Oruka Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update
Rhea-AI Summary
Oruka Therapeutics (Nasdaq: ORKA) reported Q3 2024 financial results and corporate updates. The company raised over $475 million through two transactions and completed its public listing on Nasdaq. Key highlights include accelerated clinical timelines for ORKA-001 and ORKA-002, with Phase 1 trials planned for Q1 2025 and Q3 2025 respectively. Financial results show $410.9 million in cash and equivalents, with a net loss of $28.6 million. R&D expenses totaled $25.7 million, while G&A expenses were $3.8 million. The company expects its current cash position to provide runway through 2027.
Positive
- Raised over $475 million through successful financing rounds
- Strong cash position of $410.9 million providing runway through 2027
- Accelerated clinical timelines for both lead programs
- ORKA-001 showed 3x longer half-life than competitor risankizumab
- ORKA-002 demonstrated 2x longer half-life than bimekizumab
Negative
- Net loss of $28.6 million in Q3 2024
- High R&D expenses of $25.7 million in Q3 2024
- Both lead products still in pre-clinical stage
News Market Reaction – ORKA
On the day this news was published, ORKA declined 6.43%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Successful go-public transaction and over
ORKA-001 non-human primate (NHP) pharmacokinetic and in vitro potency data, presented at EADV in September, further support and derisk the program
Strong execution allowed for acceleration of clinical timelines for both ORKA-001 and ORKA-002, as previously announced
MENLO PARK, Calif., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today reported third quarter 2024 financial results and provided a corporate update.
“We had a highly eventful third quarter which included going public, closing on over
Third Quarter Business and Pipeline Updates
Corporate
- Oruka consummated its go-public transaction and began trading on the Nasdaq under the ticker ORKA.
- The Company raised over
$475 million , including a$275 million private placement previously announced in April that closed concurrently with the merger and an additional$200 million private placement shortly thereafter from a group of new and existing investors.
ORKA-001: a novel half-life extended IL-23p19 monoclonal antibody
- Oruka plans to initiate a Phase 1 trial of ORKA-001 in the first quarter of 2025, which was accelerated from the first half of 2025. The Company expects to share interim data from the first-in-human trial in healthy volunteers, including initial pharmacokinetic data, in the second half of 2025 and initial efficacy data in psoriasis patients in the second half of 2026.
- Data presented at the European Academy of Dermatology and Venereology (EADV) Congress showed that ORKA-001 has a half-life in NHP of more than 30 days, over three times longer than risankizumab and one of the longest NHP half-lives observed for an extended half-life antibody. In addition, the data showed that ORKA-001 binds to a similar epitope as risankizumab and displays similar binding affinity and potency across a variety of in vitro assays.
- These findings support the potential for ORKA-001 to achieve extended dosing intervals of once every six months or even once a year while maintaining high antibody exposures and further derisk its development path.
ORKA-002: a novel half-life extended IL-17A/F monoclonal antibody
- Oruka plans to initiate a Phase 1 trial of ORKA-002 in the third quarter of 2025, which was accelerated from the second half of 2025. The Company expects to share interim data from the first-in-human trial in healthy volunteers, including initial pharmacokinetic data, in the first half of 2026.
- A precursor antibody to ORKA-002 showed a half-life in NHP of approximately 20 days, double that seen with bimekizumab, supporting the potential to achieve significantly longer dosing intervals than currently marketed agents targeting IL-17. This extended half-life could enable a dosing interval of once every four to six months for ORKA-002.
Third Quarter 2024 Financial Results
Cash Position: As of September 30, 2024, Oruka had available cash and cash equivalents of
Research and Development (R&D) expenses: R&D expenses totaled
General and Administrative (G&A) expenses: G&A expenses totaled
Other income (expense): Other income, net for the third quarter of 2024 was
Net loss: Net loss totaled
Shares Outstanding: Oruka has approximately 55.1 million shares of the Company’s Common Stock and Common Stock equivalents issued and outstanding, including shares of Common Stock underlying pre-funded warrants and Series A and Series B non-voting convertible preferred stock.
About Oruka Therapeutics
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn.
Forward Looking Statements
Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-001 and ORKA-002, including timelines to clinical and data release milestones, the potency, binding affinity, efficacy and antibody exposures of ORKA-001, including vis-à-vis risankizumab, the potential half-life of ORKA-001 and ORKA-002 and their potential dosing intervals, and Oruka’s cash runway. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission, including its Quarterly Reports on Form 10-Q. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements.
Investor Contact:
Alan Lada
(650)-606-7911
alan.lada@orukatx.com
| ORUKA THERAPEUTICS, INC. | |||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
| (in thousands) | |||||||
| (unaudited) | |||||||
| September 30, | February 6, | ||||||
| Assets | 2024 | 2024 | |||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 410,875 | $ | — | |||
| Subscription receivables | — | 1 | |||||
| Prepaid expenses and other current assets | 2,074 | ||||||
| Total current assets | 412,949 | 1 | |||||
| Property and equipment, net | 160 | — | |||||
| Operating lease right-of-use assets | 938 | — | |||||
| Other non-current assets | 43 | — | |||||
| Total assets | $ | 414,090 | $ | 1 | |||
| Liabilities, Convertible Preferred Stock and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 2,145 | $ | — | |||
| Accrued expenses and other current liabilities | 1,710 | — | |||||
| Operating lease liability, current | 146 | — | |||||
| Related party common stock warrant liability | 7,681 | — | |||||
| Related party accounts payable and current liabilities | 6,357 | — | |||||
| Total current liabilities | 18,039 | — | |||||
| Operating lease liability, non-current | 842 | — | |||||
| Total liabilities | 18,881 | — | |||||
| Commitments and contingencies | |||||||
| Preferred stock | 52,841 | — | |||||
| Stockholders’ equity: | |||||||
| Preferred stock | 2,931 | — | |||||
| Common stock | 35 | — | |||||
| Additional paid-in capital | 397,345 | 1 | |||||
| Accumulated deficit | (57,943 | ) | — | ||||
| Total stockholders’ equity | 342,368 | 1 | |||||
| Total liabilities, convertible preferred stock and stockholders’ equity | $ | 414,090 | $ | 1 | |||
| ORUKA THERAPEUTICS, INC. | |||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||
| (in thousands, except share and per share data) | |||||||
| (unaudited) | |||||||
| Three Months Ended September 30, 2024 | Period from February 6, 2024 (Inception) to September 30, 2024 | ||||||
| Operating expenses | |||||||
| Research and development(1) | $ | 25,691 | $ | 49,557 | |||
| General and administrative(1) | 3,758 | 8,248 | |||||
| Total operating expenses | 29,449 | 57,805 | |||||
| Loss from operations | (29,449 | ) | (57,805 | ) | |||
| Other income (expense) | |||||||
| Interest income | 1,330 | 1,330 | |||||
| Interest expense | (504 | ) | (1,468 | ) | |||
| Total other income (expense), net | 826 | (138 | ) | ||||
| Net loss and comprehensive loss | $ | (28,623 | ) | $ | (57,943 | ) | |
| Net loss per share attributable to common stockholders, basic and diluted | $ | 1.46 | $ | 6.08 | |||
| Net loss per share attributable to Series A non-voting convertible preferred Stockholders, basic and diluted | $ | 1,461.10 | $ | 6,077.25 | |||
| Net loss per share attributable to Series B non-voting convertible preferred Stockholders, basic and diluted | $ | 121.76 | $ | 506.44 | |||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 15,013,655 | 7,765,381 | |||||
| Weighted-average shares used in computing net loss per share attributable to Series A non-voting convertible preferred stockholders, basic and diluted | 477 | 184 | |||||
| Weighted-average shares used in computing net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted | 49,191 | 19,015 | |||||
| (1) Amounts include non-cash stock based compensation expense as follows (in thousands): | |||||||
| Three Months Ended September 30, 2024 | Period from February 6, 2024 (Inception) to September 30, 2024 | ||||||
| Research and development | $ | 7,772 | $ | 8,310 | |||
| General and administrative | 1,229 | 1,459 | |||||
| Total | $ | 9,001 | $ | 9,769 | |||
FAQ
What were Oruka Therapeutics (ORKA) Q3 2024 financial results?
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