On May 27, 2021 Oasmia reported that Interim report for the period January 1, 2021 – March 31, 2021 (Press release, Oasmia, MAY 27, 2021, View Source [SID1234580672])

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SIGNIFICANT EVENTS DURING THE FIRST QUARTER
In January, Oasmia appointed Dr. Heidi B. Ramstad as Chief Medical Officer.
In March Fredrik Järrsten took up the position as Chief Financial Officer. Robert Maiorana, who has been acting CFO since December 2020, will continue as Head of Accounting for the company.
In March, Oasmia signed an agreement with Kazia Therapeutics, an Australian oncology-focused biotechnology company, to acquire exclusive global development and commercialization rights for Cantrixil, a product candidate in development intended for the treatment of ovarian cancer.
In March Oasmia entered into a collaboration agreement with Karolinska Institutet in Stockholm. The collaboration will generate new information for the potential development of new therapeutic APIs in various cancer indications.
In March, an arbitral tribunal in Stockholm upheld Oasmia’s right to record assignment of its patents and patent applications in its own name, which enables a faster re-registration process.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
In April, Oasmia appointed Dr Reinhard Koenig as Chief Scientific Officer.
In April, Oasmia presented Cantrixil final Phase I data at the 2021 AACR (Free AACR Whitepaper) Annual Meeting.
In April, a Phase 1b trial of Oasmia’s Docetaxel Micellar in advanced prostate cancer was granted ethical committee approval by Swissmedic.
In April, Andrea Buscaglia was proposed as a new Board member by the Nomination Committee.
FIRST QUARTER: JANUARY 1, 2021 – MARCH 31, 2020
Consolidated net sales amounted to TSEK 37 (201,220)
Operating profit/loss was TSEK –40,843 (128,607)
Net profit/loss after tax amounted to TSEK –41,209 (124,706)
Earnings per share was SEK –0.09 (0.36)
CEO REVIEW – WELL POSITIONED FOR FUTURE GROWTH
Oasmia achieved several key goals in the first quarter, making further important progress in implementing the strategic transformation initiated when I joined last year.

A critical goal for Oasmia is to significantly expand our pipeline of development-stage oncology assets through M&A and in-licensing opportunities that we believe will fit with our strategic goals. This ambitious ’string of pearls strategy’ will capitalize on our proven oncology development and regulatory skills and expertise. We have a solid cash position to execute on the current strategy as laid out, with the possibility to reevaluate the financing need when these opportunities occur and with the progress of our development projects.

The acquisition of global development and commercialization rights for Cantrixil from Kazia Therapeutics in March was an exciting development for Oasmia and represented the first stage in this pipeline expansion – the first "pearl" added to our portfolio. The acquisition brings to us a promising clinical program in late-stage ovarian cancer, an area we know exceedingly well. In April, we presented final Phase I results for Cantrixil at the prestigious American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting. These highly promising results underscore our optimism about this program. Cantrixil is believed to target a wide spectrum of cancer cells, including chemotherapy-resistant tumor-initiating cells that are thought to be responsible for disease relapse. In addition to its promise as stand-alone therapy, Cantrixil has the potential to complement Oasmia’s lead product for ovarian cancer, Apealea, through treatment protocols to be developed.

Since acquiring the rights to Cantrixil, we have been working to establish an advisory board of experts to provide input on the clinical development plan and have initiated discussions with regulators at the EMA and FDA. We have also made progress towards securing drug supply for forthcoming clinical trials.

Apealea (paclitaxel micellar), a non-Cremophor based formulation of paclitaxel, is Oasmia’s most advanced development program, approved in Europe and in development elsewhere for advanced ovarian cancer. Since it was out licensed to Elevar Therapeutics last year, we’ve been working closely with Elevar and its partners to support development and commercialization activities. Post period , in April, Elevar received notification from the FDA authorizing a pharmaco-kinetic study in the US. In parallel, preparations are being made for an additional clinical study. Both studies are intended to support an NDA application in the US.

We’re also pleased to report that Docetaxel micellar, a solvent-free formulation of docetaxel to avoid the need for solubility enhancers and mandatory high-dose steroid premedication, has been granted ethical committee approval in Switzerland, paving the way for the Swiss Group for Clinical Cancer Research (SAKK) to initiate a Phase Ib trial in advanced prostate cancer.

Our technology platforms remain an important part of our business and complement our development and regulatory expertise. During the period we signed a collaboration agreement with the world renowned Karolinska Institutet here in Stockholm. The goal is to generate additional data to help us gain a deeper understanding of the potential of our proprietary XR-17 platform technology, with a focus on niche cancer indications. Over the longer term this will help us generate new pipeline candidates.

A vital part of our transformation is building a leadership team with the experience to drive our future growth. I’m pleased to say that with Fredrik Järrsten joining as CFO, and Heidi B. Ramstad and Reinhard Koenig’s appointments as CMO and CSO, we have completed our leadership team. This greatly strengthens our ability to execute our strategy and thrive as a business in the future.

Business transformations take time to achieve, but in 12 months we have put in place the right leadership team supported by a stronger Board with new expertise to take us to the next level of success. We have clearly defined and started executing on our strategy to become a leading cancer biopharma company with an emerging oncology pipeline. Thank you for your continued support during this period as we transition to an exciting future

On May 27, 2021 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported it has entered into a commercialization agreement with Bavarian Nordic for the marketing and distribution of HEPLISAV B [Hepatitis B Vaccine (Recombinant), Adjuvanted] in Germany with an expected launch in the fourth quarter of 2021 (Press release, Dynavax Technologies, MAY 27, 2021, View Source [SID1234580671]).

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In February 2021, the European Commission (EC) granted marketing authorization for HEPLISAV B for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. HEPLISAV B is the only U.S. Food and Drug Administration (FDA) and EC approved hepatitis B vaccine for adults with a two-dose regimen that is completed in one month.

Hepatitis B is a highly infectious and potentially deadly virus with increasing infection rates, and over 250 million people infected worldwide. Hepatitis B can be prevented with effective vaccination. HEPLISAV B, with a two-dose regimen that takes only one month to complete and a statistically significantly higher seroprotection rate in head-to-head clinical trials, provides a unique opportunity to address known challenges with compliance, while delivering higher levels of protection compared to the three-dose regimen of the comparator vaccine.

Ryan Spencer, Chief Executive Officer of Dynavax, commented: "We are excited to work with Bavarian Nordic on the commercialization of HEPLISAV B in Germany. Their existing marketing and distribution network in Germany provides an excellent platform to make HEPLISAV B available to patients. The strong overlap with the existing target audience within general practitioners, occupational health groups and travel medicine specialists provides a good strategic fit and clear commercial synergies for the dedicated sales force Bavarian Nordic has established in Germany."

Paul Chaplin, President and CEO of Bavarian Nordic, commented: "We are pleased to expand our commercial footprint in the largest EU market by adding a complementary product to our marketing and distribution and we look forward to assisting Dynavax in a successful market entry in Europe later this year."

About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,I and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.II Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician’s discretion.III Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.IV

About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 adjuvant to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

Important EU/EEA Product Information
HEPLISAV B is indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.

The use of HEPLISAV B should be in accordance with official recommendations.

It can be expected that hepatitis D will also be prevented by immunisation with HEPLISAV B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

For full E.U. Prescribing Information for HEPLISAV-B, click here.

Important EU/EEA Safety information
Do not receive HEPLISAV B if you have had a sudden life-threatening, allergic reaction after receiving HEPLISAV B in the past, or if you are allergic to any components of this vaccine, including yeast. Signs of an allergic reaction may include itchy skin, rash, shortness of breath and swelling of the face or tongue.

Appropriate medical treatment and supervision should be readily available in case of rare anaphylactic reactions following the administration of the vaccine.

The administration of HEPLISAV B should be postponed in subjects suffering from acute severe febrile illness.

Immunocompromised persons may have a diminished immune response to HEPLISAV B.

Because of the long incubation period of hepatitis B, it is possible for unrecognised HBV infection to be present at the time of immunisation. HEPLISAV B may not prevent HBV infection in such cases.

There are very limited data on the immune response to HEPLISAV B in individuals who did not mount a protective immune response to another hepatitis B vaccine.

As a precautionary measure, it is preferable to avoid the use of HEPLISAV B during pregnancy. Vaccination during pregnancy should only be performed if the risk-benefit ratio at the individual level outweighs possible risks for the fetus.

The most common patient-reported side effects reported within 7 days of vaccination were pain, swelling or redness at the injection site, feeling tired, headache, muscle aches, feeling unwell and fever.

Important U.S. Product Information
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

For full U.S. Prescribing Information for HEPLISAV-B, click here.

Important U.S. Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

On May 27, 2021 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) reported that Steve Hoerter, President and Chief Executive Officer, will participate in fireside chats at the following investor conferences (Press release, Deciphera Pharmaceuticals, MAY 27, 2021, View Source [SID1234580670]):

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Jefferies Virtual Healthcare Conference on June 3, 2021 at 1:30 PM ET
JMP Securities Life Sciences Conference on June 16, 2021 at 4:00 PM ET
A live webcast of both events will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of both webcasts will be archived on the Company’s website for 90 days following the presentation.

On May 27, 2021 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational conditionally activated therapeutics based on its Probody technology platform, reported that Amy Peterson, M.D., chief development officer, will participate in a virtual fireside chat at the Jefferies Virtual Healthcare Conference on June 3rd at 2:00 p.m. ET (Press release, CytomX Therapeutics, MAY 27, 2021, View Source [SID1234580669]). In addition, management will be available for one-on-one meetings with investors who are registered to attend the conference.

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A live webcast of the fireside chat will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. An archived replay will be available for 30 days following the event.

On May 27, 2021 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in the following virtual investor conferences in June (Press release, Bicycle Therapeutics, MAY 27, 2021, View Source [SID1234580668]):

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Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021; fireside chat at 11:00 a.m. ET
Goldman Sachs 42nd Annual Global Healthcare Conference on Tuesday, June 8, 2021; fireside chat at 8:00 a.m. ET
The JMP Securities Life Sciences Conference on Thursday, June 17, 2021; fireside chat at 12:00 p.m. ET
A live webcast of the fireside chats will be accessible in the Investors & Media section of Bicycle’s website at www.bicycletherapeutics.com. Archived replays of the webcasts will be available for 30 days following the presentation dates.