TD2 buyer-window signal capture

Evidence

• The company newsroom lists a September 9, 2026 announcement of an oversubscribed $62.5 million Series A and FDA clearance of the IND for its first peptide-drug conjugate.
• ClinicalTrials.gov record NCT07814248 was first posted on September 10, 2026 with status Recruiting and an actual start date of September 2, 2026.
• The record's central contact is a sponsor mailbox, ClinicalTrials@twosteptx.com, with no CRO or collaborator listed and three US sites coded Site 02, 04 and 06.
• SEC Form D filed January 20, 2026 reports $21,109,518 sold of $62,209,510 offered, first sale January 9, 2026, signed by CEO Caitlyn Miller.
• Decision owner: Joy Geallis, VP, Clinical, on the company team page, alongside CEO Caitlyn Miller, PhD and Nicolas Salem, PhD, VP, Radiopharmaceutical Clinical Development.

Practical opening

“On September 9 they announced a $62.5 million Series A and FDA clearance of their first IND. Their first trial record went live September 10 as Recruiting. The contact is their own mailbox and no CRO is listed. That suggests the operations partner is being chosen now. We could ask Joy how the three sites are being monitored.”

Claim boundaryDo not claim TwoStep has no CRO or that the first patient has been dosed; say the record is sponsor-owned and three sites are open.

Sites are coded Site 02, 04 and 06 on the registry, a convention a CRO or site-management vendor can also use; a CRO may already be engaged.

Evidence

• Stipple Bio filed a Form D on April 6, 2026 for a $100,200,007 equity offering with $65,130,013 sold and first sale March 31, 2026.
• The company's April 6, 2026 Series A release says lead candidate STP-100 is expected to enter clinical studies in early 2027 and that proceeds fund it into multiple early-stage clinical studies.
• Stipple Bio appointed Roland Gendron Chief Business Officer on July 7, 2026, and the release says the company continues to advance STP-100 into clinical studies.
• A ClinicalTrials.gov sponsor query for Stipple Bio returned zero studies on October 1, 2026.
• Decision owner: Jeffrey Landau, Chief Executive Officer, listed on the Form D as Executive Officer and Director with six other directors and no chief medical officer.

Practical opening

“Their April Form D shows $65,130,013 sold of a $100,200,007 raise. Their release says STP-100 enters clinical studies in early 2027. ClinicalTrials.gov shows no study under their name. That suggests they will buy their first-in-human execution, and nobody on the record has run a trial yet. We could ask Jeff who is writing the first-in-human plan.”

Claim boundaryDo not say an IND has been filed, that the US is the first-in-human geography, or that they have no CRO; say no CRO is visible and no trial is registered.

No CMO or clinical lead is public, so the first-study owner may not exist yet, which can push the decision past this quarter.

Evidence

• DEM BioPharma's only ClinicalTrials.gov record, NCT07805369, was first posted September 4, 2026 as Not yet recruiting with an estimated September 2026 start and 60 participants.
• The central contact on the record is a sponsor mailbox, DEM301 Study Team, clinicaltrials@dembiopharma.com, and no locations are listed.
• On January 6, 2026 the company said pre-IND studies were underway to support a Phase 1a/1b start in the second half of 2026.
• Decision owner: Humphrey Gardner, MD, Chief Medical Officer, on the company About page.
• The company describes itself as a privately held, Cambridge MA based pre-IND stage biopharmaceutical company with a $70 million launch financing in June 2022.

Practical opening

“Their first trial record was posted September 4 as Not yet recruiting, with a September start. The contact is their own study mailbox and no sites are listed. They said the Phase 1a/1b starts in the second half of 2026. That suggests site selection is happening now. We could ask Dr. Gardner which sites open first and who monitors them.”

Claim boundaryDo not claim IND clearance, a first-patient date, or that no CRO is engaged; only that none is visible on the record.

No IND clearance release was found; the record may have been posted ahead of clearance.

Evidence

• Iksuda announced from Newcastle, UK on July 30, 2026 that the FDA had cleared its IND for IKS04, enabling a Phase 1 trial in gastrointestinal cancers.
• NCT07738939 was first posted July 31, 2026, is Not yet recruiting, has an estimated November 2026 start, 120 participants, and four US sites: UCLA, MGH, Vanderbilt and MD Anderson.
• The central contact is David Browning at david.browning@iksuda.com and the study director is James O'Leary, MD of Iksuda; no CRO appears on the record.
• Decision owner: Jim O'Leary, MD, Chief Medical Officer, on the company Our Experts page, with CEO David Simpson and David Browning, Executive Director, Clinical Operations.

Practical opening

“On July 30 they announced FDA clearance of their US IND. The record posted July 31 shows a November start at four US sites. The contact is their own clinical operations director and no CRO appears. That suggests a UK sponsor needs US monitoring by November. We could ask David Browning how the US sites will be monitored from the UK.”

Claim boundaryDo not say Iksuda has no CRO; say none is on the record. Do not quote a raise.

UK sponsor running a US-only study: the shape of the Toray record that carries a TD2 contact on ClinicalTrials.gov, and at the edge of the usual pattern.

Evidence

• A company release dated July 7, 2026 states the FDA cleared the IND for CRG-150 and that CoRegen remains on track to initiate its Phase 1 trial this year.
• ClinicalTrials.gov record NCT07730125 was first posted July 28, 2026, status Not yet recruiting, estimated start November 2026, 67 participants, no locations listed.
• The record's central contacts are Kerry Biron, VP Clinical Operations, and Suzanne Petrossian, Director Clinical Operations, both at coregen.com addresses; the study director is CMO Sonal Gupta, MD.
• Decision owner: Kerry Biron, VP Clinical Operations, on the trial record; the leadership page names Sonal Gupta, M.D., Ph.D. as Chief Medical Officer.
• The careers page describes a virtual operating model relying on external GxP vendors and consultants.

Practical opening

“On July 7 they announced IND clearance and a Phase 1 start this year. Their record posted July 28 shows a November start and no sites. The contacts are their own VP and Director of Clinical Operations. That suggests site activation is being arranged this quarter. We could ask Kerry which centers open first and who covers monitoring.”

Claim boundaryDo not claim they lack a CRO; say no CRO appears on the record or in the IND release, and the sponsor's own clinical operations staff are the contacts.

Baylor College of Medicine is the collaborator, so the Phase 1 may run investigator-style with a light CRO scope.

Evidence

• On September 28, 2026 Link appointed Jie D'Elia, Ph.D. as Chief Executive Officer and Friedrich Graf Finckenstein, M.D. as Chief Medical Officer and upsized its Series A to $90 million.
• The same release says Link intends to begin a first-in-human trial in colorectal cancer in 2027.
• The only LNK001 record on ClinicalTrials.gov, NCT07564232, lists M.D. Anderson Cancer Center as lead sponsor, recruiting, first posted May 4, 2026.
• Decision owner: Friedrich Graf Finckenstein, M.D., Chief Medical Officer, described in the release as the former Chief Medical Officer of Iovance Biotherapeutics.

Practical opening

“On September 28 they appointed a new CEO and a Chief Medical Officer. They intend to begin a first-in-human colorectal trial in 2027. Their only registry record is sponsored by MD Anderson, not by Link. That suggests the first company-run CRO decision is ahead and newly owned. We could ask the new CMO how he plans to run the colorectal first-in-human.”

Claim boundaryDo not say Link is selecting a CRO now or that the kidney study is company-run; the kidney study is MD Anderson's record and the colorectal trial is only intended for 2027.

A syndicate led by Johnson & Johnson's venture arm may default to a large CRO or keep the next study inside MD Anderson.

Evidence

• Alpha-9's Phase 1-1b study of A9-3408 in metastatic melanoma, NCT07076550, is terminated with five participants, posted August 31, 2026, due to a decision to re-prioritize the portfolio.
• The new GRPR Phase 1-1b study, NCT07661641, is Recruiting with 115 planned participants, a sponsor-employed study director, a sponsor-domain contact and two Australian sites only.
• On September 8, 2026 Alpha-9 announced the first patient dosed in the GRPR Phase 1 trial.
• Decision owner: Robert Meehan, MD, Chief Medical Officer, on the team page with CEO Paul Blanchfield.

Practical opening

“On August 31 their melanoma Phase 1 was terminated to re-prioritize the portfolio. Their new radioligand study lists their own study director and two Australian sites. On September 8 they announced the first patient dosed. That suggests a US cohort is unassigned, but nothing says one is planned. We could ask Dr. Meehan whether a US cohort is planned and who would run it.”

Claim boundaryDo not say Alpha-9 dropped a CRO, that US sites are planned, or that a July 2026 Form D under its name is company funding; it is an SPV.

Australia-first design: an Australian CRO or site network may already run the first-in-human portion, and TD2's opening is a US cohort that is not on the record.

Evidence

• The STX-003 Phase 1/2 first-in-human study, NCT07751042, is Recruiting, first posted August 6, 2026, with a June 30, 2026 start and 220 planned participants.
• The record's central contact is the Chief Medical Officer with a sponsor-domain study mailbox, and the sites are HonorHealth Research Institute in Scottsdale and Sarah Cannon in Nashville.
• Strand filed a Form D on March 17, 2026 reporting $108,099,927 sold of a $120,099,940 offering, with Jacob Becraft and Tasuku Kitada as executive officers.
• Decision owner: Jason Luke, MD, Chief Medical Officer, on the leadership page with CEO Jacob Becraft and COO Samta Kundu; the company describes itself as clinical-stage and Boston-based.

Practical opening

“Their second first-in-human study was posted August 6 as Recruiting, 220 participants. The contact is their CMO, and one of two sites is HonorHealth Scottsdale. That suggests the expansion is a new award on your home site, with only their CMO on the record. We could ask Dr. Luke how the Scottsdale site is monitored before expansion opens.”

Claim boundaryDo not claim Strand has no CRO or is replacing one; only that none appears on the record. Do not cite the Series B as a 2026 event.

Well funded and may already have a CRO on the first study that it reused; the record simply does not show one.