BioRestorative Therapies, Inc. Q2 FY2024 earnings call

• The company had a loss from operations of $2.5 million in Q2 2024, a 19% year-over-year improvement and 39% sequential improvement from Q1. Cash used in operating activities was $1.9 million. Ended Q2 with $14.7 million in cash, cash equivalents, and marketable securities with no outstanding debt.
• BRTX-100 Phase 2 study: FDA cleared an amendment to the protocol replacing saline injection with sham injection in the control arm. Enrollment is ongoing with expectation to be fully enrolled by end of 2024. Initial data shows improvement in pain and function for some patients.
• ThermoStem platform: Developed a novel exosome-based biologic program targeting obesity. Entered substantive discussions with a commercial-stage regenerative medicine company regarding licensing of the ThermoStem metabolic disease program. Expanding IP portfolio with notice of allowance for a Japanese patent.
• Strategic agreement with Cartessa validates BioCosmeceuticals platform, with expectation of more revenue from new products in development by fall 2024.

In the second quarter of 2024, total revenues grew to $89,000, a 154% sequential increase from $35,000 in Q1 2024. Revenue was boosted by initial product revenue from the exclusive supply agreement with Cartessa. Although the absolute number is still relatively small, this marked the start of revenue from the commercial platform with Cartessa.

• Expect revenues to continue materially growing from the Cartessa agreement as minimum quantities are supplied. Aim to achieve sustainable profitability.
• Anticipate full enrollment in BRTX-100 Phase 2 study by end of 2024.
• Plan to roll out new BioCosmeceutical products in fall 2024, with opportunity for Cartessa to be involved in marketing and distribution.

Forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ from implied statements. Risks include those detailed in Part 1, Item 1A of the Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC.

Q: Given apparent BRTX 100 data confidence, are you seeing a 2 to 1 trend with more patients?

A: The first four patients had a 3 to 1 randomization, remaining patients are 2 to 1. Seeing improvement and flat trends, with a clear signal as with the first four patients.

Q: Can you help us understand magnitude of minimum Cartessa purchase quantities?

A: It's a low, multi-million-dollar revenue contract over 12 months, part of a five-year exclusive agreement, but specific quarterlies not guided yet.

Q: When is the 10-Q coming out?

A: It's expected to be filed before 5.30 tonight.

Q: Regarding ThermoStem partnering, would you launch study regardless of partnership?

A: Yes, DMS is strategic for third parties to reference preclinical data, allowing partners to leverage first-in-man studies quickly.

Q: What's the duration for preliminary data on BRTX-100?

A: Looking to disclose 52-week mark data on subjects in a blinded fashion.

Q: Have there been patients dosed or randomized into placebo group prior to protocol change?

A: There were a handful, but worked with stats and remain within proper powering numbers.

Q: On G&A expenses, where will they average quarterly?

A: Q1 is usually higher, with G&A likely averaging around $2 million quarterly, with trends higher as trial enrolls.

Q: Is DMF a rate-limiting step for ThermoStem partnering?

A: Not rate-limiting, but a key element to facilitate out-licensing opportunities, incorporating clinical data as programs progress.

Q: Confident in 99-patient enrollment by end of year?

A: Combination of protocol change and hiring Galen for recruiting, projected to meet enrollment target.

Q: Potential for multiple ThermoStem transactions?

A: Possibly multiple deals for different indications, with obesity and metabolic syndrome being key areas.

Q: Opportunity to expand Cartessa agreement or pursue other biocosmetic agreements?

A: Ex-U.S. opportunities for ExoCR, plan to roll out new products in fall 2024, with expectation of more revenue from new products via Cartessa's distribution and marketing.