On November 10, 2021 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported its financial results for the third quarter and the first nine months of 2021 (Press release, MorphoSys, NOV 10, 2021, View Source [SID1234595230]).

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"Monjuvi sales continued to build momentum in the third quarter where we saw a broadening of the prescriber base and increased utilization in second-line patients," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "We are excited to share new data for Monjuvi and pelabresib at the upcoming ASH (Free ASH Whitepaper) conference. For pelabresib, we will share the latest data from our MANIFEST trial, including important data from the third combination arm that confirm previous results. This further underpins our confidence in the ongoing phase 3 MANIFEST-2 study."

Tafasitamab Highlights

– Monjuvi(R) (tafasitamab-cxix) U.S. net product sales of € 18.6 million (US$ 22.0 million) for the third quarter of 2021 and € 46.4 million (US$ 55.5 million) for the first nine months of 2021.

– On August 24, 2021, Health Canada granted conditional marketing authorization for Minjuvi(R) (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma

– On August 26, 2021, MorphoSys and Incyte announced that the European Commission granted conditional marketing authorization for Minjuvi(R) (tafasitamab) in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

– In the third quarter 2021, MorphoSys received, for the first time, royalty revenue of € 82 thousand for Minjuvi sales outside of the U.S. pursuant to the agreement with Incyte.

Other Highlights after the end of the third quarter of 2021

– On October 20, 2021, MorphoSys announced that the first patient has been dosed in the Phase 2 IGNAZ clinical trial evaluating felzartamab for patients with Immunoglobulin A Nephropathy (IgAN). IgAN, also known as Berger’s disease, is a chronic and debilitating autoimmune disease affecting the kidneys and the most common glomerular disease worldwide.

– On November 4, 2021, MorphoSys announced the presentation of interim results from
M-PLACE, the ongoing Phase 1b/2a, proof of concept study with felzartamab at the 2021 Annual Meeting of the American Society of Nephrology (ASN).

– On November 4, 2021, MorphoSys announced that new data on tafasitamab and pelabresib will be presented during the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from December 11-14, 2021. Ten abstracts were accepted, including two oral presentations on the MANIFEST and RE-MIND2 clinical studies.

Financial Results for the Third Quarter of 2021 (IFRS)
Total revenues for the third quarter of 2021 amounted to € 41.2 million (Q3 2020: € 22.0 million). The Group revenues include revenues of € 18.6 million from the recognition of Monjuvi(R) product sales in the US.

Cost of Sales: In the third quarter of 2021, cost of sales increased to € 7.5 million (Q3 2020: € 3.7 million).

Research and Development (R&D) Expenses: In the third quarter of 2021, R&D expenses were € 64.4 million (Q3 2020: € 34.2 million). The increase in R&D expenses is primarily due to the inclusion of R&D expenses from Constellation and higher investment to support the advancement of clinical programs.

Selling, General and Administrative (SG&A) Expenses: Selling expenses decreased in the third quarter of 2021 to € 32.4 million (Q3 2020: € 32.9 million) and general and administrative (G&A) expenses amounted to € 19.4 million (Q3 2020: € 13.3 million). The increase of G&A expense in the third quarter was driven by transaction costs for the acquisition of Constellation and the inclusion of Constellation’s G&A expenses.

Operating Loss: Operating loss amounted to € 82.4 million in the third quarter of 2021 (Q3 2020: operating loss of € 62.0 million).

Consolidated Net Profit / Loss: For the third quarter of 2021, consolidated net loss was € 112.8 million (Q3 2020: consolidated net loss of € 65.3 million).

Financial Results for First Nine Months of 2021 (IFRS)

Total revenues for the first nine months of 2021 amounted to € 126.7 million (9M 2020: € 291.7 million). The Group revenues include revenues of € 46.4 million from the recognition of Monjuvi(R) product sales in the US. The year-over-year decline was driven by the upfront payment of the collaboration and license agreement with Incyte in the first quarter 2020 for the out-licensing of tafasitamab outside the U.S.

Cost of Sales: In the first nine months of 2021, cost of sales increased to € 22.7 million (9M 2020: income of € 0.2 million).

Research and Development (R&D) Expenses: In the first nine months of 2021, R&D expenses were € 138.2 million (9M 2020: € 86.6 million). The R&D expenses increased due to higher development activity and the inclusion of expenses from the Constellation acquisition since July 15, 2021.

Selling, General and Administrative (SG&A) Expenses: Selling expenses increased in the first nine months of 2021 to € 89.0 million (9M 2020: € 75.0 million) and general and administrative (G&A) expenses amounted to € 60.1 million (9M 2020: € 37.2 million). The year-over-year increase in selling expenses was primarily driven by the commercialization activities for Monjuvi(R) in 2021 that were higher than during the ramp up of activities in 2020. The year-over-year increase in G&A expenses was driven primarily by the transaction costs related to the Constellation and Royalty Pharma agreements and the inclusion of Constellation’s G&A expenses.

Operating Loss: Operating loss amounted to € 183.3 million in the first nine months of 2021 (9M 2020: operating profit of € 93.1 million).

Consolidated Net Profit / Loss: For the first nine months of 2021, consolidated net loss was € 133.5 million (9M 2020: consolidated net profit of € 114.4 million).

Cash and Investments: As of September 30, 2021, the Company had cash and investments of € 1,130.9 million compared to € 1,244.0 million on December 31, 2020.

Number of shares: The number of shares issued totaled 34,231,943 at the end of Q3 2021 (year-end 2020: 32,890,046).

*Group revenues include full year Tremfya royalties and exclude any royalties from potential tafasitamab sales outside of the U.S. as well as any significant milestones from development partners and/or licensing partnerships other than those that were already recorded in the first 9-month period. This revenue guidance is subject to a number of uncertainties including the potential for variability from the first full year of the Monjuvi product launch, the limited visibility that MorphoSys has on the Tremfya royalty stream as well as the ongoing COVID-19 pandemic and the impact on our as well as our partner’s business operations.

**Operating expenses is comprised of R&D and SG&A, inclusive of Incyte’s share of Monjuvi selling costs in the U.S.

MorphoSys Group Key Figures (IFRS, September 30, 2021)

*Value as of December 31, 2020

MorphoSys will hold its conference call and webcast tomorrow, November 11, 2021, to present the results for the third quarter and first nine months of 2021 and the further outlook for 2021.

A live webcast and slides will be made available at the Investors section under "Presentations and Conferences" on MorphoSys’ website at View Source and after the call, a slide-synchronized audio replay of the conference will be available at the same location.

The statement for the third quarter/first nine months of 2021 (IFRS) is available online:
View Source/Reports

About Monjuvi(R) (tafasitamab)
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).
In the United States, Monjuvi(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi(R) (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Minjuvi(R) and Monjuvi(R) are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi(R) in the U.S., and marketed by Incyte under the brand name Minjuvi(R) in the EU.

XmAb(R) is a registered trademark of Xencor, Inc.

On November 10, 2021 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that management will participate in a fireside chat at the Jefferies London Healthcare Conference on Wednesday, November 17, 2021 at 1:40 p.m. GMT/ 8:40 a.m. EST (Press release, IGM Biosciences, NOV 10, 2021, View Source [SID1234595229]).

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On November 10, 2021 Recursion (Nasdaq : RXRX), a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, data science and engineering, reported business updates and financial results for its third quarter ending September 30, 2021 (Press release, Recursion Pharmaceuticals, NOV 10, 2021, View Source [SID1234595223]).

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"In Q3, our team made progress towards our vision to industrialize drug discovery. We are now harvesting the efforts of the past few years to build a map of human cellular biology through the continued refinement and increased usage of our inference-based approach to drug discovery. With the power of our Recursion Map illuminating new and exciting relationships in biology, we are now deeply focused on extending our chemistry capabilities to significantly improve, scale and speed up new chemical entity development to address the plethora of novel biological relationships we are discovering," said Recursion Co-Founder & CEO Chris Gibson, Ph.D. "In addition, our rapidly growing development team is preparing for our four clinical-stage programs to initiate Phase 2 or Phase 2/3 studies in the first half of 2022, including two of the programs that we expect will enroll their first patients in early 2022. To facilitate our broad ambition, we continue to rapidly grow our workforce while nurturing Recursion’s culture and community."

Recursion finished the third quarter of 2021 with a portfolio of 4 clinical stage programs, 4 preclinical programs, 7 late discovery programs, and 41 early discovery programs. Additionally, Recursion continued scaling the total number of executed phenomic experiments to approximately 95 million, the size of its proprietary data universe to over 11 petabytes, and the number of biological inferences to approximately 200 billion. Data have been generated on the Recursion OS across 38 human cell types, an in-house chemical library of over 717 thousand compounds, and an in silico library of 12 billion small molecules, by a growing team of more than 330 Recursionauts that is balanced between life scientists and computational and technical experts.

Summary of Business Highlights

Clinical Programs
Neurofibromatosis type 2 (NF2) (REC-2282): In early October we received Fast Track Designation for REC-2282 from the FDA for the potential treatment of NF2 meningiomas. We plan to initiate a parallel group, two stage, Phase 2/3, randomized, multicenter study in early 2022.
Cerebral cavernous malformation (CCM) (REC-994): We plan to initiate a Phase 2, double-blind, placebo-controlled safety, tolerability and exploratory efficacy study of this candidate in early 2022.
Familial adenomatous polyposis (FAP) (REC-4881): In September we received Orphan Drug Designation for REC-4881 from the FDA for the potential treatment of Familial Adenomatous Polyposis. We plan to initiate a Phase 2, randomized, double-blind, placebo-controlled study to evaluate safety, pharmacokinetics and efficacy in the first half of 2022.
GM2 gangliosidosis (REC-3599): We plan to initiate a Phase 2 study of this candidate in the first half of 2022.
Preclinical Programs
Clostridium difficile colitis (REC-3964): We expanded our medicinal chemistry team and digital chemistry tools and made progress in IND-enabling studies for REC-3964, which is the most advanced New Chemical Entity developed by the Recursion OS.
Bayer AG Partnership: We continue to advance our collaboration with Bayer to discover small molecule drug candidates with the potential to treat fibrotic diseases. We have multiple programs progressing simultaneously with our partner.
Recursion OS
Biological Contexts: We advanced our capabilities to model diseases in multiple biological contexts, including new types of biological perturbations beyond CRISPR-based knockouts, complex cell type onboarding, and organoid model systems. Moreover, we made progress on multiple maps in iPSC-derived neural cell types.
Mechanisms of Action: We improved our computational methods to identify mechanisms of action and used this technology to increase our ability to screen out compounds with potentially toxic effects for multiple programs earlier than is possible with traditional approaches. We believe that such methods will better enable us to advance the most promising novel chemical compounds through discovery.
Transcriptomics Validation: We made significant improvements to our transcriptomics protocols to enable increases in throughput. Additionally, we have been optimizing our ability to use transcriptomics signatures for compound characterization.
Facilities and Manufacturing: We continued to make progress in expanding our current headquarters and creating a chemistry, manufacturing and controls (CMC) site in Salt Lake City. These spaces are designed with flexibility in mind to enable next-generation automated workflows and instruments for compound, tissue culture, and biobank management to further industrialize the drug discovery and development process.
Third Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents, and investments were $578.9 million as of September 30, 2021.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $2.5 million for the third quarter of 2021, compared to $1.0 million for the third quarter of 2020. The increase was due to revenue recognized from our collaboration with Bayer.
Research and Development Expenses: Research and development expenses were $33.2 million for the third quarter of 2021, compared to $16.5 million for the third quarter of 2020. The increase in research and development expenses was primarily due to an increased number of experiments run on the Recursion OS, an increased number of assets being validated, and increased clinical costs as studies progressed.
General and Administrative Expenses: General and administrative expenses were $15.7 million for the third quarter of 2021, compared to $7.0 million for the third quarter of 2020. The increase in general and administrative expenses was due to the growth in size of the company’s operations, including an increase in salaries and wages of $3.7 million, equipment costs, human resources-related costs, facilities costs, and other administrative costs associated with operating a high-growth company.
Net Loss: Net loss was $47.4 million for the third quarter of 2021, compared to a net loss of $23.9 million for the third quarter of 2020.
Additional Corporate Updates

Operations in Canada: Jordan Christensen joined Recursion as Vice President, Engineering and also became our Toronto Site Lead. Additionally, we opened our Montreal office and hired multiple machine learning research scientists.
Translational Biology: Alison O’Mahony, Ph.D., joined Recursion as Vice President, Discovery Platform and will be responsible for continued scaling and improvement of Recursion’s orthogonal validation and bespoke validation assays to continue driving down the time from initial discovery to clinical development. Dr. O’Mahony previously served as Vice President, Translational Biology at Eurofins Discovery.
Information Security: Ganesh Jagannathan joined Recursion as Chief Information Security Officer & Vice President, Information Technology and will be responsible for all strategic, innovative and operational aspects of Information Security and Information Technology. Mr. Jagannathan previously served as Chief Information Security Officer at Jazz Pharmaceuticals.
CEO Rule 10b5-1 Plans: Chris Gibson, Ph.D., the company’s Co-Founder and CEO, established personal stock trading plans in the second quarter of 2021 in accordance with Rule 10b5-1 under the Securities and Exchange Act of 1934 and Recursion’s insider trading policy. Under the plans, all outstanding stock options may be exercised and we anticipate shares representing up to approximately 4% of Dr. Gibson’s holdings may be sold or transferred to donor-advised philanthropic funds. We anticipate the Rule 10b5-1 transactions may take place over the next 13 months. Any such transactions will be disclosed through public filings as required by the SEC.

On November 10, 2021 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the third quarter ended September 30, 2021 and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, NOV 10, 2021, View Source [SID1234595222]).

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"This past quarter, Zentalis continued to execute on its clinical development strategy, and we are pleased with the progress we have made to advance our lead program, ZN-c3, a potentially best-in-class WEE1 inhibitor," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "Most recently, we initiated a Phase 1/2 trial with ZN-c3 in combination with gemcitabine in patients with osteosarcoma, further supporting the broad potential of ZN-c3 in combination therapy settings. Before year-end, we plan to have a total of six ongoing trials investigating our WEE1 inhibitor and look forward to initiating our potentially registrational biomarker-driven Phase 2 trial shortly. Additionally, the foundational research on the discovery of ZN-c3 was published in the peer-reviewed Journal of Medicinal Chemistry, which reviews our objectives for designing ZN-c3 as a potentially safer and more selective WEE1 inhibitor and in turn, overcoming limitations seen with other candidates in development."

Continued Dr. Sun, "We remain on track with our anticipated clinical milestones and are eager to provide future updates on these efforts. Looking ahead, we are excited to host a virtual R&D Day on December 16, during which our management team and key opinion leaders will provide a review of new preclinical science across multiple programs and share clinical updates on ZN-d5 and ZN-e4."

Program Highlights:

In September 2021, Zentalis dosed the first patient in the Phase 1/2 study of ZN-c3 in combination with gemcitabine, a chemotherapy used to treat certain malignant tumors, in patients with relapsed or refractory osteosarcoma. Zentalis recently received orphan drug and rare pediatric disease designations from the U.S. Food and Drug Administration (FDA) for pediatric osteosarcoma. Zentalis expects to report initial results from this trial in the second half of 2022.
Enrollment is ongoing in the potentially registrational Phase 2 trial of ZN-c3 in women with recurrent or persistent USC. Following an end-of-Phase 1 meeting in July 2021, the FDA agreed in principle that ZN-c3 has the potential for an accelerated approval pathway based on the Phase 2 study design in USC.
In September 2021, research on the discovery of ZN-c3 was published in the Journal of Medicinal Chemistry. The paper reviews Zentalis’ objectives in designing ZN-c3 as a potentially safer and more selective WEE1 inhibitor, overcoming limitations seen with other WEE1 inhibitors.
In September 2021, Zentalis presented six poster presentations on the candidates: ZN-c3, a WEE1 inhibitor; ZN-c5, an oral selective SERD and ZN-d5, a BCL-2 inhibitor at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.
Zentera Highlights:

In August 2021, Zentera, a Shanghai-based clinical-stage biopharmaceutical company formed by Zentalis, announced the completion of a $75 million Series B financing. Zentera plans to use the proceeds to advance the clinical development in China of three of Zentalis’ product candidates (ZN-c3, ZN-c5 and ZN-d5), as well as expand its pipeline through additional business development opportunities for China and global development.
Zentera received CTA acceptances in China for ZN-c3, ZN-c3 in combination, ZN-c5 and ZN-d5 and four clinical trials are ongoing.
Corporate Highlights:

In July 2021, Zentalis closed an underwritten follow-on offering of 3,565,000 shares of its common stock at a public offering price of $48.50 per share. The total net proceeds were approximately $162.2 million, after deducting underwriting discounts and commissions and offering expenses payable by Zentalis.
Third Quarter 2021 Financial Results

Cash and Marketable Securities Position: As of September 30, 2021, Zentalis had cash, cash equivalents and marketable securities of $366.8 million. We believe that our existing cash, cash equivalents and marketable securities as of September 30, 2021 will be sufficient to fund our operating expenses and capital expenditures requirements into the third quarter of 2023.
Research and Development Expenses: Research and development expenses for the three months ended September 30, 2021 were $54.0 million, compared to $24.7 million for the three months ended September 30, 2020. The increase of $29.3 million was primarily due to increases in external research and development expenses related to our clinical product candidates, as we advanced our clinical pipeline.
General and Administrative Expenses: General and administrative expenses for the three months ended September 30, 2021 were $8.9 million, compared to $10.1 million during the three months ended September 30, 2020. This decrease of $1.2 million was primarily attributable to a decrease of $0.6 million in legal fees and an increase in allocable overhead expenses to research and development expenses of $1.7 million, offset by an increase of $1.1 million of facilities and related permits/fees and licenses expenses.
Net Loss: Net loss was $10.5 million for the three months ended September 30, 2021, compared to $34.7 million for the three months ended September 30, 2020. The $24.2 million decrease in net loss was primarily the result of the gain on deconsolidation of Zentera recognized during the three months ended September 30, 2021, partially offset by increases in research and development expenses discussed above.

On November 10, 2021 Century Therapeutics, Inc., (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported financial results and business highlights for the third quarter ended September 30, 2021 (Press release, Century Therapeutics, NOV 10, 2021, View Source [SID1234595221]).

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"We continue to deepen investments in cellular reprogramming, genetic engineering, and manufacturing, in order to advance our iPSC platforms, with an ultimate goal of developing therapies that can meaningfully advance cancer care," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "We are making tangible progress in advancing our lead candidate, CNTY-101, into the clinic, with our IND filing on track for mid-2022. Additionally, through our recently announced collaboration with Outpace Bio, we are further investing in new technologies as we execute on our vision of building a next-generation cell therapy platform. We expect to provide scientific updates on our programs later this year and at our upcoming virtual research and development update."

Business Highlights

Entered into a research collaboration agreement with Outpace Bio to explore Outpace’s protein solutions for cell therapy to potentially enhance the functionality of Century’s iPSC platform. The collaboration’s initial program will focus on hematological malignancies with an option to expand to additional candidates.
Included in the small-cap Russell 2000 Index as a part of the 3Q21 Russell Indexes IPO additions.
Upcoming Milestones

Pre-clinical data from the Company’s CNTY-101 program and CAR-iT platform to be presented in two posters at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition on December 11-14, 2021 in Atlanta, Georgia, and virtually.
Virtual research and development update to be held on Thursday, December 16, 2021 from 8:00-9:30 AM EST. Century’s management team will discuss an update on the Company’s iPSC technology platform and pipeline. Eduardo Sotomayor, M.D., Director of the Cancer Institute at Tampa General Hospital, will discuss the current treatment paradigm for B-cell malignancies. For additional information on how to access the event, please visit the Events & Presentations section of Century’s website.
Current Good Manufacturing Practice (cGMP) manufacturing facility expected to be operational in early 2022.
CNTY-101 IND filing remains on track for mid-2022.
Third Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $400.3 million as of September 30, 2021, as compared to $440.0 million as of June 30, 2021.
Research and Development (R&D) expenses: R&D expenses were $19.5 million for the three months ended September 30, 2021, compared to $10.8 million for the same period in 2020. The increase in R&D expenses was primarily due to an increase in personnel expenses related to increased headcount to expand the Company’s research and development capabilities, costs for preclinical studies, costs for laboratory supplies, and facility costs.
General and Administrative (G&A) expenses: G&A expenses were $6.3 million for the three months ended September 30, 2021, compared to $2.3 million for the same period in 2020. The increase was primarily due to an increase in personnel related expense due to an increase in employee headcount and an increase in the Company’s professional fees as a result of expanded operations to support the Company’s infrastructure as well as additional costs to operate as a public company.
Net loss: Net loss was $26.0 million for the three months ended September 30, 2021, compared to $13.1 million for the same period in 2020.