On this page of StockholderLetter.com we present the latest annual shareholder letter from BIO-PATH HOLDINGS, INC. — ticker symbol BPTH. Reading current and past BPTH letters to shareholders can bring important insights into the investment thesis.

 •  10/28/2024 Letter Continued (Full PDF)
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BPTH Shareholder/Stockholder Letter Transcript:

2023 ANNUAL REPORT


Dear Stockholders:
I am excited to provide you with an update on the significant
progress Bio-Path Holdings, Inc. made during 2023 and
2024. We made exciting updates to our strategic plan, made
advancements in our drug candidates and DNAbilize  
technology and presented such progress at important
conferences in 2023 and 2024. We also raised capital to
support our ongoing development efforts and corporate
operations. We look forward to continuing our success and
furthering our goals.
On August 1, 2023, we reported positive interim data from
Stage 2 of the Phase 2 study of prexigebersen in combination
with decitabine and venetoclax in patients with AML.
Prexigebersen continues to be well-tolerated and has now
shown compelling efficacy results in two reporting cohorts
including evaluable newly diagnosed AML patients and
evaluable refractory/relapsed AML patients, which exceed
outcomes with combination treatment of decitabine and
venetoclax.
On December 14, 2023, we reported the successful
completion of the first dose cohort of the Phase 1/1b clinical
trial of BP1002 to treat patients with refractory/relapsed
acute myeloid leukemia. On January 10, 2024, we reported
the successful completion of the first dose cohort in the
Phase 1 clinical trial of BP1002 to treat refractory/relapsed
lymphoma and refractory/relapsed chronic lymphocytic
leukemia patients.
On April 2, 2024, we reported the development of molecular
biomarkers to accompany prexigebersen treatment with the
goal of identifying patients with a genetic profile more likely
to respond to treatment thereby improving the probability of
success for this program. We expect to develop molecular
biomarker packages for future programs. We also reported
our intention to investigate the use of prexigebersen for the
treatment of obesity.
On April 18, 2024, we reported the successful completion of
the higher dose second cohort in the Phase 1/1b clinical trial
of BP1002 in refractory/relapsed acute myeloid leukemia
patients. On July 8, 2024, we reported that we are evaluating
prexigebersen for the treatment of obesity with the intention
to conduct additional IND-enabling studies with an aim to
advance prexigebersen into first-in-human studies in this
indication.
On June 1, 2024, we presented interim results from the Phase
2 study of BP1001 in combination with decitabine and
venetoclax for the treatment of acute myeloid leukemia in an
oral presentation at the American Society of Clinical
Oncology Annual Meeting and on June 14, 2024, we
presented such interim results at the 2024 European
Hematology Association Congress. Adverse events were
consistent with those expected with decitabine and
venetoclax and/or acute myeloid leukemia. We will continue
to enroll patients in the study.
We also strengthened our intellectual property portfolio in
2023 and 2024. On April 15, 2024, we reported the
expansion of our intellectual property portfolio by filing
patent applications applicable to our technology and
business strategy and that newly issued patents were granted
in Mexico, Australia and Japan. Our patent portfolio
currently includes five issued patents in the U.S. and fiftyfour issued patents in foreign jurisdictions, providing
protection in twenty-one countries. We have five additional
pending patent applications in the U.S. and forty-six patent
applications in foreign jurisdictions across our six families
of applications. We continue our efforts to build protection
around our technology as it safeguards our platform
technology and target-specific technology, is a deterrent to
would-be competitors and creates value around our core
competencies.
We were also able to raise capital to fund our ongoing
development and corporate operations. From August 2023
through the date hereof, we have raised approximately $15.2
million in aggregate net proceeds, including the closings of
a public offering on August 7, 2023, registered direct
offerings with a concurrent private placement on March 27,
2024 and April 19, 2024, and private placements on June 5,
2024 and October 10, 2024. The proceeds from these
offerings help us support our short and long-term strategic
goals.
As always, we thank our dedicated employees, clinical
collaborators, board members and stockholders for their
continued support.
Sincerely,
Peter H. Nielsen
President and Chief Executive Officer

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 10/28/2024 Letter Continued (Full PDF)