On August 7, 2019 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, reported financial results for the quarter ended June 30, 2019, and provided an update on recent clinical developments (Press release, Scynexis, AUG 7, 2019, View Source [SID1234538449]).

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"We are pleased with the rapid enrollment observed in our Phase 3 VANISH program for vulvovaginal candidiasis (VVC), which underscores the significant unmet need in this patient population," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We look forward to sharing top-line data from the U.S. study in the first quarter of 2020, and from the global study in the second quarter of 2020. We are making great progress toward our goal of a planned New Drug Application (NDA) submission for VVC in the second half of 2020."

Dr. Taglietti continued, "We are committed to maximizing the full value of ibrexafungerp in multiple settings. As we approach important milestones for our VVC registration program, we are also excited by the promising data supporting the potential role of oral ibrexafungerp as a treatment for a broad range of life-threatening, hospital-based, fungal infections, including Candida auris and other multidrug-resistant pathogens for which few existing treatment options are available."

Ibrexafungerp (formerly SCY-078), the first representative of a novel family of antifungal compounds referred to as triterpenoids, is being developed for oral and intravenous (IV) administration and is in clinical development for the treatment of both serious outpatient fungal infections, including VVC, and hospital-based life-threatening fungal infections, including invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections. If approved, ibrexafungerp could potentially address significant unmet medical needs as the only oral non-azole antifungal therapy.

Ibrexafungerp Update

Significant progress made in Phase 3 VANISH program evaluating the safety and efficacy of oral ibrexafungerp (300mg BID for one day) versus placebo for the treatment of VVC
The VANISH Phase 3 program is comprised of two Phase 3, randomized, double-blind, placebo-controlled, multicenter studies:
The VANISH 303 study is being conducted in U.S. centers and is expected to enroll approximately 350 patients; enrollment in the study is exceeding expectations and SCYNEXIS anticipates top-line data in the first quarter of 2020. More information about this study can be found at: View Source
The global VANISH 306 study is being conducted in U.S. and European centers and is expected to enroll approximately 350 patients; enrollment is progressing as planned, and the Company anticipates top-line data in the second quarter of 2020. More information about this study can be found at: View Source
All NDA preparatory activities remain on track to support a planned NDA submission in the second half of 2020.
Phase 3 CANDLE study evaluating the safety and efficacy of oral ibrexafungerp versus placebo for the prevention of recurrent VVC is on track to start enrollment this quarter following the Special Protocol Assessment (SPA) agreement received from the U.S. Food and Drug Administration (FDA) in July 2019
The Company recently announced an agreement with the FDA under a SPA, on the design, trial population, endpoints and statistical analysis of the CANDLE study, a pivotal Phase 3 clinical trial of oral ibrexafungerp for the prevention of recurrent VVC. This SPA provides agreement with the FDA that the Phase 3 protocol design adequately addresses efficacy objectives that, if met, would form the primary basis of a regulatory submission for approval of oral ibrexafungerp for the prevention of recurrent VVC, an indication with no FDA-approved therapies.
The CANDLE study is a global Phase 3, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of oral ibrexafungerp (300mg BID for one day, given once per month for a total of six treatment days) compared to placebo in female patients with recurrent VVC (defined as three or more episodes of VVC in the past 12 months, including the episode at screening). The study is being conducted at approximately 50 sites and is expected to enroll approximately 320 patients. Enrollment is expected to commence this quarter with an expected supplemental NDA submission in 2021.
More information about the CANDLE study can be found at: View Source
An open-label sub-study within CANDLE will evaluate the efficacy of oral ibrexafungerp in fluconazole-failure VVC patients
All patients in the CANDLE study will initially receive three doses of oral fluconazole to treat their acute episode of VVC present at screening before progressing to the prevention phase of the study.
Patients who fail to sufficiently respond to fluconazole treatment for their acute episode will be included in the sub-study, in which they will be offered one day of oral ibrexafungerp treatment (300mg BID) for their unresolved acute episode.
More information about the sub-study within the CANDLE study can be found at: View Source
Continued advancement of oral ibrexafungerp for hospital-based invasive fungal infections with two Phase 3 studies (FURI in refractory infections and CARES in Candida auris infections) and one Phase 2 study in invasive aspergillosis (SCYNERGIA)
Enrollment is ongoing in the Company’s refractory invasive fungal infection (rIFI) program, which comprises two open-label Phase 3 studies (FURI and CARES) designed to support a potential future NDA submission through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). Positive clinical findings from these studies have so far reinforced the potential role of oral ibrexafungerp as a novel therapy to combat severe and difficult-to-treat fungal infections, including multidrug-resistant Candida auris. More information about these studies can be found at:
View Source
View Source
Enrollment continues in the Phase 2 SCYNERGIA study, a randomized, double-blind clinical trial assessing the safety and efficacy of oral ibrexafungerp in combination with voriconazole, compared to voriconazole alone. More information about this study can be found at: View Source
Data presented at the American Society for Microbiology (ASM) Microbe 2019 Meeting demonstrates broad potential utility of ibrexafungerp for the treatment and prevention of multiple severe fungal infections
A total of nine presentations revealed data further demonstrating the potential of ibrexafungerp as a treatment for invasive fungal infections (visit scynexis.com/science to view the presentations). The data presented highlighted the potent activity of ibrexafungerp against difficult-to-treat and/or multidrug-resistant pathogens, including Candida auris, Candida glabrata, and Pneumocystis pneumonia. The activity of ibrexafungerp was tested against many Candida strains resistant to echinocandins, the current standard of care for these infections, and potent activity of ibrexafungerp was observed.
In vivo chronic toxicology studies further support the safety profile of ibrexafungerp, allowing for patients suffering from invasive fungal infections to use oral ibrexafungerp for an extended period of time and enabling its potential development as a prophylactic agent and as a treatment for chronic fungal infections.
Corporate Highlight

Management Team strengthened with appointment of Dr. Nkechi Azie as Vice President of Clinical Development.
SCYNEXIS announced the appointment of Nkechi Azie, MD, MBA, FIDSA, as Vice President of Clinical Development. Dr. Azie will lead clinical development activities and strengthen medical affairs efforts in anticipation of ibrexafungerp’s potential approval and commercial launch. She joins SCYNEXIS with over 25 years of experience in drug development and medical affairs, having worked in therapeutic areas including infectious disease, women’s health and immunology.
Second Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments totaled $35.2 million as of June 30, 2019, with net working capital of $28.9 million. Based upon its existing operating plan, SCYNEXIS believes its existing cash, cash equivalents, short-term investments, and the sale of a portion of its New Jersey net operating losses (NOLs), will be sufficient to fund operations beyond the planned NDA submission for acute VVC in the second half of 2020.

Research and development expenses increased to $8.5 million for the quarter ended June 30, 2019, compared to $5.6 million in the second quarter of 2018. The increase of $2.9 million, or 51%, was primarily driven by an increase of $3.2 million in clinical development costs, an increase of $0.4 million in chemistry, manufacturing, and controls (CMC) costs, a net increase in other research and development costs of $0.6 million, offset in part by a decrease of $1.3 million in preclinical development expense.

Selling, general and administrative expenses in the second quarter of 2019 increased to $2.8 million, compared with $2.1 million in the second quarter of 2018. The increase of $0.7 million, or 31%, was primarily driven by a $0.4 million increase in business development costs.

Total other income increased to $2.8 million in the second quarter of 2019, compared to a $3.1 million loss in the second quarter of 2018. The increase in other income is attributable to the non-cash gains recognized during the second quarter of 2019 of $2.0 million and $1.3 million associated with the fair value adjustments for warrant liabilities and derivative liability, respectively.

Net loss for the second quarter of 2019 was $8.4 million, or $0.16 per share. This compares with a net loss for the second quarter of 2018 of $10.8 million, or $0.23 per share.

About Ibrexafungerp
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species. It has demonstrated broad spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia), invasive aspergillosis (IA) and VVC (including prevention of recurrent VVC), and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

On August 7, 2019 Helix BioPharma Corp. (TSX: HBP), ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that it has received approval from the U.S. Food and Drug Administration ("FDA"), to initiate a Phase Ib/II study of L-DOS47 and doxorubicin in advanced metastatic pancreatic cancer (Press release, Helix BioPharma, AUG 7, 2019, View Source [SID1234538499]).

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This is an open label, non-randomized study designed to evaluate the safety, tolerability and preliminary activity of L-DOS47 in combination with doxorubicin in patients with metastatic pancreatic cancer who have progressed on at least two prior treatment regimens.

Phase Ib will involve a dose escalation safety run-in to determine the appropriate dose to be used in combination with doxorubicin for Phase II. Phase II will evaluate preliminary anti-tumor activity and safety of the Maximum Tolerated Dose of L-DOS47 given in combination with doxorubicin.

"We are very pleased to gain this approval from the FDA," said Dr. Herman Chao, Helix’s Chief Executive Officer. "This represents an expansion of the L-DOS47 application from treating lung cancer to potentially benefiting pancreatic patients. The team is already hard at work to begin all the necessary preparatory activities to move the trial forward. We look forward to be ready to dose patients at the earliest opportunity."

On August 7, 2019 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the second quarter ended June 30, 2019 (Press release, Celldex Therapeutics, AUG 7, 2019, View Source [SID1234538293]). The Company will host a conference call at 4:30 p.m. ET today to provide an update on its pipeline and upcoming milestones for the remainder of 2019.

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"Celldex made considerable progress in the first half of the year across multiple programs," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We presented exciting data from our CDX-3379 program in head and neck squamous cell carcinoma at ASCO (Free ASCO Whitepaper), where we observed intriguing clinical activity across a number of patients with similar gene mutation patterns. As a result, we have expanded the study to allow for a deeper evaluation of these biomarkers for patient selection. This could be important for the field as patients with refractory head and neck cancer face extremely limited treatment options and a particularly poor prognosis.

We also reported data from multiple programs at AACR (Free AACR Whitepaper), including from our ongoing dose escalation study of CDX-1140. We recently successfully completed the monotherapy dosing cohorts and are advancing nicely through the combination cohorts with our dendritic cell growth factor, CDX-301. We are currently finalizing plans to initiate a combination cohort with a checkpoint inhibitor and look forward to presenting data from the ongoing program this fall.

Finally, we made an important addition to the Celldex leadership team. In June, we announced that Dr. Diane Young has joined Celldex as Senior Vice President, Chief Medical Officer. Dr. Young brings a deep background in successful drug development to Celldex that will strengthen our clinical development efforts and support the continued progress of our product pipeline," concluded Marucci.

Recent Pipeline Highlights:

· CDX-1140—a potent CD40 agonist that Celldex believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile.

Enrollment is complete in the monotherapy arm and progressing on track in the CDX-301 combination arm of the Phase 1 dose-escalation study of CDX-1140 in patients with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas. Celldex plans to present data from the ongoing study at a medical meeting this fall.
— Eight monotherapy dosing cohorts ranging from 0.01 to 3.0 mg/kg have been completed and the dose limiting toxicity (DLT) window successfully cleared.
— Three combination cohorts in solid tumors (0.09, 0.18 and 0.36 mg/kg) with CDX-301 have been completed and the DLT window successfully cleared. Patients enrolled in the fourth cohort at 0.72 mg/kg have been dosed and are currently completing the DLT observation period. Assuming successful clearance, the 1.5 mg/kg combination cohort with CDX-301 should open shortly.
— Additional patient enrollment (backfill) has been initiated to characterize the effects of CDX-1140 in the tumor microenvironment and expansion cohorts are being actively planned. Future combination opportunities include PD-1 or PD-L1 inhibitors, chemotherapy, radiation therapy and Celldex’s potent CD27 agonist monoclonal antibody varlilumab.
Interim data from the study were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in April and support that CDX-1140 is a potent activator of CD40 and can be safely administered at doses that Celldex believes will support good tissue and tumor penetration.
· CDX-3379—a differentiated human monoclonal antibody designed to block the activity of ErbB3 (HER3). ErbB3 is expressed in many cancers, including head and neck squamous cell cancer (HNSCC) and is believed to be an important receptor regulating cancer cell growth and survival as well as resistance to targeted therapies.

Enrollment continues in the Phase 2 study of CDX-3379 in advanced HNSCC in combination with Erbitux in Erbitux-resistant patients who have been previously treated with or are ineligible for checkpoint therapy.
— Interim data from the study (n=15) were presented at the 2019 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June that suggested notable clinical activity in this refractory patient population and a promising biomarker strategy.
— Emerging data from the Phase 2 study and earlier studies of CDX-3379 suggest that antitumor activity may be associated with somatic mutations in the FAT1 and NOTCH1, NOTCH2 or NOTCH3 (NOTCH1-3) genes—genes associated with tumor suppression.
— In the exploratory analyses presented at ASCO (Free ASCO Whitepaper), seven patients were identified as having FAT1 mutated tumors and four of these patients demonstrated clinical response (3 confirmed).
– All four clinical responses occurred in patients with the primary tumor site of oral cavity.
– Three of the four clinical responses occurred in patients with NOTCH1-3 mutations.
– Also, of note, all patients (n=7 of 18) who experienced clinical benefit (objective response or stable disease greater than or equal to 12 weeks) had FAT1 and/or NOTCH1-3 mutations.
— Inactivating mutations in the FAT1 and NOTCH genes occur in sizeable subsets of HPV negative HNSCC tumors, having been identified in 32% (FAT1) and 26% (NOTCH) of these tumors, respectively.
— Based on these biomarker observations and the clinical activity observed in the ongoing Phase 2 study, the study has been expanded (n= ~45 patients, including at least 15 patients with FAT1 mutations) to allow for an evaluation of the utility of biomarkers for patient selection. Enrollment is ongoing.
· CDX-0159—a monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells. In certain inflammatory diseases, such as chronic idiopathic urticaria (CIU), mast cell degranulation plays a central role in the onset and progression of the disease.

Celldex plans to submit an Investigation New Drug (IND) Application and initiate a Phase 1a study of CDX-0159 by year-end 2019. The study is designed to evaluate the safety profile, pharmacokinetics and pharmacodynamics of single ascending doses of CDX-0159 in healthy subjects. Following completion of this study, the Company plans to further study CDX-0159 in CIU, a mast cell-related disease. CIU presents as itchy hives, angioedema or both for at least six weeks without a specific trigger; multiple episodes can play out over years or even decades. The prevalence of CIU is estimated to be 0.5% to 1% of the total population or up to 3.2 million cases in the United States. About 50% of patients with CIU achieve symptomatic control with antihistamines or leukotriene receptor antagonists. Omalizumab, an IgE inhibitor, provides relief for roughly half of the remaining antihistamine/leukotriene refractory patients. Consequently, there is a need for more effective later line therapies.
· Celldex continues to advance a robust preclinical portfolio with data from multiple programs presented at AACR (Free AACR Whitepaper).

Data from the Company’s CDX-527 bispecific candidate and its TAM program were presented in April 2019 at the AACR (Free AACR Whitepaper) Annual meeting. CDX-527 uses Celldex’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway. TAM receptors (Tyro3, Axl, MerTK) are receptor tyrosine kinases (RTKs) expressed in innate immune cells. These receptors have been gaining importance in the immunotherapy field due to their role as checkpoint molecules on macrophages, dendritic cells and other immune cells, where they can negatively regulate anti-tumor immunity.
Recent Business Highlights:

· Diane C. Young, M.D. joined Celldex as Senior Vice President, Chief Medical Officer in July 2019. Over the span of a 30 year career in biopharmaceuticals, Dr. Young, a medical oncologist, has led clinical and cross-functional research and development teams responsible for the global development of numerous novel therapies from Phase 1 through successful product registrations. Dr. Young received her M.D. from Harvard Medical School and is board certified in Internal Medicine and Medical Oncology.

· Celldex continues to preserve our financial resources and direct them towards reaching meaningful development milestones across our pipeline. In June, the Company decided to consolidate its Massachusetts lab and manufacturing facilities. The lease for the Needham, MA facility will not be renewed and most functions and employees will be integrated into the Company’s Fall River, MA facility. The Company estimates that this consolidation along with a reduction in square footage at our Hampton, NJ facility earlier this year will decrease our facility footprint by over 35% and will save the Company over $3.5 million annually, starting in the second half of 2020.

Second Quarter 2019 Financial Highlights and 2019 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2019 were $81.3 million compared to $85.1 million as of March 31, 2019. The decrease was primarily driven by second quarter cash used in operating activities of $11.0 million, partially offset by $7.2 million in net proceeds from sales of common stock under the Cantor agreement. At June 30, 2019, Celldex had 14.8 million shares outstanding.

Revenues: Total revenue was $0.7 million in the second quarter of 2019 and $2.1 million for the six months ended June 30, 2019, compared to $2.8 million and $6.8 million for the comparable periods in 2018. The decrease in revenue was primarily due to lower revenue from the collaboration agreement with Bristol-Myers Squibb Company and the contract manufacturing and research and development agreements with the International AIDS Vaccine Initiative and Rockefeller University.

R&D Expenses: Research and development (R&D) expenses were $10.1 million in the second quarter of 2019 and $21.2 million for the six months ended June 30, 2019, compared to $21.4 million and $43.3 million for the comparable periods in 2018. The decrease in R&D expenses was primarily due to lower clinical trial, personnel and contract manufacturing costs.

G&A Expenses: General and administrative (G&A) expenses were $3.9 million in the second quarter of 2019 and $8.8 million for the six months ended June 30, 2019, compared to $5.6 million and $11.2 million for the comparable periods in 2018. The decrease in G&A expenses was primarily due to lower personnel and commercial planning costs and lower lease restructuring expense.

Changes in Fair Value Remeasurement of Contingent Consideration: The Company recorded a $1.0 million gain on fair value remeasurement of contingent consideration during the second quarter of 2019 and a $0.5 million loss on fair value remeasurement of contingent consideration during the six months ended June 30, 2019, primarily due to changes in discount rates and the passage of time.

Net Loss: Net loss was $11.8 million, or ($0.84) per share, for the second quarter of 2019, and $29.0 million, or ($2.21) per share, for the six months ended June 30, 2019, compared to a net loss of $16.4 million, or ($1.67) per share, for the second quarter of 2018 and $134.5 million, or ($14.01) per share, for the six months ended June 30, 2018.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at June 30, 2019, combined with the anticipated proceeds from future sales of common stock under the Cantor agreement, are sufficient to meet estimated working capital requirements and fund planned operations through 2020. This could be impacted if Celldex elects to pay Kolltan contingent milestones, if any, in cash.

Webcast and Conference Call
Celldex executives will host a conference call at 4:30 p.m. ET today to discuss financial and business results and to provide an update on key 2019 objectives. The conference call and presentation will be webcast live over the internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 9256839.

A replay of the call will be available approximately two hours after the live call concludes through August 14, 2019. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 9256839. The webcast will also be archived on the Company’s website.

Erbitux is a registered trademark of Eli Lilly & Co.

On August 7, 2019 EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, reported financial results for the second quarter ended June 30, 2019 and highlighted recent commercial and corporate developments (Press release, pSivida, AUG 7, 2019, View Source [SID1234538309]).

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"The physician feedback to date from our two commercial product launches, YUTIQ and DEXYCU, has been very positive, and we have seen a solid uptake in treatment volume along with tremendous progress in market access," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "Our field force has received similar reception and eagerness to meet from physicians in the office setting for YUTIQ and at ambulatory surgery centers (ASCs) for DEXYCU. Our efforts on training and certifying physicians during our phased launch of DEXYCU are generating sales momentum with a solid start in July, as evidenced by the number of ASCs purchasing product for the first time, as well as repeat purchases. YUTIQ continues to address a large unmet need for patients afflicted with chronic non-infectious posterior segment uveitis and July sales remain on a solid upward trajectory with the number of ordering physicians increasing month over month. With the recently accelerated October 1, 2019 effective date of a permanent and specific J code for YUTIQ, J7413, payor approval and reimbursement will soon become even easier and more streamlined."

Ms. Lurker continued, "Physicians are now actively seeing the clinical results of both YUTIQ and DEXYCU with their patients and to date have experienced positive efficacy and safety results as seen in the pivotal clinical studies. We are very proud to have launched our two exciting ophthalmic products, YUTIQ and DEXYCU, and to bring these innovative products to patients in need."

"In an effort to support our commercial activities we have enhanced our leadership team with the appointments of Scott Jones as Chief Commercial Officer and Said Saim, Ph.D., as Chief Technology Officer. We look forward to making further progress in growing the reach of our commercially available products and advancing the balance of our pipeline to deliver much-needed innovation to ophthalmic patients," concluded Ms. Lurker.

Commercial Performance in Second Quarter 2019

YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg for chronic non-infectious uveitis affecting the posterior segment of the eye

10 Key Account Managers (KAMs) are dedicated to calling predominantly uveitis specialists across the U.S.

Since the February launch, approximately 95% of the top decile uveitis specialists have been visited by the 10 KAMs.

YUTIQ has been included in more than 20 Academic Formularies and is pending inclusion for an additional 8.

As of July 31, market access has been well established with 100% of Medicare patients being covered and benefit investigations being approved for over 95% of Medicare advantage and commercial plan patients.

DEXYCU (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation following cataract surgery

33 KAMs dedicated to the promotion of DEXYCU have focused on a phased launch program to ensure proper physician training for the preparation, application and administration of DEXYCU

Since launch, over 400 surgeons in more than 275 ambulatory surgical centers (ASCs) have completed the training/certification program and are now able to purchase DEXYCU.

Since launch, over 4,200 patients have been injected with DEXYCU via the Company’s sampling program.

Since launch, over 3,000 medical professionals and office staff have been called on to discuss DEXYCU.

As of July 31, our market access initiatives have resulted in 100% of Medicare Fee-For-Service lives being covered and benefit investigations being approved for over 90% of Medicare Advantage and commercial plan patients.

R&D Highlights

At the 37th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) that took place July 26-30, 2019 in Chicago, three podium presentations highlighted data supporting YUTIQ for the treatment of non-infectious posterior segment uveitis. Highlights from each of the presentations include

Results at the 36-month follow up of the Phase 3 trial of YUTIQ demonstrated that visual acuity gains of 3-lines were more common with YUTIQ (33% vs 15%) and losses were more common with sham (9% vs 1%).

At 36-months, the recurrence rate in YUTIQ randomized eyes was significantly lower than in sham treated eyes (56.3% vs. 92.9%, respectively; p<0.001). The number of eyes with at least 1 recurrence was 49 for YUTIQ and 39 for sham treated eyes, with total recurrences of 103 for YUTIQ and 166 for sham treated eyes. The median time to the first recurrence was 1,051 days for YUTIQ (95% CI 686, 1,125) and 95 days for sham-treated eyes (95% CI 71, 117).

Safety data showed 19.5% of YUTIQ treated eyes needed the assistance of adjunctive intraocular/periocular injection medication for uveitic inflammation compared to 69.0% for sham treated eyes.

Corporate Updates

Scott Jones was appointed Chief Commercial Officer in June 2019 and will lead the Company’s sales and marketing efforts for the Company’s two ophthalmic commercial products. Mr. Jones brings significant experience commercializing drugs and devices globally to EyePoint. Most recently, he served as Chief Commercial Officer and Vice President, Business Development at Notal Vision, where he developed the commercial and growth strategy for the organization.

Also in June 2019, Said Saim, Ph.D., was appointed Chief Technology Officer, a newly created position at the Company, where he will be responsible for advancing EyePoint’s pipeline products and technology for ocular treatments from formulation, preclinical research up to clinical development, as well as pharmaceutical sciences, manufacturing and operations. Dr. Saim has more than 25 years of product development experience. He most recently served as Vice President, Pharmaceutical Development at Collegium Pharmaceutical, where his responsibilities included managing formulation development, clinical trial manufacturing, and commercial manufacturing for immediate, delayed and controlled release dosage forms.

In July 2019, Wendy DiCicco, CPA, was appointed to the Company’s Board of Directors and Audit Committee, where she serves as Chair of the Committee. Ms. DiCicco most recently was Chief Operating and Financial Officer of Centinel Spine, a privately-held designer, developer and worldwide distributor of spinal implants, where she established the Company’s international operations, and was instrumental in both the recapitalization of the Company’s financial structure as well as active in corporate development initiatives.

Review of Second Quarter Results Ended June 30, 2019

For the three months ended June 30, 2019, total revenue was $7.2 million. Net product revenue was $6.7 million generated from sales of YUTIQ. Due to adequate inventory stocking by the Company’s distributor, Cardinal Health, ahead of the mid-March launch prior to the end of the first quarter, DEXYCU did not generate product revenue during the second quarter of 2019. Neither of these products had net revenue in the corresponding quarter in 2018.

Net revenue from royalties and collaborations for the three months ended June 30, 2019 totaled $505,000 compared to $715,000 in the corresponding quarter in 2018.

Operating expenses for the three months ended June 30, 2019 increased to $17.4 million from $10.5 million in the prior year period, due primarily to investments in sales and marketing infrastructure and program costs, professional services, stock-based compensation and cost of sales related to product revenue. Non-operating expense, net, for the three months ended June 30, 2019 totaled $1.3 million of net interest expense. Net loss for the three months ended June 30, 2019 was $11.5 million, or $0.11 per share, compared to a net loss of $34.4 million, or $0.62 per share, for the prior year quarter.

Review of Six Months Results Ended June 30, 2019

For the six months ended June 30, 2019, total net product revenue was $7.9 million. Neither product had net revenue in the corresponding period in 2018. Net revenue from royalties and collaborations for the six months ended June 30, 2019 totaled $1.3 million compared to $1.6 million in the corresponding period in 2018.

Operating expenses for the six months ended June 30, 2019 increased to $34.0 million from $16.1 million in the prior year period, due primarily to investments in sales and marketing infrastructure and program costs, professional services, stock-based compensation, cost of sales related to product revenue and amortization of the DEXYCU intangible asset. Non-operating expense, net, for the six months ended June 30, 2019 totaled $5.9 million and consisted of $2.1 million of net interest expense and $3.8 million from the loss on extinguishment of debt related to the payoff of the SWK term loan. Net loss for the six months ended June 30, 2019 was $30.7 million, or $0.30 per share, compared to a net loss of $41.4 million, or $0.82 per share, for the prior year period.

Cash and cash equivalents at June 30, 2019 totaled $44.2 million compared to $45.3 million at December 31, 2018.

Financial Outlook

Given that the Company’s two commercial products, YUTIQ and DEXYCU, have not yet established a consistent sales trajectory, guidance regarding the timing of positive cash flow is not being provided at this time. We expect that the Company’s existing cash and cash equivalents at June 30, 2019 and cash inflows from anticipated YUTIQ and DEXYCU product sales will be sufficient to fund our operating plan into 2020.

Conference Call Information

EyePoint will host a conference call today, Wednesday, August 7, 2019 at 8:30 AM ET to discuss the results for the second quarter ended June 30 and recent operational developments. To access the conference call, please dial (877) 312-7507 from the U.S. and Canada or (631) 813-4828 (international) at least 10 minutes prior to the start time and refer to conference ID 5175125. A live webcast will be available on the Investor Relations section of the corporate website at View Source A replay of the webcast will also be available on the corporate website.

On August 7, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a focus on Myelodysplastic Syndromes (MDS), reported that the Company will release its second quarter financial results on August 14, 2019, before the market opens (Press release, Onconova, AUG 7, 2019, View Source [SID1234538327]). The Company will host a conference call on August 14, 2019, at 9 a.m. Eastern Time to discuss these results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the U.S. or (210) 229-8823 internationally and using conference ID 9150777. The call will also be webcast live. Please click here to access the webcast on the Investor Relations page of the Company’s website. A replay will be available for 90 days.

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About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are conditions that can occur when the blood-forming cells in the bone marrow become dysfunctional and thus produce an inadequate number of circulating blood cells. It is frequently associated with the presence of blasts or leukemic cells in the marrow. This leads to low numbers of one or more types of circulating blood cells, and to the need for blood transfusions. In MDS, some of the cells in the bone marrow are abnormal (dysplastic) and may have genetic abnormalities associated with them. Different cell types can be affected, although the most common finding in MDS is a shortage of red blood cells (anemia). Patients with higher-risk MDS may progress to the development of acute leukemia.