In re KIROMIC BIOPHARMA

 
 UNITED STATES OF AMERICA 
 Before the 
 SECURITIES AND EXCHANGE COMMISSION 
 
SECURITIES ACT OF 1933 
Release No. 11332 / December 3, 2024 
 
SECURITIES EXCHANGE ACT OF 1934 
Release No. 101797 
 
ADMINISTRATIVE PROCEEDING 
File No. 3-22337 
 
 
In the Matter of 
 
KIROMIC BIOPHARMA, 
INC., 
 
Respondent. 
 
 
 
ORDER INSTITUTING CEASE-AND-
DESIST PROCEEDINGS PURSUANT TO 
SECTION 8A OF THE SECURITIES ACT 
OF 1933 AND SECTION 21C OF THE 
SECURITIES EXCHANGE ACT OF 1934, 
MAKING FINDINGS, AND IMPOSING A 
CEASE-AND-DESIST ORDER  
   
 
I. 
 
 The Securities and Exchange Commission (“Commission” and “SEC”) deems it 
appropriate that cease-and-desist proceedings be, and hereby are, instituted pursuant to Section 8A 
of the Securities Act of 1933 (“Securities Act”) and Section 21C of the Securities Exchange Act of 
1934 (“Exchange Act”), against Kiromic BioPharma, Inc. (“Kiromic” or “Respondent”).  
 
II. 
 
 In anticipation of the institution of these proceedings, Respondent has submitted an Offer 
of Settlement (the “Offer”) which the Commission has determined to accept. Solely for the purpose 
of these proceedings and any other proceedings brought by or on behalf of the Commission, or to 
which the Commission is a party, and without admitting or denying the findings herein, except as 
to the Commission’s jurisdiction over it and the subject matter of these proceedings, which are 
admitted, Respondent consents to the entry of this Order Instituting Cease-and-Desist Proceedings 
Pursuant to Section 8A of the Securities Act of 1933 and Section 21C of the Securities Exchange 
Act of 1934, Making Findings, and Imposing a Cease-and-Desist Order (“Order”), as set forth 
below. 
 
 

 2 
III. 
 
 On the basis of this Order and Respondent’s Offer, the Commission finds
1
 that: 
 
Summary 
 
1. This matter involves violations of the federal securities laws by Kiromic BioPharma, 
Inc., a publicly traded biotherapeutics company in Houston, Texas that aims to develop and 
commercialize cell therapies that focus on immuno-oncology. Approximately two weeks before 
Kiromic raised $40 million through a public offering of company stock on July 2, 2021 (the 
“Offering”), the U.S. Food and Drug Administration (“FDA”) notified Kiromic that it had placed 
clinical holds on two Investigational New Drug (“IND”) applications that Kiromic filed in May 
2021. However, in public statements and reports filed with the Commission both before and after 
the Offering, Kiromic made materially false and misleading statements and omissions concerning 
the status of the FDA’s review of the INDs and the existence of the clinical holds. In addition, 
Kiromic and its officers made misstatements and omissions to investors on investor roadshow calls 
prior to the Offering. Kiromic’s conduct violated the antifraud and reporting provisions of the 
federal securities laws. 
 
Respondent 
 
2. Kiromic BioPharma, Inc. is a Delaware corporation formed in 2016 with its 
principal place of business in Houston, Texas. It is a clinical-stage, fully integrated biotherapeutics 
company that develops and commercializes cell therapies that focus on immuno-oncology. 
Kiromic’s stock previously traded on the Nasdaq Stock Market exchange and now trades on the 
OTCQB Venture Market under the ticker symbol “KRBP.” Kiromic’s common stock was 
previously registered under Section 12(b) of the Exchange Act and is currently registered under 
Section 12(g) of the Exchange Act. Kiromic is required to file periodic reports, including quarterly 
reports on Form 10-Q, with the Commission under Section 13(a) of the Exchange Act and related 
rules thereunder.  
 
Facts 
 
The ALEXIS INDs and FDA Clinical Holds 
 
3. At all times between May 2021 and February 2022, Kiromic was a pre-revenue 
company with no approved, commercial products for sale. In May 2021, Kiromic announced 
via press releases that it had submitted novel Investigational New Drug (“IND”) applications to 
the FDA for its cancer product candidates, ALEXIS-PRO-1 and ALEXIS-ISO-1 (collectively, 
the “ALEXIS INDs”). Other than the ALEXIS INDs, Kiromic had no other product candidates 
                                                 
1
  The findings herein are made pursuant to Respondent’s Offer of Settlement and are not 
binding on any other person or entity in this or any other proceeding.  
 

 3 
in its pipeline. In its May 2021 press releases, Kiromic stated that “FDA feedback [was] 
expected within 30 days” before the company could begin clinical trials in “Q3 2021.”   
 
4. Per FDA regulations, “[a]n IND goes into effect: Thirty days after FDA receives 
the IND, unless FDA notifies the sponsor that the investigations described in the IND are 
subject to a clinical hold . . . .” 21 C.F.R. § 312.40(b)(1). “A clinical hold is an order issued by 
FDA to the [IND] sponsor to delay a proposed clinical investigation.”  21 C.F.R. § 312.42(a). 
“The clinical hold order may be made by telephone or other means of rapid communication 
[such as email] or in writing.” 21 C.F.R. § 312.42(d). Once an IND is placed on clinical hold, 
an IND sponsor must first correct the deficiencies that the FDA cited before the agency will 
remove a clinical hold. 21 C.F.R. § 312.42(e).  
 
 The FDA imposed clinical holds on Kiromic’s ALEXIS INDs in June 2021. 
 
5. On June 16, 2021, the FDA contacted Kiromic’s then-Chief Medical Officer 
(“CMO”) via telephone to inform him that the FDA placed Kiromic’s ALEXIS-PRO-1 IND on 
clinical hold. That same day, the FDA also sent Kiromic’s CMO a confirmatory email stating 
that: Kiromic’s ALEXIS-PRO-1 had “been placed on clinical hold” because a section of the 
submission was “grossly deficient” and because the lack of information about certain factors, 
such as manufacturing and testing, prevented the FDA from assessing the risk of the product. 
The FDA also informed Kiromic in the email that a formal “clinical hold letter w[ould] be 
issued to [Kiromic] by July 16, 2021.” A formal clinical hold letter explains the FDA’s basis 
and reasoning for the hold. 
 
6. Later in the afternoon of June 16, 2021, the CMO informed Kiromic’s then-CEO, 
Maurizio Chiriva-Internati (“Chiriva”), of the FDA’s clinical hold on the ALEXIS-PRO-1. The 
CMO also forwarded to Chiriva the FDA’s June 16, 2021 clinical hold email. Chiriva reviewed 
the FDA’s June 16, 2021 email and understood that “clinical hold” meant that the FDA did not 
authorize the continuation of this IND.  
 
7. The next day, on June 17, 2021, the FDA informed the CMO via telephone that 
the FDA had similarly placed Kiromic’s second IND, the ALEXIS-ISO, on clinical hold. The 
CMO relayed to Chiriva that the FDA had placed a clinical hold on the ALEXIS-ISO IND via 
telephone that same day.  
 
8. On June 17, 2021, the CMO sent Chiriva an email recommending that Kiromic 
promptly disclose the clinical holds. In a reply email, Chiriva said that he agreed.  
 
 Chiriva updated Kiromic’s Board about the FDA communications. 
 
9. On June 18, 2021, a Kiromic Board member asked Chiriva via text message (in 
Italian): “[w]hat did the FDA say about the first IND? It’s ok, it’s not so bad, or did they raise 
issues?” Chiriva responded, “[w]e are waiting but [the FDA is] asking more information so at 
this moment we are not authorized to do anything until we will address secondary level of 
questions that will arrive by July 15.”  

 4 
 
10. The 30-day window the FDA had to review the INDs elapsed on June 16 for the 
ALEXIS PRO and June 20 for the ALEXIS ISO. 
 
11. On June 22, 2021, Chiriva convened a virtual meeting of Kiromic’s Board of 
Directors via conference call to discuss, among other things, Kiromic’s communications with 
the FDA regarding the ALEXIS INDs. The CMO, a non-Board member, and Kiromic’s legal 
counsel also attended the virtual meeting. 
 
12. Chiriva is not a native English speaker, and his messaging to the Board about the 
FDA’s communications about the status of the ALEXIS INDs was imprecise. Chiriva told the 
Board that: Kiromic had received communications from the FDA about the ALEXIS INDs; the 
FDA had requested an additional 30 days to conduct a secondary review; and the IND 
applications were on halt and administratively on hold until Kiromic received further questions 
from the FDA. While Chiriva told the Board that the CMO was involved in the meeting to give 
more specifics if there were any questions, the Board did not ask questions of Chiriva or anyone 
else on this issue, and Chiriva did not ask questions of the Board or anyone else.  
 
13. Some attendees at the meeting, including members of the Board, did not 
understand from Chiriva’s update that the FDA had already imposed clinical holds on the 
ALEXIS INDs. Rather, they understood—from Chiriva’s comments about the FDA’s 
secondary review and further questions expected in another 30 days—that the FDA was still 
reviewing the ALEXIS INDs and had not made a determination about the ALEXIS INDs. 
Chiriva did not share the June 16 email from the FDA documenting a clinical hold with key 
personnel, such as Kiromic’s then-Controller or Kiromic’s then-CFO, Tony Tontat, who were 
involved in Kiromic’s filings and statements made during the Offering. 
 
False and Misleading Statements and Omissions About the ALEXIS INDs in the Offering, 
SEC Filings, and other Public Statements 
 
14. By July 2021, Kiromic was running out of money. Without a capital infusion, 
Kiromic only had enough cash on hand for about three and a half months before the company 
would be forced to shut down. Consequently, on July 2, 2021, Kiromic raised $40 million by 
selling common stock through the Offering for the purpose of funding the company’s clinical 
trials of its ALEXIS INDs. However, Kiromic did not disclose in its SEC filings, investor 
roadshow calls, or due diligence calls that the FDA had placed the ALEXIS INDs on clinical 
hold, despite being aware of this information approximately two weeks before the Offering 
began.  
 
Kiromic made material omissions related to the FDA clinical holds in its Form S-1 and    
final prospectus. 
 
15. Kiromic filed a Form S-1 on June 25, 2021, and a final prospectus on June 30, 
2021, both of which were materially false and misleading because they discussed the clinical trial 
plan for the ALEXIS INDs and the hypothetical risk that the FDA could issue a clinical hold but 

 5 
omitted that the FDA had actually placed the ALEXIS INDs on clinical holds. This information 
was important to, among other things, the company’s projected clinical trial timeline of “third 
quarter of 2021.”   
 
16. Instead, Kiromic stated in both filings only that its “two product candidates . . . 
ALEXIS ISO-1 and ALEXIS-PRO-1 . . . are in the pre-initial new drug (‘IND’) stages of the 
[FDA] clinical trial process. We are currently going through the IND enabling trials process and 
we expect that first in human dosing in Phase I of clinical trials will commence in the third 
quarter of 2021.”  
 
17. In its risk factors in both the Form S-1 and the final prospectus, Kiromic stated: 
 
If the FDA imposes a clinical hold, trials may not recommence without FDA 
authorization and then only under terms authorized by the FDA. Accordingly, we 
cannot be sure that submission of an IND will result in the FDA allowing clinical 
trials to begin, or that, once begun, issues will not arise that suspend or terminate such 
trials. (emphasis added). 
 
18. Despite disclosing the hypothetical risk of a clinical hold and the potential negative 
consequences on Kiromic’s business, Kiromic failed to disclose the material information that the 
FDA had already issued clinical holds on the ALEXIS INDs. 
 
19. Chiriva reviewed, signed, and contributed content to the Form S-1, including 
information about the FDA clinical trials timelines. As CEO and Board Chairman, and as 
someone who knew of the FDA clinical holds, Chiriva knew or should have known that Kiromic 
omitted the FDA clinical holds before he signed Kiromic’s Form S-1.  
 
Kiromic made false and misleading statements and omissions related to the FDA 
clinical holds to prospective investors during its investor roadshow calls. 
 
20. On June 28 and 29, 2021, just days before the Offering, Kiromic’s officers 
participated in at least ten investor roadshow calls and failed to inform potential investors that the 
FDA had placed the ALEXIS INDs on clinical holds. Chiriva participated in some but not all of 
these investor roadshow calls. Tontat was primarily responsible for speaking during these calls. 
During one investor call, Tontat stated the following about the FDA’s review of Kiromic’s INDs: 
 
So the two INDs were filed on the 24th of May, and now we are at the end of June. 
The normal calendar is 30 to 60 days to get a reply back from the FDA, and they tell 
us that we are authorized to begin our first in human [trials]. So I do believe that 
within July we should be any days being able to hear back.  Our confidence in it 
going through is very high...[S]o we do believe that our chances of getting FDA 
authorization is very good.  Within this July we will hear about that. 
 
21. Chiriva attended this June 29, 2021 investor call, and he knew that the FDA had 
placed the ALEXIS INDs on clinical holds nearly two weeks earlier. Despite this knowledge, 

 6 
Chiriva did not correct the CFO’s misstatement by disclosing the clinical holds. On certain 
other investor calls on June 28 and 29, Tontat made similar false and misleading statements or 
omissions, and Chiriva did not correct Tontat’s statements by disclosing the clinical holds.  
  
Kiromic made false and misleading statements and omissions related to the FDA 
clinical holds during due diligence calls with its underwriters, lawyers, and auditors. 
 
22. In preparation for the Offering, Kiromic participated in due diligence calls with its 
underwriters, lawyers, and auditors (“external participants”), during which Kiromic did not 
disclose that the FDA had placed the INDs on clinical hold. Some due diligence questions asked 
about upcoming announcements and the timeline of the first in-human dosing for the ALEXIS 
INDs, indicating that Kiromic’s underwriters viewed the FDA’s response to Kiromic’s IND 
applications—and the effect on the clinical trials timeline—as significant information. 
 
23. For example, the underwriters were particularly interested in when Kiromic would 
receive the FDA’s authorization to begin clinical trials because this was considered a very strong 
selling point for the Offering. Kiromic’s officers, including Chiriva on at least one occasion and 
Tontat, participated in discussions in which the underwriters expressed that the clinical trials 
timeline was the most important component of the Offering.  
 
24. On June 17, 2021, one day after the FDA informed Kiromic about the clinical hold 
on the ALEXIS-PRO-1, Chiriva and Tontat participated in a “Management Due Diligence Call.” 
On behalf of Kiromic, Tontat answered questions regarding the clinical trials timeline and did not 
disclose the clinical holds. Instead, Tontat told the external participants that Kiromic was waiting 
on the FDA’s authorization to begin clinical trials. During the call, Chiriva did not correct 
Tontat’s misleading statements or omissions by disclosing the clinical holds.  
 
False and Misleading Statements Related to the Clinical-Hold Communications in 
Kiromic’s Form 10-Q 
 
The FDA’s July 13 Clinical Hold Letters. 
 
25. On July 13, 2021, Kiromic received the detailed FDA clinical-hold letters for the 
ALEXIS INDs, which explained the FDA’s reasons for issuing the June 16 and 17 clinical holds. 
Further, the letters made clear that the FDA originally communicated the clinical holds by 
telephone on June 16 and 17. That same day, Tontat reviewed the letters. The next day, Tontat 
urged Kiromic to make prompt disclosure of the clinical holds. The Kiromic Board subsequently 
discussed the letters and approved a press release. 
  
26. On July 16, 2021, Kiromic issued a press release (but not a Form 8-K) stating that 
the “FDA returned with comments” (emphasis added) regarding the INDs and that Kiromic still 
expected to meet its third quarter 2021 clinical trials timeline. Kiromic’s July 16 press release did 
not use the term “clinical hold.”  
  

 7 
27. This July 16 press release was associated with Kiromic’s stock price dropping by an 
abnormal 16.36%, eliminating roughly $9.7M in market capitalization.  
 
        Kiromic’s False and Misleading Form 10-Q. 
 
28. On August 13, 2021, Kiromic filed its Form 10-Q for the period ended June 30, 
2021, which failed to disclose that the FDA had placed the ALEXIS INDs on clinical holds. The 
Form 10-Q stated that the ALEXIS INDs “are in the pre-initial new drug (“IND”) stages of the 
[FDA] clinical trial process. We are currently going through the IND enabling trials process and 
we expect that first in human dosing in Phase I of clinical trials will commence in the first quarter 
of 2022.”   
 
29. Under the heading “Recent Developments” in the Form 10-Q, Kiromic discussed 
the submission of the INDs to the FDA in May 2021, but omitted the FDA’s June and July 
clinical-hold communications.  
 
30. As CEO and CFO, respectively, Chiriva and Tontat signed and certified Kiromic’s 
Form 10-Q, despite these false and misleading statements and omissions.  
 
31. On August 13, 2021, Kiromic issued a press release (and a Form 8-K), announcing 
that it had applied for “a Type A meeting with the FDA...[to] address the clinical hold issues 
and...discuss [a] path toward our first-in-human dosing” (emphasis added). This was Kiromic’s 
first public reference to the FDA’s “clinical hold[s]” on the ALEXIS INDs. 
 
Kiromic’s Subsequent Actions  
 
32. In August 2021, after Kiromic filed its Form 10-Q, the company received two 
complaints, via the company’s anonymous hotline, alleging risks associated with Kiromic’s 
public disclosures in its SEC filings and statements made to the public related to the anticipated 
timing of FDA authorization of Kiromic’s INDs and projected clinical trials start date.    
 
33. Thereafter, Kiromic’s Board of Directors formed a Special Committee, comprised 
only of independent directors of the Board, and engaged outside counsel to conduct an internal 
investigation into the anonymous complaints (the “Investigation”). The Investigation found that 
Kiromic had received FDA clinical-hold communications on June 16 and 17, 2021, and that 
Kiromic raised $40 million in the Offering without disclosing the June FDA clinical-hold 
communications in its Form S-1, final prospectus, or Form 10-Q for the period ended June 30, 
2021.  
 
34. Following the Investigation, the Special Committee proposed, and Kiromic’s Board 
adopted, several remedial measures to improve the effectiveness of the company’s disclosure 
controls and procedures, including: (a) appointing an interim CEO who received training on 
appropriate disclosure controls and procedures; (b) establishing a Disclosure Committee 
comprised of management; and (c) appointing two new independent directors to the Board. 

 8 
Kiromic also filed a Form 8-K in which it acknowledged that it had failed to timely disclose the 
FDA communications. The Form 8-K also stated that the company terminated Chiriva for cause.  
 
35. Kiromic also voluntarily self-reported to the SEC’s Division of Enforcement 
(“Division”) regarding its failure to disclose the FDA’s clinical-hold communications and 
cooperated with the Division’s investigation. Kiromic’s cooperation included facilitating the 
submissions of sworn declarations and testimony of foreign-based witnesses. 
 
                                                        Violations 
 
36. As a result of the conduct described above, Kiromic violated Sections 17(a)(2) and 
17(a)(3) of the Securities Act. Section 17(a)(2) prohibits any person from obtaining money or 
property in the offer or sale of a security “by means of any untrue statement of a material fact or 
any omission to state a material fact necessary in order to make the statements made, in light of 
the circumstances under which they were made, not misleading.” Section 17(a)(3) of the 
Securities Act prohibits any person from engaging “in any transaction, practice, or course of 
business which operates or would operate as a fraud or deceit upon the purchaser.”  
 
37. Also as a result of the conduct described above, Kiromic violated Section 13(a) of 
the Exchange Act and Rules 12b-20 and 13a-13 thereunder, which require every issuer of a 
security registered pursuant to Section 12 of the Exchange Act to file with the Commission 
quarterly reports containing such information as the Commission’s rules may require and such 
further material information as may be necessary to make the required statements, in light of the 
circumstances under which they were made, not misleading.  
 
38. Also as a result of the conduct described above, Kiromic violated Exchange Act 
Rule 13a-15(a), which requires every issuer with a security registered pursuant to Section 12 of 
the Exchange Act to maintain disclosure controls and procedures designed to ensure that 
information required to be disclosed by an issuer in reports it files or submits under the Exchange 
Act is recorded, processed, summarized, and reported within the time periods specified in the 
Commission’s rules and forms. 
 
Kiromic’s Cooperation and Remedial Efforts 
39. In determining to accept the Offer, the Commission considered Kiromic’s self-
report, remedial acts promptly undertaken, and cooperation afforded the Commission staff. 
IV. 
 In view of the foregoing, the Commission deems it appropriate to impose the sanctions 
agreed to in Kiromic’s Offer. 
 
 Accordingly, it is hereby ORDERED that: 
 
 A. Pursuant to Section 8A of the Securities Act and Section 21C of the Exchange Act, 
Respondent cease and desist from committing or causing any violations and any future violations of 

 9 
Sections 17(a)(2) and 17(a)(3) of the Securities Act and Section 13(a) of the Exchange Act and 
Rules 12b-20, 13a-13, and 13a-15(a) thereunder.  
 
B. Respondent acknowledges that the Commission is not imposing a civil penalty 
based upon, among other things, its cooperation in a Commission investigation and/or related 
enforcement action. If at any time following the entry of the Order, the Division obtains 
information indicating that Respondent knowingly provided materially false or misleading 
information or materials to the Commission, or in a related proceeding, the Division may, at its 
sole discretion and with prior notice to the Respondent, petition the Commission to reopen this 
matter and seek an order directing that the Respondent pay a civil money penalty. Respondent may 
contest by way of defense in any resulting administrative proceeding whether it knowingly 
provided materially false or misleading information but may not: (1) contest the findings in the 
Order; or (2) assert any defense to liability or remedy, including, but not limited to, any statute of 
limitations defense. 
 
 
 By the Commission. 
 
 
 
Vanessa A. Countryman 
        Secretary 
 
 
 

UNITED STATES OF AMERICA 

 Before the 

 SECURITIES AND EXCHANGE COMMISSION 

 

SECURITIES ACT OF 1933 

Release No. 11332 / December 3, 2024 

 

SECURITIES EXCHANGE ACT OF 1934 

Release No. 101797 

 

ADMINISTRATIVE PROCEEDING 

File No. 3-22337 

 

 

In the Matter of 

 

KIROMIC BIOPHARMA, 

INC., 

 

Respondent. 

 

 

 

ORDER INSTITUTING CEASE-AND-

DESIST PROCEEDINGS PURSUANT TO 

SECTION 8A OF THE SECURITIES ACT 

OF 1933 AND SECTION 21C OF THE 

SECURITIES EXCHANGE ACT OF 1934, 

MAKING FINDINGS, AND IMPOSING A 

CEASE-AND-DESIST ORDER  

   

 

I. 

 

 The Securities and Exchange Commission (“Commission” and “SEC”) deems it 

appropriate that cease-and-desist proceedings be, and hereby are, instituted pursuant to Section 8A 

of the Securities Act of 1933 (“Securities Act”) and Section 21C of the Securities Exchange Act of 

1934 (“Exchange Act”), against Kiromic BioPharma, Inc. (“Kiromic” or “Respondent”).  

 

II. 

 

 In anticipation of the institution of these proceedings, Respondent has submitted an Offer 

of Settlement (the “Offer”) which the Commission has determined to accept. Solely for the purpose 

of these proceedings and any other proceedings brought by or on behalf of the Commission, or to 

which the Commission is a party, and without admitting or denying the findings herein, except as 

to the Commission’s jurisdiction over it and the subject matter of these proceedings, which are 

admitted, Respondent consents to the entry of this Order Instituting Cease-and-Desist Proceedings 

Pursuant to Section 8A of the Securities Act of 1933 and Section 21C of the Securities Exchange 

Act of 1934, Making Findings, and Imposing a Cease-and-Desist Order (“Order”), as set forth 

below. 

 

 



 2 

III. 

 

 On the basis of this Order and Respondent’s Offer, the Commission finds1 that: 

 

Summary 

 

1. This matter involves violations of the federal securities laws by Kiromic BioPharma, 

Inc., a publicly traded biotherapeutics company in Houston, Texas that aims to develop and 

commercialize cell therapies that focus on immuno-oncology. Approximately two weeks before 

Kiromic raised $40 million through a public offering of company stock on July 2, 2021 (the 

“Offering”), the U.S. Food and Drug Administration (“FDA”) notified Kiromic that it had placed 

clinical holds on two Investigational New Drug (“IND”) applications that Kiromic filed in May 

2021. However, in public statements and reports filed with the Commission both before and after 

the Offering, Kiromic made materially false and misleading statements and omissions concerning 

the status of the FDA’s review of the INDs and the existence of the clinical holds. In addition, 

Kiromic and its officers made misstatements and omissions to investors on investor roadshow calls 

prior to the Offering. Kiromic’s conduct violated the antifraud and reporting provisions of the 

federal securities laws. 

 

Respondent 

 

2. Kiromic BioPharma, Inc. is a Delaware corporation formed in 2016 with its 

principal place of business in Houston, Texas. It is a clinical-stage, fully integrated biotherapeutics 

company that develops and commercializes cell therapies that focus on immuno-oncology. 

Kiromic’s stock previously traded on the Nasdaq Stock Market exchange and now trades on the 

OTCQB Venture Market under the ticker symbol “KRBP.” Kiromic’s common stock was 

previously registered under Section 12(b) of the Exchange Act and is currently registered under 

Section 12(g) of the Exchange Act. Kiromic is required to file periodic reports, including quarterly 

reports on Form 10-Q, with the Commission under Section 13(a) of the Exchange Act and related 

rules thereunder.  

 

Facts 

 

The ALEXIS INDs and FDA Clinical Holds 

 

3. At all times between May 2021 and February 2022, Kiromic was a pre-revenue 

company with no approved, commercial products for sale. In May 2021, Kiromic announced 

via press releases that it had submitted novel Investigational New Drug (“IND”) applications to 

the FDA for its cancer product candidates, ALEXIS-PRO-1 and ALEXIS-ISO-1 (collectively, 

the “ALEXIS INDs”). Other than the ALEXIS INDs, Kiromic had no other product candidates 

                                                 
1  The findings herein are made pursuant to Respondent’s Offer of Settlement and are not 

binding on any other person or entity in this or any other proceeding.  

 



 3 

in its pipeline. In its May 2021 press releases, Kiromic stated that “FDA feedback [was] 

expected within 30 days” before the company could begin clinical trials in “Q3 2021.”   

 

4. Per FDA regulations, “[a]n IND goes into effect: Thirty days after FDA receives 

the IND, unless FDA notifies the sponsor that the investigations described in the IND are 

subject to a clinical hold . . . .” 21 C.F.R. § 312.40(b)(1). “A clinical hold is an order issued by 

FDA to the [IND] sponsor to delay a proposed clinical investigation.”  21 C.F.R. § 312.42(a). 

“The clinical hold order may be made by telephone or other means of rapid communication 

[such as email] or in writing.” 21 C.F.R. § 312.42(d). Once an IND is placed on clinical hold, 

an IND sponsor must first correct the deficiencies that the FDA cited before the agency will 

remove a clinical hold. 21 C.F.R. § 312.42(e).  

 

 The FDA imposed clinical holds on Kiromic’s ALEXIS INDs in June 2021. 

 

5. On June 16, 2021, the FDA contacted Kiromic’s then-Chief Medical Officer 

(“CMO”) via telephone to inform him that the FDA placed Kiromic’s ALEXIS-PRO-1 IND on 

clinical hold. That same day, the FDA also sent Kiromic’s CMO a confirmatory email stating 

that: Kiromic’s ALEXIS-PRO-1 had “been placed on clinical hold” because a section of the 

submission was “grossly deficient” and because the lack of information about certain factors, 

such as manufacturing and testing, prevented the FDA from assessing the risk of the product. 

The FDA also informed Kiromic in the email that a formal “clinical hold letter w[ould] be 

issued to [Kiromic] by July 16, 2021.” A formal clinical hold letter explains the FDA’s basis 

and reasoning for the hold. 

 

6. Later in the afternoon of June 16, 2021, the CMO informed Kiromic’s then-CEO, 

Maurizio Chiriva-Internati (“Chiriva”), of the FDA’s clinical hold on the ALEXIS-PRO-1. The 

CMO also forwarded to Chiriva the FDA’s June 16, 2021 clinical hold email. Chiriva reviewed 

the FDA’s June 16, 2021 email and understood that “clinical hold” meant that the FDA did not 

authorize the continuation of this IND.  

 

7. The next day, on June 17, 2021, the FDA informed the CMO via telephone that 

the FDA had similarly placed Kiromic’s second IND, the ALEXIS-ISO, on clinical hold. The 

CMO relayed to Chiriva that the FDA had placed a clinical hold on the ALEXIS-ISO IND via 

telephone that same day.  

 

8. On June 17, 2021, the CMO sent Chiriva an email recommending that Kiromic 

promptly disclose the clinical holds. In a reply email, Chiriva said that he agreed.  

 

 Chiriva updated Kiromic’s Board about the FDA communications. 

 

9. On June 18, 2021, a Kiromic Board member asked Chiriva via text message (in 

Italian): “[w]hat did the FDA say about the first IND? It’s ok, it’s not so bad, or did they raise 

issues?” Chiriva responded, “[w]e are waiting but [the FDA is] asking more information so at 

this moment we are not authorized to do anything until we will address secondary level of 

questions that will arrive by July 15.”  



 4 

 

10. The 30-day window the FDA had to review the INDs elapsed on June 16 for the 

ALEXIS PRO and June 20 for the ALEXIS ISO. 

 

11. On June 22, 2021, Chiriva convened a virtual meeting of Kiromic’s Board of 

Directors via conference call to discuss, among other things, Kiromic’s communications with 

the FDA regarding the ALEXIS INDs. The CMO, a non-Board member, and Kiromic’s legal 

counsel also attended the virtual meeting. 

 

12. Chiriva is not a native English speaker, and his messaging to the Board about the 

FDA’s communications about the status of the ALEXIS INDs was imprecise. Chiriva told the 

Board that: Kiromic had received communications from the FDA about the ALEXIS INDs; the 

FDA had requested an additional 30 days to conduct a secondary review; and the IND 

applications were on halt and administratively on hold until Kiromic received further questions 

from the FDA. While Chiriva told the Board that the CMO was involved in the meeting to give 

more specifics if there were any questions, the Board did not ask questions of Chiriva or anyone 

else on this issue, and Chiriva did not ask questions of the Board or anyone else.  

 

13. Some attendees at the meeting, including members of the Board, did not 

understand from Chiriva’s update that the FDA had already imposed clinical holds on the 

ALEXIS INDs. Rather, they understood—from Chiriva’s comments about the FDA’s 

secondary review and further questions expected in another 30 days—that the FDA was still 

reviewing the ALEXIS INDs and had not made a determination about the ALEXIS INDs. 

Chiriva did not share the June 16 email from the FDA documenting a clinical hold with key 

personnel, such as Kiromic’s then-Controller or Kiromic’s then-CFO, Tony Tontat, who were 

involved in Kiromic’s filings and statements made during the Offering. 

 

False and Misleading Statements and Omissions About the ALEXIS INDs in the Offering, 

SEC Filings, and other Public Statements 

 

14. By July 2021, Kiromic was running out of money. Without a capital infusion, 

Kiromic only had enough cash on hand for about three and a half months before the company 

would be forced to shut down. Consequently, on July 2, 2021, Kiromic raised $40 million by 

selling common stock through the Offering for the purpose of funding the company’s clinical 

trials of its ALEXIS INDs. However, Kiromic did not disclose in its SEC filings, investor 

roadshow calls, or due diligence calls that the FDA had placed the ALEXIS INDs on clinical 

hold, despite being aware of this information approximately two weeks before the Offering 

began.  

 

Kiromic made material omissions related to the FDA clinical holds in its Form S-1 and    

final prospectus. 

 

15. Kiromic filed a Form S-1 on June 25, 2021, and a final prospectus on June 30, 

2021, both of which were materially false and misleading because they discussed the clinical trial 

plan for the ALEXIS INDs and the hypothetical risk that the FDA could issue a clinical hold but 



 5 

omitted that the FDA had actually placed the ALEXIS INDs on clinical holds. This information 

was important to, among other things, the company’s projected clinical trial timeline of “third 

quarter of 2021.”   

 

16. Instead, Kiromic stated in both filings only that its “two product candidates . . . 

ALEXIS ISO-1 and ALEXIS-PRO-1 . . . are in the pre-initial new drug (‘IND’) stages of the 

[FDA] clinical trial process. We are currently going through the IND enabling trials process and 

we expect that first in human dosing in Phase I of clinical trials will commence in the third 

quarter of 2021.”  

 

17. In its risk factors in both the Form S-1 and the final prospectus, Kiromic stated: 

 

If the FDA imposes a clinical hold, trials may not recommence without FDA 

authorization and then only under terms authorized by the FDA. Accordingly, we 

cannot be sure that submission of an IND will result in the FDA allowing clinical 

trials to begin, or that, once begun, issues will not arise that suspend or terminate such 

trials. (emphasis added). 

 

18. Despite disclosing the hypothetical risk of a clinical hold and the potential negative 

consequences on Kiromic’s business, Kiromic failed to disclose the material information that the 

FDA had already issued clinical holds on the ALEXIS INDs. 

 

19. Chiriva reviewed, signed, and contributed content to the Form S-1, including 

information about the FDA clinical trials timelines. As CEO and Board Chairman, and as 

someone who knew of the FDA clinical holds, Chiriva knew or should have known that Kiromic 

omitted the FDA clinical holds before he signed Kiromic’s Form S-1.  

 

Kiromic made false and misleading statements and omissions related to the FDA 

clinical holds to prospective investors during its investor roadshow calls. 

 

20. On June 28 and 29, 2021, just days before the Offering, Kiromic’s officers 

participated in at least ten investor roadshow calls and failed to inform potential investors that the 

FDA had placed the ALEXIS INDs on clinical holds. Chiriva participated in some but not all of 

these investor roadshow calls. Tontat was primarily responsible for speaking during these calls. 

During one investor call, Tontat stated the following about the FDA’s review of Kiromic’s INDs: 

 

So the two INDs were filed on the 24th of May, and now we are at the end of June. 

The normal calendar is 30 to 60 days to get a reply back from the FDA, and they tell 

us that we are authorized to begin our first in human [trials]. So I do believe that 

within July we should be any days being able to hear back.  Our confidence in it 

going through is very high…[S]o we do believe that our chances of getting FDA 

authorization is very good.  Within this July we will hear about that. 

 

21. Chiriva attended this June 29, 2021 investor call, and he knew that the FDA had 

placed the ALEXIS INDs on clinical holds nearly two weeks earlier. Despite this knowledge, 



 6 

Chiriva did not correct the CFO’s misstatement by disclosing the clinical holds. On certain 

other investor calls on June 28 and 29, Tontat made similar false and misleading statements or 

omissions, and Chiriva did not correct Tontat’s statements by disclosing the clinical holds.  

  

Kiromic made false and misleading statements and omissions related to the FDA 

clinical holds during due diligence calls with its underwriters, lawyers, and auditors. 

 

22. In preparation for the Offering, Kiromic participated in due diligence calls with its 

underwriters, lawyers, and auditors (“external participants”), during which Kiromic did not 

disclose that the FDA had placed the INDs on clinical hold. Some due diligence questions asked 

about upcoming announcements and the timeline of the first in-human dosing for the ALEXIS 

INDs, indicating that Kiromic’s underwriters viewed the FDA’s response to Kiromic’s IND 

applications—and the effect on the clinical trials timeline—as significant information. 

 

23. For example, the underwriters were particularly interested in when Kiromic would 

receive the FDA’s authorization to begin clinical trials because this was considered a very strong 

selling point for the Offering. Kiromic’s officers, including Chiriva on at least one occasion and 

Tontat, participated in discussions in which the underwriters expressed that the clinical trials 

timeline was the most important component of the Offering.  

 

24. On June 17, 2021, one day after the FDA informed Kiromic about the clinical hold 

on the ALEXIS-PRO-1, Chiriva and Tontat participated in a “Management Due Diligence Call.” 

On behalf of Kiromic, Tontat answered questions regarding the clinical trials timeline and did not 

disclose the clinical holds. Instead, Tontat told the external participants that Kiromic was waiting 

on the FDA’s authorization to begin clinical trials. During the call, Chiriva did not correct 

Tontat’s misleading statements or omissions by disclosing the clinical holds.  

 

False and Misleading Statements Related to the Clinical-Hold Communications in 

Kiromic’s Form 10-Q 

 

The FDA’s July 13 Clinical Hold Letters. 

 

25. On July 13, 2021, Kiromic received the detailed FDA clinical-hold letters for the 

ALEXIS INDs, which explained the FDA’s reasons for issuing the June 16 and 17 clinical holds. 

Further, the letters made clear that the FDA originally communicated the clinical holds by 

telephone on June 16 and 17. That same day, Tontat reviewed the letters. The next day, Tontat 

urged Kiromic to make prompt disclosure of the clinical holds. The Kiromic Board subsequently 

discussed the letters and approved a press release. 

  

26. On July 16, 2021, Kiromic issued a press release (but not a Form 8-K) stating that 

the “FDA returned with comments” (emphasis added) regarding the INDs and that Kiromic still 

expected to meet its third quarter 2021 clinical trials timeline. Kiromic’s July 16 press release did 

not use the term “clinical hold.”  

  



 7 

27. This July 16 press release was associated with Kiromic’s stock price dropping by an 

abnormal 16.36%, eliminating roughly $9.7M in market capitalization.  

 

        Kiromic’s False and Misleading Form 10-Q. 

 

28. On August 13, 2021, Kiromic filed its Form 10-Q for the period ended June 30, 

2021, which failed to disclose that the FDA had placed the ALEXIS INDs on clinical holds. The 

Form 10-Q stated that the ALEXIS INDs “are in the pre-initial new drug (“IND”) stages of the 

[FDA] clinical trial process. We are currently going through the IND enabling trials process and 

we expect that first in human dosing in Phase I of clinical trials will commence in the first quarter 

of 2022.”   

 

29. Under the heading “Recent Developments” in the Form 10-Q, Kiromic discussed 

the submission of the INDs to the FDA in May 2021, but omitted the FDA’s June and July 

clinical-hold communications.  

 

30. As CEO and CFO, respectively, Chiriva and Tontat signed and certified Kiromic’s 

Form 10-Q, despite these false and misleading statements and omissions.  

 

31. On August 13, 2021, Kiromic issued a press release (and a Form 8-K), announcing 

that it had applied for “a Type A meeting with the FDA…[to] address the clinical hold issues 

and…discuss [a] path toward our first-in-human dosing” (emphasis added). This was Kiromic’s 

first public reference to the FDA’s “clinical hold[s]” on the ALEXIS INDs. 

 

Kiromic’s Subsequent Actions  

 

32. In August 2021, after Kiromic filed its Form 10-Q, the company received two 

complaints, via the company’s anonymous hotline, alleging risks associated with Kiromic’s 

public disclosures in its SEC filings and statements made to the public related to the anticipated 

timing of FDA authorization of Kiromic’s INDs and projected clinical trials start date.    

 

33. Thereafter, Kiromic’s Board of Directors formed a Special Committee, comprised 

only of independent directors of the Board, and engaged outside counsel to conduct an internal 

investigation into the anonymous complaints (the “Investigation”). The Investigation found that 

Kiromic had received FDA clinical-hold communications on June 16 and 17, 2021, and that 

Kiromic raised $40 million in the Offering without disclosing the June FDA clinical-hold 

communications in its Form S-1, final prospectus, or Form 10-Q for the period ended June 30, 

2021.  

 

34. Following the Investigation, the Special Committee proposed, and Kiromic’s Board 

adopted, several remedial measures to improve the effectiveness of the company’s disclosure 

controls and procedures, including: (a) appointing an interim CEO who received training on 

appropriate disclosure controls and procedures; (b) establishing a Disclosure Committee 

comprised of management; and (c) appointing two new independent directors to the Board. 



 8 

Kiromic also filed a Form 8-K in which it acknowledged that it had failed to timely disclose the 

FDA communications. The Form 8-K also stated that the company terminated Chiriva for cause.  

 

35. Kiromic also voluntarily self-reported to the SEC’s Division of Enforcement 

(“Division”) regarding its failure to disclose the FDA’s clinical-hold communications and 

cooperated with the Division’s investigation. Kiromic’s cooperation included facilitating the 

submissions of sworn declarations and testimony of foreign-based witnesses. 

 

                                                        Violations 

 

36. As a result of the conduct described above, Kiromic violated Sections 17(a)(2) and 

17(a)(3) of the Securities Act. Section 17(a)(2) prohibits any person from obtaining money or 

property in the offer or sale of a security “by means of any untrue statement of a material fact or 

any omission to state a material fact necessary in order to make the statements made, in light of 

the circumstances under which they were made, not misleading.” Section 17(a)(3) of the 

Securities Act prohibits any person from engaging “in any transaction, practice, or course of 

business which operates or would operate as a fraud or deceit upon the purchaser.”  

 

37. Also as a result of the conduct described above, Kiromic violated Section 13(a) of 

the Exchange Act and Rules 12b-20 and 13a-13 thereunder, which require every issuer of a 

security registered pursuant to Section 12 of the Exchange Act to file with the Commission 

quarterly reports containing such information as the Commission’s rules may require and such 

further material information as may be necessary to make the required statements, in light of the 

circumstances under which they were made, not misleading.  

 

38. Also as a result of the conduct described above, Kiromic violated Exchange Act 

Rule 13a-15(a), which requires every issuer with a security registered pursuant to Section 12 of 

the Exchange Act to maintain disclosure controls and procedures designed to ensure that 

information required to be disclosed by an issuer in reports it files or submits under the Exchange 

Act is recorded, processed, summarized, and reported within the time periods specified in the 

Commission’s rules and forms. 

 

Kiromic’s Cooperation and Remedial Efforts 

39. In determining to accept the Offer, the Commission considered Kiromic’s self-

report, remedial acts promptly undertaken, and cooperation afforded the Commission staff. 

IV. 

 In view of the foregoing, the Commission deems it appropriate to impose the sanctions 

agreed to in Kiromic’s Offer. 

 

 Accordingly, it is hereby ORDERED that: 

 

 A. Pursuant to Section 8A of the Securities Act and Section 21C of the Exchange Act, 

Respondent cease and desist from committing or causing any violations and any future violations of 



 9 

Sections 17(a)(2) and 17(a)(3) of the Securities Act and Section 13(a) of the Exchange Act and 

Rules 12b-20, 13a-13, and 13a-15(a) thereunder.  

 

B. Respondent acknowledges that the Commission is not imposing a civil penalty 

based upon, among other things, its cooperation in a Commission investigation and/or related 

enforcement action. If at any time following the entry of the Order, the Division obtains 

information indicating that Respondent knowingly provided materially false or misleading 

information or materials to the Commission, or in a related proceeding, the Division may, at its 

sole discretion and with prior notice to the Respondent, petition the Commission to reopen this 

matter and seek an order directing that the Respondent pay a civil money penalty. Respondent may 

contest by way of defense in any resulting administrative proceeding whether it knowingly 

provided materially false or misleading information but may not: (1) contest the findings in the 

Order; or (2) assert any defense to liability or remedy, including, but not limited to, any statute of 

limitations defense. 

 

 

 By the Commission. 

 

 

 

Vanessa A. Countryman 

        Secretary 

 

 

 


	UNITED STATES OF AMERICA
	Respondent
	Facts