CARES Act Summary - Key Provisions for Small Biotech Companies

Earlier this week we tuned into the BIO Coronavirus Collaboration Initiative Summit. Here, we translated our notes into a quick read. 

For starters, Ambassador Deborah Birx, MD, Coronavirus Response Coordinator for the White House Coronavirus Task Force, made it clear that her expectations were high for our industry… “because you have delivered for us in the past.” 

Key take-a-ways and resources for #ALBioTech:

• Dr. Richard Whitley, Co-Division Director of Pediatric Infectious Diseases at UAB, represented Alabama among a national roster of presenters. He spoke about the biology of the virus, symptoms, and the incubation period. Dr. Whitley stressed that the shortness of breath experienced is a key differentiator of COVID19 between the flu, common cold, and allergies. 

• Domestic manufacturing capacity: Dr. Rick Bright, Deputy Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority (BARDA), stressed the importance of mobilizing the industry to be able to scale up, scale out, fill-finish, and create redundancies with raw material supply chains by “leveraging existing partnerships and forging new partnerships.” Please help share the word among #ALBioTech manufacturers that we need them. They can register online at hub.bio.org to communicate what resources they have available and how they can contribute to the fight.

• Request a meeting with a federal agency: The U.S. Government has provided a portal for the submission of market research packages and meeting requests strictly related to COVID-19. They are particularly interested in products and technologies that have progressed into or beyond non-clinical trials, have established large-scale cGMP manufacturing capability, or utilize an approved platform. Information regarding diagnostics, therapeutics, vaccines, and other products or technologies relevant to addressing this outbreak are sought. Please visit: https://medicalcountermeasures.gov/ to learn more. Due to the volume of requests, they ask that all submissions go through the portal. Please do not email individual agencies. 

BIO Coronavirus Hub: BIO has created a Coronavirus Hub to coordinate the connection of companies with resources needed. hub.bio.org is a new platform for companies to post what information and supplies they need and what they can share, from RNA kits to pipette tips to general information and guidance. The goal is to maximize the efficiency of all of our companies to make sure we have the tools, the resources, and the capacities we need to win this war against the coronavirus. We encourage you to register on the site to have access to real-time updates.

SBA Disaster Loans: In addition to “all hands on deck” regarding research, supplies, and resources. Further resources are available from the Alabama SBDC Network including assistance with SBA Disaster Loan application process. The SBDC Capital Access team, and all of our SBDC locations statewide are prepared to help businesses with the application process and any other Covid-19 related issues. Due to extremely high call volume, they are asking companies to register online at ASBDC.org/register, to help ensure that you are directed to the next available SBDC Business Advisor.

Let's share joy and encouragement: There are positive and meaningful stories to share amidst this public health crisis. We encourage you to send us your stories to share and offer encouragement to our peers and colleagues around the state and beyond. Send your story to sonia@bioalabama.com. 

Washington, DC (March 12, 2020) – The Securities and Exchange Commission (SEC) has adopted regulatory changes to provide small public companies with a temporary exemption from Sarbanes-Oxley 404(b) compliance. 404(b) requires public companies to report on the internal controls they have in place over their financial reporting. While well-intended, this regulatory requirement has proven to reduce market capitalizations, increase audit fees, force companies to exit public markets, and reduce R&D investments in pre-revenue startups that result in fewer inventions. 

“Biotech companies across the country conduct their research without the certainty of a return on their investment, so they highly value resource efficiency,” said Jim Greenwood, BIO’s President and CEO. “Cost burdens like 404(b) can slow a company’s progress in the lab and lengthen the amount of time it takes to deliver treatments for patients in need. I applaud the SEC for adopting a commonsense approach to ensuring less capital is going into unnecessary compliance and instead into lifesaving science.” 

Under the amendment, small public companies with public float of less than $700 million that have annual revenues of less than $100 million would be exempt from the 404(b) requirements. This regulatory obligation has been a longstanding burden for small biotechnology companies because of its extraordinary expense, their pre-revenue status, and the fact that it is of little use to their investors. 

A similar proposal to the one adopted today was championed by Senators Kyrsten Sinema and Thom Tillis and Representatives Trey Hollingsworth and Ben McAdams. Together, they have sponsored the Fostering Innovation Act (S. 452, H.R. 3886), a bipartisan bill that would provide for a 5-year extension of 404(b) exemption for qualifying public companies included in the 2012 JOBS Act. 

Background

BIO, along with other industry voices, has long advocated for providing small biotech startups relief from costly 404(b) compliance regulations. 

• In 2012, BIO supported the passage of the JOBS Act. BIO has also long supported the Fostering Innovation Act, which has been introduced in every Congress since 2012. 
   
• The SEC Government Business Forum on Small Business Capital Formation has recommended for expanded exemptions from 404(b) every year since 2008, and several comments on past SEC actions, including SEC’s SRC proposed rules in 2017 also recommended expanding the Section 404(b) exemption.   
   
• In 2018, a broad coalition of organizations included expanding the section 404(b) exemption for low-revenue companies as part of its recommendations to help companies go and stay public.
   
• In 2019, economists Craig Lewis and Joshua White released a study, Science or Compliance: Will Section 404(b) Compliance Impede Innovation by Emerging Growth Companies in the Biotech Industry?, which pointed to mounting evidence that 404(b) compliance was overly burdensome and costly. 
   
• In 2019, BIO submitted comments to the SEC in strong support of the proposed amendments. BIO was joined by a chorus of other comments in support of the proposal, including more than 20 individual biotech companies, and more than a dozen other trade associations and interest groups who all supported the proposal.
   

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Yuva Biosciences, Inc. is seeking an exceptional drug discovery scientist to drive the development and incorporation of new approaches to test candidate agents to enhance mitochondrial function. Research scientist will be responsible for designing, developing, and executing in vivo assays in mice to support progression, optimization, and mechanism of action of mitochondrial therapeutics. This is a Yuva Bio sponsored position in the laboratory of Keshav K. Singh, Ph.D., (Company's Scientific Founder and Chief Scientific Advisor) at University of Alabama at Birmingham. Yuva Biosciences is headquartered in Birmingham, Alabama.

Prior experience in the mitochondrial biology and genetics field is a plus. The candidate must work well in a growing organization, make clear decisions in a fast-paced drug discovery environment and be highly proficient in both verbal and written communication. Independently performs scientific experiments with a predefined goal, including developing new strategies.

Qualifications

• Ph.D. in Pharmacology, Molecular Biology, Cell Biology or related field with minimum 2 to 3 years post-doctoral experience or industry experience

• Experience and demonstrated excellence in early phase drug discovery, target identification, and validation and project team leadership.

• Strong strategic scientific and technical leadership in the design, execution, analysis, and interpretation of a broad range of mitochondrial assays to drive identification of compounds leading to progression and elucidation of the mechanism of action.

• Experience in preparing clear technical reports, publications, and oral presentations: independently communicating results; presenting clearly and effectively and defending own work at internal & external meetings; delivering updates to management in the context of overall project goals. Keeps abreast of relevant literature relevant to research projects and competitive landscape.

• Understanding of classical pharmacological principles and drug discovery process, in order to support an assessment of potency, efficacy and contribute to predictions of human efficacy

• Ability to critically analyze and interpret data and effectively document and communicate results
  
  
• Has a demonstrated ability to apply a variety of state-of-the-art biochemical and genetic methods related to cell proliferation, apoptosis, cytotoxicity, and molecular pathways related to therapeutic agents.

• Has solid hands-on experience in handling mice and basic cell culture / genetic manipulation techniques as well as molecular and cell biology approaches.

• Strong working knowledge of computer software including Excel and PowerPoint and additional scientific analysis software including Prizm GraphPad, SpotFire, XL-Fit or comparable scientific data applications.

Additional/Preferred Qualifications

• Experience in mitochondrial assays including biochemical and cell-based assays
• Experience in development of innovative translational in vitro and/or in vivo models that predict human efficacy

 About Yuva Biosciences

Yuva Biosciences is an anti-aging company harnessing the cutting edge of mitochondrial science to develop cosmeceuticals as well as pharmaceuticals targeted at aging-related hair loss, wrinkled skin, and reduced energy. The Company's Scientific Founder and Chief Scientific Advisor, Keshav K. Singh, Ph.D., is a world leader in the field of mitochondrial biology and genetics and its role in health, disease, and aging. Dr. Singh is the Joy and Bill Harbert Endowed Chair and Director of Cancer Genetics at the University of Alabama at Birmingham and the founding editor-in-chief of the Mitochondrion journal published by Elsevier. Yuva Biosciences is headquartered in Birmingham, Alabama.

Apply online at http://yuvabio.com/careers.php

Alabama-based Acclinate Genetics Partners with the National HBCU Speech & Debate Association to Tackle Health Disparity Among Minorities

Speech and debate is a skill, one studies and practices much like that of a sports athlete. The mental and emotional endurance required for students participating in a national speech & debate championship rivals that of athletes on the field. Their competitive advantage - words. Pair that with a meaningful problem worth solving and a movement begins.

A movement, that is what Acclinate Genetics is creating through their efforts to include, engage, and educate minorities on the serious topic of health disparities. An issue debated at the National HBCU Speech and Debate Championship held February 28-March 1, 2020 at Prairie View A&M University in Prairie View, Texas.

“Partnering with the National HBCU Speech & Debate Association amplifies our voice,” said Tiffany Jordan, Director of Strategic Partnerships at Acclinate Genetics. “It empowers minority students who are passionate about impacting change to vocalize the importance of having conversations regarding difficult topics but to also present solutions to problems worth solving.”

The National HBCU Speech and Debate Association is primarily funded by the Charles Koch Foundation.  The 2020 national competition attracted over 150 students, with over 350 entries.

“Speech and debate challenges students to analyze issues from various perspectives, create  solutions, passionately advocate their positions, and leverage their skills of persuasion to influence  others,” said Executive Director, Christopher Medina. “ Our students are presented with difficult  topics and the topic of health disparities is extremely relevant and poignant, given the global rise of precision medicine.”

Recently the FDA and NIH have focused their attention on the importance of diversifying clinical trials and genomic research. Acclinate Genetics is prepared to deliver educated,

minority clinical trial participants who have historically been left out. Yet, the solution to this problem goes beyond technology and policy that demands diverse representation.

“To be included in the conversation around the efficacy of medications, the process to engage in a clinical trial, and the future health of our country and world is a trust problem, “ adds Jordan. “To be invited to the table and heard is so important. As a minority-owned small business founded in Alabama, a state with a difficult past in regards to clinical trials, we are ready to change the narrative.”

The partnership between Acclinate and the National HBCU Speech & Debate Association is planned to grow and expand and include other minority-serving institutions including Latino, Tribal, and Asian American associations. Together they will expand the historic tradition of HBCU exceptionalism and societal equity through speech and debate excellence, free speech, and civic engagement.

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Contact Information:

Tiffany Jordan, Director of Strategic Partnerships

tiffany@acclinategenetics.com

256-322-2387

About Acclincate Genetics: Acclinate Genetics helps biopharmaceutical companies and contract research organizations achieve the most representative research sample by expanding their genomic studies and clinical trials to include diverse ethnic groups. Their Enhanced Diversity in Clinical Trials (e-DICT) is a HIPPA compliant platform that utilizes artificial intelligence, machine learning, and predictive analytics to automate the identification, education, engagement, and retention of willing & diverse clinical trial participants. The result is a ready supply of willing, educated, and diverse participants for genomic research and clinical trials. Their unique system helps decrease the overall cost of drug development and increase the speed of FDA approval. Learn more at acclinategenetics.com. Connect on LinkedIn.

About National HBCU Speech & Debate Association: The National HBCU Speech and Debate Association is committed to providing students and educators, at Historically Black Colleges and Universities the skills and training necessary for leadership development in traditional and emerging career fields; positioning them for personal and professional excellence. The Association prepares students for professional/graduate level education through enhancement of research, analytical, organizational, and critical thinking skills; increasing appreciation for the arts, global awareness; and the communication of current events, literature, and creative thought, through performance and free speech.

By William Thornton | wthornton@al.com

Two companies took home a combined $150,000 Thursday in the finale pitch competition for Alabama Launchpad in Montgomery.

Huntsville-based Acclinate Genetics won $50,000 in the concept stage, while Birmingham’s CerFlux took the $100,000 seed stage prize. Both companies gave their pitch before a four-judge panel.

Acclinate Genetics is working to increase the diversity of participants in clinical trials. Company founder Del Smith created Acclinate to address the lack of minority participation, which results in problems in drug efficacy for minority populations. The company also looks to capitalize on the FDA’s current national focus on the issue.

CerFlux offers personalized medicine solutions to identify the most effective cancer therapeutics for patients. CerFlux had previously won the concept stage prize during Alabama Launchpad in 2019. CEO Karim Budhwani is a visiting scientist at UAB.

Alabama Launchpad, a program of the Economic Development Partnership of Alabama, is the state’s most active early seed funding source. To date, it has funded 92 startups, invested $5.5 million with a post money valuation of more than $325 million.

“It’s wonderful to see two life sciences companies win Alabama Launchpad,” EDPA President Steve Spencer. “It’s a strong indicator of the strength of this growing industry in the state, and all of the finalists competing exemplify Alabama’s diverse vertical sectors.”

Originally published by AL.com.

Their mission is clear, diversify clinical trials and genetic research by engaging the very population that needs to be represented - people of color. Yet, Acclinate Genetics has found itself in a business world where diversity among entrepreneurs, diversity among ventured backed entrepreneurs, is limited, too. 

Previous reports from the National Bureau of Economic Research reveals that minority entrepreneurs represented just 20% of entrepreneurs funded by venture capital. Not to mention that loan denial rates have been reported to be higher for minority entrepreneurs. 

As an Alabama Launchpad finalist, Acclinate Genetics mission is amplified. 

“These are new conversations around a real problem, health disparities among minorities. We have presented our ‘how’ and it’s very different from the way things have traditionally been done,” said Del Smith,PhD, CEO of Acclinate Genetics. “We have a big vision and it involves impacting a lot of communities and a lot of lives.”

When it comes to impacting lives, Smith takes it a step further. He serves as a role model for minority students, too. His tenure as the Dean of the Business School at Alabama Agricultural and Mechanical University, a historical black college and university (HBCU), takes his story to another level.

“There’s an overwhelming sense of responsibility to my students to show them that they can be successful entrepreneurs,” Smith said. “Part of that involved role modeling what that looks like. It takes drive, grit, and determination. I want my students to know that there are many paths to success and sometimes you will take two paths during the same season of your life. Having dual careers may allow you to have an even greater impact on the world,” Smith adds.

Smith and his team will present their final Alabama Launchpad pitch February 27, 2020 at The Warehouse at Alley Station located at 130 commerce street, Montgomery, Alabama 36104. Event details can be found online here.

“Regardless of the outcome, being an Alabama Launchpad finalist provides an opportunity to share our vision more broadly,” said Smith. “This is an opportunity for an Alabama-based company to tackle a tough subject regarding health disparity among minorities. We take that responsibility very seriously.” 

Download full release here.

BIO Alabama among twenty-three states participating in national survey

BIO Alabama is seeking participation from life sciences human resource leaders & hiring managers in the 2020 National Life Sciences Hiring & Compensation Survey, which we are producing in collaboration with the Coalition of State Bioscience Institutes and Gallagher Surveys. 

With hundreds of positions broken out by research specialty, region, size and other factors, the survey will be a premier source of detailed compensation, hiring and HR policy data for life science organizations across the country. 

The survey consists of two distinct parts: 

1. A short online workforce development survey that seeks to identify the most pressing talent needs of the life sciences industry. The workforce trends report is used by legislators, academic institutions, and HR representatives seeking to develop the industry’s workforce, and will be released at the BIO International Convention in San Diego in June. All participants will receive a complimentary report.  

2. An optional compensation survey for the life sciences industry, which will be made available to participants at very low cost (between $400-800 based on company size) later this year. The survey is designed to make participation simple with flexible data submission options.  The compensation report will be made available to survey participants only.

Please click here to complete the survey by no later than March 13, 2020.

Thank you for providing this important information for Alabama’s life science industry.  

A program of the Economic Development Partnership of Alabama (EDPA), the Launchpad final will take place at the Warehouse at Alley Station in Montgomery. For more information, click here.

Alabama Launchpad has finalists in two stages of its competition: concept stage, for companies usually pre-revenue, and early seed stage, for companies looking to accelerate growth.

The companies competing in the concept stage for $50,000 are:

•  Acclinate Genetics, a company addressing the lack of diversity in clinical drug trials.
• Pure Game Sports Network, a sports media and marketing company created for high school athletic departments and fans.
• Smart Solutions, assistive technology allowing more living independence for persons with disabilities.

The companies in the early seed stage, which will be competing for $100,000, are:

• Buolo Solutions, a company connecting professional women to talent-seeking companies with flexible jobs.
• CerFlux, a cancer-fighting company creating personalized medicine solutions to identify the best and most effective cancer therapeutics.
• MOXIE, producing custom-designed Internet of Things solutions for clients within 30 days.

Alabama Launchpad is the state’s most active early seed funding source and, to date, has funded 90 startups, investing $5.3 million in companies with a post money valuation of more than $325 million.

“Alabama Launchpad is here to serve early stage companies all over Alabama, and we look forward to seeing these finalists compete onstage in our state’s capital," EDPA President Steve Spencer said.

Original article from AL.com

Alabama is recognized as a growing hub for biotechnology, drug discovery, medical devices, agriculture and chemicals, and other life sciences. To demystify the biotech startup process, BIO Alabama has organized a morning of informational presentations with highly experienced speakers who offer insight to facilitate successful startup ventures.

Events Details:

Date: Tuesday, November 19, 2019

Time: 8:30 a.m. - Noon

Location: The Fuse Factory 200 Government St 4th Floor, Mobile, AL 36602 

Cost: $10 / FREE for students

Register online

Speaker Line-Up:

"Federal funding is available — how to win it"

Andrew  Byrd, MBA, PhD
Director, University of South Alabama Office of Commercialization and Industry Collaboration (OCIC) 

Dr. Byrd joined the OCIC after receiving his PhD in Basic Medical Sciences from USA College of Medicine. A native of Mobile, AL, Dr. Byrd has been affiliated with USA for almost two decades. Dr. Byrd’s involvement in USA technology transfer is pervasive, from technology scouting, invention disclosure and due diligence assessment, through patent strategy and licensing negotiations, including those for the USA Foundation for Research and Commercialization. Dr. Byrd is also an inventor on two patent pending technologies.

"Your ideas have value - how to protect them"

Nick Landau PhD, Partner & Registered Patent Attorney, Bradley Arant Boult Cummings

Nick Landau works with individuals, universities, startups, growing businesses, and publicly traded companies to procure, protect and litigate all forms of intellectual property, including patents, trademarks, and trade secrets. He combines his research background in microbiology with his training in law to strategically serve life science companies.

“Startup accounting & finance - why the numbers matter”

Phillip Rivers, CPA, Warren Averett

Phillip leads the Warren Averett Mobile office and has more than 18 years of accounting experience in a wide range of industries including real estate, healthcare, financial services, manufacturing, and transportation. He is a Member of the Firm, and Joined Warren Averett in July 2012 after previously spending over 11 years with a Big 4 firm. Phillip specializes in handling complex accounting and auditing matters for his clients. Services he provides include internal control reviews, due diligence, debt issuances as well as assistance with mergers and acquisitions and spinoffs. Phillip resides in Spanish Fort with his wife and three children.

"Investors are out there - how to find the right ones"

Kenneth Dale Speetjens , Co-Founder & CEO of Shipshape Urban Farms

Dale began his career by serving in the United States Armed Forces.  After leaving the military he began his studies at Auburn University. After graduation, Dale joined Mobile's Bloomberg Innovation Team. Now, Dale is the Co-Founder and CEO of Shipshape Urban Farms, an agritech company focused on the design, manufacturing, and operation of hydroponic farms built inside up-cycled shipping containers.  

“Tapping into local resources for startups, trade, and contracting”

Melvin Washington, Regional Director of the Small Business Development Center at the University of South Alabama

Mel Washington provides one on one confidential counseling to entrepreneurs and small businesses in six counties in South Alabama. He is the former Executive Director & CEO of Project Enterprise, a micro-lending organization supporting entrepreneurs and small businesses in under-resourced communities in New York City. Mel has held executive level positions in Finance, Operations, and Strategy and Planning in the financial services and telecommunications sectors.  His career includes successful stints at top tier firms including AT&T, Salomon Brothers, Morgan Stanley, JP Morgan Chase, and Citibank.