UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On August 14, 2023, Biora Therapeutics, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2023 and an updated corporate presentation. The press release and corporate presentation are furnished as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K.
As provided in General Instruction B.2 of Form 8-K, the information in this Item 2.02 and Exhibit 99.1 and Exhibit 99.2 incorporated herein shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall such information or Exhibits 99.1 and 99.2 be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 |
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99.2 |
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Cover Page Interactive Data File (embedded with the Inline XBRL document) |
SIGNATURES
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.
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Biora Therapeutics, Inc. |
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Date: |
August 14, 2023 |
By: |
/s/ Aditya P. Mohanty |
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Aditya P. Mohanty |
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Exhibit 99.1 |
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Biora Therapeutics Provides Corporate Update and Reports
Second Quarter 2023 Financial Results
NaviCapTM targeted oral delivery platform on track for September IND filing; achieved successful device function study results in humans with phase 1-ready device
BioJetTM systemic oral delivery platform device development achieved function targets while continuing to exceed bioavailability targets
The company strengthened its intellectual property position with additional patents for both platforms
Management will host conference call and webcast today at 4:30 PM Eastern / 1:30 PM Pacific
SAN DIEGO, August 14, 2023 – Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today provided a corporate update and reported financial results for the second quarter ended June 30, 2023.
Biora recently announced preliminary results from a device function study in humans with the phase 1-ready device for its NaviCapTM targeted oral delivery platform. The company subsequently completed the study as planned with a total of sixteen healthy volunteers participating in the study. The NaviCap device accurately identified entry into the colon, triggered release of its non-drug payload, and achieved distribution throughout the colon in 15 out of 16 subjects.
“In this fourth human functional study, we once again demonstrated the robustness of our NaviCap platform, which performed as designed across a range of expected differences in GI motility among study participants,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “We remain on track for IND filing in September for our BT-600 program. We believe the NaviCap platform can address the large unmet need for ulcerative colitis patients by solving one of the primary treatment gaps, which is the inability to achieve high enough drug levels in the diseased tissue without systemic toxicity,” continued Mr. Mohanty.
“During the second quarter, we continued development of our BioJet™ platform, which has shown category-leading oral bioavailability of large molecules. We successfully tested the autonomously triggered version of our next-gen device, achieving our device function targets, while continuing to exceed our performance target of 15% average bioavailability,” said Mr. Mohanty.
Also during the second quarter, Biora presented data at the American Diabetes Association assessing the delivery of semaglutide via the BioJet device in an animal model. In two studies,
the company achieved more than double its target average bioavailability. Biora will be presenting additional data from the BioJet platform at the European Association for the Study of Diabetes annual meeting in Hamburg, Germany, October 2-6, 2023.
In addition, Biora recently further strengthened its intellectual property position for both platforms. The company was awarded a group of US and European patents related to additional therapeutic targets for its NaviCap targeted oral delivery platform, which could help the company broaden its NaviCap pipeline in the future. Biora also recently announced additional patents covering key features of the proprietary liquid jet injection technology used in its BioJet platform. The company’s recent patents are part of its larger corporate portfolio consisting of 73 patent families, including approximately 167 issued patents and 143 pending applications in major jurisdictions around the world.
Second Quarter 2023 and Other Recent Corporate Highlights
Second Quarter 2023 Financial Results
Comparison of Three Months Ended June 30, 2023 and March 31, 2023
Operating expenses were $14.9 million for the three months ended June 30, 2023, compared to $15.5 million for the three months ended March 31, 2023.
Net loss was $17.8 million and net loss per share was $1.47 for the three months ended June 30, 2023, compared to a net loss of $17.4 million and net loss per share of $1.59 for the for the three months ended March 31, 2023.
Comparison of Three Months Ended June 30, 2023 and 2022
Operating expenses were $14.9 million for the three months ended June 30, 2023, compared to $14.3 million for the three months ended June 30, 2022.
Net loss was $17.8 million and net loss per share was $1.47 for the three months ended June 30, 2023, compared to a net loss of $5.5 million and net loss per share of $0.75 for the three months ended June 30, 2022.
Webcast and Conference Call Information
Biora Therapeutics will host a webcast and conference call to discuss the second quarter financial results and provide a corporate update today, Monday, August 14, 2023 at 4:30 PM Eastern time / 1:30 PM Pacific time.
The live call may be accessed by dialing 1-877-423-9813 (domestic) or 1-201-689-8573 (international) and entering the conference code: 13740025. A live webcast will be available via the Investors section of the company website, with a replay available online for 60 days following the call.
About Biora Therapeutics
Biora Therapeutics is the biotech company that is reimagining therapeutic delivery. By creating innovative smart pills designed for targeted drug delivery to the GI tract, and systemic, needle-free delivery of biotherapeutics, the company is developing therapies to improve patients’ lives.
Biora is focused on development of two therapeutics platforms: the NaviCap™ targeted oral delivery platform, which is designed to improve outcomes for patients with inflammatory bowel disease through treatment at the site of disease in the gastrointestinal tract, and the BioJet™ systemic oral delivery platform, which is designed to replace injection for better management of chronic diseases through needle-free, oral delivery of large molecules.
For more information, visit bioratherapeutics.com or follow the company on LinkedIn or Twitter.
Safe Harbor Statement or Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, 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 press release, including statements concerning the progress and future expectations and goals of our research and development and clinical efforts, and phase 1 readiness, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan,” “target,” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, our ability to innovate in the field of therapeutics, our ability to make future filings and initiate clinical trials on expected timelines or at all, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, our expectations regarding allowed patents or intended grants to result in issued or granted patents, our expectations regarding opportunities with current or future pharmaceutical collaborators, our ability to raise sufficient capital to achieve our business objectives, and those risks described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC and other subsequent documents, including Quarterly Reports, that we file with the SEC.
Biora Therapeutics expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
Investor Contact
Chuck Padala
Managing Director, LifeSci Advisors
IR@bioratherapeutics.com
(646) 627-8390
Media Contact
media@bioratherapeutics.com
Biora Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share amounts)
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Three Months Ended |
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June 30, |
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March 31, |
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Revenues |
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$ |
2 |
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$ |
2 |
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Operating expenses: |
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Research and development |
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5,983 |
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7,190 |
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Selling, general and administrative |
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8,953 |
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8,356 |
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Total operating expenses |
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14,936 |
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15,546 |
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Loss from operations |
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(14,934 |
) |
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(15,544 |
) |
Interest expense, net |
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(2,703 |
) |
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(2,680 |
) |
(Loss) gain on warrant liabilities |
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(161 |
) |
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864 |
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Other expense, net |
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(5 |
) |
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(81 |
) |
Loss before income taxes |
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(17,803 |
) |
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(17,441 |
) |
Income tax expense |
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4 |
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— |
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Net loss |
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$ |
(17,807 |
) |
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$ |
(17,441 |
) |
Net loss per share, basic and diluted |
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$ |
(1.47 |
) |
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$ |
(1.59 |
) |
Weighted average shares outstanding, basic and diluted |
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12,143,108 |
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10,970,583 |
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Biora Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share amounts)
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Three Months Ended |
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2023 |
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2022 |
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Revenues |
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$ |
2 |
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$ |
104 |
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Operating expenses: |
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Research and development |
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5,983 |
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5,904 |
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Selling, general and administrative |
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8,953 |
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8,410 |
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Total operating expenses |
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14,936 |
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14,314 |
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Loss from operations |
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(14,934 |
) |
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(14,210 |
) |
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Interest expense, net |
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(2,703 |
) |
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(2,772 |
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(Loss) gain on warrant liabilities |
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(161 |
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4,413 |
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Other (expense) income, net |
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(5 |
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5,735 |
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Loss before income taxes |
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(17,803 |
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(6,834 |
) |
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Income tax expense (benefit) |
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4 |
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(837 |
) |
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Loss from continuing operations |
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(17,807 |
) |
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(5,997 |
) |
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Gain from discontinued operations |
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— |
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484 |
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Net loss |
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$ |
(17,807 |
) |
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$ |
(5,513 |
) |
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Net loss per share from continuing operations, basic and diluted |
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$ |
(1.47 |
) |
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$ |
(0.81 |
) |
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Net gain per share from discontinued operations, basic and diluted |
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$ |
— |
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$ |
0.06 |
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Net loss per share, basic and diluted |
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$ |
(1.47 |
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$ |
(0.75 |
) |
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Weighted average shares outstanding, basic and diluted |
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12,143,108 |
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7,374,865 |
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Biora Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
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June 30, |
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December 31, |
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(1) |
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Assets |
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Current assets: |
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Cash, cash equivalents and restricted cash |
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$ |
26,452 |
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$ |
30,486 |
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Income tax receivable |
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819 |
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828 |
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Prepaid expenses and other current assets |
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4,105 |
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4,199 |
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Current assets of disposal group held for sale |
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2,509 |
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2,603 |
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Total current assets |
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33,885 |
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38,116 |
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Property and equipment, net |
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1,351 |
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1,654 |
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Right-of-use assets |
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1,887 |
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1,482 |
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Other assets |
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6,478 |
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6,201 |
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Goodwill |
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6,072 |
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6,072 |
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Total assets |
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$ |
49,673 |
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$ |
53,525 |
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Liabilities and Stockholders' Deficit |
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Current liabilities: |
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Accounts payable |
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$ |
5,042 |
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$ |
3,606 |
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Accrued expenses and other current liabilities |
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21,791 |
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16,161 |
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Warrant liabilities |
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10,835 |
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3,538 |
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Total current liabilities |
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37,668 |
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23,305 |
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Convertible notes, net |
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128,568 |
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127,811 |
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Other long-term liabilities |
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4,318 |
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4,696 |
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Total liabilities |
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$ |
170,554 |
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$ |
155,812 |
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Stockholders' deficit: |
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Common stock |
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11 |
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8 |
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Additional paid-in capital |
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760,277 |
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743,626 |
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Accumulated deficit |
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(862,091 |
) |
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(826,843 |
) |
Treasury stock |
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(19,078 |
) |
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(19,078 |
) |
Total stockholders' deficit |
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|
(120,881 |
) |
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|
(102,287 |
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Total liabilities and stockholders' deficit |
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$ |
49,673 |
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|
$ |
53,525 |
|
(1) The condensed consolidated balance sheet data as of December 31, 2022 has been derived from the audited consolidated financial statements
CORPORATE PRESENTATION August 2023 Exhibit 99.2
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 fact included in this presentation, including statements concerning our plans, objectives, goals, strategies, future events, plans or intentions relating to product candidates, estimates of market size, the anticipated timing, design and conduct of our planned pre-clinical and clinical trials, the anticipated timing for pre-clinical and clinical data, the development of our product candidates, the potential clinical benefits of our product candidates, including efficacy and safety benefits, the potential benefits of strategic partnerships and licensing arrangements and our intent to enter into any strategic partnerships or licensing arrangements, the timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated product development efforts, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this presentation, including competition from third parties with respect to our product candidates; risks related to the supply and manufacturing of and complexity of components in our devices; whether we will be able to develop our precision medicine products, and, if developed, that such product candidates will be authorized for marketing by regulatory authorities, or will be commercially successful; and those described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and elsewhere in such filing and in other subsequent disclosure documents, including our Quarterly Reports on Form 10-Q, filed with the U.S. Securities and Exchange Commission. We cannot assure you that we will realize the results, benefits or developments that we expect or anticipate or, even if substantially realized, that they will result in the consequences or affect us or our business in the way expected. Forward-looking statements are not historical facts and reflect our current views with respect to future events. Given the significant uncertainties, you should evaluate all forward-looking statements made in this presentation in the context of these risks and uncertainties and not place undue reliance on these forward-looking statements as predictions of future events. All forward-looking statements in this presentation apply only as of the date made and are expressly qualified in their entirety by the cautionary statements included in this presentation. We disclaim any intent to publicly update or revise any forward-looking statements to reflect subsequent events or circumstances, except as required by law. Industry and Market Data: We obtained the industry, market, and competitive position data used throughout this presentation from our own internal estimates and research, as well as from industry and general publications, and research, surveys, and studies conducted by third parties. Internal estimates are derived from publicly available information released by industry analysts and third-party sources, our internal research and our industry experience, and are based on assumptions made by us based on such data and our knowledge of the industry and market, which we believe to be reasonable. In addition, while we believe the industry, market, and competitive position data included in this prospectus is reliable and based on reasonable assumptions, we have not independently verified any third-party information, and all such data involve risks and uncertainties and are subject to change based on various factors. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us.
Treatment at the site of disease in the GI tract could improve outcomes for patients with inflammatory bowel disease Our mission is to reimagine therapeutic delivery Needle-free, oral delivery of large molecules designed to replace injection for better management of chronic diseases Innovating smart capsule technologies to deliver the right dose to the right place, safely
THERAPEUTIC PIPELINE PROGRAM PROGRAM INDICATION DESIGN/FEASIBILITY PRECLINICAL CLINICAL TARGETED THERAPEUTICS NaviCap™ Targeted Oral Delivery Platform -- BT-600 NaviCap + tofacitinib UC BT-001 NaviCap + adalimumab variant UC SYSTEMIC THERAPEUTICS BioJet™ Systemic Oral Delivery Platform -- BT-200 BioJet + GLP-1 receptor agonist Diabetes BT-002 BioJet + adalimumab variant Autoimmune Ionis Collaboration BioJet + antisense therapy Undisclosed Large Pharma 1 Collaboration BioJet + undisclosed drug Undisclosed Large Pharma 2 Collaboration BioJet + undisclosed drug Undisclosed
ULCERATIVE COLITIS: THE TREATMENT GAP Despite therapeutics targeting different pathways, few patients achieve long-term remission Alsoud D, Verstockt B, Fiocchi C, Vermeire S. Breaking the therapeutic ceiling in drug development in ulcerative colitis. Lancet Gastroenterol Hepatol. 2021;6(7):589-595. Hirten RP, Sands BE. New Therapeutics for Ulcerative Colitis. Annu Rev Med. 2021;72:199-213. Shivashankar R, Tremaine WJ, Harmsen WS, Loftus EV Jr. Incidence and Prevalence of Crohn's Disease and Ulcerative Colitis in Olmsted County, Minnesota From 1970 Through 2010. Clin Gastroenterol Hepatol. 2017;15(6):857-863. Inflammatory bowel disease (IBD) includes Crohn’s disease and ulcerative colitis (UC) UC causes inflammation and damage to the large intestine About 1 million people in the U.S. are affected with UC, and ~40,000 cases are diagnosed each year3 ABOUT ULCERATIVE COLITIS Treatment begins with 2-3 months of drug therapy to reach therapeutic levels 15-30% of patients achieve remission of symptoms after induction with any drug therapy1,2 UC TREATMENT CYCLE Patients undergo induction (2-3 months) with different drug Efficacy rate decreases with successive rounds of therapy1 60% of patients in remission relapse within 12 months2 INDUCTION TRIAL INDUCTION TRIAL RELAPSE NO RESPONSE MAINTENANCE Patients in remission continue drug therapy to prevent relapse
UNMET NEED IN ULCERATIVE COLITIS Targeted delivery could enable rapid induction and improve patient response THERAPEUTIC CHALLENGES POTENTIAL SOLUTION Systemic toxicity issues may limit daily dosage of UC drugs Reduced systemic uptake is designed to reduce toxicity and adverse events Difficulty of achieving sufficient drug levels at site of disease 1 Targeted delivery is designed to increase drug levels at the site of disease, which is correlated with improved outcomes1 2 Combination therapy is limited by toxicity 3 Reduced toxicity could enable combination therapy2 Development in partnership with: Verstockt B, Alsoud D, van Oostrom J, et al. Tofacitinib tissue exposure correlates with endoscopic outcome. Poster presented at: 17th Congress of the European Crohn’s and Colitis Organisation (ECCO), February 18, 2022, virtual. van Oostrom J, Verstockt B, Hanzel J, et al. Pharmacokinetic stratification of cytokine profiles during anti-TNF induction treatment in moderate-to-severe ulcerative colitis. Poster presented at: 17th Congress of the European Crohn’s and Colitis Organisation (ECCO), February 18, 2022, virtual.
RESEARCH DATA SUPPORTS TARGETED APPROACH Tissue drug concentration correlates with endoscopic outcomes in UC Verstockt B, Alsoud D, van Oostrom J, et al. Tofacitinib tissue exposure correlates with endoscopic outcome. Poster presented at: 17th Congress of the European Crohn’s and Colitis Organisation (ECCO), February 18, 2022, virtual. RESULTS 30 consecutive UC patients with active endoscopic disease initiated treatment with tofacitinib and prospectively monitored median tissue exposure Responders Non-responders IC90 P= 0.04 TOFACITINIB TISSUE EXPOSURE EXCEEDED IC90 IN RESPONDERS Research presented at ECCO 2022 and DDW 2022 in collaboration with: Tofacitinib tissue exposure at the end of induction was associated with endoscopic improvement by week 16 (p=0.04) In responders (n=14), median tofacitinib tissue exposure exceeded IC90
NAVICAP™ TARGETED DRUG DELIVERY PLATFORM Needle-free, oral drug delivery to the colon ORAL ADMINISTRATION Convenient oral capsule the size of a fish-oil pill 1. Lee SN, Razag G, Stork C, et al. Potential effects of food on a novel Drug Delivery System (DDS) to deliver therapeutic compound into the colon. Poster presented at: Crohn’s & Colitis Congress, January 19-21, 2023, Denver, CO. AUTONOMOUS LOCATION GITrac™ autolocation technology enables targeted delivery to the colon, regardless of fasted or fed state1 TARGETED DRUG DELIVERY Method designed to coat the length of the colon with liquid formulation, minimizing systemic uptake
https://biora.wistia.com/medias/r65935rbqs NAVICAP™ TARGETED DRUG DELIVERY PLATFORM Autonomous location and delivery to the colon
DEVICE FUNCTION STUDIES Four successful studies in humans showing the NaviCap™ device was well tolerated and performed as intended 83% of devices accurately identified entry into the colon (10/12)1 Achieved distribution of payload across the entire colon1 No early deployment before colon detection1 PM-601 Device Function Study in Healthy Volunteers – Fasted State Q4 2022 PM-611 Device Function Study in Healthy Volunteers – Fasted & Fed PM-602 Device Function Study in Patients with Active UC BT-603 Device Function Study in Healthy Volunteers – Fasted State HEALTHY VOLUNTEERS Lee SN, Sandefer E, Doll W, et al. A Scintigraphic Study to Evaluate the Safety, Tolerability, and Functionality of a Drug Delivery System (DDS) Device in Healthy Volunteers in Fasted State. Poster presented at: American College of Gastroenterology Annual Scientific Meeting, October 21-26, 2022, Charlotte, NC. Lee SN, Razag G, Stork C, et al. Potential effects of food on a novel Drug Delivery System (DDS) to deliver therapeutic compound into the colon. Poster presented at: Crohn’s & Colitis Congress, January 19-21, 2023, Denver, CO. Martin K, Lee SN, Stork C, et al. A Scintigraphic Study to Evaluate the Localization and Delivery Function of a Drug Delivery System (DDS) Device in Patients with Active Ulcerative Colitis (UC) in Fasted State. Poster presented at: American College of Gastroenterology Annual Scientific Meeting, October 21-26, 2022, Charlotte, NC. Biora Therapeutics internal data FUNCTION WITH/WITHOUT FOOD ACTIVE UC PATIENTS PHASE 1-READY DEVICE 100% of analyzed devices successfully identified entry to the colon and activated gas cells for delivery in all fasted/fed schedules (39/39)2 97.4% of analyzed devices activated the payload release function (38/39)2 100% of devices accurately identified entry into the colon, triggered release of a liquid payload, and achieved distribution across the entire colon (7/7)3 94% of devices accurately identified entry into the colon, triggered release of a liquid payload, and achieved distribution across the entire colon (15/16)4 Q4 2022 Q1 2023 Q2 2023
DEVICE FUNCTION STUDIES Demonstrated accurate localization and delivery to colon Biora Therapeutics internal data ACCURATE LOCALIZATION AND DELIVERY TO HUMAN COLON Clinical device validation for localization and delivery function using scintigraphic imaging in patients with active ulcerative colitis Achieved distribution across the entire colon ACCURATE DELIVERY TO COLON IN CANINES Pharmacokinetic data from two marker drugs administered in canine model Successful delivery to colon via device No early release of drug No drug absorption in upper GI tract
https://www.bioratherapeutics.com/pipeline/targeted-therapeutics#scintigraphy DEVICE FUNCTION STUDIES Scintigraphic imaging of NaviCap delivery in healthy subject Despite variability in the GI environment among subjects, the NaviCap device has been shown to perform as designed across a range of expected differences in motility.
BT-600 PRECLINICAL STUDY RESULTS Reduced systemic uptake, better distribution and tissue coverage Biora Therapeutics internal data RESULTS Non-GLP study; 7 days/QD in canine model compared BT-600 (tofacitinib 10mg liquid formulation delivered via device) vs. standard oral tablet (tofacitinib 10mg) Reduced drug levels in blood vs. standard oral tablet Tissue drug levels at average ~100X higher along the length of the colon vs. standard oral tablet Data suggest that a dose lower than the standard 10mg tofacitinib may provide increased tissue levels while reducing systemic exposure PLASMA LEVEL CMAX ~5X LOWER COLON TISSUE COVERAGE ~100X HIGHER BT-600 10mg Tofacitinib Oral Tablet 10mg
BT-600 (NAVICAP™ + TOFACITINIB) Clinical Development Plan H1 2023 H2 2023 H1 2024 14-DAY GLP TOX STUDY INTERIM DATA Preclinical / IND enabling Clinical 2 weeks/QD Design: SAD/MAD Primary endpoint Safety & tolerability Key secondary endpoints PK/PD ANALYSIS & REPORTING POTENTIAL PHASE 1B IN ACTIVE UC IND FILING & PHASE 1 IN HEALTHY VOLUNTEERS
PHASE 1: SINGLE AND MULTIPLE ASCENDING DOSE STUDIES Evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of BT-600 in healthy volunteers SAD 24 subjects MAD 24 subjects D7 Blood Stool D1 Blood Stool D2 Blood Stool D3 Blood Stool BT-600 Baseline D1 Blood Stool D2 Blood Stool D3 Blood Stool D7 Blood & Tissue Stool Placebo or BT-600 7 days/QD Baseline Blood Stool PATIENT POPULATION Normal healthy volunteers Total of 48 subjects (24 SAD and 24 MAD subjects) STUDY DESIGN Randomized, double-blind (participant and site), placebo-controlled study to evaluate the safety, tolerability, and PK/PD of SAD and MAD doses of BT-600 in healthy subjects OBJECTIVES Demonstrate safety and tolerability of BT-600, assess PK and PD effects of tofacitinib released from BT-600 over 8 days in NHV in blood and in tissue N=9 N=3 5mg Placebo N=9 N=3 10mg Placebo N=9 N=3 10mg 7x QD Placebo N=9 N=3 5mg 7x QD Placebo
Source: Evaluate Pharma; GlobalData Global annual sales forecast for ulcerative colitis therapeutics: $7 billion in 20221 >10 FDA-approved drugs for UC ULCERATIVE COLITIS: TREATMENT LANDSCAPE Potential for market-leading efficacy in tofacitinib creates sizeable opportunity Vedolizumab Adalimumab Ustekinumab Infliximab Tofacitinib / Ozanimod* PRE-BIOLOGICS FIRST-LINE BIOLOGIC SECOND-LINE BIOLOGIC THIRD-LINE BIOLOGIC Adalimumab Infliximab Vedolizumab *Non-biologic drug therapies
UNMET NEED Needles are associated with poor disease management Frost & Sullivan research commissioned by Rani Therapeutics Holdings, Inc. https://ir.ranitherapeutics.com/static-files/b1f080bf-a860-4136-87cb-d6f7c49c1502 Spain CV, Wright JJ, Hahn RM, Wivel A, Martin AA. Self-reported Barriers to Adherence and Persistence to Treatment With Injectable Medications for Type 2 Diabetes. Clin Ther. 2016;38(7):1653-1664.e1. doi:10.1016/j.clinthera.2016.05.009 of diabetics miss 4+ injections per week1 38 % of patients fail to maintain diabetes treatment due to injection concerns when using an injectable GLP-1 agonist2 42 % higher discontinuation rate for diabetes patients initiating treatment with an injectable GLP-1 agonist vs. those starting oral therapy2 71 %
BIOJET™ SYSTEMIC DRUG DELIVERY PLATFORM Needle-free, oral delivery to small intestine ORAL CAPSULE Convenient oral capsule the size of a multivitamin for ease of swallowing PRECISE DELIVERY Enteric trigger for precise timing of drug delivery to the small intestine NEEDLE-FREE ADMINISTRATION Liquid jet injection to the small intestine to maximize systemic uptake RESEARCH COLLABORATIONS Ionis Large Pharma 1 Large Pharma 2
https://biora.wistia.com/medias/embr15eh3a BIOJET™ SYSTEMIC DRUG DELIVERY PLATFORM Liquid jet delivery to the small intestine
Lee SN, Stork C, Valenzuela R, et al. Evaluation of the pharmacokinetics of glucagon-like-peptide-1 (GLP-1) receptor agonist delivered through the BioJet™ oral biotherapeutic delivery platform in a porcine model. Poster presented at: American Diabetes Association 83rd Scientific Sessions, June 23-26, 2023, San Diego, California. PRECLINICAL RESULTS Excellent systemic uptake for orally delivered large molecules demonstrated in animals RESULTS Preclinical studies in swine model with endoscopically placed and triggered next-gen device compared to IV administration of GLP-1 agonist (semaglutide) Average oral bioavailability of 37% ± 15% (N=7; CV:40%), ranging up to 60%1 A repeat study (PSS10) showed similar results with average oral bioavailability of 37% (N=5; CV:57%)1 All dosed animals showed detectable drug levels up to ten days post-dosing.1 No significant clinical signs were observed in any of the animals for up to 10 days1 SYSTEMIC EXPOSURE TO SEMAGLUTIDE FOLLOWING INTRADUODENAL ADMINISTRATION OF THE BIOJET DEVICE (ID) vs. IV CONTROLS
Biora Therapeutics preclinical studies in porcine model with endoscopically placed and activated next-generation device to evaluate device function. Internal data, pending presentation of results at upcoming conference(s). Bioavailability target of 15% set by Biora Therapeutics and pharma collaborators for progression of systemic therapeutics platform. Abbvie, Inc. Humira (adalimumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s417lbl.pdf. Revised February 2021. Accessed March 3, 2023. Lee SN, Stork C, Valenzuela R, et al. Evaluation of the pharmacokinetics of glucagon-like-peptide-1 (GLP-1) receptor agonist delivered through the BioJet™ oral biotherapeutic delivery platform in a porcine model. Poster presented at: American Diabetes Association 83rd Scientific Sessions, June 23-26, 2023, San Diego, California. Novo Nordisk A/S. Rybelsus (oral semaglutide) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213051s006lbl.pdf. Revised January 2023. Accessed March 3, 2023. PRECLINICAL RESULTS Achieved more than double our target bioavailability levels using next-generation device variant of adalimumab (monoclonal antibody) bioavailability average1 51.3% semaglutide (GLP-1 receptor agonist) bioavailability average4 37% 15% target bioavailability2 64% bioavailability via subcutaneous injection in humans for adalimumab3 COMPARISON 15% target bioavailability2 1% bioavailability in humans for commercially available oral semaglutide5 COMPARISON Observed variability (CV) similar to subcutaneous injection for each drug
DEVELOPMENT TIMELINE Systemic Therapeutics Platform Milestones H1 2022 H2 2022 H1 2023 H2 2023 MILESTONES/CATALYSTS Successfully confirmed viability of platform with research-grade device Incorporating updated medical-grade components Intent to replicate data from research-grade device with next-generation device Progress existing collaborations and develop additional agreements Next-Gen Device Development Expand Collaborations & Partnerships Research-Grade Device Function Preclinical Data Generation
Preparing for IND filing with the FDA Subsequently entering the clinic with phase 1 trial Our mission is to reimagine therapeutic delivery Completing development of next-generation device Progressing pharma collaborations Innovating smart capsule technologies to deliver the right dose to the right place, safely
APPENDIX
TARGETED THERAPEUTICS PUBLICATIONS bioratherapeutics.com/publications Development of targeted therapeutic antibodies for the treatment of inflammatory bowel disease: A proof of concept. Poster presented at DDW 2019. A comparison of systemic versus targeted anti-TNFα antibody in treatment of colitis induced by adoptive transfer of CD44-/CD62L+ T-cells into RAG2-/- mice recipients. Presented at DDW 2019. Targeted delivery of soluble tofacitinib citrate to the site of inflammation to improve efficacy and safety. Poster presented at DDW 2021. Development of a novel drug delivery system for treatment of Ulcerative Colitis. Poster resented at DDW 2021. Development of a Novel Drug Delivery System to Deliver Drugs Directly to the Colonic Mucosa, Resulting in Improved Efficacy and Reduced Systemic Exposure for the Treatment of Ulcerative Colitis. Crohn's & Colitis 360. 2021, 3, 1–5. Tofacitinib tissue exposure correlates with endoscopic outcome. Oral presentation at DDW 2022 and BWG. Poster presented at ECCO 2022. Pharmacokinetic stratification of cytokine profiles during anti-TNF induction treatment in moderate-to-severe UC. Poster presented at ECCO 2022 and DDW 2022. Pilot study to assess pharmacokinetic and pharmacodynamic markers following enema-dosing with adalimumab in patients with active ulcerative colitis. Poster presented at ACG 2022. A scintigraphic study to evaluate the safety, tolerability, and functionality of a Drug Delivery System (DDS) device in healthy volunteers in fasted state. Poster presented at ACG 2022. A scintigraphic study to evaluate the localization and delivery function of a Drug Delivery System (DDS) device in patients with active ulcerative colitis (UC) in fasted state. Poster presented at ACG 2022. Development of a novel Drug Delivery System (DDS) to deliver drugs directly to the colonic mucosa to improve efficacy and reduce systemic exposure for the treatment of ulcerative colitis (UC). Poster presented at Crohn’s & Colitis Congress 2023. Potential effects of food on a novel Drug Delivery System (DDS) to deliver therapeutic compound into the colon. Poster presented at Crohn’s & Colitis Congress 2023.
BIOJET™ SYSTEMIC DRUG DELIVERY PLATFORM bioratherapeutics.com/publications Development of ex-vivo and in-vivo models to assess the performance of an oral biotherapeutic delivery system (OBDS) capsule. Poster presented at the Controlled Release Society Annual Meeting, July 13-14, 2022 and at the American College of Gastroenterology Annual Scientific Meeting, October 21-26, 2022. Assessing the performance of an oral biotherapeutic delivery system (OBDS) using intra-duodenal endoscopy delivery in Yucatan minipigs. Poster presented at the Controlled Release Society Annual Meeting, July 13-14, 2022 and at the American College of Gastroenterology Annual Scientific Meeting, October 21-26, 2022. Development of preclinical models to assess the performance of the oral biotherapeutic delivery system (OBDS) capsule. Poster presented at the Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, October 18-19, 2022. Evaluation of the pharmacokinetics of glucagon-like-peptide-1 (GLP-1) receptor agonist delivered through the BioJet™ oral biotherapeutic delivery platform in a porcine model. Poster presented at the American Diabetes Association 83rd Scientific Sessions, June 23-26, 2023.
Other Device & Diagnostic IP 37 patent families covering: Ingestible devices for GI sampling and diagnostics GI sample preservation GI analyte detection & quantification Diagnostic biomarkers & assays BioJet™ Platform 5 patent families covering: Device designs, materials, components, and manufacturing GI-specific trigger compositions Dosing and PK/PD profiles Jet parameters GI delivery by drug class and drug size NaviCap™ Platform 31 patent families covering: Device designs, materials, components, and manufacturing Localization in the GI tract Dosing and PK/PD profiles Liquid drug formulations IBD-specific drug combinations INTELLECTUAL PROPERTY PORTFOLIO Diverse patent portfolio with 73 distinct patent families1 Approximately 167 granted patents and 143 pending applications in major countries and regions around the world
