Mr. Hochman continued, “We stay actively engaged with our different strategic companion, Terumo, to replace our operational and monetary plans to advance Advantage SAB for the therapy of sufferers with coronary in-stent restenosis, a breakthrough indication for which we’ve conditional Investigational Gadget Exemption approval from the FDA, in addition to different breakthrough coronary and peripheral indications. Globally, the therapy of coronary in-stent restenosis and different difficult artery illness indications is quickly shifting towards drug-coated balloons. We proceed to imagine Advantage SAB, the one non-coated balloon angioplasty system that gives protected focal supply of extended-release sirolimus, has the potential to supply a best-in-class resolution with necessary benefits for sufferers and physicians in a longtime goal world market we estimate at over $4 billion yearly. General, we look ahead to persevering with 2023’s momentum within the yr forward with a deal with robust execution, one of the best validation of our partnership-enabled enterprise mannequin.”
Fourth Quarter 2023 and Current Highlights
Advancing AVIM Remedy in Excessive Unmet Want Hypertension Populations
- Initiated enrollment of the BACKBEAT pivotal examine evaluating the efficacy and security of atrioventricular interval modulation (“AVIM”) remedy in hypertensive pacemaker sufferers in December 2023, with a goal for completion of enrollment in mid-2025.
- Japanese Prescription drugs and Medical Gadgets Company (“PMDA”) indicated that the prevailing BACKBEAT world pivotal examine, if enough to help FDA approval of BackBeat CNT would doubtless be enough to help a regulatory approval of AVIM remedy in Japan.
- Continued to discover future alternatives to make the most of AVIM remedy and different types of Cardiac Neuromodulation Remedy (“CNT”) for high-risk populations with hypertension and coronary heart failure.
Maximizing the Alternative for Extremely Differentiated Advantage SAB
- Initiation of Advantage ISR-US pivotal examine of Advantage SAB for the therapy of coronary in-stent restenosis (“ISR”), in addition to submissions to Japanese PMDA in coronary ISR and small vessel illness are pending ongoing operational and monetary plan calibration with Terumo, strategic companion for improvement and commercialization of Advantage SAB for coronary and peripheral artery illness therapy.
Monetary Outcomes for the Yr Ended December 31, 2023
- Money and money equivalents and marketable securities totaled $87.6 million as of December 31, 2023. Anticipated runway prolonged into the second half of 2026 based mostly on internally ready forecast reflecting up to date working priorities and sure potential future proceeds.
- Internet money utilized in working actions and for the acquisition of fastened belongings was $46.2 million throughout 2023, in contrast with $29.9 million for 2022, with the first drivers of elevated spending being prices related to preparation for the initiation of the BACKBEAT pivotal examine in addition to bills related to being a public firm.
- Income for 2023 was $2.8 million, in contrast with $3.5 million for 2022. The lower was primarily attributable to decreased recognition of partnership revenues earned below the settlement with Terumo.
- Analysis and improvement bills for 2023 had been $33.8 million, in contrast with $21.9 million for 2022. The rise was primarily attributable to further prices related to preparation for the initiation of the BACKBEAT pivotal examine.
- Promoting, normal and administrative bills for 2023 had been $20.3 million, in contrast with $14.0 million for 2022. The rise was primarily attributable to further personnel prices, authorized, insurance coverage and finance prices, and extra prices associated to being a public firm.
- Internet loss for 2023 was $49.1 million, or ($1.48) per share, in contrast with a internet lack of $33.6 million, or ($2.24) per share, for 2022. Internet loss for the year-ended 2023 included non-cash stock-based compensation expense of $7.6 million, in contrast with $3.4 million for a similar interval in 2022.
About Orchestra BioMed
Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation firm accelerating high-impact applied sciences to sufferers by way of risk-reward sharing partnerships with main medical machine corporations. Orchestra BioMed’s partnership-enabled enterprise mannequin focuses on forging strategic collaborations with main medical machine corporations to drive profitable world commercialization of merchandise it develops. Orchestra BioMed’s lead product candidate is atrioventricular interval modulation (AVIM) remedy (also referred to as BackBeat Cardiac Neuromodulation Remedy (CNT™)) for the therapy of hypertension, a major threat issue for dying worldwide. Orchestra BioMed can also be growing the Advantage ® Sirolimus AngioInfusion™ Balloon (SAB) for the therapy of atherosclerotic artery illness, the main reason for mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of many largest medical machine corporations on the planet, for improvement and commercialization of AVIM remedy for the therapy of hypertension in pacemaker-indicated sufferers, and a strategic partnership with Terumo, a world chief in medical expertise, for improvement and commercialization of Advantage SAB for the therapy of artery illness. Orchestra BioMed has further product candidates and plans to probably develop its product pipeline by way of acquisitions, strategic collaborations, licensing and natural improvement. For additional details about Orchestra BioMed, please go to www.orchestrabiomed.com , and comply with us on LinkedIn .
References to Web sites and Social Media Platforms
References to info included on, or accessible by way of, web sites and social media platforms don’t represent incorporation by reference of the data contained at or out there by way of such web sites or social media platforms, and you shouldn’t contemplate such info to be a part of this press launch.
About AVIM Remedy (BackBeat CNT TM )
AVIM remedy, also referred to as BackBeat CNT™, is an investigational remedy appropriate with normal dual-chamber pacemakers designed to considerably and persistently decrease blood stress. It has been evaluated in pilot research in sufferers with hypertension who’re additionally indicated for a pacemaker. MODERATO II, a double-blind, randomized, pilot examine, confirmed that sufferers handled with AVIM remedy skilled internet reductions of 8.1 mmHg in 24-hour ambulatory systolic blood stress (aSBP) and 12.3 mmHg in workplace systolic blood stress (oSBP) at six months when in comparison with management sufferers. The worldwide IDE BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) pivotal examine will additional consider the security and efficacy of AVIM remedy in reducing blood stress in the same goal inhabitants of sufferers who’ve been indicated for, and just lately implanted with, a dual-chamber cardiac pacemaker.
About Advantage SAB
Advantage SAB is a patented drug/machine mixture product candidate in improvement for the therapy of sure types of artery illness that’s designed to ship a proprietary, investigational, extended-release formulation of sirolimus, SirolimusEFR™, to the vessel wall throughout balloon angioplasty with none coating on the balloon floor or the necessity to depart a stent or different everlasting implant within the artery. Advantage SAB demonstrated constructive three-year scientific knowledge in coronary ISR within the SABRE examine, a multi-center potential, impartial core lab-adjudicated scientific examine of fifty sufferers performed in Europe. Advantage SAB has been granted Breakthrough Gadget designation by the FDA for particular indications regarding coronary ISR, coronary small vessel illness and peripheral artery illness below-the-knee. The FDA granted IDE approval to provoke the Advantage ISR-US examine to guage this novel therapy in coronary ISR sufferers. Orchestra BioMed has a strategic partnership with Terumo (Terumo, TSE: 4543), a world chief in medical expertise headquartered in Tokyo, Japan, in addition to Terumo Medical Company, its U.S. subsidiary, to collaborate on the worldwide improvement and commercialization of Advantage SAB in coronary and peripheral vascular indications.
Ahead-Wanting Statements
Sure statements included on this press launch that aren’t historic information are forward-looking statements for functions of the protected harbor provisions below the USA Personal Securities Litigation Reform Act of 1995. Ahead-looking statements usually are accompanied by phrases similar to “imagine,” “might,” “will,” “estimate,” “proceed,” “anticipate,” “intend,” “anticipate,” “ought to,” “would,” “plan,” “predict,” “potential,” “appear,” “search,” “future,” “outlook” and comparable expressions that predict or point out future occasions or tendencies or that aren’t statements of historic issues. These forward-looking statements embody, however should not restricted to, statements regarding the initiation, enrollment, timing, implementation and design of the Firm’s deliberate and ongoing pivotal trials and reporting of top-line outcomes, the sufficiency of regulatory approval of BackBeat CNT by the FDA to help regulatory approval in Japan, realizing the scientific and business worth of BackBeat CNT and Advantage SAB, the anticipated runway of the Firm’s present money, money equivalents, marketable securities and anticipated proceeds from a revised Terumo settlement, the potential security and efficacy of the Firm’s product candidates, the power of the Firm’s partnerships to speed up scientific improvement, the Firm’s late-stage improvement applications, strategic partnerships and plans to develop its product pipeline, and the Firm’s capability to barter mutually agreeable changes to its present settlement with Terumo. These statements are based mostly on varied assumptions, whether or not or not recognized on this press launch, and on the present expectations of the Firm’s administration and should not predictions of precise efficiency. These forward-looking statements are supplied for illustrative functions solely and should not meant to function and should not be relied on as a assure, an assurance, a prediction, or a definitive assertion of reality or chance. Precise occasions and circumstances are tough or inconceivable to foretell and will differ from assumptions. Many precise occasions and circumstances are past the management of the Firm. These forward-looking statements are topic to quite a few dangers and uncertainties, together with modifications in home and international enterprise, market, monetary, political, and authorized circumstances; dangers associated to regulatory approval of the Firm’s business product candidates and ongoing regulation of the Firm’s product candidates, if permitted; the timing of, and the Firm’s capability to attain anticipated regulatory and enterprise milestones; the affect of aggressive merchandise and product candidates; and the chance components mentioned below the heading “Merchandise 1A. Danger Components” within the Firm’s annual report on Type 10-Ok for the yr ended December 31, 2023, which was filed with the SEC on March 27, 2024.
The Firm operates in a really aggressive and quickly altering setting. New dangers emerge on occasion. Given these dangers and uncertainties, the Firm cautions towards putting undue reliance on these forward-looking statements, which solely communicate as of the date of this press launch. The Firm doesn’t plan and undertakes no obligation to replace any of the forward-looking statements made herein, besides as required by legislation.
| ORCHESTRA BIOMED HOLDINGS, INC. Consolidated Stability Sheets (in hundreds, besides share and per share knowledge) |
||||||||
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Money and money equivalents | $ | 30,559 | $ | 19,784 | ||||
| Marketable securities | 56,968 | 63,915 | ||||||
| Strategic investments, present portion | 68 | 86 | ||||||
| Accounts receivable, internet | 99 | 96 | ||||||
| Stock | 146 | 276 | ||||||
| Pay as you go bills and different present belongings | 1,274 | 533 | ||||||
| Complete present belongings | 89,114 | 84,690 | ||||||
| Property and tools, internet | 1,279 | 1,489 | ||||||
| Proper-of-use belongings | 1,555 | 2,187 | ||||||
| Strategic investments, much less present portion | 2,495 | 2,495 | ||||||
| Deposits and different belongings | 769 | 4,711 | ||||||
| TOTAL ASSETS | $ | 95,212 | $ | 95,572 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 2,900 | $ | 3,968 | ||||
| Accrued bills and different liabilities | 5,149 | 5,376 | ||||||
| Working lease legal responsibility, present portion | 649 | 697 | ||||||
| Warrant legal responsibility | — | 2,089 | ||||||
| Deferred income, present portion | 2,510 | 6,436 | ||||||
| Complete present liabilities | 11,208 | 18,566 | ||||||
| Deferred income, much less present portion | 14,923 | 13,103 | ||||||
| Mortgage payable | — | 9,490 | ||||||
| Working lease legal responsibility, much less present portion | 1,038 | 1,683 | ||||||
| Different long-term liabilities | — | 196 | ||||||
| TOTAL LIABILITIES | 27,169 | 43,038 | ||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Most popular inventory, $0.0001 par worth per share; 10,000,000 shares licensed; none issued or excellent at December 31, 2023 and December 31, 2022. | — | — | ||||||
| Widespread inventory, $0.0001 par worth per share; 340,000,000 shares licensed; 35,777,412 and 20,187,850 shares issued and excellent as of December 31, 2023 and December 31, 2022, respectively. | 4 | 2 | ||||||
| Extra paid-in capital | 316,903 | 252,274 | ||||||
| Gathered different complete loss | (10 | ) | (8 | ) | ||||
| Gathered deficit | (248,854 | ) | (199,734 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 68,043 | 52,534 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 95,212 | $ | 95,572 | ||||
| ORCHESTRA BIOMED HOLDINGS, INC. Consolidated Statements of Operations and Complete Loss (in hundreds, besides share and per share knowledge) |
||||||||
| Yr Ended December 31, | ||||||||
| 2023 | 2022 | |||||||
| Income: | ||||||||
| Partnership income | $ | 2,106 | $ | 2,862 | ||||
| Product income | 654 | 671 | ||||||
| Complete income | 2,760 | 3,533 | ||||||
| Bills: | ||||||||
| Price of product revenues | 186 | 211 | ||||||
| Analysis and improvement | 33,822 | 21,945 | ||||||
| Promoting, normal and administrative | 20,258 | 14,034 | ||||||
| Complete bills | 54,266 | 36,190 | ||||||
| Loss from operations | (51,506 | ) | (32,657 | ) | ||||
| Different revenue (expense): | ||||||||
| Curiosity revenue, internet | 3,849 | 50 | ||||||
| Loss on honest worth adjustment of warrant legal responsibility | (294 | ) | (1,350 | ) | ||||
| Loss on debt extinguishment | (1,151 | ) | (682 | ) | ||||
| (Loss) achieve on honest worth of strategic investments | (18 | ) | 1,031 | |||||
| Complete different revenue (expense) | 2,386 | (951 | ) | |||||
| Internet loss | $ | (49,120 | ) | $ | (33,608 | ) | ||
| Internet loss per share | ||||||||
| Primary and diluted | $ | (1.48 | ) | $ | (2.24 | ) | ||
| Weighted-average shares utilized in computing internet loss per share, primary and diluted | 33,225,227 | 14,988,584 | ||||||
| Complete loss | ||||||||
| Internet loss | $ | (49,120 | ) | $ | (33,608 | ) | ||
| Unrealized loss on marketable securities | (2 | ) | (8 | ) | ||||
| Complete loss | $ | (49,122 | ) | $ | (33,616 | ) | ||
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
