On August 10, 2020 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported operating results for the second quarter ended June 30, 2020 (Press release, Sesen Bio, AUG 10, 2020, View Source [SID1234563277]). The Company also provided an update on recent business development activities and the progress of manufacturing activities related to the PPQ campaign. The Company’s lead program, Vicineum, also known as VB4-845, is currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC"). In December 2019, the Company initiated the BLA submission for Vicineum to the FDA under Rolling Review.

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"We are extremely pleased with the progress at Sesen Bio over the past quarter," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We signed our first licensing agreement for Vicineum outside the US with Qilu Pharmaceutical, which is a strong sign of confidence in our mission to bring this innovative therapy to more patients in need. We expect to sign additional partnerships over the next six months. Equally important, we have now completed the manufacturing of the PPQ campaign drug substance batches at Fujifilm, an important milestone in our path to completion of the BLA submission. We are currently in an exciting phase at Sesen Bio and we remain as driven as ever to bring Vicineum to market to save and improve the lives of patients with cancer."

US and European Regulatory Update

US:

On June 17, 2020, Sesen received conditional acceptance of the proprietary brand name Vicineum for the Company’s product candidate, oportuzumab monatox. The Company believes Vicineum is a name with strong marketing potential that is also consistent with the FDA’s goal of preventing medication errors and potential harm to the public by ensuring that only appropriate proprietary names are approved for use. Final approval of the Vicineum brand name is conditional on FDA approval of the Company’s product candidate. The conditional acceptance of Vicineum is an important milestone in commercial readiness in the US. The Company remains on track to complete the BLA submission in the fourth quarter of 2020 and anticipates potential approval in mid-2021.
Europe:

Sesen Bio concluded a five-month scientific opinion process in Europe and received positive Scientific Advice for both clinical and CMC. Importantly, the Committee for Medical Products for Human Use ("CHMP") agreed that the nonclinical and clinical pharmacology studies, and safety database are all sufficient to support a Marketing Authorization Application ("MAA") submission for Vicineum and no additional clinical trials were requested. Additionally, the CHMP agreed that the CMC comparability plan provides a strong analytical package, and no additional clinical trials to establish comparability are deemed necessary at this time. Based on the guidance received, the Company expects to submit the MAA for Vicineum to the EMA in early 2021 with potential approval anticipated in early 2022.
On July 3, 2020, the Company received a product-specific pediatric waiver from the EMA for Vicineum. As part of the regulatory process for the registration of new medicines with the EMA, pharmaceutical companies are required to provide a Pediatric Investigation Plan ("PIP") that outlines the clinical development strategy for studying the investigational product in the pediatric population. In some instances, a waiver from required pediatric studies for certain conditions may be granted by the EMA when development of a medicine for use in children is not feasible or appropriate. The PIP waiver from the EMA applies to Vicineum across all subsets of the pediatric population for the treatment of urothelial carcinoma. The receipt of the waiver will allow the Company to submit a MAA for Vicineum to the EMA without the requirement to conduct clinical studies in a pediatric population either pre-approval or post-approval.
Business Development Update

On July 30, 2020, Sesen Bio and Qilu Pharmaceutical signed a license agreement for the commercialization of Vicineum in Greater China. Under the terms of the agreement, Sesen granted Qilu Pharmaceutical a license to manufacture, develop and commercialize Vicineum for the treatment of NMIBC and other types of cancer in China, Hong Kong, Macau and Taiwan ("Greater China"). Key terms of the deal include:

Financial terms include significant sources of non-dilutive capital
Upfront payment of $12M in cash
Eligibility to receive up to $23M in regulatory and tech transfer milestones in addition to sales royalties for at least 12 years
Qilu will be the Marketing Authorization Holder and will have the exclusive rights to develop, manufacture and commercialize Vicineum in Greater China
Qilu will be responsible for all expenses related to these activities
Sesen retains full development and commercialization rights in the US and the rest of world excluding Greater China
Terms of the agreement include tech transfer, creating an opportunity for future CMO partnership to meet significant global demand forecasts
Manufacturing Update

Sesen Bio completed the manufacturing of the PPQ campaign drug substance batches at Fuji on schedule. Release testing is underway, and upon completion, the drug substance will be shipped to Baxter to finish the PPQ campaign for drug product, which is anticipated to be completed in September 2020. Comparability data from the PPQ campaign for drug substance and drug product are the last material deliverables before submitting the BLA in the fourth quarter of 2020.

Second Quarter 2020 Financial Results

Cash Position: Cash and cash equivalents were $37.7 million as of June 30, 2020, compared to $48.1 million as of December 31, 2019.
R&D Expenses: Research and development expenses for the second quarter of 2020 were $4.6 million compared to $7.9 million for the same period in 2019. The second quarter decrease was due primarily to timing of costs related to the ongoing technology transfer process and commercial manufacturing, in addition to lower employee compensation and lower clinical expenses related to the Phase 3 VISTA trial for Vicineum.
G&A Expenses: General and administrative expenses for the second quarter of 2020 were $3.3 million compared to $2.6 million for the same period in 2019. The second quarter increase was due primarily to increases in employee compensation, and legal and insurance costs, offset by slightly lower audit and professional fees.
Net Income (Loss): Net loss was $26.3 million, or $0.24 per basic and diluted share, for the three months ended June 30, 2020, compared to a net loss of $54.3 million, or $0.67 per basic and diluted share, for the same period in 2019. The change was primarily the result of the non-cash change in fair value of contingent consideration due to significantly higher discount rates associated with market conditions related to the COVID-19 pandemic.
About VicineumTM

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicineum for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

About the VISTA Clinical Trial

The VISTA trial is an open-label, multicenter, single-arm Phase 3 clinical trial evaluating the efficacy and tolerability of Vicineum as a monotherapy in patients with high-risk, bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC). The primary endpoints of the trial are the complete response rate and the duration of response in patients with carcinoma in situ with or without papillary disease. Patients in the trial received locally administered Vicineum twice a week for six weeks, followed by once-weekly treatment for another six weeks, then treatment every other week for up to two years. To learn more about the Phase 3 VISTA trial, please visit www.clinicaltrials.gov and search the identifier NCT02449239.

On August 10, 2020 Morphic Therapeutic (NASDAQ: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, reported corporate highlights and second quarter 2020 financial results (Press release, Morphic Therapeutic, AUG 10, 2020, View Source [SID1234563276]).

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"Morphic has made tremendous strides with our lead program, MORF-057, an oral small molecule inhibitor of α4β7 in development to treat inflammatory bowel disease. I’m so proud of the efforts of our team that has taken this program from the bench in Dr. Tim Springer’s Lab to the clinic in just a few short years," commented Praveen Tipirneni, M.D., president and chief executive officer of Morphic Therapeutic. "We recently presented a substantive preclinical data set at Digestive Disease Week that support MORF-057’s profile as a candidate for the treatment of IBD through the proven mechanism of α4β7 inhibition with many potential advantages, including oral administration. While we are just beginning our clinical journey, I congratulate the Morphic team for the achievement of these important milestones on our mission to deliver a new generation of oral integrin therapeutics."

Peter Linde, M.D., Morphic’s chief medical officer, added "We expect to initiate a robust clinical development program for MORF-057 imminently, beginning with a phase 1 clinical trial designed to evaluate the safety, pharmacokinetic and pharmacodynamic profile of this compound with single and multiple ascending dose cohorts. The phase 1 trial will also generate important receptor occupancy data that we believe could provide early clinical proof of concept and dose selection guidance for use in future studies within the MORF-057 program in IBD patients."

Morphic is developing MORF-057 as a selective, oral small molecule inhibitor of the α4β7 integrin, a target for the treatment of inflammatory bowel disease (IBD) with an initial focus on moderate-to-severe ulcerative colitis (UC). The mechanism of α4β7 inhibition to treat IBD has been clinically validated by the success of the approved infused antibody therapy, vedolizumab.

Second quarter and recent corporate highlights:

●Announced acceptance of the Investigational New Drug (IND) filing for MORF-057 by the U.S. Food and Drug Administration (FDA), with a phase 1 clinical trial in healthy subjects expected to begin in the third quarter of 2020
oThe phase 1 trial is a randomized, double-blind placebo-controlled single and multiple ascending dose study in healthy adults evaluating endpoints including safety, tolerability, and pharmacokinetic and pharmacodynamic measures, as well as a concurrent food effect study
oThe full data set from the MORF-057 phase 1 trial is expected to be presented by mid-2021
●Presented new positive preclinical data supporting MORF-057 in models of increasing complexity at the virtual Digestive Disease Week 2020
oThese data demonstrated MORF-057’s inhibition of α4β7 -expressing lymphocyte migration to the gut, a fundamental contributor to IBD, acting through the same mechanism of action as the approved antibody therapeutic, vedolizumab
oFurther, oral administration of a MORF-057 analog in non-human primate studies demonstrated saturation of the α4β7 receptor throughout the entire 7-day dosing period – receptor saturation at the dosages assessed in preclinical studies provide further evidence that MORF-057 is an extremely potent inhibitor of α4β7 and may produce clinical efficacy
●Continued progress in our collaboration with AbbVie on the development of integrin inhibitors, including αvβ6 and other integrin targets
●Appointed Marc Schegerin, M.D., M.B.A., as chief operating officer and chief financial officer; Dr. Schegerin was previously chief financial officer of ArQule until its acquisition by Merck. His prior roles include senior positions in finance, business development and healthcare investment banking

COVID-19 Preparedness
Morphic is not currently aware of any significant delay to its timelines due to the COVID-19 pandemic. In light of the evolving circumstances, Morphic will continue to assess any potential impact of the COVID-19 pandemic in dialogue with regulators, partners and vendors.

Financial Results for Second Quarter 2020

Net loss for the quarter ended June 30, 2020 was $15.9 million or $0.52 per share compared to a net loss of $9.4 million or $4.73 per share for the same quarter last year.

●Revenue was $7.7 million for the quarter ended June 30, 2020 compared to $5.6 million for the same quarter last year. The increase was due to higher level of research & development efforts in collaboration agreements signed with AbbVie in October 2018 and Janssen in February 2019
●Research and development expenses were $19.9 million for the quarter ended June 30, 2020, compared to $13.9 million in the same quarter last year. The $6.0 million increase year-over-year reflects development and manufacturing costs associated with lead wholly owned product candidate, MORF-057; research costs associated with preclinical studies related to our partnered product candidate MORF-720 with AbbVie; as well as increased personnel-related costs to support continued progress with the company’s pipeline
●General and administrative expenses were $4.2 million for the quarter ended June 30, 2020, compared to $2.1 million in the same quarter last year. The $2.1 million increase year-over-year was primarily attributable to increased headcount and higher professional fees to operate as a public company along with consulting fees associated with ongoing business development activities

As of June 30, 2020, Morphic had cash, cash equivalents, and marketable securities of $202.5 million, compared to $237.0 million at the end of 2019. Morphic believes its cash, cash equivalents, and marketable securities balance as of June 30, 2020 will be sufficient to fund operating expenses and capital expenditure requirements at least through the end of 2022.

On August 10, 2020 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, reported financial results for the second quarter ended June 30, 2020 and provided an overview of the Company’s recent developments (Press release, UroGen Pharma, AUG 10, 2020, View Source [SID1234563275]).

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"The second quarter of 2020 has proved to be the most transformational time for UroGen, marked by the U.S. Food and Drug Administration approval of Jelmyto for patients with low-grade upper tract urothelial cancer and our successful transition to a commercial-stage company. Despite global challenges and uncertainty as a result of the ongoing COVID-19 pandemic, the innovative solutions developed by our team have led to strong launch execution; a testament to our commitment to advancing this important medicine for patients in need of better options," said Liz Barrett, President and Chief Executive Officer of UroGen. "In addition to continuing our commercialization efforts of Jelmyto, we are on track to start our planned Phase 3 pivotal study of UGN-102 in patients with low-grade intermediate risk non-muscle invasive bladder cancer by the end of this year."

Recent Highlights and Upcoming Milestones

Jelmyto (mitomycin) for pyelocalyceal solution, formerly known as UGN-101, for adult patients with low-grade upper tract urothelial cancer (LG-UTUC)

On April 15, 2020, the U.S. FDA granted approval of Jelmyto for the treatment of adult patients with LG-UTUC. Jelmyto is the first and only FDA approved non-surgical treatment option for patients with LG-UTUC.

UroGen successfully commenced the commercial launch of Jelmyto on June 1, 2020.

The commercial team continues to utilize innovative solutions, such as its virtual platform, to effectively engage health care professionals and patients in this unprecedented environment.

To date, approximately 100 sites have been activated, which means they have completed their internal processes and have treated or are ready to treat patients.

Multiple treatments have been successfully reimbursed – both in the hospital and community setting – and the Company has submitted both our C-Code and J-Code applications and continues to expect receipt of a C-Code by October 2020 and a J-Code in January 2021.

UGN-102 (mitomycin) for intravesical solution for patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC)

UroGen announced the presentation of positive interim data from the investigational agent UGN-102 Phase 2b OPTIMA II trial in patients with LG-IR-NMIBC, which was accepted for the 2020 AUA Annual Meeting, published as a supplement to the April 2020 issue of The Journal of Urology, and presented as part of the AUA Virtual Experience.

The trial results demonstrated that 65% (41/63) of patients treated with UGN-102 achieved a complete response (CR) three months after the start of therapy.

In this subset of patients, 97% (35/36) of patients (95% Confidence Interval), 86% (24/28) of patients and 85% (11/13) of patients who were present for evaluation at each timepoint, remained disease free at six, nine and 12 months following treatment initiation, respectively. Follow-up will continue until all patients have reached the 12-month time point.

The most common adverse events (≥ 10%) were reported as mild to moderate and include dysuria, hematuria, urinary frequency, fatigue, urgency and urinary tract infection.

The Company remains on track to initiate a pivotal UGN-102 Phase 3 trial by year end.

UGN-102 has the potential to provide a non-surgical treatment alternative for approximately 80,000 patients diagnosed with LG-IR-NMIBC in the United States. There are no drugs currently approved by the FDA as first-line treatment for LG-IR-NMIBC.

UGN-302 (combination of UGN-201 and zalifrelimab) for patients with high-grade non muscle invasive bladder cancer (HG NMIBC)

UGN-302 is the combination of UGN-201, a TLR7/8 agonist, and zalifrelimab, an anti-CTLA-4 antibody, and is initially targeting HG NMIBC.

Delivering the investigational combination intravesically has the potential to sidestep certain systemic side effects and adverse events associated with systemic CTLA-4 antibody administration.

In murine models, UGN-201, given sequentially with local anti-CTLA-4, increased survival.

Second Quarter 2020 Financial Results; 2020 Guidance

UroGen recorded net product sales of Jelmyto for the second quarter ended June 30, 2020 of approximately $371,500.

As of June 30, 2020, cash, cash equivalents and marketable securities totaled $151.6 million, excluding restricted cash.

Research and development expenses for the second quarter ended June 30, 2020 were $8.1 million, including non-cash share-based compensation expense of $1.6 million. This compares to $10.0 million, including non-cash share-based compensation expense of $2.0 million, for the same period in 2019. Research and development expenses for the six months ended June 30, 2020 were $24.7 million, including non-cash share-based compensation expense of $3.5 million. This compares to $19.7 million, including non-cash share-based compensation expense of $4.3 million, for the same period in 2019.

Selling, general and administrative expenses for the second quarter ended June 30, 2020 were $24.0 million, including non-cash share-based compensation expense of $5.5 million. This compares to $13.8 million, including non-cash share-based compensation expense of $5.2 million, for the same period in 2019. Selling, general and administrative expenses for the six months ended June 30, 2020 were $46.0 million, including non-cash share-based compensation expense of $11.2 million. This compares to $26.5 million, including non-cash share-based compensation expense of $10.3 million, for the same period in 2019.

UroGen reported a net loss of $31.3 million, or basic and diluted net loss per ordinary share of $1.44, for the second quarter ended June 30, 2020. This compares to $22.5 million, or basic and diluted net loss per ordinary share of $1.08, for the same period in 2019. UroGen reported a net loss of $69.1 million, or basic and diluted net loss per ordinary share of $3.22,for the six months ended June 30, 2020. This compares to $43.9 million, or basic and diluted net loss per ordinary share of $2.19, for the same period in 2019.

UroGen adjusted expense guidance down for 2020, driven by change in estimated non-cash share-based compensation expense for 2020. UroGen now expects 2020 total operating expenses in the range of $143 to $153 million, including non-cash share-based compensation expense of $30 to $34 million, subject to market conditions. No other changes have occurred regarding our previously provided guidance for 2020.

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 (855) 765-5685 (U.S.) or (615) 247-5916 (International) to listen to the live conference call. The conference ID number for the live call will be 9168696. An archive of the webcast will be available for two weeks on the Company’s website.About Jelmyto

Jelmyto (mitomycin) for pyelocalyceal solution, is a drug formulation of mitomycin indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC). Utilizing the RTGel technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, Jelmyto is designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. Jelmyto is delivered to patients using standard ureteral catheters or nephrostomy tube. The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC. On April 15, 2020, the FDA approved Jelmyto, making it the first drug approved for the treatment of LG-UTUC in adult patients.

About Upper Tract Urothelial Cancer (UTUC)

Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as upper tract urothelial cancers (UTUC). In the U.S., there are approximately 6,000 – 7,000 new or recurrent low-grade UTUC patients annually. Most cases are diagnosed in patients over 70 years old, and these older patients often face comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). These treatments can lead to a high rate of recurrence and relapse.

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 2b development for the treatment of low-grade intermediate risk non-muscle invasive bladder cancer. Utilizing the RTGel Technology Platform, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter. The Company completed enrollment in the Phase 2b OPTIMA II trial in September 2019 and intends to advance the program to a pivotal study to further investigate UGN-102 in the treatment of this condition.

About the Phase 2b OPTIMA II Trial

OPTIMA II (OPTimized Instillation of Mitomycin for Bladder Cancer Treatment) is an open-label, single-arm, multi-center Phase 2b clinical trial of investigational agent UGN-102 (mitomycin) for intravesical solution to evaluate its safety and efficacy in patients with low-grade non-muscle invasive bladder (LG NMIBC) cancer at intermediate risk of recurrence. Intermediate risk is defined as one or two of the following: multiple tumors, solitary tumor >3 cm, or recurrence (≥ 1 occurrence of LG NMIBC within one year of the current diagnosis).

On August 10, 2020 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the second quarter ended June 30, 2020, and provided business updates (Press release, Galera Therapeutics, AUG 10, 2020, View Source [SID1234563274]).

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"During the second quarter, we continued to advance the development of our small molecule superoxide dismutase mimetics in clinical trials evaluating their ability to address radiation toxicities and augment the anti-cancer efficacy of radiation," said Mel Sorensen, M.D., President and CEO of Galera. "We were pleased to announce the completion of enrollment in our randomized, blinded, placebo-controlled, adaptive Phase 1b/2a trial of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy (SBRT) for patients with locally advanced pancreatic cancer (LAPC). We expect to report topline data from that trial as well as initiate a Phase 1b/2a trial of GC4711 with SBRT in non-small cell lung cancer in the second half of this year. We also remain on track to complete enrollment of the Phase 3 ROMAN trial of avasopasem in the first half of next year and to report topline data from the ROMAN trial in the second half of 2021."

Second Quarter 2020 and Recent Corporate Highlights

In July, announced the completion of patient enrollment in the randomized, blinded, placebo-controlled, adaptive Phase 1b/2a clinical trial of avasopasem in combination with SBRT in patients with LAPC. Topline data from this trial are expected in the second half of this year.

In June, dosed the first patient in a Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with head and neck cancer (HNC) undergoing standard-of-care radiotherapy.

Continued enrollment in the Phase 2a clinical trial of avasopasem to evaluate its ability to reduce the incidence of radiation-induced esophagitis in patients with lung cancer.

In May, presented new data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program, which demonstrated statistically significant reductions by avasopasem on markers of chronic kidney disease due to concurrent cisplatin chemoradiation in a retrospective

analysis of the completed Phase 2b trial for the reduction of severe oral mucositis in patients with HNC. As a result, the assessment of these markers has been incorporated into the ROMAN Phase 3 trial.

In May, entered into an amendment to the royalty purchase agreement with Blackstone Life Sciences (Blackstone), which adds $37.5 million in additional funding to the existing $80 million royalty financing commitment that Blackstone (formerly Clarus Ventures) made in 2018. Under the updated agreement terms, Galera agreed to pay Blackstone up to a high single-digit percentage of future commercial royalties from the sales of avasopasem and GC4711 until the total royalty amount achieves an unchanged fixed single-digit multiple of the aggregate financing sum received, upon which the royalty terminates. As partial consideration for the amendment, Galera issued two warrants to Blackstone to purchase an aggregate of 550,661 shares of its common stock at an exercise price of $13.62 per share, each of which will become exercisable upon the receipt by Galera of the applicable specified milestone payment.

In April, announced the appointment of Linda B. West to its Board of Directors. Ms. West most recently served as Vice President for DuPont Corporate Planning & Analyses, where she led the execution of transformational transactions.

Second Quarter 2020 Financial Highlights

Research and development expenses were $13.8 million in the second quarter of 2020, compared to $9.5 million for the same period in 2019. The increase was primarily attributable to avasopasem development costs due to increased expenses in the Phase 3 ROMAN trial, additional clinical trials including the Phase 2a trial for the treatment of esophagitis in patients with lung cancer and the Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with HNC, and costs associated with manufacturing scale-up activities. Employee-related costs also increased due to increased headcount and share-based compensation expense.

General and administrative expenses were $3.9 million in the second quarter of 2020, compared to $1.8 million for the same period in 2019. The increase was primarily the result of employee-related costs from increased headcount and share-based compensation expense, and increased insurance, professional fees and other operating costs as a result of becoming a public company.

Galera reported a net loss of $(18.7) million, or $(0.75) per share, for the second quarter of 2020, compared to a net loss of $(11.6) million, or $(45.30) per share, for the same period in 2019.

As of June 30, 2020, Galera had cash, cash equivalents and short-term investments of $104.4 million. Galera expects that its existing cash, cash equivalents and short-term investments, together with the expected payments from Blackstone in the amount of $57.5 million upon the achievement of certain clinical enrollment milestones in the ROMAN trial and the anti-cancer program in combination with SBRT under the amended royalty agreement, will enable Galera to fund its operating expenses and capital expenditure requirements into the second half of 2022.

On August 10, 2020 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three and six months ended June 30, 2020 (Press release, Eagle Pharmaceuticals, AUG 10, 2020, View Source [SID1234563273]).

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Business and Recent Highlights:

·Centers for Medicare & Medicaid Services ("CMS") established unique Healthcare Common Procedure Coding System ("HCPCS") code, or J-code, for PEMFEXY (Pemetrexed for Injection, 10 mg), a branded alternative to ALIMTA effective October 1, 2020;

·Granted a supplement approval by U.S. Food and Drug Administration ("FDA") for 500mg multiple-dose vial of PEMFEXY. The Company has initial market entry (equivalent to approximately a three-week supply of current ALIMTA utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022;

·The Company’s strategic collaboration partner, Tyme Technologies, Inc. ("Tyme"), announced that FDA granted Orphan Drug Designation for its lead product candidate, SM-88, a treatment for patients with pancreatic cancer;

·On August 7, 2020, the Company received a Complete Response Letter for its New Drug Application ("NDA") for RYANODEX for the treatment of exertional heat stroke ("EHS"); Eagle has decided that it will no longer pursue this indication;

·Received encouraging recent additional data for the Company’s fulvestrant product candidate, EA-114, for HR-positive advanced breast cancer; next steps are to meet with FDA to finalize clinical trial plans; product could potentially represent cornerstone of Eagle’s oncology franchise treating HR positive breast cancer patients;

·Favorable patent litigation decision issued by the U.S. District Court for the District of Delaware for Eagle and Teva Pharmaceutical Industries Ltd. for BENDEKA upholding the asserted patent claims as valid and infringed by the defendants’ proposed Abbreviated New Drug Application ("ANDA") products. Under this decision, defendants are enjoined from launching their ANDA products before 2031;

Page 2: Eagle Pharmaceuticals Reports Second Quarter 2020 Results

·SymBio, the Company’s Japanese licensing partner, announced that it expects regulatory approval of its TREAKISYM Ready-to-Dilute ("RTD") formulation late this year. Eagle is entitled to receive a $5 million milestone payment upon approval of either TREAKISYM Ready-to-Dilute or TREAKISYM Rapid Infusion, as well as royalties and milestones that could total $10 to $25 million per year if SymBio first launches TREAKISYM RTD and then its Rapid Infusion product; and

·Despite the ongoing COVID-19 pandemic, the Company has not experienced significant disruptions to its supply chain to date, and believes it has sufficient supply chain inventory to continue manufacturing and to provide product without interruption consistent with its current business plan; the Company has experienced limited impacts on the timing of its pre-clinical programs due to the COVID-19 pandemic; the Company continues to monitor the ongoing pandemic and evaluate and evolve its business plans and response strategy thereto.

Second Quarter 2020 Financial Highlights

·Total revenue for Q2 2020 was $41.9 million, compared to $56.7 million in Q2 2019, primarily reflecting lower product sales of BELRAPZO and BENDEKA, partially offset by higher product sales of RYANODEX.

·Net loss for Q2 2020 was $0.3 million, or ($0.02) per basic and diluted share, compared to net income for Q2 2019 of $6.7 million, or $0.49 per basic and $0.48 per diluted share.

·Adjusted non-GAAP net income for Q2 2020 was $8.0 million, or $0.59 per basic and $0.57 per diluted share, compared to adjusted non-GAAP net income for Q2 2019 of $11.8 million, or $0.86 per basic and $0.84 per diluted share.

·Cash and cash equivalents were $108.2 million, net accounts receivable was $46.8 million, and debt was $37.0 million as of June 30, 2020.

"We had an excellent start to the first half of the year, advancing our exciting pipeline of oncology and critical care products. Our ANDA and orphan drug exclusivity legal wins for BENDEKA, CMS’ decision to establish a separate J-Code and supplement approval for the 500mg dose for PEMFEXY, along with continued progress on our fulvestrant product candidate and the opportunity for vasopressin, supports the diversification and acceleration of Eagle’s earnings power," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Gross margin was 69% during the second quarter of 2020, as compared to 62% in the second quarter of 2019. The expansion in gross margin in the second quarter of 2020 was driven by an increase in RYANODEX product sales, lower BENDEKA product sales in the period to the Company’s marketing partner, on which Eagle earns no profit, and the increase in BENDEKA royalty revenue.

R&D expense was $7.1 million for the second quarter of 2020, compared to $9.0 million in the second quarter of 2019. The change primarily resulted from a decrease in spending for vasopressin, partly offset by an increase in spending for the Company’s fulvestrant product candidate. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the second quarter of 2020 was $6.0 million.

SG&A expense in the second quarter of 2020 increased to $18.0 million compared to $17.2 million in the second quarter of 2019. The change primarily resulted from an increase in stock compensation expense, partially offset by decreases in T&E, trade show costs, and external legal expenses. Excluding stock-based compensation and other non-cash and non-recurring items, second quarter 2020 SG&A expense was $12.2 million.

Net loss for the second quarter of 2020 was $0.3 million, or ($0.02) per basic and diluted share, compared to net income of $6.7 million, or $0.49 per basic and $0.48 per diluted share, in the second quarter of 2019.

Adjusted non-GAAP net income for the second quarter of 2020 was $8.0 million, or $0.59 per basic and $0.57 per diluted share, compared to adjusted non-GAAP net income of $11.8 million or $0.86 per basic and $0.84 per diluted share in the second quarter of 2019. For a full reconciliation of adjusted non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

"We’re also pleased with our collaborations with Tyme, NorthShore University HealthSystem, and UPenn to advance important products. Furthermore, we have made progress on the study of RYANODEX for the treatment of brain damage secondary to Nerve Agent exposure, as we continue to pursue expanded indications. We have important work ahead in the second half of the year, regardless of EHS, and we will continue to identify opportunities that fulfill our strategic vision and bring innovative therapeutics to the patients who can benefit," concluded Tarriff.

Second Quarter 2020 Financial Results

Total revenue for Q2 2020 was $41.9 million, as compared to $56.7 million for Q2 2019.

Page 3: Eagle Pharmaceuticals Reports Second Quarter 2020 Results

Q2 2020 BELRAPZO product sales were $4.1 million, compared to $15.4 million in Q2 2019. Second quarter 2019 BELRAPZO revenue reflected wholesaler stocking occasioned by the June 2019 transition to the branded name.

Q2 2020 RYANODEX product sales were $4.7 million, compared to $2.9 million in Q2 2019.

2020 Expense Guidance

·As a result of COVID-related delays, with respect to our pre-clinical programs, we are lowering our previously reported 2020 R&D Non-GAAP expense guidance to $40 million-$44 million, as compared to $31 million in 2019.

Page 4: Eagle Pharmaceuticals Reports Second Quarter 2020 Results

·SG&A spend in 2020, on a non-GAAP basis, is expected to be $61-$64 million, as compared to $56 million in 2019.

The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.

Liquidity

As of June 30, 2020, the Company had $108.2 million in cash and cash equivalents plus $46.8 million in net accounts receivable, $35.7 million of which was due from Teva. The Company had $37.0 million in outstanding debt. Therefore, at June 30, 2020, the Company had net cash plus receivables of $118.0 million. In the second quarter of 2020, the Company repaid the full $110.0 million amount borrowed under its revolving credit facility.

In the second quarter of 2020, the Company repurchased $4.0 million of Eagle’s common stock as part of the share repurchase program. From August 2016 through June 30, 2020, the Company repurchased $176.9 million of its common stock.

Conference Call

As previously announced, Eagle management will host its second quarter 2020 conference call as follows:

Date Monday, August 10, 2020

Time 8:30 A.M. ET

Toll free (U.S.) 877-876-9173

International 785-424-1667

Webcast (live and replay) www.eagleus.com, under the "Investor + News" section

Participants should dial in 15 minutes prior to the start of the call to ensure timely access.

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-4014 (US) or 402-220-2983 (International) and entering conference call ID EGRXQ220. The webcast will be archived for 30 days at the aforementioned URL.