the Company in 2019 to pursue other professional opportunities, including Board of Director roles. Mr. Lobacki intends to continue in his role until the Company identifies and appoints a successor. During this transition, Brian Stuglik, RPh, a member of the Company’s Board of Directors and the former Chief Marketing Officer of Lilly Oncology, will provide strategic oversight and advisory support for the commercial organization.
Amended Hercules Loan Facility – In April 2019, the Company announced an amendment to its existing Loan and Security Agreement with Hercules Capital, Inc., changing key terms of the agreement, including a lower overall interest rate and an extended principal repayment timeline. The amendment also increases the borrowing limit from $50 million to $75 million in financing.
First Quarter 2019 Financial Results

Net product revenue for the 2019 Quarter was $1.7 million, which reflects the second full quarter of recorded sales for COPIKTRA. The Company did not have any product revenue for the 2018 Quarter as the FDA approved COPIKTRA on September 24, 2018.

Research and development (R&D) expense for the 2019 Quarter was $9.8 million, compared to $10.9 million for the 2018 Quarter. The decrease of $1.1 million, or 11%, was primarily related to a decrease in consulting fees as a result of activities to file a New Drug Application for COPIKTRA in the 2018 Quarter and lower R&D costs associated with the development of COPIKTRA as a result of site closures in the Company’s Phase 3 DUO and Phase 2 DYNAMO studies throughout 2018 and 2019 as patients continue to complete treatment. All of these lower costs were partially offset by an increase in costs related to the Phase 2 PRIMO study for the treatment of patients with relapsed or refractory PTCL.

Selling, general and administrative expense for the 2019 Quarter was $26.0 million, compared to $9.8 million for the 2018 Quarter. The increase of $16.2 million, or 165%, was primarily due to higher personnel and related costs, as well as promotional and consulting costs in support of the launch of COPIKTRA.

Net loss for the three months ended March 31, 2019 (2019 Quarter) was $38.1 million, or $0.52 per share (basic and diluted), as compared to $21.1 million, or $0.41 per share (basic and diluted), for the three months ended March 31, 2018 (2018 Quarter). In addition, net loss includes non-cash stock-based compensation expense of $2.2 million and $1.3 million for the 2019 and 2018 Quarters, respectively.

As of March 31, 2019, Verastem Oncology had cash, cash equivalents and short-term investments of $211.7 million.

Financial Outlook

For 2019, the Company expects net product revenue from sales of COPIKTRA to be in the range of $10-12 million, based on product revenue to date, current run rates and near-term expectations.

Conference Call and Webcast Information

The Verastem Oncology management team will host a conference call and webcast today, Thursday, May 9, 2019, at 4:30 PM (ET). The call can be accessed by dialing (877) 341-5660 (U.S. and Canada) or (315) 625-3226 (international), five minutes prior to the start of the call and providing the passcode 7199457.

The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the Company’s website at www.verastem.com. A replay of the webcast will be archived on the Company’s website for 90 days following the call.

About Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are cancers that affect lymphocytes and are essentially the same disease, with the only difference being the location where the cancer primarily occurs. When most of the cancer cells are located in the bloodstream and the bone marrow, the disease is referred to as CLL, although the lymph nodes and spleen are often involved. When the cancer cells are located mostly in the lymph nodes, the disease is called SLL. The symptoms of CLL/SLL include a tender, swollen abdomen and feeling full even after eating only a small amount. Other symptoms can include fatigue, shortness of breath, anemia, bruising easily, night sweats, weight loss, and frequent infections. However, many patients with CLL/SLL will live for years without symptoms. In 2018, there were approximately 200,000 patients in the United States affected by CLL/SLL with nearly 20,000 new diagnoses. While there are therapies currently available, real-world data reveals that a significant number of patients either relapse following treatment, become refractory to current agents, or are unable to tolerate treatment, representing a significant medical need. The potential of additional oral agents, particularly as a monotherapy that can be used in the general community physician’s armamentarium, may hold significant value in the treatment of patients with CLL/SLL.

About Follicular Lymphoma

Follicular lymphoma (FL) is typically a slow-growing or indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes, making it a B-cell lymphoma. In 2018, this lymphoma subtype accounted for 20 to 30 percent of all NHL cases, with more than 140,000 people in the United States with FL and more than 13,000 newly diagnosed patients. Common symptoms of FL include enlargement of the lymph nodes in the neck, underarms, abdomen, or groin, as well as fatigue, shortness of breath, night sweats, and weight loss. Often, patients with FL have no obvious symptoms of the disease at diagnosis. Follicular lymphoma is usually not considered to be curable, but more of a chronic disease, with patients living for many years with this form of lymphoma. The potential of additional oral agents, particularly as a monotherapy that can be used in the general community physician’s armamentarium, may hold significant value in the treatment of patients with FL.

About Peripheral T-Cell Lymphoma

Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma (NHL) that develops in mature white blood cells called "T cells" and "natural killer (NK) cells"1 which circulate with the lymphatic system.2 PTCL accounts for between 10-15% of all non-Hodgkin lymphomas (NHLs) and generally affects people aged 60 years and older.1 Although there are many different subtypes of peripheral T-cell lymphoma, they often present in a similar way, with widespread, enlarged, painless lymph nodes in the neck, armpit or groin.2 There is currently no established standard of care for patients with relapsed or refractory disease.1

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.3,4,5 COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.6 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

On May 9, 2019 Sofinnova Partners, a leading European venture capital firm specialized in the life sciences, reported that the firm led Twentyeight-Seven Therapeutics, Inc’s [28-7] Series A extension with a $15 million investment (Press release, Twentyeight-Seven Therapeutics, MAY 9, 2019, View Source [SID1234638814]). In addition to Sofinnova Partners, Osage University Partners (OUP) participated in the Series A extension bringing the total Series A financing to $82.75 million. Sofinnova Partners and OUP join the initial 28-7 investors that include MPM Capital, Novartis Venture Fund, Johnson & Johnson Innovation – JJDC, Inc., Vertex Ventures HC, Longwood Fund and Astellas Venture Management.

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"Sofinnova Partners is known for being a company-builder, with a strong focus on teams and science. With Sofinnova’s participation, we are able to work on proteins that regulate additional classes of RNA, including mRNA, as well as to leverage the programs into indications outside of oncology"

"Sofinnova Partners views 28-7 as the clear leader in capitalizing on the emerging science around RNA biology and how its dysregulation contributes to many serious diseases such as cancer," said Henrijette Richter, Ph.D., Managing Partner at Sofinnova Partners. "We were captivated by the Company with its strong team of serial entrepreneurs possessing an incredible track record of successes, an exceptional group of academic founders, and the impressive scientific data and drug discovery progress around their lead RNA-focused program. They are developing game-changing therapeutics to treat cancers with high unmet need. We are therefore thrilled to be joining 28-7 early in the Company’s progress and to be investing in their exciting pipeline." Dr. Richter will join the Company’s Board of Directors.

Since the close of the initial $65M Series A announced in September 2018, 28-7 has moved into its new facilities in Watertown, MA. Kazumi Shiosaki, Ph.D., CEO of 28-7, noted that the additional investment by Sofinnova Partners allows the Company to accelerate its current programs, build out its technology platform and expand into additional opportunities. "Sofinnova Partners is known for being a company-builder, with a strong focus on teams and science. With Sofinnova’s participation, we are able to work on proteins that regulate additional classes of RNA, including mRNA, as well as to leverage the programs into indications outside of oncology," said Dr. Shiosaki.

28-7’s technology does not directly target small-molecules to the RNA itself but rather targets RNA-modulating proteins (RMPs). The lead program focuses on regulating levels of let-7, an important micro RNA (miRNA) that suppresses the translation of major oncogenes, whose levels can be disrupted by a protein called LIN28. In certain cancers, LIN28 is re-expressed and its binding of the let-7 precursor prevents the production of mature let-7 needed to maintain oncogene suppression. The Company’s lead program is developing small molecules that prevent the binding of let-7 precursor to LIN28 and restore the beneficial levels of mature let-7.

On May 9, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, cancer vaccines and adoptive cell therapies1, provided corporate updates and reported financial results for the first quarter of 2019 (Press release, Agenus, MAY 9, 2019, View Source [SID1234536002]).

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Agenus Logo

"2019 is off to a strong start. We have made significant progress towards our efforts to bring transformative treatments to cancer patients." said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "In the first quarter of this year, we have strengthened our balance sheet, accelerated enrollment in our BLA path trials, and started a new clinical trial with our second generation CTLA4."

Achievements
Strengthened balance sheet
Closed on our collaboration with Gilead, which included $120M upfront, $30M equity investment and up to $1.7B in potential additional fees and milestone payments plus royalties
Received $7.5 million from Gilead as milestone payment for IND acceptance of AGEN1423 (now GS-1423), by the FDA
Enrollment in lead trials progressing; On track for BLA in 2020
Ongoing trials in cervical cancer are designed to support BLA via accelerated pathway
We plan to expand PD-1 development in additional indications through novel funding mechanisms
Enrollment proceeding in next-gen CTLA-4 trial
Started first-in-human trial with our next-gen CTLA4.
Enrollment advancing, and combinations and data expected this year
Advanced new discoveries, towards the clinic
First-in-class bispecific licensed to Gilead, GS-1423 IND accepted by the FDA
On track to file an IND for a CD137 agonist and an off-the shelf phosphorylated neoantigen vaccine
QS-21 Updates
Sales of Shingrix, containing our QS-21 Stimulon, continue to increase; GSK projects 2019 sales will exceed $1.3Bn and pledged $100M investment to expand production of its adjuvant system
A large-scale trial with QS-21 containing Mosquirix vaccine against malaria, began in Africa
AgenTus Cell Therapy Business:
2019 INDs are on track
Partnership and private financing discussions are underway
First Quarter 2019 Financial Results

We ended the first quarter of 2019 with a cash balance of $158 million as compared to $53 million at December 31, 2018.

For the first quarter ended March 31, 2019, we reported net income of $17 million or $0.14 per share compared to a net loss for same period in 2018 of $54 million, or $0.53 per share. In the first quarter we recognized revenue of $80 million which includes revenue from our transaction with Gilead and non-cash royalties earned.

Conference Call, Webcast and Prepared Statement Information

Date: Thursday, May 9, 2019
Time: 8:30 a.m. ET
Domestic Dial-in Number: (866) 682-6100
International Dial-in Number: (862) 298-0702
Conference ID: Agenus

Live Webcast: accessible from the Company’s website at View Source or with this link View Source

A replay will be available on the Company’s website approximately two hours after the call and will remain available for 90 days.

On May 9, 2019 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company," "We" or "Sophiris"), a biopharmaceutical company developing topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, reported financial results for the first quarter of 2019 (Press release, Sophiris Bio, MAY 9, 2019, View Source [SID1234536042]).

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"We continue to have dialog with the European Medicines Agency (EMA) regarding the design for a potential Phase 3 clinical trial, which we developed with input from our scientific advisory board for the treatment of localized prostate cancer," said Randall E. Woods, president and CEO of Sophiris. "We anticipate obtaining formal scientific advice from the EMA before the end of the second quarter and look forward to taking the next step in the clinical development of topsalysin for the focal treatment of localized prostate cancer before the end of the year. We have cash runway to continue operations into September and believe that the ideal funding option for a potential registration Phase 3 clinical trial will either be a potential development partnership or other strategic transaction."

Financial Results:

At March 31, 2019, the Company had cash, cash equivalents and securities available-for-sale of $9.0 million and working capital of $4.7 million. The Company expects that its cash and cash equivalents and securities available-for-sale will be sufficient to fund its operations through September 2019, assuming no new clinical trials are initiated and the Company continues operating as a going concern. The Company will require significant funding to advance topsalysin in clinical development. As of March 31, 2019, the outstanding principal balance of the Company’s term loan was $7.0 million. The Company began making principal payments on its term loan in April 2019.

The Company reported a net loss of $2.4 million or ($0.08) per share for the three months ended March 31, 2019, compared to net loss of $3.3 million or ($0.11) per share for the three months ended March 31, 2018.

Research and development expenses

Research and development expenses were $1.6 million for the three months ended March 31, 2019, compared to $3.3 million for the three months ended March 31, 2018. The decrease in research and development costs is primarily attributable to decreases in the costs associated with manufacturing activities for topsalysin, and to a lesser extent, a decrease in clinical costs associated with our Phase 2b clinical trial of topsalysin for localized prostate cancer. Included in the research and development costs for the three months ended March 31, 2019, were costs associated with the completion of a fill finish campaign at commercial scale which produced drug product for future clinical trials. Analysis for release of this recently filled drug product is underway.

General and administrative expenses

General and administrative expenses were $1.3 million for the three months ended March 31, 2019, compared to $1.2 million for the three months ended March 31, 2018.

Gain on revaluation of the warrant liability

Gain on revaluation of the warrant liability was $0.6 million for the three months ended March 31, 2019, compared to $1.4 million for the three months ended March 31, 2018. As the Company’s warrants may require the Company to pay the warrant holder cash under certain provisions of the warrant, the Company accounts for the warrants as a liability, and the Company is required to calculate the fair value of these warrants each reporting date. Certain inputs utilized in the Company’s Black-Scholes fair value calculation may fluctuate in future periods based upon factors which are outside of the Company’s control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change to the fair value of the Company’s warrant liability, which could also result in a material non-cash gain or loss being reported in the Company’s consolidated statement of operations and comprehensive loss.