On February 13, 2020 Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported that it has completed the first closing under a recently executed Securities Purchase Agreement with Innoviva, Inc. (NASDAQ: INVA) ("Innoviva"), a company with a portfolio of royalties that include respiratory assets partnered with Glaxo Group Limited (Press release, AmpliPhi Biosciences, FEB 13, 2020, View Source [SID1234554282]). In connection with the closing, Armata issued 993,139 common shares and warrants to purchase 993,139 common shares in exchange for net proceeds of approximately $2.8 million. The first closing occurred following the satisfaction of certain closing conditions, including the execution of voting agreements by greater than 50.1% of the existing common stockholders of Armata in support of the $25 million private placement financing transaction. In connection with the closing, Richard Bear and Michael S. Perry, D.V.M., Ph.D., resigned from Armata’s Board of Directors and two individuals designated by Innoviva, Sarah Schlesinger, M.D. and Odysseas Kostas, M.D., were appointed to fill the newly created vacancies. Armata also announced that it has withdrawn its registration statement on Form S-1 that was previously filed with the SEC.

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"We are very pleased to close the first tranche of this Securities Purchase Agreement with Innoviva, and, together with my fellow Directors, we welcome Drs. Kostas and Schlesinger to our Board," stated Todd R. Patrick, Chief Executive Officer of Armata. "These additional funds significantly strengthen our financial position and provide ample cash runway to pursue meaningful clinical and corporate milestones in 2020 and 2021. We are very fortunate to partner with Innoviva and we look forward to mutual success as we advance our emerging bacteriophage platform to treat the growing global health challenge of multi-drug resistant infections."

Pursuant to and subject to the terms and conditions of the Securities Purchase Agreement and related agreements, Innoviva will purchase a total of approximately 8.7 million newly issued shares of Armata’s common stock, at a price of $2.87 per share, and warrants to purchase up to approximately 8.7 million additional shares of Armata’s common stock, at an exercise price of $2.87 per share. The stock purchases will occur in two tranches, the first of which has now been completed. Upon the closing of the second tranche, which is expected to occur during the first quarter of 2020, subject to the satisfaction or waiver of certain closing conditions, including approval by Armata shareholders, Innoviva will purchase approximately 7.7 million additional shares of common stock and warrants to purchase approximately 7.7 million additional shares of common stock for an aggregate purchase price of $22.2 million.

Immediately following the closing of the second tranche, expected in the first quarter of 2020, Armata will have approximately 18.6 million shares of common stock and warrants exercisable for approximately 10.6 million shares of common stock outstanding. The Company expects the proceeds from the offering to provide sufficient cash resources to achieve meaningful clinical milestones in 2020 and 2021.

This release does not constitute an offer to sell or the solicitation of an offer to buy any security. The shares offered have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws and may not be offered or sold in the United States or any state thereof absent registration under the securities act and applicable state securities laws or an applicable exemption from registration requirements.

On February 13, 2020 Medical Marijuana, Inc. (OTC: MJNA) (the "Company"), the first-ever publicly traded cannabis company in the United States that launched the world’s first-ever cannabis-derived nutraceutical products, brands and supply chain, reported that its portfolio investment company Kannalife, Inc. ("Kannalife") (OTC: KLFE), a biopharmaceutical company specializing in the research and development of cannabinoid therapeutics, has completed its phase 1 study funded by a grant (1R41DA044898-01) from the National Institutes of Health’s (NIH) National Institute on Drug Abuse (NIDA) (Press release, Medical Marijuana Sciences, FEB 13, 2020, https://www.prnewswire.com/news-releases/medical-marijuana-inc-portfolio-investment-company-kannalife-inc-announces-completion-of-nih-nida-phase-1-grant-and-results-from-temple-university-301004359.html [SID1234554333]).

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The study was performed by Kannalife and the Lewis Katz School of Medicine at Temple University (LKSOM) to assess KLS-13019, Kannalife’s patented cannabidiol (CBD)-like molecule, as a potential treatment of neuropathic pain and drug dependence.

"KLS-13019 continues to show potential as a much-needed treatment for CIPN," said Dr. Stuart Titus, CEO of Medical Marijuana, Inc. "According to a recent study conducted by RRI, it is estimated that the total global neuropathic pain market will be worth more than $8.3 billion by 2024."

The pre-clinical grant study was performed in an animal model to evaluate the potential use of KLS-13019 as a potent, non-opioid alternative in the prevention and reversal of chemotherapy-induced peripheral neuropathy (CIPN). The animal model portion of the study was conducted by Sara Jane Ward, Ph.D., Assistant Professor of Pharmacology at LKSOM.

"These recent study results suggest that Kannalife’s proprietary CBD-like molecule is at least as effective as CBD in preventing neuropathic pain in animal models. Even further, KLS-13019 goes a step further than CBD by showing the potential to reverse neuropathic pain," said Dean Petkanas, CEO of Kannalife. "Kannalife looks to bring effective new treatment options to market as soon as possible and this research puts us one step closer to that goal."

The completed study could lead to a Phase 2 grant and further advances Kannalife’s belief that KLS-13019 could become a viable drug candidate, and an alternative to opioids, as a treatment for patients suffering from CIPN and chronic pain management.

The research reported in this press release was supported by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) in the amount of $299,916 under award number 1R41DA044898-01.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About KLS-13019
KLS-13019 is Kannalife’s leading proprietary investigational CBD-like product for the potential treatment of a range of neurodegenerative and neuropathic pain disorders, beginning with chemotherapy-induced peripheral neuropathy (CIPN). KLS-13019 has not been reviewed or approved for patient use by the U.S. Food and Drug Administration (FDA) or any other healthcare authority in the world. Its safety and efficacy have not been confirmed by FDA-approved research.

On February 13, 2020 Decipher Biosciences, a commercial-stage precision oncology company committed to improving patient care, initially focused on urologic cancers, reported that a Decipher GRID molecular subtyping signature, studied in patients from the phase III, randomized controlled trial, CHAARTED, successfully predicted which prostate cancer patients diagnosed with metastatic hormone sensitive prostate cancer (mHSPC) benefited from the addition of chemotherapy to androgen deprivation hormone therapy (Press release, Decipher Biosciences, FEB 13, 2020, View Source [SID1234554330]).

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The standard of care treatment for patients with mHSPC is androgen deprivation hormone therapy with the option for additional systemic therapy, such as taxane chemotherapy. Optimal treatment selection for these patients, however, remains challenging without knowledge of how each patient will respond. The Decipher GRID signature has demonstrated that patients with specific molecular subtypes have varying responses to systemic therapies, and investigators from the practice-changing CHAARTED trial used the signature to profile tumor tissue from trial participants and to identify which patients would receive the most benefit from the addition of taxane chemotherapy.

The investigators found that patients with the luminal B molecular subtype derived the most benefit from the addition of taxane chemotherapy, with a 55% reduction in risk of death, adding 22 months of median survival. In the trial population tested, 48% of the patients were found to have the luminal B molecular subtype. Patients with the remaining molecular subtypes received no significant survival benefit from the addition of taxane chemotherapy.

"Identifying which patients will benefit from chemotherapy is one of the most important clinical questions in the management of metastatic prostate cancer," said Christopher Sweeney, MBBS, a medical oncologist and professor of medicine at Dana-Farber Cancer Institute. "The ability to identify these patients at diagnosis is a very important step towards improving patient outcomes and accelerating the inclusion of novel drugs into the standard of care."

Results will be presented February 13, 2020, at the Genitourinary Cancer Symposium Oral Abstract A session:

Hamid A, et al. Luminal B subtype as a predictive biomarker of docetaxel benefit for newly diagnosed metastatic hormone sensitive prostate cancer (mHSPC): A correlative study of E3805 CHAARTED. Abstract #162

Findings from nine other studies of Decipher tests will be presented at the Genitourinary Cancer Symposium:

Ganguly S, et al. Tumor cell intrinsic androgen biosynthesis by 3β-hydroxy steroid dehydrogenase (HSD3B1) to modulate radiosensitivity in prostate cancer cells. Abstract #349

Grist E, et al. Multiregion expression profiling of prostate cancer from men randomized in the STAMPEDE trial: Stage I results of a multistage biomarker analysis. Abstract #349

Gupta S et al. Results from BLASST-1 (Bladder Cancer Signal Seeking Trial) of nivolumab, gemcitabine, and cisplatin in muscle invasive bladder cancer (MIBC) undergoing cystectomy. Abstract #439

Feng FY, et al. Transcriptome profiling of NRG Oncology/RTOG 9601: Validation of a prognostic genomic classifier in salvage radiotherapy prostate cancer patients from a prospective randomized trial. Abstract #276

King M, et al. INTREPId (INTermediate Risk Erection Preservation Trial): A randomized trial of radiation therapy and darolutamide for prostate cancer. Abstract #TPS384

Muralidhar V, et al. Clinical-genomic sub-classification of high-risk prostate cancer: Implications for tailoring therapy and clinical trial design. Abstract #337

Necchi A, et al. Association of an immune-gene signature with pathologic response and outcome after neoadjuvant pembrolizumab (pembro), compared to neoadjuvant chemotherapy (NAC), in muscle-invasive bladder cancer (MIBC). Abstract #533

Necchi A, et al. Development of a composite biomarker-based calculator to predict the probability of pathologic complete response (pT0) after neoadjuvant pembrolizumab (pembro) in muscle invasive bladder cancer (MIBC). Abstract #539

Shahait M, et al. Head-to-head comparison between decipher and prolaris tests: Two commercially available post-prostatectomy genomic tests. Abstract #348
About Decipher Prostate RP and Decipher GRID

Our Decipher Prostate RP genomic tests are currently marketed and sold to physicians treating prostate cancer through the adjuvant therapy decision for patients who have received a radical prostatectomy and are being considered for additional therapy. The test reports the Decipher score which prognosticates a patient’s risk of metastasis within five years. The Decipher score is intended to improve clinical decision making by helping physicians identify patients who have high risk of metastasis and require more intensive therapy or who have low risk of metastasis and can reduce treatment intensity. We have obtained Medicare coverage for patients, including for those who have been diagnosed with adverse pathology following a radical prostatectomy and are being considered for additional therapy. Decipher Prostate RP can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

Decipher GRID is our Real-World Evidence genomic database containing over 75,000 urologic cancer transcriptomes matched to patient demographics and including clinical trial outcome data, which is one of the largest and well-annotated urologic cancer genomic databases in the world. Decipher GRID’s patient data is derived from decades of clinical trials and is continuously being expanded through a growing community of pharmaceutical and academic partners. The diversity of clinical sample inputs, ranging from global clinical trials to standard-of-care practices in urban, suburban and rural centers, help provide a comprehensive view of the future and current states of the practice of urologic cancer care. We leverage Decipher GRID outputs to partner with investigators and pharmaceutical companies to help identify patient populations that might benefit from earlier use of proprietary drugs or combination therapeutic strategies, or that are prime candidates for novel therapeutics. Decipher GRID is our proprietary engine that drives product development for us, and informs the product development efforts for our pharmaceutical partners.

On February 13, 2020 Sosei Group Corporation ("the Company") (TSE: 4565) reported an update on operational activities and reports its consolidated results for the twelve months ended 31 December 2019 (Press release, Sosei Heptares, FEB 13, 2020, View Source [SID1234554329]). The full report can be accessed by clicking here.

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Operational Highlights for Q4 2019

US$3 million payment received from Genentech – triggered by the nomination of a new GPCR disease target under the multi-target research collaboration and license agreement, signed in July 2019
Positive results announced from Phase III IRIDIUM study of QVM149 in patients with uncontrolled asthma announced by Novartis – QVM149 is an investigational, once-daily, inhaled combination treatment for asthma submitted for registration in Europe (Q2 2019) and Japan (Q3 2019) in which Sosei Heptares has an economic interest
US$5 million clinical milestone from Pfizer – triggered by Pfizer dosing the first subject in a clinical trial with a new drug candidate nominated from the multi-target drug discovery collaboration between the two companies
US$3 million pre-clinical milestone from Pfizer – payment resulted from the nomination of a third clinical candidate from the multi-target drug discovery collaboration between the two companies
Creation of Scientific Advisory Board (SAB) – new SAB includes experts from academia and the pharmaceutical industry in the US and Europe. The SAB will provide valuable insight and perspective relevant to strategic areas of focus for Sosei Heptares
Operational Highlights for the Full Year 2019

Two new multi-target collaborations initiated with major global partners – Genentech and Takeda – together, these collaborations are expected to generate up to US$52 million in the form of upfront and early progress payments over the next two to three years, with potential for significant future milestone payments plus royalties
Excellent progress with other partnered programs – AstraZeneca (AZD4635), Pfizer (two candidate nominations), Novartis (QVM149), all triggering progress-related milestones
Creation of two spin-out companies – Spin out of discovered assets (orexin agonists targeting neurological diseases) into Orexia Ltd and Inexia Ltd with funding of up to €40 million from Medicxi, an international investment firm focused on the life sciences sector. Significant progress, triggering release of funding, reported in January 2020
R&D Day for investors (September 2019) – successful event held in Japan showcasing the Company’s state-of-the-art UK R&D center, the potential of StaR technology and artificial intelligence in drug discovery and how this positions Sosei Heptares to continue delivering high-quality drug candidates, strategic partnerships and significant shareholder value
Financial Highlights for the 12-month Period ended 31 December 2019

Revenue totalled JPY 9,726 million (US$89.2 million) (an increase of JPY 6,176 million (US$57.0 million) vs. the prior corresponding period), and related primarily to strong growth in milestones, upfront fees from new partnerships plus royalty payments received.
Total cash operating expenses[1] were down to JPY 6,101 million (US$55.9 million) (an improvement of JPY 2,865 million (US$25.4 million) vs. the prior corresponding period), primarily due to a decrease in R&D costs.
Cash profit[2] totalled JPY 2,802 million (US$25.7 million) vs. a cash loss of JPY 5,704 million (US$51.7 million) in the prior corresponding period, as a result of strong revenue growth and tight cost management.
Net profit totalled JPY 1,432 million (US$13.1 million) vs. a net loss of JPY 6,919 million (US$62.7 million) in the prior corresponding period, on the back of strong business plan execution.
Term loan facilities were fully repaid in FY2019. New ¥5bn ($45m) commitment line (undrawn) established with Mizuho Bank provides financial flexibility for the future
The Company remains well capitalized, with Cash at Hand of JPY 15,375 million (US$140.3 million) as at 31 December 2019.
* Convenience conversion to US$ at the following rates: 2019: 1US$ =109.035 JPY; 2018: 1US$ =110.291 JPY

On February 13, 2019 Medivir AB reported Year End Report January-December 2019 (Press release, Medivir, FEB 13, 2020, View Source [SID1234554328])

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Preclinical data showing that in addition to its direct effect on cancer cells, MIV-818 also modulates the anti-tumor immune response, presented at the AACR (Free AACR Whitepaper)-NCI-EORTC conference in Boston .
The ninth and final liver cancer patient was included in the phase Ia study with MIV-818. Based on safety and tolerability as well as pharmaco-kinetics and positive biomarker data, it was decided to initiate the phase Ib part of the study.
In December, an investigator-initiated phase II clinical trial of remetinostat was started in patients with squamous cell carcinoma. The study is conducted at the Stanford University School of Medicine in the United States.
The first patient was included in a phase I study evaluating the safety and tolerability of a combination of birinapant and radiation therapy in patients with recurrent Head and Neck Squamous Cell Carcinoma. The study is sponsored and funded as part of the National Cancer Institute’s Cancer Treatment Evaluation Program.
A futility analysis of the phase II combination study with birinapant and Keytruda in colorectal cancer patients was performed. Medivir decided to end the study since the results of the analysis indicated that the study’s goals were unlikely to be achieved.
The first milestone payment for the candidate drug MIV-701 in veterinary medicine was received in October.
Financial summary for the quarter

Net turnover amounted to SEK 1.4 (13.6) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -30.3 (-96.6) million. Basic and diluted earnings per share amounted to SEK -1.32 (-4.72) and SEK -1.32 (-4.72) respectively.
Cash flow from operating activities amounted to SEK -22.6 (-72.4) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 134.6 (286.3) million.
January – December
Financial summary

Net turnover amounted to SEK 8.7 (23.9) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -118.9 (-326.5) million. Basic and diluted earnings per share amounted to SEK -5.08 (-14.62) and SEK -5.08 (-14.62) respectively.
Cash flow from operating activities amounted to SEK -148.5 (-320.5) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 134.6 (286.3) million.
Significant events after the end of the period

The phase II study of MIV-711 in patients with osteoarthritis was published in Annals of Internal Medicine (DOI: 10.7326/M19-0675).
Conference call for investors, analysts and the media
The Year End Report January – December 2020 will be presented by Medivir’s President & CEO, Uli Hacksell.

Time: Thursday, February 13, 2020, at 14.00 (CET).

Phone numbers for participants from:
Sweden +46-8-505-583-52
Europe +44-33-3300-9268
US +1-833-5268-396

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.
ombined with other medications and exhibits synergistic anticancer activity in preclinical models.