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Third Harmonic Bio

Third Harmonic Bio Inc is a biopharmaceutical company focused on the development of the next wave of medicine for the treatment of inflammatory diseases, including dermal, respiratory, and gastrointestinal diseases. The company's product candidate, THB001, is a selective, oral small-molecule inhibitor of KIT, a cell surface receptor that serves as the master regulator of mast cell function and survival. Its other product candidate THB335, is a potent, selective, oral small molecule KIT inhibitor, for the treatment of multiple mast cell-driven inflammatory diseases of the skin, airway, and gastrointestinal tract.

Third Harmonic Bio Inc

Third Harmonic Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRD#NASDAQ">THRD</a>) reported quarterly losses of $(0.80) per share which missed the analyst consensus estimate of $(0.28) by 185.71 percent.

Earnings

Earnings Misses

News

THRD

Third Harmonic Bio Q3 2024 GAAP EPS $(0.80) Misses $(0.28) Estimate

<h3>Gainers</h3>
<ul>
<li>Nuwellis (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NUWE#NASDAQ">NUWE</a>) shares rose 127.9% to $3.1 during Monday's regular session. The company's market cap stands at $5.7 million. </li>
<li>Singular Genomics Sys (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMIC#NASDAQ">OMIC</a>) stock moved upwards by 58.24% to $21.3. The company's market cap stands at $53.1 million. </li>
<li>Neurogene (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NGNE#NASDAQ">NGNE</a>) shares increased by 44.04% to $66.36. The market value of their outstanding shares is at $862.2 million. </li>
<li>Integra Lifesciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IART#NASDAQ">IART</a>) stock rose 24.27% to $23.96. The company's market cap stands at $1.8 billion. As per the press release, Q3 earnings came out today. </li>
<li>BioSig Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BSGM#NASDAQ">BSGM</a>) stock rose 23.42% to $1.37. The market value of their outstanding shares is at $22.3 million. </li>
<li>Disc Medicine (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IRON#NASDAQ">IRON</a>) shares moved upwards by 22.19% to $57.59. The market value of their outstanding shares is at $1.7 billion. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>XTL Biopharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/XTLB#NASDAQ">XTLB</a>) shares decreased by 15.8% to $1.98 during Monday's regular session. The company's market cap stands at $10.7 million. </li>
<li>BioCryst Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BCRX#NASDAQ">BCRX</a>) stock declined by 15.6% to $7.12. The company's market cap stands at $1.4 billion. The company's, Q3 earnings came out today. </li>
<li>Third Harmonic Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRD#NASDAQ">THRD</a>) shares declined by 15.57% to $12.1. The market value of their outstanding shares is at $497.2 million. </li>
<li>Cadrenal Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CVKD#NASDAQ">CVKD</a>) shares decreased by 15.52% to $14.87. The market value of their outstanding shares is at $22.2 million. </li>
<li>Tevogen Bio Holdings (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TVGN#NASDAQ">TVGN</a>) stock declined by 13.5% to $2.05. The company's market cap stands at $349.8 million. </li>
<li>Journey Medical (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DERM#NASDAQ">DERM</a>) stock decreased by 13.3% to $5.35. The market value of their outstanding shares is at $110.8 million. 
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</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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WIIM

Third Harmonic shares are trading higher on continued strength after the company reported Q2 financial results yesterday. Also, Morgan Stanley upgraded the stock from Equal-Weight to Overweight and raised its price target from $12 to $20.

Morgan Stanley analyst Michael Ulz upgrades Third Harmonic Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRD#NASDAQ">THRD</a>) from Equal-Weight to Overweight and raises the price target from $12 to $20.

Upgrades

Price Target

Analyst Ratings

Morgan Stanley Upgrades Third Harmonic Bio to Overweight, Raises Price Target to $20

Third Harmonic Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRD#NASDAQ">THRD</a>) reported quarterly losses of $(0.19) per share which beat the analyst consensus estimate of $(0.27) by 29.63 percent.

Earnings Beats

Third Harmonic Bio Q2 2024 Adj EPS $(0.19) Beats $(0.27) Estimate

Stifel analyst Alex Thompson initiates coverage on Third Harmonic Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRD#NASDAQ">THRD</a>) with a Buy rating and announces Price Target of $23.

Initiation

Stifel Initiates Coverage On Third Harmonic Bio with Buy Rating, Announces Price Target of $23

Raymond James analyst Laura Prendergast initiates coverage on Third Harmonic Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRD#NASDAQ">THRD</a>) with a Outperform rating and announces Price Target of $18.

Raymond James Initiates Coverage On Third Harmonic Bio with Outperform Rating, Announces Price Target of $18

Third Harmonic Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRD#NASDAQ">THRD</a>) reported quarterly losses of $(0.20) per share which beat the analyst consensus estimate of $(0.31) by 35.48 percent.

Third Harmonic Bio Q1 2024 Adj EPS $(0.20) Beats $(0.31) Estimate

Third Harmonic Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRD#NASDAQ">THRD</a>) reported quarterly losses of $(0.17) per share which beat the analyst consensus estimate of $(0.31) by 45.16 percent. This is a 52.78 percent increase over losses of $(0.36) per share from the same period last year.

Third Harmonic Bio Q4 EPS $(0.17) Beats $(0.31) Estimate

Third Harmonic Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRD#NASDAQ">THRD</a>) reported its Q4 earnings results on Tuesday, March 26, 2024 at 08:05 AM.
Here's what investors need to know about the announcement.
<h3>Earnings</h3>
Third Harmonic Bio beat estimated earnings by 45.0%, reporting an EPS of $-0.17 versus an estimate of $-0.31.
Revenue was down $0 from the same period last year.
<h3>Past Earnings Performance</h3>
Last quarter the company beat on EPS by $0.08 which was followed by a 1.0% increase in the share price the next day.

&#x2A;&#x2A; Listen to the earnings announcement yourself by <a href="">clicking here</a>. &#x2A;&#x2A;
To track all earnings releases for Third Harmonic Bio <a href="https://www.benzinga.com/quote/THRD/earnings">visit their earnings calendar here.</a> 
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Recap: Third Harmonic Bio Q4 Earnings

Summary of Financial Results
Cash Position: Cash and cash equivalents totaled $269.1 million as of December&nbsp;31, 2023. Based on the company's current operating plan, Third Harmonic Bio believes that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements through at least 2026.
R&amp;D Expenses: Research and development (R&amp;D) expenses decreased to $5.9 million for the three months ended December&nbsp;31, 2023, from $9.3 million for the same period in 2022. R&amp;D expenses for the year ended December&nbsp;31, 2023 decreased to $24.0 million, from $24.4 million for the same period in 2022. The decreases were primarily due to decreases in development costs relating to the termination of the THB001 program, partially offset by increases in discovery and development and personnel-related costs relating to the research and nonclinical development of THB335 and other next-generation discovery efforts.
G&amp;A Expenses: General and administrative (G&amp;A) expenses increased to $4.5 million for the three months ended December&nbsp;31, 2023, from $4.3 million for the same period in 2022. G&amp;A expenses for the year ended December&nbsp;31, 2023 increased to $20.0 million, from $13.3 million for the same period in 2022. The increases were primarily attributable to increased costs associated with being a public company and personnel-related expenses.
Net Loss: Net loss for the three months ended December&nbsp;31, 2023 decreased to $6.8 million from a net loss of $11.5 million for the same period in 2022. Net loss for the year ended December&nbsp;31, 2023 was $30.8 million, compared to a net loss of $35.2 million for the same period in 2022. The decreases were primarily due to increased costs associated with being a public company and personnel-related expenses, partially offset by increases in interest income.

Third Harmonic Bio FY23 EPS $(0.78) Vs $(2.45) YoY

Chris brings extensive enterprise-level leadership experience in business development, commercial operations, and corporate strategy &nbsp;
IND-enabling toxicology studies of THB335 nearing completion; Pre-IND interaction with the U.S. FDA now complete
Program remains on track to file a U.S. IND and initiate a Phase 1 study of THB335 during the first half of 2024
SAN FRANCISCO, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Third Harmonic Bio, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRD#NASDAQ">THRD</a>), a biopharmaceutical company focused on advancing the next wave of medicine for inflammatory diseases, today announced the appointment of Christopher Murphy as Chief Financial and Business Officer. Chris brings extensive experience in business development, commercial operations, corporate strategy and investment banking in the biopharmaceutical industry to the company's leadership team. In his role, Chris will be responsible for strategic leadership and direction of the company's finance, corporate strategy, and business development functions.
"We are very excited to welcome Chris, a high-caliber enterprise leader with a clear track record of translating thoughtful corporate strategy into meaningful shareholder value," said Natalie Holles, Chief Executive Officer at Third Harmonic Bio. "I look forward to Chris' thought partnership as we advance THB335 for the treatment of mast-cell mediated inflammatory diseases and evaluate opportunities to expand our work through strategic business development opportunities."
Chris Murphy most recently served as a member of the leadership team that transformed Horizon Therapeutics PLC from a primary care-focused specialty pharmaceutical company with a market capitalization of approximately $800 million to a fully integrated, highly profitable rare disease-focused biopharmaceutical company, which was acquired by Amgen Inc. for $28 billion in October 2023. While at Horizon, he served in roles of increasing responsibility in business development and commercial operations. In business development, Chris was most recently Group Vice President, where he oversaw a number of strategic transactions and integrations. In commercial operations, Chris most recently served as Group Vice President, overseeing market access, sales and marketing operations, and analytics across Horizon's portfolio of medicines, including during the preparation and initial launch of TEPEZZA&#xAE; (teprotumumab-trbw) for the treatment of thyroid eye disease. Earlier in his career, Chris held positions of increasing responsibility in the Life Sciences Investment Banking Group at JMP Securities LLC.
Third Harmonic Bio also provided a business update on its lead program, THB335, a potent, highly selective oral small molecule KIT inhibitor in development for the treatment of chronic spontaneous urticaria and other mast-cell mediated inflammatory disorders. IND-enabling toxicology studies of THB335 are nearing completion, and the company recently completed its pre-IND written correspondence with the U.S. FDA. The company is on track to file a U.S. IND and initiate a Phase 1 SAD/14-day MAD study of THB335 during the first half of 2024.&nbsp;
The company maintains a strong financial position with cash and cash equivalents totaling $273.9 million as of&nbsp;September 30, 2023.

Biotech

Management

General

Third Harmonic Bio Appoints Christopher Murphy As Chief Financial And Business Officer And Provides Business Update

Third Harmonic Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRD#NASDAQ">THRD</a>) reported its Q3 earnings results on Thursday, November 9, 2023 at 04:00 PM.
Here's what investors need to know about the announcement.
<h3>Earnings</h3>
Third Harmonic Bio missed estimated earnings by 125.93%, reporting an EPS of $-0.61 versus an estimate of $-0.27.
Revenue was down $0 from the same period last year.
<h3>Past Earnings Performance</h3>
Last quarter the company beat on EPS by $0.11 which was followed by a 0.64% increase in the share price the next day.

&#x2A;&#x2A; Listen to the earnings announcement yourself by <a href="">clicking here</a>. &#x2A;&#x2A;
To track all earnings releases for Third Harmonic Bio <a href="https://www.benzinga.com/quote/THRD/earnings">visit their earnings calendar here.</a> 
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Third Harmonic Bio: Q3 Earnings Insights

Third Harmonic Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRD#NASDAQ">THRD</a>) reported quarterly losses of $(0.61) per share which missed the analyst consensus estimate of $(0.27) by 125.93 percent. This is a 32.22 percent increase over losses of $(0.90) per share from the same period last year.

Third Harmonic Bio Q3 EPS $(0.61) Misses $(0.27) Estimate

Offerings

Third Harmonic Bio Inc Files For Mixed Shelf Of Up To $400M

Morgan Stanley analyst Michael Ulz maintains Third Harmonic Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRD#NASDAQ">THRD</a>) with a Equal-Weight and raises the price target from $5 to $7.

Morgan Stanley Maintains Equal-Weight on Third Harmonic Bio, Raises Price Target to $7

Summary of Financial Results
Cash Position:&nbsp;Cash and cash equivalents totaled&nbsp;$278.1 million&nbsp;as of June&nbsp;30, 2023. Based on the company&#39;s current operating plan, Third Harmonic Bio believes that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements through at least 2025.
R&amp;D Expenses:&nbsp;Research and development (R&amp;D) expenses increased to&nbsp;$5.3 million&nbsp;for the three months ended June&nbsp;30, 2023, from&nbsp;$4.2 million&nbsp;for the same period in 2022. R&amp;D expenses for the six months ended June&nbsp;30, 2023 increased to&nbsp;$12.1 million, from&nbsp;$10.4 million&nbsp;for the same period in 2022. The increases were primarily due to increases in discovery and development costs relating to the research and nonclinical development of THB335 and other next-generation discovery efforts.
G&amp;A Expenses:&nbsp;General and administrative (G&amp;A) expenses increased to&nbsp;$5.4 million&nbsp;for the three months ended June&nbsp;30, 2023, from&nbsp;$3.6 million&nbsp;for the same period in 2022. G&amp;A expenses for the six months ended June&nbsp;30, 2023 increased to&nbsp;$10.6 million, from&nbsp;$5.2 million&nbsp;for the same period in 2022. The increases were primarily attributable to increased costs associated with being a public company and personnel-related expenses.
Net Loss:&nbsp;Net loss for the three months ended June&nbsp;30, 2023 decreased to&nbsp;$7.6 million&nbsp;from a net loss of&nbsp;$7.7 million&nbsp;for the same period in 2022. Net loss for the six months ended June&nbsp;30, 2023 increased to&nbsp;$16.6 million, compared to a net loss of&nbsp;$15.5 million&nbsp;for the same period in 2022, primarily due to increases in research and development expenses and public company costs that were partially offset by increases in interest income.

Third Harmonic Bio Announces Q2 2023 Financial Results; Financial Position With Cash And Cash Equivalents Totaling $278.1M As Of June 30, 2023

THB335 retains selectivity and potency of first-generation oral KIT inhibitor, THB001, with differentiated metabolic, distribution and physicochemical profile 
&nbsp;
THB001 demonstrated evidence of pharmacodynamic (PD) activity and clinical benefit in discontinued Phase 1b study in chronic inducible urticaria
Extensive nonclinical studies of THB001 identified a potential mechanistic basis for observed hepatotoxicity; structural modifications introduced in THB335 believed to address this risk
U.S. Investigational New Drug (IND) Application filing and initiation of clinical trials of THB335 planned for&nbsp;the first half of 2024
SAN FRANCISCO, July 25, 2023 (GLOBE NEWSWIRE) -- Third Harmonic Bio, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRD#NASDAQ">THRD</a>), a biopharmaceutical company focused on advancing the next wave of medicine for inflammatory diseases, today announced its next-generation product candidate, THB335, a potent, highly selective oral small molecule KIT inhibitor with a meaningfully differentiated product profile as compared to the company&#39;s first-generation product candidate THB001. Third Harmonic plans to file a U.S. IND and initiate clinical development of THB335 for the treatment of mast cell-mediated inflammatory diseases during the first half of 2024.
The company also disclosed topline results of the Phase 1b clinical trial of THB001 for the treatment of chronic inducible urticaria, which was discontinued in December 2023 due to observed liver transaminitis in two of five patients enrolled. The results demonstrated evidence of clinical benefit in four of the five patients, achieving partial or complete responses despite early termination of the trial.
In addition, the company shared preliminary results from extensive studies of THB001 that were conducted to identify the mechanism for the observed liver toxicity, which was not predicted by nonclinical toxicology studies. These in-depth studies identified a metabolic pathway resulting in the formation of an intermediate reactive metabolite. Reactive metabolite formation has been previously implicated as a mechanistic basis for drug-induced liver injury. Structural modifications introduced into THB335 are believed to address this risk and studies conducted to date support its differentiated metabolic profile.
&quot;Based on extensive studies of our first-generation product candidate, THB001, we selected THB335, a next-generation compound that incorporates structural modifications which we believe maintain the potency and selective KIT inhibitory activity of THB001, while improving its safety profile,&quot; said Natalie Holles, Chief Executive Officer of Third Harmonic Bio. &quot;In addition, we are very encouraged by the clinical efficacy results observed in the discontinued Phase 1b study of THB001, demonstrating clinical responses in four out of five patients enrolled in the lowest planned dose cohort of the study. The combined structural modification and efficacy data give us confidence that we have the potential in THB335 for the optimal therapeutic profile against KIT for the treatment of mast cell-mediated inflammatory disorders. We are currently executing on our plans to be back in the clinic during the first half of next year.&quot;
THB001 Clinical Results
The Phase 1b clinical trial of THB001 in chronic inducible urticaria was designed to evaluate the preliminary safety and tolerability, efficacy and pharmacokinetics of three dose levels of THB001 over 12 weeks of treatment. Five patients were enrolled in the lowest planned dose cohort of 200mg BID before study discontinuation. The first patient enrolled completed 12 weeks of treatment; the next two patients enrolled were discontinued from study drug at week eight due to observed liver transaminitis. The two remaining patients were discontinued from study drug at weeks three and four and followed for safety per the trial protocol.
The transaminitis adverse events (AEs) were reported as moderate and resolved at weeks 17 and 25. All other AEs were reported as mild and demonstrated to be reversible. The overall AE profile, including mild hematologic and hair color changes, was consistent with the known on-target effects of KIT inhibition.
Rapid and sustained reduction in serum tryptase, a serum biomarker associated with mast cell activation and correlated with clinical response in urticaria studies, was observed in the trial, with an&nbsp;83.1%&nbsp;mean change from baseline by week one. Four out of the five patients treated in the study achieved partial (n=2) or complete (n=2) Critical Temperature Threshold responses despite early termination of dosing.
The company plans to present the full results of the study at a scientific conference later this year.
THB335
THB335, the company&#39;s next-generation oral small molecule wild-type KIT inhibitor product candidate, retains the potency and selectivity profile of THB001, with structural modifications which are expected to mitigate the hepatoxicity risk as well as provide a differentiated metabolic, distribution and physiochemical profile.
Key attributes of THB335:
<ul>
<li>Nanomolar potency against KIT</li>
<li>High degree of selectivity against closest related kinases, including PDGRF and CSF1R, as measured by biochemical assays and confirmed in cell-line viability assays</li>
<li>No evidence for reactive metabolite formation as observed with THB001</li>
<li>High oral bioavailability and metabolic stability</li>
<li>Improved peripheral restriction compared to THB001 (decreased CNS penetrance)</li>
<li>Improved solubility and lipophilicity compared to THB001</li>
<li>Favorable pharmacokinetic profile with long circulating half-life 
	&nbsp;</li>
</ul>
The company plans to file a U.S. IND and initiate clinical trials of THB335 in the first half of 2024. Phase 2 development is expected to initially focus on chronic spontaneous urticaria, with planned expansion into other mast-cell mediated inflammatory disorders.
As previously reported, Third Harmonic Bio had&nbsp;$282.2 million&nbsp;in cash and cash equivalents as of March 31, 2023.

Third Harmonic Bio Announces Next-Generation Oral KIT Inhibitor Product Candidate THB335

Third Harmonic Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRD#NASDAQ">THRD</a>) reported quarterly losses of $(0.81) per share which missed the analyst consensus estimate of $(0.35) by 131.43 percent. This is a 302.5 percent decrease over earnings of $0.40 per share from the same period last year.

CORRECTION: Third Harmonic Bio Q1 EPS $(0.81) Misses $(0.35) Estimate

Third Harmonic Bio (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/thrd#NASDAQ">THRD</a>) reported quarterly losses of $(0.81) per share which missed the analyst consensus estimate of $(0.35) by 131.43 percent. This is a 302.5 percent decrease over earnings of $0.40 per share from the same period last year.

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Third Harmonic Bio Q1 EPS $(0.81) Misses $(0.35) Estimate

Alex Thompson CFA, an analyst from Stifel Nicolaus, has initiated a new Buy rating on Third Harmonic Bio, Inc. (THRD). Alex Thompson CFA has given ...

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Stifel starts Third Harmonic at buy, cites mast cell disease approach

Third Harmonic Bio GAAP EPS of $0.46

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Third Harmonic Bio (NASDAQ:<a href="https://investorplace.com/stock-quotes/thrd-stock-quote/">THRD</a>) just reported results for the second quarter of 2024.<ul><li>Third Harmonic Bio reported earnings per share of -26 cents. This was above the analyst estimate for EPS of -27 cents.</li><li>The company did not report any revenue for the quarter.</li></ul><div>InvestorPlace Earnings is a project that leverages data from <a href="https://www.tradesmith.com">TradeSmith</a> to automate coverage of quarterly earnings reports. InvestorPlace Earnings distills key takeaways including earnings per share and revenue, as well as how a company stacks up to analyst estimates. These articles are published without human intervention, allowing us to inform our readers of the latest figures as quickly as possible. To report any concerns or inaccuracies, please contact us at <a href="mailto:editor@investorplace.com">editor@investorplace.com</a>.</div><h3>More From InvestorPlace</h3>
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