On November 8, 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 its participation in the fifth annual Barclays Gene Editing & Gene Therapy Summit on Monday, November 15, 2021 (Press release, Decibel Therapeutics, NOV 8, 2021, View Source [SID1234594719]). Laurence Reid, Ph.D., Chief Executive Officer of Decibel, will participate in a fireside chat at 3:30 pm ET and in a panel discussion titled "Addressing Development Challenges and the Regulatory Hurdles" at 4:45 pm ET.

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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 November 8, 2021 Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for patients of all ages with genomically defined cancers, reported financial results for the third quarter of 2021 and highlighted recent corporate achievements (Press release, Day One, NOV 8, 2021, View Source [SID1234594718]).

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"We continue to build momentum in our lead program with the granting of Rare Pediatric Disease Designation for DAY101 for the treatment of pediatric low-grade glioma during the third quarter," said Jeremy Bender, Ph.D., chief executive officer of Day One. "Additionally, with the further strengthening of our leadership team and continued progress with enrollment in our pivotal Phase 2 study, FIREFLY-1, we remain on track to present initial clinical data from this trial in the first half of 2022. We continue to grow our company, advance our development programs, and work to achieve our mission of impacting the lives of all people with cancer, whatever their age, starting from Day One."

Program Highlights

FIREFLY-1, a pivotal Phase 2 clinical trial of DAY101 in pediatric low-grade glioma (pLGG), continues active enrollment; initial data are expected in the first half of 2022. The single arm, open-label, global registrational Phase 2 study is anticipated to enroll 60 patients and has activated approximately 25 sites globally.

Day One will present a poster at the 2021 Connective Tissue Oncology Society (CTOS) Virtual Annual Meeting on November 12, 2021. The poster reviews a compassionate use case of a child with recurrent spindle cell sarcoma harboring a novel SNX8-BRAF gene fusion who had exhausted all treatment options, including a MEK inhibitor, and was treated with DAY101 monotherapy. Following treatment, the patient’s symptoms resolved and there was no evidence of measurable disease at the site of previously visualized tumor, indicating a complete response to treatment with DAY101.

Day One is also conducting a Phase 2 monotherapy trial of DAY101 in adult patients with recurrent, progressive, or refractory solid tumors harboring MAPK pathway aberrations.
Corporate Highlights

Day One strengthened its leadership team with appointment of Jaa Roberson as chief people officer. Ms. Roberson will oversee all aspects of Day One’s human resources and talent acquisition efforts as the Company continues to grow.

The Company recently expanded its board of directors with the appointment of Scott Garland. Mr. Garland is a 30-year veteran of the biopharmaceutical industry with deep commercial and executive leadership experience.
Third Quarter 2021 Financial Highlights

Cash Position: Cash and cash equivalents and short-term investments totaled $297.2 million at September 30, 2021. Based on Day One’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations into the second half of 2023.

R&D Expenses: Research and development expenses were $9.8 million for the third quarter 2021 compared to $2.5 million for the third quarter 2020. The increase was primarily due to additional employee compensation costs, clinical trial expenses, and CMC activity.

G&A Expenses: General and administrative expenses were $9.4 million for the third quarter 2021 compared to $1.0 million for the third quarter 2020. The increase was primarily due to additional employee compensation costs, legal, and professional expenses associated with operating as a public company.

Net Loss: Net loss totaled $19.2 million and $3.8 million for the third quarters of 2021 and 2020, respectively, with non-cash stock compensation expense of $5.1 million and $0.1 million for the third quarters of 2021 and 2020, respectively.
Upcoming Events

Connective Tissue Oncology Society (CTOS) Virtual 2021 Annual Meeting (November 10-13, 2021) Day One will present the following poster:

Title: "Activity of Pan-Raf Inhibitor Day101 in a Pediatric Patient with a Recurrent Spindle Cell Sarcoma Harboring a Novel SNX8:BRAF Gene Fusion"
Presenter: Katherine Offer, MD
Date: Friday, November 12, 2021
Time: 2:30 PM – 3:15 PM EST
30th Annual Credit Suisse Virtual Healthcare Conference, November 8-11, 2021
33rd Annual Piper Sandler Healthcare Conference, November 29-December 3, 2021
About DAY101
DAY101 is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway. Studies have shown DAY101 has high brain distribution and exposure in comparison to other MAPK pathway inhibitors, thus potentially benefiting patients with primary brain tumors or brain metastases of solid tumors. DAY101 is a type II RAF inhibitor found to selectively inhibit both monomeric and dimeric RAF kinase, which may broaden its potential clinical application to treat an array of RAF-altered tumors.

DAY101 has been studied in over 250 patients, and as a monotherapy demonstrated good tolerability and encouraging anti-tumor activity in pediatric and adult populations with specific MAPK pathway-alterations. In November 2020, Day One announced preliminary results from PNOC014, an ongoing Phase 1 Pacific Pediatric Neuro-Oncology Consortium (PNOC) network study with DAY101 sponsored by the Dana-Farber Cancer Institute. Preliminary results demonstrated that of the eight relapsed pLGG patients in the study with RAF fusions, two patients achieved a complete response by Response Assessment for Neuro-Oncology (RANO), three had a partial response, two achieved prolonged stable disease, and one experienced progressive disease. DAY101 also demonstrated a tolerable safety profile with the most common side effects being skin rash and hair color changes.

DAY101 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with pLGG harboring an activating RAF alteration who require systemic therapy and who have either progressed following prior treatment or who have no satisfactory alternative treatment options. The FDA has also granted Rare Pediatric Disease Designation to DAY101 for the treatment of low-grade gliomas harboring an activating RAF alteration that disproportionately affects children. In addition, DAY101 has received Orphan Drug designation from the FDA for the treatment of malignant glioma and orphan designation from the European Commission for the treatment of glioma.

Day One is conducting a pivotal Phase 2 trial (FIREFLY-1) of DAY101 in pediatric, adolescent and young adult patients with pLGG. Day One also plans to study DAY101 alone or in combination with other agents that target key signaling nodes in the MAPK pathway, such as the Company’s MEK inhibitor pimasertib, in patient populations where various RAS and RAF alterations are believed to play an important role in driving disease.

On November 8, 2021 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the first patient has been dosed in the combination therapy portion of the Phase 1/2 clinical study evaluating CA-4948, a novel, small molecule IRAK4 kinase inhibitor, in acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) (Press release, Curis, NOV 8, 2021, View Source [SID1234594717]).

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"We are very pleased to announce the initiation of our Phase 1 combination therapy study of CA-4948, which is an important part of our development strategy to address the broader AML/MDS patient population," said James Dentzer, President and Chief Executive Officer of Curis. "This comes on the heels of the promising initial monotherapy data with CA-4948 in this patient population. Armed with these results and combined with preclinical data highlighting CA-4948’s synergistic antitumor activity when used in combination with azacitidine and venetoclax, and the absence of overlapping dose-limiting toxicity, we are hopeful that this combination portion of the trial will allow us to advance CA-4948 as a promising new treatment for an additional population of patients with AML/MDS."

"Based on CA-4948’s initial efficacy and tolerability in monotherapy, we are looking forward to exploring safety and efficacy for CA-4948 in combination with azacitidine or venetoclax," said Dr. Stefano Tarantolo, M.D., hematologist and oncologist at Nebraska Cancer Specialists and a leading investigator on the study. "We are hopeful that CA-4948 may offer an important new treatment option, as many of these patients are ineligible for intensive chemotherapy and face an extremely poor prognosis."

About the CA-4948 Phase 1/2 Study in Patients with AML/MDS

The Phase 1/2 study was expanded to include both a monotherapy dose expansion and a combination dose escalation. The monotherapy portion of the study includes R/R MDS patients with and without a spliceosome mutation and R/R AML patients with and without a FLT3 mutation. The combination therapy portion of the study includes two arms: CA-4948 plus azacitidine, for patients naïve to HMA, and CA-4948 plus venetoclax, for patients naïve to venetoclax.

When combined with azacitidine, CA-4948 will be dosed at 200 mg twice daily for 21 days of a 28-day cycle, followed by a 300 mg dose cohort if tolerability allows. Azacitidine will be given in 7 consecutive doses or split doses starting at 75 mg/m2.

When combined with venetoclax, CA-4948 will be dosed at 200 mg twice daily for 21 days of a 28-day cycle, followed by a 300 mg cohort if tolerability allows. Venetoclax will be administered at 100 mg orally with a ramp up over 3 days to 400 mg for 21 days of a 28-day cycle.

The primary objective of the combination portion of the study is to determine the recommended Phase 2 dose (RP2D) for CA-4948 in combination with azacitidine and in combination with venetoclax based on safety and tolerability, dose-limiting toxicities (DLT), and any biologic activity, pharmacokinetic and pharmacodynamic findings from the study population. Additional objectives include characterization of CA-4948’s pharmacokinetic parameters and overall response rate.

On November 8, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT) ("Corcept") a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported that it has commenced a modified Dutch Auction tender offer for the purchase of up to 10 million shares of Corcept’s common stock, par value $0.001 per share (each, a "Share," and collectively, "Shares") or such lesser number of Shares as are properly tendered and not properly withdrawn, at a price not greater than $23.75 per Share nor less than $20.75 per Share, to be paid to the seller in cash less any applicable withholding taxes (Press release, Corcept Therapeutics, NOV 8, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-commencement-tender-offer [SID1234594716]). The tender offer is made in accordance with the terms and subject to the conditions described in the offer to purchase, the related letter of transmittal and other related materials, as each may be amended or supplemented from time to time.

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The closing price of the Shares on The Nasdaq Stock Market on November 5, 2021, the last full trading day before the start of the tender offer, was $20.68 per Share. The tender offer is scheduled to expire one minute after 11:59 P.M., New York City Time, December 7, 2021, unless the offer is extended or terminated.

Corcept believes that the repurchase of Shares pursuant to the tender offer is consistent with its long-term goal of maximizing stockholder value and that the tender offer is an efficient way to give stockholders the opportunity to receive a return of their investment by tendering some or all of their Shares.

The tender offer is contingent upon at least three million Shares being tendered. The tender offer is also subject to terms and conditions, which are described in detail in the offer to purchase. Specific instructions and a complete explanation of the terms and conditions of the tender offer are contained in the offer to purchase, the related letter of transmittal and other related materials, which will be mailed to stockholders of record promptly.

None of Corcept, the members of its Board of Directors, the dealer manager, the financial advisor, the information agent or the depositary for the tender offer makes any recommendation as to whether or not any stockholder should participate in the tender offer or as to the purchase price or purchase prices at which stockholders may choose to tender their Shares.

The sole dealer manager for the tender offer is Truist Securities, Inc. D.F. King is serving as the information agent for the tender offer and Continental Stock Transfer & Trust Company is serving as the depositary. Canaccord Genuity LLC is serving as a financial advisor. For all questions relating to the tender offer, please contact the information agent, D.F. King & Co., Inc. at [email protected] or call toll-free at 1 (800) 431-9646, or call the dealer manager, Truist Securities, Inc. at 1 (404) 926-5832.

On November 8, 2021 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported financial results for the quarter ended September 30, 2021 and highlighted recent achievement of key milestones toward potential near-term expansion of the commercial product portfolio (Press release, Coherus Biosciences, NOV 8, 2021, View Source [SID1234594715]):

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ACHIEVEMENT OF KEY MILESTONES DRIVING NEAR-TERM COMMERCIAL PRODUCT PORTFOLIO EXPANSION

Successful UDENCYA on-body injector clinical trial is expected to enable 2022 submission of a prior approval supplement to the UDENYCA BLA.
FDA accepted the BLA for CHS-201, a biosimilar Lucentis (ranibizumab), and assigned a target action date of August 2022.
FDA review of the BLA for CHS-1420, a biosimilar Humira (adalimumab), is advancing toward the target action date in December 2021.
FDA accepted the toripalimab BLA for advanced nasopharyngeal carcinoma and granted priority review with a target action date of April 2022.
Positive esophageal squamous cell carcinoma Phase 3 clinical data is expected to enable submission of a toripalimab BLA supplement in 2022.
Positive progression free survival data (PFS) from the CHOICE-01 Phase 3 clinical trial evaluating toripalimab in non-small cell lung cancer were presented in September. A final analysis of PFS and an additional interim overall survival analysis are expected by early first quarter 2022, after which Coherus and partner Junshi Biosciences plan to discuss a potential submission of a BLA supplement with FDA.
THIRD QUARTER 2021 FINANCIAL HIGHLIGHTS

Net product revenue, consisting of net sales of UDENYCA (pegfilgrastim-cbqv), was $82.5 million.
GAAP net loss of $38.5 million was driven by lower net product revenue and increased R&D and regulatory expenses to support the development and regulatory submissions of toripalimab and biosimilar pipeline product candidates.
Non-GAAP net loss was $26.6 million, adjusting for $11.9 million in stock-based compensation expense.
At September 30, 2021, cash, cash equivalents and marketable securities were $468.7 million.
"With three BLAs currently under FDA review, and positive clinical data expected to enable submission of multiple additional applications for marketing authorization in 2022, we are making rapid progress toward our goals to diversify and grow our commercial product portfolio," said Denny Lanfear, Coherus CEO. "UDENYCA continues to provide strong funding for Coherus as we invest in our pipeline and prepare for a succession of anticipated new product launches in 2022 and 2023."

THIRD QUARTER 2021 FINANCIAL RESULTS

Net product revenue, consisting of net sales of UDENYCA, was $82.5 million and $113.6 million during the three months ended September 30, 2021 and 2020, respectively, and $253.2 million and $365.4 million during the nine months ended September 30, 2021 and 2020, respectively. The decreases were primarily due to a decrease in the number of units of UDENYCA sold during the three and nine months ended September 30, 2021, as well as an increase in discounts and allowances during the nine months ended September 30, 2021.

Cost of goods sold (COGS) was $21.3 million and $9.0 million during the three months ended September 30, 2021 and 2020, respectively, and $45.5 million and $26.0 million during the nine months ended September 30, 2021 and 2020, respectively. Until the first quarter of 2021, Coherus sold inventory that was manufactured and expensed prior to the approval of UDENYCA in late 2018. This inventory was depleted in the first quarter of 2021, and COGS now fully reflects per unit acquisition cost. Additionally, COGS for the third quarter of 2021 included a $5.2 million write-off of inventory that did not meet Coherus’ acceptance criteria. UDENYCA COGS also includes a mid single digit royalty on net sales payable through the first half of 2024.

Research and development (R&D) expense for the three months ended September 30, 2021 was $54.1 million compared to $38.9 million for the same period in 2020, an increase of $15.2 million which was mainly the result of higher development and regulatory costs in support of the advancement of pipeline product candidates. For the nine months ended September 30, 2021, R&D expense was $312.3 million compared to $98.1 million for the same period in 2020, an increase of $214.2 million which included the $136.0 million upfront license fee paid to Junshi Biosciences in 2021.

Selling, general and administrative (SG&A) expense for the three months ended September 30, 2021 was $39.9 million compared to $32.0 million for the three months ended September 30, 2020, an increase of $7.9 million which was primarily driven by increased commercialization expenses to support UDENYCA sales. For the nine months ended September 30, 2021, SG&A expense was $119.7 million compared to $101.4 million for the same period in 2020, an increase of $18.3 million, which was primarily due to an increase of $10.7 million in stock-based and other compensation expense and an increase in UDENYCA commercialization expenses.

Net loss for the third quarter of 2021 was $38.5 million, or $(0.49) per share on a diluted basis, compared to a net income of $27.9 million, or $0.33 per share on a diluted basis for the same period in 2020.

Non-GAAP net loss for the third quarter of 2021 was $26.6 million, or $(0.34) per share on a diluted basis, compared to non-GAAP net income of $39.7 million, or $0.47 per share on a diluted basis for the same period in 2020. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net (loss) income and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and investments in marketable securities were $468.7 million as of September 30, 2021, compared to $454.4 million at June 30, 2021.

2021 FINANCIAL OUTLOOK

Excluding the upfront payment made to Junshi Biosciences in the first quarter, Coherus projects full year 2021 R&D and SG&A expenses in a range of $370 million to $400 million. R&D spending is focused on development, regulatory and other activities in preparation for the potential launch of toripalimab, as well as manufacturing-related and regulatory activities for CHS-1420 (Humira biosimilar), development activities for CHS-305 (Avastin biosimilar), and additional presentations of UDENYCA. Increases in SG&A spending in 2021 are primarily driven by marketing activities and headcount to support UDENYCA and the potential launches in 2022 of toripalimab and CHS-201 (Lucentis biosimilar).

This financial guidance excludes the effects of any potential future strategic acquisitions, collaborations or investments, the exercise of rights or options related to collaboration programs, and any other transactions or items not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below and the section titled "Risk Factors" in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 to be filed with the Securities & Exchange Commission on November 8, 2021.

Coherus is planning to host an analyst day event in January 2022.

Conference Call Information

When: Monday, November 8, 2021 starting at 5:00 p.m. ET

Dial-in: (844) 452-6826 (Toll-Free U.S. and Canada) or (765) 507-2587 (International)

Conference ID: 1838568

Webcast: View Source

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