- U.S. Food and Drug Administration ("FDA") granted Investigational Device Exemption ("IDE") approval with conditions for Virtue SAB® coronary in-stent restenosis ("ISR") U.S. pivotal study (in collaboration with Terumo Corporation ("Terumo")); study expected to start before the end of 2023
- BackBeat CNT global pivotal study in hypertensive pacemaker patients (in collaboration with Medtronic) on track for initiation in the second half of 2023
NEW HOPE, Pa., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today reported its second quarter 2023 financial results and provided a business update.
"We are excited about this week's announcement of the FDA's IDE approval for our Virtue ISR-US pivotal study. This latest milestone kicks off what is expected to be a busy second half of 2023 for Orchestra BioMed, which we believe will feature the initiation of pivotal studies for both of our flagship partnered development programs. These two studies are key next steps toward realizing the substantial potential clinical and commercial value of BackBeat CNT and Virtue SAB," commented David Hochman, Chairman, Chief Executive Officer and Founder of Orchestra BioMed. "We are focused on delivering on these milestones and continuing to build upon the significant momentum from the first half of the year. To support our growth strategy, we recently entered the public markets as a Nasdaq-listed company and strengthened our leadership team with the appointments of several highly skilled senior executives. Looking ahead, we are well-funded, have outstanding partners and are well-positioned to accomplish our mission of accelerating high impact medical innovations to physicians and patients."
Pipeline highlights
- BackBeat Cardiac Neuromodulation Therapy (CNT) - Hypertension in Pacemaker Patients
- Global pivotal study evaluating the efficacy and safety of BackBeat CNT in adult patients with hypertension who are indicated for a pacemaker on track to start in the second half of 2023
- Virtue® Sirolimus AngioInfusion Balloon (SAB) - Coronary Indications
- FDA granted IDE approval with conditions of U.S. pivotal study evaluating Virtue SAB in adult patients with coronary ISR, expected to start before the end of 2023
- Planned Clinical Trial Notification ("CTN") submissions to the Japanese Pharmaceutical and Medical Devices Agency ("PMDA") for initiation of Japanese registrational studies of Virtue SAB in coronary small vessel disease and ISR are on track for Q4 2023
Corporate highlights
- Established new corporate development function with the appointment of Bill Little as Executive Vice President of Corporate Development and Strategy
- Appointed Andrew Taylor as Chief Financial Officer
Financial Results for the Second Quarter Ended June 30, 2023
- Cash and cash equivalents and marketable securities totaled $117.7 million as of June 30, 2023. Based on current clinical development, other research and development plans, and budget estimates, the Company anticipates the cash and cash equivalents and marketable securities are sufficient to fund operations into 2026.
- Net cash used in operating activities and for the purchase of fixed assets was $10.5 million during the second quarter of 2023, compared with $7.9 million for the same period in 2022.
- Revenue for the second quarter of 2023 was $0.9 million, compared with $0.4 million for the same period in 2022. The increase was primarily due to increased recognition of partnership revenues earned under the agreement with Terumo.
- Research and development (R&D) expenses for the second quarter of 2023 were $8.5 million, compared with $5.0 million for the same period in 2022. The increase was primarily due to additional costs associated with preparation for the initiation of the Virtue SAB and BackBeat CNT pivotal clinical studies.
- Selling, general and administrative expenses for the second quarter of 2023 were $5.3 million, compared with $2.9 million for the same period in 2022. The increase was primarily due to additional personnel costs, legal, insurance and finance costs, and additional costs related to being a public company.
- Net loss for the second quarter of 2023 was $12.0 million, or $0.35 per share, compared with a net loss of $7.8 million, or $0.77 per share, for the same period in 2022.
About Orchestra BioMed
Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed's partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed's flagship product candidates include BackBeat Cardiac Neuromodulation Therapy (CNT) for the treatment of hypertension, a significant risk factor for death worldwide, and Virtue® Sirolimus AngioInfusion Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of BackBeat CNT for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. Orchestra BioMed has additional product candidates and plans to potentially expand its product pipeline through acquisitions, strategic collaborations, licensing, and organic development. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn and Twitter.
References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release.
About BackBeat CNT
BackBeat CNT is an investigational bioelectronic treatment designed to lower blood pressure. It is compatible with standard pacemakers as a firmware upgrade and has been evaluated in pilot studies in patients with hypertension who are also indicated for pacemakers. It is estimated that more than 70% of the approximately 1.1 million people globally who are implanted with cardiac pacemakers each year are also diagnosed with hypertension1.
The peer-reviewed, double-blind, randomized pilot study, MODERATO II, showed that patients treated with BackBeat CNT experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) when compared to control patients at six months. Orchestra BioMed plans to conduct a global pivotal study to further evaluate the safety and efficacy of BackBeat CNT in lowering blood pressure in a similar target population of patients who have been indicated for, and recently received, a cardiac pacemaker implant. The strategic collaboration with Medtronic will provide Orchestra BioMed with development, clinical, and regulatory support for this planned global study. Upon regulatory approval, Medtronic will have the global rights to commercialize BackBeat CNT-enabled pacing systems for this target population. Orchestra BioMed will share in the revenues generated from Medtronic sales of the BackBeat CNT-enabled pacing systems.
About Virtue SAB
Virtue SAB is a patented drug/device combination product candidate in development for the treatment of certain forms of artery disease that is designed to deliver a proprietary, investigational, extended-release formulation of sirolimus, SirolimusEFR, to the vessel wall during balloon angioplasty without any coating on the balloon surface or the need to leave a stent or other permanent implant in the artery. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center prospective, independent core lab-adjudicated clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee.
Orchestra BioMed has a strategic partnership with Terumo (Terumo, TSE: 4543), a global leader in medical technology headquartered in Tokyo, Japan, as well as Terumo Medical Corporation, its U.S. subsidiary, to collaborate on the global development and commercialization of Virtue SAB in coronary and peripheral vascular indications.
Forward-Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the FDA's conditional approval of the Virtue ISR-US pivotal study, the initiation and timing of the Company's planned pivotal trials, realizing the clinical and commercial value of BackBeat CNT and Virtue SAB, the expected runway of the Company's current cash and cash equivalents, the potential efficacy of the Company's product candidates, the ability of the Company's partnerships to accelerate clinical development, and the Company's late-stage development programs, strategic partnerships and plans to expand its product pipeline. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; failure to realize the anticipated benefits of the business combination; risks related to regulatory approval of the Company's product candidates; the timing of, and the Company's ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading "Item 1A. Risk Factors" in the Company's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission on May 12, 2023 as updated by any risk factors disclosed under the heading "Item 1A. Risk Factors" in the Company's subsequently filed quarterly reports on Form 10-Q.
The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law.
References
- Company estimates based on published sources, including National Inpatient Survey (NIS) and National Health and Nutrition Examination Survey (NHANES).
| ORCHESTRA BIOMED HOLDINGS, INC. Condensed Consolidated Balance Sheets (in thousands, except share and per share data) (Unaudited) | ||||||||
| June 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 16,409 | $ | 19,784 | ||||
| Marketable securities | 101,295 | 63,915 | ||||||
| Strategic investments, current portion | 69 | 86 | ||||||
| Accounts receivable, net | 171 | 96 | ||||||
| Inventory | 178 | 276 | ||||||
| Prepaid expenses and other current assets | 1,468 | 533 | ||||||
| Total current assets | 119,590 | 84,690 | ||||||
| Property and equipment, net | 1,407 | 1,489 | ||||||
| Right-of-use assets | 1,874 | 2,187 | ||||||
| Strategic investments, less current portion | 2,495 | 2,495 | ||||||
| Deposits and other assets | 517 | 4,711 | ||||||
| TOTAL ASSETS | $ | 125,883 | $ | 95,572 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 3,011 | $ | 3,968 | ||||
| Accrued expenses and other liabilities | 3,826 | 5,376 | ||||||
| Operating lease liability, current portion | 729 | 697 | ||||||
| Warrant liability | - | 2,089 | ||||||
| Deferred revenue, current portion | 4,294 | 6,436 | ||||||
| Total current liabilities | 11,860 | 18,566 | ||||||
| Deferred revenue, less current portion | 13,498 | 13,103 | ||||||
| Loan payable | 9,563 | 9,490 | ||||||
| Operating lease liability, less current portion | 1,310 | 1,683 | ||||||
| Other long-term liabilities | 213 | 196 | ||||||
| TOTAL LIABILITIES | 36,444 | 43,038 | ||||||
| STOCKHOLDERS' EQUITY | ||||||||
| Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized; none issued or outstanding at June 30, 2023 and December 31, 2022. | - | - | ||||||
| Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 35,743,007 and 20,187,850 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively. | 4 | 2 | ||||||
| Additional paid-in capital | 312,251 | 252,274 | ||||||
| Accumulated other comprehensive loss | (96 | ) | (8 | ) | ||||
| Accumulated deficit | (222,720 | ) | (199,734 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 89,439 | 52,534 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 125,883 | $ | 95,572 | ||||
| ORCHESTRA BIOMED HOLDINGS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (Unaudited) | ||||||||
| Three Months Ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| Revenue: | ||||||||
| Partnership revenue | $ | 728 | $ | 229 | ||||
| Product revenue | 187 | 172 | ||||||
| Total revenue | 915 | 401 | ||||||
| Expenses: | ||||||||
| Cost of product revenues | 54 | 60 | ||||||
| Research and development | 8,499 | 5,029 | ||||||
| Selling, general and administrative | 5,318 | 2,946 | ||||||
| Total expenses | 13,871 | 8,035 | ||||||
| Loss from operations | (12,956 | ) | (7,634 | ) | ||||
| Other income (expense): | ||||||||
| Interest income (expense), net | 941 | (246 | ) | |||||
| Loss on fair value adjustment of warrant liability | - | (1,015 | ) | |||||
| Loss on debt extinguishment | - | (682 | ) | |||||
| (Loss) gain on fair value of strategic investments | (31 | ) | 1,730 | |||||
| Total other income (expense) | 910 | (213 | ) | |||||
| Net loss | $ | (12,046 | ) | $ | (7,847 | ) | ||
| Net loss per share | ||||||||
| Basic and diluted | $ | (0.35 | ) | $ | (0.77 | ) | ||
| Weighted-average shares used in computing net loss per share, basic and diluted | 34,613,466 | 10,138,169 | ||||||
| Comprehensive loss | ||||||||
| Net loss | $ | (12,046 | ) | $ | (7,847 | ) | ||
| Unrealized loss on marketable securities | (61 | ) | - | |||||
| Comprehensive loss | $ | (12,107 | ) | $ | (7,847 | ) | ||
Investor Contact:
Bob Yedid
LifeSci Advisors
(516) 428-8577
Bob@lifesciadvisors.com
Media Contact:
Kelsey Kirk-Ellis
Orchestra BioMed
(484) 682-4892
Kkirkellis@orchestrabiomed.com
