On November 8, 2021 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, reported financial results for the third quarter ended September 30, 2021 (Press release, Allakos, NOV 8, 2021, View Source [SID1234594699]).

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Recent Accomplishments

Presented data at American College of Gastroenterology (ACG) 2021 Annual Scientific Meeting from prospective study showing high prevalence rates of eosinophilic gastritis and/or eosinophilic duodenitis (EG/EoD) with systemic evaluation. Forty-five percent (45%, 181/405) of patients with moderate-to-severe unexplained gastrointestinal symptoms who underwent upper endoscopy with biopsy met the diagnostic criteria for EG/EoD. This data suggests that these conditions are significantly underdiagnosed and may be a common cause of moderate-to-severe gastrointestinal symptoms.
Upcoming 2021 Milestones

Topline data from a Phase 3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with EG/EoD expected in the fourth quarter of 2021 or early in the first quarter of 2022.
Topline data from a Phase 2/3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with EoE expected in the fourth quarter of 2021 or early in the first quarter of 2022.
Initiation of a Phase 2/3 randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with EG and/or EoD expected in the fourth quarter of 2021.
Initiation of a Phase 2 randomized, double-blind, placebo-controlled study in a non-eosinophilic gastrointestinal disease in the fourth quarter of 2021.
Third Quarter 2021 Financial Results

Research and development expenses were $43.6 million in the third quarter of 2021 as compared to $30.4 million in the same period in 2020, an increase of $13.2 million.

General and administrative expenses were $19.1 million in the third quarter of 2021 as compared to $12.1 million in the same period in 2020, an increase of $7.0 million.

Allakos reported a net loss of $62.7 million in the third quarter of 2021 as compared to $42.1 million in the same period in 2020, an increase of $20.6 million. Net loss per basic and diluted share was $1.16 for the third quarter of 2021 compared to $0.86 in the same period in 2020.

Allakos ended the third quarter of 2021 with $505.6 million in cash, cash equivalents and marketable securities.

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

Please dial-in 15 minutes early to ensure a timely connection to the call.

On November 8, 2021 Affimed N.V. (Nasdaq: AFMD) and NKGen Biotech, both clinical stage biotech companies focused on harnessing the power of the body’s innate immune system, reported the initiation of patient recruitment in the open-label, multi-center phase 1/2a study (NCT05099549) evaluating the safety, tolerability, and anti-tumor activity of the innate cell engager (ICE) AFM24 (Affimed’s tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding ICE) in combination with SNK01 (ex vivo expanded and activated autologous NK cell therapy from NKGen Biotech) (Press release, NKMax America, NOV 8, 2021, View Source [SID1234594731]).

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The objective of the phase 1 dose escalation is to evaluate safety and tolerability data for escalating AFM24 doses in combination with a fixed dose of SNK01 and to determine the maximum tolerated and recommended phase 2 dose for the expansion phase. Phase 2a will investigate additional tolerability, safety and anti-tumor activity. The trial will include patients with non-small cell lung cancer (NSCLC, EGFR-wildtype), squamous cell carcinoma of the head and neck (SCCHN), as well as patients with microsatellite instability (MSI) low/DNA mismatch repair proficient colorectal cancer (CRC) regardless of KRAS mutational status.

"Existing therapeutics that target EGFR rely on inhibiting EGFR signaling, an approach that has been hampered by intrinsic and acquired resistance mechanisms," said Dr. Anthony El-Khoueiry, Phase I Program Director at the USC Norris Comprehensive Cancer Center, part of Keck Medicine of USC. El-Khoueiry is also associate professor of clinical medicine, Keck School of Medicine of USC and principal investigator for the study. "The combination of AFM24 with SNK01 represents a novel approach to leverage EGFR expression in multiple solid tumor types and optimally engage the innate immune system; this may be especially beneficial for patients with an impaired immune system or low NK cell numbers."

The clinical study is supported by preclinical data generated through the collaboration of Affimed and NKGen Biotech, including data that were recently presented at the AACR (Free AACR Whitepaper)-NCI-EORTC conference on Molecular Targets and Cancer Therapeutics. In the preclinical studies, AFM24 demonstrated robust binding to SNK01 cells and enhancement of the cytotoxic activity of SNK01 cells towards EGFR-positive A-431 cells, compared to untargeted SNK01 cells. In addition, markers for NK cell degranulation and intracellular IFNγ were increased in the combined therapy, indicating increased anti-tumor activity.

The AACR (Free AACR Whitepaper)-NCI-EORTC conference presentation may be found at: View Source and View Source

About AFM24

AFM24 is a tetravalent, bispecific innate cell engager (ICE) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

In addition to the AFM24-103 study presented here, Affimed is evaluating AFM24 as a monotherapy (AFM24-101) for patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies. The first-in-human phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation and expansion study and can be found at www.clinicaltrials.gov using the identifier NCT04259450.

About SNK01

SNK01 is a cell-based, patient-specific, ex vivo expanded and activated autologous NK cell therapy agent, manufactured from the patient’s leukapheresis or whole blood. NK cells are a subset of cytotoxic lymphocytes with the ability to directly attack virally infected cells or cancer cells and carry out immunoregulatory functions by the secretion of cytokines and chemokines.

On November 8, 2021 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported that Janux management will participate in fireside chats at two upcoming virtual investor conferences (Press release, Janux Therapeutics, NOV 8, 2021, View Source [SID1234594748]):

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Cowen’s 5th Annual IO Next Summit
Forum: Fireside Chat
Date: Monday, November 15th, 2021
Time: 12:15-12:35 p.m. ET

Evercore ISI 4th Annual Health CONx Virtual Conference
Forum: Fireside Chat
Date: Thursday, December 2nd, 2021
Time: 2:40 – 3:00 p.m. ET

Both fireside chats and subsequent archived replays may be accessed via the Investors & Media section of Janux’s website. An archived replay of both webcasts will be available on the website for approximately 90 days following the presentation.

On November 8, 2021 Idera Pharmaceuticals, Inc. ("Idera," the "Company," "we," "us," or "our") (Nasdaq: IDRA) reported its financial and operational results for the third quarter ended September 30, 2021 (Press release, Idera Pharmaceuticals, NOV 8, 2021, View Source [SID1234594796]).

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"We are maintaining our focus on identifying new development or commercial-stage assets for Idera’s portfolio and we are encouraged by the opportunities presented to us," stated Vincent Milano, Idera’s Chief Executive Officer. "As a number of these prospects advance and as we continue to preserve cash, we remain optimistic in Idera’s future potential."

Added Mr. Milano, "Studies also continue in patients with microsatellite-stable colorectal cancer (ILLUMINATE-206) and, in partnership with AbbVie, in patients with head and neck squamous cell carcinoma. We expect to share results from the second stage of ILLUMINATE-206, which involves tilsotolimod in combination with Bristol Myers Squibb’s nivolumab and ipilimumab, by the end of the year."

Third Quarter Financial Results
Our cash position as of September 30, 2021 was $36.6 million. Research and development expenses for the three months ended September 30, 2021 totaled $3.5 million, compared to $4.8 million for the same period in 2020. General and administrative expense for the three months ended September 30, 2021 totaled $2.3 million, compared to $2.7 million for the same period in 2020. Restructuring costs for the three months ended September 30, 2021 totaled approximately $0.1 million and relate to a reduction in force initiated in April 2021 to better align our workforce to our ongoing operational and business development activities. No such costs were incurred during the three months ended September 30, 2020. Additionally, during the three months ended September 30, 2020, we recorded $0.7 million and $12.4 million non-cash warrant revaluation loss and non-cash future tranche right revaluation loss, respectively, related to securities issued in connection with our December 2019 private placement transaction. No such non-cash losses were recognized in the three months ended September 30, 2021.

As a result of the factors above, net loss applicable to common stockholders for the three months ended September 30, 2021 was $6.0 million or $0.11 per basic and diluted share compared to net loss applicable to common stockholders of $20.6 million or $0.59 per basic and diluted share for the same period in 2020. Excluding the non-cash loss of approximately $13.1 million for the three months ended September 30, 2020 related to the securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $7.5 million.