UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
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Registrant’s Telephone Number, Including Area Code: ( |
4330 La Jolla Village Drive, Suite 200 San Diego, California |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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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 March 28, 2022, Progenity, Inc. issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2021 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 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 Exhibit 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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104 |
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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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Progenity, Inc. |
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Date: |
March 28, 2022 |
By: |
/s/ Aditya P. Mohanty |
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Aditya P. Mohanty |
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Exhibit 99.1 |
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Progenity Provides Corporate Update and Reports
Fourth Quarter and Full Year 2021 Financial Results
Accelerated Company Transformation Toward Oral Delivery of Biotherapeutics and Targeted Therapeutics Programs
Progressed Company’s Targeted Therapeutics Clinical Programs with Initiation of Clinical Device Performance Study in Patients with Ulcerative Colitis
Management will host conference call and webcast today at 4:30 p.m. Eastern / 1:30 p.m. Pacific
SAN DIEGO, March 28, 2022 – Progenity, Inc. (Nasdaq: PROG), an innovative biotechnology company, today provided a corporate update and reported financial results for the fourth quarter and full-year ended December 31, 2021.
In the fourth quarter Progenity made important progress in transforming into an innovation-led biotherapeutics company initially focused on its targeted and systemic biotherapeutics platforms.
The strategy of achieving rapid induction and remission in ulcerative colitis (UC) patients through targeted delivery of therapeutics directly to the tissue of the lower gastrointestinal (GI) tract, which cannot currently be achieved, is gaining momentum. Progenity and its associated key opinion leaders presented at important scientific conferences during the fourth quarter and, more recently, key data demonstrating the potential benefits of that therapeutic approach.
“Progenity is making great strides in its transformation into a biotherapeutics company. In the last few months we have completed the sale of our Avero affiliate, strengthened the focus of the company on our oral therapeutics programs and positioned the company to successfully deliver on its potential to impact the treatment of serious diseases,” said Adi Mohanty, Chief Executive Officer of Progenity.
Mr. Mohanty continued, “We are on track to complete our transformation in the first half of 2022, and look forward to the execution of important clinical study phases of our therapeutics programs this year, which we believe will confirm our early lab and animal data. We are particularly keen to see the progress of our targeted therapeutics program in UC where there is a significant unmet need and growing recognition of the potential of our therapeutic solution as a significant step forward by key opinion leaders”.
Fourth Quarter 2021 Results and Other Recent Corporate Highlights
Fourth Quarter and Full Year 2021 Financial Results
Comparison of Three Months Ended December 31, 2021 and September 30, 2021
The company generated $7.7 million in revenues during the fourth quarter, out of which $7.2 million came from discontinued operations. The company generated $9.7 million in revenues during the third quarter, out of which $9.5 million came from discontinued operations. Operating expenses were $20.6 million for the three months ended December 31, 2021, compared to $30.7 million for the three months ended September 30, 2021.
Net loss was $92.9 million for the three months ended December 31, 2021 and net loss per share was $0.56, compared to net loss of $43.7 million and net loss per share of $0.46 for the three months ended September 30, 2021.
Net loss from discontinued operations was $10.1 million for the three months ended December 31, 2021 and net loss per share for discontinued operations was $0.06, compared to net loss from discontinued operations of $6.9 million and net loss per share of $0.07 for the three months ended September 30, 2021.
Comparison of Three Months Ended December 31, 2021 and 2020
Operating expenses were $20.6 million for the three months ended December 31, 2021, compared to $28.5 million for the three months ended December 31, 2020.
Net loss was $92.9 million for the three months ended December 31, 2021 and net loss per share was $0.56, compared to net loss of $75.5 million and net loss per share of $1.53 for the three months ended December 31, 2020.
Net loss from discontinued operations was $10.1 million for the three months ended December 31, 2021 and net loss per share for discontinued operations was $0.06, compared to net loss from discontinued operations of $23.0 million and net loss per share for discontinued operations of $0.47 for the three months ended December 31, 2020.
Comparison of Full Year Ended December 31, 2021 and 2020
The company generated $60.6 million in revenues during the year ended December 31, 2021, of which $59.4 million were generated from discontinued operations. The company generated $74.3 million in revenues during the year ended December 31, 2020, of which $74.2 million were generated from discontinued operations. Operating expenses were $119.1 million for the year ended December 31, 2021, compared to $107.8 million for the year ended December 31, 2020.
Net loss was $247.4 million for the year ended December 31, 2021 and net loss per share was $2.57, compared to net loss of $192.5 million and net loss per share of $7.00 for the year ended December 31, 2020.
Net loss from discontinued operations was $68.9 million for the year ended December 31, 2021 and net loss per share for discontinued operations was $0.72, compared to net loss from discontinued operations of $87.4 million and net loss per share for discontinued operations of $3.18 for the year ended December 31, 2020.
Webcast and Conference Call Information
Progenity will host a webcast and conference call to discuss the third quarter financial results and answer investment community questions today, Monday, March 28, 2022 at 4:30 p.m. Eastern / 1:30 p.m. Pacific. The live call may be accessed by dialing 877-423-9813 for domestic callers and 201-689-8573 for international callers and entering the conference code: 13727360. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.progenity.com.
About Progenity
Progenity, Inc. is a biotechnology company innovating in the fields of gastrointestinal health and oral biotherapeutics and is developing a suite of investigational ingestible devices designed to provide precise drug delivery solutions and diagnostic sampling. Progenity’s vision is to transform healthcare to become more precise and personal by improving patient outcomes through localized treatment with targeted therapies and improving disease diagnoses.
For more information, visit www.progenity.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 of our research and development efforts, expectations regarding future cash burn and cash burn and expectations regarding cost savings resulting from cost-cutting measures 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 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 precision medicine, 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 future test volumes and revenues, our ability to raise sufficient capital to achieve our business objectives, the ongoing COVID-19 pandemic, and those risks described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Progenity’s Annual Report on Form 10-K for the year ended December 31, 2021 to be filed with the SEC and other subsequent documents, including Quarterly Reports, that we file with the SEC.
Progenity 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@progenity.com
(917) 741-7792
Media Contact:
Kristin Schaeffer
CG Life
media@progenity.com
(858) 457-2436
Progenity, 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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December 31, |
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September 30, |
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Revenues |
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$ |
435 |
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$ |
182 |
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Cost of sales |
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— |
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— |
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Gross profit |
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435 |
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182 |
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Operating expenses: |
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Research and development |
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8,485 |
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12,226 |
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Selling and marketing |
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321 |
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573 |
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General and administrative |
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11,788 |
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17,944 |
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Total operating expenses |
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20,594 |
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30,743 |
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Loss from operations |
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(20,159 |
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(30,561 |
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Interest income (expense), net |
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(2,186 |
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(3,458 |
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Loss on warrant liability |
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(48,339 |
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(3,322 |
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Other income (expense), net |
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(12,222 |
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467 |
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Loss before income taxes |
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(82,906 |
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(36,874 |
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Income tax benefit |
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(119 |
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— |
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Loss from continuing operations |
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(82,787 |
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(36,874 |
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Loss from discontinued operations |
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(10,087 |
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(6,870 |
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Net loss |
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$ |
(92,874 |
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$ |
(43,744 |
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Net loss per share from continuing operations, basic and diluted |
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$ |
(0.50 |
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$ |
(0.38 |
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Net loss per share from discontinued operations, basic and diluted |
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$ |
(0.06 |
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$ |
(0.07 |
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Net loss per share, basic and diluted |
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$ |
(0.56 |
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$ |
(0.46 |
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Weighted average shares outstanding, basic and diluted |
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166,072,192 |
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95,846,672 |
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Progenity, 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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Year Ended December 31, |
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2021 |
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2020 |
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2021 |
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2020 |
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Revenues |
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$ |
435 |
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106 |
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$ |
1,247 |
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$ |
162 |
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Cost of sales |
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— |
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— |
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— |
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— |
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Gross profit |
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435 |
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106 |
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1,247 |
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162 |
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Operating expenses: |
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Research and development |
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8,485 |
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11,226 |
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45,785 |
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47,743 |
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Selling and marketing |
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321 |
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1,151 |
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4,758 |
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5,949 |
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General and administrative |
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11,788 |
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16,110 |
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68,541 |
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54,089 |
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Total operating expenses |
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20,594 |
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28,487 |
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119,084 |
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107,781 |
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Loss from operations |
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(20,159 |
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(28,381 |
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(117,837 |
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(107,619 |
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Interest income (expense), net |
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(2,186 |
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(2,687 |
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(12,636 |
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(9,915 |
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Loss on warrant liability |
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(48,339 |
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— |
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(54,157 |
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— |
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Other income (expense), net |
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(12,222 |
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(21,294 |
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5,990 |
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(25,084 |
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Loss before income taxes |
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(82,906 |
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(52,362 |
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(178,640 |
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(142,618 |
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Income tax benefit |
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(119 |
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164 |
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(119 |
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(37,532 |
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Loss from continuing operations |
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(82,787 |
) |
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(52,526 |
) |
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(178,521 |
) |
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(105,086 |
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Loss from discontinued operations |
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(10,087 |
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(23,002 |
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(68,891 |
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(87,442 |
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Net loss |
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(92,874 |
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(75,528 |
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(247,412 |
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(192,528 |
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Dividend paid to preferred stockholders |
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— |
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— |
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— |
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(268 |
) |
Net loss attributable to common stockholders |
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$ |
(92,874 |
) |
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$ |
(75,528 |
) |
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$ |
(247,412 |
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$ |
(192,796 |
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Net loss per share from continuing operations, |
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$ |
(0.50 |
) |
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$ |
(1.07 |
) |
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$ |
(1.86 |
) |
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$ |
(3.82 |
) |
Net loss per share from discontinued operations, |
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$ |
(0.06 |
) |
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$ |
(0.47 |
) |
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$ |
(0.72 |
) |
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$ |
(3.18 |
) |
Net loss per share, basic and diluted |
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$ |
(0.56 |
) |
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$ |
(1.53 |
) |
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$ |
(2.57 |
) |
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$ |
(7.00 |
) |
Net loss per share attributable to common |
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$ |
(0.56 |
) |
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$ |
(1.53 |
) |
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$ |
(2.57 |
) |
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$ |
(7.01 |
) |
Weighted average shares outstanding, |
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166,072,192 |
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49,288,579 |
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96,154,672 |
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27,512,876 |
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Progenity, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
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December 31, |
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December 31, |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
88,397 |
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$ |
92,076 |
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Accounts receivable, net |
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653 |
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6,634 |
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Prepaid expenses and other current assets |
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7,232 |
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8,632 |
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Current assets of disposal group held for sale |
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2,147 |
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18,996 |
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Total current assets |
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98,429 |
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126,338 |
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Property and equipment, net |
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4,012 |
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8,106 |
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Other assets |
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326 |
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169 |
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Goodwill |
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6,072 |
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6,072 |
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Long-term assets of disposal group held for sale |
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— |
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13,755 |
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Total assets |
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$ |
108,839 |
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$ |
154,440 |
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Liabilities and Stockholders' Deficit |
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Current liabilities: |
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Accounts payable |
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$ |
8,709 |
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$ |
17,379 |
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Accrued expenses and other current liabilities |
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34,157 |
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54,437 |
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Warrant liability |
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18,731 |
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— |
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Current portion of mortgages payable and capital lease obligations |
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12 |
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|
338 |
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Current liabilities of disposal group held for sale |
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— |
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|
516 |
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Total current liabilities |
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61,609 |
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72,670 |
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Mortgages payable and capital lease obligations, net of current portion |
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— |
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1,317 |
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Convertible notes, net |
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126,392 |
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158,886 |
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Embedded derivative liability |
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— |
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18,370 |
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Other long-term liabilities |
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|
5,814 |
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|
8,667 |
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Long-term liabilities of disposal group held for sale |
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— |
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|
1,524 |
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Total liabilities |
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$ |
193,815 |
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$ |
261,434 |
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Stockholders' deficit: |
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Common stock |
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146 |
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59 |
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Additional paid-in capital |
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722,646 |
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452,992 |
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Accumulated deficit |
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(788,686 |
) |
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(541,274 |
) |
Treasury stock |
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(19,082 |
) |
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(18,771 |
) |
Total stockholders' deficit |
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(84,976 |
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(106,994 |
) |
Total liabilities and stockholders' deficit |
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$ |
108,839 |
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$ |
154,440 |
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CORPORATE PRESENTATION March 2022 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 facts 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 clinical trials, the anticipated timing for 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 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, 2021, 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.
WHAT WE DO Developing innovative oral biotherapeutics for gastrointestinal health and beyond. TARGETED THERAPEUTICS SYSTEMIC THERAPEUTICS PGN-001 Adalimumab variant + DDS PGN-OB1 Adalimumab variant + OBDS PGN-OB2 GLP-1 agonist + OBDS Ionis Pharma Antisense therapy + OBDS Large Pharma 1 Undisclosed drug + OBDS Large Pharma 2 Undisclosed drug + OBDS OBDS Systemic Oral Biotherapeutics Delivery System DDS Targeted Drug Delivery System PGN-600 Tofacitinib + DDS Capsule technology designed for systemic delivery of biotherapeutics, replacing injection with needle-free, oral delivery technology. Targeted delivery of therapeutics to the site of disease in the gastrointestinal tract could improve outcomes for patients with IBD.
PROGRAM PROGRAM INDICATION DESIGN/FEASIBILITY PRECLINICAL CLINICAL TARGETED THERAPEUTICS DDS IBD PGN-600 Ulcerative Colitis PGN-001 Ulcerative Colitis SYSTEMIC THERAPEUTICS OBDS -- PGN-OB1 Autoimmune PGN-OB2 Diabetes -- Undisclosed -- Undisclosed -- Undisclosed THERAPEUTICS PIPELINE GLP-1 agonist + Device Antisense Therapy + Device Undisclosed Drug + Device Adalimumab variant + Device Tofacitinib + Device Undisclosed Drug + Device Targeted Therapeutics Device Adalimumab variant + Device Systemic Therapeutics Device in partnership with LARGE PHARMA 1 in partnership with LARGE PHARMA 2 in partnership with
TARGETED THERAPEUTICS
Despite advanced therapeutics targeting different pathways, few patients achieve long-term remission ULCERATIVE COLITIS: THE TREATMENT GAP 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. Treatment begins with induction: 2-3 months of drug therapy to reach therapeutic levels Only 15% of patients achieve remission of symptoms following induction with any drug therapy1,2 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 The goal is deep remission: a combination of symptom remission and endoscopic healing TREATMENT OBJECTIVE UC TREATMENT CYCLE Patient undergoes induction (2-3 months) with a different drug. Efficacy rate decreases with successive rounds of therapy1 60% of patients who achieve short-term remission relapse within 12 months2 INDUCTION TRIAL INDUCTION TRIAL RELAPSE NO RESPONSE MAINTENANCE Patients who achieve remission continue drug therapy to prevent relapse
TARGETED THERAPEUTICS: A POTENTIAL SOLUTION FOR UNMET NEED IN UC Verstockt B, Alsoud D, van Oostrom J, et al. Tofacitinib tissue exposure correlates with endoscopic outcome. Oral presentation at the 34th edition of the Belgian Week of Gastroenterology, February 9, 2022. 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. doi:10.1016/S2468-1253(21)00065-0 Van Oostrom J, Hanzel J, Verstockt B, et al. Pharmacokinetic stratification of cytokine profiles during anti-TNF induction treatment in moderate-to-severe ulcerative colitis. Poster presented at the 17th Congress of the European Crohn’s and Colitis Organisation (ECCO); February 18, 2022. UC drugs have systemic toxicity issues that may limit daily dosage Achieving sufficient drug levels at the site of disease is difficult with systemic delivery. Only 1 in 4 UC patient achieves short-term response2 UC has multiple pathways,3 but current protocols target single pathways due to toxicity concerns Reduced systemic uptake should reduce toxicity and adverse events Increased drug levels in tissue are correlated with improved endoscopic outcomes1 Targeted delivery could enable rapid induction, which should improve patient response Targeted delivery could enable combination therapy to target multiple inflammatory pathways simultaneously3 1 2 3 4 CURRENT THERAPEUTIC CHALLENGES FOR UC TARGETED THERAPEUTIC DELIVERY: POTENTIAL SOLUTIONS
OUR IBD SOLUTION: TARGETED THERAPEUTICS Targeted drug delivery to the GI tract designed to improve efficacy and safety Targeted delivery designed to improve endoscopic outcomes by increasing drug levels at the site of disease Payload delivery method designed to minimize systemic uptake, potentially reducing adverse effects Reduced systemic toxicity could finally enable combination therapy ORAL ADMINISTRATION Oral capsule approximately the size of a fish oil capsule for patient convenience FLEXIBLE FORMULATION Delivers a payload of ~500µl liquid or solid formulation to the desired location ACCURATE DELIVERY Proprietary autolocation in the GI tract for accurate drug delivery Research in partnership with: watch activation video ADVANTAGES OF OUR APPROACH
TARGETED THERAPEUTICS: PRECLINICAL RESULTS BETTER PK EFFECT & COVERAGE Pharmacokinetic data from two marker drugs administered in canine model indicated: Successful delivery to colon via DDS No early release of drug No drug absorption in upper GI tract Standard oral dose vs. PGN-600 (tofacitinib delivered via DDS capsule) in canine model demonstrated: Reduced drug levels in blood vs. standard oral dose Tissue drug levels at least 25x higher along the length of the colon vs. standard oral dose ACCURATE DELIVERY TO THE COLON
TARGETED THERAPEUTICS: CLINICAL DEVICE PERFORMANCE Accurate localization and delivery demonstrated in humans Successful clinical device validation for localization and delivery function using scintigraphic imaging: Safety and tolerability in normal healthy volunteers; devices recovered intact 83% accuracy of localization function (10/12) No early release before colon detection DEVICE LOCALIZATION AND DELIVERY TO COLON
TARGETED DELIVERY: SUPERIOR PHARMACODYNAMICS IN MULTIPLE MOLECULES Anti-TNFα in animal models Systemic delivery via intraperitoneal injection (IP) vs. targeted intracecal delivery (IC) of anti-TNFα in mouse model of T-cell transfer colitis demonstrated: Significantly improved histopathology score vs. systemic delivery Significantly reduced inflammatory cytokines vs. systemic delivery T-cell counts reduced in proximal colon (decrease in inflammation) vs. systemic delivery *Pair-wise comparisons by two-tailed Mann-Whitney U-Test; p<0.05 Targeted Delivery (IC) of anti-TNFα to Proximal Colon Systemic Delivery (IP) of anti-TNFα to Proximal Colon IMPROVED HISTOPATHOLOGY SCORE T-Cell Immunohistochemistry (CD4+) REDUCED INFLAMMATORY CYTOKINES REDUCED T-CELL COUNTS
TARGETED THERAPEUTICS CLINICAL PLAN FUNCTION STUDIES TOX STUDY PHASE 1 CLINICAL STUDIES PHASE 1B/2A CLINICAL STUDIES PM-601 Device Function Study in Normal Healthy Volunteers Device was well tolerated Achieved pan-colon distribution of payload Accurately identified entry into the colon (10/12); no early deployment PM-602 Device Function Study in Patients with Active Ulcerative Colitis Recruiting PGN-600 Tox GLP Up to 30 animals in three groups: Oral pill Device only (10 mg) Device + drug (25 mg) 8 weeks/QD PGN-600 Single & Multiple Dose in Healthy Volunteers Up to 50 total subjects (25 single dose / 25 multiple dose) 1 week PGN-600 Safety and Efficacy in Subjects with Moderate to Severe Ulcerative Colitis Who Have Been Previously Exposed to TNF Antagonist OBJECTIVES Scintigraphy confirmation of device location, drug release, and colon coverage OBJECTIVES Confirmation of device location, drug release, and colon coverage Previous Tox Study (2021) 7 days/QD in canines No safety signals were observed OBJECTIVES Scintigraphy confirmation of device location, drug release, and colon coverage OBJECTIVES Demonstrate safety & tolerability, PK/PD of PGN-600 in UC patients Estimate % of patients with clinical remission after 8 weeks treatment with PGN-600
Rx SYSTEMIC THERAPEUTICS
among diabetes patients initiating treatment with injectable GLP-1 agonist NEEDLE AVERSION LEADS TO POOR PATIENT ADHERENCE Patients prefer oral delivery of medication Wright S, Yelland M, Heathcote K, Ng SK, Wright G. Fear of needles--nature and prevalence in general practice. Aust Fam Physician. 2009;38(3):172-176. 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 Frost & Sullivan research commissioned by Rani Therapeutics Holdings, Inc. https://ir.ranitherapeutics.com/static-files/b1f080bf-a860-4136-87cb-d6f7c49c1502 of patients fail to maintain injectable treatment due to needle aversion3 of adults avoid medical treatment due to fear of needles1 42% 20% 88% of patients prefer a daily oral capsule to bi-weekly injection3 among rheumatoid arthritis patients undergoing anti-TNFα therapy
SYSTEMIC THERAPEUTICS DELIVERY SYSTEM Needle-free, oral delivery to small intestine designed for optimal systemic uptake Needle-free, liquid jet administration to intestinal tissue for enhanced systemic uptake More frequent administration vs. injection may improve outcomes Versatile platform can deliver a range of large molecules, including: Monoclonal antibodies Peptides Nucleic acids LIQUID FORMULATION Delivers a payload of ~400µl liquid drug with little to no reformulation PRECISE DELIVERY Enteric trigger for precise timing of drug delivery to the small intestine NEEDLE-FREE ADMINISTRATION Capsule about the size of a multivitamin for pain-free oral administration RESEARCH PARTNERSHIPS ADVANTAGES OF SYSTEMIC ORAL BIOTHERAPEUTICS Large Pharma 1 Large Pharma 2 watch activation video
SYSTEMIC THERAPEUTICS: PRECISION DELIVERY Preclinical studies demonstrate precise and reliable release of payload ACCURATE DELIVERY IN SMALL INTESTINE STUDY DESIGN RESULTS Capsule loaded with a radio-opaque marker (iohexal) Two different enteric triggers evaluated Sequential imaging as the capsule transits through the GI tract in canines Reliable triggering and iohexal release Ability to optimize timing of trigger release No safety issues observed chamber empty After deployment in the small intestine T iohexol in chamber Immediately after dosing in the stomach
EXCELLENT SYSTEMIC UPTAKE FOR ORALLY DELIVERED LARGE MOLECULES Demonstrated up to 67% bioavailability for monoclonal antibodies Progenity internal data Multiple studies in swine model with endoscopically placed, autonomous device compared to IV administration Achieved up to 67% bioavailability for a variant of adalimumab1 Most recent study had an average of 22% bioavailability in animals where drug was detected in blood1 For comparison, commercially available oral large molecules achieve bioavailability of 1% or less BIOAVAILABILITY COMPARABLE TO IV ADMINISTRATION
MILESTONES & CORPORATE HIGHLIGHTS
OTHER PLATFORMS IN DEVELOPMENT PLATFORM DESCRIPTION DEVELOPMENT PLANS RSS: RECOVERABLE SAMPLING SYSTEM Ingestible capsule designed to autonomously identify locations in the GI tract, collect and preserve a sample for recovery and analysis. Presenting microbiome sampling data at DDW 2022 Continuing device development PIL Dx Ingestible capsule designed to sample, measure, and transmit results. Potential for on-board fluorescent assays measuring bacteria, proteins, and drugs, plus additional detection modalities. Continuing device development and preclinical research PREECLUDIA™ TEST SINGLE-MOLECULE DETECTION PLATFORM For patients with symptoms of possible preeclampsia, the Preecludia test assesses risk by evaluating multiple pathophysiological pathways. Novel, single-molecule counting assay, initially for NIPT. Potentially applicable to known genomic, epigenomic, and proteomic targets. Validation study results were published in the Journal of Pharmaceutical and Biomedical Analysis Further development of diagnostic testing has been discontinued at Progenity; managed process for licensing to potential commercial partners is ongoing
PROGRAM Q1 2022 Q2 2022 Q3 2022 Q4 2022 Q1 2023 ENABLES PM-611 PM-602 Establishes device performance in healthy volunteers & UC patients PRECLINICAL TOXICOLOGY Preclinical toxicology to support phase 1b/2a study PHASE 1 CLINICAL TRIAL Evaluate the safety & tolerability, PK/PD of PGN-600 subject to FDA review PRECLINICAL STUDIES Bioavailability performance of oral delivery of biologics using OBDS; enables human studies CLINICAL STUDIES Establish device performance in healthy volunteers NEAR-TERM POTENTIAL CATALYSTS Preclinical Tox Initiate clinical studies Preclinical PK studies SYSTEMIC THERAPEUTICS TARGETED THERAPEUTICS PM-611 PM-602 Phase 1
