On October 19, 2021 OncoMyx Therapeutics, a privately-held oncolytic immunotherapy company, reported two poster presentations at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting being held November 10-14, 2021, both virtually and in Washington, D.C (Press release, OncoMyx Therapeutics, OCT 19, 2021, View Source [SID1234594855]).

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Onsite posters will be presented in the Poster Hall at the Walter E. Washington Convention Center. The posters will be available for onsite viewing November 12-14 from 7am to 5pm EST. Even numbered posters will be presented Saturday, November 13. ePosters will be on display on the SITC (Free SITC Whitepaper) 2021 virtual meeting platform from 7am EST on Friday, November 12 until the virtual meeting platform is closed on January 9, 2022.

Titles of the presentations are as follows:

(742) Multi-armed myxoma virus induces potent anti-tumor responses in vitro and in vivo
(744) Multi-armed myxoma virus has therapeutic potential for treatment of multiple myeloma
Full abstracts will be available on November 9th on the SITC (Free SITC Whitepaper) 2021 Annual Meeting website. Posters for both presentations will be available on OncoMyx’s website on November 12th.

About Oncolytic Immunotherapy and Myxoma Virus

Oncolytic viruses (OV) selectively replicate in and lyse tumor cells and provide stimulation to the immune system, representing a promising therapeutic option in development to treat cancers that do not respond well tOncolytic viruses (OV) selectively replicate in and lyse tumor cells and provide stimulation to the immune system, representing a promising therapeutic option in development to treat cancers that do not respond well to treatment with immune checkpoint inhibitors. Myxoma virus (MYXV) is a member of the Pox family of double stranded DNA viruses. The natural host of MYXV is a subset of rabbits and hares, but MYXV is able to infect cancer cell lines of humans and other species. The genome of MYXV is relatively large and is amenable to engineering for expression of transgenic proteins, making it an excellent oncolytic virus for introduction of immunomodulatory proteins.

On October 20, 2021 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported that Laurence Reid, Ph.D., Chief Executive Officer of Decibel, will participate in a fireside chat at the Jefferies Gene Therapy/Editing Summit on Wednesday, October 27, 2021 at 10:30 am ET (Press release, Decibel Therapeutics, OCT 20, 2021, View Source [SID1234591569]).

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A live webcast of the fireside chat may be accessed by visiting the Investors section of the Decibel Therapeutics website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the fireside chat.

On October 20, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that it will host a webcast and conference call to provide a corporate and financial update for the third quarter of 2021 on Wednesday, November 3, 2021 at 8:30 a.m. ET (Press release, G1 Therapeutics, OCT 20, 2021, View Source [SID1234591586]).

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The live call may be accessed by dialing (866) 763-6020 (domestic) or (210) 874-7713 (international) and entering the conference code: 4404009. The live and archived webcast will be available on the Events & Presentations page of View Source

On October 20, 2021 Enzychem Lifesciences (KOSDAQ: 183490) reported that positive Phase 2 results from a U.S. clinical trial of its lead candidate EC-18 in chemoradiation-induced oral mucositis (CRIOM). EC-18, a novel, first-in-class, small molecule oral immunomodulator, reduced the duration and incidence of severe oral mucositis in patients with head and neck cancer undergoing concurrent chemoradiation therapy (Press release, Enzychem Lifesciences, OCT 20, 2021, View Source [SID1234591606]).

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CRIOM is a painful and debilitating side effect of chemoradiation in which patients experience severe mouth ulcerations that significantly impacts everyday activities, such as eating, swallowing, and talking. The pain from severe ulcerations can prevent a patient’s intake of solid food and fluids, leading to malnutrition and dehydration that requires hospitalization. Patients with the most severe form of oral mucositis often have to discontinue or modify their cancer treatment.

"Severe CRIOM affects almost 75% of patients being treated with concomitant chemoradiation for head and neck cancers with symptoms that are so severe that they challenge a patients’ ability to tolerate optimal treatment," said Dr. Stephen Sonis, Professor, Harvard School of Dental Medicine and Key Advisor for the U.S. Phase 2 CRIOM Study. "Despite its frequency and burden it places on patients and their caregivers, there is no approved pharmaceutical intervention. The results observed with EC-18 support its continued development and offer encouragement as an effective CRIOM therapy."

"We are delighted to announce these positive results from our Phase 2 U.S. study, which confirm that EC-18 is safe and well-tolerated," said Ki-Young Sohn, CEO & Chairman, Enzychem Lifesciences. "In addition, EC-18 may have a number of key advantages, including oral route of administration and convenience of use. We are excited to advance this novel candidate into a pivotal study and will also evaluate EC-18 for other radiation-induced inflammatory diseases."

The Phase 2 U.S. study evaluated EC-18 in oral mucositis in patients with concomitant chemo-irradiation (standard fractionated Intensity-Modulated Radiation Therapy with cisplatin) for cancers of the mouth, oropharynx, hypopharynx and nasopharynx. In Stage 1 of the study, 24 subjects were randomized to receive one of three doses of EC-18 (500 mg, 1000 mg, or 2000 mg; unit dose of 500 mg) or placebo. For Stage 2 of the study, 81 patients were randomized to receive either placebo or 2000 mg of EC-18 twice-daily over a period of approximately 7 weeks.

EC-18 successfully met both its primary and secondary endpoints in terms of efficacy and safety in the Phase 2 U.S. study. Patients on EC-18 reported a reduction in the duration of severe oral mucositis (SOM) through a short-term follow-up period from 13.5 days to 0 day (100% reduction) in comparison to the placebo arm. EC-18 also reduced the incidence of SOM through completion of radiation by 37.1% in comparison to the placebo arm (65% vs. 40.9%). The incidence of SOM through a short-term follow-up period was reduced by 35.1% in comparison to the placebo arm (70% vs. 45.5%). No serious adverse events (SAE) were reported between placebo and EC-18 groups and none of the SAEs were related to EC-18. Safety was also comparable across arms with all adverse events (AEs) attributable to expected chemoradiation-related toxicity. One-year long-term follow-up for tumor outcomes is ongoing.

Based on positive Phase 2 data, Enzychem plans to file for Breakthrough Therapy Designation to the FDA later this year, and advance EC-18 into a global Phase 3 clinical program.

On October 20, 2021 Biogen Inc. (Nasdaq: BIIB) reported third quarter 2021 financial results (Press release, Biogen, OCT 20, 2021, View Source [SID1234591629]).

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"The potential uptake of ADUHELM in the U.S. is delayed, but we continue to believe in its long-term potential. At the same time, Biogen has continued to execute well across its leading MS, SMA and biosimilars businesses, and we are particularly encouraged by the ongoing launch of VUMERITY," said Michel Vounatsos, Biogen’s Chief Executive Officer. "2021 continues to be a transformative year for Biogen with the launch of ADUHELM and the initiation of the rolling submission for lecanemab in Alzheimer’s disease. In addition, along with Sage Therapeutics we are pursuing a filing for zuranolone in depression."

Third Quarter 2021 Financial Results
• Third quarter total revenue of $2,779 million decreased 18% versus the prior year at both actual currency and constant currency*. o Multiple sclerosis (MS) revenue, including royalties on sales of OCREVUS, of $1,820 million decreased 19% versus the prior year at actual currency and 20% at constant currency. o SPINRAZA revenue of $444 million decreased 10% versus the prior year at actual currency and 11% at constant currency. o ADUHELM revenue was $0.3 million. o Biosimilars revenue of $203 million decreased 2% versus the prior year at actual currency and 4% at constant currency. 2
• Third quarter GAAP net income and diluted earnings per share (EPS) attributable to Biogen Inc. were $329 million and $2.22, respectively.
• Third quarter Non-GAAP net income and diluted EPS attributable to Biogen Inc. were $710 million and $4.77, respectively. A reconciliation of GAAP to Non-GAAP financial measures included in this news release can be found in Table 4 at the end of this news release. * Percentage changes in revenue growth at constant currency are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. The current period’s foreign currency revenue values are converted into U.S. dollars using the average exchange rates from the prior period.Beginning in the second quarter of 2021 material upfront payments and premiums paid on the acquisition of common stock associated with significant collaboration and licensing arrangements along with the related transaction costs incurred are no longer excluded from Non-GAAP R&D and SG&A expenses. Non-GAAP financial results for the third quarter of 2020 have been updated to reflect the $601 million payment related to the collaboration with Denali Therapeutics Inc. along with the associated transaction costs and income tax effect. o Third quarter 2021 GAAP and Non-GAAP R&D expense includes a $125 million upfront payment related to our collaboration with InnoCare Pharma Limited. In addition, during the third quarter we suspended further development of BIIB111 (timrepigene emparvovec) in choroideremia and BIIB112 (cotoretigene toliparvovec) in X-linked retinitis pigmentosa and recorded $39 million of estimated clinical trial close-out costs and manufacturing commitments. o Third quarter 2021 GAAP and Non-GAAP SG&A expense increased versus the prior year primarily due to investments in support of the launch of ADUHELM. Beginning in the second quarter, upon FDA approval, the reimbursement from Eisai for its share of U.S. ADUHELM SG&A expenses is reflected in collaboration profit sharing rather than SG&A.

3 • Third quarter 2021 GAAP amortization and impairment of acquired intangible assets was $111 million, including an impairment charge of $15 million related to BIIB111 and a $28 million impairment charge related to BIIB112. These amounts are excluded from Non-GAAP financial results. Non-GAAP amortization was $7 million.
• Third quarter 2021 GAAP and Non-GAAP collaboration profit sharing was a net expense of $21 million, which includes a reimbursement of $51 million from Eisai Co., Ltd. (Eisai) related to the commercialization of ADUHELM in the U.S.
• Third quarter 2021 GAAP other expense was $503 million, primarily driven by unrealized losses on our strategic equity investments of $424 million. Third quarter 2021 Non-GAAP other expense was $79 million, primarily driven by interest expense.
• Third quarter 2021 effective GAAP and Non-GAAP tax rates were (8.9%) and 14.5%, respectively. The third quarter 2021 effective GAAP tax rate was impacted by non-cash tax favorability from both the unrealized losses on our strategic equity investments and the previously described impairment charges related to BIIB111 and BIIB112. Financial Position
• As of September 30, 2021, Biogen had $7,271 million in total debt. Cash, cash equivalents, and marketable securities totaled $3,923 million. This resulted in net debt of $3,348 million.
• In the third quarter of 2021 Biogen repurchased approximately 2.2 million shares of the Company’s common stock for a total value of $750 million.
As of September 30, 2021, there was $2,800 million remaining under the share repurchase program authorized in October 2020.
• For the third quarter of 2021 the Company’s weighted average diluted shares were 149 million.
• Third quarter 2021 cash from operations was $805 million. Capital expenditures were $42 million, and free cash flow, defined as cash flow from operations less capital expenditures, was $763 million.