CAMP4 Therapeutics (CAMP) clears CMP-002 trial in Australia, eyes $50.1M raise
Rhea-AI Filing Summary
On July 27, 2026, CAMP4 Therapeutics Corporation received clearance from Australia’s Therapeutic Goods Administration and a local Human Research Ethics Committee to begin a Phase 1/2 first‑in‑human trial of CMP‑002, its investigational therapy for SYNGAP1‑related disorder, a rare condition with no approved treatments.
This regulatory milestone satisfies conditions under CAMP4’s September 9, 2025 Securities Purchase Agreement, including the CTA Milestone, Price Threshold Waiver and Second Closing Trigger. CAMP4 is now eligible, subject to remaining closing conditions and investor participation, to receive up to approximately $50.1 million in gross proceeds from a second private placement closing in exchange for up to 32,721,172 shares of common stock or pre‑funded warrants, expected on or about August 3, 2026. CMP‑002 is an ASO candidate designed to upregulate SYNGAP1 expression by targeting regulatory RNA, supporting CAMP4’s broader strategy of developing disease‑modifying treatments for genetic disorders.
Positive
- Australian regulators cleared CAMP4 to start a Phase 1/2 first‑in‑human clinical trial of CMP‑002 for SYNGAP1‑related disorder, advancing its lead program into human testing.
- Completion of the regulatory milestone makes CAMP4 eligible for up to approximately $50.1 million in gross proceeds from a second private placement linked to up to 32,721,172 shares or pre‑funded warrants.
Negative
- None.
Filing Explained
The financing trigger is satisfied, but no second-closing shares or proceeds are reported; common-stock issuance would reduce existing ownership percentages.
The exhibit says the clearance enables a second closing, but the 8-K records eligibility only: it does not report receipt of the additional proceeds or issuance of the referenced shares. The practical holder consequence is conditional dilution: if common stock is issued at the second closing, total shares would rise and existing holders’ percentage ownership would fall absent offsetting changes.
For certain investors, pre-funded warrants may be used in lieu of common stock; these instruments convert to shares when exercised, so the disclosed consideration is either common stock or a share-convertible warrant, subject to closing.
8-K Event Classification
3 items: 7.01, 8.01, 9.01
3 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Potential gross proceeds from Second Closing: $50.1 million
Shares or warrants in Second Closing: 32,721,172 shares
Initial gross proceeds under Purchase Agreement: approximately $50 million
+3 more
6 metrics
Potential gross proceeds from Second Closing
$50.1 million
Maximum gross proceeds CAMP4 is eligible to receive from the second private placement closing
Shares or warrants in Second Closing
32,721,172 shares
Maximum common shares or pre-funded warrants issuable in exchange for the Second Closing proceeds
Initial gross proceeds under Purchase Agreement
approximately $50 million
Gross proceeds previously received under the September 9, 2025 Securities Purchase Agreement
CMP-002 trial phase
Phase 1/2
First-in-human clinical trial of CMP-002 in SYNGAP1-related disorder permitted by Australian clearance
Individuals affected by SYNGAP1-related disorder
over 10,000
Estimated number of affected individuals in the United States
Epilepsy prevalence in SYNGAP1 patients
approximately 85%
Proportion of SYNGAP1-related disorder patients experiencing epilepsy
Key Terms
SYNGAP1-related disorder, Therapeutic Goods Administration, Human Research Ethics Committee, pre-funded warrants, +2 more
6 terms
Therapeutic Goods Administration regulatory
"received clearance from Australia’s Therapeutic Goods Administration (TGA)"
The Therapeutic Goods Administration is the Australian government agency that assesses and regulates medicines, medical devices, vaccines and other health products for safety, quality and effectiveness before they can be marketed. For investors, a TGA decision is like a building inspector’s sign-off: approval opens access to the Australian market and can unlock sales and valuation, while delays, restrictions or safety warnings can limit revenue, force product changes or raise compliance and legal costs.
Human Research Ethics Committee regulatory
"and local Human Research Ethics Committee (HREC) to initiate"
A human research ethics committee is an independent group that reviews and approves medical or social studies involving people to make sure participants are treated safely, understand the risks, and give proper consent. Think of it as a safety and fairness check before a study can run. For investors, these committees matter because their approval is often required for clinical trials and product testing, and delays or rejection can affect development timelines, regulatory risk and potential returns.
pre-funded warrants financial
"common stock (or, for certain investors, pre-funded warrants in lieu of common stock)"
Pre-funded warrants are financial instruments that give investors the right to purchase a company's stock at a set price, but with most or all of the purchase price paid upfront. They function like a coupon or gift card for stock, allowing investors to buy shares later at a fixed price, which can be beneficial if they want to avoid future price increases. This makes them important for investors seeking flexibility and certainty in their investment plans.
haploinsufficient medical
"genes underlying haploinsufficient and recessive partial loss-of-function disorders"
A haploinsufficient gene is one where losing or disabling just one of the two inherited copies causes a loss of normal function, because the remaining copy cannot make enough product to keep things working. This matters to investors because such genes often drive disease biology, influence how well drugs or genetic therapies must restore function, affect diagnostic and regulatory strategies, and can change the size and risk of a treatment’s potential market—like a two-engine plane that can’t fly properly on one engine.
regulatory RNA-targeting therapeutics medical
"developing a pipeline of regulatory RNA-targeting therapeutics designed to upregulate gene expression"
Regulatory RNA-targeting therapeutics are medicines designed to change how cells read their internal instruction manuals by binding to small RNA molecules that control gene activity. Like using a sticky note to hide or highlight a paragraph in a manual, these drugs can dial up or down production of specific proteins, offering precise ways to treat disease; investors care because they promise targeted benefits but come with high scientific, regulatory and commercial risk and potential payoff.
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What regulatory clearance did CAMP4 Therapeutics (CAMP) obtain in Australia?
CAMP4 received clearance from Australia’s Therapeutic Goods Administration and a local Human Research Ethics Committee to initiate a Phase 1/2 first‑in‑human trial of CMP‑002, its investigational therapy targeting SYNGAP1‑related disorder, enabling the company to open a clinical trial site in Australia.
How much funding could CAMP4 Therapeutics (CAMP) receive from the second closing?
Subject to remaining conditions and investor participation, CAMP4 is eligible to receive up to approximately $50.1 million in gross proceeds from a second private placement closing in exchange for up to 32,721,172 shares of common stock or, for some investors, pre‑funded warrants.
When is CAMP4 Therapeutics (CAMP) expecting the second closing to occur?
The second closing tied to the Securities Purchase Agreement is expected to occur on or about August 3, 2026, subject to customary closing conditions and investor participation, following satisfaction of the CTA Milestone, Price Threshold Waiver and Second Closing Trigger.
What is CMP-002 in CAMP4 Therapeutics’ (CAMP) pipeline?
CMP‑002 is CAMP4’s lead investigational ASO therapeutic candidate designed to bind a SYNGAP1‑specific regulatory RNA to increase SYNGAP1 gene expression and restore SYNGAP protein toward near wild‑type levels, aiming to provide a disease‑modifying treatment for SYNGAP1‑related disorder.
Which condition is CAMP4 Therapeutics (CAMP) targeting with CMP-002?
CMP‑002 targets SYNGAP1‑related disorder, a rare CNS condition affecting over 10,000 individuals in the United States, characterized by universal intellectual disability, epilepsy in about 85% of patients, severe behavioral and sleep problems, and a high rate of limited or absent verbal communication.
Which investors committed to CAMP4 Therapeutics’ (CAMP) second closing?
Investors that have committed to participate in the second closing include Coastlands Capital, Janus Henderson Investors, Balyasny Asset Management, Vivo Capital, 5AM Ventures, Adage Capital Management LP, Trails Edge Capital Partners, and the patient‑focused group CURE SYNGAP1.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 27, 2026
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||||||||
| (Address of principal executive offices) | (Zip Code) | |||||||||||||
(Registrant’s telephone number, including area code): (617 ) 651-8867
Not Applicable
(Former name or former address, if changed since last report)
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 (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
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 x
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 7.01 Regulation FD Disclosure.
On July 27, 2026, CAMP4 Therapeutics Corporation (the “Company”) issued a press release announcing it has received clearance from Australia’s Therapeutic Goods Administration and local Human Research Ethics Committee to initiate the Company’s Phase 1/2 clinical trial of CMP-002, the Company’s investigational product candidate for the treatment of SYNGAP1-related disorder.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, 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, nor shall it be deemed 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 a filing.
Item 8.01 Other Events.
On July 27, 2026, the Company announced that it received clearance from Australia’s Therapeutic Goods Administration and the local Human Research Ethics Committee to initiate the Company’s Phase 1/2 clinical trial of CMP-002, the Company’s investigational product candidate for the treatment of SYNGAP1-related disorder. As a result of receiving such clearance, the Company achieved the CTA Milestone (as defined in the Securities Purchase Agreement, dated September 9, 2025 (the “Purchase Agreement”), previously disclosed by the Company in a Current Report on Form 8-K filed with the Securities and Exchange Commission on September 9, 2025). The Company also received a Price Threshold Waiver (as defined in the Purchase Agreement).
As a result, the Second Closing Trigger (as defined in the Purchase Agreement) has been satisfied. Subject to the satisfaction of the remaining conditions to the Second Closing (as defined in the Purchase Agreement) and investor participation in accordance with the Purchase Agreement, the Company is eligible to receive up to approximately $50.1 million in gross proceeds from the Second Closing in exchange for up to 32,721,172 shares of common stock (or, for certain investors, pre-funded warrants in lieu of common stock). The Second Closing is expected to occur on or about August 3, 2026, subject to customary closing conditions.
Additional information regarding the Second Closing is included in the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |||||||
| 99.1 | Press Release issued by CAMP4 Therapeutics Corporation on July 27, 2026. | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
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.
| CAMP4 THERAPEUTICS CORPORATION | ||||||||
| By: | /s/ Josh Mandel-Brehm | |||||||
| Name: Josh Mandel-Brehm | ||||||||
| Title: President and Chief Executive Officer | ||||||||
Date: July 27, 2026
Exhibit 99.1
CAMP4 Therapeutics Secures Australian Regulatory Clearance to Initiate First-in-Human Clinical Trial of CMP-002 in Patients With SYNGAP1-Related Disorder
Planned first-in-human clinical trial to assess a disease modifying intervention for patients with SYNGAP1-related disorder
Regulatory milestone enables Company to raise up to $50 million through second closing of private placement announced September 2025
CAMBRIDGE, Mass., July, 27, 2026 (GLOBE NEWSWIRE) -- CAMP4 Therapeutics Corporation ("CAMP4" or "the Company") (Nasdaq: CAMP), a clinical-stage biopharmaceutical company developing a pipeline of regulatory RNA-targeting therapeutics designed to upregulate gene expression with the goal of restoring healthy protein levels to treat a broad range of genetic diseases, today announced that it has received clearance from Australia’s Therapeutic Goods Administration (TGA) and local Human Research Ethics Committee (HREC) to initiate the Company’s Phase 1/2 clinical trial of CMP-002, a potential first-in-class disease-modifying therapeutic for SYNGAP1-related disorder.
"For patients living with SYNGAP1-related disorder, a condition with no approved treatments, this clearance means a potentially disease modifying therapy is now one step closer to moving into human studies for the first time,” said Josh Mandel-Brehm, President and Chief Executive Officer of CAMP4. "Securing this clearance underscores our commitment to rapidly advancing global clinical development for CMP-002, and we are pursuing additional regulatory filings to expand the trial internationally. We look forward to initiating this critical study in the hopes of offering SYNGAP patients and families a potentially transformative solution that could one day dramatically improve their lives."
The TGA clearance satisfies the regulatory milestone under CAMP4's September 9, 2025 Securities Purchase Agreement, pursuant to which the Company previously received approximately $50 million in gross proceeds. CAMP4 is now eligible to receive up to an additional $50 million in gross proceeds in exchange for up to 32,721,172 shares of common stock (or, for certain investors, pre-funded warrants in lieu of common stock) to support the advancement of CMP-002 and its broader pipeline. Closing is expected to occur within five business days of this announcement, subject to customary conditions.
Investors who have committed to participating in the second closing include Coastlands Capital, Janus Henderson Investors, Balyasny Asset Management, Vivo Capital, 5AM Ventures, Adage Capital Management LP, Trails Edge Capital Partners, and CURE SYNGAP1.
Leerink Partners is acting as lead placement agent in connection with the second closing. Piper Sandler & Co., Cantor Fitzgerald & Co. and Wedbush Securities Inc. are acting as co-placement agents.
The regulatory clearance from Australia’s TGA and local HREC permits CAMP4 to open a clinical trial site in the country, which is expected to serve as one of the initial enrollment sites for the Phase 1/2 trial. Australia was selected as the first regulatory filing jurisdiction given the presence of regional expertise in diagnosing and treating SYNGAP1 patients, as well as its established clinical trial infrastructure and the TGA’s efficient review process for innovative therapies. CAMP4 continues to advance global regulatory activities to support broader enrollment across multiple sites.
About SYNGAP1-Related Disorder
SYNGAP1-related disorder (also referred to as SYNGAP1) is a rare, haploinsufficient CNS disorder caused by mutations in the SYNGAP1 gene, resulting in approximately 50% of normal SYNGAP protein levels. The condition affects over 10,000 individuals in the United States and is characterized by intellectual disability in 100% of patients, epilepsy in approximately 85%, severe behavioral problems in approximately 70%, sleep problems in approximately 60%, and limited communication, with approximately 30% of patients being non-verbal. There are currently no approved disease-modifying therapies for patients living with SYNGAP1.
About CMP-002
CMP-002 is CAMP4's lead investigational ASO therapeutic candidate designed to bind to a SYNGAP1-specific regRNA to increase SYNGAP1 gene expression and restore SYNGAP protein toward near wild-type levels. Administered intrathecally, CMP-002 has demonstrated dose-dependent increases in SYNGAP protein expression in patient-derived neurons, reversal of disease-relevant behavioral phenotypes in a humanized haploinsufficient mouse model, statistically significant improvement of seizure phenotypes and parameters in a chemically induced seizure mouse model, and broad brain distribution with significant SYNGAP protein upregulation in non-human primates.
About CAMP4 Therapeutics
CAMP4 is developing disease-modifying treatments for a broad range of genetic diseases where amplifying healthy protein may offer therapeutic benefits. Our approach amplifies mRNA by harnessing a fundamental mechanism of how genes are controlled. To amplify mRNA, our therapeutic ASO drug candidates target regulatory RNAs (regRNAs), which act locally on transcription factors and are the master regulators of gene expression. CAMP4's proprietary RAP Platform® enables the mapping of regRNAs and generation of therapeutic candidates designed to target the regRNAs associated with genes underlying haploinsufficient and recessive partial loss-of-function disorders, of which there are more than 1,200, in which a modest increase in protein expression may have the potential to be clinically meaningful. For more information, visit camp4tx.com.
Forward-Looking Statements
This press release contains forward-looking statements which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements regarding the initiation, timing, conduct, and advancement of CMP-002 into a clinical trial; the potential therapeutic benefits of CMP-002; the Company’s regulatory, clinical and development plans; the anticipated second closing under the Securities Purchase Agreement; the satisfaction of closing conditions; investor participation in the second closing; and the amount and timing of proceeds that may be received by the Company in the second closing. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company's actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the uncertainty of preclinical and clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company's current product candidates or any future product candidates; the Company's dependence on the services of the Company's senior management and other clinical and scientific personnel, and the Company's ability to retain these individuals or recruit additional management or clinical and scientific personnel; risks related to the manufacturing of the Company's product candidates, which is complex, and the risk that the Company's third-party manufacturers may encounter difficulties in production; the Company's ability to obtain and maintain sufficient intellectual property protection for the Company's platform technology and product candidates; and other risks and uncertainties described in the section "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as well as other information the Company files with the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain and are not guarantees of future events. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company's control, you should not unduly rely on these forward-looking statements. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Except as required by applicable law, the Company does not
undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Contacts
Investor Relations:
Sara Michelmore
Milestone Advisors
sara@milestone-advisorsllc.com
Media:
Sofia Bermudez
LifeSci Communications
sbermudez@lifescicomms.com