お知らせ • Mar 07
Bellerophon Therapeutics, Inc. Files Form 15 Bellerophon Therapeutics, Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Common Stock under the Securities Exchange Act of 1934, as amended. The par value of the company's Common Stock was $0.01 per share. New Risk • Oct 14
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 23% 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$11m free cash flow). Share price has been highly volatile over the past 3 months (23% average weekly change). Earnings are forecast to decline by an average of 38% per year for the foreseeable future. Market cap is less than US$10m (US$1.25m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$15m net loss next year). Shareholders have been diluted in the past year (28% increase in shares outstanding). New Risk • Aug 17
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$11m 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$11m free cash flow). Share price has been highly volatile over the past 3 months (27% average weekly change). Earnings are forecast to decline by an average of 38% per year for the foreseeable future. Market cap is less than US$10m (US$4.81m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$15m net loss next year). Shareholders have been diluted in the past year (28% increase in shares outstanding). Significant insider selling over the past 3 months (US$82k sold). New Risk • Aug 07
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 36% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (28% average weekly change). Earnings are forecast to decline by an average of 36% per year for the foreseeable future. Market cap is less than US$10m (US$4.79m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$13m net loss next year). Shareholders have been diluted in the past year (9.5% increase in shares outstanding). Significant insider selling over the past 3 months (US$82k sold). お知らせ • Jul 25
Bellerophon Therapeutics to Be Delisted from the Nasdaq Capital Market At Opening of Business on July 28, 2023 Unless It Timely Requests A Hearing Before Nasdaq Hearings Panel to Address Deficiencies and Present Plan to Regain Compliance On July 19, 2023, Bellerophon Therapeutics, Inc. (the “Company”) was notified by the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) that in light of the Company’s previously disclosed workforce reduction plan and focus on exploring strategic alternatives, based upon the Staff’s belief that the Company is a “public shell” as that term is defined in Nasdaq Listing Rule 5101 and the Company’s non-compliance with the $1.00 bid price requirement set in Nasdaq Listing Rule 5550(a)(2), the Company would be delisted from The Nasdaq Capital Market at the opening of business on July 28, 2023 unless the Company timely requests a hearing before a Nasdaq Hearings Panel (the “Panel”) to address the deficiencies and present a plan to regain compliance. The Company plans to timely request a hearing before the Panel, which request will stay any further delisting action by the Staff pending the ultimate outcome of the hearing and the expiration of any extension that may be granted by the Panel. The Company’s common stock will remain listed and eligible for trading on Nasdaq at least pending the ultimate conclusion of the hearing process. お知らせ • Jul 15
Bellerophon Therapeutics, Inc. Announces Resignation of Crispin Teufel as Board of Director On July 10, 2023, Crispin Teufel, a member of the board of directors of Bellerophon Therapeutics, Inc. notified the board that he will resign as a director of the company and its subsidiaries, effective immediately. Mr. Teufel’s decision to resign is not due to any disagreement with the company on any matters relating to the company’s operations, policies, or practices. New Risk • Jul 01
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$9.8m 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$9.8m free cash flow). Share price has been highly volatile over the past 3 months (29% average weekly change). Market cap is less than US$10m (US$7.21m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$7.9m net loss in 3 years). Shareholders have been diluted in the past year (9.5% increase in shares outstanding). Significant insider selling over the past 3 months (US$82k sold). New Risk • Jun 08
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.40m 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$9.8m free cash flow). Share price has been highly volatile over the past 3 months (30% average weekly change). Market cap is less than US$10m (US$9.40m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$19m net loss in 3 years). Shareholders have been diluted in the past year (9.5% increase in shares outstanding). Significant insider selling over the past 3 months (US$82k sold). Major Estimate Revision • Jun 07
Consensus EPS estimates fall by 21% The consensus outlook for earnings per share (EPS) in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$4.61m to US$4.22m. Losses expected to increase from US$1.06 per share to US$1.28. Biotechs industry in the US expected to see average net income decline 84% next year. Consensus price target of US$10.50 unchanged from last update. Share price fell 87% to US$0.90 over the past week. お知らせ • Jun 06
Bellerophon Therapeutics, Inc. Announces Top-Line Data from Phase 3 REBUILD Clinical Trial of INOpulse® for Treatment of Fibrotic Interstitial Lung Disease Bellerophon Therapeutics, Inc. announced top-line results from its pivotal Phase 3 REBUILD clinical trial evaluating the safety and efficacy of INOpulse® for the treatment of fibrotic Interstitial Lung Disease (fILD). The REBUILD clinical trial was designed as a randomized, double-blind, placebo-controlled Phase 3 study evaluating the safety and efficacy of INOpulse® for the treatment of patients with fILD. A total of 145 fILD patients were enrolled and treated with either INOpulse® at a dose of iNO45 or a placebo. The primary endpoint was the change in moderate to vigorous physical activity (MVPA) as measured by actigraphy after 16 weeks of chronic treatment. The trial did not meet its primary endpoint, with iNO45 performing worse than placebo by 5.49 minutes per day (p=0.2646). The secondary endpoints demonstrated minimal difference between the two groups with none approaching statistical significance. Overall, INOpulse® was well-tolerated with no safety concerns, consistent with what has been observed in the prior Phase 2 studies. Key REBUILD clinical trial secondary endpoints and safety outputs assessed over 16 weeks of blinded treatment included: Overall Activity showed 3.51 count/min benefit in favor of iNO45 (p=0.8572) 6 Minute Walk Distance showed 0.19 meter benefit in favor of iNO45 (p=0.9866) Patient reported outcomes (St. George’s Respiratory Questionnaire and UCSD Shortness of Breath) were slightly in favor of placebo, while time to event assessments (Clinical Worsening, Clinical Deterioration and Clinical Improvement) showed little difference and none were statistically significant Subjects with treatment emergent adverse events was slightly in favor of placebo (84.0% vs 74.3%) Subjects with serious treatment emergent adverse events was balanced (20% vs 21.4%) Deaths were balanced (4.0% vs 4.3%). Price Target Changed • Jun 02
Price target decreased by 8.0% to US$25.75 Down from US$28.00, the current price target is an average from 4 analysts. New target price is 274% above last closing price of US$6.89. Stock is up 550% over the past year. The company is forecast to post a net loss per share of US$1.06 next year compared to a net loss per share of US$2.08 last year. Recent Insider Transactions • May 24
Insider recently sold US$82k worth of stock On the 18th of May, Bobae Kim sold around 8k shares on-market at roughly US$10.00 per share. This transaction amounted to 83% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months. Major Estimate Revision • May 22
Consensus revenue estimates increase by 157% The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$2.39m to US$6.14m. Forecast losses expected to reduce from -US$1.75 to -US$0.907 per share. Biotechs industry in the US expected to see average net income decline 81% next year. Consensus price target of US$28.00 unchanged from last update. Share price fell 9.1% to US$7.92 over the past week. お知らせ • May 12
Bellerophon Therapeutics, Inc. Announces Last Patient Has Completed Blinded Treatment in Phase 3 REBUILD Study for INOpulse® in Fibrotic Interstitial Lung Disease Bellerophon Therapeutics, Inc. announced that the last patient has completed blinded treatment in the ongoing Phase 3 REBUILD study of INOpulse®, a proprietary pulsatile nitric oxide delivery system, for the treatment of fibrotic interstitial lung disease (fILD). The Company expects to report top-line results from this study in mid-2023. The REBUILD study is a Phase 3, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of pulsed inhaled nitric oxide (iNO) in patients at risk for pulmonary hypertension associated with pulmonary fibrosis on long-term oxygen therapy. A total of 145 fILD patients were enrolled and treated with either INOpulse at a dose of iNO45 or placebo. The Phase 3 program builds on the results from the Company’s previously reported Phase 2 studies which showed improvement in multiple cardiopulmonary parameters, including pulmonary vascular resistance after acute treatment and benefit in Moderate to Vigorous Physical Activity (MVPA) as measured by actigraphy after 16 weeks of chronic treatment. With a total of 145 patients enrolled, the study is powered >90%, (p-value of 0.01) for the primary endpoint of a change in MVPA measured by actigraphy. If approved, INOpulse would become the first therapy to treat a broad fILD population, including patients at low-, intermediate- and high-risk pulmonary hypertension. Major Estimate Revision • Apr 05
Consensus revenue estimates fall by 20% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$4.49m to US$3.59m. Forecast losses increased from -US$1.69 to -US$1.87 per share. Biotechs industry in the US expected to see average net income decline 50% next year. Consensus price target of US$24.50 unchanged from last update. Share price rose 49% to US$11.40 over the past week. Breakeven Date Change • Apr 02
Forecast to breakeven in 2025 The 2 analysts covering Bellerophon Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$13.5m in 2025. Average annual earnings growth of 56% is required to achieve expected profit on schedule. お知らせ • Feb 10
Bellerophon Therapeutics, Inc. Receives IND Clearance from China NMPA to Conduct Phase 3 Clinical Trial in China for INOpulse(R) in Fibrotic Interstitial Lung Disease Bellerophon Therapeutics, Inc. announced clearance of its Investigational New Drug (IND) application from the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) to conduct a Phase 3 clinical trial to support the registration of INOpulse for the treatment of fibrotic interstitial lung disease (fILD) in China. The study will utilize Moderate to Vigorous Physical Activity (MVPA) as the primary endpoint and be conducted in collaboration with Bellerophon’s regional partner, Baylor BioSciences, a life sciences company dedicated to the development and commercialization of innovative medical products for Greater China. お知らせ • Jan 19
Bellerophon Therapeutics, Inc. Announces Completion of Enrollment in Phase 3 REBUILD Study for INOpulse® in Fibrotic Interstitial Lung Disease Bellerophon Therapeutics, Inc. announced that the last patient has been enrolled in the ongoing Phase 3 REBUILD study of INOpulse®, a proprietary pulsatile nitric oxide delivery system, for the treatment of fibrotic interstitial lung disease (fILD). The Company now expects to report pivotal top-line results in mid- 2023. The REBUILD study is a pivotal Phase 3, randomized, double-blind, placebo-controlled dose escalation and verification clinical trial evaluating the safety and efficacy of pulsed inhaled nitric oxide (iNO) in patients at risk for pulmonary hypertension associated with pulmonary fibrosis on long-term oxygen therapy. With a total of 145 patients enrolled, the study is powered >90%, (p-value of 0.01) for the primary endpoint of a change in MVPA measured by actigraphy, based on the results from Phase 2, and will be the basis for the submission of NDA for approval in fILD. Price Target Changed • Nov 16
Price target decreased to US$24.50 Down from US$28.00, the current price target is an average from 2 analysts. New target price is 2,107% above last closing price of US$1.11. Stock is down 69% over the past year. The company is forecast to post a net loss per share of US$2.07 next year compared to a net loss per share of US$1.87 last year. Board Change • Nov 16
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. 5 experienced directors. No highly experienced directors. Independent Director Crispin Teufel was the last director to join the board, commencing their role in 2019. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Price Target Changed • Apr 27
Price target decreased to US$24.50 Down from US$28.00, the current price target is an average from 2 analysts. New target price is 1,601% above last closing price of US$1.44. Stock is down 68% over the past year. The company is forecast to post a net loss per share of US$2.16 next year compared to a net loss per share of US$1.87 last year. Board Change • Apr 27
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. 5 experienced directors. No highly experienced directors. Independent Director Crispin Teufel was the last director to join the board, commencing their role in 2019. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Board Change • Apr 02
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. 5 experienced directors. No highly experienced directors. Independent Director Crispin Teufel was the last director to join the board, commencing their role in 2019. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Executive Departure • Sep 14
CFO & Secretary Assaf Korner has left the company On the 10th of September, Assaf Korner's tenure as CFO & Secretary ended. As of June 2021, Assaf still personally held only 4.41k shares (US$21k worth at the time). A total of 2 executives have left over the last 12 months. The current median tenure of the management team is 5.13 years. Price Target Changed • Sep 03
Price target decreased to US$25.00 Down from US$37.50, the current price target is an average from 3 analysts. New target price is 510% above last closing price of US$4.10. Stock is down 59% over the past year. 