On August 9, 2019 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying 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 second quarter 2019 and recent corporate highlights (Press release, Sophiris Bio, AUG 9, 2019, View Source [SID1234538520]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"During the second quarter of 2019, we received positive feedback from the EMA regarding the design of our Phase 3 clinical trial for localized prostate cancer which was a significant step forward in our development of topsalysin," said Randall E. Woods, president and CEO of Sophiris. "We are now focused on our plan to fund this study and the Company going forward. We continue to believe that the ideal funding option will either be a potential development partnership or other strategic transaction and we are currently in discussions with multiple parties capable of funding the continued development of topsalysin."

Second Quarter Corporate Highlights:

The Company received formal scientific advice from the European Medicines Agency (EMA) regarding a proposed design of a Phase 3 clinical trial to evaluate the potential of topsalysin as a targeted focal therapy to treat patients with intermediate risk localized prostate cancer. The Phase 3 study design, agreed upon by the EMA, will enroll patients with a confirmed diagnosis of intermediate risk disease. Approximately 700 men who meet the eligibility criteria will be equally randomized to receive a single administration of either topsalysin or placebo.

The company is now actively engaged in discussions with the FDA on the design of the proposed Phase 3 clinical trial. The goal is to conduct a single Phase 3 trial, which if successful, will provide the clinical data for approval in both the US and Europe.

The Company participated at both the H.C. Wainwright Global Life Sciences Conference and the 18th Annual Needham Healthcare Conference.

Financial Results:

At June 30, 2019, the Company had cash, cash equivalents and securities available-for-sale of $6.0 million and working capital of $1.8 million. The Company expects that its cash and cash equivalents and securities available-for-sale will be sufficient to fund its operations through November 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 and to continue its operations As of June 30, 2019, the outstanding principal balance of the Company’s term loan was $6.3 million. The Company began making principal payments on its term loan in April 2019.

For the three months ended June 30, 2019

The Company reported a net loss of $2.2 million or ($0.07) per share for the three months ended June 30, 2019, compared to net loss of $6.1 million or ($0.20) per share for the three months ended June 30, 2018.

Research and development expenses

Research and development expenses were $1.1 million for the three months ended June 30, 2019, compared to $3.6 million for the three months ended June 30, 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 the Company’s completed Phase 2b clinical trial of topsalysin for localized prostate cancer.

General and administrative expenses

General and administrative expenses were relatively consistent at $1.2 million for the three months ended June 30, 2019, compared to $1.1 million for the three months ended June 30, 2018.

Gain (loss) on revaluation of the warrant liability

Gain on revaluation of the warrant liability was $0.3 million for the three months ended June 30, 2019, compared to a loss of $1.4 million for the three months ended June 30, 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.

For the six months ended June 30, 2019

The Company reported a net loss of $4.5 million or ($0.15) per share for the six months ended June 30, 2019 compared to a net loss of $9.4 million or ($0.31) per share for the six months ended June 30, 2018.

Research and development expenses

Research and development expenses were $2.6 million for the six months ended June 30, 2019 compared to $6.9 million for the six months ended June 30, 2018. The decrease in research and development costs was 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 the Company’s completed Phase 2b clinical trial of topsalysin for localized prostate cancer.

General and administrative expenses

General and administrative expenses were relatively consistent at $2.5 million for the six months ended June 30, 2019 compared to $2.3 million for the six months ended June 30, 2018.

Gain (loss) on revaluation of the warrant liability

Gain on revaluation of the warrant liability was $0.8 million for the six months ended June 30, 2019 as compared to a loss of $10,000 for the six months ended June 30, 2018.

On August 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 second quarter ended June 30, 2019 and provided an overview of the Company’s recent developments (Press release, UroGen Pharma, AUG 9, 2019, View Source [SID1234538547]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our team has continued to make significant progress on key initiatives during the second quarter, including the submission of the CMC modules to our rolling New Drug Application (NDA) for UGN-101. We have locked the database on our Phase 3 OLYMPUS study and are on track to complete the submission in Q4 as we prepare for a potential approval and launch in the first half of 2020," said Liz Barrett, President and Chief Executive Officer of UroGen. "We are confident that our account-based commercial strategy will allow for seamless adoption and integration into urology practices following anticipated approval. We look forward to sharing further details about UGN-101 commercial preparations, ongoing clinical programs, and new developments at our Investor Day on September 24, 2019."

Recent Highlights and Upcoming Milestones

UGN-101 Clinical Development:

UroGen recently submitted the CMC modules to the rolling NDA for investigational agent UGN-101 for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). Completion and acceptance of the Company’s rolling NDA submission remains on track for 2H 2019. If approved, the Company expects to launch UGN-101 in the United States in 1H 2020. It would be the first medicine approved for this unique, orphan indication.

At the 114th American Urological Association (AUA) Annual Meeting in Chicago, a presentation in the plenary session highlighted findings from a secondary analysis from the pivotal Phase 3 OLYMPUS trial which demonstrated the unmet need and potential for UGN-101 to transform the treatment paradigm for patients with LG UTUC.

The Company expects to announce updated Phase 3 data from the OLYMPUS trial at its upcoming Investor Day on September 24, 2019.

Pipeline Advancement:

UGN-102:

The Company continues to enroll patients in its Phase 2b OPTIMA II clinical trial of investigational agent 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. UGN-102 has the potential to address an unmet need for the approximately 80,000 patients with intermediate risk LG NMIBC.

The OPTIMA II trial is enrolling ahead of schedule, and the company plans to present early complete response data on a portion of patients at its upcoming Investor Day on September 24, 2019.

If approved, UGN-102 would represent a novel advance in the treatment of recurrent non-muscle invasive bladder cancer, as there are currently no drugs approved by the FDA as first-line treatment for LG NMIBC.

UGN-201:

The Company is developing investigational agent UGN-201, a TLR7/8 immunomodulatory agent for the treatment of high-grade bladder disease. UroGen is exploring the utility of UGN-201 in the context of novel combinatorial immunotherapy for NMIBC.

Commercial Preparations:

UroGen has made considerable progress to accelerate educational initiatives to drive awareness of the significant unmet need for patients with LG UTUC where current SOC is kidney removal. Little education and support have previously been available for patients and stakeholders and UroGen is in a unique position to lead in this space. These pre-commercial activities and infrastructure build out will help to reinforce rapid adoption and seamless integration of UGN-101 into urology practices following anticipated regulatory approval.

In conjunction with the Company’s educational efforts, UroGen is also engaging in a proactive market access strategy to define the cost burden to the system for LG UTUC via an HEOR study.

Corporate:

Robert G. Uzzo, M.D., FACS, Chair of the Department of Surgical Oncology at Fox Chase Cancer Center in Philadelphia, PA, has joined UroGen as a special advisor working closely with UroGen’s Medical Affairs team. Dr. Uzzo is well-known as a key opinion leader in the field of urological oncology and has made important clinical and scientific contributions to the field.

In the second quarter, UroGen 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.

The Company will host a live webcast in conjunction with its Investor Day taking place on Tuesday, September 24th at 10:00AM Eastern Time in New York, NY.

Second Quarter 2019 Financial Results; 2019 Guidance

As of June 30, 2019, cash, cash equivalents and marketable securities totaled $233.3 million.

Research and development expenses for the three months ended June 30, 2019 were $10.0 million, including non-cash share-based compensation expense of $2.0 million. Research and development expenses for the six months ended June 30, 2019 were $19.7 million, including non-cash share-based compensation expense of $4.3 million.

General and administrative expenses for the three months ended June 30, 2019 were $13.8 million, including non-cash share-based compensation expense of $5.2 million. General and administrative expenses for the six months ended June 30, 2019 were $26.5 million, including non-cash share-based compensation expense of $10.3 million.

The Company reported a net loss of $22.5 million, or basic and diluted net loss per ordinary share of $1.08, for the three months ended June 30, 2019. The Company reported a net loss of $43.9 million, or basic and diluted net loss per ordinary share of $2.19, for the six months ended June 30, 2019.

The 2019 financial guidance set forth during the Company’s year-end earnings call on February 28, 2019 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 on Monday, August 12, 2019 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 48773603. An archive of the webcast will be available for two weeks on the Company’s website.

On August 9, 2019 Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") reported financial results for the three and six months ended June 30, 2019 (Press release, Intech Pharmaceuticals, AUG 9, 2019, View Source [SID1234538571]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Highlights of the second quarter 2019 and recent weeks include:

Completed the qualification studies for the commercial scale manufacture of Accordion Pill-Carbidopa/Levodopa (AP-CD/LD) with LTS LohmanTherapie-Systeme;
Announced topline results from the Company’s pivotal Phase 3 trial (the ACCORDANCE trial) evaluating the safety and efficacy of the AP-CD/LD compared with immediate release CD/LD (IR-CD/LD; Sinemet) as a treatment for the symptoms of advanced Parkinson’s disease (PD), reporting that AP-CD/LD provided treatment for Parkinson’s disease symptoms but did not demonstrate statistically superiority to IR-CD/LD in terms of reduction in OFF time from baseline under the conditions established in the protocol;
Completed the pharmacokinetic (PK) study of the custom-designed AP developed for a proprietary compound under the previously announced feasibility and option agreement with Novartis Pharmaceuticals;
Entered into an agreement with Merck to explore using the AP platform for an undisclosed development program;
Published a review highlighting the benefits of the AP oral drug delivery platform in the peer-reviewed journal, Therapeutic Delivery;
Published the results from an earlier Phase 2 clinical study of the AP-CD/LD in PD patients in the peer-reviewed journal, Parkinsonism and Related Disorders;
Presented data from the PK study of AP-CD/LD 50/500 mg TID in a poster at the XXIV World Congress on Parkinson’s Disease and Related Disorders; and
Granted European patent titled, "Delivery Device for Oral Intake of an Agent," which covers Intec’s gastro-retentive drug delivery device with perforated external film.
Management Commentary

"We were very disappointed that the ACCORDANCE study did not meet its target endpoints. In our preliminary review of the top-line data, we noted sub-sets of patients that performed particularly well, showing meaningful reduction in OFF time compared with IR-CD/LD. Based on our preliminary review, we believe we may not have been able to administer enough LD to certain patients as it was agreed with the U.S. Food and Drug Administration (FDA) that the maximum dose would be three APs per day. Given the long-term safety profile established by this trial, we believe this limitation should be removed and that this could present a method of providing additional LD to those patients who need it. We believe the on-going analyses of this study will lead to an improved understanding of what will be required in future studies to generate approvable clinical data with the AP delivery platform in PD," stated Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma.

"During the second quarter, we made significant progress advancing and expanding our partner-sponsored programs. We are excited to have successfully completed the PK study for our custom-designed AP for Novartis’ proprietary compound and are looking forward to advancing this program into potential partnership discussions. This partnership holds significant promise as the market opportunity for this proprietary compound is in excess of $1 billion. In addition, we entered into a research collaboration with Merck for the development of a custom-designed AP for one of Merck’s proprietary compounds and are now initiating the design and construction of this new AP for this very promising program.

"We continue to make progress refining the AP for our cannabis program and hope to advance our proprietary AP containing synthetic tetrahydrocannabinol (AP-THC), one of the primary cannabinoids contained in cannabis, into a new PK study next year. The Accordion Pill has the potential to address several major drawbacks of current methods of use and treatment with cannabis and cannabinoids, such as short duration of effect, delayed onset, variability of exposure, variable potency batch to batch, variability of the administered dose and adverse events that correlate with rate of rise and peak levels. Given the known analgesic properties of cannabinoids, we remain enthusiastic about the potential for these programs and believe our AP-cannabinoids will be applicable to a variety of pain indications.

"While the ACCORDANCE results were not what we expected, we continue to believe in the potential of the AP platform. Toward that end, we plan to seek to move forward with a commercial agreement with Novartis. In addition, once we obtain the final data from our ACCORDANCE study, we plan to look for ways to advance this program forward, whether on our own or through a potential partnership. In tandem, we plan to continue to build our AP drug delivery platform with the addition of both partner-sponsored R&D programs, such as Novartis and Merck, and through internally led drug reformulation programs, such as our cannabis program in pain indications. We believe this strategy provides the best opportunities for both short- and long-term growth," concluded Mr. Meckler.

Financial Highlights for the Three and Six Months Ended June 30, 2019

Research and development expenses, net, for the three-month period ended June 30, 2019 were approximately $7.9 million, a decrease of approximately $500,000, or 6%, compared with approximately $8.4 million for the second quarter of 2018. Research and development expenses, net, for the six-month period ended June 30, 2019 amounted to approximately $16.4 million, a decrease of approximately $900,000, or 5%, compared with approximately $17.3 million in the six-month period ended June 30, 2018. The decrease in both periods was primarily due to a decrease in expenses related to our ACCORDANCE study and open label extension study, offset by an increase in expenses related to the scale up activities for the commercial-scale production capabilities for AP-CD/LD at LTS.

General and administrative expenses for the three-month period ended June 30, 2019 were approximately $2.1 million, a decrease of approximately $100,000 or 5%, compared with approximately $2.2 million in the three-month period ended June 30, 2018. General and administrative expenses for the six-month period ended June 30, 2019 amounted to approximately $4.3 million, an increase of approximately $200,000, or 5%, compared with approximately $4.1 million in the six-month period ended June 30, 2018. The increase in the six-month period was primarily related to the increase in payroll and related expenses mainly due to an increase in headcount and salary raises and insurance expenses, offset by a decrease in professional services.

Net loss for the three-month period ended June 30, 2019 was approximately $10.0 million, compared with a net loss of $11.0 million in the prior year’s second quarter. Net loss for the six-month period ended June 30, 2019 was $20.7 million compared with $21.8 million during the six-month period ended June 30, 2018.

Loss per ordinary share for the three-month period ended June 30, 2019 was $0.30 compared with a loss per ordinary share of $0.34 for the three-month period ended June 30, 2018. Loss per ordinary share for the six-month period ended June 30, 2019 was $0.62 compared with a loss per ordinary share of $0.75 for the six-month period ended June 30, 2018.

As of June 30, 2019, the Company had cash and cash equivalents and marketable securities of approximately $21.6 million compared with approximately $40.6 million at December 31, 2018.

Net cash used in operating activities during the six-month period ended June 30, 2019 was approximately $17.7 million compared with net cash used in operating activities of approximately $19.9 million during the six-month period ended June 30, 2018. This decrease resulted primarily from the decrease in the net loss for the period in the amount of $1.1 million and from changes in operating assets and liabilities items of approximately $300,000.

The Company had negative cash flow from investing activities of approximately $1.0 million during the six-month period ended June 30, 2019 compared to negative cash flow from investing activities of approximately $4.3 million during the six-month period ended June 30, 2018. This decrease resulted primarily from a decrease in purchase of property and equipment in the amount of approximately $2.5 million, an increase in proceeds from the disposal of marketable securities in the amount of approximately $576,000 and a decrease of approximately $261,000 in investment in other assets related to the establishment of the commercial scale production capabilities for AP-CD/LD at LTS.

Net cash provided by financing activities during the six-month period ended June 30, 2019 was approximately $268,000, which was provided by the proceeds from the exercise of options by employees. Net cash provided by financing activities for the six months ended June 30, 2018 was approximately $35.0 million which was mainly provided by funds received from our April 2018 public offering of ordinary shares.

On August 8, 2019 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the second quarter of 2019 (Press release, Navidea Biopharmaceuticals, AUG 8, 2019, View Source [SID1234538425]). Navidea reported total revenues for the quarter of $260,000. Net loss attributable to common stockholders was $2.7 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"During the second quarter, Navidea continued to deliver on its renewed focus to complete its NAV 3-31 trial and raise the funding to cover it," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "The Company furthered its partnership discussions around the globe but most importantly Navidea met its internal recruiting and enrollment goals for its ongoing RA trials. The Company remains focused on bringing its RA diagnostic to market."

Second Quarter 2019 Highlights and Subsequent Events

Effected a one-for-twenty reverse stock split and received notification of stock price compliance from the NYSE American

Announced that results of the Company’s NAV3-21 clinical study for diagnosis of rheumatoid arthritis were presented at the Society of Nuclear Medicine and Molecular Imaging ("SNMMI") Annual Meeting by Arash Kardan, M.D.

Completed an underwritten public offering with gross proceeds of $6.0 million

Achieved double-digit subject enrollment in our NAV3-31 Phase 2b study and are on track with recruitment projections to date

Received an Intent to Fund notification from the National Heart, Lung and Blood Institute for its Small Business Technology Transfer Phase 1 grant application that will support a collaboration with the University of Alabama at Birmingham titled "Gallium 68 Tilmanocept for PET Imaging of Atherosclerosis Plaques"

"We were extremely pleased with the recognition received at the annual SNMMI meeting following our Phase 1 and 2 study results, and we are pressing forward with recruitment in the ongoing Phase 2B," said Dr. Michael Rosol, Chief Medical Officer of Navidea. "This Phase 2b study will provide the fundamental test-retest and longitudinal data to validate our power calculations for the upcoming Phase 3 trial."

Financial Results

Our consolidated balance sheets, statements of operations, and statements of stockholders’ equity have been restated, as required, for all periods presented to reflect the reverse stock split as if it had occurred on January 1, 2018. Our consolidated statements of cash flows were not impacted by the reverse stock split.

Total revenues for the second quarter of 2019 were $260,000, compared to $542,000 in the same period of 2018. Total revenues for the first six months of 2019 were $302,000, compared to $819,000 in the same period of 2018. The decrease was primarily due to a decrease in license revenue related to the sublicense of our NAV4694 technology which included a non-refundable upfront payment in 2018, coupled with a reduction in grant revenue related to SBIR grants from the NIH supporting Manocept development.

Research and development ("R&D") expenses were approximately $1.1 million in each of the second quarters of 2019 and 2018. R&D expenses for the first six months of 2019 were $1.8 million, compared to $2.1 million in the same period of 2018. The year-to-date decrease was primarily due to net decreases in drug project expenses including therapeutics, Tc99m tilmanocept, and NAV4694 development costs, offset by increased Manocept diagnostic development costs. The net decrease in R&D expenses also included decreased compensation costs resulting from net decreased salaries and headcount.

Selling, general and administrative ("SG&A") expenses for the second quarter of 2019 were $1.9 million, compared to $1.8 million in the same period of 2018. SG&A expenses were approximately $3.6 million in each of the first six months of 2019 and 2018. Increased legal and professional services were offset by decreased compensation costs.

Navidea’s net loss attributable to common stockholders for the second quarter of 2019 was $2.7 million, or $0.24 per share, compared to a net loss attributable to common stockholders of $2.4 million, or $0.29 per share, for the same period in 2018. Navidea’s net loss attributable to common stockholders for the first six months of 2019 was $5.1 million, or $0.48 per share, compared to a net loss attributable to common stockholders of $9.1 million, or $1.12 per share, for the same period in 2018.

Navidea ended the second quarter of 2019 with $5.3 million in cash and investments.

Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.

Event:

Q2 2019 Earnings and Business Update Conference Call

Date:

Thursday, August 8, 2019

Time:

5:00 p.m. (EDT)

U.S. & Canada Dial-in:

877-407-0312

International Dial-in:

+1 201-389-0899

Conference ID:

13693119

Webcast Link: View Source

The recorded conference call can be replayed and will be available for 90 days following the call, available on the investor relations page of Navidea’s corporate website at www.navidea.com.

On August 8, 2019 Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR, reported financial results for the second quarter ended June 30, 2019 and provided a corporate update (Press release, Selecta Biosciences, AUG 8, 2019, View Source [SID1234538441]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our gene therapy program has gained a lot of momentum, most notably with our new strategic partnership with AskBio, which will combine our ImmTOR platform technology with AskBio’s AAV technology and know-how. We believe this partnership will allow us to develop a robust pipeline of products that can potentially be re-dosed and offer patients a new treatment paradigm in areas of high unmet need," said Carsten Brunn, Ph.D., President and CEO of Selecta. "We are also pleased that the COMPARE trial continues to actively enroll patients, and we look forward to differentiating SEL-212 compared to the current FDA-approved uricase therapy in adult patients with chronic refractory gout. We believe the clinical profile of SEL-212, along with its more convenient monthly dosing, makes it a compelling product for patients and their providers and represents a very large market opportunity of over $1.0 billion."

Recent Highlights and Anticipated Upcoming Milestones

Chronic Refractory Gout Program:

COMPARE Clinical Trial of SEL-212 vs. Krystexxa Enrolling Patients: In March 2019, Selecta initiated a six-month head-to-head clinical trial (COMPARE) designed to evaluate the superiority of its lead product candidate, SEL-212 (ImmTOR + Pegadricase), compared to Krystexxa, the current U.S. Food and Drug Administration (FDA)-approved uricase therapy, in adult patients with chronic refractory gout. The COMPARE trial, which is currently enrolling patients, is expected to enroll 150 patients, and the primary endpoint is the maintenance of serum uric acid (sUA) levels of <6mg/dL at six months. An interim data analysis is expected in the fourth quarter of 2019 with a full statistical superiority analysis expected in the second quarter of 2020.
AAV Gene Therapy Program:

New Strategic Partnership with Gene Therapy Leader AskBio: In August 2019, Selecta announced a strategic partnership with Asklepios BioPharmaceutical, Inc. (AskBio), to jointly develop, manufacture and commercialize a broad portfolio of life-changing, next-generation adeno-associated virus (AAV) gene therapies. This partnership will leverage the unique proprietary technology platforms of both companies with a human proof of concept trial to validate this portfolio of products and their potential for re-dosing in patients.
Advancing Collaboration with CureCN Consortium: Under a collaboration with the European consortium, CureCN, for an ImmTOR+AAV gene therapy combination product candidate in Crigler-Najjar Syndrome, Selecta expects CureCN to obtain scientific advice from the German drug regulatory authority in the second half of 2019.
Corporate Updates:

Strengthened Management Team: Selecta announced the appointment of Alison Schecter, M.D., as Chief Medical Officer in July 2019. Dr. Schecter has over 20 years of combined drug development, strategic management and practical clinical experience in academia and industry and joins Selecta from Sanofi, where she was the Global Project Head, Rare Diseases, and was responsible for leading the Niemann-Pick Disease (ASMD) project.
Expanded Board of Directors: Selecta announced the addition of Scott D. Myers to its Board of Directors, in June 2019. Mr. Myers has more than 20 years of leadership experience in the biopharmaceutical industry and currently serves as Chief Executive Officer and Chairman of the Board of Rainier Therapeutics.
Second Quarter 2019 Financial Results:

Revenue: For the second quarter ended June 30, 2019, the company recognized less than $0.1 million of revenue under its collaboration agreement with Spark.

Research and Development Expenses: Research and development expenses for the second quarter ended June 30, 2019 were $12.1 million, which compares with $14.4 million for the second quarter of 2018. Research and development expenses decreased by $2.3 million, or 16%, as compared to the same period in 2018. The decrease reflects the reduced salaries and benefits as a result of the company’s headcount reduction at the beginning of fiscal 2019. There were further cost reductions related to discontinued programs. These cost reductions were offset by the timing of costs incurred for both the company’s Phase 2 and Phase 3 clinical programs for SEL-212.

General and Administrative Expenses: General and administrative expenses for the second quarter ended June 30, 2019 were $4.1 million, which compares with $4.4 million for the second quarter of 2018. General and administrative expenses decreased by $0.3 million, or 6%, as compared to the same period in 2018. The reduction in costs was primarily the result of reduced legal fees, offset by an increase in professional fees.

Net Loss: For the second quarter ended June 30, 2019, Selecta reported a net loss of $16.4 million, or $0.37 per share, compared to a net loss of $18.8 million, or $0.84 per share, for the same period in 2018.

Cash Position: Selecta had $42.0 million in cash, cash equivalents, restricted cash and short-term investments as of June 30, 2019, which compares to cash, cash equivalents, restricted cash and short-term investments of $48.7 million as of March 31, 2019.
Financial Outlook:

Selecta believes its available cash, cash equivalents and restricted cash will be sufficient to meet its operating requirements into the first quarter of 2020.

Conference Call and Webcast Reminder
Selecta management will host a conference call at 8:30 a.m. ET today to provide a corporate update and review the company’s second quarter 2019 financial results. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, View Source Individuals may also participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10127459.