Announcement • May 16
Bio-Path Holdings, Inc. announced delayed 10-Q filing On 05/15/2026, Bio-Path Holdings, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Nov 18
Bio-Path Holdings, Inc. announced delayed 10-Q filing On 11/17/2025, Bio-Path Holdings, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Jul 04
Nasdaq to Delist Common Stock of Bio-Path Holdings The Nasdaq Stock Market announced that it will delist the common stock of Bio-Path Holdings, Inc. Bio-Path’s stock was suspended on February 19, 2025 and has not traded on Nasdaq since that time. Announcement • Jun 03
Bio-Path Holdings, Inc. Provides Clinical and Operational Update Bio-Path Holdings, Inc. announced highlights from the recent clinical development and operational update conference call and webcast held May 26, 2025. Prexigebersen Phase 2 Clinical Trial - Bio-Path's Phase 2 clinical trial for the treatment of AML is comprised of three cohorts of patients and treatments, each separately approvable by the FDA as a new indication. The first two cohorts are treating patients with the triple combination of prexigebersen, decitabine and venetoclax. These patients have each received over 15 treatment cycles and remain in complete remission. Bio-Path expects to utilize an advisory panel of AML experts to assist in the design of the final clinical development plans through potential FDA approval. Other significant milestones expected during 2025 include the completion of Cohort 2 and an interim analysis for Cohort 3. Phase 1b Clinical Trial in BP1001-A in Advanced Solid Tumors - A Phase 1/1b clinical trial of BP1001-A in patients with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer, is ongoing. BP1001-A is a modified product candidate that incorporates the same drug substance as prexigebersen but has a slightly modified formulation designed to enhance nanoparticle properties. The Phase 1 study has advanced to the second, higher dose level and the first patient in the second dose cohort continued experiencing a positive response which may signal that this analog of prexigebersen has potential as a new treatment for advanced solid tumors. The patient continues to be doing well after failing extensive chemotherapy and surgical treatment for gynecologic cancer, demonstrating a 15% reduction in her primary tumor through ten cycles of treatment. Phase 1/1b Clinical Trial in BP1002 in Relapsed/Refractory AML - A Phase 1/1ss clinical trial for BP1002 to treat relapsed/refractory AML patients, including venetoclax-resistant patients, is ongoing. In 2025, Bio-Path expects to complete preclinical testing and to file an Investigational New Drug (IND) application. These composition patents allow the Company to apply its core technology to new protein targets and receive new 20-year patents. Announcement • May 01
Bio-Path Holdings, Inc. Achieves Third Pre-Clinical Milestone Confirming Potential of Bp1001-A as Treatment for Obesity in Type 2 Diabetes Patients Bio-Path Holdings, Inc. reported the achievement of a third milestone from recent preclinical studies of BP1001-A that provide additional support for its potential as a treatment for obesity. These studies showed BP1001-A rescues the decrease in AKT activity in liver cells and prevents cells from becoming insulin resistant, confirming its potential as a treatment for diabetes patients. A high fat diet rich in saturated fatty acids can lead to insulin resistance. Palmitic acid, the most common saturated fatty acid in a high fat diet, has been shown to impair insulin signaling in skeletal muscle and liver. Accordingly, Bio-Path has focused preclinical testing of BP1001-A in C2C12 myoblasts (a muscle proteitor cell model), C2C12 myotubes (a skeletal muscle fiber cell model), and HepG2 cells (a liver cell model). Bio-Path previously announced that by downregulating Grb2 expression, BP1001-A attenuated palmitic acid-induced insulin resistance and restored insulin signaling in C2C12 myobubes and myotubes. In the final step of pre-clinical testing, Bio-Path will use a mouse model to assess the impact of BP1001-A on animal weight and its effect on insulin sensitivity and glucose tolerance. If successful, Bio-Path anticipates filing an Investigational New Drug (IND) application in 2025 to initiate a first-in-human Phase 1 clinical trial to further validate safety, measure pharmacokinetics and establish dosing for potential pivotal trials. BP1001-A downregulates growth factor receptor-bound protein 2 (Grb2) expression to increase insulin sensitivity and helps lower blood glucose level in Type 2 diabetes patients. Bio-Path is conducting preclinical studies to investigate the effectiveness of BP1001-A in affecting insulin signaling and its potential efficacy as a therapeutic treatment for obese patients who have Type 2 diabetes. Announcement • Apr 12
Bio-Path Holdings, Inc. has filed a Follow-on Equity Offering. Bio-Path Holdings, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock Announcement • Apr 10
Bio-Path Holdings, Inc. has withdrawn its Follow-on Equity Offering in the amount of $10 million. Bio-Path Holdings, Inc. has withdrawn its Follow-on Equity Offering in the amount of $10 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 13,003,901
Price\Range: $0.769
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 13,003,901
Security Name: Series A Common Warrants
Security Type: Equity Warrant
Securities Offered: 13,003,901
Security Name: Series B Common Warrants
Security Type: Common Stock
Securities Offered: 13,003,901
Security Name: Series C Common Warrants
Security Type: Equity Warrant
Securities Offered: 13,003,901 Announcement • Mar 29
Bio-Path Holdings, Inc. announced that it expects to receive $0.1005 million in funding from 1800 Diagonal Lending, LLC Bio-Path Holdings, Inc. entered into a securities purchase agreement with 1800 Diagonal Lending LLC to issue promissory note in the aggregate principal amount of $100,050 for a purchase price of $87,000 after deducting the original issue discount of $13,050 on March 28, 2025. The Note bears a one-time interest charge of 12% that is applied on the date of issuance, March 28, 2025. The Note shall be paid in five payments with the first payment of $56,028 due on September 30, 2025 and each subsequent payment shall be equal to $14,007 which are due on October 30, 2025, November 30, 2025, December 30, 2025 and January 30, 2026. Announcement • Mar 18
Bio-Path Holdings Announces Pre-Clinical Results Signaling Increased Potential for BP1001-A as Treatment for Obesity in Type 2 Diabetes Patients Bio-Path Holdings, Inc. reported results from recent preclinical studies of BP1001-A that support its potential as a treatment for obesity. In these studies, BP1001-A attenuated fatty acid-induced insulin resistance and restored insulin sensitivity in muscle progenitor and skeletal muscle fiber cell models, which signal increased potential for BP1001-A as a treatment for obesity and related metabolic diseases in Type 2 diabetes patients. Updated results from BP1001-A obesity and Type 2 diabetes testing from the second stage of pre-clinical testing are as follows: Previously, Bio-Path reported BP1001-A increased insulin sensitivity in myoblast cells (muscle progenitor cells). These data show BP1001-A has increased potential as a treatment for obese patients who have Type 2 diabetes. In the final step of pre-clinical testing, Bio-Path will use a mouse model to assess the impact of BP1001-A on animal weight and its effect on insulin sensitivity and glucose tolerance. If successful, Bio-Path anticipates filing an Investigational New Drug (IND) application in 2025 to initiate a first-in-human Phase 1 clinical trial to further validate safety, measure pharmacokinetics and establish dosing for potential pivotal trials. Announcement • Mar 08
Bio-Path Holdings, Inc. announced that it has received $0.14 million in funding from 1800 Diagonal Lending, LLC Bio-Path Holdings, Inc entered into a securities purchase agreement with new investor, 1800 Diagonal Lending LLC, for the issuance and sale of a promissory note in the aggregate principal amount of $161,000 for a purchase price of $140,000 after deducting the original issue discount of $21,000 for gross proceeds $140,000 on March 5, 2025. A one-time interest charge of 12% matures on December 30, 2025. Announcement • Feb 21
Bio-Path Holdings, Inc.(OTCPK:BPTH) dropped from S&P TMI Index Bio-Path Holdings, Inc.(OTCPK:BPTH) dropped from S&P TMI Index Announcement • Feb 19
Bio-Path Holdings, Inc.(OTCPK:BPTH) dropped from NASDAQ Composite Index Bio-Path Holdings, Inc. has been dropped from the NASDAQ Composite Index. Announcement • Feb 14
Bio-Path Holdings, Inc. Provides an Update from It's Ongoing Phase 1/1B Clinical Trial of BP1001-A in Solid Tumor Patients and Reports Continued Patient Progress from it's Ongoing Phase 2 Triple Combination Study of Prexigebersen in Acute Myeloid Leukemia Bio-Path Holdings, Inc. provided an update from the Company's ongoing Phase 1/1b clinical trial of BP1001-A in solid tumor patients and reports continued patient progress from the Company's ongoing Phase 2 triple combination study of prexigebersen in Acute Myeloid Leukemia (AML). Solid Tumor Patient Response in Second, Higher Dose Cohort – Previously, Bio-Path reported its first patient in the second dose cohort in its Phase 1/1b advanced solid tumor clinical trial experienced a positive response that may signal that this analog of prexigebersen has potential as a new treatment for advanced solid tumors. The patient appears to be doing well on study after failing extensive chemotherapy and surgical treatment for gynecologic cancer, demonstrating a 15% reduction in her primary tumor through six cycles of treatment. Moreover, it appears that these positive outcomes may have contributed to allowing her to continue with rigorous exercise and improved quality of life. As of January 2025, this patient continues doing well on treatment, recently completing nine cycles and is now in her tenth treatment cycle. The dose finding portion of the Phase 1/1b trial is comprised of BP1001-A monotherapy with no accompanying chemotherapy. This clinical trial of BP1001-A in patients with advanced or recurrent solid tumors has successfully completed the initial prescribed dose in the first cohort of 60 mg/m and began enrollment in the higher dose cohort of 90 mg/m. The Phase 1b portion of the study is expected to commence after completion of three planned BP1001-A monotherapy dose level cohorts and is intended to assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors. Phase 1b studies are also expected to be opened in combination with gemcitabine in late-stage pancreatic cancer. AML Patients Demonstrate Extended Treatment Durability – Previously, Bio-Path reported two patients were identified in the Phase 2 clinical trial treating AML patients who demonstrated continued treatment durability. As of January 2025, both these patients are receiving treatment and are continuing to do well. The first patient is an elderly female who had received 16 cycles of treatment over 21 months when first reported on. She continues on study having received 20 cycles over 26 months and she remains in complete remission. The second patient is an elderly male who had received 12 cycles of treatment over 14 months when first reported on. He continues on study having received 16 cycles over 20 months and remains in complete remission. Both patients are being treated with the triple combination of prexigebersen, decitabine and venetoclax. Announcement • Feb 13
Bio-Path Holdings, Inc. Provides Update from Phase 1/1b Clinical Trial of BP1002 for Treatment of Refractory/Relapsed Acute Myeloid Leukemia Bio-Path Holdings, Inc. provided an update from the Company's ongoing Phase 1/1b clinical trial evaluating BP1002 for the treatment of refractory/relapsed acute myeloid leukemia (AML), including venetoclax-resistant patients. The Company announced a meaningful patient response to treatment and the clinical trial has progressed to the fourth, higher dose cohort of 90 mg/m2. A published study found that AML patients who had relapsed from frontline venetoclax-based treatment were refractory to salvage therapy and had a median survival of less than 3 months. By targeting Bcl-2 at the mRNA level rather than the protein, BP1002 may overcome and prevent some of the mechanisms of resistance that affect venetoclax treatment. The Phase 1/1b clinical study is being conducted at several leading cancer centers in the United States, including the Weill Medical College of Cornell University, The University of Texas MD Anderson Cancer Center, Scripps Health, and The University of California at Los Angeles Cancer Center. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study is expected to commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients. Gary Schiller, M.D., The University of California at Los Los Angeles Cancer Center, Maro Ohanian, D.O., Department of Leukemia, University of Texas MD Anderson Cancer center, and David Hermel, M.D., Scripps Health, are each serving as principal investigators. Announcement • Dec 19
Bio-Path Holdings, Inc. Announces Preclinical Testing of Bp1001-A as Potential Treatment for Obesity in Type 2 Diabetes Patients Enhances Insulin Sensitivity Bio-Path Holdings, Inc. reported that results from preclinical studies of BP1001-A for obesity demonstrated enhanced insulin sensitivity, confirming BP1001-A as a potential treatment for obesity and related metabolic diseases in Type 2 diabetes patients. BP1001-A downregulates growth factor receptor-bound protein 2 (Grb2) expression to increase insulin sensitivity and helps lower blood glucose level in Type 2 diabetes patients. Scientific evidence suggests that by downregulating Grb2 expression, BP1001-A could help lower blood glucose level by affecting insulin signaling. Bio-Path conducted preclinical studies that confirmed the effectiveness of BP1001-A in affecting insulin signaling and its potential efficacy as a therapeutic treatment for obese patients who have Type 2 diabetes. The study results showed: BP1001-A reduced Grb2 protein expression in myoblast cells; BP1001-A increased the levels of phosphorylated AKT and phosphorylated FOXO-1 in myoblast and hepatoma cells in the presence of insulin. These initial data confirmed that by downregulating Grss2 expression, BP1001- A could enhance insulin-induced metabolic events by affecting the insulin/phosphoinositol-3 kinase (PI3K)/AKT pathway and increase insulin sensitivity. Bio-Path has initiated animal studies to confirm the efficacy of BP1001-A as a potentially treatment for obesity and related metabolic disease in Type 2 diabetes patients. If successful, Bio-Path anticipates initiating a first-in-human Phase 1 clinical trial in 2025 to further validate safety, measure pharmacokinetics and establish dosing for potential pivotal trials. Announcement • Dec 14
Bio-Path Holdings Receives Non-Compliance Letter Regarding Nasdaq Listing Rule 5550(a)(2) On December 12, 2024, Bio-Path Holdings, Inc. (the Company") received a letter (the Letter") from the Listing Qualifications Department of the Nasdaq Stock Market (Nasdaq") indicating that, based upon the closing bid price of the Company's common stock for the last 30 consecutive business days, the Company did not meet the minimum bid price of $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the Rule"). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided an initial period of 180 calendar days, or until June 10, 2025, to regain compliance with the Rule. The Letter also indicated that if at any time before June 10, 2025 the closing bid price for the Company's common stock is at least $1.00 for a minimum of ten consecutive business days, Nasdaq will provide written notification to the Company that it complies with the Rule. The Letter has no effect on the listing of the Company's common stock at this time, and the Company's common stock will continue to trade on The Nasdaq Capital Market under the symbol BPTH." If the Company does not regain compliance with the Rule by June 10, 2025, the Company may be eligible for a second compliance period of 180 calendar days, provided that the Company meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and notifies Nasdaq of the Company's intention to cure the deficiency during such second compliance period, including by effecting a reverse stock split, if necessary. If the Company does not regain compliance with the Rule by June 10, 2025 and is not eligible for a second compliance period at that time, Nasdaq will provide written notification to the Company that its common stock may be delisted. At that time, the Company may appeal Nasdaq's delisting determination to a Nasdaq Hearings Panel (the Panel"). If the Company timely appeals, it would remain listed pending the Panel's decision. There can be no assurance that, if the Company does appeal the delisting determination by Nasdaq to the Panel, such appeal would be successful. The Company intends to continue to monitor the closing bid price of its common stock and may, if appropriate, consider implementing available options to regain compliance with the Rule, including by effecting a reverse stock split. Announcement • Dec 12
Bio-Path Holdings, Inc. Announces Plans to Discontinue Its Phase 1 Clinical Trial Evaluating Bp10012 as A Treatment for Obesity and Relapsed/Refractory Chronic Lymphocytic Leukemia Due to Enrollment Challenges in Niche Patient Populations Bio-Path Holdings, Inc. outlined the growing body of scientific evidence that Bio-Path believes supports the development of BP1001-A for the treatment for obesity and related metabolic diseases in Type 2 diabetes patients. Patients diagnosed with Type 2 diabetes are at high risk of developing life-threatening co-morbidities and often experience a poor quality of life. Lowering blood glucose levels is the principal goal in the treatment of patients with Type 2 diabetes. Scientific evidence suggests that by downregulating growth factor receptor-bound protein 2 (Grb2) expression, BP1001-A could help lower blood glucose level by affecting insulin signaling. Bio-Path expects that by downregulating Grb2 expression, BP1001-A will lower blood glucose level by enhancing insulin-mediated AKT activation and glucose uptake and storage. Bio-Path is conducting preclinical studies to determine the effectiveness of BP1001-A in affecting insulin signaling and its potential as a therapeutic for obese patients who have Type 2 diabetes. Resource Allocation - Separately, the Company announces its plans to reallocate resources toward its advancing metabolic program and to discontinue its Phase 1 clinical trial evaluating BP1002 as a treatment for refractory/relapsed lymphoma and refractory/relapsed chronic lymphocytic leukemia. This decision was based on enrollment challenges in these niche indications, particularly given the crowded development landscape that includes multiple competing trials. New Risk • Nov 17
New major risk - Negative shareholders equity The company has negative equity. Total equity: -US$712k This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$712k). Shareholders have been substantially diluted in the past year (over 5x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.01m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$12m net loss in 3 years). Share price has been volatile over the past 3 months (16% average weekly change). Announcement • Nov 09
Bio-Path Holdings, Inc. to Report Q3, 2024 Results on Nov 15, 2024 Bio-Path Holdings, Inc. announced that they will report Q3, 2024 results on Nov 15, 2024 Announcement • Oct 21
Bio-Path Holdings, Inc., Annual General Meeting, Dec 12, 2024 Bio-Path Holdings, Inc., Annual General Meeting, Dec 12, 2024. Location: winstead pc, 24 waterway avenue, suite 500, the woodlands, texas 77380., United States Announcement • Oct 09
Bio-Path Holdings, Inc. announced that it expects to receive $4.000001 million in funding Bio-Path Holdings, Inc. entered into a definitive agreements for the issuance and sale of an aggregate of 4,597,702 shares of its common stock , series A warrants to purchase up to 6,407,657 shares of common stock and short-term series B warrants to purchase up to 6,407,657 shares of common stock at a purchase price of $0.87 per share of common stock for gross proceeds of $4,000,000.74 on October 8, 2024. The series A warrants and short-term series B warrants will have an exercise price of $1.00 per share and will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the warrants. The series A warrants will expire five years from the Stockholder Approval Date and the short-term series B warrants will expire twenty-four months from the Stockholder Approval Date. The closing of the offering is expected to occur on or about October 10, 2024, subject to the satisfaction of customary closing conditions. Announcement • Oct 08
Bio-Path Holdings, Inc. Initiates Development of Therapeutic Program for Treatment of Obesity Bio-Path Holdings, Inc. announced the initiation of a therapeutic program to develop BP1001-A for the treatment of obesity and related metabolic diseases. This program marks the first application of DNAbilize technology for development of a non-cancer application, which highlights the broad therapeutic potential of this technology. The Company also reported completion of enrollment in the third dosing cohort of its ongoing Phase 1/1b clinical trial evaluating BP1002 for the treatment of refractory/relapsed acute myeloid leukemia (AML) patients, including venetoclax-resistant patients. The cohort enrolled more quickly than projected, which underscores the ongoing need for new treatment options for these relapsed/refractory patients. These studies are expected to provide crucial insights into the mechanism and efficacy of BP1001-A in enhancing insulin sensitivity and reveal its therapeutic potential for obesity and Type 2 diabetes. Following successful preclinical studies, Bio-Path anticipates that a Phase 1 clinical trial would follow. After the U.S. Food and Drug Administration (FDA) completed its review of data from the first two dosing cohorts in the Phase 1/1b clinical trials in refractory/relapsed AML patients, Bio-Path initiated enrollment for the third, higher-dosing cohort of 60 mg/m2. Enrollment was completed faster than projected within six weeks, which underscores the continuing need for new treatment options. By targeting the key protein involved in the venetoclax treatment at the mRNA level, BP1002 may overcome and prevent some of the mechanisms of resistance that affect venetoclax treatment. Announcement • Sep 14
Bio-Path Holdings Receives Non-Compliance Letter from Nasdaq Regarding Minimum Stockholders’ Equity Requirement As previously disclosed, on March 12, 2024, Bio-Path Holdings, Inc. received a deficiency letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that it is not in compliance with the minimum stockholders’ equity requirement of at least $2,500,000 for continued inclusion on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(1) (the ‘Stockholders’ Equity Requirement’). On April 26, 2024, in accordance with Nasdaq Listing Rule 5810(c)(2)(A), the Company submitted a plan to Nasdaq to regain compliance (the ‘Compliance Plan’) with the Stockholders’ Equity Requirement and on June 12, 2024, the Company received a letter from Nasdaq granting an extension (the ‘Extension Letter’) until September 8, 2024 to demonstrate compliance with the Stockholders’ Equity Requirement. On September 12, 2024, the Company received a delisting determination letter from Nasdaq advising the Company that the Company did not meet the terms of the Extension Letter. Specifically, the Company did not confirm or demonstrate compliance with the Stockholders’ Equity Requirement by completing its proposed transactions as set in the Extension Letter. As a result, unless the Company requests an appeal of the Staff’s determination, trading of the Company’s common stock will be suspended at the opening of business on September 23, 2024, and a Form 25-NSE will be filed with the Securities and Exchange Commission (the ‘SEC’) which will remove the Company’s securities from listing and registration on The Nasdaq Stock Market. ? The Company intends to submit a hearing request to the Nasdaq Hearings Panel (the ‘Panel’) no later than 4:00 p.m. Eastern Time on September 19, 2024, which request will stay suspension of the Company’s securities and the filing of the Form 25-NSE pending the Panel’s decision. At the Panel hearing, the Company intends to present a plan to regain compliance with the Stockholders’ Equity Requirement. In the interim, the Company’s common stock will continue to trade on the Nasdaq Capital Market under the symbol ‘BPTH’ pending the Panel’s decision. There can be no assurance that the Company’s appeal will be successful or that the Company will be able to regain compliance with the Stockholders’ Equity Requirement. Announcement • Aug 21
Bio-Path Holdings, Inc. Reports Solid Tumor Patient Response Supporting BP1001-A's Compelling Potential as Treatment for Advanced Solid Tumors Bio-Path Holdings, Inc. provided an update from the Company's ongoing Phase 1/1b clinical trial of BP1001-A in solid tumor patients and reports continued patient progress from the Company's ongoing Phase 2 triple combination study of prexigebersen in Acute Myeloid Leukemia (AML). Through testing in numerous animal studies and dosing in clinical trials, the Company's DNAbilize drug candidates have demonstrated a promising safety and efficacy profile. Solid Tumor Patient Response in Second, Higher Dose Cohort - Bio-Path's first patient in the second dose cohort in its Phase 1/1b advanced solid tumor clinical trial experiencing a positive response may signal that this analog of prexigebersen has potential as a new treatment for advanced solid tumors. This clinical trial of BP1001- A in patients with advanced or recurrent solid tumors has successfully completed the initial prescribed dose in the first cohort of 60 mg/m2 and began enrollment in the higher dose cohort of 90 mg/m2. Phase 1b studies are also expected to be opened in combination with gemcitabine in late-stage pancreatic cancer. AML Patients Demonstrate Extended Treatment Durability - During the Company's recent pause for an interim analysis of results for Bio-Path's Phase 2 clinical trial treating AML patients, attention focused on two elderly patients who demonstrated continued treatment durability. The second patient is an elderly male who is completing his twelfth cycle of treatment over fourteen months and continues in complete removal. The clinical trial investigator treating these two patients indicated that they are both doing very well on treatment. New Risk • Aug 16
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$8.9m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$8.9m free cash flow). Share price has been highly volatile over the past 3 months (20% average weekly change). Shareholders have been substantially diluted in the past year (263% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.10m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). Announcement • Aug 08
Bio-Path Holdings, Inc. to Report Q2, 2024 Results on Aug 15, 2024 Bio-Path Holdings, Inc. announced that they will report Q2, 2024 results on Aug 15, 2024 Announcement • Jun 15
Bio-Path Holdings Presents Data from Ongoing Phase 2 Combination Study of Prexigebersen for Treatment of Acute Myeloid Leukemia At European Hematology Association Congress Bio-Path Holdings, Inc. presented interim results from the Company’s Phase 2 study of prexigebersen (BP1001) in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML) in a poster presentation at 2024 European Hematology Association (EHA) Congress, on June 14, 2024 in Madrid, Spain. In Cohort 1, 31 newly diagnosed patients were enrolled; 20 evaluable patients (9 male: 45%) with a median age of 75 years (range, 69 - 84), treated with at least one cycle of prexigebersen, decitabine and venetoclax, had adverse-risk (n=12, 2017 ELN guidelines) or secondary AML (sAML; n=7) evolved from myelodysplastic syndromes (n=4), chronic myelomonocytic leukemia (n=1) or treatment-related AML (n=2). Fifteen patients (75% of evaluable; 54% of enrolled) achieved complete remission (CR), CRh (CR with partial recovery of peripheral blood counts), or CRi (CR with incomplete hematologic recovery); two patients achieved partial remission (PR) and two patients achieved stable disease (SD). In Cohort 2, 38 relapsed/refractory patients were enrolled; 23 evaluable patients (13 male: 57%) with a median age of 63 years (range, 24 - 89), treated with at least one cycle of prexigebersen, decitabine and venetoclax, had adverse-risk (n=13) or sAML (n=5). Twelve patients (55% of evaluable; 32% of enrolled) achieved CR/CRi/CRh; one patient achieved PR, eight patients achieved SD and one patient had treatment failure. Among the evaluable patients of both cohorts, adverse events were consistent with those expected with decitabine and venetoclax and/or AML, including fatigue (72%), anemia (60%) and neutropenia (49%), while the most frequent severe adverse events were febrile neutropenia (26%) and sepsis (5%). Given these promising interim results, Bio-Path expects to continue enrollment of up to 98 and 54 evaluable patients for Cohorts 1 and 2, respectively. New Risk • May 16
New major risk - Negative shareholders equity The company has negative equity. Total equity: -US$2.6m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (20% average weekly change). Negative equity (-US$2.6m). Shareholders have been substantially diluted in the past year (293% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.51m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). Announcement • May 10
Bio-Path Holdings, Inc. to Report Q1, 2024 Results on May 15, 2024 Bio-Path Holdings, Inc. announced that they will report Q1, 2024 results on May 15, 2024 Announcement • Apr 20
Bio-Path Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $1.209375 million. Bio-Path Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $1.209375 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 375,000
Price\Range: $3.225
Discount Per Security: $0.242
Transaction Features: Registered Direct Offering New Risk • Apr 19
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (89% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.21m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). Announcement • Apr 19
Bio-Path Holdings, Inc. Announces Successful Completion of Higher Dose Second Cohort in Phase 1/1B Clinical Trial of Bp1002 in Refractory/Relapsed Acute Myeloid Leukemia (AML) Patients Bio-Path Holdings, Inc. announced completion of the second dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1002 evaluating the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia (AML) patients, including venetoclax-resistant patients. BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. The current standard of care for patients with AML not eligible for intensive chemotherapy is venetoclax, an oral Bcl-2 inhibitor that targets the BH3 domain of the Bcl-2 protein, in combination with a hypomethylating agent or with low-dose cytarabine. However, many patients become resistant to venetoclax treatment. A published study found that AML patients who had relapsed from frontline venetoclax-based treatment were refractory to salvage therapy and had a median survival of less than 3 months. By targeting Bcl-2 at the mRNA level rather than the protein, BP1002 may overcome and prevent some of the mechanisms of resistance that affect venetoclax treatment. Published preclinical Bio-Path studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target, and believe that its benign safety profile should enable effective BP1002 combination therapy with approved agents, such as decitabine. The Phase 1/1b clinical trial is being conducted at several leading cancer centers in the United States, including the Weill Medical College of Cornell University, The University of Texas MD Anderson Cancer Center, Scripps Health, and The University of California at Los Angeles Cancer Center. Initially, the dose escalation portion of the clinical plan calls for a total of six evaluable patients to be treated with BP1002 monotherapy over two dose levels in a standard 3+3 design, with a starting dose of 20 mg/m2 and the second dose of 40 mg/m2. The testing of these two dose levels is now complete and the clinical trial will pause for a brief data review by the FDA, and then expect that dose testing will continue at the next planned higher dose of 60 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study is expected to commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients. Announcement • Apr 16
Bio-Path Holdings, Inc. Expands Global Patent Portfolio Bio-Path Holdings, Inc. announced the receipt of newly issued patents in Mexico, Australia and Japan, and updated investors on the extent of its global intellectual property portfolio. Bio-Path has expanded its intellectual property portfolio by filing patent applications that are applicable to its technology and business strategy. Bio-Path’s patent portfolio currently includes five issued patents in the U.S. and 54 issued patents in foreign jurisdictions, providing protection in 21 countries. Bio-Path’s composition of matter patents are intended to protect encroachment from third parties on its proprietary products. This technology is solely owned by Bio-Path. These composition patents, including composition and methods of use patents covering the DNAbilize technology, should allow the Company to apply its core technology to new protein targets and receive an additional 20-years of patent exclusivity. On this basis, Bio-Path has one additional patent application allowed in the U.S. and five additional patent applications allowed in foreign jurisdictions, for a total of six additional patent grants expected this year. Further, the Company has five pending patent applications in the U.S. and 46 pending patent applications in key foreign jurisdictions across six families of applications, for a total of 51 pending applications. Announcement • Apr 05
Bio-Path Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $2 million. Bio-Path Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $2 million.
Security Name: COMMON STOCK
Security Type: Common Stock
Transaction Features: At the Market Offering New Risk • Apr 02
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$16m Forecast net loss in 3 years: US$14m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (89% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.47m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Announcement • Mar 27
Bio-Path Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $0.29925 million. Bio-Path Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $0.29925 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 75,000
Price\Range: $3.99
Discount Per Security: $0.3
Transaction Features: Registered Direct Offering Announcement • Mar 25
Bio-Path Holdings, Inc. has withdrawn its Follow-on Equity Offering in the amount of $7.499995 million. Bio-Path Holdings, Inc. has withdrawn its Follow-on Equity Offering in the amount of $7.499995 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,152,073
Price\Range: $6.51
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 1,152,073
Security Name: Common Warrants
Security Type: Equity Warrant
Securities Offered: 2,304,146 Announcement • Mar 14
Bio-Path Holdings Receives Deficiency Letter from the Listing Qualifications Department of the Nasdaq Regarding Listing Rule 5550(b)(1) On March 12, 2024, Bio-Path Holdings, Inc. received a deficiency letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it is not in compliance with the minimum stockholders’ equity requirement of at least $2,500,000 for continued inclusion on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(1) (the “Stockholders’ Equity Requirement”). The Letter has no effect on the listing of the Company’s common stock at this time, and the Company’s common stock will continue to trade on The Nasdaq Capital Market under the symbol “BPTH.” In accordance with Nasdaq Listing Rule 5810(c)(2)(A), the Company has 45 calendar days, or until April 26. 2024, to submit a plan to Nasdaq to regain compliance (the “Compliance Plan”) with the Stockholders’ Equity Requirement. If the Compliance Plan is accepted, Nasdaq can grant an extension of up to 180 days from the date of the Letter for the Company to evidence compliance. If the Compliance Plan is not accepted, Nasdaq could provide written notification to the Company that its common stock may be delisted. At that time, the Company may appeal Nasdaq’s delisting determination to a Nasdaq Hearings Panel (the “Panel”). If the Company timely appeals, it would remain listed pending the Panel’s decision. There can be no assurance that, if the Company does appeal the delisting determination by Nasdaq to the Panel, such appeal would be successful. The Company is considering available options to regain compliance with the Stockholders’ Equity Requirement. However, there can be no assurance that the Company will be successful in developing the Compliance Plan, that the Compliance Plan will be accepted by Nasdaq, or even if it is accepted, that the Company will ultimately be able to regain compliance with the Stockholders’ Equity Requirement within the allotted extension period, which may be less than 180 calendar days. Announcement • Mar 09
Bio-Path Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $7.499995 million. Bio-Path Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $7.499995 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,152,073
Price\Range: $6.51
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 1,152,073
Security Name: Common Warrants
Security Type: Equity Warrant
Securities Offered: 2,304,146 Announcement • Mar 02
Bio-Path Holdings, Inc. to Report Q4, 2023 Results on Mar 08, 2024 Bio-Path Holdings, Inc. announced that they will report Q4, 2023 results on Mar 08, 2024 Announcement • Feb 29
Bio-Path Holdings, Inc. has withdrawn its Follow-on Equity Offering in the amount of $23.75 million. Bio-Path Holdings, Inc. has withdrawn its Follow-on Equity Offering in the amount of $23.75 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Security Name: Common Warrants
Security Type: Equity Warrant New Risk • Feb 23
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 197% a day. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (197% average daily change). Shareholders have been substantially diluted in the past year (55% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$4.47m market cap). Announcement • Jan 11
Bio-Path Holdings Announces Completion of First Dose Cohort in Phase 1 Clinical Trial Evaluating BP1002 to Treat Refractory/Relapsed Lymphoma and Refractory/Relapsed Chronic Lymphocytic Leukemia Patients Bio-Path Holdings, Inc. announced completion of the first dose cohort of the dose escalation portion of its Phase 1 clinical trial of BP1002 evaluating the ability of BP1002, a liposomal Bcl-2 nanoparticle antisense, for the treatment of refractory/relapsed lymphoma and refractory/relapsed chronic lymphocytic leukemia (CLL) patients. As a result, Bio-Path believes that BP1002 could provide an alternative treatment for venetoclax refractory/relapsed CLL patients. Bio-Path also believes there may be AML patients who fail or relapse from venetoclax-based frontline treatment for the same reason, potentially representing an additional opportunity for Bio-Path to treat those patients with BP1002. The Phase 1 clinical trial is being conducted at several leading cancer centers, including the Georgia Cancer Center, The University of Texas Southwest and New York Medical College. Locke Bryan, M.D., Associate Professor of Medicine at the Georgia Cancer Center, is serving as National Principal Investigator for the Phase 1 trial. A total of six evaluable patients will be treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m2. Enrollment is now open for patients for the second dose cohort of 40 mg/m2. The primary objective of the study is to evaluate the safety and tolerability of escalating doses of BP1002. Announcement • Dec 24
Bio-Path Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $19 million. Bio-Path Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $19 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Security Name: Common Warrants
Security Type: Equity Warrant Announcement • Dec 14
Bio-Path Holdings Successfully Completes First Dose Cohort of Phase 1/1B Clinical Trial of Bp1002 in Refractory/Relapsed Acute Myeloid Leukemia Bio-Path Holdings, Inc. announced completion of the first dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1002 evaluating the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia (AML) patients including venetoclax-resistant patients. A total of three evaluable patients per dosing cohort are scheduled to be treated with BP1002 monotherapy in a standard 3+3 design, unless there is a dose limiting toxicity which would require an additional three patients tested. A published study found that AML patients who had relapsed from frontline venetoclax-based treatment were refractory to salvage therapy and had a median survival of less than 3 months. By targeting Bcl-2 at the mRNA level rather than the protein, BP1002 may overcome and prevent some of the mechanisms of resistance that affect venetoclax treatment. Published preclinical studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target and its benign safety profile should enable effective BP1002 combination therapy with approved agents, such as decitabine. Breakeven Date Change • Nov 16
No longer forecast to breakeven The analyst covering Bio-Path Holdings no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of US$472.0k in 2025. New forecast suggests the company will make a loss of US$15.7m in 2025. Announcement • Nov 11
Bio-Path Holdings, Inc. to Report Q3, 2023 Results on Nov 15, 2023 Bio-Path Holdings, Inc. announced that they will report Q3, 2023 results on Nov 15, 2023 Announcement • Oct 29
Bio-Path Holdings, Inc., Annual General Meeting, Dec 14, 2023 Bio-Path Holdings, Inc., Annual General Meeting, Dec 14, 2023, at 16:00 Central Standard Time. Location: Winstead PC, 24 Waterway Avenue, Suite 500 The Woodlands Texas United States Agenda: To consider and approve the election of Director; to consider ratification of Ernst and young LLP as the company independent registered public accounting firm for the fiscal year ending 31 December 2023; and to transact any other matter. Announcement • Sep 16
Bio-Path Holdings, Inc. Receives Non-Compliance Letter from the Listing Qualifications Department of the Nasdaq Stock Market On September 13, 2023, Bio-Path Holdings, Inc. received a letter from the Listing Qualifications Department of the Nasdaq Stock Market indicating that, based upon the closing bid price of the Company’s common stock for the last 30 consecutive business days, the Company did not meet the minimum bid price of $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Rule”). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided an initial period of 180 calendar days, or until March 11, 2024, to regain compliance with the Rule. The Letter also indicated that if at any time before March 11, 2024 the closing bid price for the Company’s common stock is at least $1.00 for a minimum of ten consecutive business days, Nasdaq will provide written notification to the Company that it complies with the Rule. The Letter has no effect on the listing of the Company’s common stock at this time, and the Company’s common stock will continue to trade on The Nasdaq Capital Market under the symbol “BPTH.” If the Company does not regain compliance with the Rule by March 11, 2024, the Company may be eligible for a second compliance period of 180 calendar days, provided that the Company meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and notifies Nasdaq of the Company’s intention to cure the deficiency during such second compliance period, including by effecting a reverse stock split, if necessary. If the Company does not regain compliance with the Rule by March 11, 2024 and is not eligible for a second compliance period at that time, Nasdaq will provide written notification to the Company that its common stock may be delisted. At that time, the Company may appeal Nasdaq’s delisting determination to a Nasdaq Hearings Panel (the “Panel”). If the Company timely appeals, it would remain listed pending the Panel’s decision. There can be no assurance that, if the Company does appeal the delisting determination by Nasdaq to the Panel, such appeal would be successful. The Company intends to continue to monitor the closing bid price of its common stock and may, if appropriate, consider implementing available options to regain compliance with the Rule, including by effecting a reverse stock split. Price Target Changed • Aug 11
Price target decreased by 7.7% to US$12.00 Down from US$13.00, the current price target is provided by 1 analyst. New target price is 2,900% above last closing price of US$0.40. Stock is down 90% over the past year. The company is forecast to post a net loss per share of US$1.89 next year compared to a net loss per share of US$1.91 last year. Announcement • Aug 09
Bio-Path Holdings, Inc. to Report Q2, 2023 Results on Aug 15, 2023 Bio-Path Holdings, Inc. announced that they will report Q2, 2023 results on Aug 15, 2023 New Risk • Aug 05
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 60% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$16m free cash flow). Share price has been highly volatile over the past 3 months (20% average weekly change). Shareholders have been substantially diluted in the past year (60% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$4.59m market cap). New Risk • Aug 03
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$16m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (US$6.04m market cap). Minor Risk Shareholders have been diluted in the past year (11% increase in shares outstanding). Announcement • Aug 02
Bio-Path Holdings, Inc. Announces Positive Results from Interim Analysis of Phase 2 Clinical Trial of Prexigebersen in Acute Myeloid Leukemia Bio-Path Holdings, Inc. reported interim data from Stage 2 of the Company’s Phase 2 study of prexigebersen in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (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 frontline therapy. The protocol for the Phase 2 study allows Bio-Path to conduct an interim efficacy analysis on each cohort at its discretion. Additional data will become available as final efficacy reviews are conducted. Stage 2 of the Phase 2 clinical trial is a multi-center, open label study designed with three patient cohorts that offer Bio-Path three pathways to registration: Newly diagnosed AML patients treated with prexigebersen in combination with decitabine plus venetoclax; Refractory/relapsed AML patients treated with prexigebersen in combination with decitabine plus venetoclax; and Refractory/relapsed AML patients, resistant or intolerant to venetoclax, treated with prexigebersen in combination with decitabine. The primary objective of the study is to assess whether prexigebersen in combination with decitabine plus venetoclax provides higher response rates than decitabine plus venetoclax in AML patients and whether prexigebersen in combination with decitabine provides higher response rates than decitabine alone in AML patients. Data Highlights: Fourteen newly diagnosed patients were evaluable in Cohort 1 and treated with at least one cycle of the prexigebersen, decitabine and venetoclax combination therapy. All patients in this cohort (median age 75) were adverse risk by 2017 European Leukemia Net (ELN) guidelines (n=10) or secondary AML (n=4). Prexigebersen was well-tolerated, and adverse events (AEs) were generally consistent with decitabine and venetoclax treatment and/or for AML. Twelve of the fourteen evaluable patients (86%) achieved complete remission (CR/CRi) and two (14%) achieved partial remission (PR). In total, 100% of the evaluable patients had a response to treatment. The complete remission rate (CR/CRi) of (86%) for the evaluable patients in Cohort 1 is significantly higher than complete remission (CR/CRi) rates (62%) for newly diagnosed patients treated with the frontline combination treatment of decitabine and venetoclax. This result is further highlighted by the high-risk rating of Bio-Path’s Cohort 1 evaluable patients and the inclusion of secondary AML patients (29%), both of which are classes of patients with very difficult to treat disease. Fourteen refractory/relapsed evaluable AML patients in Cohort 2 were treated with at least one cycle of the prexigebersen, decitabine and venetoclax combination therapy. All patients in this cohort (median age 56.5) were adverse risk by 2017 ELN guidelines (n=11) or secondary AML (n=2). Prexigebersen was well-tolerated, and AEs were generally consistent with decitabine and venetoclax treatment and/or for AML. Eight of the fourteen evaluable patients (57%) achieved complete remission (CR/CRi), two (14%) achieved partial remission (PR) and three (22%) achieved stable disease. In total, 93% of the evaluable patients had a response to treatment. The complete remission rate (CR/CRi) of (57%) for the evaluable refractory and relapsed patients in Cohort 2 is significantly higher than complete remission (CR/CRi) rate (21%) for refractory/relapsed patients treated with the combination treatment of decitabine and venetoclax. As with newly diagnosed patients in Cohort 1, this result is further highlighted by the high-risk rating of Bio-Path’s Cohort 2 evaluable patients and the inclusion of secondary AML patients (15%). Next Steps: Efficacy data from the initial interim analysis of Cohort 1 and Cohort 2 are compelling and show that prexigebersen-based combination therapy was not only safely administered in Cohort 1 and Cohort 2 to high-risk newly diagnosed and refractory/relapsed AML patients considered unsuitable for standard chemotherapy, but also demonstrated efficacy signals significantly better than current therapies. This is particularly encouraging as refractory/relapsed patients are a challenging population in which current treatment options are suboptimal. As a result of the interim review, Bio-Path has demonstrated superiority of prexigebersen combination therapy in treating AML patients and currently plans to pursue U.S. Food and Drug Administration (FDA) expedited programs for Fast Track and Breakthrough Therapy designations. Fast Track Designation is designed to expedite the development and review of drugs to treat serious conditions and to fulfill an unmet medical need. Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that may demonstrate substantial improvement over available therapies. The next steps for Bio-Path are to conduct an administrative review to affirm the cohorts that will continue with enrollment. Nineteen patients had been chosen as an initial sample size for a cohort to provide interim efficacy data; however, the protocol for the Phase 2 allows Bio-Path to conduct interim efficacy analysis sooner at its discretion. Operations in the United States are expected to remain unchanged with an expected six to ten treatment sites. In addition, Bio-Path is evaluating whether to seek to expand Stage 2 of the Phase 2 clinical trial by pursuing operations in Europe, as it believes there are more potential patients for Stage 2 of the Phase 2 clinical trial there, which could meaningfully enhance enrollment and accelerate completion of clinical trial milestones. New Risk • Jul 21
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.71m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$16m free cash flow). Revenue is less than US$1m. Market cap is less than US$10m (US$9.71m market cap). Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (11% increase in shares outstanding). New Risk • Jun 23
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$16m free cash flow). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (11% increase in shares outstanding). Market cap is less than US$100m (US$13.5m market cap). Announcement • May 06
Bio-Path Holdings, Inc. to Report Q1, 2023 Results on May 12, 2023 Bio-Path Holdings, Inc. announced that they will report Q1, 2023 results on May 12, 2023 Breakeven Date Change • Apr 02
Forecast to breakeven in 2025 The analyst covering Bio-Path Holdings expects the company to break even for the first time. New forecast suggests the company will make a profit of US$7.77m in 2025. Average annual earnings growth of 65% is required to achieve expected profit on schedule. Announcement • Dec 08
Bio-Path Holdings, Inc. Announces First Patient Dosed in Phase 1/1b Clinical Trial of BP1001-A in Solid Tumors Bio-Path Holdings, Inc. announced the enrollment and dosing of the first patient in a Phase 1/1b clinical trial of BP1001-A (liposomal Grb2) in patients with solid tumors, including ovarian, endometrial, pancreatic and breast cancer. BP1001-A is a modified drug product with the same drug substance as prexigebersen but includes formulation enhancements to produce smaller drug nanoparticles. The goal of this product enhancement is to produce smaller drug nanoparticles that can pass through vasculature pore spaces, thereby enabling release of the drug product into the interior of the tumor to enhance drug effectiveness. The dose escalation portion of the Phase 1/1b clinical trial is planned to be conducted at more than six leading cancer centers in the United States, including The University of Texas MD Anderson Cancer Center, The Mary Crowley Cancer Research Center, and Karmanos Cancer Center. Initially, a total of nine evaluable patients are scheduled to be treated with BP1001-A monotherapy in a standard 3+3 design, with a starting dose of 60 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study will commence after successful completion of BP1001-A monotherapy cohorts and will assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors. Price Target Changed • Nov 16
Price target decreased to US$11.00 Down from US$12.50, the current price target is an average from 2 analysts. New target price is 619% above last closing price of US$1.53. Stock is down 67% over the past year. The company is forecast to post a net loss per share of US$1.76 next year compared to a net loss per share of US$1.55 last year. Announcement • Nov 09
Bio-Path Holdings, Inc. to Report Q3, 2022 Results on Nov 15, 2022 Bio-Path Holdings, Inc. announced that they will report Q3, 2022 results on Nov 15, 2022 Announcement • Oct 29
Bio-Path Holdings, Inc., Annual General Meeting, Dec 15, 2022 Bio-Path Holdings, Inc., Annual General Meeting, Dec 15, 2022, at 16:00 Central Standard Time. Location: At Winstead PC, 24 Waterway Avenue, Suite 500 The Woodlands Texas United States Agenda: To elect five directors, each to serve until the 2023 Annual Meeting of Stockholders or until their successors have been duly elected and qualified, to approve the Company's 2022 Stock Incentive Plan, to consider a non-binding advisory vote to approve the compensation of the Company's named executive officers; and to consider any other matters. Announcement • Oct 25
Bio-Path Holdings, Inc. Announces First Patient Dosed in Phase 1/1b Study of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia Patients Bio-Path Holdings, Inc. announced the enrollment and dosing of the first patient in a Phase 1/1b clinical trial evaluating the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia (AML) patients. BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. By targeting Bcl-2 at the mRNA level rather than the protein, BP1002 may overcome and prevent some of the mechanisms of resistance that affect venetoclax treatment. The current standard of care for patients with AML not eligible for intensive chemotherapy is venetoclax, an oral Bcl-2 inhibitor that targets the BH3 domain of the Bcl-2 protein, in combination with a hypomethylating agent or with low-dose cytarabine. High expression of Bcl-2 has been correlated with adverse prognosis for patients diagnosed with AML. Preclinical studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target, and its benign safety profile should enable BP1002 combination therapy with approved agents, such as decitabine. The Phase 1/1b clinical trial is being conducted at several leading cancer centers in the United States, including the Weill Medical College of Cornell University, The University of Texas MD Anderson Cancer Center, the Georgia Cancer Center, Scripps Health, and The University of California at Los Angeles Cancer Center. Initially, a total of six evaluable patients are scheduled to be treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study will commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients. Announcement • Aug 10
Bio-Path Holdings, Inc. to Report Q2, 2022 Results on Aug 16, 2022 Bio-Path Holdings, Inc. announced that they will report Q2, 2022 results on Aug 16, 2022 Price Target Changed • May 19
Price target decreased to US$11.00 Down from US$12.50, the current price target is an average from 2 analysts. New target price is 244% above last closing price of US$3.20. Stock is down 42% over the past year. The company is forecast to post a net loss per share of US$1.90 next year compared to a net loss per share of US$1.55 last year. Announcement • May 12
Bio-Path Holdings, Inc. to Report Q1, 2022 Results on May 17, 2022 Bio-Path Holdings, Inc. announced that they will report Q1, 2022 results on May 17, 2022 Price Target Changed • Apr 27
Price target increased to US$12.50 Up from US$11.50, the current price target is an average from 2 analysts. New target price is 334% above last closing price of US$2.88. Stock is down 53% over the past year. The company is forecast to post a net loss per share of US$1.77 next year compared to a net loss per share of US$1.55 last year. Board Change • Apr 27
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Director Paul Aubert was the last independent director to join the board, commencing their role in 2018. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Apr 13
Bio-Path Holdings Presents BP1003 Data at 2022 American Association for Cancer Research Annual Meeting Bio-Path Holdings, Inc. presented a poster highlighting preclinical BP1003 data at the 2022 American Association for Cancer Research (AACR) Annual Meeting. STAT3 is a transcription factor that regulates various tumorigenic processes, such as tumor proliferation, metastasis and drug resistance. Its overexpression and aberrant activation characterize many cancers, including breast, lung, ovarian, liver and colon cancer. Activation of the STAT3 pathway in breast and ovarian cancer cells promotes tumor initiation, migration, and taxol resistance. STAT3 also contributes to epithelial-mesenchymal transition and promotes 5-FU resistance in colorectal cancer cells. Its role in numerous malignancies made STAT3 a potential cancer therapeutic target. BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide, efficiently reduces STAT3 expression and enhances the sensitivity of breast and ovarian cancer cells to taxol and 5-FU. These results are in line with previous work in which BP1003 plus gemcitabine displayed enhanced anti-tumor activity in pancreatic ductal adenocarcinoma. Together these results strongly suggest that BP1003 combination therapy is a novel strategy for patients with advanced solid tumors. Announcement • Apr 07
Bio-Path Holdings, Inc. Appoints Aline Sherwood to its Board of Directors Bio-Path Holdings, Inc. announced the appointment of Aline Sherwood to its Board of Directors on March 31, 2022. Ms. Sherwood replaced Martina Molsbergen, who stepped down from the Board of Directors on February 14, 2022. Ms. Sherwood is Principal of Scienta Communications, an independent communications consultancy providing strategic public relations and corporate communications counsel to life sciences companies. Before founding the firm, she served in roles of increasing responsibility at several public relations firms, most recently at WeissComm Group. Earlier, she managed corporate communications for The Liposome Companyprior to its acquisition by Elan Pharmaceuticals. Announcement • Mar 06
Bio-Path Holdings, Inc. to Report Fiscal Year 2021 Results on Mar 11, 2022 Bio-Path Holdings, Inc. announced that they will report fiscal year 2021 results on Mar 11, 2022 Board Change • Feb 23
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 3 highly experienced directors. Member of the Scientific Advisory Board Jason Fleming was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Announcement • Feb 19
Bio-Path Holdings, Inc. Announces Resignation of Martina Molsbergen as Member of the Board and All Committees of the Board Bio-Path Holdings, Inc. announced on February 14, 2022, Martina Molsbergen resigned from her position as a member of the Board and all committees of the Board on which she served. The resignation of Ms. Molsbergen was not because of a disagreement with the company on any matters relating to the company’s operations, policies, or practices. Announcement • Dec 14
Bio-Path Holdings, Inc. Presents Data from Ongoing Phase 2 Study of Prexigebersen At 2021 American Society of Hematology Annual Meeting Bio-Path Holdings, Inc. announced a poster highlighting the safety and preliminary efficacy data of its Phase 2 study of prexigebersen (BP1001) was presented at the 2021 American Society of Hematology (ASH) Annual Meeting, taking place from December 11-14, 2021. The poster, titled, “Safety and Efficacy of Lower Intensity Induction Therapy with Intravenous Prexigebersen (BP1001) in Patients with High-Risk and Relapsed/Refractory Acute Myeloid Leukemia (AML),” was presented by Maro Ohanian, D.O., Department of Leukemia, University of Texas MD Anderson Cancer Center. The poster described the safety and preliminary efficacy of Bio-Path’s lead drug candidate, prexigebersen (liposomal Grb2 antisense), from a Phase 2 study in combination with decitabine or decitabine plus venetoclax as a potential treatment for patients diagnosed with AML. The Phase 2 clinical trial is a multi-center, open label study with three patient cohorts: Untreated AML patients treated with prexigebersen in combination with decitabine plus venetoclax; Refractory/relapsed AML patients treated with prexigebersen in combination with decitabine plus venetoclax; and Refractory/relapsed AML patients, resistant or intolerant to venetoclax, treated with prexigebersen in combination with decitabine. The primary objective of the study is to assess whether prexigebersen in combination with decitabine plus venetoclax provides higher response rates than decitabine plus venetoclax in AML patients and whether prexigebersen in combination with decitabine provides higher response rates than decitabine alone in AML patients. The study was amended to obtain safety run-in data for patients treated with prexigebersen + decitabine first before proceeding to safety run-in for patients treated with prexigebersen + decitabine + venetoclax. In the Poster report the safety run-in and efficacy data of AML patients treated with prexigebersen + decitabine or prexigebersen + decitabine + venetoclax. Data Highlights: Six patients, including four patients (67%) with de novo AML and two secondary AML patients (33%), were treated with at least one cycle of prexigebersen + decitabine combination therapy. All patients in this cohort (median age 72 years) were considered high risk due to having either adverse risk status by ELN (n=5) or treated secondary AML (n=1). Data showed that adverse events (AEs) were generally consistent with those expected with decitabine and/or AML. Three of the six patients (50%) had a response, including two de novo patients (33%) who achieved a CRi (complete remission with incomplete blood count recovery) and one secondary AML patient (17%) who achieved a partial remission (PR). Patients with these conditions generally have a less than 20% CR/CRi response rate. Six patients were treated with at least one cycle of prexigebersen + decitabine + venetoclax combination therapy. Of the six patients, two (33%) had de novo AML and four (67%) were relapsed/refractory. All patients in this cohort were adverse-risk by ELN (n=2) or relapsed/refractory (n=4). AEs were generally consistent with decitabine and venetoclax treatment and/or for AML. Four patients (67%) achieved a complete remission (CR)/CRi/morphological leukemia free state (MLFS) (n=1/2/1) and one (17%) achieved a PR. Of these five patients, three were relapsed/refractory (75% of relapsed/refractory patients) (1 CR/1 CRi/1 MLFS) and two were de novo (1 CRi/1 PR) (100% of the de novo patients). CR rates to combination treatment with decitabine and venetoclax for relapsed/refractory AML patients are 42-52% and 0-39% for relapsed/refractory secondary AML patients. The preliminary efficacy data are compelling and show that prexigebersen -based combination therapy was not only safely administered to high-risk and relapsed/refractory AML patients considered unsuitable for standard chemotherapy, but also demonstrated encouraging efficacy signals. This is particularly encouraging as relapsed/refractory patients are a challenging population in which current treatment options are suboptimal. Announcement • Aug 25
Bio-Path Holdings Announces Clearance of Investigational New Drug Application for BP1002 in Refractory/Relapsed Acute Myeloid Leukemia Patients Bio-Path Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has reviewed and cleared the Investigational New Drug (IND) application for BP1002 (liposomal Bcl-2), the Company’s second drug candidate, for an initial Phase 1/1b clinical trial that will evaluate the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia (AML) patients. By targeting Bcl-2 at the DNA level rather than the protein, BP1002 might overcome and prevent some of the mechanisms of resistance that affect venetoclax. The current standard of care for patients with AML not eligible for intensive chemotherapy is venetoclax, an oral Bcl-2 inhibitor that targets the BH3 domain of the Bcl-2 protein, in combination with a hypomethylating agent or with low-dose cytarabine. High expression of Bcl-2 has been correlated with adverse prognosis for patients diagnosed with AML. Preclinical studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target, and its benign safety profile should enable BP1002 combination therapy with approved agents, such as decitabine. Price Target Changed • Apr 07
Price target increased to US$12.50 Up from US$11.50, the current price target is an average from 2 analysts. New target price is 66% above last closing price of US$7.52. Stock is up 63% over the past year.