On November 7, 2019 EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, reported financial results for the third quarter ended September 30, 2019 and highlighted recent corporate developments (Press release, pSivida, NOV 7, 2019, View Source [SID1234550719]).

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"We are pleased with the strong growth in customer orders during the quarter as our sales team is making significant progress in penetrating targeted accounts for both DEXYCU and YUTIQ," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "At the customer level, DEXYCU is gaining momentum at high volume ambulatory surgery centers with increasing repeat orders by physicians who favor its targeted, efficient ocular administration, and its positive efficacy and safety profile. We also saw continued strong growth of 17% in physician demand for YUTIQ quarter over quarter despite a cumbersome reimbursement process under a miscellaneous J-Code. We expect that the issuance of a permanent and specific J-Code for YUTIQ, which went into effect on October 1, 2019, will enable customers to experience a faster and more straightforward reimbursement process and will support continued growth in demand for this important product. These positive customer and reimbursement trends were masked by our distributor’s strategic decision to substantially reduce carried inventory, limiting their restocking during the quarter and resulting in decreased reported revenue from the prior quarter."

Commercial Performance in Third Quarter 2019

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

Customer orders up 207% over Q2 with September representing the highest volume month to date, and with repeat customers representing 74% of Q3 order volume.

The average time for an account to re-order dropped from 4.8 weeks during Q2 to 2.5 weeks during Q3, as customers incorporate DEXYCU as part of their surgical protocol.

Medicare fee for service claims continue to be paid consistently, and Medicare Advantage and Commercial insurance claims increased quarter over quarter.

The average time to payment in all payor sectors continues to improve post launch. We expect the time to payment to decrease as payor systems incorporate DEXYCU’s J-Code.

Since launch, over 5,400 patients have been injected with DEXYCU. In that time, over 500 physicians have been trained to use the product.

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

Customer orders up 17% over Q2, prior to effective date of a permanent J-Code.

Repeat customers represented 85% of order volume, and importantly, 40% of the target account list has ordered, representing solid adoption with continued growth opportunity.

Medicare fee for service claims paid consistently and Medicare Advantage and Commercial payors beginning to cover YUTIQ.

The permanent and specific J-Code, J7314, was issued by the Centers for Medicare and Medicaid Services (CMS) one quarter earlier than under prior CMS policy and is in effect as of October 1, 2019.

Corporate Developments

In November 2019, EyePoint announced two new agreements to expand the reach of DEXYCU and YUTIQ within large integrated healthcare networks. An interim agreement with the U.S. Department of Veterans Affairs (VA) became effective on November 2, 2019, adding DEXYCU and YUTIQ to the Federal Supply Schedule. The VA serves approximately nine million beneficiaries. A final VA contract is anticipated within several months and is expected to have a five-year term. In addition, a three-year contract was signed with Vizient Inc., effective November 1, 2019, offering DEXYCU to its diverse membership network. Vizient provides solutions and services to over 50% of the nation’s acute care providers, including 95% of the nation’s academic medical centers, and more than 20% of ambulatory care providers.

In August 2019, EyePoint received a $1 million milestone payment from Ocumension Therapeutics triggered by the approval of its Investigational New Drug (IND) in China for Eyepoint’s three-year intravitreal micro-insert containing 0.18mg of fluocinolone acetonide using the Durasert technology (known as YUTIQ in the United States). The IND allows the importation of finished product into China for use in its initiated clinical trial to support regulatory approval for the treatment of chronic uveitis affecting the posterior segment of the eye. Ocumension has also received a special approval by the Hainan Province People’s Government to market this product for chronic, non-infectious posterior segment uveitis in the Hainan Bo Ao Lecheng International Medical Tourism Pilot Zone.

R&D Highlights

Two oral presentations highlighting 36-month data supporting YUTIQ for the treatment of non-infectious uveitis affecting the posterior segment of the eye occurred at the annual Retina Society meeting held in London, United Kingdom, on September 11-15, 2019. The first presentation "Minimizing Uveitic Recurrences: Results from a 36M Study of Fluocinolone Acetonide Intravitreal Insert (FAi) in Subjects with Chronic Non-Infectious Uveitis Affecting the Posterior Segment" concluded that treatment with YUTIQ not only resulted in a reduction in the 3-year rate of uveitic recurrences but that YUTIQ also reduced the cumulative number of inflammatory episodes in eyes that did relapse. The second presentation, "The Use of Adjunctive Anti-inflammatory Medications: Results from a 36M Study of a Fluocinolone Acetonide

Intravitreal Insert (FAi) in Subjects with Chronic Non-Infectious Uveitis (NIPU) Affecting the Posterior Segment" highlighted that the treatment with a single intravitreal injection of YUTIQ significantly reduced the need for adjunctive therapies in this group of patients.

YUTIQ was highlighted in separate events at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting held October 12 – 15, 2019 in San Francisco, CA. First, an oral presentation entitled, "Effect of Fluocinolone Acetonide Insert on the Presence of Uveitic Macular Edema: Outcomes at 36 Months" was presented at a well-attended session at the Retina Subspecialty Day and demonstrated the long-term durability of YUTIQ for this difficult to treat ocular disease. Additionally, a poster entitled, "Fluocinolone Acetonide Intravitreal Insert for Noninfectious Posterior Uveitis: Analysis of Significant IOP Elevation" provided further evidence of the favorable safety and tolerability profile of YUTIQ.

Review of Results for Third Quarter Ended September 30, 2019

For the three months ended September 30, 2019, total revenue was $2.5 million. Net product revenue was $1.0 million, primarily generated from sales of DEXYCU.

DEXYCU and YUTIQ are sold through a distributor under a title model and, accordingly, product revenue is recognized as inventory is shipped to the distributor and title transfers. Due to this title model, quarterly reported revenue and underlying customer sales will likely track separately for an extended period of time beyond initial launch, as customer demand patterns may not align with the distributor’s inventory restocking procedures.

Net revenue from licenses, royalties and collaborations for the three months ended September 30, 2019 totaled $1.5 million compared to $486,000 in the corresponding quarter in 2018.

Operating expenses for the three months ended September 30, 2019 increased to $16.6 million from $14.0 million in the prior year period, due primarily to investments in sales and marketing infrastructure and program costs, professional services, and cost of sales related to product revenue, partially offset by a decrease in research and development expense. Non-operating expense, net, for the three months ended September 30, 2019 totaled $1.6 million of net interest expense. Net loss for the three months ended September 30, 2019 was $15.6 million, or $0.15 per share, compared to a net loss of $33.1 million, or $0.44 per share, for the prior year quarter.

Review of Nine Months Results Ended September 30, 2019

For the nine months ended September 30, 2019, total net product revenue was $8.9 million. Neither product had net revenue in the corresponding period in 2018. Net revenue from licenses, royalties and collaborations for the nine months ended September 30, 2019 totaled $2.8 million compared to $2.1 million in the corresponding period in 2018.

Operating expenses for the nine months ended September 30, 2019 increased to $50.6 million from $30.1 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, partially offset by a decrease in research and development expense. Non-operating expense, net, for the nine months ended September 30, 2019 totaled $7.5 million and consisted of $3.7 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 nine months ended September 30, 2019 was $46.4 million, or $0.45 per share, compared to a net loss of $74.5 million, or $1.27 per share, for the prior year period.

Cash and cash equivalents at September 30, 2019 totaled $31.8 million compared to $44.2 million at June 30, 2019.

Financial Outlook

We expect that the Company’s existing cash and cash equivalents at September 30, 2019 and cash inflows from anticipated YUTIQ and DEXYCU product sales will be sufficient to fund the Company’s operating plan into 2020.

Conference Call Information

EyePoint will host a conference call today, Thursday, November 7, 2019 at 8:30 AM ET to discuss the results for the third quarter ended September 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 3149087. 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 November 7, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results for the third quarter ended September 30, 2019 and provided a corporate update (Press release, Jounce Therapeutics, NOV 7, 2019, View Source [SID1234550718]).

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"We have continued to work diligently on advancing our pipeline and further executing on our clinical development plans through our Translational Science Platform and reverse translational analysis. Both of our clinical-stage programs, vopratelimab and JTX-4014, continue to progress well. We are pleased to be presenting both new data from JTX-4014, as well as the dosing and sequencing strategy for vopratelimab in our ongoing EMERGE Phase 2 trial, at the SITC (Free SITC Whitepaper) 2019 Annual Meeting this weekend," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We continue to focus on the underlying mechanistic science of our immunotherapies as we work towards bringing meaningful and long-lasting benefits to cancer patients. We look forward to executing on several key milestones in 2020 across our robust pipeline."

Clinical Programs:
Vopratelimab

Two development paths established for vopratelimab program: The reverse translational analysis from the ICONIC trial established the correlation between ICOS hi CD4 T cells, which emerged due to vopratelimab, and clinical benefit. The first development path focuses on the biology of optimizing the induction of ICOS hi CD4 T cells prior to vopratelimab administration. The second path focuses on the use of a predictive biomarker to identify and select patients who may be more likely to benefit from a combination of vopratelimab and a PD-1 inhibitor. The first of the induction studies, EMERGE, is underway.
Dosing and sequencing strategy for EMERGE Phase 2 trial to be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper): On November 9, 2019, Jounce will present a Trials in Progress poster on the EMERGE trial, which will include the combination dosing and sequencing strategy based on its understanding of the kinetics of induction of ICOS hi CD4 T effector cells by ipilimumab and their expansion and sustained activation by vopratelimab. The EMERGE Phase 2 clinical trial began enrollment in mid-June 2019. Jounce expects to report EMERGE data including preliminary efficacy and biomarker relationships to clinical outcomes for up to 80 patients in 2020.
Predictive biomarker approach: In the second development path, Jounce will focus on the use of a predictive biomarker. In the analysis of ICONIC patients, Jounce was able to identify a biomarker from baseline samples that correlated with the emergence of ICOS hi CD4 T cells, ORR, PFS and OS, in patients treated with vopratelimab alone or in combination with nivolumab. Jounce plans to use this potential predictive biomarker to select patients in a new trial with vopratelimab and JTX-4014. Jounce will provide more details in the next few months on this clinical trial.
JTX-4014

New safety and preliminary efficacy data from JTX-4014 Phase 1 trial to be presented at SITC (Free SITC Whitepaper): On November 8, 2019, Jounce will present new safety and preliminary efficacy data from the Phase 1 trial of JTX-4014 during a poster session at the SITC (Free SITC Whitepaper) 2019 Annual Meeting.
JTX-4014 identified as combination agent: Based on the encouraging safety and preliminary efficacy data, Jounce plans to use JTX-4014 as the PD-1 inhibitor in combination with its other product candidates, including in the new predictive biomarker trial with vopratelimab.
Discovery Pipeline:

On track to announce next development candidate: Jounce continues to advance and develop its broad discovery pipeline, which includes multiple programs targeting T-regulatory cells, macrophages and stromal cells. Jounce expects to move its next novel program into IND-enabling studies by the end of the year.
Corporate Highlights:

Senior appointments: During the third quarter of 2019, Jounce announced the addition of Jacqui Fahey Sandell to its management team as Chief Legal Officer and Corporate Secretary. In October, Haley Laken, Ph.D., VP of Program and Portfolio Strategy, who has been with Jounce since early 2018, also joined the management team.
Third Quarter 2019 Financial Results:

Cash position: As of September 30, 2019, cash, cash equivalents and investments were $185.1 million, compared to $195.9 million as of December 31, 2018. The decrease in cash, cash equivalents and investments was primarily due to operating costs incurred during the period, offset by the $50.0 million license fee received in July 2019 pursuant to Jounce’s new license agreement with Celgene.
License and collaboration revenue: License and collaboration revenue was $119.4 million for the third quarter of 2019, compared to $14.5 million for the same period in 2018. License and collaboration revenue recognized during the third quarter of 2019 was comprised of $50.0 million of cash revenue related to Jounce’s new license agreement with Celgene and $69.4 million of non-cash revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s original strategic collaboration with Celgene. In connection with the termination of the original strategic collaboration, Jounce recognized the remaining deferred revenue relating to this agreement in the third quarter of 2019. License and collaboration revenue recognized during the third quarter of 2018 was comprised solely of non-cash revenue recognition related to the $225.0 million upfront payment.
Research and development expenses: Research and development expenses were $15.1 million for the third quarter of 2019, compared to $16.8 million for the same period in 2018. The decrease in research and development expenses was primarily due to $2.2 million of decreased external research and development costs attributable to vopratelimab manufacturing expenses and JTX-4014 IND-enabling expenses incurred during the third quarter of 2018. This decrease was partially offset by $0.9 million of increased employee compensation costs.
General and administrative expenses: General and administrative expenses were $6.5 million for both the third quarter of 2019 and the same period in 2018.
Net income (loss): Net income was $98.9 million for the third quarter of 2019, resulting in basic net income per share of $2.99 and diluted net income per share of $2.90. This increase in net income was primarily attributable to $119.4 million of license and collaboration revenue recognized under Jounce’s agreements with Celgene. Net loss was $7.6 million for the same period in 2018, or a basic and diluted net loss per share of $0.23.
Financial Guidance:

Based on its operating and development plans for the remainder of 2019, Jounce now expects gross cash burn on operating expenses and capital expenditures for the full year 2019 to be approximately $75.0 million to $85.0 million, a decrease from its previously announced guidance of approximately $80.0 million to $95.0 million for the full year 2019.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 3379867. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcast will be archived and made available for replay on Jounce’s website approximately two hours after the call and will be available for 30 days.

On November 7, 2019 TOT BIOPHARM International Company Limited ("TOT BIOPHARM" or the "Company", reported together with its subsidiaries, the "Group", stock code: 1875) was well received by the capital market and should be the eleventh 18A Biotech company listed in Hong Kong since the inception of the new listing regulation last year (Press release, Tot Biopharm, NOV 7, 2019, View Source [SID1234550717]).

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The Company’s shares will commence trading on the Main Board of The Stock Exchange of Hong Kong Limited at 9:00 a.m. HKT tomorrow (8 November 2019, Friday) under the stock code of 1875, with board lot of 400 Shares each.

The final offer price of TOT BIOPHARM was determined at HK$6.55 per Offer Share. The net proceeds to be received by the Company is estimated to be approximately HK$511.4 million from the Global Offering (assuming that the Over-allotment Option is not exercised, after deduction of the underwriting fees and commission and estimated expenses payable by the Company in connection with the Global Offering). The Hong Kong Offer Shares initially offered under the Hong Kong Public Offering have been significantly over-subscribed by approximately 11.95 times of the total number of 9,000,000 Hong Kong Offer Shares initially available for subscription under the Hong Kong Public Offering. The International Offer Shares initially offered under the International Offering have been moderately over-subscribed.

Focusing on Innovative Oncology Drugs and Therapies, Developed Diversified Product Mix

TOT BIOPHARM is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative oncology drugs and therapies. The Company has a comprehensive portfolio of oncology drug candidates, which include monoclonal antibodies (mAbs), antibody drug conjugates (ADCs), oncolytic virus products and specialty oncology drugs such as liposome drugs, targeting various types of cancers.

The Company focuses on achieving a diverse product mix. The Company’s comprehensive product pipeline consists of seven biological and five chemical drug candidates, 11 of which are in-house developed. Product pipeline covers a wide variety of cancer types and extended applications with sustainable launch schedule. Leveraging commercial-scale manufacturing and proven sales and marketing capabilities of TOT BIOPHARM, the Company is able to shorten time-to-market and time-to-peak sales of the products when approved.

At present, four biological drug candidates of TOT BIOPHARM are in the clinical stage. Moreover, the Company has submitted the ANDA for one chemical drug candidate, which was accepted by the NMPA in July 2019. In addition, two chemical drug candidates of the Company are undergoing CMC or BE study. The Company targets to launch the products from 2020.

Full Industry Value Chain Capabilities, Attractive to Quality Business Partner

Since inception in 2009, the Group has built and established a fully integrated in-house platform of discovery, process development, quality management, pre-clinical and clinical development, as well as commercial-scale manufacturing facilities and proven sales and marketing capabilities, which provides flexibility and scalability for its business to expand along the innovative drug industry value chain. Equipped with full industry value chain capabilities, TOT BIOPHARM adopts an open platform business model under which the Company collaborates with third party business partners at different stages of the industry value chain. Benefiting from the strong platform capabilities, the Company has great support from several reputable investors such as Vivo Capital and Advantech Capital.

Ms. Yeh-Huang Chun-Ying, Executive Director and General Manager of TOT BIOPHARM said, "Since the inception of TOT BIOPHARM, we strive to develop innovative drugs that have high viability for commercialization and clear market demands to reach a wider group and benefit the majority of patients. Currently, our product pipeline consists 12 of biological and chemical drug candidates, of which our core product TAB008 is expect to launch between late 2020 and early 2021. In the future, we target to commercialize these pipeline products in China once approved and plan to establish our presence in the overseas markets in the long term."

One of the First Mover in Bevacizumab Market

The bevacizumab market in China has significant growth potential. The bevacizumab market in China is expected to reach RMB3.2 billion in 2018 and is estimated to grow to RMB13.1 billion in 2023, representing a CAGR of 32.7%, according to Frost & Sullivan.

TAB008, the most advanced biological drug candidate and Core Product of the Company, is currently undergoing Phase III clinical trials in China, and is expected to be launched between the end of 2020 and early 2021, subject to regulatory approval. It is an anti-VEGF mAb and biosimilar drug candidate to bevacizumab, which will be sold under the trade name of Avastin. The Company adopts and develops cost-effective technologies the Company use 2,000L bioreactors to manufacture TAB008, demonstrating the readiness for cost-efficient commercial production. Leveraging commercial-scale manufacturing and proven sales and marketing capabilities of, the Company is able to shorten time-to-market and time-to-peak sales of our TAB008 when approved.

Well-Established and Advanced Technology Platforms and Manufacturing Facilities

The Company owns and operates cost-efficient commercial-scale and state-of-the-art manufacturing facilities, built to and operating at international standards, at Suzhou Production Center, of which the No. 2 campus has a designed capacity of 16,000L to accommodate high-quality commercial manufacturing. At the same time, TOT BIOPHARM has established three advanced technology platforms, including the Therapeutic Monoclonal Antibody and ADC Technology Platform, the Gene Engineering Based Therapeutics Technology Platform and the Innovative Drug Delivery Technology System, to develop different types of oncology drugs. TOT BIOPHARM owns self-developed know-how for manufacturing processes and developed a robust product pipeline, which will continue to further the clinical and pre-clinical development of drug candidates and manage pipeline development to achieve fast-to-market commercialization. Supported by three advanced technology platforms, the Company has gained five invention patents and one utility model patent in China.

Industry-leading Talent Base

TOT BIOPHARM has assembled a senior management team with extensive experience and profound knowledge in cancer treatment. The senior management team of the Company represents a full spectrum of complementary skillsets, including pre-clinical research, clinical development, manufacturing, quality control and assurance and commercialization, and broad experience in different cancer treatments including mAbs, ADCs, oncolytic virus and specialty oncology drugs, which lead the Company to achieve future success. The Company’s research and development staff are also able to progress the development efficiently, keep track of achievements in their respective fields and create innovative solutions.

Ms. Yeh-Huang Chun-Ying concluded, "Looking ahead, TOT BIOPHARM’s mission is to build a leading brand name of oncology treatments trusted by patients and their families as well as medical professionals in China. We believe, by commercializing TAB008, rapidly advancing our clinical trials for drug candidates, enriching product portfolio by focusing on immune-oncology combination therapies, strengthening our in-house sales and marketing force and commercial-scale manufacturing capacities and maximizing the value of our integrated platform, the Group has even brighter prospects."

On November 7, 2019 Genomic Health, Inc. (NASDAQ: GHDX) reported that its stockholders voted to approve the company’s proposed combination with Exact Sciences Corp (NASDAQ: EXAS) at a special meeting held earlier (Press release, Genomic Health, NOV 7, 2019, View Source [SID1234550716]).

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As previously announced on July 29, 2019, Genomic Health and Exact Sciences entered into the merger agreement by which Exact Sciences will acquire Genomic Health in a cash and stock transaction. With the receipt of the required stockholder approval, Genomic Health and Exact Sciences expect to close the transaction on Friday, November 8 subject to satisfaction of the remaining customary closing conditions.

Final vote tallies from the Genomic Health special meeting of stockholders are subject to certification by the Company’s inspector of elections and will be included in a report to be filed by the Company with the Securities and Exchange Commission (the "SEC").

On November 7, 2019 Affimed N.V. ("Affimed" or the "Company") (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported that it has commenced an underwritten public offering of its common shares (Press release, Affimed, NOV 7, 2019, View Source [SID1234550715]). The Company expects to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the number of common shares sold in connection with the offering. All of the shares in the offering will be sold by Affimed. This offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Jefferies LLC and SVB Leerink LLC are acting as joint book-running managers of the offering. A shelf registration statement relating to these securities filed with the Securities and Exchange Commission (the "SEC") was declared effective by the SEC on November 7, 2018. The offering will be made only by means of a prospectus and prospectus supplement. A preliminary prospectus supplement and accompanying prospectus related to the offering have been filed with the SEC and are available at the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus related to the offering may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388 or by email at [email protected], or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.