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|Item 7.01|| |
Regulation FD Disclosure.
On November 18, 2021, Better Therapeutics, Inc. (the “Company”) issued a press release entitled “Better Therapeutics Completes Enrollment of Pivotal Trial for BT-001, a Prescription Digital Therapeutic for Type 2 Diabetes.” A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
On November 18, 2021, the Company expects to present an updated Company presentation to certain parties. A copy of the presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference.
The information contained in Item 7.01 of this Current Report on Form 8-K and the Exhibits 99.1 and 99.2 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
|Item 9.01|| |
Financial Statements and Exhibits.
(d) Exhibits. The exhibits shall be deemed to be filed or furnished, depending on the relevant item requiring such exhibit, in accordance with the provisions of Item 601 of Regulation S-K (17 CFR 229.601) and Instruction B.2 to this form.
|99.1||Press release issued November 18, 2021|
|99.2||Company Presentation dated November 2021|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document)|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|Better Therapeutics, Inc.|
|Dated: November 18, 2021||By:|| |
/s/ Mark Heinen
|Title:||Chief Financial Officer|
Better Therapeutics Completes Enrollment of Pivotal Trial for BT-001,
a Prescription Digital Therapeutic for Type 2 Diabetes
Primary endpoint data expected in Q1 2022
SAN FRANCISCO, November 18, 2021 Better Therapeutics, Inc. (Better Therapeutics; NASDAQ: BTTX), a prescription digital therapeutics company developing cognitive behavioral therapy to address the root causes of cardiometabolic diseases, today announced the completion of patient enrollment in its potentially pivotal study to evaluate the safety and efficacy of BT-001 for the treatment of type 2 diabetes.
BT-001 is being developed as an FDA-regulated, prescription digital therapeutic that delivers a novel form of cognitive behavioral therapy to patients with uncontrolled type 2 diabetes. The study exceeded its target, enrolling 662 patients from California, Illinois, Florida, Georgia, New York, and Texas.
We are deeply thankful to our study participants, investigators and partners for their dedication to this study. With their help, we now can demonstrate that use of BT-001 can meaningfully improve upon the Standard of Care, said Mark Berman, M.D., chief medical officer of Better Therapeutics. With roughly half of all patients living with type 2 diabetes not reaching treatment goals despite use of medications, the need for a novel treatment approach is urgent. We see tremendous potential for the development of prescription digital therapeutics, such as BT-001, to improve treatment outcomes without adding to the burden of drug-related side-effects.
If positive, study results may support a regulatory submission for marketing authorization from the U.S. Food & Drug Administration (FDA). Exploratory endpoint data captured during this study, including change in insulin resistance, blood lipids, inflammation, blood pressure and weight, could accelerate the development of Better Therapeutics product candidates to treat other cardiometabolic conditions.
Better Therapeutics is also conducting a real-world evidence study with Mass General Brigham, Colorado Prevention Center and Catalyst Health Network to evaluate the long-term effectiveness and healthcare utilization changes associated with the use of BT-001. It is expected that primary care providers will prescribe, and insurers will reimburse the companys therapeutics much like they would a traditional medication.
The Better Therapeutics platform blends clinical, behavioral, and psychological inputs into a series of therapy lessons and skill-building modules. These are designed to isolate and shift the underlying thoughts and beliefs which guide diet and lifestyle behaviors that cause a wide range of cardiometabolic diseases, including type 2 diabetes
Clinical data on the efficacy and safety of Better Therapeutics developmental product candidates has been published in multiple peer-review journals including Journal of the Endocrine Society, JMIR Cardio, JMIR Diabetes and more.
About Better Therapeutics
Better Therapeutics is a prescription digital therapeutics (PDT) company developing a novel form of cognitive behavioral therapy to address the root causes of cardiometabolic diseases. The company has developed a proprietary platform for the development of FDA-regulated, software-based solutions for type 2 diabetes, heart disease and other conditions. The cognitive behavioral therapy delivered by Better Therapeutics PDT is designed to enable changes in neural pathways of the brain so lasting changes in behavior become possible. Addressing the underlying causes of these diseases has the potential to dramatically improve patient health while lowering healthcare costs. Better Therapeutics clinically validated mobile applications are intended to be prescribed by physicians and reimbursed like traditional medicines. For more information visit: bettertx.com
Certain statements made in this press release are forward-looking statements within the meaning of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are typically identified by words such as plan, believe, expect, anticipate, intend, outlook, estimate, forecast, project, continue, could, may, might, possible, potential, predict, should, would and other similar words and expressions, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements are based on the current expectations of the management of Better Therapeutics and are inherently subject to uncertainties and changes in circumstances and their potential effects and speak only as of the date of such statement. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements including: risks related to Better Therapeutics business, such as the willingness of the FDA to approve PDTs and insurance companies to reimburse their use; and other risks and uncertainties included under the header Risk Factors in the definitive proxy statement/prospectus filed by us on October 12, 2021.
+1 619 203 5391
Exhibit 99.2 COMPANY PRESENTATION | NOVEMBER 2021
Disclaimer This presentation (“Presentation”) is for informational purposes only. The information contained herein does not purport to be all-inclusive and neither Better Therapeutics, Inc. (“BetterTX” or the Company“) nor any of its respective affiliates nor any of its or their control persons, officers, directors, employees or representatives makes any representation or warranty, express or implied, as to the accuracy, completeness or reliability of the information contained in this Presentation. You should consult your own counsel and tax and ﬁnancial advisors as to legal and related matters concerning the matters described herein, and, by accepting this Presentation, you conﬁrm that you are not relying upon the information contained herein to make any decision. The reader shall not rely upon any statement, representation or warranty made by any other person, ﬁrm or corporation in making its investment or decision to invest in the Company. Neither the Company nor any of its respective affiliates nor any of its or their control persons, officers, directors, employees or representatives, shall be liable to the reader for any information set forth herein or any action taken or not taken by any reader, including any investment in shares of the Company. Certain information contained in this Presentation relates to or is based on studies, publications, surveys and the Company’s own internal estimates and research. In addition, all of the market data included in this Presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while the Company believes its internal research is reliable, such research has not been veriﬁed by any independent source. This meeting and any information communicated at this meeting are strictly conﬁdential and should not be discussed outside your organization. Forward-Looking Statements. Certain statements in this Presentation may be considered forward-looking statements. Forward-looking statements generally relate to future events or the Company’s future ﬁnancial or operating performance. For example, these forward-looking statements include, but are not limited to, statements regarding the delivery of cognitive behavioral therapy and/ or prescription digital therapeutics by the Company to address the root causes of type 2 diabetes and other cardiometabolic diseases; development of a proprietary platform and software-based solutions for treatment of type 2 diabetes, heart disease and other conditions; achievement of changes in neural pathways of the brain and lasting changes in behavior through cognitive behavioral therapy delivered by the Company’s PDT; the capability of the Company to address the underlying causes of certain diseases and its related potential to improve patient health while lowering healthcare costs; the potential for Better Tx’s clinically validated mobile applications to be prescribed by physicians and reimbursed like traditional medicines; potential and signiﬁcance of the results of the pivotal study of BT-001 or any clinical or other trial; the potential success of BT-001 as a prescribed treatment used under physician supervision for people with uncontrolled type 2 diabetes; the possibility for the results of the pivotal study to support a regulatory submission for marketing authorization from the FDA; the potential timing of and the Company's expected progress towards developing and obtaining FDA approval for its products, related research and validation studies; the future ﬁnancial stability, strength or success of Better Tx. In addition, any statements that refer to projections (including EBITDA, adjusted EBITDA, EBITDA margin and revenue projections), forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements are typically identiﬁed by words such as “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “continue,” “could,” “may,” “might,” “possible,” “potential,” “predict,” “should,” “would” and other similar words and expressions, but the absence of these words does not mean that a statement is not forward-looking. Any forward-looking statements in this presentation are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the FDA may not be satisﬁed with the design of any of the Company's studies and trials, and even satisﬁed, payers may not reimburse BT-001, if approved, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that the current COVID-19 pandemic will impact our platform validation, product testing, and the timing of the Company's submission of the BT-001 for marketing approval from the FDA. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in BetterTX’s ﬁlings on ﬁle with the Securities and Exchange Commission, available at the Securities and Exchange Commission’s website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in Better Tx’s subsequent/future ﬁlings, if any, with the Securities and Exchange Commission. All information in this Presentation is as of the date of the release, and the Company undertakes no duty to update this information unless required by law. 2
Pivotal trial of BT-001 (type 2 diabetes) is fully enrolled; primary endpoint Q1 2022 BT-002 (hypertension) pivotal trial expected to begin in 2022 Early clinical discovery in non-alcoholic fatty liver Recent disease (NAFLD) to enroll 1st patient in Q1 2022 Progress Real-world evidence study enrolled 1st patient in Q4 2021; Mass General Brigham joins study New patent family filed covering inventions in nutritional CBT and use of AI to guide treatment Completed deSPAC and PIPE transactions; funded through Q1 2023 3
Executive Team David Kevin Mark Justin Mark Kristin Thiago Deepti Jaggi, Perry Appelbaum Berman, MD Zamirowski Heinen Wynholds Oliveira PharmD Co-Founder, Co-Founder, Chief Chief Medical Chief Commercial Interim Chief Chief Product Chief People Chief Strategy Chairman Executive Officer Officer Officer Financial Officer Officer Officer Officer 4
Next Generation Therapeutics: Using Software Instead of Drugs A Digital Therapeutics Platform – delivering novel cognitive behavioral therapy targeting the root causes of cardiometabolic diseases Demonstrated Results– clinically meaningful results in multiple trials for Type 2 Diabetes and Hypertension 1 Major Market Opportunities – $490 billion spent in treating the effects of cardiometabolic diseases each year, while leaving the causes in place Platform Leverage – because we treat common root causes, we believe we can rapidly iterate our software and efficiently advance our pipeline with minimal product changes 1. Milken Institute. 2017. 5
We are spending more and more money to get worse and worse outcomes DIABETES HYPERTENSION US Healthcare Expenditures ($ in trillions) Americans Diagnosed with Hypertension (millions) US Healthcare Expenditures ($ in trillions) Americans Diagnosed with Diabetes (millions) $4 30 $4 110 $3 $3 22.5 82.5 $2 15 55 $2 $1 7.5 27.5 $1 0 0 1965 1975 1985 1995 2005 2015 1965 1975 1985 1995 2005 2015 CORONARY ARTERY DISEASE OBESITY US Healthcare Expenditures ($ in trillions) Americans Diagnosed with Heart Disease (millions) US Healthcare Expenditures ($ in trillions) Americans Diagnosed with Obesity (millions) 100 $4 $4 18 75 $3 $3 13.5 50 $2 $2 9 25 $1 $1 4.5 0 0 1965 1975 1985 1995 2005 2015 1965 1975 1985 1995 2005 2015 6
Hypertension (high blood pressure) 70M people $30B Rx drug spending That’s because Type 2 Diabetes (high blood sugar) Root Causes existing therapeutics 35M people Poor diet $52B Rx drug spending Sedentary lifestyle treat symptoms but Stress Poor sleep leave the common Alcohol, Tobacco root causes untouched Hyperlipidemia (high cholesterol) 40M people $28B Rx drug spending 7
Cognitive Behavioral Therapy (CBT) is effective at addressing the behavioral root causes of cardiometabolic diseases but is neither scalable nor affordable Treatment plans to treat cardio metabolic “The results of this study show that PC-CBT lifestyle intervention [for patients diseases with CBT are not standardized and with cardio-metabolic syndrome] leads to remarkable reductions in waist different health professionals have different levels circumference, fasting serum-triglycerides levels, resting systolic blood tension, of success with their patients 1 and improved quality of life when compared to the control group” Patients must commit to 8 - 20 CBT 3 sessions with their healthcare professional. “The results of this meta-analysis showed that CBT can be effective in reducing depression symptoms and fasting glucose in diabetes patients with Psychotherapists charge upwards of $100/ comorbid depression as well as in improving quality of life and anxiety in the hour and not all patients have insurance that 2 long-term.” $ 4 covers treatment. Sources: 1. Zhang, Y., Mei, S., Yang, R. et al. Effects of lifestyle intervention using patient-centered cognitive behavioral therapy among patients with cardio-metabolic syndrome: a randomized, controlled trial. BMC Cardiovasc Disord 16, 227 (2016) 2. Li C, Xu D, Hu M, Tan Y, Zhang P, Li G, Chen L. A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for patients with diabetes and depression. J Psychosom Res. 2017 Apr;95:44-54. 3. Turner, J. The use of cognitive behavioral therapy in diabetes care: A review and case study. Journal of Diabetes Nursing 14, 3 (2010); Mayo Clinic Cognitive Behavioral Therapy primer 4. Anxiety and Depression Association of America 8
Better Therapeutics was founded on the hypothesis that we could create software that would change patient behavior and treat underlying causes of cardiometabolic diseases; and deliver it in a scalable and affordable mobile application 9
Our first submission will be a de novo In 2017, the FDA classification request established a Subsequent submissions may be 510(k)s pathway for the approval of software Pear Therapeutics, Akili Interactive, Mahana as a treatment Therapeutics have received authorization or clearance via this approach 10
Both patients and healthcare providers are highly interested in treatment alternatives that address the underlying causes of disease Provider Qualitative Research Results (n=30) 80% rate it a 6 or 7 Provider Average 7% 14% 28% 52% 6.2 / 7 1 2 3 4 5 6 7 Patient Qualitative Research Results (n=20) 69% rate it a 6 or 7 Patient Average 6% 6% 19% 31% 38% 5.8 / 7 1 2 3 4 5 6 7 Source: Better Therapeutics Market Research, Oct 2020. The 1 to 7 scale represents the intent of the patient to ask their provider to prescribe BT-001, and the intent of the provider to prescribe BT-001, where 1 was “not at all likely” and 7 was “extremely likely.” 11
Payer research supports our coverage and reimbursement assumptions $1,000 High Risk $900 At this price range, payers will likely attempt to strictly • • Blinded interviews conducted with 17 key manage BT-001 beyond label >$600 decision-makers in Commercial and $800 Not covered, Medical Exception only • Medicare Advantage payers $700 • Payers viewed evidence from our pivotal Moderate Risk $600 and real world evidence studies as Payers will likely start implementing stricter management • comprehensive and compelling to support on par with branded, non-preferred T2D treatments $500 $250 - $600 favorable coverage Patient population may be restricted to inclusion/exclusion • criteria from clinical trial $400 • Payers responded favorably to BT-001 BT-001 Expected target product profile with a willingness to Price Range $300 pay within the range of other branded T2D Low Risk treatments Payers will likely cover with non-limiting criteria similar to $200 • $100 - $250 branded, preferred T2D treatments $100 12 30-day Wholesale Acquisition Cost
Now is a unique time to build a very valuable prescription digital therapeutics company We can’t continue to pay more money for worse outcomes CBT is well established to treat the underlying causes of these diseases Our software platform has demonstrated clinically meaningful results in multiple trials The FDA has established a pathway for regulation and multiple companies have used it successfully Payers are increasingly interested in these solutions The field of digital health has significant momentum 13 13
We have created a software platform that delivers nutritional CBT and it has demonstrated clinically meaningful results in multiple trials NEUROSCIENCE LIFESTYLE MEDICINE ARTIFICIAL INTELLIGENCE Behavior Therapy Treatment Plans Personalization Changes thoughts and A pre-programmed beliefs so that difficult Guides changes in treatment algorithm behavior changes are dietary behavior and dynamically adjusts possible. Builds the physical activity, while goals to maximize acceptance and improving medication treatment response, resilience needed to adherence and self- and provides a handle challenging monitoring. feedback loop that obstacles and emotions. sustains engagement. 14
In our most recent pilot study in patients with type 2 diabetes, we observed that use of our software generated results similar to prescription drugs with few side effects Change in Fasting Blood Glucose Clinical Observations 1 (n = 80, enrolled with baseline A1c 7.0 to 11.0%) Greater than expected changes in fasting blood glucose Study Week Mean (mg/dL) Est. A1c Change Data quality is high in frequency, 2 -8.9 -0.4% prevalence and consistency of self- 4 -17.9 -0.8% reporting 6 -23.9 -1.0% Greater engagement with behavioral 8 -24.4 -1.1% therapy content results in greater 10 -21.6 -0.9% improvement in blood glucose; even a 12 -22.6 -1.0% low level of use resulted in meaningful improvement 1 This data is based on a single-arm, uncontrolled, unblinded pilot study conducted by BTX. Type 2 diabetes is defined as an A1c of 6.5% or higher. 15
*PIVOTAL TRIAL - BT-001 A pivotal trial of our product for treating type 2 diabetes is underway; we expect primary data in Q1 2022 and an FDA submission in mid 2022 First Patient First Patient Primary Endpoint Last Patient Interim Analysis Screened Randomized Data Out Feb-21 Apr-21 Dec-21 Q1-22 Q2-22 Sample Size: 648 participants with type 2 diabetes Randomization: 1:1 randomization to Standard of Care Primary Safety Endpoint: Occurrence, relatedness & located in 5 geographically distinct US regions arm (control) or Standard of Care + BT-001 arm severity of adverse events at Day 90 (intervention) Power: 90% power to detect 0.4% A1c difference Secondary Safety Endpoint: Occurrence, with 0.05 alpha Primary Efficacy Endpoint: Day 90 A1c (difference in relatedness & severity of adverse events at Day 180 the mean change from baseline in A1c between Inclusion: 18-75 years old; baseline A1c 7% or above Exploratory Endpoints: Changes in insulin resistance, groups) but less than 11%; stable drug regimen for 4 months blood lipids, inflammation, blood pressure, prior to randomization Secondary Efficacy Endpoint: Day 180 A1c cardiovascular risk score, weight, medications, quality (difference in the mean change from baseline in A1c of life; NPS (BT-001 only) Exclusion: Use of prandial insulin; any unstable life- between groups) threatening medical condition; COVID-19 16
We believe we can develop this pipeline faster and at less cost than traditional therapeutics, allowing us to scale much more quickly Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 Q3 2022 Q4 2022 Q1 2023 Q2 2023 Q3 2023 Q4 2023 Pivotal FDA Review Type 2 Diabetes Pilot Pivotal Hyperlipidemia Pivotal FDA Review Hypertension Pilot Pilot T2DM w/ Hypertension Discovery Liver Disease (NAFLD) Discovery Liver Disease (NASH) Additional Scientific Areas of Interest Chronic Kidney Disease Familial Hypercholesterolemia Increasingly, it is appreciated that there are shared pathways of pathophysiology, such as Pre-Eclampsia Alzheimer’s Disease inflammation and immune activation that underlie the development of cardiometabolic Coronary Artery Disease Gestational Diabetes conditions as well as conditions in other disease classes, such as Alzheimer’s disease, multiple sclerosis and certain cancers. Peripheral Artery Disease Treatment-resistant Hypertension 17
In the current treatment paradigm, disease symptoms worsen and healthcare costs increase for the remainder of life Progression of Disease Additional Non-Insulin Advanced Pre-Diabetes / Insulin Non-Insulin Diagnosis Treatment Comorbidities At-Risk Stage Treatment Treatments +3.2x +1.8x drug cost / drug cost / patient / year patient / year 18 Number of Patients
By treating the underlying causes of disease, we make a new paradigm possible; one in which disease progression stops and in many patients is reversed Progression of Disease Pre-Diabetes / Diagnosis At-Risk Stage Additional Non-Insulin Non-Insulin Treatment Treatments Advanced Insulin Comorbidities Treatment Reduce the number of patients Reduce the number patients who who start drug treatment progress to insulin treatment 19 Number of Patients
In diabetes alone, there is over $40B of addressable drug spending on insured patients with uncontrolled diabetes 12M 73% $4,500 = $40B Patients with Covered by Annual diabetes drug Immediate uncontrolled diabetes Commercial Payers costs per patient Addressable Market and A1c 7-11% or Medicare Part D 20 20
Diabetes drug spending is expected to grow by 2.5x over the next 10 years, but our approach could begin to reduce the cost of treating diabetes and almost every other metabolic disease $120 $105B $93B $90 $60 $40B $30 $15B $0 2010 2020 2030 2030 w/BT-001 authorized Yesterday Today Tomorrow 21
Aligned with Existing Clinical Guidelines By choosing to seek Physician examines patient FDA approval for our products, we seek to Physician diagnoses patient fit seamlessly within the existing Physician prescribes therapy healthcare system to Payer reimburses like a drug enable adoption and scale, while only Patient remains in care of physician changing the form of therapy New Product Form requiring NEW Patient + Provider Education 22
4% of Primary Care Providers Treat 20% of Patients 86% of type 2 23,000,000 388,717 diabetes patient care 224,364 (pre insulin) is 162,082 17,250,000 delivered by primary 121,206 90,558 care providers. 11,500,000 66,249 46,468 A small portion of 23,592 5,750,000 providers care for a 16,998 6,636 disproportionate 0 0 100,000 200,000 300,000 400,000 number of patients. Providers Primary Care Providers include: Family Practice, Internal Medicine, General Medicine and Geriatric Physicians, Nurse Practitioners and Physicians Assistants Source: The State of Primary Care in the United States. 2018.; Metformin 2020 Medicare Prescription Data 23 Patients
Commercial Team Composition Sizing at FDA Annualized Role Focus Authorization Cost We plan to build a Health System formulary acceptance and Engagement and digital first engagement and education for ~20 $8M Education providers and patients commercial capability KOL engagement, real world study to launch BT-001 and support, advocacy organization Medical Liaisons ~3 $1M engagement scale an emerging National and regional payer coverage, portfolio of digital Payer Executives ~4 $3M contracting and reimbursement support therapeutics in Technical EHR integration support for e-prescribing Implementation ~2 $1M primary care. and health system data exchange Specialists Patient focused, coordinated virtual Patient Services support for information and ~7 $2M Specialists reimbursement support Total ~40 ~$15M 24
BT-001 is expected to both improve patient outcomes and save payers money 3-year Cost Clinical Impact Branded Drug Cost (Wholesale) (A1c Reduction) (30 day wholesale cost) Trulicity (GLP-1 RA Inj.) Trulicity (GLP-1 RA Inj.) Trulicity (GLP-1 RA Inj.) 1.7% $797 $21,336 Rybelsus (GLP-1 RA Oral) Rybelsus (GLP-1 RA Oral) $772 $20,678 Rybelsus (GLP-1 RA Oral) 1.2% Jardiance (SGLT2) Jardiance (SGLT2) $522 $13,985 Jardiance (SGLT2) 0.9% Janumet (DPP4) Janumet (DPP4) $451 $12,073 Janumet (DPP4) 0.8% BT-001 BT-001 $347 $2,730 BT-001 1.0% (Pilot Data) $0 $200 $400 $600 $800 $0 $11,000 $22,000 25 25 BT-001 expected price range
We have begun enrolling a 1,000 participant real-world evidence (RWE) study to understand BT-001 durability of effect and impact on total cost of care 6-Month Data 9-Month Data 9-Month Data Last Patient In First Patient In (250 pts) (750 pts) (1000 pts) Q4-23 Oct-21 Q3-22 Q4-22 Q2-23 BT-001 Study Size Duration Population: Participants with type 2 diabetes; A1c between 7.0% and Participants 11.0%, not on prandial insulin Design: Open-label, real world interventional studies using within participant comparison or control arm 500 750 18-month Primary Measures: Mean change in A1c after 6 and 12-months (mean change within participant or compared to control) 250 500 24-month Secondary Measures: Mean change in medication usage after 6 and 12-months (mean change within participant or compared to control) Exploratory Endpoints: Changes in quality of life, diabetes treatment 250 250 12-month satisfaction, blood pressure, cholesterol, weight, lipids and HbA1c trends, medication use, diabetes related hospitalizations, emergency room visits, and outpatient visits at 12 months or more 26
We have the opportunity to create a valuable company based on diabetes revenues alone Gross Proﬁt EBIT Revenues $400 $400 $35 $390 $16 $0 -$30 -$44 -$117 -$132 $300 $300 $310 -$35 $200 $200 -$70 $100 $100 $88 -$105 $63 $0 $0 $0 $7 $0 $0 -$140 2021 2023 (Launch Year) 2025 2021 2022 2023 2024 2025 2021 2022 2023 2024 2025 27
We expect multiple value creation milestones over the next 18 months Enrollment Pivotal Trial Pivotal Trial Pilot Data Complete First Patient In First Patient In [BT-002, -003] [BT-001] [BT-002] [BT-003] Secondary Endpoint FDA Interim [BT-001] FDA Authorization Primary Endpoint Close SPAC Submission Analysis [BT-001] [BT-001] Transaction [BT-001] [BT-001] Q2 2022 Q4 2021 Q1 2022 Q3 2022 Q4 2022 Q1 2023 Ending Cash: $38M $28M $27M $30M $18M $3M Cash forecast assumes: Minimum/latest borrowings on the Hercules debt agreement ($5M in Q2 2022 and $10M) 28