On November 9, 2021 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company"), reported that the Company will hold a conference call on Tuesday, November 16, 2021, at 2 p.m. CET / 8 a.m. ET, to give an update on business progress during the third quarter of 2021 (Press release, Innate Pharma, NOV 9, 2021, View Source [SID1234594844]).

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Participating in the call will be Innate’s Chief Executive Officer Mondher Mahjoubi, MD and Chief Medical Officer Joyson Karakunnel, MD, MSc, FACP.

On November 9, 2021 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer, bacterial diseases and viral infections, reported the third quarter 2021 financial results and provided an operational update (Press release, Evaxion Biotech, NOV 9, 2021, View Source [SID1234594843]).

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Lars Wegner, CEO of Evaxion, said: "Evaxion has continued to make very encouraging clinical progress in the third quarter of 2021, reporting data in July 2021 which we believe support advancing two of our lead programs into Phase 2b clinical trials. Phase 1/2a clinical trial data on our lead product candidate, EVX-01, showed that 67% of the patients benefited from EVX-01 in combination with anti-PD-1 for the treatment of metastatic melanoma, compared to the historical data of only 40% benefiting from the check point inhibitor alone. In addition, EVX-02 showed T-cell activation in adjuvant melanoma and appeared to be well tolerated. We plan to initiate a Phase 2b clinical trial for EVX-01 in melanoma by the end of 2021 in collaboration with Merck and initiate a Phase 2b clinical trial of EVX-02, in conjunction with our third product candidate, EVX-03, in Q2 2022. Our cash reserves of $11.9 million as of the end of the third quarter, combined with the follow-on financing provide a solid financial foundation and will facilitate the continued development of our lead programs."

Operational and Business Highlights in Q3 2021

Reported new clinical data in early July 2021 from Phase 1/2a clinical trials of EVX-01 and EVX-02.

EVX-01, our peptide-based patient-specific cancer therapy, demonstrated anti-tumor effect in combination with anti-PD-1 treatment, for metastatic melanoma. Results from the combination therapy compares favorably to historical data from anti-PD-1 treatment alone. A Phase 2b clinical trial of EVX-01 is planned to start by the end of 2021.
Preliminary data with EVX-02, our DNA-based patient-specific cancer therapy, demonstrated T-cell activation induced by EVX-02 and appeared to be well tolerated. We intend to submit a regulatory filing for a Phase 2b clinical trial of EVX-02 and EVX-03, in combination with anti-PD-1 in adjuvant melanoma in a three-arm trial, in the first half of 2022.
Events after the Reporting Period

Announced clinical trial and supply agreement with subsidiaries of Merck & Co., Inc. (known as MSD outside of the United States and Canada) to evaluate the combination of Evaxion’s cancer immunotherapy EVX-01 with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a new Phase 2b clinical trial in patients with metastatic melanoma
Awarded this year’s Enabling Technology Leadership Award in the artificial intelligence-enabled drug discovery industry by global research and consulting firm Frost & Sullivan
Presentation at the Immuno UK 2021 conference held in London in October
Announced pricing of our FPO on November 5, 2021, and expect to raise gross proceeds of $27.6 million before deducting underwriting discounts and commissions and other offering expenses.
Expected milestones in 2021 & 2022

Phase 2b Investigational New Drug (IND) / Clinical Trial Application (CTA) of EVX-01 in metastatic melanoma – H2 2021.
Phase 2b IND / CTA filing for EVX-02 in combination with EVX-03 in adjuvant melanoma – H1 2022.
Phase 1a IND / CTA filing for EVX-B1 for S. aureus in skin and soft tissue infections (SSTIs) – H2 2022.
First viral candidate selected from RAVEN platform – H2 2022.
Third Quarter 2021 Financial Results

Cash position: As of September 30, 2021, cash and cash equivalents were $11.9 million compared to $5.8 million as of December 31, 2020. On February 9, 2021, we closed our IPO raising net proceeds of $27.9 million after deducting underwriting discounts and commissions, but before offering expenses.
Research and Development expenses were $4.4 million for the quarter ended September 30, 2021, compared to $3.0 million for the same period in 2020. The increase of $1.4 million was primarily related to increased spending, net of grant income, for ongoing development utilizing our AI platforms, preclinical product candidates, and clinical trials. In addition, employee-related costs increased due to higher headcount.
General and Administrative expenses were $1.5 million for the quarter ended September 30, 2021, compared to $1.7 million for the same period in 2020. The decrease of $0.2 million was primarily related to higher share-based compensation in the period ended September 30, 2020 due to accelerated vesting period and sign-on warrants issued associated with the IPO.
Net loss was $5.3 million for the quarter ended September 30, 2021 or ($0.27) loss per basic and diluted share, compared to $4.0 million, or ($0.26) loss per basic and diluted share, for the same period in 2020.
Guidance

We expect the net proceeds from our IPO and FPO combined with our existing cash reserves will be sufficient to fund our operating expenses and capital expenditure requirements through at least 12 months from September 30, 2021.
Webcast and Conference Call

Evaxion will host a webcast and conference call today, November 9, at 8:30 a.m. EST.

On November 9, 2021 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, reported the closing on November 8, 2021, of its previously announced sale-leaseback transaction with an affiliate of Creative Manufacturing Properties (Press release, Mannkind, NOV 9, 2021, View Source [SID1234594842]). The transaction results in $102.25 million in non-dilutive gross proceeds to MannKind. Simultaneous with closing of the purchase and sale agreement, MannKind entered into a 20-year lease agreement with the purchaser, with multiple renewal options available.

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The real property sale includes 263,900 square feet of manufacturing space at 1 Casper Street in Danbury, Conn. (commonly known as Building 1), but does not include MannKind’s research and development facility (commonly known as Building 8). MannKind will continue to be the sole operator of the entire Connecticut facility. This location is where MannKind produces Afrezza (insulin human) Inhalation Powder, the company’s first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States. It is also where MannKind manufactures Tyvaso DPI (inhaled treprostinil) under its collaboration with United Therapeutics.

On November 9, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported its updated corporate presentation and recent webcasts (Press release, Greenwich LifeSciences, NOV 9, 2021, View Source [SID1234594841]).

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A webcast of the Company’s updated corporate presentation with comments by CEO Snehal Patel is available in the investor section of the Company’s website here.

Mr. Patel commented, "We are very excited to be presenting the combined analysis of our 5 year Phase IIb data from our recently published posters on one timeline, and we expect more upcoming publications. Integrated analysis of efficacy, immune response, and safety data has attracted the interest of large institutions, including large pharma, regional pharma, and biotech institutional investors, whom we are presenting to at investor and international partnering conferences. We have been discussing possible licensing of GP2, new investment banking partners, collaboration in our Phase III clinical trial, commercial manufacturing, expansion of our pipeline, expansion of our clinical trials in Europe, and initiation of additional GP2 Phase II/III trials."

Additional webcasts of Mr. Patel’s participation on a Benzinga cancer panel and a TD Ameritrade interview can be viewed at the links below:

On September 30, 2021, Mr. Patel participated in a live panel discussion at the Benzinga Healthcare Small-Cap Conference entitled: Immuno-Oncology – Harnessing the Human Body’s Power to Battle Cancer. A webcast of the entire panel discussion can be seen here with Mr. Patel speaking at the time points available at these links: 2:15, 18:03, and 34:00.

On July 20, 2021, Mr. Patel appeared as a featured guest in a live interview on TD Ameritrade Network’s The Watch List with host Nicole Petallides. A webcast of the interview can be seen here.

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On November 9, 2021 The Bayer Group reported that registered a significant increase in sales and earnings in the third quarter of 2021 (Press release, Bayer, NOV 9, 2021, View Source [SID1234594840]). "We delivered strong operational performance, with all divisions showing strong growth momentum," said Werner Baumann, Chairman of the Board of Management, on Tuesday when presenting the company’s third-quarter results. Bayer posted substantial growth in the agricultural business, while the Pharmaceuticals Division benefited in particular from large gains for the Eylea ophthalmology drug. Business at the Consumer Health Division was up in all regions and product categories. Bayer has also updated the upgraded outlook for 2021 that it had issued in August.

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Group sales in the third quarter of 2021 rose by 14.3 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.) to 9.781 billion euros. There was a positive currency effect of 67 million euros. EBITDA before special items increased by 16.4 percent to 2.089 billion euros, and included a negative currency effect of 44 million euros. EBIT came in at 530 million euros (Q3 2020: minus 9.399 billion euros) after net special charges of 694 million euros (Q3 2020: 10.181 billion euros) that primarily related to restructuring measures at all three divisions. Net income amounted to 85 million euros (Q3 2020: minus 2.744 billion euros), while core earnings per share advanced by 29.6 percent to 1.05 euros, mainly due to the development of business within the Crop Science Division.

Free cash flow increased by 58.0 percent to 1.954 billion euros. Net financial debt as of September 30, 2021, decreased to 33.981 billion euros, down 1.1 percent from June 30, 2021.

Crop Science reports strong sales gains and significant earnings growth

In the agricultural business (Crop Science), sales rose by 25.8 percent (Fx & portfolio adj.) to 3.850 billion euros thanks to a substantial increase in volumes and prices. Growth was particularly strong at Corn Seed & Traits (Fx & portfolio adj. 92.6 percent), driven by gains in North America due to lower product returns and the later receipt of license revenues. As expected, these license revenues were recorded in the third quarter this year as opposed to the second quarter as in 2020. Sales also advanced in Latin America due to the launch of the new VTPro4 trait for improved pest control as well as higher volumes and prices. Soybean Seed & Traits also registered strong growth (Fx & portfolio adj. 58.0 percent), driven by gains in North America – due to lower product returns and higher license revenues – and in Latin America as a result of higher prices and volumes. Herbicides also posted a substantial increase in sales (Fx & portfolio adj. 15.2 percent), with the business recording encouraging gains in North America and Europe/Middle East/Africa, mainly due to an increase in prices for glyphosate-based products and higher volumes.

EBITDA before special items at Crop Science rose to 471 million euros (Q3 2020: minus 34 million euros), resulting in a margin of 12.2 percent. The improvement in earnings was mainly attributable to higher prices and volumes, an increase in license revenues, and contributions from ongoing efficiency programs. By contrast, earnings were diminished in particular by an increase in the cost of goods sold.

Pharmaceuticals reports higher sales – new products provide boost

Sales of prescription medicines (Pharmaceuticals) rose by 7.1 percent (Fx & portfolio adj.) to 4.539 billion euros. The division’s ophthalmology business was able to grow market share and continued to recover following the COVID-19 restrictions, especially in Europe. As a result, sales of Eylea advanced by 19.0 percent (Fx & portfolio adj.). Sales of the oral anticoagulant Xarelto increased by 4.3 percent (Fx & portfolio adj.), with substantial volume growth in Russia and Germany in particular offsetting a price-related decline in China. Sales of Adalat, one of the company’s products for the treatment of heart disease, rose by 24.2 percent (Fx & portfolio adj.) thanks to higher volumes in China. An increase in volumes in the United States resulted in sales gains for the pulmonary hypertension product Adempas (Fx & portfolio adj. 21.0 percent). Sales of Nubeqa rose significantly, driven by the cancer drug’s successful launch in the United States, which is currently ongoing. In addition, Bayer initiated the market launch of Kerendia, its product for the treatment of patients with chronic kidney disease and type 2 diabetes, in the United States. By contrast, sales of the cancer drug Nexavar declined against the prior-year period (Fx & portfolio adj. 27.8 percent), particularly in China, where business was negatively impacted by strong competition and modified tender procedures for various classes of active ingredients.

EBITDA before special items at Pharmaceuticals decreased by 9.8 percent to 1.366 billion euros, resulting in a margin of 30.1 percent. Earnings were diminished by an increase in marketing costs, which was largely attributable to the launch of Kerendia and Nubeqa, and by a rise in research and development expenses, which was partly related to the division’s cell and gene therapy unit.

Consumer Health continues to grow and increases earnings

Sales of self-care products (Consumer Health) came in at 1.346 billion euros, up 10.9 percent (Fx & portfolio adj.) against a very strong prior-year quarter, with growth in all regions and categories. Business primarily benefited from continued high demand in Nutritionals, which saw sales rise 20.1 percent (Fx & portfolio adj.), and the launch of innovative products in all categories throughout the year. The Pain & Cardio category also registered particularly strong growth of 17.4 percent (Fx & portfolio adj.)

EBITDA before special items at Consumer Health increased by 2.3 percent to 308 million euros, resulting in a margin of 22.9 percent. The growth in earnings was driven by the division’s strong business performance and continuous cost management efforts. This was partially offset by investments associated with the launch of innovative products and by inflation-related increases in costs. 

Updated outlook

Following the very good business performance in the third quarter, Bayer has revised the upgraded outlook for 2021 that it issued in August. On a currency-adjusted basis (i.e. based on the average monthly exchange rates from 2020), the company continues to expect sales to come in at approximately 44 billion euros. This now corresponds to currency- and portfolio-adjusted growth of approximately 7 percent (previously: approximately 6 percent). The forecast for the currency-adjusted EBITDA margin before special items remains unchanged at around 26 percent. Core earnings per share are now expected to come in at approximately 6.50 euros to 6.70 euros after adjusting for currency effects (previously: approximately 6.40 euros to 6.60 euros). Free cash flow is now anticipated to amount to between approximately minus 0.5 billion euros and minus 1.5 billion euros (previously: between approximately minus 2 billion euros and minus 3 billion euros) as a portion of the settlement payments for the glyphosate litigations are now expected to be made in 2022 instead of 2021. In addition, Bayer is now anticipating net financial debt of around 35.5 billion euros (previously: around 36 billion euros) at the end of the year after adjusting for currency effects.

Based on the closing exchange rates on September 30, 2021, the company continues to expect full-year sales to come in at approximately 43 billion euros. This now corresponds to currency- and portfolio-adjusted sales growth of approximately 7 percent (previously: approximately 6 percent). The EBITDA margin before special items is now expected to amount to approximately 25.5 percent (previously: approximately 25 percent). The company is now anticipating core earnings per share of approximately 6.10 euros to 6.30 euros (previously: approximately 6.00 euros to 6.20 euros). Free cash flow is now expected to come in at between approximately minus 0.5 billion euros and minus 1.5 billion euros (previously: between approximately minus 2 billion euros and minus 3 billion euros). The company’s forecast for net financial debt remains unchanged at around 35 billion euros.

"New technologies vitally important for health and nutrition"

"Our third-quarter performance shows that we are very much on the right track – both in terms of operational development and the market launch of new products," said Baumann, underlining Bayer’s strength in delivering innovations. "We have aligned our corporate strategy and our innovation potential toward health and nutrition, which are areas of systemic importance. In doing so, we are looking to help solve a question of fundamental importance: How do we feed and satisfy the health needs of a growing population in the face of climate change?"

New technologies are vitally important in this respect, he explained. Together with its partners, the company is working on numerous projects involving technologies that can really make a difference for society. For example, Bayer is working on two novel therapeutic approaches for Parkinson’s, a nervous system disorder for which there is currently no cure. Via its Leaps unit, the company has also invested in three biotech start-ups that are harnessing various technologies in their research on microbial engineering, potentially paving the way for more crops to fertilize themselves in the future. This would be great news for the climate, as it would enable farmers to bypass nitrogen fertilizers, which are used to grow around 40 percent of the world’s food but also account for roughly 4 percent of all greenhouse gas emissions worldwide.

Sustainability: Three-fold increase in volume of renewable energy sourced via supply agreements

Bayer is also working intensively on its ambitious sustainability targets, with the company committed to becoming carbon neutral in its own production operations by 2030. In addition to investing in more energy-efficient facilities and building technologies, it is also extensively harnessing renewable energy sources. As of the end of the third quarter, Bayer has this year concluded agreements covering around 400,000 megawatt-hours of green energy, representing a three-fold increase in volume.

Reinforcing its commitment to improve access to family planning, especially in low- and middle-income countries, the company recently initiated the construction of a new production site in Costa Rica and the expansion of an existing facility in Finland. Both sites are set to produce long-acting reversible contraceptives in the future. These investments are a milestone as the company works toward meeting its sustainability target of providing 100 million women with access to modern family planning by 2030.