On August 19, 2021 Medivir AB reported that Interim Report January – June 2021 (Press release, Medivir, AUG 19, 2021, View Source;interim-report-january–june-2021-301358672.html [SID1234586772])

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April – June
Financial summary for the quarter

Net turnover amounted to SEK 0.9 (4.0) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -17.1 (-12.4) million. Basic and diluted earnings per share amounted to SEK -0.35 (-0.52) and SEK -0.35 (-0.52) respectively.
Cash flow from operating activities amounted to SEK -21.9 (-23.3) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 247.8 (94.9) million.
Significant events during the quarter

On April 16, it was announced that Magnus Christensen had been appointed interim CEO of Medivir. He took up his new role in connection with Medivir’s AGM on May 5, 2021.
On April 19, it was announced that the overall results from the first part of the phase Ib study with MIV-818 were positive with a good safety and tolerability profile. Thus, the starting dose for the second part of the phase Ib study could be determined.
In May, positive results from an investigator-initiated phase II clinical study of remetinostat in patients with squamous cell carcinoma (SCC) were released on clinicaltrials.gov.
In May, the design for the upcoming phase 1b/2a combination study with the company’s leading candidate drug, MIV-818 against liver cancer, was presented. In the study, MIV-818 will be administered in two combinations, with either lenvatinib, a tyrosine kinase inhibitor, or pembrolizumab, an anti-PD-1 checkpoint inhibitor.
January – June
Financial summary for the period

Net turnover amounted to SEK 10.8 (11.4) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -24.3 (-33.1) million. Basic and diluted earnings per share amounted to SEK -0.57 (-1.49) and SEK -0.57 (-1.49) respectively.
Cash flow from operating activities amounted to SEK -23.3 (-40.0) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 247.8 (94.9) million.
Significant events after the end of the period

In July, Malene Jensen was appointed Vice President Clinical Development. She will assume her role on September 6, 2021.
In August, it was announced that data from the MIV-818 phase 1b study will be presented at the ESMO (Free ESMO Whitepaper) Congress in September.
In August, the positive results from the phase II study with remetinostat against basal cell carcinoma were published in the scientific journal Clinical Cancer Research.
In August, it was announced that Medivir, through a renegotiated multi-party agreement, strengthens the business development potential for remetinostat.
Conference call for investors, analysts and the media
The Interim Report January – June 2021 will be presented by Medivir’s interim CEO, Magnus Christensen.

The conference call will also be streamed via a link on the website: www.medivir.com
The presentation will be available on Medivir’s website after completion of the conference.

CEO’s message
The clinical development of MIV-818 remains in focus. Positive topline results in the phase 1b monotherapy study. The design determined for the phase 1b/2a combination study in the clinical MIV-818 program.

Medivir’s central task is to advance the clinical program for our leading candidate drug MIV-818, which has the potential to be a liver-directed, orally administered drug that can help patients with various cancers of the liver. This work has also characterized our operations also in the past quarter.

In April we were able to announce that the results from the first part of the phase 1b study with MIV-818 were positive with a good safety and tolerability profile. Thereby, we were also able to determine the starting dose for the second part of the study, where we combine MIV-818 with standard treatment. Data from the first part of the phase 1b study will be presented at the ESMO (Free ESMO Whitepaper) scientific conference in September.

Due to its unique mechanism of action, MIV-818 is attractive to combine with a multitude of other drugs for the treatment of hepatocellular carcinoma (HCC). We have been working on refining the design for the next step in the clinical program, the upcoming phase 1b/2a combination study with MIV-818, and at the end of May we presented how the study is structured. MIV-818 will be administered in two combinations, either with lenvatinib, a tyrosine kinase inhibitor, or with pembrolizumab, an anti-PD-1 checkpoint inhibitor.

The study is an open-label, multi-center phase 1b/2a study that begins with a dose escalation part to determine the recommended phase 2 dose (RP2D). This is followed by the expansion study (phase 2a) with an initial evaluation of the safety and efficacy of the combinations of MIV-818 with lenvatinib or pembrolizumab. The study will include patients with HCC who have progressed on, or are intolerant of, first line standard therapy.

We plan to recruit the first patient for the combination study in the second half of 2021. However, we cannot guarantee that the Covid-19 pandemic will not affect our schedule.

MIV-818 is proprietary and wholly owned by Medivir, i.e. we do not have to pay any future milestones or royalties to any third party.

We have two more drug development projects in the clinical development phase, remetinostat, and MIV-711. Medivir does not conduct clinical development of these projects on its own, but instead seeks partners for further development.

During the quarter, positive results were published from an investigator-initiated clinical phase II study of remetinostat in patients with squamous cell carcinoma (SCC). The study was conducted at the Stanford University School of Medicine in California, USA. The primary objective of the study was to assess the effects of topical remetinostat on biopsy-proven SCC and SCC in situ tumors. In August, the positive results from the phase II study with remetinostat in patients with BCC were also published in the scientific journal Clinical Cancer Research.

The results are very promising and provide further support for the potential of remetinostat as a treatment for a number of skin-associated cancers in addition to cutaneous T-cell lymphoma (CTCL). Medivir renegotiated in August a multi-party agreement with the originators of remetinostat and TetraLogic Pharmaceuticals Corporation and The Leukemia & Lymphoma Society regarding the financial obligations for remetinostat in order to create better conditions for business development.

Medivir’s birinapant project, for the treatment of solid tumors, was outlicensed to the American company IGM Biosciences at the beginning of the year. IGM has the global and exclusive rights to develop birinapant. According to IGM’s Q2 report, they plan to initiate clinical trials with birinapant in combination with their proprietary antibody IGM-8444 during 2021.

At Medivir’s AGM on May 5, former CEO Yilmaz Mahshid was elected new board member and Uli Hacksell was elected chairman of the board. This guarantee continued scientific vitality and business acumen in the Board’s work.

In July, Malene Jensen was recruited as Vice President Clinical Development and a member of the company’s management team. With extensive experience in clinical development, Malene will focus on the clinical studies with MIV-818.

I am really impressed by the determination and dedication shared by all Medivir employees. The goal is to develop an effective drug against liver cancer through MIV-818. Given that this work continues to show good results, it could make a big difference for patients and for healthcare and thus also for the company’s shareholders.

On August 19, 2021 Calliditas Therapeutics reported that During the 2nd quarter we significantly ramped up our pre commercial activities in the US following the strengthening of the team announced in Q1 (Press release, Calliditas Therapeutics, AUG 19, 2021, View Source [SID1234586741]). We have added significant internal resources as well as entered into some key partnerships, in order to ensure that we are well positioned to initiate commercialization in Q4, subject to a positive outcome of the FDA approval process.

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During Q2 we also explored avenues to non-dilutive financing by way of a competitive process in order to provide the company with access to additional capital in advance of, as well as post a potential regulatory approval. In parallel we also ran a successful competitive process focused on securing a strong European commercial partner for Nefecon. The result of these processes which was announced in Q3 resulted in over $100m of non- dilutive capital potentially being available to the company, divided between approximately $50m available pre-approval with the remainder becoming available post FDA and EMA approvals and subsequent US commercialization. These processes, together with the accelerated book building procedure raising approximately gross $37m (SEK 324 million) which we completed in Q3, have significantly enhanced our financial strength after the close of Q2."

Renée Aguiar-Lucander, CEO

Summary of Q2 2021
April 1 – June 30, 2021

No net sales were recognized for the three months ended June 30, 2021 and 2020, respectively.
Operating loss amounted to SEK 159.4 million and SEK 66.6 million for the three months ended June 30, 2021 and 2020, respectively.
Loss before income tax amounted to SEK 165.2 million and SEK 61.3 million for the three months ended June 30, 2021 and 2020, respectively.
Loss per share before and after dilution amounted to SEK 3.20 and SEK 1.50 for the three months ended June 30, 2021 and 2020, respectively.
Cash amounted to SEK 709.3 million and SEK 1,459.6 million as of June 30, 2021 and 2020, respectively.
Significant events during Q2 2021, in summary
In April 2021, Calliditas was granted accelerated assessment procedure by the European Medicine Agency’s (EMA) Committee for Human Medicinal Products (CHMP) for Nefecon, reducing the maximum timeframe for review of the application for marketing authorization. If approved, Nefecon could be available to patients in Europe in first half of 2022.
In April 2021, Calliditas announced that the FDA accepted the submission and granted Priority Review for the NDA for Nefecon. The FDA have set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. Subject to approval, this would enable commercialization of Nefecon in the US in Q4, 2021.
In May 2021, Calliditas announced that the company submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Nefecon.
Significant events after the end of reporting period, in summary
In July 2021, Calliditas signed a loan facility of up to the EUR equivalent of $75 million with Kreos Capital.
In July 2021, Calliditas and STADA Arzneimittel AG entered into a license agreement to register and commercialize Nefecon in the European Economic Area (EEA) member states, Switzerland and the UK valued at a total of 97.5 million EUR ($115m) in initial upfront and potential milestone payments, plus royalties.
In August 2021, Calliditas received FDA fast track designation for setanaxib in PBC.
In August 2021, Calliditas completed an accelerated book building procedure and resolved on a directed share issue in the amount of 2.4 million shares, raising proceeds of SEK 324.0 million before transaction costs.
Investor presentation August 19, 14:30 CET
Audio cast with teleconference, Q2 2021, August 19, 2021, 14:30 (Europe/Stockholm)

Financial calendar
Interim Report for the period January 1 – September 30, 2021 November 18, 2021

Year-end Report for the period January 1 – December 31, 2021 February 24, 2022

On August 19, 2021 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported the second quarter 2021 (Press release, Oncopeptides, AUG 19, 2021, View Source [SID1234586773]).

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Financial overview April-June

Net sales amounted to SEK 66.4 M (0.0)
Operating loss amounted to SEK 344.8 M (loss: 399.3)
Loss for the period was SEK 24.1 M (loss: 401.0)
Loss per share, before and after dilution, was SEK 0.32 (loss: 6.79)
Cash and cash equivalents amounted to SEK 999.4 M (937.8) on June 30
Financial overview January-June

Net sales amounted to SEK 85.7 M (0.0)
Operating loss amounted to SEK 692.2 M (loss: 696.2)
Loss for the period was SEK 258.8 M (loss: 698.4)
Loss per share, before and after dilution, was SEK 3.63 (loss: 12.20)
Cash and cash equivalents amounted to SEK 999.4 M (937.8) on June 30
Significant events April-June

An application for conditional marketing authorization of melflufen in the EU was submitted in April
Topline results from the phase 3 OCEAN study were announced in May
Patient enrollment in the phase 2 PORT study was completed in May
A German affiliate was established in May
Clinical abstracts on melflufen was presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June
New clinical and preclincal melflufen data was presented at the European Hematology Association (EHA) (Free EHA Whitepaper) meeting in June
Significant events after the reporting period

Updated results from the phase 3 OCEAN study were announced on July 8: melflufen met the primary endpoint of superior PFS
Overall survival data, also released on July 8, led to the FDA requesting a partial clinical hold of all clinical studies with melflufen, pending further investigation
FDA issued a safety alert to patients and health care professionals on July 28, regarding an increased risk of death associated with Pepaxto in the OCEAN study.

Conference call for investors, analysts and the media

Investors, financial analysts and media are invited to participate in a webcast with a Q&A session at 12:00 CEST. The event will be hosted by CEO, Marty J Duvall, CMO, Klaas Bakker and CFO, Anders Martin-Löf.

The webcast will be streamed via this link which can also be found on the website: www.oncopeptides.com.

This information is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 07:00 CET on August 19, 2021.

On August 19, 2021 Oasmia reported that Interim report for the period January 1, 2021 – June 30, 2021 (Press release, Oasmia, AUG 19, 2021, View Source [SID1234586742])

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SIGNIFICANT EVENTS DURING THE SECOND QUARTER
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 May, Andrea Buscaglia was appointed as a new Board member by the Annual General Meeting.
In June, following the ethical approval in April, the first Patient was enrolled in the Swiss Group for Clinical Cancer Research (SAKK) Investigator-Initiated Phase 1b trial of Docetaxel Micellar in advanced prostate cancer.
In June, in addition to commercialization rights previously transferred for the rest of Europe, Oasmia also transferred the Nordic commercialization rights for Apealea to Inceptua Group.
In June, Cantrixil positive Phase I trial data were published in the open access oncology journal Cancers.
SECOND QUARTER: APRIL 1, 2021 – JUNE 30, 2021
Consolidated net sales amounted to TSEK 4,596 (254)
Operating profit/loss was TSEK -56,165 (-78,296)
Net profit/loss after tax amounted to TSEK -57,677 (-80,090)
Earnings per share was SEK –0.12 (-0.18)
THE PERIOD: JANUARY 1, 2021 – JUNE 30, 2021
Consolidated net sales amounted to TSEK 4,633 (201,474)
Operating profit/loss was TSEK –97,007 (50,311)
Net profit/loss after tax amounted to TSEK –98,889 (44,615)
Earnings per share was SEK –0.22 (0.10)
CEO REVIEW
Oasmia continued to make progress during the second quarter. In particular, we made strides in progressing our development candidates, announcing a number of important milestones in key programs. All our development candidates target hard-to-treat or late-stage cancers where patients usually have limited treatment options and very poor prognoses.

Final data from a Phase I trial of Cantrixil, the ovarian cancer program we in-licensed from Kazia Therapeutics earlier in the year, was presented in an oral presentation at the prestigious American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April. We also announced publication of this data in the peer-reviewed journal Cancers and it generated substantial interest among oncologists. What is highly interesting from a scientific perspective is the fact that Cantrixil may induce death in ovarian cancer stem cells and sensitize cancer cells to standard chemotherapy, prolonging survival in advanced ovarian cancer patients. There is a lot of work going on to prepare for the initiation of the Phase II trial in the second half of next year. Activities include establishing a clinical advisory board and initiating interactions with the FDA/EMA and of course securing drug supply and validating our Phase 2 trial design.

Also in Q2, the first patient was dosed in an open label, multicenter, single stage Phase 1b clinical trial of Docetaxel micellar in advanced prostate cancer. Docetaxel micellar is a solvent-free formulation of docetaxel, developed to avoid the need for the solubility enhancers in solvent-based docetaxel and mandatory high-dose steroid premedication, while still providing an effective treatment option. The trial is being conducted at major hospitals in Switzerland by the non-profit organization Swiss Group for Clinical Cancer Research (SAKK) which has been conducting clinical trials in oncology since 1965. Prostate cancer is a significant and increasingly prevalent health problem worldwide and is the leading cause of male cancer deaths so there remains a critical need for new therapeutics.

We made great progress in the second quarter on simplifying and focusing our activities. We entered into an agreement to transfer the rights for the commercialization of Apealea (paclitaxel micellar) in the Nordics and Baltics to Inceptua Group. Inceptua already has exclusive rights for the commercialization of Apealea in the rest of Europe, following an agreement signed with Oasmia’s global strategic partner, Elevar Therapeutics, Inc. in 2020. Apealea is our most advanced product and is approved by the European regulatory authorities for use in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Inceptua is in the process of transferring all licenses and marketing approvals for Apealea in major European markets including Germany and the UK which will delay the full commercialization process across Europe and receipt of royalties. Elevar and Oasmia are confident Inceptua has the network, expertise and commitment to maximize the commercial value of Apealea in Europe. In the US, Elevar is reporting progress in the preparation of the PK study and the Phase 3 clinical trial for Apealea.

Our main objective is to build our oncology pipeline through mergers, acquisitions, or in-licensing. I’m pleased to report we’re evaluating a number of opportunities and we look forward to updating you on any progress.

In addition to building a strong clinical product pipeline in cancer, we are committed to enhancing our proprietary drug delivery technology platform, XR-17, which has already been applied in the creation of Apealea and Docetaxel micellar and has potential in many therapeutic areas. We provided an update on R&D progress during the quarter. XR-18 is in an evaluation process as an enhancement to the XR-17 platform, while XR-19 may feature additional functionalities, specifically encapsulation of multiple APIs to enable combination therapy.

I am a firm believer that a quality team is critical to success. I’m pleased to report that we continued to build the capabilities of the Board and Management in Q2. Dr. Reinhard Koenig has accepted a position as Chief Scientific Officer as of April, bringing expertise in successful product development and commercialization in a number of fields, including oncology. Andrea Buscaglia was elected as new member of the Board of Directors at the Annual General Meeting on 27 May 2021. He brings over 30 years of financial experience in the biopharmaceutical, MedTech, investment banking and accounting sectors.

Working responsibly and ethically is central to the way we do business here at Oasmia and will become more important as we grow. Based on external expertise, we conducted an in-depth internal materiality assessment during Q2 on ESG (environment, social and governance) considerations relevant to us and over the course of the next few months we will decide which kind of key performance indicators and targets in this area we will continue working on and report progress implementing these by year end. Another key aspect of our ethical activities is the fact that we have appointed an external Data Protection Officer (DPO) to fully comply with GDPR regulations.

To increase our visibility and expand our sphere of influence with key stakeholders ever further, and also gain expertise, Oasmia has recently joined the European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA is dedicated to working with members to ensure faster and more equitable access to medicines across Europe and create the policy environment in which the European industry can be a world leader in medical innovation.

After a lot of necessary changes since I joined last March I am confident that Oasmia is now well positioned with the vision of becoming one of the leading cancer biopharma company with an innovative oncology pipeline focused on late-stage, hard-to-treat cancers.

I’d like to close by thanking all of my colleagues and board members for their continued dedication and great work and to you, our shareholders, for your support.

On August 19, 2021 PharmaCyte Biotech, Inc. (NASDAQ: PMCB) (PharmaCyte or Company), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has entered into definitive agreements with institutional investors for the purchase and sale, in a registered direct offering priced at-the-marked under Nasdaq rules, of 14,000,000 shares of the Company’s common stock (or common stock equivalents) at an effective purchase price of $5.00 per share for gross proceeds of $70 million (Press release, PharmaCyte Biotech, AUG 19, 2021, View Source [SID1234586758]). PharmaCyte has also agreed to issue to the investors unregistered warrants to purchase up to an aggregate 7,000,000 shares of common stock. The closing of the offering is expected to occur on or about August 23, 2021, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price equal to $5.00 per share, are exercisable immediately upon issuance and will expire five years from the issuance date.

PharmaCyte intends to use the net proceeds of this offering to (i) complete activities requested by the U.S. Food and Drug Administration (FDA) in order to address the FDA’s clinical hold on its Investigational New Drug application (IND) with respect to the Company’s planned Phase 2b clinical trial in locally advanced, inoperable, pancreatic cancer (LAPC), including conducting several additional preclinical studies and assays and providing the FDA with the additional information it requested, (ii) fully fund and conduct the Phase 2b clinical trial in LAPC, if and when the clinical hold on the IND is lifted, and (iii) for general working capital purposes.

The shares of common stock (and common stock equivalents) described above (but not the warrants or the shares of common stock underlying the warrants) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-255044) that was previously filed with and subsequently declared effective by the U.S. Securities and Exchange Commission (SEC) on April 14, 2021, and an additional registration statement on Form S-3 filed on August 19, 2021, pursuant to Rule 462(b), which became effective automatically upon filing. The offering of the shares of common stock (or common stock equivalents) is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the shares of common stock (or common stock equivalents) being offered in the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained, when available, from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or by email at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. (Press release, PharmaCyte Biotech, AUG 19, 2021, View Source [SID1234586758])