On August 5, 2021 Imugene Ltd ("Imugene") (ASX: IMU), a clinical stage immuno-oncology company and Celularity Inc. ("Celularity") (Nasdaq: CELU), a clinical-stage biotechnology company developing off-the-shelf placental-derived allogeneic therapies, reported they have entered into a research collaboration in 2021 (Press release, Celularity, AUG 5, 2021, View Source [SID1234591814]). As part of the partnership, Imugene and Celularity will initially collaborate to develop the combination of Imugene’s CD19 oncolytic virus technology and Celularity’s CD19 targeting allogeneic chimeric antigen receptor (CAR) T cellular therapy, CYCART-19, for the treatment of solid tumors. CYCART-19 is a placental-derived T-cell therapy engineered with a CAR that is cryopreserved, allogeneic and available off-the-shelf to clinicians.

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Imugene exclusively licensed the CD19 oncolytic virus technology from City of Hope, a world-renowned independent cancer research and treatment center near Los Angeles. Imugene’s novel strategy to treat solid tumors uses an oncolytic virus to prime the tumor cells for destruction by eliciting the expression of a validated tumor marker, CD19, that can then be used as a target for CAR T cellular therapy.

"We believe the synergy between Celularity’s placental derived cells and our OnCARlytic platform has the potential to shift the cellular medicine paradigm," said Leslie Chong, Managing Director & Chief Executive Officer of Imugene. "In preclinical studies Celularity’s cellular therapies have shown the ability to overcome limitations that have hindered other approaches, including increased proliferation and persistence in vivo, resistance to T-cell exhaustion and low immunogenicity, which allows for repeated dosing. These unique characteristics perfectly align with our vision for a combination treatment strategy, and we look forward to closely working together to bring this treatment strategy to the clinic and patients in need."

Robert J. Hariri, M.D., Ph.D., founder, Chairperson and Chief Executive Officer of Celularity, said, "We are excited to initiate this research collaboration, which we believe will lay the foundation for a new approach to the treatment of solid tumors. Most solid tumors have variable targetable antigens, limiting CAR T-cell therapy efficacy. This treatment strategy with Imugene has the potential to apply to a new range of indications by enabling CD 19 targeted cellular medicine to expand from its current effective usage in CD19 positive lymphomas and leukemia and potentially become applicable to a variety of solid tumors through inducing uniform expression of CD19 in solid tumors.

On August 5, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported its financial results for the quarter ended June 30, 2021 and highlighted recent events (Press release, GlycoMimetics, AUG 5, 2021, View Source [SID1234585802]). Cash and cash equivalents at June 30, 2021 were $118.9 million.

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"There are now six trials underway evaluating our lead clinical candidate, uproleselan, including three registration trials and three ISTs, which we anticipate will provide clinical data flow beginning in 2022. Importantly, recruitment rates in both our Company-sponsored Phase 3 trial and the National Cancer Institute’s Phase 2 portion of the Phase 2/3 trial support our expectation that enrollment in both studies can be completed by the end of this year. The support of clinicians who are enrolling patients in our global studies, and now the new ISTs, has made it possible to broaden the scope of our uproleselan clinical research to address unmet needs in AML and beyond," commented Chief Executive Officer Rachel King.

Operational Highlights

Uproleselan

Enrollment of GlycoMimetics’ pivotal Phase 3 trial in relapsed/refractory AML continued in the U.S., Canada, Australia and Europe at a steady pace throughout the second quarter of 2021. The Company continues to project that enrollment will be completed by year-end 2021.
The pace of enrollment in the National Cancer Institute (NCI)-sponsored Phase 2/3 registration trial, designed to evaluate the use of uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy, continues to support the Company’s expectation that the Phase 2 portion will complete in 2021, and allow for a subsequent interim Event-Free Survival analysis of 262 patients.
During the quarter and shortly after the quarter close, clinicians initiated three ISTs designed to evaluate uproleselan in AML and in bone marrow transplantation for multiple myeloma. These trials are expected to begin producing clinical data in 2022, which the Company believes will support the potential of uproleselan to be used as a foundational treatment in AML to overcome well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment and reduce adverse effects of chemotherapy.
GMI-1359

In April 2021 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting, Duke University clinicians reported biologic activity, as demonstrated by cell mobilization, redistribution of immune subset profiles and changes in other pharmacodynamic markers, observed in the initial two patients treated in the ongoing Phase 1b study in patients with advanced breast cancer with bone metastases. The initial clinical data support the dual functionality of the compound and the potential of GMI-1359 to enhance responses to chemo and immune therapies.
GMI-1687

The Company continued to advance GMI-1687 towards filing of an investigational new drug application (IND), anticipated in the first half of 2022.
Management Transition

Yesterday, the Company announced that its Board of Directors has appointed Harout Semerjian as chief executive officer (CEO), effective August 6, 2021, to succeed Founding CEO Rachel King. Mrs. King, who has served as CEO since the Company’s founding, has decided to retire for personal reasons and will continue her involvement with the Company through her role on the Board of Directors and serving as an advisor during a transition period. Mr. Semerjian, a seasoned executive with strong commercial oncology experience, will lead the Company as it advances its registration trials for uproleselan in AML, accelerates planning for potential commercialization, and continues to build out the Company’s pipeline.
Second Quarter 2021 Financial Results

Cash position: As of June 30, 2021, GlycoMimetics had cash and cash equivalents of $118.9 million as compared to $137.0 million as of December 31, 2020.
R&D Expenses: Research and development expenses increased to $10.2 million for the quarter ended June 30, 2021 as compared to $9.9 million for the quarter ended June 30, 2020. This increase was primarily due to an increase in clinical trial costs in our ongoing global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML.
G&A Expenses: General and administrative expenses were $4.2 million for the second quarter ended June 30, 2021 and 2020.
Shares Outstanding: Shares of common stock outstanding as of June 30, 2021 were 51,539,010.
The Company will host a conference call and webcast today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants, with participant code 9977599. Participants are encouraged to connect 15 minutes in advance of the call to ensure they are able to connect. A webcast replay will be available via the "Investors" tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 for domestic participants and (404) 537-3406 for international participants, with participant code 9977599.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. FDA and from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4, which are adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow, such as AML and multiple myeloma, or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor affecting about 900 adolescents a year in the United States. GMI-1359 completed a Phase 1 clinical trial in healthy volunteers, and a Phase 1b clinical study designed to enable investigators to study dose ranging and to generate initial biomarker data around the drug’s activity in breast cancer patients is in progress. In the first two patients evaluated, the study showed evidence of on-target effects, immune-activation and cell mobilization. GMI-1359 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for the treatment of osteosarcoma.

About GMI-1687

Discovered and developed by GlycoMimetics, GMI-1687 is a highly-targeted, highly-potent E-selectin antagonist. It has been shown in preclinical studies to be bioavailable via subcutaneous administration. During 2020, data from oral presentations at major scientific conferences pointed to the potential for a self-administered drug to treat VOC of sickle cell disease. Previously, GlycoMimetics demonstrated in preclinical models that GMI-1687 could be a potentially self-administered drug to be used in treatment of AML. The investigational drug also represents a potential life-cycle extension opportunity for uproleselan.

On August 5, 2021 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the second quarter of 2021. Net loss for the second quarter was $61.6 million, or $0.86 per share, compared to net loss for the second quarter of 2020 of $40.8 million, or $0.68 per share (Press release, Cytokinetics, AUG 5, 2021, View Source [SID1234585849]). Cash, cash equivalents and investments totaled $424.0 million at June 30, 2021. After the quarter, Cytokinetics raised approximately $297.3 million in net proceeds after deducting the applicable underwriting discounts and commissions through a public offering of common stock. Cytokinetics expects to end 2021 with more than $600 million in cash.

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"During the second quarter, we made progress in advancing our late-stage muscle biology-directed pipeline and are now preparing for our first NDA submission while two other programs are expected to proceed in pivotal Phase 3 trials this year," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "Results from REDWOOD-HCM and GALACTIC-HF demonstrate the potential of modulating cardiac myosin to improve outcomes in patients with HCM and heart failure for which there are no medical treatments that address underlying impaired contractility. Following our recent financing, we are also taking steps to build our commercial organization in anticipation of our first potential product launch next year in parallel with our continued clinical progress."

Q2 and Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Engaged with the U.S. Food and Drug Administration (FDA) in both a Type C meeting and a pre-NDA meeting to inform our plans to submit a New Drug Application (NDA) for omecamtiv mecarbil in 2H 2021. The submission will be based on GALACTIC-HF which demonstrated a positive effect on the primary composite endpoint of cardiovascular death or heart failure events in patients with heart failure and reduced ejection fraction who were receiving standard of care plus omecamtiv mecarbil.

Results from a secondary analysis of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) were presented at the American College of Cardiology 70th Annual Scientific Session & Expo (ACC.21) showing that the treatment effect of omecamtiv mecarbil increased progressively as baseline ejection fraction decreased. The results were also published in the Journal of the American College of Cardiology.

Additional results from GALACTIC-HF were presented at Heart Failure 2021, an International Congress of the European Society of Cardiology demonstrating that the patients who derived greater treatment benefit from omecamtiv mecarbil included patients without atrial fibrillation or flutter, patients with higher baseline NT-proBNP and patients with severe heart failure based on modified criteria from the Heart Failure Association of the European Society of Cardiology (ESC-HFA) advanced heart failure position statement.

Completed enrollment in METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil. We expect to complete conduct of METEORIC-HF by year end and report results in early 2022.

Expanded Medical Affairs team and activities. Hired medical directors and deployed Medical Science Liaisons in key U.S. locations. Organized framework for the Investigator Sponsored Study Program.

Established Go-to-Market-strategy and conducted commercial readiness activities, including organizational design, market research, forecasting, market access preparations and supply chain and logistics planning.
aficamten (CK-3773274, cardiac myosin inhibitor)

Received approval from the World Health Organization and the United States Adopted Name Council for aficamten to be used as the International Nonproprietary Name for CK-3773274.

Announced positive topline results from Cohorts 1 and 2 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM) demonstrating that treatment with aficamten for 10 weeks resulted in statistically significant reductions from baseline compared to placebo in the average resting left ventricular outflow tract pressure gradient (LVOT-G) (p=0.0003, p=0.0004, Cohort 1 and Cohort 2, respectively) and the average post-Valsalva LVOT-G (p=0.001, p<0.0001, Cohort 1 and Cohort 2, respectively). The majority of patients treated with aficamten (78.6% in Cohort 1 and 92.9% in Cohort 2) achieved the target goal of treatment, defined as resting gradient <30 mmHg and post-Valsalva gradient <50 mmHg at Week 10 compared to placebo (7.7%). Treatment with aficamten in REDWOOD-HCM was generally well tolerated. The incidence of adverse events was similar between treatment arms. No serious adverse events were attributed to aficamten and no treatment interruptions occurred on aficamten, and no new cases of atrial fibrillation in patients treated with aficamten were reported.

Opened enrollment in Cohort 3 of REDWOOD-HCM for patients whose background therapy includes disopyramide. Activated the first site for enrollment in REDWOOD-HCM OLE, the open label extension clinical study designed to assess the long-term safety and tolerability of aficamten in patients with symptomatic obstructive HCM who have participated previously in REDWOOD-HCM.

Engaged FDA in a Type C meeting and subsequent end-of Phase 2 interaction to review the design of the planned Phase 3 clinical trial of aficamten in patients with obstructive HCM as well as the intended dosing strategy. Feedback was supportive of our objectives and progression.

Conducted preparations for a pivotal Phase 3 clinical trial of aficamten in patients with obstructive HCM, expected to begin in Q4 2021.

Ji Xing Pharmaceuticals continued enrolling patients in a Phase 1 study of aficamten in China and is preparing to participate in the planned Phase 3 clinical trial of aficamten in patients with obstructive HCM.

Presented scientific data related to the optimization of aficamten, including the first disclosure of its chemical structure, at the American Chemical Society Spring 2021 Virtual Meeting.
Skeletal Muscle Program

reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))

Recently started COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), the planned pivotal Phase 3 clinical trial of reldesemtiv in patients with ALS.
Pre-Clinical Development and Ongoing Research

Continued to advance new chemical entities and to conduct IND-enabling studies with expectation of our potentially advancing 1-2 potential drug candidates into clinical development over the next year.

Continued research activities directed to our other muscle biology research programs.
Corporate

Raised approximately $297.3 million in net proceeds, after deducting underwriting discounts and commissions from an underwritten public offering of 11,500,000 shares of common stock including the underwriter’s exercise of their overallotment option.

Executed agreements related to the termination of our Collaboration Agreement with Amgen and the transition to Cytokinetics of the development and commercialization rights for omecamtiv mecarbil and CK-136.

Announced the continuation of our partnership with The ALS Association in the fight against ALS.
Financials

Revenues for the three and six months ended June 30, 2021 were $2.8 million and $9.4 million, respectively, compared to $3.6 million and $7.4 million for the corresponding periods in 2020. The changes in revenues are due to changes in reimbursable collaborative activities with Amgen and Astellas.

Research and development expenses for the three and six months ended June 30, 2021 increased to $36.4 and $68.0 million, respectively, compared to $21.8 million and $43.5 million for the same periods in 2020. The changes were primarily due to increases in spending for COURAGE-ALS and our clinical development activities for our cardiac muscle inhibitor programs. In addition, this quarter, we incurred transition costs related to the termination of our collaboration with Amgen and the purchase from Amgen of approximately $7.3 million of materials including manufactured quantities of the active pharmaceutical ingredient for omecamtiv mecarbil.

General and administrative expenses for the three and six months ended June 30, 2021 increased to $21.2 million and $36.8 million from $14.2 million and $26.6 million in 2020 due primarily to an increase in personnel related costs including stock-based compensation and higher outside spending for commercial readiness.

Financial Guidance and Cash Runway

The company recently updated its financial guidance for 2021. We expect our revenues for 2021 will be in the range of $23 million to $28 million, our operating expenses will be in the range of $230 million to $250 million, and our net cash utilization will be in the range of $195 million to $215 million. This new guidance includes non-recurring new building construction costs of approximately $35 million and assumes receipt of $45 million under our funding agreement with RTW Investments, LP.

The company ended the second quarter with $424 million cash. With the common stock offering in July and our having raised approximately $297 million in net proceeds, we believe that we have more than three years of cash runway based on our revised 2021 cash utilization guidance.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s second quarter results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 7387377.

An archived replay of the webcast will be available via Cytokinetics’ website until August 19, 2021. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 7387377 from August 5, 2021 at 7:30 PM Eastern Time until August 19, 2021.

On August 5, 2021 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported financial results for the quarter ended June 30, 2021 (Press release, Coherus Biosciences, AUG 5, 2021, View Source [SID1234585866]). The Company also provided a progress update on its PD-1 blocking antibody, toripalimab, its lead immuno-oncology candidate for the potential treatment of various solid tumors, as well as other late-stage pipeline product candidates including CHS-201, a biosimilar Lucentis (ranibizumab), CHS-1420, a wholly owned biosimilar Humira (adalimumab), and CHS-305, a biosimilar Avastin (bevacizumab).

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"With two biosimilar BLAs currently under FDA review and a toripalimab BLA submission expected to be completed soon, we are making strong progress toward our objective to diversify and grow our product portfolio," said Denny Lanfear, Coherus CEO. "We project that within one year we will have four approved products, including UDENYCA, in the United States, and that in 2023 we will have five marketed products generating revenue to invest in our immuno-oncology business."

SECOND QUARTER 2021 FINANCIAL HIGHLIGHTS

Net product revenue, consisting of net sales of UDENYCA (pegfilgrastim-cbqv) was $88 million.
GAAP net loss of $29.9 million was primarily driven by increased R&D and regulatory expenses to support the advancement of toripalimab and the biosimilar pipeline product candidates.
Non-GAAP net loss was $27.3 million.
At June 30, 2021, Coherus had cash, cash equivalents and marketable securities of $454.4 million.
In April 2021, the Company received $50 million from Junshi Biosciences’ acquisition of 2,491,988 shares of Coherus stock.
PIPELINE HIGHLIGHTS

Coherus is planning an analyst day event in the fourth quarter of 2021

Toripalimab, a PD-1 blocking antibody product candidate, in collaboration with Junshi Biosciences:

Following a recent meeting with the United States Food and Drug Administration ("FDA"), Coherus’ immuno-oncology partner, Junshi Biosciences, plans to submit the biologics license application ("BLA") for toripalimab in combination with chemotherapy for 1st line treatment of metastatic or recurrent nasopharyngeal carcinoma ("NPC") concurrently with toripalimab monotherapy in second or third line treatment of recurrent or metastatic NPC. Junshi Biosciences expects to complete the BLA submission for these indications later this quarter.
Data from a Phase 3 clinical trial evaluating toripalimab for the treatment of non-small cell lung cancer will be presented in September at the World Conference on Lung Cancer.
Data from a Phase 3 clinical trial evaluating toripalimab for the treatment of esophageal squamous cell carcinoma will be presented in September at the annual meeting of the European Society for Medical Oncology.
CHS-201, a biosimilar Lucentis (ranibizumab) product candidate in collaboration with Bioeq AG:

Bioeq AG recently submitted the CHS-201 BLA. Pending acceptance of the BLA by the FDA, Coherus anticipates a mid-2022 target action date for the BLA review.
CHS-1420, a wholly owned biosimilar Humira (adalimumab) product candidate:

The review of the CHS-1420 BLA is progressing with a target action date of December 2021. Coherus plans to launch CHS-1420 on or after July 1, 2023, if approved.
CHS-305, a biosimilar Avastin (bevacizumab) product candidate in collaboration with Innovent Biologics (Suzhou) Co. Ltd:

Coherus is conducting the three-way pharmacokinetic study to facilitate the potential CHS-305 BLA submission.
SECOND QUARTER 2021 FINANCIAL RESULTS

Net product revenue, consisting of net sales of UDENYCA, was $87.6 million and $135.7 million during the three months ended June 30, 2021 and 2020, respectively, and $170.7 million and $251.9 million during the six months ended June 30, 2021 and 2020, respectively.

Cost of goods sold (COGS), increased to $16.7 million in the second quarter of 2021 as compared to $10.1 million in second quarter of 2020. 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 the second quarter of 2021 is the first period with per unit acquisition costs fully reflected within COGS. 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 June 30, 2021 was $54.8 million compared to $26.2 million for the same period in 2020, an increase of $28.6 million. The increase was mainly due to higher development and regulatory costs in support of the advancement of toripalimab and the biosimilar pipeline product candidates. For the six months ended June 30, 2021, R&D expense was $258.3 million compared to $59.3 million for the same period in 2020, an increase of $199.0 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 June 30, 2021 was $40.3 million compared to $34.1 million for the three months ended June 30, 2020, an increase of $6.3 million which was primarily driven by increased UDENYCA commercialization expenses including an increase in sales personnel and travel. For the six months ended June 30, 2021, SG&A expense was $79.7 million compared to $69.4 million for the same period in 2020, an increase of $10.3 million, which was primarily due to an increase of $5.8 million in stock-based compensation expense and a $4.1 million increase in UDENYCA commercialization expenses.

Net loss for the second quarter of 2021 was $29.9 million, or $0.40 per share on a diluted basis, compared to a net income of $59.0 million, or $0.70 per share on a diluted basis for the same period in 2020.

Non-GAAP net loss for the second quarter of 2021 was $27.3 million, or $0.36 per share on a diluted basis, compared to non-GAAP net income of $68.3 million, or $0.81 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 $454.4 million as of June 30, 2021, compared to $399.5 million at March 31, 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, development activities for CHS-305, 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 June 30, 2021 to be filed with the Securities & Exchange Commission on August 5, 2021.

On August 5, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the second quarter of 2021 (Press release, Y-mAbs Therapeutics, AUG 5, 2021, View Source [SID1234585881]).

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"We are very pleased with our second quarter 2021 results. The commercialization of DANYELZA (naxitamab-gqgk) is progressing throughout the U.S. as we continue to see new sites gaining experience with DANYELZA. In addition, the DANYELZA BLA submission has recently been accepted by the National Medical Products Administration of China ("NMPA"), and we continue to advance our deep pipeline. We ended the quarter with a cash balance of $233.6 million, so we believe we are well positioned to elevate our business to new levels," stated Thomas Gad, founder, Chairman and President.

Dr. Claus Moller, Chief Executive Officer, continued, "We submitted the European Marketing Authorization Application to the European Medicines Agency (the "EMA") for omburtamab in April. In parallel, after our Type B meeting with the FDA in June, we believe we now have a clearer path towards the resubmission of the omburtamab BLA to the FDA. Pending a positive Type B meeting with the FDA in the third quarter, we hope to initiate rolling resubmission of the omburtamab BLA by the end of the year."

Recent Corporate Developments

After the close of the first quarter, on July 6, 2021, Y-mAbs announced that SciClone Pharmaceuticals had submitted the Biologics License Application to the National Medical Products Administration ("NMPA") of China for DANYELZA for the treatment of patients with relapsed/refractory high-risk neuroblastoma.

On June 25, 2021, Y-mAbs announced that 177Lu-omburtamab-DTPA for the treatment of medulloblastoma had received a positive opinion on Orphan Medicinal Product Designation by EMA.

On June 23, 2021, Y-mAbs announced updated timelines for resubmission of the BLA for omburtamab for neuroblastoma, with an anticipated initiation of a rolling BLA submission by the end of 2021.

On May 19, 2021, Y-mAbs announced an exclusive distribution agreement with Adium Pharma S.A. for DANYELZA and omburtamab in Latin America.

On April 27, 2021, Y-mAbs announced the submission to the EMA of a European Marketing Authorization Application for omburtamab for the treatment of pediatric patients with central nervous system/leptomeningeal metastasis from neuroblastoma.

On April 12, 2021, Y-mAbs announced data from GPA33-SADA, which in a xenograft model of colorectal cancer showed radioactivity uptake with a tumor to blood ratio of 122 measured 24 hours after injection. We expect to file an IND for GPA33-SADA next year.
Financial Results

Y-mAbs reported net loss of $22.9 million, or ($0.53) per basic and diluted share, for the quarter ended June 30, 2021, compared to a net loss of $40.4 million, or ($1.01) per basic and diluted share, reported for the quarter ended June 30, 2020. The decreased net loss was caused by the DANYELZA revenues in 2021 and the reduced R&D expenses for the quarter ended June 30, 2021 compared to June 30, 2020.

For the six months ended June 30, 2021, Y-mAbs reported a net income of $10.5 million, or $0.25 per basic share and $0.23 per diluted share, compared to the net loss of $66.6 million, or ($1.67) per basic and diluted share, reported for the six months ended June 30, 2020. The net income was primarily caused by the sale of a priority review voucher and the DANYELZA revenues in the first six months of 2021.

Revenues

Y-mAbs reported net revenues of $11.0 million for the quarter ended June 30, 2021, consisting of $9.0 million of DANYELZA revenues and $2.0 million of licensing revenue.

Revenues were $16.3 million for the six months ended June 30, 2021 and consisted of $14.3 million from the sales of DANYELZA and $2.0 million of licensing revenue.

No revenues were reported for the quarter ended and six months ended June 30, 2020.

Operating Expenses

Research and Development
Research and development expenses were $19.8 million for the three months ended June 30, 2021, compared to $30.1 million for the three months ended June 30, 2020, a decrease of $10.3 million. The decrease in research and development expenses was primarily due to the following:

$13.3 million decrease in milestone payments and license acquisition costs driven by the $13.3 million SADA agreement entered into in 2020 which included an upfront payment of $2.0 million, $3.3 million in equity issuances to Memorial Sloan Kettering ("MSK") and Massachusetts Institute of Technology ("MIT"), $7.4 million for the issuance of shares to two non-employees, and $0.6 million for milestone payments which were deemed probable for the period ending June 30, 2020.This decrease was partially offset by a $3.0 million increase in personnel costs.
Research and development expenses were $41.4 million for the six months ended June 30, 2021, compared to $48.7 million for the six months ended June 30, 2020, a decrease of $7.3 million. The decrease in research and development expenses was primarily due to:

$13.3 million decrease in milestone payments and license acquisition costs driven by the $13.3 million SADA agreement which included an upfront payment of $2.0 million, $3.3 million in equity issuances to MSK and MIT, $7.4 million for the issuance of shares to two non-employees, and $0.6 million for milestone payments which were probable for the period ending June 30, 2020; and
$3.5 million decrease in outsourced manufacturing expenses.
These decreases were partially offset by increases of:

$5.5 million in personnel costs;
$1.3 million in outsourced manufacturing;
$0.5 million in clinical trials; and
$1.0 million in premises expenses.
Selling, General, and Administration

Selling, general, and administrative expenses were $13.5 million for the three months ended June 30, 2021, compared to $10.4 million for the three months ended June 30, 2020, an increase of $3.1 million. The increase in selling general and administrative expenses primarily reflects a $3.1 million increase in personnel costs due to the continued hiring of our commercialization team.

Selling, general, and administrative expenses were $25.4 million for the six months ended June 30, 2021, compared to $18.5 million for the six months ended June 30, 2020, an increase of $6.9 million. The increase in selling general and administrative expenses primarily reflects a $6.4 million increase in personnel costs due to the continued hiring of our commercialization team.
Cash and Cash Equivalents

The Company had $233.6 million in cash and cash equivalents as of June 30, 2021, compared to $114.6 million as of December 31, 2020. The increase of $119.0 million was primarily attributable to the following:

The completion of the sale of our DANYELZA priority review voucher in January 2021. Y-mAbs netted $62.0 million after paying 40% of the net proceeds from the sale to MSK pursuant to the terms of the license agreement with MSK, and
$107.7 million in net proceeds raised in our public offering in February 2021.
These increases were partially offset by the net cash used in operational activities of $50.6 million for the six months ended June 2021.

Webcast and Conference Call

The Company will host a conference call on Friday, August 6, 2021 at 9 a.m. Eastern Time. To participate in the call, please dial 855-327-6838 (domestic) or 604-235-2082 (international) and reference the conference ID 10015973. A webcast will be available at: View Source