Shattuck Labs Reports Second Quarter 2024 Financial Results and Recent Business Highlights

Rhea-AI Summary

Shattuck Labs (Nasdaq: STTK) reported Q2 2024 financial results and business highlights. Key points include:

1. Updated positive interim data from Phase 1B trial of SL-172154 with Azacitidine in HR-MDS and TP53m AML patients.

2. Enrollment ongoing in randomized Phase 1B dose-expansion cohort for frontline HR-MDS.

3. FDA granted Orphan Drug Designation for SL-172154 in AML treatment.

4. Q2 2024 financials: $105.3M cash and investments, $19.2M R&D expenses, $5.3M G&A expenses, $21.5M net loss ($0.42 per share).

5. Cash runway expected into 2026, beyond Phase 1 trial results for SL-172154.

Positive

• 67% Objective Response Rate in frontline HR-MDS patients with 58% complete remission rate
• 43% Objective Response Rate in frontline TP53m AML patients
• FDA granted Orphan Drug Designation for SL-172154 in AML treatment
• Addition to Russell 2000® and Russell 3000® Indexes
• Cash runway expected into 2026, beyond Phase 1 trial results

Negative

• Net loss increased to $21.5 million in Q2 2024 from $21.3 million in Q2 2023
• Cash and investments decreased to $105.3 million from $117.2 million year-over-year
• R&D expenses increased to $19.2 million from $18.2 million year-over-year
• G&A expenses increased to $5.3 million from $4.7 million year-over-year

Insights

Financial Analyst

Shattuck Labs' Q2 2024 financial results reveal a mixed picture. The company's cash position of $105.3 million shows a 10.2% decrease from the same period last year, indicating ongoing cash burn. R&D expenses increased by 5.5% to $19.2 million, reflecting continued investment in clinical programs. G&A expenses also rose by 12.8% to $5.3 million.

The net loss of $21.5 million ($0.42 per share) is slightly higher than last year's $21.3 million, but the loss per share improved from $0.50, suggesting an increase in outstanding shares. The company's guidance of cash runway into 2026 is positive, providing a substantial buffer for ongoing clinical trials.

However, investors should note the lack of revenue and increasing expenses. The company's financial health hinges on the success of its clinical programs, particularly SL-172154. While the cash position appears adequate for near-term operations, continued losses may necessitate additional funding in the future.

Oncology Doctor

The interim data from Shattuck's Phase 1B trial of SL-172154 in combination with Azacitidine (AZA) shows promising results in difficult-to-treat patient populations. For HR-MDS patients, primarily with TP53 mutations, the 67% Objective Response Rate (ORR) and 58% complete remission rate are notably higher than historical data for AZA monotherapy, which typically shows ORRs around 30-40%.

In TP53m AML patients, the 43% ORR and 33% CR rate are also encouraging, given the poor prognosis associated with TP53 mutations. The fact that median overall survival had not been reached in either cohort at the data cut-off is a positive sign, though longer follow-up is needed to assess durability.

The manageable safety profile, with infusion-related reactions as the primary concern, is reassuring. However, it's important to see how these response rates translate to survival benefits in the ongoing randomized, controlled expansion cohort. The Orphan Drug Designation for AML treatment is a regulatory milestone that could expedite development and provide market exclusivity if approved.

Market Research Analyst

Shattuck Labs' focus on bi-functional fusion proteins positions it in a niche but growing segment of the biotechnology market. The company's lead candidate, SL-172154, is targeting high-need areas in oncology, particularly in hematological malignancies with poor prognoses.

The HR-MDS and TP53m AML markets are relatively small but have significant unmet needs. With an aging global population, the incidence of these diseases is likely to increase. If SL-172154 continues to show strong efficacy and safety data, it could potentially capture a substantial market share in these indications.

The company's pipeline diversity, including applications in solid tumors like ovarian cancer, provides multiple shots on goal. However, the competitive landscape is intensifying, with several companies developing novel therapies for these indications. Shattuck's success will depend on demonstrating superior efficacy or a better safety profile compared to emerging competitors.

Investor sentiment may be cautiously optimistic, as reflected in the company's recent addition to the Russell 2000® and Russell 3000® Indexes. This inclusion could increase visibility and potentially improve liquidity for the stock. However, as with many clinical-stage biotech companies, Shattuck's valuation will be highly sensitive to clinical trial outcomes and regulatory decisions in the coming years.

– Announced updated positive interim data from the Phase 1B dose-expansion clinical trial of SL-172154 in combination with Azacitidine (AZA) in frontline Higher-Risk Myelodysplastic Syndromes (HR-MDS) and TP53 mutant (TP53m) Acute Myeloid Leukemia (AML) patients at the European Society of Hematology (EHA) 2024 Annual Meeting –

– Enrollment ongoing in the randomized, controlled Phase 1B dose-expansion cohort in frontline HR-MDS patients –

– Announced Orphan Drug Designation (ODD) granted by the U.S. Food and Drug Administration (FDA) for SL-172154 for the treatment of AML–

AUSTIN, TX and DURHAM, NC, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today reported financial results for the quarter ended June 30, 2024 and provided recent business highlights.

“Our data presentation at EHA last quarter included complete remission rates for both HR-MDS and TP53m AML patients treated with SL-172154 in combination with AZA that exceeded the expected complete remission rates for AZA alone. It is encouraging to see in our EHA presentation that our complete remission rate improved as the number of patients in each cohort increased, since our initial data presented at ASH in December of 2023. The next milestone for this program is to see how these response rates translate to an overall survival benefit, and those data will mature over the second half of this year,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “In parallel, we are pleased that enrollment has begun so swiftly in our randomized, controlled expansion cohort in frontline HR-MDS patients. We look forward to sharing clinical updates from these trials in the months ahead.”

Second Quarter 2024 Business Highlights and Other Recent Developments

SL-172154 (SIRPα-Fc-CD40L)

Phase 1B Trial of SL-172154 in Frontline HR-MDS and TP53m AML

HR-MDS

• Announced updated interim data from the Phase 1B dose expansion clinical trial of SL-172154 in combination with AZA in frontline HR-MDS and TP53m AML patients. These data were featured in a poster presentation during the EHA 2024 Congress.
  • Observed 67% Objective Response Rate (ORR) in frontline HR-MDS patients, primarily with TP53 mutations, and an initial complete remission (CR)/marrow complete remission rate of 58%. As of the data cut-off date on April 23, 2024, median overall survival had not yet been reached.
  • SL-172154 demonstrated a manageable interim safety profile in combination with AZA, with infusion related reactions (IRRs) as the most common drug related adverse event.
• Initiated enrollment of the Part D cohort, a randomized, controlled Phase 1B dose-expansion cohort in frontline HR-MDS patients. Approximately 60 patients will be randomized in a 1:1:1 ratio to receive SL-172154 at 3mg/kg in combination with AZA, SL-172154 at 1mg/kg in combination with AZA, or AZA as monotherapy.

TP53m AML

• Observed 43% ORR in frontline TP53m AML patients and 33% CR/complete remission rate with incomplete hematologic recovery. As of the data cut-off date of June 4, 2024, the median overall survival had not yet been reached. SL-172154 demonstrated a manageable interim safety profile in combination with AZA.
• In June 2024, the U.S. FDA granted ODD to SL-172154 for the treatment of AML.

Phase 1B Trial of SL-172154 in Platinum-Resistant Ovarian Cancer (PROC)

• Reported data from the Phase 1B clinical trial of SL-172154 in PROC patients, demonstrating an acceptable safety profile in combination with pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (Elahere). IRRs were the most common treatment emergent AE as of the data cutoff.
  • As of April 23, 2024, four of 21 (19%) treated patients in the Phase 1B study of SL-172154 in combination with PLD achieved partial responses. Two additional patients with stable disease showed maximum tumor reductions of 17% and 27%.
  • Completed enrollment for the cohort combining SL-172154 with Elahere. As of the April 23, 2024 data cutoff, ORR benefit beyond Elahere alone was not observed.
  • Shattuck continues to follow patients for progression free survival and overall survival and, should such results mature favorably in either PROC cohort, will evaluate further development in PROC at that time.

Corporate Updates

• On July 1, 2024, Shattuck announced its addition to the Russell 2000® and Russell 3000® Indexes at the conclusion of the 2024 Russell U.S. Indexes annual reconstitution.
  

Upcoming Events

• Shattuck plans to attend the following investor conferences. Details will be included on the Events & Presentations section of the Company’s website.
  • BTIG Biotechnology Conference (Virtual) August 5-6, 2024
  • Wells Fargo Healthcare Conference (Boston, MA) September 4-6, 2024
  • H.C. Wainwright 26th Annual Global Investment Conference (New York, NY) September 9-11, 2024

Second Quarter 2024 Financial Results

• Cash and Cash Equivalents and Investments: As of June 30, 2024, cash and cash equivalents and investments were $105.3 million, as compared to $117.2 million as of June 30, 2023.
• Research and Development (R&D) Expenses: R&D expenses were $19.2 million for the quarter ended June 30, 2024, as compared to $18.2 million for the quarter ended June 30, 2023.
• General and Administrative (G&A) Expenses: G&A expenses were $5.3 million for the quarter ended June 30, 2024, as compared to $4.7 million for the quarter ended June 30, 2023.
• Net Loss: Net loss was $21.5 million for the quarter ended June 30, 2024, or $0.42 per basic and diluted share, as compared to a net loss of $21.3 million for the quarter ended June 30, 2023, or $0.50 per basic and diluted share.

Financial Guidance

Shattuck believes its cash and cash equivalents and investments will be sufficient to fund its operations into 2026, beyond results from its Phase 1 clinical trials of SL-172154. This cash runway guidance is based on the Company’s current operational plans and excludes any additional capital that may be received, proceeds from business development transactions, and/or additional costs associated with clinical development activities that may be undertaken.

About SL-172154

SL-172154 (SIRPα-Fc-CD40L) is an investigational ARC® fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor to bolster an anti-tumor immune response in patients with advanced cancer. Multiple Phase 1 clinical trials are ongoing for patients with AML, HR-MDS, and PROC.

About Shattuck Labs, Inc.

Shattuck Labs, Inc. (Nasdaq: STTK) is a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease. Compounds derived from Shattuck’s proprietary Agonist Redirected Checkpoint, (ARC®), platform are designed to simultaneously inhibit checkpoint molecules and activate costimulatory molecules with a single therapeutic. The company’s lead SL-172154 (SIRPα-Fc-CD40L) program, which is designed to block the CD47 immune checkpoint and simultaneously agonize the CD40 pathway, is being evaluated in multiple Phase 1 trials. Shattuck has offices in both Austin, Texas and Durham, North Carolina. For more information, please visit: www.ShattuckLabs.com.

Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, our expectations regarding: plans for our preclinical studies, clinical trials and research and development programs; plans for expansion of clinical trials; the anticipated timing of the results from our clinical trials; the anticipated timing and pace of enrollment in our clinical trials; the clinical benefit, safety and tolerability of SL-172154; and expectations regarding the time period over which our capital resources will be sufficient to fund our anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While we believe these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in our filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of our preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of our clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in our Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent disclosure documents filed with the SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

Investor & Media Contact:
Conor Richardson
Vice President of Investor Relations
Shattuck Labs, Inc.
InvestorRelations@shattucklabs.com 

SHATTUCK LABS, INC.
CONDENSED BALANCE SHEETS
(In thousands)
	June 30, 2024				December 31,  2023
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	60,693			$	125,626
Investments		44,651				4,999
Prepaid expenses and other current assets		9,081				12,595
Total current assets		114,425				143,220
Property and equipment, net		11,895				13,804
Other assets		2,294				2,540
Total assets	$	128,614			$	159,564
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable	$	2,822				1,587
Deferred revenue		2,997				343
Total current liabilities		15,026				11,453
Non-current operating lease liabilities		2,972				3,406
Total liabilities	$	17,998			$	14,859
Stockholders’ equity:
Common stock		5				5
Additional paid in capital		456,982				451,006
Accumulated other comprehensive (loss) income		(5	)			4
Accumulated deficit		(346,366	)			(306,310	)
Total stockholders' equity		110,616				144,705
Total liabilities and stockholders' equity	$	128,614			$	159,564

SHATTUCK LABS, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands, except share and per share amounts)
	Three Months Ended June 30,								Six Months Ended June 30,
	2024				2023				2024				2023
Collaboration revenue	$	1,609			$	200			$	2,724			$	257
Operating expenses:
Research and development		19,239				18,205				35,503				34,872
General and administrative		5,332				4,742				10,227				9,793
Expense from operations		24,571				22,947				45,730				44,665
Loss from operations		(22,962	)			(22,747	)			(43,006	)			(44,408	)
Other income		1,410				1,401				2,950				2,338
Net loss	$	(21,552	)		$	(21,346	)		$	(40,056	)		$	(42,070	)
Unrealized gain (loss) on investments		9				265				(9	)			803
Comprehensive loss	$	(21,543	)		$	(21,081	)		$	(40,065	)		$	(41,267	)
Net loss per share – basic and diluted	$	(0.42	)		$	(0.50	)		$	(0.79	)		$	(0.99	)
Weighted-average shares outstanding – basic and diluted		50,791,241				42,467,664				50,678,818				42,453,513

FAQ

What were Shattuck Labs' (STTK) Q2 2024 financial results?

Shattuck Labs reported a net loss of $21.5 million ($0.42 per share), R&D expenses of $19.2 million, and G&A expenses of $5.3 million for Q2 2024. Cash and investments stood at $105.3 million as of June 30, 2024.

What clinical trial updates did Shattuck Labs (STTK) announce for SL-172154?

Shattuck Labs announced positive interim data from the Phase 1B trial of SL-172154 with Azacitidine in HR-MDS and TP53m AML patients, showing a 67% Objective Response Rate in HR-MDS and 43% in TP53m AML patients.

Did Shattuck Labs (STTK) receive any FDA designations in 2024?

Yes, in June 2024, the U.S. FDA granted Orphan Drug Designation (ODD) to SL-172154 for the treatment of Acute Myeloid Leukemia (AML).

What is Shattuck Labs' (STTK) cash runway projection as of Q2 2024?

Shattuck Labs believes its current cash and investments will be sufficient to fund operations into 2026, beyond the results from its Phase 1 clinical trials of SL-172154.