Hark,What News?

news and views for entrepreneurs .....as of Jun 1, 2020

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Note: Carl Nelson Consulting, Inc is not an investment adviser and may hold a financial interest or client relationship in companies discussed.   Looking for older stories? Visit the archives

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Dynavax Tech up 26% [May 29, 20]

Minerva Neurosciences down 72% [May 29, 20] announced  that the Phase 3 trial of roluperidone to treat negative symptoms in schizophrenia did not meet its primary (reduction in PANSS Marder Negative Symptoms Factor Score or NSFS) and key secondary (improvement in the Personal and Social Performance Scale Total Score or PSP) endpoints. [company press release, May 29, 20]

Macrogenics down 16% [May 29, 20]

VentureOhio announced  that it plans to cease operations. The organization worked to attract venture capital for early-stage companies to Ohio. VentureOhio directors decided to wind down after losing its leader earlier this year and because the pandemic put its biggest event of the year, an awards dinner that usually attracts around 600 people, in jeopardy. Leaders say that their advocacy work will continue through other programs throughout the state,

Q. I don’t remember being taught much of anything about [the 1918 Spnish flu] in school. Why are we not more familiar with how devastating it was? A. Well, until a couple of decades ago, historians wrote only about what people did to people. It was very unusual for historians to write about what nature did to people. [Joe Heim interviewing John M. Barry, the author of The Great Influenza: The Story of the Deadliest Pandemic in History, WashPo, May 30, 20] If people and their polticians ignore or make up history, we will repeat epidemics about every decade. And with little appreciation of history and mathematics, the country will be putty in the hands of unscrupulous politicians.

Science doubted. A housing crisis is imminent. Many parts of the country are reopening prematurely. Protesters have stormed state capitals, demanding that businesses reopen. The country is starkly dividing between those who believe in science and those who don’t. [Roxane Gay, NY Times, May 30, 20]  Politics creates a lot of experts with expertise that extends only to getting elected. 

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ARCA biopharma (Westminster, CO; no SIR) up 386% [May 28, 20] announced a new development program to evaluate AB201 (rNAPc2), a potent, selective inhibitor of tissue factor (TF), as a potential treatment for COVID-19 associated coagulopathy (CAC) and the related inflammatory response. CAC is one of the most serious adverse effects seen in COVID-19 patients. AB201 has previously undergone clinical testing through Phase 2 in more than 700 patients for other indications, generating substantial safety data, which the Company believes may enable more rapid development. [company press release, May 28, 30]

Phasebio Pharma up 36% [May 28, 20] receives clearance of IND application from U.S. FDA under Coronavirus Treatment Acceleration Program (CTAP) "VANGARD" trial will assess the efficacy and safety of PB1046 in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and acute respiratory distress syndrome Based on FDA feedback, PhaseBio believes that positive, clearly interpretable and clinically meaningful trial results may enable PhaseBio to submit a Biologics License Application [company press release, May 27, 30]

Five Prime Therapeutics down 16% [May 28, 20]

IDEAYA Biosciences up 23% [May 28, 20]

Novavax developing next-generation vaccines for serious infectious diseases, announced the acquisition of Praha Vaccines 9(Czech Republic) [for $167M] cash .... includes a biologics manufacturing facility and associated assets in Czech Republic. The facility is expected to provide an annual capacity of over 1 billion doses of antigen starting in 2021 for NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate [compamy press release, May 27, 20]

Six months after banking a $100 million venture round, Avidity Biosciences (La Jolla, CA; $200K SBIR) is heading to the public market. The company filed to raise up to $100 million in its IPO, which will push its lead muscle disorder program through IND-enabling studies and into the clinic in 2021. [Amirah Al Idrus, Fierce Biotech, May 26, 20]

Wake-up coming. Subsidies will soon end. Americans will then feel the economic pain—and revolt. Historically, American elections after a crisis have been decided on the question of who can more competently lead the country to better days. Yet unlike previous challenges, the true nature of America’s economic crisis hasn’t set in on the American people. When it does, the familiar political fault lines fused with millions unemployed could make 2020 the most explosive ideological election in modern history. [Josh Holmes, Wall Street Journal, May 29, 20]

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Mersana Thera (Cambridge, MA; no SBIR) up 69% [May 27, 20] a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today reported interim safety, tolerability and efficacy data from the ongoing expansion portion of the Phase 1 study evaluating XMT-1536, its first-in-class ADC candidate targeting NaPi2b, in patients with ovarian cancer and non-small cell lung (NSCLC) adenocarcinoma. [company press release, May 27, 20]

Arcturus Thera down 29% [May 27, 20]

Q32 Bio (Cambridge, MA; no SBIR) developing biologics to restore healthy immune regulation, announced the company's pipeline and plans to enter the clinic this year with its lead candidate. Enabled by a $46M Series A financing [is] advancing a portfolio of biologics targeting the body's innate and adaptive immune systems. The company has a robust product pipeline including a monoclonal antibody antagonist of the interleukin-7 receptor (IL-7R), and a complement therapeutics platform that has generated fusion proteins that downregulate complement activity specifically in disease-affected tissues. [company press release, May 27, 20]

RE2 Robotics (Pittsburgh, PA; no SBIR), a developer of human-like robotic manipulation systems, has received $2.5 million in funding from the Office of Naval Research to continue the development and commercialization of its technology under the Dexterous Maritime Manipulation System (DM2S) program. [David Edwards, Robotics & Automation, May 27 20]

Virna Therapeutics (Boston, MA: no SBIR) announces that they are partnering with University of Toronto to in-license neutralizing antibodies, to treat COVID-19. The discovery was made in the laboratory of Sachdev Sidhu, PhD., a professor of Molecular Genetics at the University of Toronto ... Virna Therapeutics has a three-pronged strategy to target the COVID-19 virus: (1) neutralizing antibodies that will prevent the virus from entering host cells, (2) CRISPR/Cas13d-based and LNA-based technologies for the treatment and prevention of RNA virus infection and (3) novel protease inhibitors that will prevent replication and release from host cells. [company press release, May 27, 20]

Investors have just pumped $27.5 million into Nanotech Energy (Los Angeles, CA; no SBIR) Because the company claims its graphene based lithium batteries can charge 18 times faster than conventional lithium-ion batteries. [Steve Hanley, Cleantechnica, May 25, 20]

A group of bipartisan lawmakers introduced legislation to boost research into emerging technology including artificial intelligence and quantum computing. The Endless Frontiers Act would create a Directorate of Technology at the National Science Foundation (NSF), and would rename the NSF the National Science and Technology Foundation. The new directorate would be given $100 billion over five years to invest in American science and technology research, with specific research areas including cybersecurity, robotics, AI, quantum computing, national disaster prevention and biotechnologies. In addition, the Department of Commerce would be given $10 billion over five years to establish “regional technology hubs” across the nation. [Maggie Miller, The Hill, May 27, 20]

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Moderna down 16% [May 26, 20]

Purinomia Biotech (Woburn, MA; no SBIR), which focuses on biologicals and small molecule development to target key ectonucleotidases for treatment of cancer, autoimmunity, inflammatory disease and metabolic syndrome, raised $2.8M in equity in a $3.8M funding round, according to an SEC filing. [Srividya Kalyanaraman, BostInno, May 26, 20]

GelSight (Waltham, MA; $200K SBIR) announced that it has been awarded a $728,000 [NSF SBIR] grant to develop a compact sensor toolkit that will provide human-like tactile sensing capabilities for robotics.[company press release, May 26, 20] prior funding $10M [crunchbase.com]

Savi Technology (Alexandria, VA; $2.4M SBIR) is working with the Department of Defense to get its logistics tech to the Army National Guard, a 221-unit order amounting to $3.2M in business. It’s one of two multimillion-dollar orders from the DoD, to help get first responders logistics equipment — Savi’s Portable Deployment Kit, as it’s called — amid the coronavirus crisis. The other? The Army Reserve’s $5.1M order for 354 units [DCInno, May 26, 20]

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Xeris Pharmaceuticals (Chicago, IL; no SBIR) up 28% [May 22, 20], a specialty pharmaceutical company leveraging its novel formulation platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced positive findings from the outpatient stage of a Phase 2 proof-of-concept study of its developmental ready-to-use (RTU) glucagon in patients who experience postprandial hypoglycemic episodes following bariatric surgery. [company press release, May 22, 20]

Zynerba Pharma up 18% [May 22, 20]

AMAG Pharmaceuticals has completed the sale of its rights to vaginal pain relief drug Intrarosa to Millicent Pharma Limited. The sale is worth up to $125M.   [company press release, May 21, 20] 

Biotech Day One Pharmaceuticals (Menlo Park, CA; no SBIR) debuts with $60M to change cancer care—starting with children. The drug has been tested in more than 250 patients, adults and children, and it’s in an investigator-sponsored trial testing it in children with relapsed gliomas. [Amirah Al Idrus, Fierce Biotech, May 21, 20]

SQZ Biotech (Watertown, MA; $1.7M SBIR) a clinical stage cell therapy c ompany developing innovative treatments for multiple therapeutic areas, announced the completion of a $65 million Series D preferred stock financing. [company press release, May 18, 20] total funding $166M [crunchbase.com]

Atea Pharmaceuticals (Boston, MA; no SBIR), a biopharmaceutical company engaged in the discovery and development of next-generation therapeutics for severe human viral infections, today announced a $215 million Series D financing [company press release, May 20, 20]

Inflammatory disease biotech Applied Molecular Transport [South San Francisco, CA; no SBIR) aims for $100M IPO to bring its lead program, an oral IL-10 agonist, into phase 2 studies. [Amirah Al Idrus, Fierce Biotech, May 19, 20] total funding $73M [crunchbase.com]

A staggeringly large proportion of people in the so-called "free world" have the emotional maturity of toddlers; they genuinely think their immediate desire is an existential need. Those countries who have done well in this crisis are those with unified, socially-cohesive populations who recognise the simple truth: "What is good for all of us, is probably good for me too." [commenter, NYTimes, May 24, 20]

One of Donald Trump’s special talents is to hold every conceivable position on a given subject at the same time. [The Economist, Apr 18, 20]

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Nanoviricides down 16% [May 21, 20]

Mammoth Biosciences (South San Francisco, CA; no SBIR), is leveraging its CRISPR-based DETECTR platform with GSK Consumer Healthcare’s global reach and commercialization expertise to develop an accurate, easy-to-use, fully disposable, rapid and handheld test that consumers and health care providers in clinics can use to detect active SARS-CoV-2, the novel coronavirus that causes COVID-19. [Christine Hall, crunchbase news, May 20, 2020] What happens to test results is unclear.

Aperiomics (Sterling, VA). has teamed up with  biotech Antibody Biopharm (Gaithersburg, MD) to offer a rapid antibody test for Covid-19. The Loudoun County diagnostics startup has used its existing testing platform — the same tech involved in its own testing kits — in its Northern Virginia lab to validate and, now, begin offering the test to other laboratories that meet Clinical Laboratory Improvement Amendments, or CLIA, requirements. But the partners still need a nod from the FDA to administer the test as a point-of-care diagnostic given by doctors and other health care providers, which Aperiomics said it expects within two months. [DCInno, May 21, 20]

[DOD] has shelved some of its most ambitious laser plans in order to focus on getting fiber lasers up to a power level where they will actually be useful. especially for lasers on planes to shoot down ICBMs, says Mike Griffin, top DOD science leader and former 1990s overseer of Stars Wars tech group that contained my SBIR program. [Patrick Tucker, DefOne, May 21, 20]

The annual DOD budget battle is on, with a request for $700+B, to do what? We are pulling out of our international role of the hegemonic world organizer and defender. East Asia will have to defend itself from the expanding regional hegemon. World shipping powers will protect the sea lanes. The US will defend itself from Mexican border invasions with a magic wall. And taxes can be cut for the abused wealthy. We used to call that a peace dividend, especially in 1992 when the Bush 41 establishment, and then Clinton, discovered the use of SBIR for dual-use technology.

Act in haste. Hundreds of millions of dollars in unemployment funds were lost to fraud even as jobless claims soar. [New York Times, May 22, 20] A law passed in haste, to be admininstered by an Executive Branch stuffed by loyalists nto the Grupenfuhrer, with control devolved to private enterprise sound like something right of the 19th century. Act in haste, repent at leisure.

For Spy Agencies, Briefing Trump Is a Test of Holding His Attention [NY Times, May 22, 20] When your audience is only thinking of what he will say next, he may miss the message about a possible pandemic. You, of course, will be blamed when it happens.

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Liquidia Tech up 18% [May 20, 20]

Vir Biotech up 17% [May 20, 20]

Immunogen up 16% [May 20, 20]

Novavax filed a prospectus to sell up to $250 million of shares of common stock as it prepares to scale up production of its coronavirus vaccine candidate. [yahoofinance.com, May 20, 20]

HotSpot Therapeutics (Boston, MA; no SBIR) a biotechnology company pioneering the discovery and development of first-in-class allosteric therapies targeting nature’s regulatory sites, announced the completion of a $65 million Series B financing. .... to realize our vision of designing and developing first-in-class allosteric medicines,” said Jonathan Montagu, CEO and co-founder [company press release, May 21, 20]

Vividion Therapeutics (San Diego, CA; no SBIR), discovering and developing highly selective small molecule medicines that drug traditionally inaccessible targets, announced it has entered into an exclusive worldwide option and license agreement with Roche to leverage its proteomics screening platform and proprietary small molecule library to target novel E3 ligases, as well as a range ofoncology and immunology therapeutic targets. Roche has the exclusive right to license resulting compounds at different stages of development. will receive $135 million in a cash upfront payment from Roche and is eligible to receive several billion dollars in payments based on the achievement of preclinical, development and commercial milestones, as well as royalties on sales of commercialized products resulting from the collaboration. [company press release, May 21, 20]

Exceptional nation. The United States’ military might and economic prowess remain unrivaled. America’s cultural influence and soft power remain enormous, even with the most inward-looking president in over a century sitting in the White House. It should also surprise no one that a country born in the Age of Enlightenment would thrive so mightily in science, medicine and technology. [Joe Scarborough, WashPo, May 20, 20] Trump shows no grasp of the exceptional nature of US history that brought it to a wholesome influence on the whole world. He lives in a 19th century mercantile world of whoever has the most gold wins.

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Dynavax Tech (Berkeley, CA; $6.5M SBIR) up 34% [May 19, 20] in anticipation of the company's COVID-19 vaccine program update, which is scheduled for later today. One of the main reasons for all the excitement is that Dynavax has already announced that one or more of its collaboration partners should initiate an early stage COVID-19 vaccine trial by July. [Motley Fool, May 19, 20]

Bellerophon Pharma down 20% [May 19, 20] announced the pricing of offerings its common stock at a public offering [company press release, May 19, 20]

Sorrento Thera down 17% [May 19, 20]

immuno-oncology startup Scorpion Therapeutics (Boston, MA; no SBIR) raised $24.7M in equity, according to an SEC filing. [Rowan Walrath, BostInno, May 19, 20]

NBD Nanotechnologies (Lexington, MA; $1.5M SBIR) which develops advanced liquid repellant surface coatings and additives, raised $1M in debt in a $2.3M funding round, according to an SEC filing. [Srividya Kalyanaraman, BostInno, May 19, 20] prior funding $15M [crunchbase.com]

food supplements company ChromaDex (Westwood, CA; $800K SBIR) announced the expansion of its partnership with A.S. Watson Group into Europe and the launch of its main product, Tru Niagen, in more than 200 Superdrug stores across the United Kingdom. [LA Business Journal, May 18, 20]

In a book published more than a decade ago, I argued that the internet might lead to a choose-your-own-facts world in which different segments of society believe in different versions of reality. The Trump era, and now the coronavirus, has confirmed this grim prediction. [Farhad Manjoo, NY Times, May 20, 20]

Anything but science. ask what evidence Trump had that the [hydroxecholorquine] drug was at all efficacious in addressing the virus and disease it causes, covid-19. Simple, Trump replied: Lots of people called him and said it worked. [Philip Bump, WashPo, May 19, 20]  A man who hears only what he wants to believe. All grievance politics, all the time.

Moderna up 20% [May 18, 20] reported “positive” data on its potential coronavirus vaccine from an early clinical trial, raising hopes about the effort. [The Hill, May 18, 20]  announced itt will sell $1.25 billion worth of stock to fund manufacturing and distribution of its vaccine candidate, referred to as mRNA-1273, [Yahoo finance, May 18, 20] The company said early data from a Phase 1 clinical trial showed that people given the potential vaccine generated an immune response similar to that in people who had recovered from the disease.

Amplyx Pharmaceuticals (San Diego, CA; $11M SBIR) a biotech company developing innovative therapies for debilitating and life-threatening diseases in patients with compromised immune systems, announced it has closed a $53 million Series C extension, which brings the Series C round to over $90 million [to] advance the clinical development of the company’s product candidates, fosmanogepix and MAU868. [company press release May 19, 20]

Rallybio (New Haven, CT; no SBIR) committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare disorders, today announced the completion of a $145 million Series B financing [to] advance Rallybio’s current portfolio of product candidates targeting devastating rare diseases, including its lead program, RLYB211. RLYB211 is in development for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT), a potentially life-threatening rare disease that can cause uncontrolled bleeding in fetuses and newborns. [company press release May 19, 20]

Vir Biotech up 32% [May 18, 20] announced the publication of research findings from the company's efforts to develop therapeutics for COVID-19 in the May 18, 2020 issue of the journal Nature. The paper, entitled "Cross-neutralization of SARS-CoV and SARS-CoV2 by a human monoclonal antibody" (Pinto, et al., Nature), details the identification and characterization of S309, an antibody isolated from a patient who recovered from severe acute respiratory syndrome (SARS) in 2003, which has been shown to prevent SARS-CoV-2 live virus infection of cells. [company press release, May 18, 20]

Novavax up 30% [May 18, 20]

Translate Bio up 23% [May 18, 20]

Zynerba Pharma up 22% [May 18, 20]

FDA approved Deciphera Pharmaceuticals (Walham, MA; no SBIR) drug ripretinib (Qinlock), a new treatment intended for patients with a gastrointestinal stromal tumor (GIST) who have failed at least three previous treatments. [Sarah de Crescenzo, xconomy.com, May 15, 20]

OnKure Therapeutics (Boulder, CO; no SBIR), developing small molecule drugs for cancer treatment, raised $3.2 million in equity funding as part of a $5.2 million round, according to a Form D filing. The company spun out of research performed in a CU Boulder biochemistry lab and enrolled its first cancer patient in clinical trials last year. [Colorado Inno]

America Alone, again.  A time must come when the United States as a powerful world state and a great creditor nation, hence vitally interested in world trade and world prosperity, will  realize that a policy of self-sufficiency is not only impossible, but that a policy which presupposes it to be possible is stultifying and impoverishing.  [Edwin Gay, Foreign Affairs, Jul 1932]  

To govern, at least at the level of the presidency, is to make hard choices among competing options with incomplete information. Easier problems are resolved before they ever reach the Oval Office. Neither scientific data nor public sentiments can properly [alone] answer the questions that face elected officials. Both are important and must be integrated into the judgments that political leaders make. [Wall Sreeet Journal, May 16, 20] To govern is to choose, and therby make enemies. Elections choose whch leader will have to make those choices. Think carefully for whom to vote. Trump apparently denies the Adam Smith's economic principle of comparative advantage.

We got ours. With jobless numbers rising, Republicans’ refusal to negotiate on another round of pandemic relief is proving difficult to sustain. [Carl Hulse, NY Times, May 15, 20]

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Sorrento Therapeutics (San Diego, $4.8M SBIR thru 2014, 300 employees) up 158% [May 15, 20] announced that its anti-SARS-CoV-2 antibody, STI-1499, demonstrated 100% inhibition of SARS-CoV-2 virus infection in an in vitro virus infection experiment at a very low antibody concentration. [company press release, May 15, 20] But was effective in a laboratory setting, which precedes any clinical trials. There is not yet any evidence that the treatment candidate is safe or effective in human beings. [Charley Grant, WSJ, May 15, 20]

Cassava Sciences (Austin, TX; no SBIR down 74% [May 15, 20] reported top-line results from a Phase 2b study of PTI-125, its lead investigational drug, in patients with Alzheimer's disease. This study did not meet its primary endpoint. [company press release, May 15, 20]

Nanovircides down 17% [May 15, 20]

Immunology startup Immunai (NYC, NY) came out of stealth mode with $20 million in a seed funding round [to] build the world's largest proprietary clinical immunology data set to better detect, diagnose and treat disease. [crunchbase.com, May 15, 20]

Dyno Therapeutics (Cambidge, MA; no SBIR) emerged from stealth with Novartis and Sarepta Therapeutics as partners. The biotech’s technology designs superior versions of the viruses commonly used in gene therapies. Financial terms weren’t disclosed. [Sarah de Crescenzo, xconomy.com, May 11, 20]

Travecta Therapeutics (New York and Singapore, no SBIR), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain-barrier, announces today it has secured US$15 million in its Series A round of financing ... Travecta's mVECTATM proprietary platform is built upon a deep understanding of the Mfs2da transporter protein and its function at the blood-brain-barrier as well as in other key physio-pathological conditions discovered by Dr. David Silver, Professor at Duke-NUS and Scientific Founder of Travecta. [company press release, May 12, 20]

Thermedical (Waltham, MA; $8M SBIR), which is developing a proprietary thermal ablation therapy, raised $7.9M in debt in a $9.5M funding round, according to an SEC filing.  [BostInno, May 14, 20]

Some truth from the doc. Bob Wachter,chair of the [UCSF] department of medicine, sets aside at least two hours to keep informed: his Twitter [now 64,000] followers [as part of a growing group of scientists and public-health officials drawing large audiences on social media [to] provide credible information online and steer the conversation away from dubious claims, such as those in “Plandemic,” [Georgia Wells, Wall Street Journal, May 15, 20]

Ultimately, the Chinese are competing to become the world’s leading innovators, and the United States is not playing to win. [Eric Schmidt, ex-chair Alphabet, quoted by Naomi Kein, The Guardian, May 13, 10]

Faster, faster, but how? The president named a former pharmaceutical executive and a retired general to lead a crash development program that if successful would shatter speed records for vaccine development. [NY Times, May 15, 20] Left unsaid: what will they do, and who will pay for it? With something like 100 labs already chasing the golden prize with both public and private money to find a vaccine and manufacture it in a competitve race. At least three each have multi-hundred million dollars committed.

Federal R&D spending has fallen to a mere 0.6% of GDP. Whereas America once led the world in the share of our economy invested in R&D, we now rank 12th globally. [Sen. Chuck Schumer (D-NY), Sen.Todd Young (D-IN), Rep. Ro Khanna (D-CA) and Rep. Mike Gallagher (R-WI),, USA Today, May 14, 20] Everybody has a great idea of what government can and should do, but few poliicians have the courage to stand for the taxes needed to pay for it.

Building and isolating. The Trump administration said it would impose export restrictions designed to cut off the Chinese telecom-equipment maker from overseas suppliers, threatening to ignite a new round of U.S.-China economic tensions. [Bob Davis and Katy Stech Ferek, Wall Street Journal, May 16]

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Imara up 20% [May 14, 20]

CytomX Thera down 36% [May 14, 20]

Arcadia Biosciences down 17% [May 14, 20]

FluGen (Madison, WI; $4.3M SBIR) raised $8.18M in debt funding from a total of 47 undisclosed investors, according to an SEC filing. ... currently working with the University of Wisconsin-Madison and India-based Bharat Biotech to develop and test a vaccine for Covid-19. [WiscInno, May 14,20]

AeroVironment landed a potential three-year, $146M contract to provide loitering missile systems designed to help military users reach targets for operations beyond line of sight. The company said Thursday it will start to deliver the Switchblade miniature aerial missiles to the service branch beginning in September under the sole-source contract with a $75.9M base value awarded by the Army Tactical Aviation and Ground Munitions project office due to "joint urgent operational need." Switchblade can be deployed from a six-pack launch platform and seeks to help warfighters hit a target up to six miles from a fixed or a mobile location. The contract includes two option years that would extend work through April 2023. [Nicholas Martin, govconwire.com, May 14, 20]

C2N Diagnostics (St. Louis, MO; no SBIR) received a $20 million Program-Related Investment from GHR Foundation, an independent global philanthropy. [to] position C2N’s Alzheimer’s blood test for entry into the clinic. [company press release, May14, 20]

ReAlta Life Sciences (Norfolk,VA; $800K SBIR, founded 208) prepares to transition into a clinical-stage organization later this year, the Norfolk-based biotech startup closed a $14 million series A2 to support this critical transition [and[ brings the total Series A to $26 million, ... building a technology platform that features a family of over 160 engineered peptides, or short strings of amino acids that are considered the building blocks of proteins. [Will Flanagan, DC Inno, May 5, 2020]

“The cupboard was bare,”[Trump] told ABC News last week. Asked why he more to replenish the stockpile, Mr. Trump said he had been busy, citing the Russia investigation and his impeachment trial. President Obama requested more funding for the stockpile, but his request was rejected by fiscal hawks in Congress. [Rebecca Ballhaus, Wall Street Journal, May 14, 20]

"an angry disgruntled employee who frankly according to some people didn’t do a very good job,” Trump told reporters. [Morgan Chalfant, The Hill, May 14, 20] Evidence? none offered, as usual, for "according to some people." Trump does it week and week out as he avoids showing competent evidence for his claims, such as suggested the coronavirus testing may be "overrated."

We got ours: tax cuts for corporations and the wealthy, bailouts of corporations and financiers. Now "we" can't afford to help the 36 million unemployed with more public debt. How long can the Trump base stand to get nothing for their loyalty?

Australia and China are openly sparring over China’s handling of the coronavirus epidemic, in a sign of how Beijing’s efforts to extend its global influence are backfiring even in places where it is an economic lifeline. [Wall Street Journal, May 14, 20] Lying and evasion can only go so far before the audience demands truth. But politicians and corporate executives seem to first try evasion and denial before being dragged into truth, usually by an alert press.

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Infinera down 255 [May 13, 20]

Capricor Therapeutics down 165 [my 13, 20]

Apellis Pharmaceuticals (Waltham, MA; no  SBIR)  a global biopharmaceutical company pioneering targeted C3 therapies, today announced that it had entered into subscription agreements with a number of institutional investors for a private placement of $300.0 million aggregate principal amount of 3.500% convertible senior notes due 2026  [company press release, May 7, 20]

Trump to visit medical distribution company in Pennsylvania, where he is pressuring the governor to reopen more quickly. [WashPo, May 14, 20] Damn the torpedos, full speed ahead. [Admiral Farragut, 1864] Trump undercuts his case by refusing to recognize and plan for the scientifically established dangerous realities. As if his will alone will cancel them.

Misplaced faith. The Abbott coronavirus test hailed by President Trump and used by the White House failed to detect infected samples in a large number of cases [25% false negatives] [Carolyn Y. Johnson and Steven Mufson, WashPo, May 13, 20]

McConnell’s claim that Obama left behind no ‘game plan’ for the coronavirus outbreak [is wrong] [Glenn Kessler, WashPo, May 13, 20] and irrelevant. Trump has had three years to fix any planning problem. Apparently he is fixated on the present and confident that he can fix any future problem when it happens. A truly magnificent president in his mirror.

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Novavax up 53% [May 12, 20] announced that the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $384 million of additional funding, on top of $4 million it invested in March, to advance clinical development of NVX-CoV2373, Novavax' coronavirus vacccine against CoVid-19. [company press release, May 11, 20]

Nanoviricides up 28% [May 12, 20] announced that it has developed drug candidates that have demonstrated very high anti-viral effectiveness in cell culture studies against multiple coronaviruses. [company press release, May 11, 20]

II-VI up 21% [May 12, 20] reported Record Bookings and Backlog

QurAlis (Cambridge, MA; $200K SBIR), a biotech company focused on developing precision therapeutics for amyotrophic lateral sclerosis (ALS) and other neurologic diseases,announnced the raise of a $42 million Series A financing, bringing the total funds raised to $50.5 million. [company press release, May 13, 20]

Day Zero Diagnostics (Boston, MA; $200K SBIR, founded 2016) an infectious disease diagnostics company using genome sequencing and machine learning to combat the rise of antibiotic-resistant infections, today announced it was awarded up to $6.2 million in non-dilutive funding [to]support the development of Day Zero’s diagnostic system that is intended to help physicians quickly and accurately diagnose and treat life-threatening bacterial infections. [company press release, May 11, 20]

Kriya Therapeutics (Palo Alto, CA and Research Triangle Park, NC; no SBIR, founded 2019) announced that it has raised $80.5 million in a Series A financing to fund the development of transformative gene therapies for highly prevalent serious diseases. ... focused on developing gene therapies for diseases affecting millions of patients, expanding the field of gene therapy beyond rare monogenic disorders. Kriya is targeting diseases where the underlying biology is well-understood, with the goal of rationally designing one-time gene therapies to durably express therapeutic proteins within the appropriate human tissues. [company press release, May 12, 20]

Bristol Myers Squibb and bluebird bio, announced that the companies received a Refusal to File letter from [FDA] regarding the Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March 2020. [companies press release, May 12, 20] With its Bristol Myers-partnered CAR-T therapy under FDA review, bluebird bio is getting a $200 million payout. The Big Pharma is forking over the cash to get out of future payments on the treatment outside the U.S. The duo retooled their deal to focus on the impending U.S. rollout of the anti-BCMA treatment, known as idecabtagene vicleucel (ide-cel) or bb2121, according to a statement. [Amirah Al Idrus, Fierce Biotech, May 11, 20]

AMAG Pharma Cuts 140 Jobs Amid Restructuring, COVID-19 Disruptions [xconomy.com, May 12, 20]

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MyoKardia (Brisbane, CA; no SBIR) up 59% [May 11, 20] announced positive topline data from the company's Phase 3 pivotal EXPLORER-HCM clinical trial of mavacamten for the treatment of patients with symptomatic, obstructive hypertrophic cardiomyopathy (HCM) (clinicaltrials.gov NCT03470545). [company press release, May 11, 20]

Quidel up 32% [May 11, 20]

Cytokinetics up 33% [May 11, 20]

Novavax up 31% [May 11, 20] announced that the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $384 million of additional funding, on top of $4 million it invested in March, to advance clinical development of NVX-CoV2373, Novavax' coronavirus vaccine candidate. [company press release, May 11, 20]

Macrogenics up 29% [May 11, 20]

Bellerophon Therapeutics up 19% [May 11, 20]

Everspin Technologies up 18% [May 11, 20]

BioCryst Pharmaceuticals up 18% [May 11, 20]

AVROBIO up 17% [May 11, 20]

Dicerna Pharma up 17% [May 11, 20]

Immunic up 16% [May 11, 20]

Fluidigm up 16% [May 11, 20]

Capricor Thera up 16% [May 11, 20]

Recro Pharma down 40% [May 11, 20] reported financial results

Moderna announced  that the Food and Drug Administration has given them fast-track designation, which is designed to expedite the development of treatments for life-threatening diseases, such as COVID-19. [The Hill, May 12, 20]

OraSure Technologies (Bethlehem, PA; one SBIR in 2012) has a $700 million federal contract to develop a saliva-based antigen test that could be performed at home. The company has antigen tests for other viruses — including HIV and Ebola — and those have accuracy rates of over 95%. Along with accuracy, the company is focused on speed, aiming to delivers results in 20 to 30 minutes. [AP, May 11. 20]

Years before the Covid-19 pandemic, the billionaire [Bill Gates] tried to warn global leaders of the threat from new infectious diseases. Few listened. ‘I feel terrible.’ [Betsy McCay, WSJ, May 11, 20] World's richest man, college dropout, donated tens of billions to his foundation to attack diseases ignored by rich-world nations.

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Protagonist Therapeutics (Newark, CA; $3.2M SBIR) up 84% [May 8, 20] announced initial data from the ongoing Phase 2 study of PTG-300 in patients with polycythemia vera. The current results demonstrate that treatment with PTG-300 at individualized doses ranging from 10 mg to 80 mg for up to 28 weeks provided dose-related control of hematocrit levels and eliminated the need for phlebotomy in all six out of six patients that received the dosing as per protocol. [company press release, May 7, 20]

Everspin Tech (Chandler AZ; $600K SBIR) up 52% [May 8, 20] announced unexpectedly higher revenue

BioCryst Pharma up 20% [May 8, 20] announced financial results

CytomX Thera up 16% [May 8, 20]

Quidel (San Diego, CA; one SBIR in 2004), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel has received Emergency Use Authorization (EUA) from [FDA] to market its Sofia® 2 SARS Antigen FIA, a rapid point-of-care test to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detection of SARS-CoV-2 in nasal or nasopharyngeal specimens from patients meeting the Centers for Disease Control and Prevention’s (CDC) criteria for suspected COVID-19 infection. [company press release, May 9, 20]

Boston Dynamics [Waltham, MA; $5.4M SBIR)’ Spot is patrolling a Singapore park to encourage social distancing. In a new pilot program, a remote operator will control Spot as it patrols around two miles of Singapore’s Bishan-Ang Mo Kio Park. A recorded message encourage social distancing will be broadcast from the robot. [Brian Heater, TechCrunch, May 8, 20] The park is a Lush 153-acre urban park along the banks of a former canal with lawns, walking tracks & playground. [park website] where the daily high is 88F in a stable well organized city-state island where hundreds of ships idle offshore awaiting their turn into the port.  

Nearly two weeks after the federal government relaunched its small-business aid program with an additional $310 billion, more than 40% of the money remains available. [Wall Street Journal, May 9, 20

On our own.  as we try to gauge the dangers, we’re pretty much on our own. The government has been a wildly inconsistent, if not wholly incompetent, counselor in these difficult moments. President Trump has both led the national response and encouraged insurrection against it, while extruding misinformation volcanically. Public health officials on the White House coronavirus task force are routinely forced to do misinformation control. The Centers for Disease Control and Prevention is a treasured institution filled with expertise, but it hasn’t held a news briefing since early March. Governors go their own way, as if entitled to their own epidemiological truths. [Joel Achenbach, WashPo, May 10, 20]

If only. “We’re going to do something very fast, and we’re going to have a phenomenal year next year.” The president predicted the virus eventually would disappear even without a vaccine — a prediction at odds with his own science officials. [Josh Dawsey, Ashley Parker, Philip Rucker and Yasmeen Abutaleb, WashPo, May 10, 20]

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Fluidigm up 18% [May 7, 20]

Macrogenics down 18% [May 7, 20]

Moderna announced that [FDA] had cleared its application to proceed to a clinical trial involving about 600 people. The main goal of this set of tests is to find out if the vaccine is safe and if positive results from the first few dozen volunteers in the first phase can be replicated in a much larger group. [Knvul Sheikh, NY Times, May 8, 20]

PTC Therapeutics (SOUTH PLAINFIELD, N.J; $6M SBIR) announced that it has entered into an agreement to acquire Censa Pharmaceuticals (WELLESLEY, MA; no SBIR), a biopharmaceutical company focused on the development of CNSA-001 (sepiapterin), a clinical-stage investigational therapy for orphan metabolic diseases, including phenylketonuria (PKU) and other diseases associated with defects in the tetrahydrobiopterin (BH4) biochemical pathways diagnosed at birth. PTC will pay an upfront consideration of approximately $10 million in cash and up to 850,000 shares of PTC common stock. In addition to the upfront payments, potential future consideration includes $217.5 million in development and regulatory milestones for the two most advanced programs and receipt of a priority review voucher, including $30 million to be paid in either cash or PTC common stock at our option for completing the enrollment of a Phase 3 clinical trial for CNSA-001 for PKU, $109 million in development and regulatory milestones for each additional indication of CNSA-001, net sales milestones up to an aggregate amount of $160 million and a contingent value payment of a percentage of annual net sales ranging from single to low double digits. [PTC press release, May 6, 20]

Defense Logistics Agency has awarded Intuitive Surgical a potential five-year, $420M contract to provide surgical robots and related equipment to service branches and federal civilian agencies. [Brenda Marie Rivers, govexec.com, May 8, 20]

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Macrogenics up 231% [May 6,20] the biotech company's management said it remains on track to report final overall survival (OS) data for the phase 3 SOPHIA study of margetuximab in HER2-positive metastatic breast cancer this year. If the data is solid, MacroGenics believes it could get a Food and Drug Administration decision as soon as December 2020. [Motley Fool, May 6, 20]

Ventus Therapeutics (Waltham, MA; no SBIR) announced a $60 million Series A financing .. to advance three pipeline programs and to expand the company’s structural immunology platform to pursue previously intractable drug targets. [company press release, May 6, 20]

Admin shelves CDC guide to reopening country [JASON DEAREN and MIKE STOBBE AP, May 7, 20] as Fears of ‘second wave’ hang over coronavirus successes [JILL LAWLESS, ELAINE KURTENBACH and CARLA K. JOHNSON, AP, May 7, 2020] Don't let our experts tell them how, let them guess, so we can blame them when it goes wrong?

A man of money, not of people. The president’s cure-can’t-be-worse-than-the-disease logic is clear: As bad as the virus may be, the cost of the virtual national lockdown has grown too high. [Peter Baker, NYTimes, May 7, 20] Fortunetely on the at question, he is only an advisor to states and cities, since he punted on being a supply source. After all, his base includes a lot of money he has already paid off with a new tax law. Interestingly to limit the bad news of more eaths and illness he advocates less testing which correlates with his lackluster support of helping tates with a huge expanse of testing. If you don't want the answer, don't ask the question. A major barrier to agreement is that no one wants to tackle the controversial question of the monetary value of a human life.

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