On March 15, 2022 Champions Oncology, Inc. (Nasdaq: CSBR), a leading global technology-enabled biotech that is transforming drug discovery through innovative AI-driven pharmaco-pheno-multiomic integration, reported its financial results for its third quarter of fiscal 2022, ended January 31, 2022 (Press release, Champions Oncology, MAR 15, 2022, View Source [SID1234610103]).

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Third Quarter and Recent Highlights:

•Record quarterly revenue of $13.2 million, an increase of 22% year over year
•Reported adjusted EBITDA of $1.5 million
•Gross margin for the nine months ended January 31, 2022 improved to 52%
•Signed co-development discovery partnerships with Fannin Innovation Studio and Gigamune

Ronnie Morris, CEO of Champions, commented, "Our third quarter results represent an execution of our long term strategy to deliver strong growth in our core business while driving key strategic initiatives forward by investing in therapeutic discovery. The co-development deals signed this quarter represent meaningful progress in our discovery efforts and provides external validation of our platform."

David Miller, CFO of Champions, said, "We achieved another quarterly revenue record reaching $13.2 million, which represents a year over year increase of 22% and positions the company to achieve the 15% – 20% revenue growth guidance for fiscal 2022. Additionally, we exceeded 50% gross margin for the third sequential quarter demonstrating the leverage in our core business."

Third Fiscal Quarter Financial Results For the third quarter of fiscal 2022, revenue increased 22% to $13.2 million compared to $10.8 million for the third quarter of fiscal 2021. The increase in revenue was due to continued demand and growth for our pharmacology studies, including in-vivo, ex-vivo and biomarker services. Total costs and operating expenses for the third quarter of fiscal 2022 were $12.4 million compared to $9.8 million for the third quarter of fiscal 2021, an increase of $2.5 million or 25.8%.

For the third quarter of fiscal 2022, Champions reported net income from operations of $830,000, including $310,000 in stock-based compensation and $396,000 in depreciation and amortization expenses, compared to net income from operations of $982,000, inclusive of $232,000 in stock-based compensation and $297,000 in depreciation and amortization expenses, in the third quarter of fiscal 2021. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported adjusted EBITDA of $1.5 million for both the third quarter of fiscal 2022 and the third quarter of fiscal 2021.
Cost of oncology solutions was $6.4 million for the three-months ended January 31, 2022, an increase of $1.8 million, or 38.6% compared to $4.6 million for the three-months ended January 31, 2021. For the three-months ended January 31, 2022, gross margin was 51.4% compared to 57.2% for the three-months ended January 31, 2021. The increase in cost of sales was primarily related to compensation and lab supply expenses resulting from the increase in study volume. Cost of sales for the third quarter of fiscal year 2021 was atypically low resulting in a temporary, inflated gross margin. The decrease in gross margin from the third quarter of fiscal year 2021 does not represent a systemic decline.

Research and development expense for the three-months ended January 31, 2022 was $2.2 million, an increase of $302,000 or 16.1%, compared to $1.9 million for the three-months ended January 31, 2021. The increase was primarily the result of increased investment in our therapeutic target discovery platform. Sales and marketing expense for the three-months ended January 31, 2022 was $1.5 million, an increase of $57,000, or 3.8%, compared to $1.5 million for the three-months ended January 31, 2021. General and administrative expense for the three-months ended January 31, 2022 was $2.2 million, an increase of $391,000, or 21.3%, compared to $1.8 million for the three-months ended January 31, 2021. The increase was primarily due to an increase in compensation and IT related expenses for infrastructure investment to support business growth.

Net cash generated from operating activities for the quarter was $4.3 million resulting from increased operating income excluding stock-based compensation and other non-cash related expenses and an increase in deferred revenue stemming from our bookings growth. Net cash used in investing activities was $404,000 primarily from investment in additional lab equipment and software development. The Company ended the quarter with a strong cash position of $8.7 million and no debt.

Year-to-Date Financial Results

For the first nine months of fiscal 2022, revenue increased 19% to $36.2 million compared to $30.5 million for the first nine months of fiscal 2021. The increase in revenue was due to the expansion of our platforms, business lines, and demand for our services. Total costs and operating expenses for the first nine months of fiscal 2022 were $35.3 million compared to $29.5 million for the first nine months of fiscal 2021, an increase of $5.9 million or 20%.
For the first nine months of fiscal 2022, Champions reported net income from operations of $918,000, including $724,000 in stock-based compensation and $1.1 million in depreciation and amortization expenses, compared to income from operations of $1.0 million, inclusive of $437,000 in stock-based compensation and $881,000 in depreciation and amortization expenses, in the first nine months of fiscal 2021. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported adjusted EBITDA of $2.7 million for the first nine months of fiscal 2022 compared to non-GAAP income from operations of $2.3 million in the first nine months of fiscal 2021.

Cost of oncology solutions was $17.4 million for the nine-months ended January 31, 2022, an increase of $1.8 million, or 11.6% compared to $15.6 million for the nine-months ended January 31, 2021. The increase was attributable to an increase in compensation and lab supply expenses due to our increase in study volume. For the nine-months ended January 31, 2022, gross margin was 51.9% compared to 48.8% for the nine-months ended January 31, 2021. The improvement in gross margin was the direct result of decreasing the Company’s reliance on outsourcing and leveraging revenue growth over the fixed cost component of cost of sales.

Research and development expense for the nine-months ended January 31, 2022 was $6.8 million, an increase of $1.7 million or 32.4%, compared to $5.1 million for the nine-months ended January 31, 2021. The increase was primarily from increased investment in our therapeutic target discovery platform. Sales and marketing expense for the nine-months ended January 31, 2022 was $4.8 million, an increase of $716,000, or 17.7%, compared to $4.0 million for the nine-months ended January 31, 2021. The increase was primarily due to compensation expense driven by the continued investment in expanding our business development teams. General and administrative expense for the nine-months ended January 31, 2022 was $6.4 million, an increase of $1.7 million, or 35.6%, compared to $4.7 million for the nine-months ended January 31, 2021. The increase was primarily due to an increase in compensation as well as an increase in IT related expenses to support the overall infrastructure growth of the organization.

Net cash provided by operating activities was $5.7 million for the nine-months ended January 31, 2022. The cash generated from operating activities was primarily due to increased operating income excluding stock-based compensation, depreciation and amortization expenses. Net cash used in investing activities was $1.9 million and was primarily from investment in additional lab equipment and software development. Net cash provided by financing activities was approximately $191,000 generated from option exercise activity.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its third quarter financial results. To participate in the call, please call 888-506-0062 (Domestic) or 973-528-0011 (International) and enter the access code 692343 ten minutes ahead of the call.
Full details of the Company’s financial results will be available by Wednesday, March 16, 2022 in the Company’s Form 10-Q at www.championsoncology.com.
* Non-GAAP Financial Information
See the attached Reconciliation of GAAP net income to Non-GAAP net income for an explanation of the amounts excluded to arrive at Non-GAAP net income and related Non-GAAP earnings per share amounts for the three and nine months ended January 31, 2022 and 2021. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net income and Non-GAAP earnings per share are not, and should not, be viewed as a substitute for similar GAAP items. Champions defines Non-GAAP dilutive earnings per share amounts as Non-GAAP net earnings divided by the weighted average number of diluted shares outstanding. Champions’ definition of Non-GAAP net earnings and Non-GAAP diluted earnings per share may differ from similarly named measures used by other companies.

Adjusted EBITDA is defined as earnings before interest, taxes, depreciation and amortization, and stock-based compensation expenses. Adjusted EBITDA represents a measure that Champions believes is customarily used by investors and analysts to evaluate the financial performance of companies in addition to the GAAP measures that we present. The Company’s management also believes that adjusted EBITDA is useful in evaluating our core operating results. However, adjusted EBITDA is considered to be Non-GAAP in nature and should not be considered an alternative to net income or operating income as an indicator of Company operating performance or to net cash provided by operating activities as a measure of its liquidity. The company’s adjusted EBITDA measure may not provide information that is directly comparable to that provided by other companies in the Company’s industry, as other companies in its industry may calculate non-GAAP financial results differently, particularly related to non-recurring, unusual items.

On March 15, 2022 Molecular Partners AG (SIX: MOLN, NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built proteins known as DARPin therapeutics, reported its corporate highlights and audited financial results for 2021 (Press release, Molecular Partners, MAR 15, 2022, View Source [SID1234610098]).

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"Ensovibep is our first antiviral DARPin, set to face one of the greatest medical challenges of our time, the COVID pandemic," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "Our strong clinical data represent not only a clinical win against the virus, but also constitute a major milestone for DARPins as a new class of protein drugs. Along with the development of ensovibep, we were able to continue advancing our oncology DARPin programs and initiate additional virology programs, underlining the versatile potential of our platform. As we enter 2022, we have never been better positioned to deliver on the promise of DARPins to help patients around the world living with serious diseases."

Antiviral program

In early January, Molecular Partners and Novartis announced positive topline data from the randomized, double-blind, placebo-controlled EMPATHY Part A study of ensovibep for acute COVID-19 ambulatory patients.

Results from the study showed that the primary endpoint was met with a statistically significant reduction in viral load over eight days, compared to placebo. The secondary endpoint of ER visits, hospitalization or death related to COVID-19 showed an overall 78% reduction in risk of events across ensovibep arms compared to placebo. Ensovibep also demonstrated a clinically meaningful time to sustained recovery benefit over placebo. No deaths occurred in any of the patients treated with ensovibep. All three dosing arms met the primary endpoint of viral load reduction over time, were well-tolerated with no unexpected safety issues, allowing for selection of the lowest dose of 75mg for future development.

Following these results, Novartis exercised its option to in-license the global rights to ensovibep, triggering a milestone payment of CHF 150 million to Molecular Partners. These data are part of a submission to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA), which was announced in February 2022. Novartis has also indicated its intentions to submit ensovibep for review in the E.U. and additional relevant territories.

If approved or authorized, ensovibep would be the first multi-specific antiviral candidate approved for the treatment of COVID-19 and Molecular Partners’ first DARPin therapy approved by a regulatory agency.

Ensovibep has continued to show retained potency against all variants of concern throughout the pandemic in in vitro studies. In December of 2021, preclinical studies confirmed that ensovibep maintains full neutralization of Omicron pseudoviruses that contain the identical mutations of the viral variant. In a panel of biologic drugs tested against the original (wild type) and Omicron variants of SARS-CoV-2, ensovibep maintained a uniformly high neutralizing potency across variants, while substantial reduction in potency was observed for numerous antibody drugs, both approved and investigational. The study design and results are published in BioRxiv, and have been submitted for peer-review publication.

As a DARPin candidate, ensovibep is uniquely designed to retain pan-variant activity across all variants of COVID-19, including most recently the Omicron BA.2 variant, by engaging three domains of the SARS-CoV-2 virus simultaneously to inhibit viral entry into cells. This allows for a potentially broader efficacy and reduces the likelihood for the development of viral drug resistance. In addition, DARPin candidates are produced through rapid, high-yield microbial fermentation for potential speed and logistical advantages over mammalian cell production employed for antibodies.

In November of 2021, Molecular Partners also announced that a planned futility analysis of ensovibep in the NIH-sponsored ACTIV-3 clinical study did not meet the thresholds required to continue enrollment of adults with COVID-19 in the hospitalized setting.

Oncology programs: New programs launched in AML and radioligand therapies

MP0533 nominated as AML candidate

Molecular Partners nominated MP0533 in 2021 as a new candidate for development for the treatment of acute myeloid leukemia (AML). MP0533 is a multi-specific DARPin T-cell engager candidate designed to deliver a highly potent and specific anti-tumor response to AML cells, with a reduced effect on healthy normal cells, and with the potential to counteract target escape mechanisms expected due to tumor heterogeneity. MP0533 is designed to engage CD3 on T cells and target AML cells via the tumor associated antigens CD33, CD123 and CD70.

At the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, Molecular Partners presented preclinical data from MP0533 demonstrating a significant decrease cytokine release syndrome (CRS) when compared to other mono-targeting T-cell engager therapies, confirming MP0533’s potential for an improved safety profile compared to other approaches. In an ex vivo assay using fresh blood from healthy donors, the candidate induced significantly lower inflammatory cytokine production and reduction in platelet counts than T-cell engager candidates in development by other parties.

The Company announced a research collaboration with the University of Bern in December 2021 to advance the development of MP053 into clinical studies, leveraging the Bern group’s expertise in leukemic stem cells, a hard-to-target cancer progenitor cell population relevant to AML. The Company plans to initiate a Phase 1 clinical study of MP0533 in 2022.

MP0317 study initiation

In November 2021, Molecular Partners announced the first patient had been dosed in its Phase 1 clinical trial evaluating the safety and tolerability of MP0317, which targets both the fibroblast activation protein (FAP) and the immunostimulatory protein CD40 to enable tumor-localized immune activation. MP0317 is the second DARPin therapeutic candidate in the company’s immuno-oncology pipeline to enter clinical trials. Through this mechanism of action, MP0317 is designed to activate immune cells specifically within the tumor microenvironment, potentially delivering greater efficacy with fewer side effects compared to other CD40-targeting agents.

The open-label dose escalation study is designed to assess the safety and tolerability as well as pharmacokinetics and pharmacodynamics of MP0317 as a monotherapy in patients with solid tumors known to express fibroblast activation protein (FAP). Enrollment is taking place in the Netherlands and France. A total of up to 30 patients are expected to be enrolled across six dosing cohorts and up to 15 patients will be enrolled in a dose expansion cohort. In addition to evaluating monotherapy dynamics, the study will gather a wide variety of biomarker data to support the establishment of combination therapies with MP0317 in specific indications.

In December 2021, Molecular Partners presented data on MP0317 and the Phase 1 clinical trial design at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress. Initial data from this clinical study is expected in the second half of 2022.

MP0310 clinical progress

The ongoing Phase 1 clinical trial of MP0310 progressed in 2021, evaluating the optimal dosing regimen of MP0310. MP0310 is the second DARPin therapeutic candidate in the company’s immuno-oncology pipeline to enter clinical trials targeting FAP and 4-1BB. It is designed to activate immune cells specifically in the tumor expressing these targets and not in the rest of the body, potentially delivering greater efficacy with less toxicity.

Molecular Partners expects to share initial clinical data from the Phase 1 trial with Amgen in the first half of 2022.

In April of 2021, Molecular Partners presented four posters highlighting research across its immuno-oncology programs at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) virtual Annual Meeting.

New radioligand collaboration

In December 2021, Molecular Partners announced a collaboration with Novartis in the form of a license agreement to develop, manufacture and commercialize DARPin-conjugated radioligand therapies (DARPin-RLTs). The collaboration combines DARPins’ unique properties, including small size (under 20kDa) and very high affinities (low picomolar), with the RLT capabilities and expertise of Novartis. DARPin-RLTs have the potential to deliver molecularly targeted radiation deeply into the tumor thereby harnessing the power of radioactive atoms for precise tumor-killing. Under the terms of the agreement, Molecular Partners will collaborate with Novartis to discover DARPin-RLTs that target specific tumor-associated antigens. Both parties will collaborate on the discovery and optimization of the therapeutic candidates for further development.

Ophthalmology program: Meeting with FDA signals further development pathway for abicipar

In August 2021, Molecular Partners regained global development and commercial rights to abicipar for the treatment of neovascular age-related macular degeneration (nAMD) and Diabetic Macular Edema (DME). The Company has reported two positive Phase 3 studies of abicipar, CEDAR and SEQUOIA, which supported the non-inferior efficacy of its quarterly dosing regimen with 50 percent fewer injections than ranibizumab.

Molecular Partners has formed a special committee to evaluate the further development of abicipar, and correspondence with the FDA is underway. Feedback obtained from the agency in February of 2022 provided clinical guidance which is now being further evaluated.

Corporate Governance further strengthened

Agnete Fredriksen and Dominik Höchli were elected to the Board of Directors at the Annual General Meeting of April 21, 2021.
Alexander Zürcher has been promoted to Chief Operating Officer. Alexander has most recently served as SVP Development of Molecular Partners and oversaw project and portfolio management, manufacturing, pharmacology, and quality assurance activities and has more than 20 years of industry experience.
Coinciding with Alexander’s promotion, Michael Stumpp, the Company’s current COO, will transition to the newly formed position of EVP Projects and will continue to be a member of the Management Board.
Renate Gloggner has been promoted to EVP People and Community. Renate was most recently Senior Vice President, Human Resources of Molecular Partners. She joined the company in October 2021. Prior to joining Molecular Partners, Renate held European and International Human Resource leadership positions at two US companies, Global Blood Therapeutics and Tesaro Bio.
Both Alexander and Renate will be appointed to the Management Board effective July 1, 2022.
ESG initiative expanded

At Molecular Partners our values support three core activities: developing treatments for patients suffering from serious diseases; cultivating a culture of initiative, integrity and excellence; and creating a socially interactive, environmentally aware company culture.

As an innovative biotechnology company, our purpose is to find, develop and bring to market novel therapeutics to improve the lives of patients in need. Our company-wide efforts to develop a COVID-19 treatment for the world, ensovibep, exemplify this value well. When partnering with Novartis to fight COVID-19, we and Novartis agreed to waive all profits from ensovibep in developing regions as part of a commitment to corporate social responsibility in a time of urgent global medical need. In oncology, we are focusing the powers of our platform toward finding truly innovative therapeutics for diseases that currently have no sustainable solution, such as in our recent work in AML, a blood cancer with no reliably effective treatment where we are advancing a truly differentiated potential option for patients through DARPins.

We believe that our growth and constant improvement as a company are closely linked to the well-being and growth of our employees. As a part of that, we are focused on programs to support our internal culture, encouraging employees to show initiative, integrity and to strive to excellence in their work. Further, we are applying employee engagement and retention programs, including a reinforced focus on executive-led initiatives in these areas.

Finally, we find it important to foster a socially and environmentally aware company culture, which we believe helps our team to better appreciate their contribution to society and the importance of their work. To help accomplish all of this, we have engaged external support to help guide our ESG journey, and we are currently in the process of collecting a baseline status evaluation as the next step toward applying an ESG plan with measurable metrics.

Financial Highlights: Company extends cash runway into 2025

Following its initial public offering of ADSs in the United States in June 2021, and Novartis’ licensing of ensovibep in January 2022, Molecular Partners remains well funded to capture upcoming value inflection points in 2022. In the financial year 2021, Molecular Partners recognized total revenues and other income of CHF 9.8 million (2020: CHF 9.3 million) and incurred total expenses of CHF 73.2 million (2020: CHF 67.7 million). This led to an operating loss of CHF 63.4 million for 2021 (2020: Operating loss of CHF 58.3 million). The net financial loss recorded in 2021 was CHF 0.4 million, compared to a net financial loss of CHF 4.4 million in 2020. This resulted in a 2021 net loss of CHF 63.8 million (2020: Net loss of CHF 62.8 million).

The net cash used for operating activities in 2021 was CHF 91.0 million (2020: net cash used of CHF 29.0 million). Including short-term time deposits, the cash and cash equivalents position decreased by CHF 40.9 million as compared to year-end 2020, to CHF 132.8 million as of December 31, 2021 (December 31, 2020: CHF 173.7 million). Total shareholders’ equity stood at CHF 107.3 million as of December 31, 2021, a rounded increase of CHF 0.1 million (December 31, 2020: CHF 107.2 million).

On January 7, 2022, Novartis informed the Group of its intention to exercise the option under the option and equity rights agreement. This was followed by the signing of a license agreement between the two parties on January 17, 2022. This license agreement resulted in the Group becoming eligible to receive CHF 150 million for the option exercise payment and in addition the Group was allowed to charge Novartis CHF 13.1 million for items related to the commercial supply of ensovibep and drug substance secured by the Group.

The proceeds from the Company’s initial public offering in the United States further increased the Company’s solid cash position with no debt on the balance sheet. The Company’s cash position as per December 31, 2021, together with the funds received from Novartis in early 2022, continues to provide the Company with financial flexibility and a forecasted cash runway into 2025.

The Company’s balance sheet continued to be debt-free in 2021. As of December 31, 2021, the Company employed 163.2 FTE (full time equivalents), up 12% year-on-year. About 82% of the employees are employed in R&D-related functions.

Business outlook and priorities

In 2022, we look forward to working in close collaboration with Novartis to support an expedited regulatory review process for ensovibep, first via the U.S. FDA’s EUA process. By entering into the licensing agreement, Novartis will now lead all further development and commercialization efforts for the program. The global Phase 3 trial is expected to be initiated in parallel with expedited submissions to global regulatory bodies. The trial is expected to enroll patients around the world, using the 75mg dose of ensovibep, the lowest dose identified in Part A of the EMPATHY trial.

If approved or authorized, ensovibep will be the first multi-specific antiviral candidate for the treatment of COVID-19 and Molecular Partners’ first DARPin therapy approved by a regulatory agency. Molecular Partners is assessing further viral disease areas where DARPins can offer advantages over existing antivirals or where no effective antivirals exist and plans to showcase such programs in a "Virology Day" targeted for mid-2022. We look forward to making continued progress across our oncology programs and anticipate sharing clinical data from AMG 506 (MP0310) with Amgen and reporting initial data from MP0317 in the first and second half of this year, respectively. We also plan to initiate a Phase 1 clinical study of MP0533 in 2022. In addition to our collaborations with Novartis, Amgen, AbbVie and the University of Bern, in 2022 we also plan to seek out additional partnerships with leading biopharmaceutical organizations or academic institutions to bring the class’s power to bear across diverse disease areas.

The Company plans to detail the path forward for its registrational-stage ophthalmology asset, abicipar following internal strategic assessments that will incorporate any feedback received from regulators.

Financial outlook 2022

For the full year 2022, at constant exchange rates, the Company expects total P&L expenses of CHF 75-85 million, of which around CHF 8 million will be non-cash effective costs for share-based payments, IFRS pension accounting and depreciation. This cash flow guidance does not include any potential payments from R&D partnerships.

Based upon the 2022 year to date received payments from Novartis, the Group currently anticipates reporting an operating profit as well as positive cash flows from operations for the year ended December 31, 2022. There is no assurance that such positive metrics will be achieved or maintained in future periods, as the Group plans to continue to invest into research and development activities as they are fundamental to executing Molecular Partners’ strategic objectives.

Based on the Company’s cash position as of December 31, 2021, together with the payments received from Novartis in January 2022 and no debt, the Company expects its cash runway to extend into 2025, excluding any potential receipts from R&D partners.

Documentation

This press release, the Company’s Annual Report on Form 20-F for the year ended December 31, 2021 to be filed with the U.S. Securities and Exchange Commission (SEC), and the Company’s annual report 2021 will be made available through www.molecularpartners.com after 9:30 pm (CET) on March 15, 2022.

Full year 2021 conference call & audio webcast

Molecular Partners will hold a conference call and audio webcast on March 16, 1 pm CET (8 am EST). To register for the full year 2021 conference call, please dial the following numbers approximately 10 minutes before the start of the presentation:

Participants in the conference call will have the opportunity to ask questions after the presentation.

Audio webcast
The full year 2021 results will be webcast live and will be made available on the Company’s website under the investor section. The replay will be available for 90 days following the presentation.

On March 15, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported it will host a conference call on March 25, 2022, at 8:30 AM Eastern Time to discuss results for its fourth quarter and full year ended December 31, 2021 (Press release, Delcath Systems, MAR 15, 2022, View Source [SID1234610097]).

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Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

On March 15, 2022 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, reported financial results for the three months and year ended December 31, 2021 and provided a business update (Press release, Aprea, MAR 15, 2022, View Source [SID1234610096]).

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Fourth Quarter Financial Results

Cash and cash equivalents: As of December 31, 2021, the Company had $53.1 million of cash and cash equivalents compared to $89.0 million of cash and cash equivalents as of December 31, 2020. The Company expects cash burn for the full year 2022 to be between $25.0 million and $30.0 million. The Company believes its cash and cash equivalents as of December 31, 2021 will be sufficient to meet its current projected operating requirements into 2023.

Research and Development (R&D) expenses: R&D expenses were $4.5 million for the quarter ended December 31, 2021, compared to $9.3 million for the comparable period in 2020. The decrease in R&D expenses was primarily due to decreases in clinical trial costs for the Company’s pivotal Phase 3 clinical trial of eprenetapopt with azacitidine for the frontline treatment of TP53 mutant MDS and the Company’s Phase 2 post-transplant MDS/AML clinical trial. These decreases were partially offset by increases in clinical trial costs for other ongoing clinical trials.

General and Administrative (G&A) expenses: G&A expenses were $3.4 million for the quarter ended December 31, 2021, compared to $4.9 million for the comparable period in 2020. The decrease in G&A expenses was primarily due to a decrease in pre-commercialization development activities which was partially offset by increased non-cash stock-based compensation.

Net loss: Net loss was $7.8 million, or $0.36 per share for the quarter ended December 31, 2021, compared to a net loss of $13.1 million, or $0.73 per share for the quarter ended December 31, 2020. The Company had 21,859,413 shares of common stock outstanding as of December 31, 2021.
Business Operations Update:

Myeloid Malignancy Program

The Company’s myeloid malignancy program includes fully enrolled and completed clinical trials in MDS, AML and post-transplant maintenance therapy in MDS/AML. In August 2021, the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on the clinical trials of eprenetapopt in combination with azacitidine in the Company’s Phase 3 frontline MDS clinical trial, the Company’s Phase 2 MDS/AML Post-Transplant clinical trial and the Company’s Phase 1/2 AML clinical trial. In December 2021 the Company discussed with FDA the requested data and analyses from the Phase 3 frontline MDS clinical trial and reached agreement on the Company’s proposals for new clinical trials in myeloid malignancies. In the first quarter of 2022 the Company received clearance from FDA to proceed under its existing myeloid malignancy IND with a new clinical trial in relapsed/refractory MDS and AML.

Lymphoid Malignancy Program

The Company’s lymphoid malignancy program includes a clinical trial evaluating eprenetapopt in patients with non-Hodgkin lymphomas (NHL). In August 2021, FDA placed a clinical hold on this trial. In October 2021, the Company discussed with FDA the requested data and analyses from the Phase 3 frontline MDS clinical trial and proposed amendments for clinical trials to proceed in its lymphoid malignancy program. Following interaction with the FDA, the clinical hold was lifted in December 2021.

The Company is in the planning phase for new clinical trials in both myeloid and lymphoid malignancies and is continuing to evaluate other development opportunities. The Company plans to provide updates on progress on all programs throughout 2022.

APR-548 Phase I Trial

The Company’s second product candidate, APR-548, is a next generation p53 reactivator that is being developed in an oral dosage form. The Company initiated a Phase 1 clinical trial testing APR-548 in relapsed/refractory MDS and AML. Enrollment in the first dosing cohort was completed and pharmacokinetic and adverse event data will be collected and analyzed. The Company does not plan to enroll additional patients into the trial.

Solid Tumor Program

The Company’s solid tumor program includes its clinical trial evaluating eprenetapopt with anti-PD-1 therapy in advanced solid tumors. The Company completed enrollment in its Phase 1/2 clinical trial in relapsed/refractory gastric, bladder and non-small cell lung cancers assessing eprenetapopt with anti-PD-1 therapy. The Company is in the planning phase for a future clinical trial to further evaluate orally-administered eprenetapopt with immunotherapy checkpoint inhibitors.

On March 15, 2022 MorphoSys U.S. Inc., a fully owned subsidiary of MorphoSys AG (FSE: MOR; NASDAQ: MOR), reported that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (NCCN Guidelines) in Oncology for B-cell Lymphomas have been updated, and the designation for Monjuvi (tafasitamab-cxix) in combination with lenalidomide is now a Preferred Regimen for second-line therapy in patients with Diffuse Large B-cell Lymphoma (DLBCL) who are not candidates for transplant (Press release, MorphoSys, MAR 15, 2022, View Source [SID1234610095]).

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"Updates to NCCN Guidelines are made periodically when additional efficacy and safety data are available, providing current information on the use of cancer therapies," said Joe Horvat, U.S. General Manager, MorphoSys. "Monjuvi is a targeted immunotherapy that addresses an immediate medical need for certain adult patients living with Diffuse Large B-cell Lymphoma. We are gratified the NCCN panel acknowledged the additional data submitted for Monjuvi and updated the designation of Monjuvi in combination with lenalidomide to a Preferred Regimen in its Clinical Practice Guidelines in Oncology."

In July 2020, the U.S. Food and Drug Administration (FDA) approved Monjuvi 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 (ORR) from the one-year primary analysis of the L-MIND study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In the U.S., Monjuvi is the only approved second-line targeted immunotherapy for this patient population.

The NCCN is a not-for-profit alliance of 30 leading cancer centers devoted to patient care, research, and education. The intent of the NCCN Guidelines is to assist in the decision-making process of individuals involved in cancer care – including physicians, nurses, pharmacists, payers, patients, and their families – with the ultimate goal of improving patient care and outcomes. The updated NCCN Guidelines are available at www.nccn.org.
NCCN and the NCCN Guidelines are registered trademarks of National Comprehensive Cancer Network.
About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs.1 It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter, leading to a high medical need for new, effective therapies, especially for patients who are not eligible for an autologous stem cell transplant in this setting.2
About Monjuvi (tafasitamab-cxix)
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeted immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb 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 (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 (tafasitamab) received conditional marketing authorization 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.
Monjuvi and Minjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and marketed by Incyte under the brand name Minjuvi in the EU.
XmAb is a registered trademark of Xencor, Inc.
Important Safety Information
What are the possible side effects of MONJUVI?
MONJUVI may cause serious side effects, including:
•Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, rash, flushing, headache, or shortness of breath during an infusion of MONJUVI.
•Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4ºF (38ºC) or above, or any bruising or bleeding.
•Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4ºF (38ºC) or above, or develop any signs and symptoms of an infection.
The most common side effects of MONJUVI include:
•Feeling tired or weak
•Diarrhea
•Cough
•Fever
•Swelling of lower legs or hands
•Respiratory tract infection
•Decreased appetite
These are not all the possible side effects of MONJUVI.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you
•Have an active infection or have had one recently.
•Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
◦You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
◦Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
•Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.
You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.
Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.