On November 10, 2021 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results and provided a corporate update for the third quarter ended September 30, 2021 (Press release, Tempest Therapeutics, NOV 10, 2021, View Source [SID1234595233]).

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"The third quarter of 2021 saw continued execution and progress in our programs, including the opening of a collaborative clinical trial with Roche in first line HCC patients comparing TPST-1120 in combination with atezolizumab and bevacizumab to the standard of care regimen, atezolizumab and bevacizumab," said Stephen R. Brady, chief executive officer of Tempest. "In the fourth quarter of this year and the first half of 2022, we plan to continue this focused approach as our second clinical program, TPST-1495, is poised to move into a set of studies that select patients predicated on strong mechanistic rationale, genetically-defined histologies, and a potential mutation-based biomarker."

Recent Highlights

TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): continued enrollment in monotherapy dose optimization towards recommended Phase 2 dose ("RP2D").
TPST-1120 (clinical PPARα antagonist): (i) after completion of monotherapy dose escalation, continued enrollment in combination dose escalation towards RP2D; and (ii) commencement of first line, randomized global Phase 1b/2 study in HCC patients, under a collaboration with F. Hoffmann La Roche.
New Drug Discovery Program: entered into an exclusive license with U.C. Berkeley for intellectual property covering a new drug target discovered in the laboratory of Russell Vance, Ph.D., professor of molecular and cell biology at U.C. Berkeley and a Howard Hughes Medical Institute investigator.
Advisory Board: announced the appointment of Dr. Vance to Tempest’s Advisory Board, joining a distinguished roster consisting of Toni Choueiri, M.D., Benjamin Cravatt, Ph.D., Raymond DuBois, M.D., Ph.D., Jason Luke, M.D., Drew Pardoll, M.D., and Peppi Prasit, Ph.D.
Planned Near-Term Milestones

TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) selection of monotherapy RP2D expected in the first half of 2022; (ii) commencement of a combination study with anti-PD-1 checkpoint inhibitor expected prior to the end of 2021; and (iii) commencement of monotherapy expansion in targeted indications and biomarker-selected patient populations expected in the first half of 2022.
TPST-1120 (clinical PPARα antagonist): (i) identification of RP2D of TPST-1120 in combination with nivolumab expected prior to the end of 2021; and (ii) presentation of Phase 1 monotherapy and combination data in mid 2022.
TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in the first half of 2022.
Financial Results

Third Quarter

Tempest ended the third quarter of 2021 with $59.8 million in cash and cash equivalents and short-term restricted cash, compared to $18.8 million in December 31, 2020. The increase was primarily due to the merger and concurrent PIPE, which closed in June 2021.
Net loss and net loss per share for the third quarter of 2021 were $8.1 million and $1.21, respectively, compared to $5.4 million and $11.22, respectively, for the third quarter of 2020. The increase was primarily due to an increase in compensation expense and professional fees associated with the merger.
Research and development expenses for the third quarter of 2021 were $4.6 million, compared to $4.3 million for the same period in 2020. The $0.3 million increase was primarily attributable to increased outside services, insurance and compensation expenses.
For the three months ended September 30, 2021, general and administrative expenses were $3.1 million compared to $1.2 million for the same period in 2020. The increase was primarily due to growth in compensation and rent expense, as well as professional fees associated with the merger.
Year-to-Date

Net cash used in operations for the nine months ended September 30, 2021 was $18.0 million.
Net loss and net loss per share for the nine months ended September 30, 2021 were $20.5 million and $7.49, respectively, compared to $14.9 million and $31.91, respectively, for the same period in 2020.
Research and development expenses for the nine months ended September 30, 2021 were $12.5 million compared to $11.4 million for the same period in 2020. The $1.1 million increase was primarily due to increased compensation expenses and consulting services.
For the nine months ended September 30, 2021, general and administrative expenses were $7.2 million compared to $3.6 million for the same period in 2020.
Based on current cash position and operating plan, Tempest expects to have sufficient resources to fund operations into the second quarter of 2023.

On November 10, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported its financial results for the third quarter 2021 (Press release, Cyclacel, NOV 10, 2021, View Source [SID1234595232]). The quarter’s business highlights include an update on the Company’s progress with fadraciclib and CYC140, Cyclacel’s novel CDK2/9 and PLK1 inhibitors, respectively.

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"The Cyclacel team continued to execute on our plan during the quarter with the opening of two Phase 1/2 studies for oral fadraciclib and filing an IND for a Phase 1/2 study of our oral PLK1 inhibitor, CYC140," said Spiro Rombotis, President and Chief Executive Officer. "We have now enrolled a total of six patients across two dosing levels in our fadraciclib study in solid tumors and have started the first dose level in the fadraciclib study in leukemia. We are pleased with the strong investigator interest in our studies as we build a global network of participating institutions for our clinical studies and preclinical collaborations.

We are also looking forward to the near future with the planned initiation of two registration-enabling Phase 1/2 studies of CYC140 in patients with solid tumors and leukemias and reporting initial data for fadraciclib in solid tumors. We remain diligently focused on bringing innovative treatment options to cancer patients with unmet medical needs and realizing the promise of our pipeline."

Key Corporate Highlights

Oral fadraciclib program

·Six patients with advanced solid tumors treated in the first two dosing levels of 065-101, Phase 1/2, registration-directed study
·Two additional internationally-recognized cancer treatment centers added to 065-101 selected for their expertise with tumor types of interest; for a total of four sites
·First patient dosed in the 065-102, Phase 1/2, registration-directed study in patients with leukemia
·Multiple preclinical studies in progress which will inform fadraciclib’s clinical development

Oral CYC140 program

·Filed with FDA an IND for a streamlined, registration-directed, Phase 1/2 study of orally-available CYC140 in solid tumors
·Initial data in preclinical models show that KRAS mutant cancers are sensitive to oral CYC140 inhibition
·Preclinical collaborative studies ongoing to support selection of histologies to be included in the Phase 1/2 study

Key Near-Term Business Objectives

·FDA clearance of IND filing and initiation of oral CYC140 Phase 1/2 advanced solid tumor study
·Initial data from first part of 065-101 study with oral fadraciclib in advanced solid tumors
·First patient to be dosed with oral CYC140 in Phase 1/2 leukemia study
·Initial data from first part of 065-102 study with oral fadraciclib in leukemia

Financial Highlights

As of September 30, 2021, cash and cash equivalents totaled $40.2 million, compared to $43.6 million as of June 30, 2021. The decrease of $3.4 million was primarily due to $6.3 million net cash used in operating activities, offset by $2.9 million cash provided by financing activities. The Company estimates that available cash resources will fund currently-planned programs through early 2023.

Research and development (R&D) expenses were $4.2 million for the three months ended September 30, 2021 as compared to $1.1 million for the same period in 2020. R&D expenses relating to fadraciclib increased by approximately $2.5 million for the three months ended September 30, 2021 due to clinical supply manufacturing and opening of clinical trial sites for the evaluation of fadraciclib in Phase 1/2 studies. Additionally, R&D expenses related to CYC140 increased $0.5 million for the quarter as preclinical evaluation and clinical trial supply manufacturing of CYC140 progressed.eneral and administrative expenses for the three months ended September 30, 2021 were $1.8 million, compared to $1.5 million for the same period of the previous year due to increased legal, professional and recruitment costs relating to expansion of the clinical team.

United Kingdom research & development tax credits were $1.0 million for the three months ended September 30, 2021, as compared to $0.3 million for the same period in 2020 due to the increase in R&D expenditure.

Net loss for the three months ended September 30, 2021 was $5.0 million, compared to $2.3 million for the same period in 2020.

On November 10, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported financial results for the quarter ended September 30, 2021 (Press release, Kinnate Biopharma, NOV 10, 2021, View Source [SID1234595231]).

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"With the active recruitment of additional patients at multiple centers in the United States ongoing in the KN-8701 clinical trial, we are pleased with the continued advancement of the KIN-2787 program," said Nima Farzan, Chief Executive Officer of Kinnate. "We believe our recent collaboration with Guardant Health also presents a unique opportunity to assess real-world outcomes and further supports our work to improve the lives of cancer patients with limited treatment options. Unlike currently available treatments that target only Class I BRAF kinase alterations, KIN-2787 targets Class II and Class III BRAF alterations, where it has the potential to be a first-line targeted therapy, in addition to covering Class I BRAF alterations."

Other Recent Business Highlights and Corporate Update:

Announced a collaboration with Guardant Health, a leading precision oncology company, focused on characterizing the prevalence of patients with advanced solid tumors bearing BRAF Class I, II and III alterations. The study will also assess real-world clinical outcomes stratified by BRAF alteration class and by treatment line and type. Preliminary analyses conducted utilizing the GuardantINFORM platform suggest that the prevalence of Class II and III alterations across patients with advanced and metastatic solid tumors screened via liquid biopsy-based comprehensive genomic profiling (CGP) is higher than previously understood. Among the nearly 6,000 patients who were identified as having BRAF alteration-positive cancers, approximately 55% were found to be harboring Class II and III alterations across all tumor types. When looking across common tumor types – Non-Small Cell Lung Cancer (NSCLC), Melanoma and Colorectal Cancer (CRC) – approximately 65%, 20% and 30% of oncogenic BRAF alterations, respectively, are BRAF Class II and III. In addition to NSCLC, Melanoma, and CRC, BRAF Class II and III alterations are also detected at substantial rates in other common and rare tumor types such as prostate, breast, duodenal adenocarcinoma, renal pelvis urothelial carcinoma, and cholangiocarcinoma. These findings, as well as other studies that will assess real-world clinical outcomes stratified by BRAF Class and by treatment, are planned for presentation at a future date.
Presented design and rationale details of a Phase 1 clinical trial (KN-8701: NCT04913285) evaluating KIN-2787 during the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). KN-8701 is a first-in-human, multicenter, non-randomized, open-label, Phase 1 clinical trial of KIN-2787 in adult patients with BRAF mutant advanced and metastatic solid tumors (AMST). KIN-2787 is given orally BID continuously in 28-day cycles until drug intolerance or disease progression. Planned sample size is approximately 115 patients in two parts: Part A is a trial of dose-escalation to maximum tolerated dose open to patients with AMST driven by BRAF Class I, Class II or Class III genomic alterations. Part B will evaluate a selected dose of KIN-2787 in three cohorts of patients with melanoma, NSCLC, or other AMST, each driven by BRAF Class II or Class III alterations. Standard Phase 1 enrollment criteria are required, and key exclusion criteria include known clinically active brain metastases from non-brain tumors, and prior receipt of BRAF-, MEK-, or MAPK-directed inhibitor therapy (except for cases in which these inhibitors were used in indications approved by the U.S. Food and Drug Administration (FDA)).
Announced results from preclinical studies evaluating Kinnate’s lead Fibroblast Growth Factor Receptor (FGFR) inhibitor candidate, KIN-3248 during a virtual poster session at the joint JCA-AACR Precision Cancer Medicine International Conference. The poster presentation highlighted data which show that in biochemical and cellular assays, KIN-3248 exhibited nanomolar potency against all four wild-type FGFR family members but not against other non-FGFR kinases. Importantly, KIN-3248 was active against mutations associated with resistance to FGFR inhibitors both in the clinic and in experimental models, including the FGFR2 and FGFR3 gatekeeper (V565X and V555M, respectively), molecular brake (N550X and N540X, respectively), and activation loop (L618V and K650M, respectively) mutations with less than a five-fold difference in IC50 values relative to corresponding wild-type receptors. In addition, dose-dependent inhibition of FGFR2- and FGFR3-driven human in vivo xenografts, including one with an acquired gatekeeper mutation, was attained with once-daily KIN-3248 treatment and was well tolerated. This efficacy was accompanied by both pharmacodynamic biomarker modulation and downstream pathway inhibition. Kinnate anticipates filling an Investigational New Drug application for KIN-3248 with the FDA in the first half of 2022.
Announced that on December 3, 2021 Eric Murphy, Ph.D. will transition from the company’s Chief Scientific Officer to a member of its Scientific Advisory Board.
Third Quarter 2021 Financial Results

Third quarter net loss for 2021 was $24.7 million, compared to $10.5 million for the same period in 2020.
Third quarter research and development expenses for 2021 were $18.7 million, compared to $8.5 million for the same period in 2020.
Third quarter general and administrative expenses for 2021 were $6.1 million, compared to $2.0 million for the same period in 2020.
As of September 30, 2021, the total of cash and cash equivalents and investments was $347.9 million, exclusive of the China joint venture’s cash.

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.