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Biora Therapeutics(BIOR) - 2022 Q1 - Earnings Call Presentation
2022-05-13 18:50
CORPORATE PRESENTATION May 2022 FORWARD-LOOKING STATEMENTS This presentation contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this presentation, including statements concerning our plans, objectives, goals, strategies, future events, plans or intentions relating to product candidates, esti ...
Biora Therapeutics(BIOR) - 2022 Q1 - Earnings Call Transcript
2022-05-11 02:16
Biora Therapeutics, Inc. (NASDAQ:BIOR) Q1 2022 Earnings Conference Call May 10, 2022 4:30 PM ET Company Participants Chuck Padala – Managing Director, LifeSci Advisors Adi Mohanty – Chief Executive Officer Eric d’Esparbes – Chief Financial Officer Conference Call Participants Julian Harrison – BTIG Sahil Kazmi – B. Riley Securities Operator Welcome to the Biora Therapeutics First Quarter 2022 Earnings Call. During the presentation, all participants will be in a listen-only mode. Afterwards, we’ll conduct a ...
Biora Therapeutics(BIOR) - 2022 Q1 - Quarterly Report
2022-05-09 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39334 Biora Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 27-3950390 (State or other jurisdiction of ...
Progenity (PROG) Investor Presentation - Slideshow
2022-03-30 15:52
progenity® © 2022 Progenity, Inc. All rights reserved. CORPORATE PRESENTATION March 2022 FORWARD-LOOKING STATEMENTS This presentation contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this presentation, including statements concerning our plans, objectives, goals, strategies, future events, ...
Biora Therapeutics(BIOR) - 2021 Q4 - Earnings Call Transcript
2022-03-29 01:41
Progenity, Inc. (PROG) Q4 2021 Earnings Conference Call March 28, 2022 4:30 PM ET Company Participants Chuck Padala - Managing Director of LifeSci Advisors Adi Mohanty - Chief Executive Officer Eric d'Esparbes - Chief Financial Officer Conference Call Participants Joseph Pantginis - H.C. Wainwright & Co, LLC Catherine Schulte - Robert W. Baird & Co. Inc. Operator Greetings, and welcome to the Progenity Fourth Quarter and Full-Year 2021 Earnings Call. At this time, all participants are in a listen-only mode. ...
Biora Therapeutics(BIOR) - 2021 Q4 - Annual Report
2022-03-27 16:00
Part I [Business](index=4&type=section&id=Item%201.%20Business) Progenity, Inc. is a biotechnology company focused on developing oral biotherapeutics using ingestible smart capsules for targeted GI and systemic delivery - In June 2021, the company announced a strategic transformation to refocus on its R&D pipeline, which included closing its genetics lab in Michigan and selling its Avero laboratory business. These former Laboratory Operations are now reported as discontinued operations[13](index=13&type=chunk)[436](index=436&type=chunk)[551](index=551&type=chunk) - The company's new focus is on developing oral biotherapeutics through two primary platforms: targeted delivery to the GI tract for IBD and systemic delivery of large molecules to replace injections[10](index=10&type=chunk)[14](index=14&type=chunk) - Progenity holds rights to approximately **350** issued patents and pending patent applications covering its therapeutic and device methods, systems, and compositions[33](index=33&type=chunk)[89](index=89&type=chunk) [Product Pipeline](index=4&type=section&id=Product%20Pipeline) The company's pipeline focuses on drug-device combinations, including targeted GI therapeutics, systemic oral biotherapeutics, and GI diagnostic platforms Key Product Candidates and Platforms | Platform | System | Lead Candidate(s) | Indication | Status | | :--- | :--- | :--- | :--- | :--- | | **Targeted Therapeutics** | DDS Capsule | PGN-600 (tofacitinib) | Ulcerative Colitis | Phase 1 planned for late 2022 | | | | PGN-001 (anti-TNF-alpha) | Ulcerative Colitis | Preclinical | | **Systemic Therapeutics** | OBDS Capsule | PGN-OB1 (anti-TNF-alpha) | Autoimmune Conditions | Preclinical | | | | PGN-OB2 (GLP-1 agonist) | Type 2 Diabetes | Preclinical | | **GI Diagnostics** | RSS Capsule | N/A | GI Sampling | Proof of concept study completed | | | PIL Dx Capsule | N/A | SIBO Diagnosis | Subsystem testing completed | - The company has active partnerships with Ionis Pharmaceuticals and two other leading pharmaceutical companies to evaluate the OBDS platform for delivering their proprietary drugs[25](index=25&type=chunk)[70](index=70&type=chunk) - Projects for a preeclampsia rule-out test (Preecludia™) and a single-molecule detection assay have been deprioritized and are being marketed to potential commercial partners[30](index=30&type=chunk)[32](index=32&type=chunk) [Competition](index=16&type=section&id=Competition) Progenity faces substantial competition from major pharmaceutical and biotechnology companies across its IBD, systemic oral delivery, and GI diagnostics markets - The IBD therapeutics market is mature, with competition from large pharmaceutical companies like AbbVie, Eli Lilly, Gilead, J&J, Pfizer, Roche, and Takeda[84](index=84&type=chunk) - In systemic oral biotherapeutics, competition comes from various technologies, including functional excipients (Enteris, Novo Nordisk), enteric coatings (Catalent, Cosmo), and other ingestible devices (Novo Nordisk, Rani Therapeutics, Amgen)[85](index=85&type=chunk) [Government Regulation](index=18&type=section&id=Government%20Regulation) The company's drug-device combination product candidates are subject to extensive FDA regulation, requiring complex reviews and adherence to data privacy laws like HIPAA - Medical device product candidates are regulated by the FDA and classified into Class I, II, or III based on risk, determining the pathway to market (e.g., 510(k) clearance or PMA)[95](index=95&type=chunk)[96](index=96&type=chunk) - Drug and biologic product candidates require a comprehensive development process, including preclinical testing and multi-phase clinical trials, before submitting a New Drug Application (NDA) or Biologics License Application (BLA) to the FDA[123](index=123&type=chunk)[124](index=124&type=chunk)[128](index=128&type=chunk) - The company's drug-device combination products will be regulated by the FDA, with one center having primary jurisdiction based on the product's primary mode of action. The company expects its therapeutic candidates to be reviewed as drugs or biologics[168](index=168&type=chunk)[172](index=172&type=chunk)[173](index=173&type=chunk) - The company is subject to data privacy and security laws, including HIPAA, which imposes obligations regarding the handling of protected health information (PHI)[176](index=176&type=chunk)[267](index=267&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including strategic transformation challenges, going concern doubts, complex product development, intense competition, and stock price volatility - The company's strategic transformation to focus on R&D has materially reduced operating expenditures but also revenue, creating difficulties in managing the changes and potential adverse effects on financial condition[205](index=205&type=chunk)[207](index=207&type=chunk)[209](index=209&type=chunk) - The company has a history of losses and expects to need significant additional capital to fund operations. If it cannot raise capital, it may have to curtail or cease operations[218](index=218&type=chunk)[219](index=219&type=chunk) - The development of new product candidates is complex and costly, with no assurance of success in clinical trials, obtaining regulatory authorization, or achieving market acceptance[233](index=233&type=chunk)[237](index=237&type=chunk)[241](index=241&type=chunk) - The company's outstanding convertible notes may impair financial flexibility, and the issuance of shares upon conversion will dilute existing stockholders. Hedging activity related to these notes could also depress the stock price[260](index=260&type=chunk)[394](index=394&type=chunk)[395](index=395&type=chunk) - The company's common stock may be a target of "short squeezes," which can cause extreme price volatility disconnected from the company's underlying value, posing a risk of significant loss to investors[392](index=392&type=chunk) [Properties](index=68&type=section&id=Item%202.%20Properties) Progenity maintains its primary office and lab facilities through a combination of leased and owned properties in San Diego, CA, Irving, TX, and Ann Arbor, MI - The company's main facilities include leased office and lab space in San Diego, CA, and owned/leased space in Ann Arbor, MI[419](index=419&type=chunk) [Legal Proceedings](index=68&type=section&id=Item%203.%20Legal%20Proceedings) Progenity is involved in various legal and regulatory matters, including Medicaid recoupment claims, government subpoenas, patent infringement, and securities litigation - The Colorado Department of Health is seeking recoupment of approximately **$9.0 million** ($5.7M + $3.3M) for historical Medicaid payments related to carrier screening tests[420](index=420&type=chunk)[676](index=676&type=chunk)[677](index=677&type=chunk) - The company received a subpoena from the California Attorney General's Office related to its former genetic testing practices, particularly NIPT, for California patients[423](index=423&type=chunk)[678](index=678&type=chunk) - Ravgen, Inc. filed a patent infringement suit against Progenity related to its former NIPT testing business. The litigation is currently stayed pending patent validity challenges[425](index=425&type=chunk)[689](index=689&type=chunk) - The company is facing securities litigation related to its June 2020 IPO, with plaintiffs alleging false and misleading statements and omissions in the registration statement. The company is vigorously defending against these claims[426](index=426&type=chunk)[690](index=690&type=chunk) Part II [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=72&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section discusses Progenity's financial performance reflecting its strategic transformation, reporting increased net losses and a going concern doubt, with historical laboratory operations as discontinued - The company's financial statements reflect the Strategic Transformation, with its historical Laboratory Operations now reported as discontinued operations. The company's focus is now on its R&D pipeline for oral biotherapeutics[436](index=436&type=chunk)[444](index=444&type=chunk) Comparison of Operations (Continuing Operations) | Statement of Operations Data (in thousands) | 2021 | 2020 | | :--- | :--- | :--- | | Revenues | $1,247 | $162 | | Research and development | $45,785 | $47,743 | | Selling and marketing | $4,758 | $5,949 | | General and administrative | $68,541 | $54,089 | | **Loss from continuing operations** | **($178,521)** | **($105,086)** | - The increase in G&A expenses in 2021 was primarily due to consulting fees for the strategic restructuring, legal fees for litigation, and higher D&O insurance premiums[467](index=467&type=chunk) - As of December 31, 2021, the company had **$88.4 million** in cash and cash equivalents. Management has stated there is substantial doubt about the company's ability to continue as a going concern without additional funding[475](index=475&type=chunk)[476](index=476&type=chunk)[552](index=552&type=chunk) [Financial Statements and Supplementary Data](index=86&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited financial statements, highlighting the auditor's going concern doubt, significant losses, accumulated deficit, and details of financing activities - The report from independent auditor KPMG LLP includes a "Going Concern" paragraph, highlighting that the company's recurring losses and accumulated deficit raise substantial doubt about its ability to continue as a going concern[534](index=534&type=chunk) Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $88,397 | $92,076 | | Total current assets | $98,429 | $126,338 | | **Total assets** | **$108,839** | **$154,440** | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $61,609 | $72,670 | | Convertible notes, net | $126,392 | $158,886 | | **Total liabilities** | **$193,815** | **$261,434** | | Accumulated deficit | ($788,686) | ($541,274) | | **Total stockholders' deficit** | **($84,976)** | **($106,994)** | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | Loss from continuing operations | ($178,521) | ($105,086) | | Loss from discontinued operations | ($68,891) | ($87,442) | | **Net loss** | **($247,412)** | **($192,528)** | | **Net loss per share, basic and diluted** | **($2.57)** | **($7.00)** | - In 2021, the company raised significant capital through multiple offerings: a **$25M** private placement in February, a **$40M** private placement in June, a **$40M** public offering in August, a **$20M** registered direct offering in October, and initiated a **$90M** at-the-market (ATM) program in November[493](index=493&type=chunk)[494](index=494&type=chunk)[495](index=495&type=chunk) [Controls and Procedures](index=123&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2021, following its strategic transformation - Management concluded that disclosure controls and procedures were effective as of December 31, 2021[749](index=749&type=chunk) - Management concluded that internal control over financial reporting was effective as of December 31, 2021[751](index=751&type=chunk) Part III [Directors, Executive Compensation, and Corporate Governance](index=123&type=section&id=Items%2010-14) Information on directors, executive compensation, and corporate governance is incorporated by reference from the company's forthcoming 2022 proxy statement - Information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the forthcoming 2022 proxy statement[752](index=752&type=chunk)[753](index=753&type=chunk)[754](index=754&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=125&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section provides an index of all financial statements and exhibits filed with the Form 10-K, including governance documents and officer certifications - This section provides an index of all exhibits filed with the Form 10-K, including governance documents, material agreements, and officer certifications[758](index=758&type=chunk)
Progenity (PROG) Investor Presentation - Slideshow
2021-11-29 20:21
CORPORATE PRESENTATION November 2021 FORWARD-LOOKING STATEMENTS This presentation contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this presentation, including statements concerning our plans, objectives, goals, strategies, future events, future revenues or performance, plans or intentions ...
Biora Therapeutics(BIOR) - 2021 Q3 - Earnings Call Presentation
2021-11-12 13:31
THIRD QUARTER 2021 – FINANCIAL RESULTS November 2021 FORWARD-LOOKING STATEMENTS This presentation contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this presentation, including statements concerning our plans, objectives, goals, strategies, future events, future revenues or performance, fin ...
Biora Therapeutics(BIOR) - 2021 Q3 - Earnings Call Transcript
2021-11-11 03:49
Financial Data and Key Metrics Changes - The company generated $9.6 million in revenues during Q3 2021, with $9.4 million from discontinued operations, indicating a shift away from molecular testing operations [21] - Operating expenses, excluding stock-based compensation, were $32.7 million in Q3 2021, representing a $9 million favorable variance compared to previous guidance [22] - The company achieved a $110 million annual operating expenses run rate reduction during Q3 2021, with expectations to reach less than $25 million in Q4 [20][22] Business Line Data and Key Metrics Changes - The Oral Biotherapeutics program targets a $250 billion global biologics market, focusing on oral delivery of biomolecules [9] - The Drug Delivery System (DDS) program aims to treat GI localized diseases, initially targeting the $15 billion IBD market with lead drugs PGN-600 and PGN-001 [14] - The Preecludia test for preeclampsia demonstrated strong performance in validation studies, with potential for significant market impact [18][19] Market Data and Key Metrics Changes - The company is focusing on the biotherapeutics market, particularly oral delivery solutions and treatments for inflammatory bowel disease [26] - The Preecludia test has the potential to capture a share of the approximately $3 billion market in the U.S. [26] Company Strategy and Development Direction - The company is transforming into an innovation-led biotherapeutics company, focusing on oral delivery of biomolecules and GI IBD platforms [7][26] - There is a clear focus on advancing the pipeline, generating value from unique assets, and exploring partnerships [6][26] - The company aims to reduce cash burn and optimize capital allocation towards innovation [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the transformation process and the potential for the company's innovation pipeline to create value [26] - The company is focused on generating compelling data in the near term to de-risk its programs and enhance value [34] Other Important Information - The company raised $40 million in gross proceeds during Q3 2021 and had a cash balance of $54 million at the end of the quarter [24] - A proactive approach to managing capital structure has led to a 38% reduction in the balance of convertible notes [25] Q&A Session Summary Question: Update on Preecludia strategy and licensing opportunities - Management indicated that outreach to potential licensees for Preecludia is in the initial phase, with positive data supporting its value [28][29] Question: Details on the third pharma partnership for OBDS - Management stated that it is still early to provide detailed information on the partnership, emphasizing the importance of generated data [31] Question: Expectations for upcoming PK/PD data in UC and future clinical trials - Management noted that more data will be generated soon, which will help define necessary studies, and emphasized the unique nature of their drug development approach [34]
Biora Therapeutics(BIOR) - 2021 Q3 - Quarterly Report
2021-11-09 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39334 Progenity, Inc. (Exact name of registrant as specified in its charter) Delaware 27-3950390 (State or other jurisdiction of incor ...