On February 27, 2020 The American Society for Radiation Oncology reported that a new phase II trial finds that a combination of radiation therapy and immunotherapy led to encouraging survival outcomes and acceptable toxicity for patients with locally advanced head and neck squamous cell carcinoma (HNSCC) (Press release, ASTRO, FEB 27, 2020, View Source [SID1234555007]). The combination of radiation and pembrolizumab may offer a new treatment option for patients who are ineligible for cisplatin chemotherapy, part of standard treatment for the disease. Findings will be presented at the 2020 Multidisciplinary Head and Neck Cancers Symposium, taking place February 27-29 in Scottsdale, Arizona.

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The single-arm trial was designed specifically for patients who normally would receive platinum chemotherapy together with radiation but may not be able to tolerate its side effects, most often due to preexisting hearing problems that place patients at risk of permanent hearing loss. Preexisting kidney damage and nerve damage also tend to be aggravated by cisplatin and place patients at risk for permanent side effects.

"That is a common dilemma in the exam room because cisplatin, while effective, tends to be particularly toxic for patients and can lead to permanent side effects for some," explained lead author Jared Weiss, MD, an associate professor of medicine at the University of North Carolina Lineberger Comprehensive Cancer Center. "I will have patients I want to treat with platinum chemotherapy, but I also want to align treatment with their values. Is the patient willing to accept a risk of deafness or exacerbated ringing in their ears? These are not acceptable consequences for most people."

The single-arm trial included 29 patients with locally advanced HNSCC. All patients would have ideally received cisplatin with their radiation but were ineligible for platinum chemotherapy. Patients were treated with three cycles of pembrolizumab and concurrent radiation therapy over six weeks, followed by three additional cycles of the immunotherapy drug.

With a median follow-up of 21 months, the rates of one-year progression-free and overall survival were 76% [95% CI 56-88] and 86% [67-95], respectively. Estimated two-year PFS was 71% [49-84] and estimated two-year OS was 75% [51-88]. For patients with p16+ oropharynx cancer, the one-year PFS and OS rates were 88% and 94%, respectively; for the other patients, the rates were 58% and 75%, respectively.

Most toxicities were mild (grade 1-2) with the exception of grade 3-4 lymphopenia, which affected 59% of patients. "This toxicity profile is better than what patients generally experience with cisplatin and radiation," explained Dr. Weiss. "It was more consistent with what we see from radiation therapy alone, with the exception of a high rate of lymphopenia that warrants additional study."

While engaging PD-1/PD-L1 blockade following chemoradiotherapy has improved survival in lung cancer, this trial is one of the first to show its potential efficacy for head and neck cancers. "There are convincing arguments that radiation sensitizes patients to immunotherapy and can enhance its effects. And the opposite direction also seems to be true – radiation therapy needs a functional immune system to work, and our hope was that pembrolizumab might be a radiation sensitizer for these patients," said Dr. Weiss.

Additionally, unlike chemoradiation therapy, the combination of radiation and pembrolizumab pairs two active modalities that can be curative by themselves. "If you look back to the historic studies, radiation alone often cures patients with this disease.Some of the first patients treated with pembrolizumab for recurrent/metastatic cancer are still alive many years out, with no evidence of disease," said Dr. Weiss. "And so, our concept was that, in addition to whatever synergy the immunotherapy might provide with radiation, we also conceived of it in a more straightforward way as a ‘second shot on goal’ toward cure."

Dr. Weiss cautioned that findings need confirmation in a randomized trial before the combination is recommended to patients.

Dr. Weiss will present "Progression-free survival, overall survival and immunophenotyping outcomes for patients with stage III-IV head and neck cancer and cisplatin contraindication treated with definitive radiotherapy plus pembrolizumab" tomorrow during the symposium’s Oral Abstract Session. The study was funded by Merck. Email [email protected] for a copy of the abstract or presentation slides from the meeting.

Attribution to the 2020 Multidisciplinary Head and Neck Cancers Symposium requested in all coverage. This release includes updated information not available in the abstract.

2020 Head and Neck Cancers Symposium News Planning Team
Robert L. Ferris, MD, PhD; Maie St. John, MD, PhD; Francis P. Worden, MD; Charu Aggarwal, MD, MPH; Sue Yom, MD, PhD; Brian O’Sullivan, MD, FASTRO; disclosures available online.

ABOUT THE SYMPOSIUM
The 2020 Multidisciplinary Head and Neck Cancers Symposium is a two-and-a-half-day meeting that convenes radiation oncologists, medical oncologists, surgeons and all members of the treatment team for a practical and comprehensive examination of treatment advances for patients with head and neck cancers. Scientific, interactive and case-based educational sessions will cover the latest research on multidisciplinary therapies, clinical applications and new treatment strategies, supportive care and toxicity mitigation. The meeting is cosponsored by the American Society for Radiation Oncology (ASTRO), the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the American Head and Neck Society (AHNS) and the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).

On February 27, 2020 Two scientists from Wake Forest School of Medicine, part of Wake Forest Baptist Health, reported that they have received a total of $1.5 million in research funding from the American Cancer Society (ACS) to study new chemotherapy and immunotherapy treatments for cancer (Press release, Wake Forest Baptist Medical Center, FEB 27, 2020, View Source [SID1234555006]).

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One of the grants, for $792,000 over four years, was awarded to Yong Lu, Ph.D., assistant professor of microbiology and immunology, to study a new approach to immunotherapy for metastatic and treatment-resistant cancers.

Using specialized white blood cells or T cells that he discovered, Lu and his research team will determine if the administration of these blood cells can eradicate advanced tumors and prevent recurrence of resistant tumors in an animal model.

Cancer recurrence may cause cancer treatment failure and death in more than 90% of patients with advanced tumors, especially with metastatic disease, which often develops resistance to the initial treatments, Lu said.

"We hope our work will shed light on the mechanisms underlying how T cells, the major type of white blood cells, prevent resistance and hopefully establish a foundation for translating that into more effective immunotherapies in human cancers," Lu said.

The second grant, for $782,000 over four years, was awarded to David Soto-Pantoja, Ph.D., assistant professor of surgery and cancer biology.

The grant will support his team’s efforts to create preclinical models to study cardiotoxicity – damage to the heart muscle – that results from some chemotherapy and immunotherapy drugs.

"In the next 10 to 15 years, there will be 20 million cancer survivors in the U.S. thanks to newer cancer drugs that are very effective," Soto-Pantoja said. "Unfortunately, many of these drugs have other side effects such as heart disease that can occur many years after treatment."

Soto-Pantoja’s goal is to better understand how chemotherapy drugs can affect the heart and develop strategies to prevent future development of cardiac diseases, as well as to find new treatments for those patients who have already developed heart disease.

For example, when he was a fellow at the National Institutes of Health prior to coming to Wake Forest Baptist, his team identified a molecule present on cells that when blocked prevents some of the damage caused by chemotherapy drugs.

"The molecule enhanced the immune system to attack the tumor but protected normal tissue from the negative effects of chemotherapy," Soto-Pantoja said.

This grant will support his continued efforts to understand how this molecule works and hopefully lead to a new approach to cancer therapy.

On February 27, 2020 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported full-year 2019 financial results (Press release, CytomX Therapeutics, FEB 27, 2020, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-full-year-2019-financial-results" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-full-year-2019-financial-results" rel="nofollow">View Source [SID1234554988]).

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As of December 31, 2019, CytomX had cash, cash equivalents and short-term investments of $296.1 million.

"During 2019, CytomX made substantial progress in advancing our clinical stage pipeline of innovative Probody therapeutics from Phase 1 platform proof of concept into Phase 2 clinical studies. We took major steps forward with our proprietary programs and in our partnerships and set the stage for significant updates throughout 2020," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "We also strengthened our product development capabilities with the recruitment of deeply experienced leadership, positioning ourselves to maximize the potential of our lead, wholly-owned assets, CX-072 and CX-2009, and of our entire portfolio. My colleagues and I look forward to continued pipeline momentum throughout the coming year as we maintain our focus on the discovery, development and ultimate commercialization of potentially transformative cancer treatments."

Business Highlights and Recent Developments

Initiation of Combination Phase 2 Study of CX-072, An Anti-PD-L1 Probody Therapeutic

In the fourth quarter of 2019, CytomX initiated the PROCLAIM (Probody Clinical Assessment In Man) CX-072-002 Phase 2 study evaluating the efficacy and tolerability of the anti-PD-L1 Probody CX-072, in combination with the anti-CTLA-4 antibody Yervoy (ipilimumab), in patients with relapsed or refractory melanoma. Stage 1 of this two-stage trial will enroll up to 40 patients with initial data anticipated in 2020. Additional information is available at ClinicalTrials.gov using the identifier NCT03993379.
Initiation of Phase 2 Study of CX-2009, An Anti-CD166 Probody Drug Conjugate

In the fourth quarter of 2019, CytomX initiated the PROCLAIM CX-2009 Phase 2 expansion study of CX-2009 monotherapy (7 mg/kg, administered every three weeks) in up to 40 patients with hormone receptor (ER, PR) positive, HER2-negative breast cancer. Initial data from this trial is anticipated in 2021. Additional information on this trial is available at ClinicalTrials.gov using the identifier NCT03149549.
Initiation of Part 2a of Ongoing Study by Bristol-Myers Squibb of BMS-986249, An Anti-CTLA-4 Probody Therapeutic

Initiation by Bristol-Myers Squibb of a Phase 2 randomized cohort expansion in its ongoing first-in-human Phase 1/2a trial of the anti-CTLA-4 Probody BMS-986249, a Probody version of the anti-CTLA-4 antibody Yervoy (ipilimumab), in combination with Opdivo (nivolumab) in patients with metastatic melanoma. The advancement of BMS-986249 into this study triggered a milestone payment of $10 million from BMS to CytomX. Additional information is available at ClinicalTrials.gov using the Identifier NCT03369223.
Ongoing Dose Escalation Phase 1 Study of CX-2029, An Anti-CD71 Probody Drug Conjugate, within AbbVie Alliance

Continued patient enrollment by CytomX in the dose escalation phase of PROCLAIM-CX-2029 Phase 1/2 study, partnered with AbbVie, evaluating CX-2029 as monotherapy in patients with solid tumors. Initial data from Phase 1 dose escalation arm is anticipated in 2020 with proof-of-concept data from the first cohort expansion studies in specific tumor types anticipated in 2021. Additional information is available at ClinicalTrials.gov using the Identifier NCT003543813.
Phase 1 Study Initiation by Bristol Myers Squibb of BMS-986288, An Anti-CTLA-4 Probody Therapeutic

In September 2019, Bristol-Myers Squibb initiated the dose escalation phase of a Phase 1/2a clinical study of a second anti-CTLA-4 Probody, BMS-986288, based on a modified version of Yervoy, administered as monotherapy and in combination with Opdivo in patients with selected advanced solid tumors. Additional information is available at ClinicalTrials.gov using the Identifier (NCT03994601).
ImmunoGen Collaboration

In December 2019, CytomX obtained exclusive worldwide development and commercial rights to ImmunoGen’s preclinical epithelial cell adhesion molecule (EpCAM)-targeting program that was developed utilizing CytomX’s Probody technology and ImmunoGen’s drug conjugate technology.
Probody T-Cell Bispecific Program

CytomX’s most advanced program in the T-Cell Bispecific (TCB) modality is an Epidermal Growth Factor Receptor-CD3 TCB which is partnered with Amgen. CytomX anticipates advancing a lead candidate for this program during 2020.
Clinical Development Team Appointments

In October 2019, the Company announced the appointment of Amy C. Peterson, M.D., as executive vice president and chief development officer. In this new role, Dr. Peterson has oversight of a multi-disciplinary team focused on advancing all aspects of CytomX’s clinical development and product registration activities.
In February 2020, the Company announced the appointment of Alison Hannah, M.D., as senior vice president and chief medical officer. In this role, Dr. Hannah oversees CytomX’s clinical development activities.
Anticipated 2020 Milestones

PROCLAIM-CX-072 (Anti-PD-L1)

Data is anticipated from the expansion arms of the Phase 1/2 trial of CX-072 as monotherapy in multiple selected tumor types.
Initial data is anticipated from Stage 1 of the Phase 2 study of CX-072 in combination with Yervoy.
PROCLAIM-CX-2009 (Anti-CD166)

Data is anticipated from the CX-2009 Phase 1 dose escalation and dose ranging studies.
PROCLAIM-CX-2029 (Anti-CD71)

Initial data is anticipated by CytomX and its partner, AbbVie, from the Phase 1 dose escalation stage of the PROCLAIM CX-2029 Phase 1/2 study.
Full Year 2019 Financial Results

Cash, cash equivalents and short-term investments totaled $296.1 million as of December 31, 2019, compared to $436.1 million as of December 31, 2018.

Revenue was $57.5 million for the year ended December 31, 2019, compared to $59.5 million for the year ended December 31, 2018. The net decrease in revenue of $2.0 million for 2019 compared to 2018 was primarily due to a decrease in revenue of $13.1 million from AbbVie under the CD71 Co-Development and Licensing Agreement with AbbVie Unlimited Company (AbbVie), as well as decreases in revenue under our agreements with Amgen, Pfizer and ImmunoGen, partially offset by an increase in revenue from Bristol-Myers Squibb due to the accelerated recognition of revenue related to the cessation of research on certain targets under our agreement with Bristol-Myers Squibb in the first quarter of 2019.

Research and development expenses increased by $27.8 million during the year ended December 31, 2019 compared to the corresponding period in 2018. The increase was largely attributed to an increase in personnel-related expenses; expenses relating to the acquisition of technical know-how during the first quarter of 2019; license fees paid to the University of California, Santa Barbara (UCSB) in connection with an amendment to our license agreement with UCSB in the second quarter of 2019; and an upfront license fee paid to ImmunoGen in the fourth quarter of 2019 for the EpCAM program.

General and administrative expenses increased by $3.3 million during the year ended December 31, 2019 compared to the corresponding period in 2018. The increase was primarily due to an increase in personnel-related expenses due to an increase in headcount.

Teleconference Scheduled Today at 5:00 p.m. ET
Conference Call/Webcast Information

CytomX management will host a conference call today at 5:00 p.m. ET. Interested parties may access the live audio webcast of the teleconference through the "Investor & News" section of CytomX’s website at View Source or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) and using the passcode 1686972. An archive of the webcast will be available on the CytomX website from February 27, 2020, until March 6, 2020.

On February 27, 2020 Bayer reported it was strategically and operationally successful last year (Press release, Bayer, FEB 27, 2020, View Source [SID1234554978]). "We delivered in 2019 and kept our promises in all areas," Werner Baumann, Chairman of the Board of Management, said on Thursday at the Financial News Conference in Leverkusen. "We achieved our financial targets despite coming up against a challenging market environment in the agriculture sector in particular," Baumann said. Bayer is also optimistic for the current year, with the company targeting an increase in sales, earnings and free cash flow.

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"We’ve also delivered in terms of the portfolio, efficiency and structural measures announced in late 2018," Baumann continued. In 2019, Bayer agreed the divestment of its Animal Health business to Elanco for 7.6 billion U.S. dollars, completed the sale of its stake in site services provider Currenta and also divested the Dr. Scholl’s and Coppertone brands. Including the synergies from the acquired agriculture business, the efficiency and structural measures last year already delivered around 30 percent of the 2.6 billion euros in annual contributions targeted by 2022.

The company also significantly stepped up its sustainability efforts in 2019 and set itself ambitious targets. "We have made sustainability an integral part of our strategy, reflecting our responsibility as a company and society’s increased expectations," Baumann said. "We are pursuing our sustainability targets with the same vigor as our financial targets. In line with this, we will submit a proposal to the Annual Stockholders’ Meeting in April that the sustainability targets be integrated into the compensation system for the Board of Management."

Increase in Group sales and earnings

Group sales increased by 3.5 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.) to 43.545 billion euros last year. On a reported basis, sales were up by 18.5 percent. EBITDA before special items rose by 28.3 percent to 11.503 billion euros. It was diminished by negative currency effects of 43 million euros.

EBIT increased by 21.3 percent to 4.189 billion euros after net special charges of 2.818 billion euros. The special charges were primarily related to the ongoing restructuring program, the acquisition and integration of Monsanto, impairments in connection with the dicamba production facility at Crop Science and the divestment of Dr. Scholl’s at Consumer Health, and legal fees. Net income advanced by 141.4 percent to 4.091 billion euros and included the gain from the sale of Bayer’s stake in the Currenta Group (1.637 billion euros). Core earnings per share from continuing operations rose by 14.3 percent to 6.40 euros.

The Board of Management and Superivsory Board of Bayer AG will propose to the Annual Stockholders’ Meeting on April 28, 2020, a dividend payment for fiscal 2019 of 2.80 euros (fiscal 2018: 2.80 euros) per share entitled to the dividend. With 982.42 million (2018: 932.55 million) shares entitled to the dividend, the total dividend payment would amount to 2.751 billion euros (fiscal 2018: 2.611 billion euros).

In 2019, free cash flow declined by 9.4 percent to 4.214 billion euros, "but was still well above the 3 to 4 billion euros we originally anticipated and we’re therefore very satisfied," said Chief Financial Officer Wolfgang Nickl. Bayer reduced its net financial debt by 4.5 percent year on year to 34.068 billion euros.

Crop Science substantially raises earnings thanks to acquired business

In the agricultural business (Crop Science), Bayer increased sales by 1.4 percent (Fx & portfolio adj.) to 19.832 billion euros. This development was largely due to growth in Latin America, while business in North America was at the prior-year level despite flooding and heavy rains in the Midwestern United States in the first half of the year.

On a pro-forma basis – presented as if both the acquisition of Monsanto and the associated divestments had already taken place as of January 1, 2018 – Crop Science saw sales decline by 1.4 percent after adjusting for currency effects (Fx adj.). On this basis, sales were up at Insecticides, Fungicides and Corn Seed & Traits, for instance. Declines were primarily recorded at Soybean Seed & Traits, particularly in North America, where business was held back by a decrease in acreages, strong competition, the weather conditions and ongoing uncertainties due to trade conflicts.

EBITDA before special items at Crop Science advanced by 80.9 percent to 4.796 billion euros. The increase was primarily attributable to the earnings contribution from the newly acquired business and the realization of synergies as its integration progressed.

As of February 6, 2020, lawsuits from approximately 48,600 plaintiffs had been served in the United States in connection with the crop protection product glyphosate. Bayer believes that the verdicts in the first three cases that went to trial are not supported by the evidence at trial and the law and therefore is pursuing the appeals vigorously. "The U.S. government just recently expressed its explicit support for key elements of our reasoning," Baumann said, referring to the official court filing to this effect issued in December 2019. "We will pursue the three appeals through all judicial instances if necessary." Meanwhile, Bayer continues to constructively engage in the confidential court-ordered mediation proceedings to explore whether a settlement can be reached on reasonable terms that is structured in a way that will bring this entire series of litigations to a reasonable conclusion.

Strong earnings growth at Pharmaceuticals

Sales of prescription medicines (Pharmaceuticals) increased by 5.6 percent (Fx & portfolio adj.) to 17.962 billion euros. Growth in China remained strong, while the oral anticoagulant Xarelto and the eye medicine Eylea again delivered substantial sales gains, with both products up 12.6 percent (Fx & portfolio adj.). Xarelto primarily benefited from expanded volumes in China, Russia and Europe, whereas Eylea showed particularly strong development in the Europe/Middle East/Africa region, especially the United Kingdom and Germany, and in Japan. The radiology business also delivered encouraging performance.

Bayer also posted substantial sales gains for its cancer drug Stivarga (Fx & portfolio adj.: 27.3 percent) and the pulmonary hypertension treatment Adempas (Fx & portfolio adj.: 14.4 percent). While sales of Adempas were driven by positive development in the United States, Stivarga primarily benefited from expanded volumes in China. Sales of the multiple sclerosis treatment Betaferon/Betaseron continued to decline substantially (Fx & portfolio adj.: minus 18.0 percent), mainly as a result of strong competition in the United States.

EBITDA before special items at Pharmaceuticals advanced by 6.7 percent to 5.975 billion euros. The growth in earnings was driven by higher volumes and a decrease in the cost of goods sold. By contrast, earnings were diminished by an increase in selling expenses for product launches and new indications. In addition, earnings in the prior year included a positive one-time effect of around 190 million euros in connection with income from a development collaboration.

Consumer Health sees growth in all categories

Bayer increased sales of self-care products (Consumer Health) by 2.6 percent (Fx & portfolio adj.) to 5.462 billion euros. After adjusting for currency and portfolio effects, the division grew sales in all categories and in three of the four regions. Sales growth was strongest in the Allergy & Cold (Fx & portfolio adj.: 5.0 percent) and Dermatology (Fx & portfolio adj.: 3.8 percent) categories.

EBITDA before special items at Consumer Health came in at 1.090 billion euros, matching the level of the prior year (minus 0.5 percent). Positive contributions to earnings came primarily from the growth of the business as well as the ongoing efficiency program, which led to a significant decrease in selling expenses. Earnings were primarily held back by the absence of the contribution from the divested prescription dermatology business.

Outlook: Bayer aiming to increase sales, earnings and free cash flow

For 2020, Bayer expects currency-adjusted sales from continuing operations to amount to around 44 billion to 45 billion euros. This corresponds to an increase of about 3 to 4 percent on a currency- and portfolio-adjusted basis. Bayer aims to raise the Group’s EBITDA margin before special items to around 28 percent after adjusting for currency effects. EBITDA before special items is seen rising to between 12.3 billion and 12.6 billion euros on a currency-adjusted basis. Core earnings per share are expected to increase to between 7.00 and 7.20 euros on a currency-adjusted basis, while free cash flow is planned to amount to around 5 billion euros after adjusting for currency effects. The forecast does not yet include an estimate of the potential impact of the coronavirus outbreak. In addition, the outlook is based on the assumption that the Animal Health business will transfer to the acquirer effective July 1, 2020, and that the purchase price will be received on that date in cash and Elanco shares as agreed.

Following the divestments last year, Bayer changed the way the costs of the enabling functions are allocated to the divisions, which has an impact on the EBITDA margin before special items. At Crop Science, the margin for 2019 amounted to 24.2 percent as reported or 23.8 percent when adjusted to reflect this change. On this basis, Bayer expects an increase to around 26 percent after adjusting for currency effects. At Pharmaceuticals, the margin came in at 33.3 percent as reported or 32.6 percent when adjusted, and is expected to reach around 33 percent this year on a currency-adjusted basis. At Consumer Health, the margin in 2019 amounted to 20.0 percent or 20.9 percent when adjusted, and is anticipated to increase to a currency-adjusted 22 to 23 percent in 2020.

On February 27, 2020 BioInvent reported that Financial Statement January 1 – December 31, 2019 (Press release, BioInvent, FEB 27, 2020, View Source;december-31-2019-301012311.html [SID1234554953]).

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"We are proud that we have delivered on our goals for the year and feel confident that we will continue to do so in 2020, with a number of important milestones approaching. Our cooperation with Merck & Co is our second large pharma collaboration and an excellent validation of BioInvent’s work, as we develop BI-1206 in solid tumors as well as in haematological cancers."

Martin Welschof, CEO BioInvent

Financial information

Fourth quarter 2019

Net sales SEK 25.4 (10.4) million.
Loss after tax SEK -40.9 (-32.7) million.
Loss after tax per share before and after dilution SEK -0.08 (-0.09).
Cash flow from operating activities and investment activities SEK -28.5 (-38.2) million.
January – December, 2019

Net sales SEK 93.7 (38.5) million.
Loss after tax SEK -138.6 (-123.2) million.
Loss after tax per share before and after dilution SEK -0.31 (-0.36).
Cash flow from operating activities and investment activities SEK -129.3 (-145.2) million. Liquid funds as of December 31, 2019: SEK 154.0 (68.9) million.
Events in the fourth quarter

BioInvent entered into a clinical trial collaboration and supply agreement with Merck & Co to evaluate BI-1206 in combination with KEYTRUDA in advanced solid tumors. (R)
Selection of second target and extension of the research collaboration and license agreement with Pfizer Inc. announced. (R)
BioInvent and Transgene announced compelling preclinical data for BT-001 in solid tumors.
Manufacturing agreement signed with Cancer Research UK expected to generate approximately SEK 30 million (~$3 million). (R)
BI-1206 preclinical data in mantle cell lymphoma presented at ASH (Free ASH Whitepaper) 2019.
(R)= Regulatory event
Comments from the CEO

As we look back at 2019 for BioInvent, we can be proud of the delivery on our goals for the year. It is particularly exciting to pursue our lead clinical candidate BI-1206 in solid tumors as well as in hematological cancers.

In December, we concluded an agreement with Merck & Co. to evaluate the combination of BI-1206 and Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a Phase l/lla clinical trial for the treatment of advanced solid tumors. This expands BI-1206 clinical development and builds on preclinical data that demonstrates its ability to address an important mechanism of resistance to PD-1 inhibition, in combination, with one of the most successful immune-oncology drug. The collaboration is an excellent validation of our work and scientific excellence, as Merck has carefully evaluated the pre-clinical data and mode of action that Bioinvent has generated. They have provided insightful feedback on the clinical protocol, and provided input on the strategy for the development of BI-1206 before concluding this agreement.

Our partnership with Pfizer is also progressing well, and further validates the high scientific quality of the work performed by the team at BioInvent. Pfizer has now selected the second target under our cancer immunotherapy research collaboration and license agreement, and we have extended the research term by six months.

These agreements with two of the largest and most highly-respected pharmaceutical companies in the world strongly endorse BioInvent’s proprietary F.I.R.S.T platform. The platform enables us to simultaneously identify targets and high-quality antibodies that bind to them and generates promising new drug candidates that broaden our pipeline and create licensing and partnering opportunities.

Importantly, we also presented pre-clinical data indicating a broad and clinically relevant role of FcγRIIb in mantle cell lymphoma and highlight the potential of BI-1206 to help overcome resistance to treatment in this disease. This further reinforces our belief that FcγRIIb will become a key component for the treatment of advanced hematological and solid malignancies.

We have made important strategic advances in our collaboration with Cancer Research UK (CRUK). Given the overlap with BioInvent’s own Phase I/IIa trial of BI-1206 in combination with rituximab in Non-Hodgkin Lymphoma (NHL), and the fact that standard of care for patients with chronic lymphocytic leukemia (CLL) has dramatically evolved over the last few years, recruitment in the UK study has become increasingly challenging – in particular since CRUK can only carry out trials in the UK. For these reasons we have agreed to limit the CRUK study to monotherapy, which is almost completed. This will result in a more complementary work and more efficient use of resources. BioInvent and CRUK look forward to explore the possibilities for a continued collaboration as we move forward.

We reported compelling results from extensive in vitro and in vivo preclinical studies with BT-001, an oncolytic virus expressing our proprietary anti-CTLA4 antibody and the cytokine GM-CSF. We are developing BT-001 in collaboration with Transgene and intend to submit a clinical trial application in Q1 2020. Preclinical data on BT-001 will be presented at scientific meetings in the coming months.

We anticipate several important milestones in 2020. This will include early results from the Phase I open label study with a combination of BI-1206 and rituximab in indolent NHL in the second half of the year. We will also be initiating the Phase l/lla study of BI-1206 in combination with pembrolizumab, as mentioned above, with early results from the Phase I study expected in the second half of 2021. We are expecting to advance two compounds into clinical programs in solid cancer: in 2020 the anti-TNFR2 antibody BI-1808, as single agent and in combination with an anti-PD1 antibody; and in 2021 the anti-FcγRllB antibody BI-1607 in combination with a checkpoint inhibitor.

As BioInvent continues to bring new opportunities and programs towards clinical development, financing is of course, a focus and priority for us, and we will continue to use a combination of sources for funding. Firstly, we are engaged in several business development discussions with the aim of partnering one or more of the programs in our portfolio. Secondly, the collaboration with Pfizer, which is also a model for other potential collaborations which commercialize our platform. Thirdly, our manufacturing capabilities generate revenue, with the most recent agreement with CRUK expected to generate SEK 30 million. CRUK has the potential to become a long-term strategic partner, as it works with a number of small- to mid-sized companies that need manufacturing support. And our fourth option is to use capital markets for financing. Based on the support from our large institutional investors and increased interest in our programs we feel optimistic that a combination of these four sources will continue to support BioInvent financially.

BioInvent consistently delivered on its strategy in 2019 and this is continuing into 2020. We are looking forward to keeping you updated on the exciting developments ahead.