PDS Biotech (PDSB) After the Soon-Shiong PIPE: What the Filings and Trials Show About PDS0301, and What Could Come Next

In two months PDS Biotechnology changed almost everything. On August 11, 2026 it stopped funding its Phase 3 head and neck cancer trial and made PDS0301, a tumor-targeted interleukin-12 (IL-12) drug, its lead program; the stock fell 65% that day. It reported $5.6 million of cash at June 30 with a going-concern warning, cut 36% of its staff, and lost its CFO and COO. Then, on September 7, Patrick Soon-Shiong’s Nant Capital agreed to lead a private placement, and he joined the board. The shares, which had closed at $0.22 the session before the deal was signed, closed at $1.02 on October 8 (PDSB on BioRadar; PDS 8-Ks, August 11 to October 6, 2026).

Investor discussion has added a further idea: that PDS0301 could be paired with Anktiva, the IL-15 drug of ImmunityBio, the company Soon-Shiong founded and chairs. This piece separates what the filings and published trials show from what is still speculation. Two findings frame everything below. First, the colorectal cancer data behind the pivot come from a small, single-center, nonrandomized National Cancer Institute (NCI) trial. Second, no PDS filing mentions Anktiva, and the one completed clinical trial that combined PDS0301 with Anktiva’s active ingredient (N-803) in colorectal cancer produced one response in 20 patients.

Jump to the four scenarios ↓

Key points

• The data are early and small. The colorectal signal rests on 9 patients in a peer-reviewed interim analysis and 21 to 22 in a later company update, compared with an earlier, nonrandomized study at the same NCI site. The study’s own authors call the survival data immature.
• Soon-Shiong’s money comes with leverage. Nant bought in at $0.2825 a unit, reports a 19.9% stake, holds two board seats, has a say in the Phase 3 design, and has a one-year option to negotiate for PDS0101.
• The Anktiva link is not a plan. No PDS filing mentions it, and the one trial that added PDS0301 to Anktiva’s active ingredient in colorectal cancer, a four-drug regimen, gave 1 response in 20 patients.

Sixty days, in order

What PDS0301 is, and where it came from

PDS0301 (earlier names: NHS-IL12, M9241, PDS01ADC) fuses two IL-12 molecules to NHS76, an antibody that binds DNA and histone complexes exposed in dying (necrotic) tumor tissue. The idea is to concentrate IL-12 in the tumor, where it activates natural killer (NK) cells, CD8 T cells and Th1 signaling, while avoiding the systemic toxicity that stopped the development of recombinant IL-12 (Victory et al., J Gastrointest Oncol, 2024; PDS corporate presentation, September 2026). Because the antibody homes in on necrosis, the drug is designed to be combined with treatments that kill tumor cells, such as chemotherapy or radiation.

The molecule has a history. Merck KGaA tested it with avelumab in the JAVELIN IL-12 trial: in the dose-expansion part, 16 patients with advanced urothelial cancer had no objective responses, and the study did not meet its criterion to continue (Strauss et al., J Immunother Cancer, 2023). In December 2022 PDS licensed worldwide rights from Merck KGaA for shares worth $5.0 million, development and first-sale milestones of up to $11 million (including one at the dosing of the fifth patient in a Phase 3 trial), sales milestones of up to $105 million and a 10% royalty on net sales (PDS 10-K, March 30, 2026). PDS says more than 380 patients have received the drug across Phase 1 and 2 trials, and the current trials are run by the NCI.

The colorectal cancer data behind the pivot

The lead indication is microsatellite stable (MSS), mismatch repair-proficient (pMMR) colorectal cancer that has spread to the liver, a group in which checkpoint immunotherapy has largely failed. The data come from NCT05286814, an NCI-run, single-center, nonrandomized Phase 2 trial. Patients who had received at least one prior line of chemotherapy got floxuridine through a surgically placed hepatic artery infusion pump (HAIP) on days 1 to 14, FOLFOX or FOLFIRI intravenously, and PDS0301 (12 µg/kg under the skin) on day 15 of each 28-day cycle, for six cycles. In the interim analysis, 13 patients were enrolled and 9 were analyzed: 2 were excluded because of peritoneal disease found at surgery and 2 because of clinical deterioration before their first PDS0301 dose. The 20 comparison patients were those analyzable out of 23 enrolled in the earlier study (Eade et al., 2026, full text).

The difference between the two groups is large, and the survival curves are the most interesting signal in PDS’s pipeline. Four facts limit what they can show:

• No randomization. The comparison patients were treated in a separate, earlier study. Differences in selection, timing or supportive care can create gaps of this size. The company’s own slide says the studies were “not randomized head-to-head”. See why control arms matter.
• Small numbers. The peer-reviewed analysis covers 9 patients. With 21 or 22, each patient moves the response rate by about 5 percentage points.
• HAIP is itself a strong liver-directed therapy. Pump placement needs surgery and is offered mainly at specialized centers, which shapes who enrolls and makes the regimen hard to scale.
• More PDS0301 patients went on to liver surgery. After treatment, 7 of 9 PDS0301 patients had liver metastases resected or ablated, against 6 of 20 in the comparison group, with decisions made patient by patient rather than by fixed criteria. Those procedures may have helped survival, but being able to operate may also reflect a better response; a nonrandomized comparison cannot separate the two.
• The survival data are immature. The company has not reported median follow-up, the number of deaths, confidence intervals or how many patients were still at risk at 24 months, so it is not possible to tell how many patients the tail of the curve rests on. The authors of the interim analysis call the survival data immature and write that only a randomized trial can conclusively determine differences in efficacy.
• The authors’ own conclusion is cautious. They write that adding the drug “is not detrimental to HAIP therapy”, that it is associated with immune changes in blood and tumor, and that the results warrant completing enrollment.

PDS also compares these results with other colorectal programs, such as zanzalintinib plus atezolizumab (4% response rate, median overall survival 10.9 months). Those trials enrolled different patients, with or without liver metastases, and gave no liver-directed chemotherapy, so the comparison says little about PDS0301’s own contribution. In the same paper, patients treated with HAIP chemotherapy alone had a median overall survival of 17.9 months, well above the under-12-month benchmark PDS cites for the broader population, so the relevant comparison for PDS0301 is HAIP chemotherapy, not systemic treatment. A randomized trial is the only way to settle it, and that is what the planned Phase 3 would have to be.

The Anktiva question: is an IL-12 plus IL-15 combination coming?

What the filings say: nothing. We searched PDS’s 2026 current reports (8-Ks), its annual report, its second-quarter report, two prospectuses and the Schedule 13D for Anktiva, N-803, nogapendekin, IL-15 and ImmunityBio. ImmunityBio appears only in Soon-Shiong’s biography. No collaboration, supply agreement or combination trial has been disclosed.

Why the idea circulates: the two drugs act on overlapping cells. PDS describes PDS0301 as activating NK cells and CD8 T cells inside the tumor, and Anktiva (nogapendekin alfa inbakicept) is an IL-15 superagonist that expands and sustains the same cell types. Soon-Shiong now sits on both boards and controls PDS’s largest shareholder. Biologically, pairing a tumor-anchored IL-12 with an IL-15 agonist is plausible.

What the one clinical test showed: the NCI has already combined them in this disease. In the QuICC trial (NCT04491955), patients with pMMR metastatic colorectal cancer and at least two prior lines of therapy received a triplet (the CV-301 vaccine, N-803 and bintrafusp alfa) or a quadruplet that added PDS0301. The quadruplet produced one objective response among 20 patients (the paper describes a complete response lasting more than 29 months in a quadruplet patient with RAS wild-type disease that had spread to lymph nodes), and the 12 triplet patients had none. The authors concluded that the role of this kind of combination immunotherapy in pMMR colorectal cancer “remains unclear” (Bracken-Clarke et al., The Oncologist, February 2026).

That trial gave no chemotherapy and no liver-directed treatment, which the colorectal HAIP trial uses to increase the tumor necrosis PDS0301 binds to, and a four-drug design cannot show which component did what. It cannot rule out other IL-12 and IL-15 designs. What it shows is narrower: in heavily pretreated patients, adding PDS0301 to N-803, a vaccine and a PD-L1/TGF-beta agent produced little anti-tumor activity. Any new combination would need its own trial and its own safety data, and with Soon-Shiong on both sides, any agreement between PDS and a Nant or ImmunityBio entity would be a related-party transaction for the boards to review.

For context, ImmunityBio is far better funded than PDS. Anktiva has been FDA approved since April 2024 for BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, a supplemental application for papillary disease has a PDUFA date of January 6, 2027, and the company reported Q2 2026 product revenue of $50.7 million and $357.4 million in cash and marketable securities at June 30 (ImmunityBio press releases, 2026; IBRX on BioRadar).

Update, October 15, 2026: The FDA approved Anktiva for papillary-only disease on October 14, 2026, ahead of the January 6, 2027 target date. For Anktiva’s sales, market and the obstacles to its growth, see our ImmunityBio analysis.

What Soon-Shiong bought, and what the terms tell us

Sources: PIPE 8-K, September 8, closing 8-K, September 14, Schedule 13D.

Read together, the terms give Nant a great deal of optionality for a modest outlay: a large position bought at a fraction of today’s price, a say over the design of PDS0301’s pivotal trial, and first rights to PDS’s other clinical asset. For other shareholders the deal brought cash, a credible backer and a buyer at the second closing. It also means the company’s two programs now depend heavily on one counterparty, and the second tranche will be priced at $0.22 whatever the stock does in the meantime.

Soon-Shiong’s record is relevant: he built Abraxane and sold Abraxis BioScience to Celgene in 2010, and he took Anktiva, an immunocytokine, to FDA approval at ImmunityBio (PDS 8-K, September 14, 2026). Both took years and large amounts of capital, which is exactly what PDS lacks.

Cash, dilution and the Nasdaq deadline

PDS had $5.6 million at June 30 against quarterly operating expenses of $6.5 million. The September closing added $11.3 million gross, of which about $4.6 million went to repay the Yorkville note, and the staff cut lowers the run rate. The ATM program allows up to $50 million of share sales, and with the stock near $1 it can now be used at prices several times higher than in August. Third-quarter figures, expected in mid-November, will show how much was sold. A registrational Phase 3 in oncology costs tens of millions of dollars at minimum, so the milestone tranche alone would not fund it. See how to read cash runway and how ATM programs work.

At the October 8 close of $1.02, that is a market value of about $83 to $97 million on common stock, about $107 to $121 million including the pre-funded warrants, and about $206 to $220 million fully diluted. Shares sold through the ATM since mid-September are not in these figures. The PIPE also requires PDS to register the investors’ shares for resale within 30 days of the closing; once that registration is effective, the PIPE shares become freely tradable. See how dilution works.

The Nasdaq deadline is January 26, 2027. Compliance needs a closing bid price of at least $1.00 for ten consecutive business days. The stock closed above $1.00 on October 5, 6, 7 and 8 (our data show closing prices, not bids); if that continues through mid-October, Nasdaq could confirm compliance (it may ask for a longer period). If not, the usual remedies are a second 180-day period, if PDS qualifies, or a reverse split.

What to watch

Where this could go: four scenarios

This section is analysis, not a forecast. It describes paths the filed terms make possible and what each would require. We do not assign probabilities.

1. A Nant-backed pivotal program

PDS submits a Phase 3 protocol designed with Nant, collects the $11 million second closing, and funds the trial through further Nant money, the ATM at higher prices, or a partner. This path needs the larger HAIP data set to hold up, FDA agreement on a design that can isolate PDS0301’s contribution, and funding well beyond what has been committed so far. An Anktiva combination could enter here, but nothing filed points to it.

2. Bridging on the ATM while the data mature

Without a large new investor, PDS funds itself through share sales while five readouts arrive between Q4 2026 and Q2 2028. Value then depends on those readouts, with steady dilution, and resale of PIPE shares can weigh on the price.

3. Assets move into the Nant ecosystem

NantWorks licenses PDS0101, and further transactions follow. What this means for other shareholders depends entirely on the terms, which the independent directors would have to negotiate with a counterparty that is also the largest shareholder and holds two board seats.

4. The signal fades

A larger or randomized data set does not confirm the colorectal gap, financing becomes harder, and the company returns to the Nasdaq and going-concern questions it faced in August. The record of the molecule (no responses in the urothelial expansion, one in twenty in QuICC) shows how often promising immune data in early trials have not carried over.

Bottom line

PDS Biotech is now a bet on one molecule and one investor. The colorectal results are striking on paper but rest on 9 peer-reviewed patients, 21 to 22 company-reported ones, and a nonrandomized comparison with an earlier study of a powerful liver-directed therapy, in which more of the PDS0301 patients went on to liver surgery or ablation. Soon-Shiong’s stake brought cash, credibility and a pivotal-trial plan, and also gave Nant strong rights over both of PDS’s programs on terms set when the stock was at $0.22. The IL-12 and Anktiva pairing is plausible biology but not a disclosed plan; the one trial that combined them in colorectal cancer, a four-drug regimen in heavily pretreated patients, gave little support, though it cannot speak for every IL-12 and IL-15 design. The next facts that will move the picture are the October 15 data update, the Q3 cash figure and the Phase 3 design.

Sources read October 9, 2026. Prices are BioRadar daily closes through October 8, 2026. This article is for information only and is not investment advice.

FAQ

Is PDS Biotech developing PDS0301 with ImmunityBio’s Anktiva?

No such program has been disclosed. PDS’s 2026 filings do not mention Anktiva or IL-15. The two drugs were combined once before, in the NCI’s QuICC trial in colorectal cancer, together with a vaccine and bintrafusp alfa, and that combination produced one response in 20 patients.

How much of PDS Biotech does Patrick Soon-Shiong own?

Through Nant Capital, he reported 19.9% beneficial ownership as of September 14, 2026: 13.0 million shares plus 7.3 million shares under currently exercisable warrants. Nant also holds further pre-funded and common warrants that a 19.9% ownership cap keeps from being exercised for now, and it can name two directors while it owns at least 15%.

What triggers the next $11 million for PDS Biotech?

The submission to the FDA of a registrational Phase 3 protocol for PDS0301, designed in collaboration with Nant. Nant would then buy $10 million and AB Group Ltd. $1 million of stock at $0.22 per share.

How strong is the PDS0301 colorectal cancer data?

Promising but early. The peer-reviewed interim analysis covers 9 of 13 enrolled patients, 7 of whom responded at six months, against 7 of 20 in an earlier study of the same liver-pump chemotherapy without PDS0301. The company reports 15 responses in 21 patients and about 80% two-year survival in 22. The trial is single-center and nonrandomized, more PDS0301 patients later had liver surgery or ablation, and the authors call the survival data immature.

Sources

• PDS Biotechnology: strategic refocus, August 11, 2026; Q2 2026 10-Q; PIPE 8-K, September 8, 2026; closing 8-K, September 14, 2026; corporate presentation, September 2026; Nasdaq notice 8-K, July 31, 2026; 2025 10-K; other 8-Ks of June 2, June 15, August 14, August 19, August 25, September 4, September 22 and October 6, 2026 (EDGAR index)
• Nant Capital and Patrick Soon-Shiong, Schedule 13D and Form 3, September 21, 2026
• Eade et al. Tumor-targeted IL-12 (PDS01ADC) with hepatic artery infusion pump therapy for colorectal liver metastases: interim analysis of a nonrandomized phase II trial. JCO Oncology Advances, 2026 (full text).
• Bracken-Clarke et al. The quadruple immunotherapy for colorectal cancer (QuICC) trial for mismatch repair-proficient metastatic colorectal cancer. The Oncologist, 2026.
• Strauss et al. First-in-human phase Ib trial of M9241 (NHS-IL12) plus avelumab. J Immunother Cancer, 2023.
• Weiss et al. PDS0101 with pembrolizumab in HPV16-positive recurrent/metastatic HNSCC (VERSATILE-002). JAMA Oncology, 2026.
• Floudas et al. Novel combination immunotherapy and clinical activity in patients with HPV-associated cancers. JAMA Oncology, 2025.
• Victory et al. HAIP therapy in combination with targeted delivery of IL-12: a phase II trial protocol. J Gastrointest Oncol, 2024.
• ClinicalTrials.gov: NCT05286814, NCT04491955, NCT06096870, NCT02994953
• ImmunityBio, Q2 2026 results and papillary sBLA acceptance
• BioRadar daily price data for PDSB (August 3 to October 8, 2026)

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