Exhibit 99.1
Kineta Reports Third Quarter 2023 Financial Results and Provides Corporate Update
Announced positive KVA12123 monotherapy safety data from its ongoing phase 1/2 VISTA-101 clinical trial
Enrolled the first patient of KVA12123 in combination with pembrolizumab in patients with advanced solid tumors
Initial KVA12123 monotherapy clinical safety, pharmacokinetic, receptor occupancy and biomarker data to be presented at SITC 2023
Expected Cash Runway into early 2025
SEATTLE — (November 3, 2023) Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.
“We are thrilled to share the significant progress made during the third quarter of 2023, highlighted by announcing, in September, initial monotherapy data from our VISTA-101 clinical trial evaluating KVA12123 in patients with advanced solid tumors. Additionally, we initiated Part B of the study enrolling the first patient in combination with pembrolizumab” said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. “We continue to execute the VISTA-101 trial on time and on budget as we remain laser focused on advancing this promising new immunotherapy for cancer patients.”
RECENT CORPORATE HIGHLIGHTS
KVA12123
CD27 monoclonal antibody (mAb) Program
Business
ANTICIPATED FUTURE MILESTONES
THIRD QUARTER AND YEAR-TO-DATE 2023 FINANCIAL HIGHLIGHTS
About Kineta
Kineta (Nasdaq: KA) is a clinical-stage biotechnology company with a mission to develop next-generation immunotherapies that transform patients’ lives. Kineta has leveraged its expertise in innate immunity and is focused on discovering and developing potentially differentiated immunotherapies that address the major challenges with current cancer therapy. For more information on Kineta, please visit www.kinetabio.com, and follow Kineta on Twitter, LinkedIn and Facebook.
Cautionary Statements Regarding Forward-Looking Statements:
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The use of words such as, but not limited to, “believe,” “expect,” “estimate,” “project,” “intend,” “future,” “potential,” “continue,” “may,” “might,” “plan,” “will,” “should,” “seek,” “anticipate,” or “could” and other similar words or expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Kineta’s current beliefs, expectations and assumptions regarding the future of Kineta’s business, future plans and strategies, clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Such forward-looking statements are subject to a number of material risks and uncertainties including, but not limited to: the adequacy of Kineta’s capital to support its future operations (including its ability to complete the second tranche of the previously disclosed contemplated private placement in the second quarter of 2024) and its ability to successfully initiate and complete clinical trials; the difficulty in predicting the time and cost of development of Kineta’s product candidates; Kineta’s plans to research, develop and commercialize its current and future product candidates, including, but not limited to, KVA12123; the
timing and anticipated results of Kineta’s planned pre-clinical studies and clinical trials and the risk that the results of Kineta’s pre-clinical studies and clinical trials may not be predictive of future results in connection with future studies or clinical trials; the timing of the availability of data from Kineta’s clinical trials; the timing of any planned investigational new drug application or new drug application; the risk of cessation or delay of any ongoing or planned clinical trials of Kineta or its collaborators; the clinical utility, potential benefits and market acceptance of Kineta’s product candidates; Kineta’s commercialization, marketing and manufacturing capabilities and strategy; developments and projections relating to Kineta’s competitors and its industry; the impact of government laws and regulations; the timing and outcome of Kineta’s planned interactions with regulatory authorities; Kineta’s ability to protect its intellectual property position; Kineta’s estimates regarding future revenue, expenses, capital requirements and need for additional financing; the intended use of proceeds from the registered direct offering completed in April 2023 and October 2023; and those risks set forth under the caption “Risk Factors” in the company’s most recent Annual Report on Form 10-K filed with the SEC on March 31, 2023, and Quarterly Reports on Form 10-Q filed with the SEC on May 11, 2023 and August 11, 2023, as well as discussions of potential risks, uncertainties and other important factors in Kineta’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Except as required by law, Kineta undertakes no obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise.
KINETA, INC.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Collaboration revenues |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
442 |
|
|
$ |
— |
|
Licensing revenues |
|
|
— |
|
|
|
— |
|
|
|
5,000 |
|
|
|
965 |
|
Grant revenues |
|
|
— |
|
|
|
200 |
|
|
|
— |
|
|
|
501 |
|
Total revenues |
|
|
— |
|
|
|
200 |
|
|
|
5,442 |
|
|
|
1,466 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
1,909 |
|
|
|
2,605 |
|
|
|
7,462 |
|
|
|
10,507 |
|
General and administrative |
|
|
2,077 |
|
|
|
2,046 |
|
|
|
9,432 |
|
|
|
5,480 |
|
Total operating expenses |
|
|
3,986 |
|
|
|
4,651 |
|
|
|
16,894 |
|
|
|
15,987 |
|
Loss from operations |
|
|
(3,986 |
) |
|
|
(4,451 |
) |
|
|
(11,452 |
) |
|
|
(14,521 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest expense (with related parties $0 for the three and nine months ended September 30, 2023 and $465 and $1,366 for the three and nine months ended September 30, 2022, respectively) |
|
|
(21 |
) |
|
|
(559 |
) |
|
|
(65 |
) |
|
|
(1,699 |
) |
Change in fair value of rights from Private Placement |
|
|
(1,401 |
) |
|
|
— |
|
|
|
(180 |
) |
|
|
— |
|
Change in fair value measurement of notes payable |
|
|
(4 |
) |
|
|
(418 |
) |
|
|
(17 |
) |
|
|
(542 |
) |
(Loss) gain on extinguishments of debt, net |
|
|
— |
|
|
|
(236 |
) |
|
|
— |
|
|
|
259 |
|
Other (expense) income, net |
|
|
101 |
|
|
|
(3 |
) |
|
|
298 |
|
|
|
(17 |
) |
Total other (expense) income, net |
|
|
(1,325 |
) |
|
|
(1,216 |
) |
|
|
36 |
|
|
|
(1,999 |
) |
Net loss |
|
$ |
(5,311 |
) |
|
$ |
(5,667 |
) |
|
$ |
(11,416 |
) |
|
$ |
(16,520 |
) |
Net (loss) income attributable to noncontrolling interest |
|
|
69 |
|
|
|
(82 |
) |
|
|
29 |
|
|
|
(81 |
) |
Net loss attributable to Kineta, Inc. |
|
$ |
(5,380 |
) |
|
$ |
(5,585 |
) |
|
$ |
(11,445 |
) |
|
$ |
(16,439 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.46 |
) |
|
$ |
(1.14 |
) |
|
$ |
(1.09 |
) |
|
$ |
(3.42 |
) |
Weighted-average shares outstanding, basic and diluted |
|
|
11,738 |
|
|
|
4,891 |
|
|
|
10,505 |
|
|
|
4,808 |
|
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
(unaudited)
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
||
|
|
(in thousands) |
|
|||||
Cash |
|
$ |
7,562 |
|
|
$ |
13,143 |
|
Total current assets |
|
|
7,843 |
|
|
|
13,600 |
|
Working capital |
|
|
228 |
|
|
|
2,113 |
|
Total assets |
|
|
10,705 |
|
|
|
17,435 |
|
Total debt |
|
|
765 |
|
|
|
748 |
|
Total stockholders' equity |
|
|
2,889 |
|
|
|
4,570 |
|
FOR FURTHER INFORMATION, PLEASE CONTACT:
Kineta, Inc. :
Jacques Bouchy
EVP Investor Relations & Business Development
+1 206-378-0400
jbouchy@kineta.us
Investor Relations:
John Mullaly
LifeSci Advisors, LLC
jmullaly@lifesciadvisors.com
Source: Kineta, Inc.