UPB 8-K
Upstream Bio, Inc. (UPB)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On March 12, 2025, Upstream Bio, Inc. (the “Company”) announced its financial results and business highlights for the quarter and year ended December 31, 2024. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information included under Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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99.1 |
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Press Release issued by Upstream Bio, Inc. on March 12, 2025, furnished herewith. |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Upstream Bio, Inc. |
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Date: |
March 12, 2025 |
By: |
/s/ E. Rand Sutherland |
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E. Rand Sutherland, M.D. |
Upstream Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights
– Completed enrollment of Phase 2 clinical trial of verekitug in patients with chronic rhinosinusitis with nasal polyps; top-line data expected in the second half of 2025 –
– Completed upsized IPO with gross proceeds of approximately $293 million, extending runway through 2027 –
WALTHAM, Mass. – March 12, 2025 - Upstream Bio, Inc. (Nasdaq: UPB), a clinical-stage company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a summary of recent business highlights. Upstream is developing verekitug, the only monoclonal antibody currently in clinical development that targets and inhibits the thymic stromal lymphopoietin (TSLP) receptor, in multiple severe respiratory diseases including chronic rhinosinusitis with nasal polyps (CRSwNP), severe asthma and chronic obstructive pulmonary disease (COPD).
“We closed 2024 and started 2025 with strong continued momentum, marked by the successful completion of enrollment in our Phase 2 clinical trial of verekitug in patients with CRSwNP in January 2025. We expect to report top-line data from this trial in the second half of 2025, enabling regulatory discussions and preparations for a Phase 3 program in CRSwNP,” said Rand Sutherland, MD, Chief Executive Officer of Upstream.
“We have also made significant progress developing verekitug in severe asthma and COPD,” Dr. Sutherland continued. “We remain on track to dose the first patient in our COPD program in the second half of 2025 and, as previously reported, we expect to report top-line data from our ongoing Phase 2 clinical trial in severe asthma in the second half of 2026. Our recently completed initial public offering has provided us with sufficient capital to fund our planned operations through 2027, supporting our strategy of leveraging verekitug's unique mechanism of action to improve treatment options for patients living with severe inflammatory diseases.”
Fourth Quarter 2024 and Recent Business Highlights
Upstream has designed this trial using endpoints that, pending interactions with regulatory authorities, could produce data to support submissions for product approval. Patients were randomized to receive either 100 mg of verekitug or placebo administered subcutaneously every 12 weeks over a 24-week treatment period. The primary endpoint is change from baseline in nasal polyp score (NPS) at week 24, a primary endpoint that has been used in several registrational trials for other biologic treatments for CRSwNP. Secondary endpoints include: nasal congestion score, sinus opacification, difficulty with sense of smell, nasal symptoms, percentage of participants requiring systemic corticosteroids or NP surgery, time to NP surgery and/or time to systemic corticosteroids for NP, and characterization of safety.
Fourth Quarter 2024 Financial Results
As of December 31, 2024, Upstream had cash, cash equivalents and short-term investments of $470.5 million, which is expected to fund planned operations through 2027.
Research and development expenses were $21.8 million for the quarter ended December 31, 2024, compared to $11.6 million for the same period in 2023. The increase of $10.2 million was primarily driven by an increase in clinical and manufacturing expenses related to our verekitug program.
General and administrative expenses were $5.2 million for the quarter ended December 31, 2024, compared to $3.2 million for the same period in 2023. The increase of $2.0 million was primarily driven by an increase in personnel-related expenses, including share-based compensation and insurance costs.
Net loss was $21.2 million for the quarter ended December 31, 2024, compared to a net loss of $11.8 million for the same period in 2023. The increase of $9.4 million was largely due to increased research and development and general and administrative expenses, partially offset by increased interest income.
Upcoming Events
Upstream expects to participate in the following investor conferences:
About Upstream Bio
Upstream Bio is a clinical-stage biotechnology company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders. Upstream is developing verekitug, the only known antagonist currently in clinical development that targets the receptor for thymic stromal lymphopoietin, a cytokine which is a clinically validated driver of inflammatory response positioned upstream of multiple signaling cascades that affect a variety of immune mediated diseases. Upstream has advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic
rhinosinusitis with nasal polyps and plans to initiate development in chronic obstructive pulmonary disease. Upstream’s team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. To learn more, please visit www.upstreambio.com.
Upstream intends to use the investor relations page on its website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor its website in addition to following press releases, filings with the Securities and Exchange Commission (SEC), public conference calls, presentations and webcasts.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “continue,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “predict,” “project,” “seeks,” “should,” “target,” “will” and variations of these words or similar expressions. Any statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, express or implied statements regarding: the clinical development of verekitug for the treatment of severe asthma, CRSwNP and COPD, including the initiation, timing, progress and results of ongoing and planned clinical trials, and expected future discussions with regulatory authorities; expectations regarding the safety, efficacy or tolerability of verekitug; Upstream’s expected operating expenses and capital expenditure requirements, including its cash runway through 2027; and participation at upcoming conferences. Any forward-looking statements in this press release are based on Upstream’s current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in Upstream’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to: Upstream’s ability to advance verekitug through clinical development, and to obtain regulatory approval of and ultimately commercialize verekitug on the expected timeline, if at all; the initiation, timing, progress and results of clinical trials; Upstream’s ability to fund its development activities and achieve development goals; Upstream’s dependence on third parties to conduct clinical trials and manufacture verekitug, and commercialize verekitug, if approved; Upstream’s ability to attract, hire and retain key personnel, and protect its intellectual property; Upstream’s financial condition and need for substantial additional funds in order to complete development activities and commercialize verekitug, if approved; regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; Upstream’s competitors and industry; and other risks and uncertainties described in Upstream’s current and future filings with the SEC, including those described from time to time under the caption “Risk Factors.” Upstream explicitly disclaims any obligation or undertaking to update any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based except to the extent required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Investor Contact:
Michael Gray
Chief Financial Officer and Chief Operating Officer
[email protected]
Media Contact:
Teri Dahlman
Red House Communications
[email protected]
UPSTREAM BIO, INC.
CONSOLIDATED BALANCE SHEET
(IN THOUSANDS)
(UNAUDITED)
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December 31, |
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2024 |
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2023 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
325,892 |
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$ |
25,833 |
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Short-term investments |
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144,559 |
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83,977 |
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Accounts receivable - related party |
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613 |
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98 |
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Prepaid expenses and other current assets |
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8,096 |
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7,088 |
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Total current assets |
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479,160 |
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116,996 |
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Property and equipment, net |
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582 |
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159 |
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Operating lease right-of-use assets |
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1,783 |
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43 |
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Restricted cash |
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194 |
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— |
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Total assets |
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$ |
481,719 |
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$ |
117,198 |
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Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) |
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Current liabilities: |
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Accounts payable |
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$ |
4,041 |
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$ |
1,990 |
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Accrued expenses and other current liabilities |
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5,992 |
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4,480 |
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Operating lease liabilities, current portion |
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704 |
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45 |
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Total current liabilities |
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10,737 |
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6,515 |
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Operating lease liabilities, net of current portion |
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1,130 |
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— |
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Preferred stock tranche right liability |
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— |
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2,874 |
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Total liabilities |
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11,867 |
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9,389 |
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Redeemable convertible preferred stock (Series A, B) |
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— |
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230,935 |
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Stockholders’ equity (deficit): |
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Common stock |
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53 |
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3 |
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Additional paid-in capital |
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660,604 |
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4,824 |
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Accumulated other comprehensive income (loss) |
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(25 |
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21 |
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Accumulated deficit |
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(190,780 |
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(127,974 |
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Total stockholders’ equity (deficit) |
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469,852 |
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(123,126 |
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Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) |
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$ |
481,719 |
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$ |
117,198 |
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UPSTREAM BIO, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS)
(UNAUDITED)
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Three Months Ended December 31, |
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Year Ended December 31, |
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2024 |
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2023 |
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2024 |
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2023 |
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Collaboration revenue - related party |
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$ |
613 |
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$ |
450 |
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$ |
2,370 |
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$ |
2,380 |
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Operating expenses: |
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Research and development |
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21,773 |
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11,554 |
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62,966 |
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31,799 |
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General and administrative |
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5,158 |
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3,226 |
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17,168 |
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10,695 |
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Total operating expenses |
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26,931 |
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14,780 |
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80,134 |
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42,494 |
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Loss from operations |
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(26,318 |
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(14,330 |
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(77,764 |
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(40,114 |
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Other income (expense): |
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Change in fair value of preferred stock |
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tranche right liabilities |
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— |
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985 |
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2,859 |
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15,527 |
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Interest income |
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5,076 |
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1,519 |
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12,123 |
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4,165 |
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Other expense, net |
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— |
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(7 |
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(24 |
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(115 |
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Total other income, net |
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5,076 |
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2,497 |
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14,958 |
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19,577 |
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Net loss |
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$ |
(21,242 |
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$ |
(11,833 |
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$ |
(62,806 |
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$ |
(20,537 |
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