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Precision BioSciences & Eli Lilly Partner to Develop In Vivo Therapies for Genetic Disorders

Source: Streetwise Reports   11/20/2020

Precision BioSciences shares traded 13% higher after the company reported it is partnering with Eli Lilly & Co. to develop in vivo therapies for genetic disorders with an initial focus on Duchenne’s muscular dystrophy and two other undisclosed gene targets.

Genome editing technology company Precision BioSciences Inc. (DTIL:NASDAQ) and pharmaceutical giant Eli Lilly and Co. (LLY:NYSE) today announced “a research collaboration and exclusive license agreement to utilize Precision’s proprietary ARCUS® genome editing platform for the research and development of potential in vivo therapies for genetic disorders, with an initial focus on Duchenne muscular dystrophy (DMD) and two other undisclosed gene targets.”

The firms noted that “genome editing technologies enable precise editing of the DNA of a living organism, opening up the possibility of correcting genetic problems at their source.” Precision BioSciences stated that “its proprietary ARCUS platform is derived from a natural genome-editing enzyme called I-CreI, a homing endonuclease that can be optimized to control for potency and specificity.”

The companies advised that under the agreement Eli Lilly will make a $35 million equity investment in Precision’s common stock and will pay Precision an upfront cash payment in the amount of $100 million. The firms noted that the agreement additionally provides Precision BioSciences with the opportunity to receive up to an additional $420 million if certain development and commercial milestones are met and from future product royalty payments.

The collaboration agreement stipulates that Precision will lead pre-clinical research and IND-enabling activities and Lilly will be in charge of clinical development activities and commercialization. Under the arrangement, Lilly has right to choose up to three additional gene targets.

Precision BioSciences’ Chief Scientific Officer and co-founder Derek Jantz commented, “We look forward to working with Lilly to leverage our deep understanding of in vivo gene editing and experience with ARCUS to develop new therapies, including a potentially transformative treatment for Duchenne muscular dystrophy…Collaborating with Lilly, a global healthcare leader with strong clinical and commercial experience in difficult-to-treat diseases, will help us accelerate our work aimed to solve genetic diseases with unique editing challenges.”

Ruth Gimeno, Ph.D., V.P. of Diabetes and Metabolic Research at Eli Lilly, remarked, “Gene-edited therapies are emerging as a promising approach to help patients afflicted with genetic conditions…We look forward to working closely with Precision’s scientific team and leveraging their platform to develop and deliver breakthrough medicines for untreated genetic disorders.”

Eli Lilly’s V.P of New Therapeutic Modalities Andrew Adams, Ph.D., added, “This collaboration with Precision BioSciences represents another milestone in the realization of our vision to create medicines with transformational potential, using new therapeutic modalities such as gene editing to tackle targets and indications which were previously undruggable.”

The firms stated that the transaction remains subject to ordinary closing conditions and regulatory approval under the Hart-Scott-Rodino Antitrust Improvements Act.

The company explained that the ARCUS proprietary genome editing technology that it created and developed in-house utilizes “sequence-specific DNA-cutting enzymes, or nucleases, that are designed to either insert (knock-in), remove (knock-out), or repair DNA of living cells and organisms.” The firm stated that it currently holds more than 65 patents that have been issued for its platform and products.

Eli Lilly is a global healthcare and pharmaceutical manufacturing company based in Indianapolis, Ind. The firm’s products include human pharmaceutical products and also animal pet and livestock feed and health products. Eli Lilly has a vast portfolio of medicines used in areas of cardiovascular, endocrinology, immunology, neuroscience and oncology. The company operates in the U.S. and 14 other countries and has a market cap of over $137 billion.

Precision BioSciences is a clinical stage biotechnology company headquartered in Durham, N.C. The firm uses its own proprietary ARCUS genome editing platform to develop “multiple “off-the-shelf” CAR T immunotherapy clinical candidates and several in vivo gene correction therapy candidates to cure genetic and infectious diseases where no adequate treatments exist.”

Precision BioSciences started the day with a market capitalization of around $508.0 million with approximately 52.48 million shares outstanding and a short interest of about 5.1%. DTIL shares opened 14% higher today at $11.05 (+$1.37, +14.15%) over yesterday’s $9.68 closing price. The stock has traded today between $10.24 and $11.45 per share and is currently trading at $10.95 (+$1.27, +13.12%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Kodiak Sciences Announces Pricing of $560.9 Million Common Stock Offering

Source: Streetwise Reports   11/18/2020

Kodiak Sciences shares reached a new 52-week high after the company announced the pricing of a $560.9 million public offering of its common stock. The report came one day after the firm advised it had completed enrollment of its Phase 2b/3 Pivotal DAZZLE Study of KSI-301 in patients with wet age-related macular degeneration.

Late yesterday evening biopharmaceutical company Kodiak Sciences Inc. (KOD:NASDAQ) which specializes in developing novel therapeutics to treat chronic, high-prevalence retinal diseases, announced “the pricing of an underwritten public offering of 5,193,237 shares of its common stock at a price to the public of $108.00 per share.”

Kodiak Sciences indicated that it expects to receive aggregate gross proceeds from the offering of about $560.9 million. The anticipated net proceeds, which take into account deductions for underwriting discounts and commissions and ordinary offering expenses payable by the company, were not specifically listed.

The firm stated that the common share offering transaction is subject to customary closing conditions and is expected to close on or about November 20, 2020. The company further advised that “it has granted the underwriters a 30-day option to purchase up to an additional 778,985 shares of its common stock at the public offering price, less underwriting discounts and commissions.”

The company also did not indicate how it planned to utilize the net proceeds from the offering in the news release.

One day earlier, on Monday of this week Kodiak Sciences announced that “recruitment has concluded in its DAZZLE pivotal study of KSI-301, Kodiak’s anti-VEGF antibody biopolymer conjugate, in patients with neovascular (wet) age-related macular degeneration.” The company stated that it initially intended to enroll a total of 550 treatment-naïve patients worldwide in the DAZZLE study and that it had exceeded that number and thus closed recruitment of additional patients.

Kodiak Sciences’ CEO Victor Perlroth commented, “We are pleased to have exceeded our enrollment target for DAZZLE and to have recruited the study in just over one year despite the challenges presented by the COVID-19 pandemic. We are very grateful for the enthusiasm and support of the retina clinical trial community in working together with us to study KSI-301’s potential…With DAZZLE having a one-year primary efficacy endpoint, Kodiak is on track for a top-line data readout of the study in early 2022, an important milestone as part of our 2022 Vision.”

The company’s Chief Medical & Development Officer Jason Ehrlich, M.D., Ph.D., added “Wet AMD remains a leading cause of vision loss in the elderly and real-world data show that vision outcomes are compromised by the unsustainable and intensive treatment burden of current medicines. In DAZZLE, we are studying a more pragmatic and achievable regimen of KSI-301 given once every three, four or five months…We look forward to the last DAZZLE patient’s one-year visit in late 2021 and to analyzing and releasing the primary results in early 2022. The Kodiak team is also executing well on the rest of the KSI-301 development program. Our pivotal studies in diabetic macular edema (DME) and retinal vein occlusion are off to a strong start. The recent presentation of KSI-301 data at the American Academy of Ophthalmology Virtual Meeting highlighted the promising combination of efficacy and durability seen with KSI-301 in DME, a leading cause of vision loss in working-aged people.”

The company explained that “the Phase 2b/3 DAZZLE study is a global, multi-center, randomized study designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve wet AMD.”.

The firm is conducting several other Phase 3 studies of KSI-301. The company noted that these include the GLEAM and GLIMMER studies, which are focusing on treating patients with treatment-naïve diabetic macular edema (DME), and the BEACON, which is studying the effects of KSI-301 on treatment-naïve macular edema due to retinal vein occlusion (RVO), including both branch and central subtypes.

The company explained in the report that “KSI-301 is an investigational anti-VEGF therapy built on the Kodiak’s Antibody Biopolymer Conjugate (ABC) Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing agents.” The firm added that “its objective with KSI-301 is to develop a new first-line agent to improve outcomes for patients with retinal vascular diseases and to enable earlier treatment and prevention of vision loss for patients with diabetic eye disease.”

The firm additionally advised that it is in the process commencing a planned study of KSI-301 for use in treating patients with non-proliferative diabetic retinopathy.

Kodiak Sciences is headquartered in Palo Alto, Calif., and describes itself as a biopharmaceutical company specializing in novel therapeutics to treat chronic, high-prevalence retinal diseases. The firm is engaged in designing and manufacturing next generation retinal medicines to prevent and treat the leading causes of blindness including retinal vascular diseases, such as age-related macular degeneration and diabetic eye diseases and glaucoma.

Kodiak Sciences began the day with a market cap of around $5.1 billion with approximately 4.48 million shares outstanding and a short interest of about 7.5%. KOD shares opened 5% higher today at $120.17 (+$5.93, +5.19%) over yesterday’s $114.24 closing price and reached a new 52-week high price this morning of $141.50. The stock has traded today between $120.00 and $141.50 per share and is currently trading at $137.66 (+$23.42, +20.50%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Psychedelic Company Expected to Begin Trading Nov. 18

Source: Streetwise Reports   11/17/2020

Delic Corp., a thought leader in psychedelics, will trade on the Canadian Securities Exchange.

Mainstream acceptance of psilocybin took a major step forward on November 3 when Oregon became the first U.S. state to legalize the use of the compound in a therapeutic setting. Psilocybin is the active ingredient in “magic mushrooms.”

Some cities, such as Denver and Oakland, Calif., had already decriminalized psilocybin use.

Studies suggest psychedelic drugs could provide relief for depression, anxiety, addiction and PTSD, and world-leading research institutions such as Johns Hopkins University have been conducting research and trials of psychedelic drugs.

Against this backdrop, Delic Corp. (DELC:CSE) becomes the latest psychedelic company to publicly trade. The firm is expected to begin trading on the Canadian Securities Exchange on November 18, under the symbol DELC, via a reverse takeover of Molystar Resources Inc.

Delic sees itself as an umbrella media platform. It currently has three subsidiary companies: a revenue generating e-commerce lifestyle brand named “The Delic,” a free public education platform providing psychedelic guides, news and culture known as “Reality Sandwich,” that offers more than 5,000 articles and other content, and “Meet Delic,” a biannual psychedelic wellness summit with the first set for Los Angeles in May 2021.

Founded by the husband and wife team of Matt and Jackee Stang, both served in high-level positions at High Times, bringing cannabis into the mainstream. The couple aim to do the same with psychedelics.

“There is so much groundbreaking research being done about psychedelics and their effectiveness to treat mental health and positively impact other human functions. Translating that (often) dense information to a mainstream audience is the difficult part. No one was doing it. That’s where Delic began, in 2018,” Delic President and CEO Jackee Stang wrote.

Delic has issued 17.25 million shares at CA$0.20 per share, raising approximately CA$3.45 million. It is expected that approximately 54 million shares will be outstanding at the time of the listing, leading to a market cap of approximately CA$10.85 million.

Disclosure:
1) Patrice Fusillo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees. As of the date of this article, an affiliate of Streetwise Reports has a consulting relationship with Delic Corp. Please click here for more information.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Delic Corp., a company mentioned in this article.

Lexicon Shares Rise 40% upon Achieving Primary Endpoints in Two Phase 3 Heart Failure Studies

Source: Streetwise Reports   11/17/2020

Shares of Lexicon Pharmaceuticals traded higher after the company published results from the Phase 3 SOLOIST and SCORED trials showing that sotagliflozin significantly reduced total cardiovascular deaths, heart failure hospitalization and urgent visits.

Biopharmaceutical company Lexicon Pharmaceuticals Inc. (LXRX:NASDAQ) yesterday announced “that both the SOLOIST and SCORED Phase 3 studies achieved their primary endpoints by demonstrating statistically significant reductions in total cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits in patients treated with sotagliflozin as compared with placebo.”

The firm reported that in the Phase 3 SOLOIST study it successfully met the primary endpoint, which was identified as a hazard ratio (HR) of 0.67 in patients with both type 2 diabetes and a recent hospitalization for worsening heart failure. The company stated it also recorded positive results in the Phase 3 SCORED study and met that primary endpoint as well, which was a HR of 0.74 in subjects with both type 2 diabetes and chronic kidney disease.

Lexicon Pharmaceuticals indicated that it presented that key results from the SOLOIST and SCORED studies yesterday at American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published the results in two separate articles in The New England Journal of Medicine.

Deepak L. Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School and study chair and lead author for the NEJM publications of the SOLOIST and SCORED results. commented, “Cardiovascular disease continues to be a leading cause of death in people with type 2 diabetes…SOLOIST demonstrates that early, in-hospital initiation of sotagliflozin in patients with worsening heart failure significantly reduces subsequent cardiovascular events, an effect that was consistent across groups with heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). SCORED demonstrates that sotagliflozin significantly reduces heart failure events in a patient population with stage 3 and 4 chronic kidney disease and cardiovascular risk. Both studies add to the evidence that SGLT2 inhibition should be standard of care in heart failure, and the SCORED data reflecting a reduction in myocardial infarction and stroke and better glucose control in CKD patients suggest potential benefits from the dual SGLT1 and SGLT2 mechanism of this particular agent.”

The company explained that the multi-center SOLOIST Phase 3 study included 1,222 patients with type 2 diabetes who had been hospitalized recently for worsening heart failure. The firm advised that “the primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients starting treatment with 200 mg sotagliflozin once daily compared with placebo, with dosing initiated either before or within 3 days of hospital discharge.”

The firm noted that the Phase 3 SCORED study included 10,584 patients with type 2 diabetes and chronic kidney disease who were determined to be at risk for cardiovascular disease. In the SCORED study, cardiovascular efficacy of sotagliflozin was evaluated versus placebo when added to existing standard of care. The established primary endpoint was “the total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.”

The company explained that sotagliflozin was first discovered using its unique approach to gene science. The firm stated that “sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney.”

Lexicon is a biopharmaceutical company headquartered in The Woodlands, Tex. The firm stated that “through its Genome5000™ program, its scientists studied the role and function of nearly 5,000 genes and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases.” Lexicon indicated that it has a pipeline of drug candidates in clinical and preclinical development in diabetes and metabolism and neuropathic pain. The firm also has a milestone and royalty interest in oncology.

Lexicon Pharmaceuticals began the day with a market capitalization of around $151.5 million with approximately 117.5 million shares outstanding and a short interest of about 8.2%. LXRX shares opened 74% higher today at $2.25 (+$0.96, +74.42%) over yesterday’s $1.29 closing price. The stock has traded today between $1.71 and $2.38 per share and closed at $1.81 (+$0.52, +40.31%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: Lexicon Pharmaceuticals. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Moderna Shares Get a Boost from Phase 3 COVID-19 Vaccine Trial Data Demonstrating 94.5% Efficacy

Source: Streetwise Reports   11/16/2020

Moderna shares traded 10% higher to a new 52-week high after the company reported its COVID-19 vaccine candidate, mRNA-1273, met its primary endpoint in the first interim analysis of the Phase 3 COVE Study by achieving an efficacy rate of 94.5%.

Coronavirus

Before the opening bell this morning, biotechnology company Moderna Inc. (MRNA:NASDAQ), which is focused on developing therapeutics and vaccines employing messenger RNA (mRNA), announced that “the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.”

The firm advised that it Phase 3 COVE trial enrolled greater than 30,000 study participants in the U.S. and is being carried out in collaboration with both the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). Moderna stated that “the primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine.”

Moderna’s CEO Stéphane Bancel remarked, “This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease…We look forward to the next milestones of submitting for an EUA in the U.S., and regulatory filings in countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE study. We remain committed to and focused on doing our part to help end the COVID-19 pandemic.”

The company stated that based on these interim safety and efficacy data “it intends to submit for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least 2 months).”

In addition, Moderna noted that it is presently working closely with the U.S. Centers for Disease Control and Prevention (CDC), Operation Warp Speed and COVID-19 vaccine distributor McKesson (MCK:NYSE) to be make preparations for the distribution of mRNA-1273 should the company receive the expected EUA and approvals from agencies in other countries across the globe.

The firm expects that it will have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. by the end of December 2020 and plans to be able to manufacture 500 million to 1 billion doses worldwide in 2021. The firm said that logistically it anticipates that vaccine distribution, storage and handling will be quite feasible using existing infrastructure and distribution channels.

The company explained that the Phase 3 COVE Study was a randomized, controlled study testing mRNA-1273 at the 100 mg dose level in 30,000 adults in the U.S. The firm stated that the pre-established primary endpoint is the prevention of symptomatic COVID-19 disease and the secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2. The COVE study participants included over 7,000 individuals over the age of 65 as well as over 5,000 people who were under 65 years of age, but were deemed to be at higher-risk due to chronic diseases such as diabetes, cardiac disease and severe obesity.

The firm noted that “mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine Research Center.” Moderna commented that under a federal contract totaling $955 million, BARDA is supporting ongoing research and development of mRNA-1273.

Moderna Inc. is headquartered in Cambridge, Mass., and is engaged in the development of transformative medicines based on messenger ribonucleic acid (mRNA). The firm is pursuing mRNA science to minimize the undesirable activation of the immune system by mRNA and to maximize the potency of mRNA once in the target cells. The company has a diverse development pipeline of 24 programs with multiple clinical studies underway. Its therapeutics and vaccine development programs span infectious diseases, oncology, cardiovascular diseases, and rare genetic diseases.

Moderna started the day with a market capitalization of around $35.4 billion with approximately 395.7 million shares outstanding and a short interest of about 6.4%. MRNA shares opened more than 12% higher today at $100.31 (+$11.00, +12.32%) over Friday’s $89.31 closing price and reached a new 52-week high price this morning of $100.50. The stock has traded today between $93.30 and $100.50 per share and is presently trading at $98.45 (+$9.06, +10.14%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Urovant Sciences Shares Double on Sumitovant Biopharma Buyout Offer

Source: Streetwise Reports   11/13/2020

Shares of Urovant Sciences traded 93% higher to a new 52-week high after the company reported that it entered into a definitive agreement to be acquired by Sumitovant Biopharma for $16.25 per share in cash.

After U.S. markets closed for trading yesterday afternoon, clinical-stage biopharmaceutical company Urovant Sciences Ltd. (UROV:NASDAQ), which is engaged in the development and commercialization of therapies for urologic conditions, announced that it entered into a definitive agreement to be acquired by Sumitovant Biopharma in a transaction valued at approximately $584 million based up an offer price of $16.25 per share in cash.

The firm noted that Sumitovant is currently its largest shareholder with approximately 72% equity ownership of the company. The company stated that the $16.25 per share offer price equates to a 92% premium over the 30-day volume weighted average share price on November 12, 2020.

Urovant Sciences advised that the acquisition bid has already been unanimously approved by each company’s board of directors and is expected to close in Q1/21 subject to approval by a majority of minority shareholders.

Pierre Legault, lead independent member of Urovant’s Board of Directors and chairman of the special committee, remarked, “After careful consideration and consultation with our financial advisors, the special committee of the Urovant Board of Directors has found that Sumitovant’s offer represents exceptional value for shareholders.”

Urovant Sciences’ President and CEO James Robinson commented, “Our business is growing, and we remain focused on the potential opportunity to launch vibegron in 2021, pending FDA approval…Sumitovant is our largest investor, and we have been partnering closely with them on plans to efficiently launch vibegron and achieve scale as quickly as possible. We believe that this investment represents a vote of confidence in Urovant’s future success and will put us in an even stronger position to bring vibegron to market as a new treatment option for patients with overactive bladder and to continue advancing our promising development pipeline.”

The firm stated that after the transaction is fully approved and finalized, Urovant will become a wholly owned subsidiary of Sumitovant and will continue to be based in Irvine, Calif.

The company pointed out that it is still expecting U.S. Food and Drug Administration (FDA) action on its New Drug Application submission for vibegron in the U.S. by December 26, 2020.

Urovant Sciences specializes in creating commercializing innovative therapies for urologic conditions. The company’ lead product candidate is vibegron, “an oral, once-daily small molecule beta-3 agonist that is being evaluated for overactive bladder.” The firm advised that it submitted a New Drug Application to the FDA in December 2019 to seek approval of vibegron in treating OAB patients.

Sumitovant Biopharma is a global biopharmaceutical firm that is owned 100% by Sumitomo Dainippon Pharma, which is among the top-10 listed pharmaceutical companies in Japan. In addition to its Urovant holdings, Sumitovant is the majority shareholder of Myovant Sciences and wholly owns Enzyvant Therapeutics, Spirovant Sciences and Altavant Sciences.

Urovant Sciences started off the day with a market capitalization of around $262.1 million with approximately 31.66 million shares outstanding and a short interest of about 2.8%. UROV shares opened 93% higher today on the news at $15.98 (+$7.70, +93.00%) over yesterday’s $8.28 closing price and reached a new 52-week high price this morning of $16.08. The stock has traded in a very tight range today between $15.98 and $16.08 per share and is closed at $16.02 (+$7.74, +93.48%).

 

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Biopharma Posts ‘Impressive’ Q3/20 Sales Amid Pandemic

Source: Streetwise Reports   11/11/2020

Paratek Pharmaceuticals’ recent and future revenue are discussed in an H.C. Wainwright & Co. report.

In a Nov. 9 research note, analyst Ed Arce recapped Paratek Pharmaceuticals Inc.’s (PRTK:NASDAQ) Q3/20, highlighting its sales growth, and noted that H.C. Wainwright & Co. increased its target price on the biopharma.

Arce reviewed Paratek’s sales during the quarter and their implications. Continuing its momentum with NUZYRA sales, the Boston-based company generated $10.9 million in net sales, a 34% increase over those in Q2/20. Further, Paratek achieved this while antibiotic sales in the broader market declined 18%.

“We find this quarter’s growth impressive and encouraging given the ongoing full or partial lockdowns and continued restricted hospital access due to the COVID-19 pandemic,” Arce commented.

H.C. Wainwright and Paratek management revisited their modeling and guidance, respectively, Arce relayed. The investment bank raised its full-year 2020 net sales estimate for Paratek to $38.3 million from $35.2 million based on its stronger than expected Q3/20 and continuing demand for NUZYRA.

Similarly, Paratek estimated that its total 2020 revenue should be at the higher end of guidance of $78–83 million. This projection includes the $38 million the company is to receive from the Biomedical Advanced Research and Development Authority’s initial purchase of NUZYRA. The possibility exists, however, that Paratek may not realize the $38 million until 2021.

Also positively affecting the balance sheet, the biotech again reduced its 2020 guidance for two expenses—research and development and sales, general and administrative—to about $120 million from the $135 million forecast at the end of Q2/20.

At Q3/20’s end, Sept. 30, 2020, Paratek had $149.5 million in cash, enough to cover runway until January 2024, the analyst stated.

Arce reported that H.C. Wainwright raised its target price on Paratek to $22 per share from $19 after updating its model to reflect current financial guidance and updated NUZYRA revenue projections. The stock is currently trading at about $6.03 per share.

The analyst also provided what he described as “an important update.” That is that Paratek should hear back from the U.S. Food and Drug Administration (FDA) around the end of January 2021 on adding to NUZYRA’s label oral-only dosing for community-acquired bacterial pneumonia. The analyst expects the FDA will approve this, which should help further boost NYZRA sales. Arce noted the company could capitalize on the 2020-2021 flu season and expand, as planned, “into the community setting early in 2021.”

Arce summarized his firm’s stance on Paratek which it rates as a Buy. It is “on course to establishing itself as a leading, commercially successful, independent antibiotic biotech company with a pathway to cash flow break even,” he wrote.

 

Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures from H.C. Wainwright & Co., Paratek Pharmaceuticals Inc., Target Price Revision, November 9, 2020

 

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

I, Ed Arce, certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst’s household has a financial interest in the securities of Paratek Pharmaceuticals, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of October 31, 2020 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Paratek Pharmaceuticals, Inc.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The firm or its affiliates received compensation from Paratek
Pharmaceuticals, Inc. for non-investment banking services in the previous 12 months.

 

The Firm or its affiliates did not receive compensation from Paratek
Pharmaceuticals, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

The Firm does not make a market in Paratek
Pharmaceuticals, Inc. as of the date of this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.

Five Prime Shares Triple in Value as Firm Meets All 3 Primary Endpoints in Phase 2 Gastric and GEJ Cancer Trial

Source: Streetwise Reports   11/11/2020

Five Prime Therapeutics shares traded 250% higher after the firm reported topline data from its Phase 2 FIGHT study of bemarituzumab in combination with chemotherapy demonstrated significant progression-free and overall survival rates in advanced gastric and gastroesophageal junction cancer.

After U.S. markets closed for trading yesterday afternoon, clinical-stage biotechnology company Five Prime Therapeutics Inc. (FPRX:NASDAQ), which is focused on the development of immune modulators and treatment for solid tumor cancers, announced “positive topline results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial.”

The firm advised that the Phase 2 FIGHT trial was designed and structured to “compare mFOLFOX6 chemotherapy in combination with bemarituzumab (bema, FPA144), a first-in-class targeted therapy, in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), non HER2 positive (non HER2+) front-line advanced gastric or gastroesophageal junction (GEJ) cancer.”

Five Prime Therapeutics’ EVP and Chief Medical Officer Helen Collins, M.D., commented, “These results bring us one step closer to the first potential targeted therapy for advanced gastric cancer in over a decade…Benefit was observed in patients whose tumors overexpressed FGFR2b, even without evidence of amplification, and that may broaden the therapeutic potential of bemarituzumab in more cancer types. We are excited about the results of the FIGHT trial and the opportunity to advance the development of bemarituzumab, the first and only investigational treatment targeting FGFR2b+.”

The company reported that all three of the pre-specified efficacy endpoints in the Global Phase 2 FIGHT trial of bemarituzumab were achieved and the data recorded met statistical significance. These primary endpoints were identified as median progression-free survival (PFS), Median overall survival (OS) and Overall response rate (ORR). The firm advised that all efficacy endpoints favored bemarituzumab despite the fact that there was a higher frequency of discontinuation of bemarituzumab in the study versus placebo. The firm noted that the trial enrolled a total of 155 patients in 15 countries across Asia, the EU and the U.S.

Five Prime stated that “overall, the Phase 2 FIGHT trial results validate the importance of the novel target, FGFR2b, which is overexpressed in approximately 30 percent of HER2- gastric cancers worldwide.”

Zev A. Wainberg, M.D., associate professor of medicine at UCLA, co-director of the Gastrointestinal Oncology Program and director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center, remarked, “We have known for some time that FGFR is a viable target in gastric cancer and many other malignancies…This is the first data to signal that a targeted therapy directed to FGFR2b may reduce the risk of disease progression and improve overall survival in gastric cancer. This study result showing bemarituzumab’s potential benefit is an important and exciting development.”

The company explained that “bemarituzumab (anti-FGFR2b, FPA144) is a first-in-class targeted antibody that blocks fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pathways and that blocking FGFR2b activation is thought to slow cancer progression.” The firm stated that it is developing bemarituzumab for use as a targeted therapy for tumors that overexpress FGFR2b in treatment of gastric and GEJ cancer.

Five Prime noted that it collaborated with Zai Lab Ltd. (ZLAB:NASDAQ) on the Phase 2 FIGHT trial and has granted an exclusive license to that firm to develop and commercialize bemarituzumab in greater China.

The company explained that gastric (stomach) cancer and GEJ cancer account for the third highest cause of cancer deaths globally. The firm indicated than more than 1 million new cases are diagnosed annually, and in areas where routine screening is not readily available as many as 90% of these cases are not found until the disease has reached an advanced, inoperable level.

Five Prime Therapeutics is headquartered in South San Francisco, Calif., and stated that “it is focused on researching and developing immuno-oncology and targeted cancer therapies paired with companion diagnostics to identify patients who are most likely to benefit from treatment with its product candidates.”

Five Prime Therapeutics started off the day with a market cap of around $203.1 million with approximately 38.04 million shares outstanding and a short interest of about 3.0%. FPRX shares opened more than 300% higher today at $22.51 (+$17.17, +321.54%) over yesterday’s $5.34 closing price and reached a new 52-week high price this morning of $24.00. The stock has traded today between $16.63 and $24.00 per share and is currently trading at $18.60 (+$13.26, +248.31%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Individuals Succeed Using This Digital Therapy, Now It’s Moving to Insurers

Source: Matt Badiali for Streetwise Reports   11/10/2020

Independent financial analyst Matt Badiali profiles a digital therapeutics company that is changing diabetes treatment.

Diabetes

I reread the study twice. The numbers blew me away.

According to the American Diabetes Association, the annual cost of diagnosed diabetes in the U.S. is over $327 billion.

That’s almost $1,000 per U.S. citizenůevery year.

The average person with diabetes costs 2.3 times more in healthcare costs than someone without diabetes. That’s a staggering number.

That’s why I get excited when I come across a company offering something new and useful in the diabetes space.

Here’s my caveatůI’m a scientist. A geologist by education, but I took enough math and science courses to get my head around statistics. I know good data from bad. And I’ve seen almost as many B.S. claims in the health sector as I have in mining.

So, when I read the claims from this tiny digital health company, I was skeptical.

However, the data is compellingŚboth from studies and from the commitment of its users. DarioHealth Corp. (DRIO:NASDAQ) is a global digital therapeutics company. It is revolutionizing the way we treat diabetes.

The company’s app has over 60,000 users today. These are individuals who bought the product and pay for it themselves (rather than getting it through their employers or insurance).

Dario makes a blood glucose monitoring system that works with your smartphone. The app collects the data and helps users manage their blood glucose. It’s so easy that the company had a massive buy-in when it began to study the actual effectiveness of its methodology.

It’s like Fitbit for diabeticsůand people love it. It has a 4.6-star rating on Google Play Store. And when you read the reviews, you see that the company immediately contacts folks with problems.

From 2017 to 2019, Dario’s clients participated in eight scientific studies presented at three leading diabetes conferences.

Here’s what they foundůAn average reduction of 1.4% in blood glucose (A1c) after one year. That represents a gross savings estimate of about $2,380 per person per year in health care costs.

That’s a huge savings. And while the company sells primarily to individuals today, management believes they will close a deal with a large business or insurance company by the end of 2020.

That’s the catalyst that will propel DarioHealth to its next level. And these digital health stocks move quickly. Take Livongo Health, for example.

Dario’s closest peer, Livongo Health, was a $1.5 billion market cap company in October 2019. On November 2, giant digital health company Teledoc Health (NYSE: TDOC) acquired it for $14.4 billion. That’s an 860% gain in a year.

DarioHealth is still in the growth stage. But this next transition, going from selling its services to individuals to insurers will be a huge turning point in the stock.

This is a great play in the digital health space, but don’t take my word for it. The company will host a conference call on Thursday, November 12, 2020, to review its second quarter results. You can sign up for their call or watch it afterwards.

–Matt Badiali

Matt Badiali is a geologist and independent financial analyst. He spent fifteen years researching and writing about great investments inside the natural resources sectors. He can be reached at www.mattbadiali.net.

Streetwise Reports Disclosure:
1) Matt Badiali: I, or members of my immediate household or family, own shares of the following companies mentioned in this article: None. I was paid by a third party to write this article. My company has a financial relationship with the following companies mentioned in this article: None. I determined which companies would be included in this article based on my research and understanding of the sector.
2) The following companies mentioned in the article are sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) Statements and opinions expressed are the opinions of the author and not of Streetwise Reports or its officers. The author is wholly responsible for the validity of the statements. The author was not paid by Streetwise Reports for this article. Streetwise Reports was not paid by the author to publish or syndicate this article. Streetwise Reports requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Streetwise Reports relies upon the authors to accurately provide this information and Streetwise Reports has no means of verifying its accuracy.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Draganfly Screening Technology Battles Campus, Public Facilities Health Challenges

Source: Knox Henderson for Streetwise Reports   11/09/2020

Knox Henderson delves into how Draganfly’s cutting-edge technology is making it possible for universities and other organizations to operate safely during the pandemic.

For a company known for its drone technology, Draganfly Inc. (DFLY:CSE; DFLYF:OTCQB) knows a lot about cameras–and then there’s the data! So, when health screening technology targeting the masses comes into play, it falls right into its wheelhouse. The best part about the well-connected Draganflyófor real, the oldest commercial drone company in the worldóis that all this drone work has led to high levels of acceptance at government and military levels. The “eye-in-the-sky” has touched down to ground level to help a more health-enlightened population battle a pandemic. For investors of DFLY these kinds of contracts are on a next-level scale. Recent wins for on-site health and social distancing technology could put Draganfly into the stratosphere. As these large, high-profile contracts continue to accumulate so will the trajectory of its share price.

“One or two of these health security deals dwarf our current revenues,” says CEO Cameron Chell whose company’s sales run rate is at about $5 million and boasts an impressive gross margin of 50%. Profitability is a non-issue at this stage as the company is focused rapid growth, organically and by acquisition.

“We could be profitable today if we weren’t continually pursuing an aggressive expansion strategy,” says Chell. “Our objective is to be at a $50 million run rate by 2023. It is not responsible to our shareholders to be satisfied in having a $5 million business, when we have the potential of a $500 million business.”

Chell says the revenue boost will be both incremental and exponential. “It will be a big, big boost for us. We’re working on multiple contracts right now that are looking to potentially be anywhere from $10ñ30 million at a time; it seems inevitable that we are going to close a couple of them and they would dwarf our entire revenue stream with one or two contracts.”

Draganfly is world-renown technical “wiz-kid” of unmanned vehicle systems (UVS), robotics, Artificial Intelligence (AI) and software that has innovated new means capturing and analyzing date. Its an award-winning, industry-leading manufacturer within the commercial UAV, RPAS, and UVS space, serving the public safety, agriculture, industrial inspections, security, and mapping and surveying large areas.

Its development in these area makes it a natural fit for pandemic related screening along data collection and analysis for the all-critical preemptive strategies for a stressed-out pubic. “It just demonstrates the fact that we’re just going to continue to build out AI and sensors and equipment. We do the manufacturing and assembly, the software development, the AI. We’ve got all that capability and this data is more important than any other data out there; security is paramount. The fact that we’re the end-to-end provider, building the hardware, through to the software, right through to the AI, is quite frankly why we’re able to be working on the government, military and public safety contracts.

What is hot right now is Draganfly’s Vital Intelligence Smart Thermal Assessment Station and Vital Sign Screening technology. It provides a quick, non-invasive (contactless) and anonymous measurement of an elevated body temperature andówith voluntary consentóheart rate, respiratory rate and O2 saturation, all from a camera that takes seconds to capture. The Social Distancing Awareness unit ensures compliance with social distancing guidelines.

Vitals Kiosk

Draganfly Vitals Screening Kiosk

Alabama State University has purchased and installed five Smart Thermal and Vital Sign Assessment units and five Social Distancing Awareness units to be stationed across the campus and accessible by its staff, faculty and 4,000-plus students. Individuals who appear to have an elevated temperature and vital signs could then be screened by a medical professional to confirm the presence of an infectious condition.

Draganfly

Early September, the company also announced that “Super-Bowl level” film producers Richard Goldstein and Ron Cicero selected Draganfly as its sole provider of Smart Vital Sign and Social Distancing equipment for television and commercial production, and the company has a host of other announcements in this area around the corner. Draganfly’s Vital Intelligence Safe Set Solution, which provides vital sign and social distancing measurement software plus hardware for the television and commercial production industry, will be the cornerstone of this new initiative. This commercial production provider is taking immediate delivery of the first four units (US$70,000) of an eventual fleet of units to supply the annualized $6-billion commercial spot production industry.

When I first covered DFLY back in March, the company was capitalizing on a U.S. military ban on Chinese-made drones. “The move against Chinese technology started last October 2019 when the U.S. Department of the Interior grounded its 800+ dronesóall made in China or with Chinese partsópending review of their data security. Since then, more divisions of the U.S. military and government are actively considering to further bar Chinese made drones. The market is now taking notice of Draganfly given its “pole position” to replace much of the up to $1 billion void left by the now-banned Chinese drone technology.

“Since then the DOD has grounded their entire Chinese fleet and now they’re Americanizing it,” says Chell. “The defense initiative department recently announced that five new drones that are pre-approved for purchase by the DOD none Chinese, one French and the rest are all U.S.” So, including Draganfly, there are now still only six manufacturers that can produce for the DOD right now and we’re one of them.”

Granted, since March the market capitalization of DFLY under was just US$50 million with a $0.70 price and has since traded slightly downward, now trading nearer to $0.55 range, with a market cap of $37 million. So, with all this excitement and potential, why is the stock trading sideways?

“I think a couple of things are at play. First, the market has a lot of variables in it currently and second the tech we are commercializing is almost to good to be true,” suggests Chell. “I see a large audience poised to see how this next quarter does. If we remain on our current growth path (last quarter we were up over 200% year over year), I think you will see the share price looking for a new level, fueled by retail, institutional and strategic investors.”

The strategic differentiator for Dragonflyóor one of themóhas always been its sensor and data work. “An air-frame is an air-frame but what’s really important to the customer is the data they can get and how they can use it and manage it. Our ability to do this type of engineering work is what wins us these opportunities.”

He says Draganfly has been deploying its screening system in schools and workplaces and has been inundated with interest and orders that it’s fulfilling right now.

Draganfly is a full service company with revenue streams in contract engineering, product development, product integration, management services and data services. Other recent wins include the National Police of Dubai recently selected Draganfly to test and develop health security monitoring. Mining companies have contracted the company to search large swaths of land to detect a wide range of mineral deposits. More opportunities are abound with power companies using drones to monitor the power grid infrastructure and agriculture uses drone-based sensors to monitor the status of crops. One can only imagine the global potential to meet urgent need to get a pandemic under control.

It’s the kind of technology that has a societal impact. While screening and monitory technology strives to strike the balance between privacy and security, it’s something we can all benefit from, especially DFLY shareholders.

Knox Henderson is a journalist and capital markets communications consultant. He has advised for a broad range of small cap companies in the resource, life sciences and technology sectors for more than 25 years.

Disclosure:
1) 1) Knox Henderson: I, or members of my immediate household or family, own shares of the following companies mentioned in this article: None. I personally am, or members of my immediate household or family are, paid by the following companies mentioned in this article: None. My company has a financial relationship with the following companies mentioned in this article: None. I determined which companies would be included in this article based on my research and understanding of the sector.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) Statements and opinions expressed are the opinions of the author and not of Streetwise Reports or its officers. The author is wholly responsible for the validity of the statements. The author was not paid by Streetwise Reports for this article. Streetwise Reports was not paid by the author to publish or syndicate this article. Streetwise Reports requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Streetwise Reports relies upon the authors to accurately provide this information and Streetwise Reports has no means of verifying its accuracy.
4) This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Draganfly, a company mentioned in this article.