What is the critical gap in (cancer treatment) antibiotic treatments that you are addressing?

In the last several decades there has been significant progress in treatments for cancers of all types. Patient life expectancies have increased, some cancer types are now easily treatable, and adverse treatment effects have improved. However, these life-saving advances, and patients’ successful outcomes, are now seriously threatened by the alarming increase in deadly infections caused by antibiotic-resistant ‘superbugs’, such as MRSA (methicillin-resistant Staphylococcus aureus). All forms of cancer treatments result in patients decreased immune functions, making them more susceptible to infections, particularly those caused by ‘superbugs’ which are resistant to the most powerful antibiotics. As a result, an increasing number of patients are surviving cancer but dying from these infections. The use of the most advanced treatments is difficult for physicians to justify if they result in patients’ death due to untreatable infections, a terrible dilemma.

In a recent survey of 100 U.K. cancer physicians, 95% expressed concern about the effects that ‘superbugs’ are having on their patients’ treatments and 46% believe chemotherapy will become futile in the near future due to antibiotic-resistant infections. More generally, changes in American lifestyles, with increases in diseases such as diabetes, and a large senior generation, make many others with lower immunity vulnerable to these infections as well. In the U.S. and globally, ‘superbug’ infections are increasing annually at pandemic rates. The Centers for Disease Control and Prevention estimates more than 2.8 million antibiotic-resistant infections in the U.S. each year, of which more than 35,000 people die (the World Economic Forum’s current estimate is closer to 100,000), and both numbers continue to rise annually.

Globally, 700,000 deaths due to these infections annually is likely a low estimate with experts predicting 10,000,000 antibiotic-resistant deaths by 2050, more than the 8,200,000 global cancer deaths currently. Experts urge immediate action to prevent the further loss of critical, life-saving cancer treatments due to the spreading antibiotic-resistant infection pandemic.

What is the key product development milestone you seek to fund?

Mētis’s team of expert scientists, each with over 25 years of experience in the anti-infectives and drug discovery fields, has developed a unique, novel approach to the treatment of antibiotic-resistant infections. Current antibiotic strategies indiscriminately kill bacteria to prevent infections, resulting in the loss of beneficial digestive organisms which can cause intestinal problems, also allowing infections by yeast and other microorganisms to thrive, and most significantly, driving pathogen survival through increased antibiotic-resistance.

Our novel Antibiotic Program is a significant paradigm shift in which novel compounds inhibit the pathogen communication processes required for ‘superbugs’ to become virulent, establish infections, and cause untreatable diseases in humans and also kills them under the abnormal stress conditions encountered during the infectious process while not harming beneficial microbiome organisms. Because the killing pressure of our compounds is discriminate, only eliminating pathogens engaged in the process of becoming infectious, gut health is maintained, other opportunistic infections are reduced, and the drive to develop antibiotic resistance is eliminated.

Our program is in the early stages of development with key milestones structured to move it forward quickly and efficiently. Initial data demonstrate that our compounds kill a variety of ‘superbugs’ and suggest that they do not have harmful side-effects like many current antibiotics, in part because the target is not present in humans. To be considered sufficiently effective and safe for use in human clinical trials, studies must first be conducted to understand how our novel compounds can best be used.

Our immediate barrier to progress, and the first key milestone we seek to fund from this campaign is the routine synthesis of our new compounds in an approved chemical laboratory. This will then allow us to pursue subsequent milestones to further optimize the compounds through our own research efforts and already established and other partnerships and collaborations with the goal of selecting the most promising compounds for use in the clinic. The development path for our novel antibiotics is straight-forward and initial Music Beats Cancer funding moves us down that path. Our program provides new hope to cancer and other patients threatened by the ‘superbug’ pandemic of antibiotic-resistance and will also provide valuable insights to guide thinking on other new approaches to disease treatments generally.

How will the funds be used? Please provide breakdown of major budget items.

Our team of science experts, business and legal advisors, and resource support specialists have a detailed timeline strategy to achieve our successive program milestones and reach the ultimate goal of providing effective and safe new antibiotics for cancer and other patients. Although our program is based on novel antibiotic technology with a new target and new compounds unlike any existing antibiotics, the development path follows the standard process to approval for clinical trials. Mētis’s immediate development milestone is the routine synthesis of our small molecule compounds in an approved chemical laboratory, followed by further successive milestones with antibiotic development assays towards the principal goal of identifying the most promising candidates. As successive milestones are achieved, intellectual property assets will be expanded and protected. Funding from this Music Beats Cancer campaign will be used to execute these prioritized budget tasks:

1. Synthesize current lead and related compounds $65,000
2. Structure Activity Relationship (SAR) experiments $60,000
3. Optimization 1.0 of selected structures $60,000
4. Optimization 2.0 of selected structures $75,000
5. Scale-up synthesis of required candidates $70,000
6. Primary in vitro screening panel (in parallel with #2, 3, 4) $20,000
7. Intellectual property determination and filing $75,000

Total:                  $425,000

Some of these tasks can be performed in parallel as noted, others must be done sequentially. As results from early work will inform decisions on later studies, budgets for item #6 and subsequent laboratory and other work may be revised. The science tasks will be conducted in-house at our research facility, by pharma/biotech contract research organizations, and through development collaborations and partnerships under the direction of our science team with guidance from the expert advisory group. Following completion of these immediate tasks, selected compounds will undergo further expanded antibiotic development assessments for efficacy as well as toxicology and safety prior to entering human clinical trials.

What key resources have/will you acquire to facilitate the accomplishment of the above product development milestone? (i.e. current funding sources, strategic partnerships, talent, infrastructure)

As an early stage biopharmaceutical company with unique technology to treat antibiotic-resistant infections, Mētis faces challenges to progress on various fronts. To meet milestones and larger goals, the team must be knowledgeable, experienced, and especially passionate about our mission to provide effective and safe new antibiotics for cancer and other patients. The development of drugs, including antibiotics, also requires very specific scientific expertise and resources as well as business and legal leadership. The Mētis team possesses these capabilities and capacities.

We recently underwent an extensive 12-week review of our science program, management and science teams, business status, and intellectual property position by 10 biotech/pharma industry experts through an entrepreneur program at the California Life Sciences Institute. The review determined that our technology is based on sound science, the science team is fully adequate with the required expertise to execute the program, and the management team and legal counsel are also fully capable of accomplishing the short-term and projected business goals. The review team concluded that the only missing component is initial funding to begin advancing the science program. One of these review experts, the serial CEO of very successful biopharmaceutical companies, was sufficiently impressed to join our team as an advisor, together with two other long-time expert advisors.

A Mētis Board of Directors member is also a successful serial life science entrepreneur and currently holds either CEO, Managing Partner, or President positions at three companies, one of which will provide us with a wide range of science and business support resources as we move forward. Mētis also recently joined the Tech Futures Group, an entrepreneur mentoring/advisory program of the Small Business Development Network.

We have connected with other antibiotic development companies, government agencies, and private research groups to foster partnerships or collaborations, and have a letter of interest from a well-funded company for a future business relationship. We continue to apply for significant funding from governmental and international agencies which recognize the critical importance of developing new antibiotics to treat ‘superbug’ infections. Mētis understands the challenges of the current antibiotic space and is prepared, and continues to prepare, to successfully address those commercialization hurdles.

If successful, how would you leverage funds raised through our portal to access key funding from other sources, (i.e. matching grants, investments).

Music Beats Cancer funding will be used immediately and efficiently to overcome immediate Antibiotic Program hurdles and achieve successive milestones. The move from early-stage to mid-stage development, referred to as the ‘Valley of Death’, can be a challenging transition in which many companies disappear. The development of new antibiotics to treat deadly, drug-resistant ‘superbug’ infections requires not only substantially new effective technology and an expert team but also financial resources necessary throughout the program to achieve the timeline goals necessary for success.

While Mētis has the required scientific and management expertise to execute its unique program, it must successfully navigate shifting sources of antibiotic funding at each stage to ensure that sufficient financial resources are on-hand throughout the development process. The funds raised through the Sounds Affects campaign will be used to achieve the immediate and successive milestones and at the same time to compete for additional funds to further advance the program.

The best opportunities to do this currently are offered by public agencies such as the National Institute of Allergy and Infectious Diseases, the Small Business Administration’s SBIR Program, and the National Science Foundation, private foundations such as the Bill & Melinda Gates Foundation, and dedicated consortiums such as CARB-X, a global nonprofit partnership dedicated to accelerating the development of novel antibiotics to address the emergence of drug-resistant ‘superbugs’. To be competitive for these and other funding opportunities, Mētis must have operating capital to execute the immediate and successive science tasks described above.

Obtaining additional data to better explain how our technology works as well as demonstrate its effectiveness is critical at this development stage. These advances will also further de-risk program concerns for investment capital. The Music Beats Cancer campaign funds raised will allow us to address these needs and greatly increase our likelihood of submitting successful applications to obtain follow-on funding.

If your Technology were to disappear in the ‘Valley of Death’ funding bottleneck how might this impact society?

The need for new antibiotics to treat antibiotic-resistant ‘superbug’ infections in cancer and other patients is critical. More generally in the U.S. population, changes in lifestyles, with increases in diseases such as diabetes, and a large senior generation, make many others with lower immunities vulnerable to these infections as well. An expert report predicts that, at the current rate, by 2050 there will 10,000,000 antibiotic-resistant deaths globally as this pandemic ravages the world. Major health agencies, including the World Health Organization, the Centers for Disease Control and Prevention, the National Institutes of Health, and others all recognize the antibiotic-resistance pandemic as a top priority global healthcare crisis.

Current antibiotics are no longer effective. All new antibiotics over the last 40 years, since the last antibiotic target was identified, have become ineffective due to the development of resistance against them and all were directed against conventional targets.

Mētis’ antibiotic program is a novel approach with a new infection target and new compounds to disrupt it that could dramatically provide new, effective, and safe therapies to treat ‘superbug’ infections while maintaining gut microbiome health. Our solution to this crisis is based on fundamental science and is unique, no one else is developing it.

The consequences to society and the world if Mētis’s Antibiotic Program disappears in the funding ‘Valley of Death’ could be severe and costly. The huge loss of lives, cancer patients and others, from this pandemic would have significant impacts on society and the global economic toll could be a devastating $100 trillion by 2050, about 10-times that of COVID-19. Cancer patients and others have greatly benefitted from medical science innovations. Now they need innovative new antibiotics to continue to receive the best cancer treatments available.

Our Antibiotic Program is early stage but has the potential to dramatically affect their outcomes and survival. Cancer patients, and the world, need a solution to this crisis. With no relief in sight from the antibiotic-resistant ‘superbug’ pandemic, please support Mētis’s efforts to address this critical unmet global healthcare need and save the lives of cancer and other patients.